diff --git a/citations.tsv b/citations.tsv
index f885d73c2..074a1986c 100644
--- a/citations.tsv
+++ b/citations.tsv
@@ -1119,8 +1119,8 @@ doi:10.1016/j.vaccine.2017.11.003	doi:10.1016/j.vaccine.2017.11.003	doi:10.1016/
 doi:10.1016/j.virol.2015.03.032	doi:10.1016/j.virol.2015.03.032	doi:10.1016/j.virol.2015.03.032	kC2tx3JC
 doi:10.3389/fimmu.2019.00594	doi:10.3389/fimmu.2019.00594	doi:10.3389/fimmu.2019.00594	K0Ltu31S
 doi:10/dn299p	doi:10/dn299p	doi:10.1016/s0065-2660(05)54011-2	U9ZIZWkB
-doi:10.1038/s41586-020-3035-9	doi:10.1038/s41586-020-3035-9	doi:10.1038/s41586-020-3035-9	4RuaSyLg
 doi:10.1128/9781555818951	doi:10.1128/9781555818951	doi:10.1128/9781555818951	iX8wXLPW
+doi:10.1038/s41586-020-3035-9	doi:10.1038/s41586-020-3035-9	doi:10.1038/s41586-020-3035-9	4RuaSyLg
 doi:10.1016/B978-0-323-35761-6.00002-X	doi:10.1016/B978-0-323-35761-6.00002-X	doi:10.1016/b978-0-323-35761-6.00002-x	wZ2tXSUH
 doi:10.3389/fimmu.2020.602256	doi:10.3389/fimmu.2020.602256	doi:10.3389/fimmu.2020.602256	7RHpaAHu
 url:https://www.hhs.gov/immunization/basics/types/index.html	url:https://www.hhs.gov/immunization/basics/types/index.html	url:https://www.hhs.gov/immunization/basics/types/index.html	zLL2yOJK
@@ -1132,6 +1132,7 @@ clinicaltrials:NCT04619628	clinicaltrials:NCT04619628	clinicaltrials:NCT04619628
 pmc:PMC8644885	pmc:PMC8644885	pmc:PMC8644885	2VWtlcwJ
 doi:10.3389/fmicb.2019.02881	doi:10.3389/fmicb.2019.02881	doi:10.3389/fmicb.2019.02881	14GSJSuHC
 clinicaltrials:NCT04798001	clinicaltrials:NCT04798001	clinicaltrials:NCT04798001	8ZMg94iW
+url:https://greenelab.github.io/covid19-review	url:https://greenelab.github.io/covid19-review	url:https://greenelab.github.io/covid19-review	yTsmmAYC
 doi:10.1038/s41577-020-0337-y	doi:10.1038/s41577-020-0337-y	doi:10.1038/s41577-020-0337-y	1CJtdlM6d
 doi:10.1093/cid/ciac182	doi:10.1093/cid/ciac182	doi:10.1093/cid/ciac182	eHrzWQ6D
 clinicaltrials:NCT04327206	clinicaltrials:NCT04327206	clinicaltrials:NCT04327206	9m3rP633
@@ -1150,29 +1151,29 @@ doi:10.1038/s41579-020-00462-y	doi:10.1038/s41579-020-00462-y	doi:10.1038/s41579
 doi:10.1021/acsinfecdis.6b00006	doi:10.1021/acsinfecdis.6b00006	doi:10.1021/acsinfecdis.6b00006	ZXAfLbxM
 doi:10.1080/21645515.2016.1177688	doi:10.1080/21645515.2016.1177688	doi:10.1080/21645515.2016.1177688	ihrfEtMq
 doi:10.1128/mBio.00554-20	doi:10.1128/mBio.00554-20	doi:10.1128/mbio.00554-20	8qw9OBKX
-doi:10.5281/zenodo.5573592	doi:10.5281/zenodo.5573592	doi:10.5281/zenodo.5573592	iGEyNO42
 url:https://covid19.trackvaccines.org/types-of-vaccines	url:https://covid19.trackvaccines.org/types-of-vaccines	url:https://covid19.trackvaccines.org/types-of-vaccines	jswAyWIs
+doi:10.5281/zenodo.5573592	doi:10.5281/zenodo.5573592	doi:10.5281/zenodo.5573592	iGEyNO42
 doi:10/fx8z	doi:10/fx8z	doi:10.1016/s1473-3099(20)30987-7	Ozya5HP5
 doi:10.1126/science.abc1932	doi:10.1126/science.abc1932	doi:10.1126/science.abc1932	14fILrRWg
 doi:10/fpcx	doi:10/fpcx	doi:10.1016/s1473-3099(20)30843-4	N1txjPtt
 url:https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-Sinovac-CoronaVac-background-2021.1	url:https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-Sinovac-CoronaVac-background-2021.1	url:https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-Sinovac-CoronaVac-background-2021.1	1A5wiKQAW
 doi:10/gk898z	doi:10/gk898z	doi:10.1016/s0140-6736(21)01429-x	1FF7JOwSH
 doi:10.1101/2021.03.31.21254494	doi:10.1101/2021.03.31.21254494	doi:10.1101/2021.03.31.21254494	UERG6dAd
+url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR	url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR	url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR	18mREgqUz
+url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html	url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html	url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html	V7MXd4X4
+doi:10.1056/NEJMoa2107715	doi:10.1056/NEJMoa2107715	doi:10.1056/nejmoa2107715	q2wQJULu
 url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html	url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html	url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html	wByD9WaX
 doi:10.1038/s41541-021-00292-w	doi:10.1038/s41541-021-00292-w	doi:10.1038/s41541-021-00292-w	miMRIMwa
 doi:10.1016/j.cell.2020.06.008	doi:10.1016/j.cell.2020.06.008	doi:10.1016/j.cell.2020.06.008	VlnLw2HV
 doi:10.1001/jama.2020.15543	doi:10.1001/jama.2020.15543	doi:10.1001/jama.2020.15543	T3MYavsH
 doi:10/ghjkrf	doi:10/ghjkrf	doi:10.1016/s1473-3099(20)30831-8	fPGgVKYL
 doi:10.1001/jama.2021.8565	doi:10.1001/jama.2021.8565	doi:10.1001/jama.2021.8565	yN5KOfvE
-doi:10/gmns9m	doi:10/gmns9m	doi:10.1101/2021.06.30.21259439	n7BupOQ6
 url:https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2940CA	url:https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2940CA	url:https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2940CA	w7gO6yGn
 doi:10.21203/rs.3.rs-76768/v1	doi:10.21203/rs.3.rs-76768/v1	doi:10.21203/rs.3.rs-76768/v1	bcGxW9fA
 doi:10.1038/s41467-021-21639-w	doi:10.1038/s41467-021-21639-w	doi:10.1038/s41467-021-21639-w	GgdjKrYi
 doi:10/gkrthh	doi:10/gkrthh	doi:10.1016/s1473-3099(20)30942-7	CGuGeB7m
 doi:10/gh7597	doi:10/gh7597	doi:10.1016/s1473-3099(21)00070-0	GxQSMH5l
-url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR	url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR	url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR	18mREgqUz
-url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html	url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html	url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html	V7MXd4X4
-doi:10.1056/NEJMoa2107715	doi:10.1056/NEJMoa2107715	doi:10.1056/nejmoa2107715	q2wQJULu
+doi:10/gmns9m	doi:10/gmns9m	doi:10.1101/2021.06.30.21259439	n7BupOQ6
 url:https://covid19.trackvaccines.org/vaccines/9	url:https://covid19.trackvaccines.org/vaccines/9	url:https://covid19.trackvaccines.org/vaccines/9	19tYVbg8H
 url:https://www.nytimes.com/interactive/2020/health/sinovac-covid-19-vaccine.html	url:https://www.nytimes.com/interactive/2020/health/sinovac-covid-19-vaccine.html	url:https://www.nytimes.com/interactive/2020/health/sinovac-covid-19-vaccine.html	aq22z8M7
 url:https://www.nytimes.com/live/2020/12/16/world/covid-19-coronavirus	url:https://www.nytimes.com/live/2020/12/16/world/covid-19-coronavirus	url:https://www.nytimes.com/live/2020/12/16/world/covid-19-coronavirus	d09adg1G
@@ -1201,11 +1202,11 @@ url:https://clinicaltrials.gov/ct2/show/NCT04992182	url:https://clinicaltrials.g
 doi:10.1038/s41591-021-01677-z	doi:10.1038/s41591-021-01677-z	doi:10.1038/s41591-021-01677-z	hcnFsRig
 doi:10.1038/s41591-022-01705-6	doi:10.1038/s41591-022-01705-6	doi:10.1038/s41591-022-01705-6	1Cd41ucny
 doi:10.1073/pnas.1402981111	doi:10.1073/pnas.1402981111	doi:10.1073/pnas.1402981111	dggZoRQD
-doi:10.1007/978-1-4615-1823-5	doi:10.1007/978-1-4615-1823-5	doi:10.1007/978-1-4615-1823-5	12eGVhH5I
-doi:10/dg35hw	doi:10/dg35hw	doi:10.1016/s0966-842x(03)00208-7	lH2HMMZi
 doi:10.1007/978-1-4939-1417-3_9	doi:10.1007/978-1-4939-1417-3_9	doi:10.1007/978-1-4939-1417-3_9	99C1xJ2E
+doi:10/dg35hw	doi:10/dg35hw	doi:10.1016/s0966-842x(03)00208-7	lH2HMMZi
 doi:10.1186/s12951-021-00806-7	doi:10.1186/s12951-021-00806-7	doi:10.1186/s12951-021-00806-7	1Bxg7Wj6w
 doi:10.1016/j.addr.2021.01.001	doi:10.1016/j.addr.2021.01.001	doi:10.1016/j.addr.2021.01.001	1FfwyYaj7
+doi:10.1007/978-1-4615-1823-5	doi:10.1007/978-1-4615-1823-5	doi:10.1007/978-1-4615-1823-5	12eGVhH5I
 doi:10.3390/vaccines2030515	doi:10.3390/vaccines2030515	doi:10.3390/vaccines2030515	124bnGvPp
 doi:10.1517/14712598.2011.573624	doi:10.1517/14712598.2011.573624	doi:10.1517/14712598.2011.573624	mv42t1HV
 doi:10.1016/j.vaccine.2019.04.055	doi:10.1016/j.vaccine.2019.04.055	doi:10.1016/j.vaccine.2019.04.055	rioTBsLc
@@ -1248,7 +1249,6 @@ doi:10.1056/NEJMoa2026920	doi:10.1056/NEJMoa2026920	doi:10.1056/nejmoa2026920	dM
 doi:10.1056/nejmoa2107659	doi:10.1056/nejmoa2107659	doi:10.1056/nejmoa2107659	1D0f8OrG8
 doi:10.1056/NEJMoa2107659	doi:10.1056/NEJMoa2107659	doi:10.1056/nejmoa2107659	1D0f8OrG8
 doi:10.1101/2021.10.05.21264567	doi:10.1101/2021.10.05.21264567	doi:10.1101/2021.10.05.21264567	oc5SBo0q
-url:https://ir.novavax.com/Novavax-Statement-on-UK-and-Mexico-Phase-3-Clinical-Trial-Participants-Considered-Fully-Vaccinated-in-the-US	url:https://ir.novavax.com/Novavax-Statement-on-UK-and-Mexico-Phase-3-Clinical-Trial-Participants-Considered-Fully-Vaccinated-in-the-US	url:https://ir.novavax.com/Novavax-Statement-on-UK-and-Mexico-Phase-3-Clinical-Trial-Participants-Considered-Fully-Vaccinated-in-the-US	1COb5Edqu
 url:https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra	url:https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra	url:https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra	q3wIcP4d
 url:https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu	url:https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu	url:https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu	P3YhxRob
 url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted	url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted	url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted	x9xXbzuY
@@ -1291,6 +1291,63 @@ doi:10.3201/eid1107.050219	doi:10.3201/eid1107.050219	doi:10.3201/eid1107.050219
 doi:10.1038/nrmicro3143	doi:10.1038/nrmicro3143	doi:10.1038/nrmicro3143	AOGjkjCq
 doi:10.1056/nejmp2005630	doi:10.1056/nejmp2005630	doi:10.1056/nejmp2005630	HyYY2agc
 doi:10.1080/21645515.2017.1358325	doi:10.1080/21645515.2017.1358325	doi:10.1080/21645515.2017.1358325	138O0v19T
+doi:10.3389/fimmu.2020.585354	doi:10.3389/fimmu.2020.585354	doi:10.3389/fimmu.2020.585354	RGPoDfHS
+doi:10.1016/j.vaccine.2012.03.010	doi:10.1016/j.vaccine.2012.03.010	doi:10.1016/j.vaccine.2012.03.010	1GUVvcQjL
+doi:10.1186/s13063-020-04775-4	doi:10.1186/s13063-020-04775-4	doi:10.1186/s13063-020-04775-4	KewHbkLZ
+doi:10.2139/ssrn.3822780	doi:10.2139/ssrn.3822780	doi:10.2139/ssrn.3822780	F1lYwPSY
+url:https://covid19.trackvaccines.org/vaccines/7	url:https://covid19.trackvaccines.org/vaccines/7	url:https://covid19.trackvaccines.org/vaccines/7	19z4gdhDS
+doi:10.1038/s41591-021-01469-5	doi:10.1038/s41591-021-01469-5	doi:10.1038/s41591-021-01469-5	8vzglCry
+doi:10/gn93	doi:10/gn93	doi:10.1016/s1473-3099(21)00319-4	6EYqf6s7
+url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf	url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf	url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf	Ks3L7qHG
+url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf	url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf	url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf	DaDKZXdu
+url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm	url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm	url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm	13yEnvOyP
+url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html	url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html	url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html	UU0pj3ii
+url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms	url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms	url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms	3Q7kvwO3
+url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23	url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23	url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23	AeulXXFm
+doi:10.1007/s12026-018-8991-x	doi:10.1007/s12026-018-8991-x	doi:10.1007/s12026-018-8991-x	1F52Wz7mx
+doi:10.1016/j.vaccine.2013.01.039	doi:10.1016/j.vaccine.2013.01.039	doi:10.1016/j.vaccine.2013.01.039	scwOT7dw
+doi:10.1016/j.vaccine.2009.09.044	doi:10.1016/j.vaccine.2009.09.044	doi:10.1016/j.vaccine.2009.09.044	aD5iMC0Q
+doi:10.1111/j.1750-2659.2011.00256.x	doi:10.1111/j.1750-2659.2011.00256.x	doi:10.1111/j.1750-2659.2011.00256.x	twmXSpc9
+doi:10.1016/j.vaccine.2011.08.042	doi:10.1016/j.vaccine.2011.08.042	doi:10.1016/j.vaccine.2011.08.042	jVCL0201
+clinicaltrials:NCT04368988	clinicaltrials:NCT04368988	clinicaltrials:NCT04368988	Nq0cimEs
+doi:10.1371/journal.pmed.1003769	doi:10.1371/journal.pmed.1003769	doi:10.1371/journal.pmed.1003769	ynvQwwo9
+url:https://ir.novavax.com/2021-01-28-Novavax-COVID-19-Vaccine-Demonstrates-89-3-Efficacy-in-UK-Phase-3-Trial	url:https://ir.novavax.com/2021-01-28-Novavax-COVID-19-Vaccine-Demonstrates-89-3-Efficacy-in-UK-Phase-3-Trial	url:https://ir.novavax.com/2021-01-28-Novavax-COVID-19-Vaccine-Demonstrates-89-3-Efficacy-in-UK-Phase-3-Trial	1EWB3hKG
+url:https://ir.novavax.com/2021-06-14-Novavax-COVID-19-Vaccine-Demonstrates-90-Overall-Efficacy-and-100-Protection-Against-Moderate-and-Severe-Disease-in-PREVENT-19-Phase-3-Trial	url:https://ir.novavax.com/2021-06-14-Novavax-COVID-19-Vaccine-Demonstrates-90-Overall-Efficacy-and-100-Protection-Against-Moderate-and-Severe-Disease-in-PREVENT-19-Phase-3-Trial	url:https://ir.novavax.com/2021-06-14-Novavax-COVID-19-Vaccine-Demonstrates-90-Overall-Efficacy-and-100-Protection-Against-Moderate-and-Severe-Disease-in-PREVENT-19-Phase-3-Trial	16iOtJ1vE
+doi:10.1056/NEJMoa2116185	doi:10.1056/NEJMoa2116185	doi:10.1056/nejmoa2116185	IQOyFnfl
+doi:10.1101/2021.06.09.21258556	doi:10.1101/2021.06.09.21258556	doi:10.1101/2021.06.09.21258556	IUekaKY0
+url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza	url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza	url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza	rclKBvtk
+doi:10.1101/2021.05.05.442782	doi:10.1101/2021.05.05.442782	doi:10.1101/2021.05.05.442782	bOwPRh6q
+10.3389/fimmu.2020.602256	10.3389/fimmu.2020.602256	doi:10.3389/fimmu.2020.602256	7RHpaAHu
+doi:10.1038/nature12005	doi:10.1038/nature12005	doi:10.1038/nature12005	yoFGwkUO
+doi:10.1038/nature12328	doi:10.1038/nature12328	doi:10.1038/nature12328	KZFnwRIN
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+url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581	url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581	url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581	I9Ha5JL3
+url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI	url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI	url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI	e8pnj0O3
+url:https://www.bharatbiotech.com/intranasal-vaccine.html	url:https://www.bharatbiotech.com/intranasal-vaccine.html	url:https://www.bharatbiotech.com/intranasal-vaccine.html	P9mD7Gc9
+url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html	url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html	url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html	gdTtuj5e
+doi:10.1001/jama.2021.1961	doi:10.1001/jama.2021.1961	doi:10.1001/jama.2021.1961	1Bgnim0gX
+url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30	url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30	url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30	V2Gz2O9G
+url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594	url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594	url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594	XJmfG8HD
+url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560	url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560	url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560	12zVLzkpB
 doi:10.3390/v10120680	doi:10.3390/v10120680	doi:10.3390/v10120680	181QWa7HL
 doi:10.1056/NEJMp2005630	doi:10.1056/NEJMp2005630	doi:10.1056/nejmp2005630	HyYY2agc
 doi:10.1126/science.345.6203.1441	doi:10.1126/science.345.6203.1441	doi:10.1126/science.345.6203.1441	vTrIB9zS
@@ -1299,6 +1356,8 @@ url:https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19	u
 doi:10.1038/d41573-020-00073-5	doi:10.1038/d41573-020-00073-5	doi:10.1038/d41573-020-00073-5	1GA95MF2m
 doi:10/fmq2	doi:10/fmq2	doi:10.1016/s0140-6736(20)32661-1	Vnbw9o3T
 doi:10.3389/fimmu.2020.576622	doi:10.3389/fimmu.2020.576622	doi:10.3389/fimmu.2020.576622	13wCBLnnu
+url:https://biorender.com	url:https://biorender.com	url:https://biorender.com	14FBejgLM
+url:https://app.biorender.com/biorender-templates/figures/all/t-5f21e90283765600b08fbe9d-human-coronavirus-structure	url:https://app.biorender.com/biorender-templates/figures/all/t-5f21e90283765600b08fbe9d-human-coronavirus-structure	url:https://app.biorender.com/biorender-templates/figures/all/t-5f21e90283765600b08fbe9d-human-coronavirus-structure	EAzPxBbg
 url:https://www.niaid.nih.gov/news-events/novel-coronavirus-sarscov2-images	url:https://www.niaid.nih.gov/news-events/novel-coronavirus-sarscov2-images	url:https://www.niaid.nih.gov/news-events/novel-coronavirus-sarscov2-images	Jzj97hJh
 doi:10.1016/j.lfs.2020.118056	doi:10.1016/j.lfs.2020.118056	doi:10.1016/j.lfs.2020.118056	R7Xdh5nH
 doi:10.1038/nature17200	doi:10.1038/nature17200	doi:10.1038/nature17200	3uddYea8
@@ -1420,6 +1479,7 @@ doi:10.1177/1076029620938149	doi:10.1177/1076029620938149	doi:10.1177/1076029620
 doi:10.1016/j.nantod.2019.100766	doi:10.1016/j.nantod.2019.100766	doi:10.1016/j.nantod.2019.100766	D7ou3S22
 doi:10.4161/rna.22269	doi:10.4161/rna.22269	doi:10.4161/rna.22269	2YZ70C2y
 doi:10.1038/nrd.2017.243	doi:10.1038/nrd.2017.243	doi:10.1038/nrd.2017.243	ENBWnhAh
+doi:10.1056/NEJMcibr2111445	doi:10.1056/NEJMcibr2111445	doi:10.1056/nejmcibr2111445	vh2AH9sg
 doi:10.1002/eji.1830230749	doi:10.1002/eji.1830230749	doi:10.1002/eji.1830230749	HCImhzy8
 doi:10.4155/tde-2016-0006	doi:10.4155/tde-2016-0006	doi:10.4155/tde-2016-0006	zNKWlCwE
 doi:10.1080/14760584.2017.1355245	doi:10.1080/14760584.2017.1355245	doi:10.1080/14760584.2017.1355245	pRoqjur8
@@ -1434,6 +1494,7 @@ doi:10.1016/j.immuni.2020.05.002	doi:10.1016/j.immuni.2020.05.002	doi:10.1016/j.
 doi:10.1101/cshperspect.a014035	doi:10.1101/cshperspect.a014035	doi:10.1101/cshperspect.a014035	1CsCQi9wT
 url:https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-data-ongoing-0	url:https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-data-ongoing-0	url:https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-data-ongoing-0	10VyxCgQU
 clinicaltrials:NCT04283461	clinicaltrials:NCT04283461	clinicaltrials:NCT04283461	Biu1CQeQ
+doi:10.3389/fphar.2020.00937	doi:10.3389/fphar.2020.00937	doi:10.3389/fphar.2020.00937	suRY1e0N
 doi:10.1056/NEJMoa2035389	doi:10.1056/NEJMoa2035389	doi:10.1056/nejmoa2035389	ZYxoabEm
 url:https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19	url:https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19	url:https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19	cAaN4Te0
 url:https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm	url:https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm	url:https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e1.htm	13Ou1UUAd
@@ -1489,7 +1550,6 @@ doi:10.15585/mmwr.mm7038e1	doi:10.15585/mmwr.mm7038e1	doi:10.15585/mmwr.mm7038e1
 url:https://www.nytimes.com/2021/08/02/world/europe/covax-covid-vaccine-problems-africa.html	url:https://www.nytimes.com/2021/08/02/world/europe/covax-covid-vaccine-problems-africa.html	url:https://www.nytimes.com/2021/08/02/world/europe/covax-covid-vaccine-problems-africa.html	17V4Lh5uy
 doi:10.1038/d41587-021-00001-x	doi:10.1038/d41587-021-00001-x	doi:10.1038/d41587-021-00001-x	4eOROyon
 doi:10.1056/NEJMe2204695	doi:10.1056/NEJMe2204695	doi:10.1056/nejme2204695	hOkTKQ6z
-doi:10.3389/fphar.2020.00937	doi:10.3389/fphar.2020.00937	doi:10.3389/fphar.2020.00937	suRY1e0N
 url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children	url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children	url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children	Ude2jR1F
 doi:10.1056/NEJMoa2022483	doi:10.1056/NEJMoa2022483	doi:10.1056/nejmoa2022483	wiGjCZC8
 url:https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy	url:https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy	url:https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy	IMmoqofb
@@ -1508,7 +1568,6 @@ doi:10.1136/bmj.m4714	doi:10.1136/bmj.m4714	doi:10.1136/bmj.m4714	31rsgfCB
 url:https://www.bbc.com/news/uk-55227325	url:https://www.bbc.com/news/uk-55227325	url:https://www.bbc.com/news/uk-55227325	fhw7l8VO
 doi:10.1101/2021.03.01.21252652	doi:10.1101/2021.03.01.21252652	doi:10.1101/2021.03.01.21252652	eV6UplSu
 doi:10/ghs3sn	doi:10/ghs3sn	doi:10.1016/s1473-3099(20)30709-x	SxiGicKs
-doi:10/ghpghz	doi:10/ghpghz	doi:10.1016/s0140-6736(20)32623-4	LZ8AtMnD
 doi:10.3390/v13010054	doi:10.3390/v13010054	doi:10.3390/v13010054	3KBugyZN
 doi:10.1136/bmj.n309	doi:10.1136/bmj.n309	doi:10.1136/bmj.n309	wCTVieA3
 url:https://abcnews.go.com/Health/wireStory/russia-cuts-size-covid-19-vaccine-study-stops-74885458	url:https://abcnews.go.com/Health/wireStory/russia-cuts-size-covid-19-vaccine-study-stops-74885458	url:https://abcnews.go.com/Health/wireStory/russia-cuts-size-covid-19-vaccine-study-stops-74885458	15qYogj0H
@@ -1544,7 +1603,6 @@ url:https://covid.cdc.gov/covid-data-tracker/#vaccinations	url:https://covid.cdc
 url:https://www.cnn.com/2021/03/02/politics/biden-merck-johnson--johnson-vaccine/index.html	url:https://www.cnn.com/2021/03/02/politics/biden-merck-johnson--johnson-vaccine/index.html	url:https://www.cnn.com/2021/03/02/politics/biden-merck-johnson--johnson-vaccine/index.html	ZkZ6ToLh
 url:https://www.bbc.com/news/world-us-canada-55721437	url:https://www.bbc.com/news/world-us-canada-55721437	url:https://www.bbc.com/news/world-us-canada-55721437	13bndHWdk
 url:https://ssrn.com/abstract=3770368	url:https://ssrn.com/abstract=3770368	url:https://ssrn.com/abstract=3770368	XOLE6iJT
-doi:10.1001/jama.2021.1961	doi:10.1001/jama.2021.1961	doi:10.1001/jama.2021.1961	1Bgnim0gX
 url:https://www.biopharma-reporter.com/Article/2021/02/18/South-Africa-starts-administering-Janssen-COVID-19-vaccine-to-health-workers	url:https://www.biopharma-reporter.com/Article/2021/02/18/South-Africa-starts-administering-Janssen-COVID-19-vaccine-to-health-workers	url:https://www.biopharma-reporter.com/Article/2021/02/18/South-Africa-starts-administering-Janssen-COVID-19-vaccine-to-health-workers	I0vakLIc
 url:https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen	url:https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen	url:https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen	17BEDzTkD
 url:https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership	url:https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership	url:https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership	hHW8U8rE
@@ -1557,64 +1615,13 @@ url:https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna#a
 url:https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna	url:https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna	url:https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna	k9X9pXJe
 url:https://ourworldindata.org/covid-vaccinations	url:https://ourworldindata.org/covid-vaccinations	url:https://ourworldindata.org/covid-vaccinations	cWMPXfju
 url:https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots	url:https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots	url:https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots	uvQMgFXB
-url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/	url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/	url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/	bXdr5Gyu
+url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine	url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine	url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine	Vwv7l7Hd
 url:https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process	url:https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process	url:https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process	P6x0Qy6s
 url:https://fortune.com/2021/02/08/international-sputnik-russia-demand	url:https://fortune.com/2021/02/08/international-sputnik-russia-demand	url:https://fortune.com/2021/02/08/international-sputnik-russia-demand	ID8IywJM
 url:https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials	url:https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials	url:https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials	37uTx4hs
 url:https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665	url:https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665	url:https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665	FAQXPsyc
 url:https://www.france24.com/en/live-news/20210203-germany-moves-to-bring-russian-vaccine-into-eu-orbit	url:https://www.france24.com/en/live-news/20210203-germany-moves-to-bring-russian-vaccine-into-eu-orbit	url:https://www.france24.com/en/live-news/20210203-germany-moves-to-bring-russian-vaccine-into-eu-orbit	zCPl6A82
 url:https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2AK07H	url:https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2AK07H	url:https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2AK07H	hpScvlYg
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-url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581	url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581	url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581	I9Ha5JL3
-url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI	url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI	url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI	e8pnj0O3
-url:https://www.bharatbiotech.com/intranasal-vaccine.html	url:https://www.bharatbiotech.com/intranasal-vaccine.html	url:https://www.bharatbiotech.com/intranasal-vaccine.html	P9mD7Gc9
-url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html	url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html	url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html	gdTtuj5e
-url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30	url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30	url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30	V2Gz2O9G
-url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594	url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594	url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594	XJmfG8HD
-url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560	url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560	url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560	12zVLzkpB
-doi:10.1016/j.vaccine.2012.03.010	doi:10.1016/j.vaccine.2012.03.010	doi:10.1016/j.vaccine.2012.03.010	1GUVvcQjL
-doi:10.1186/s13063-020-04775-4	doi:10.1186/s13063-020-04775-4	doi:10.1186/s13063-020-04775-4	KewHbkLZ
-url:https://covid19.trackvaccines.org/vaccines/7	url:https://covid19.trackvaccines.org/vaccines/7	url:https://covid19.trackvaccines.org/vaccines/7	19z4gdhDS
-url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf	url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf	url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf	Ks3L7qHG
-url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf	url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf	url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf	DaDKZXdu
-url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm	url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm	url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm	13yEnvOyP
-url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html	url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html	url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html	UU0pj3ii
-url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms	url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms	url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms	3Q7kvwO3
-url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23	url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23	url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23	AeulXXFm
-doi:10.1016/j.vaccine.2012.01.016	doi:10.1016/j.vaccine.2012.01.016	doi:10.1016/j.vaccine.2012.01.016	2Lol7zTw
-doi:10.1038/nri3488	doi:10.1038/nri3488	doi:10.1038/nri3488	OoS5TU81
-doi:10.1007/s12026-018-8991-x	doi:10.1007/s12026-018-8991-x	doi:10.1007/s12026-018-8991-x	1F52Wz7mx
-doi:10.1016/j.vaccine.2013.01.039	doi:10.1016/j.vaccine.2013.01.039	doi:10.1016/j.vaccine.2013.01.039	scwOT7dw
-doi:10.1016/j.vaccine.2009.09.044	doi:10.1016/j.vaccine.2009.09.044	doi:10.1016/j.vaccine.2009.09.044	aD5iMC0Q
-doi:10.1111/j.1750-2659.2011.00256.x	doi:10.1111/j.1750-2659.2011.00256.x	doi:10.1111/j.1750-2659.2011.00256.x	twmXSpc9
-doi:10.1016/j.vaccine.2011.08.042	doi:10.1016/j.vaccine.2011.08.042	doi:10.1016/j.vaccine.2011.08.042	jVCL0201
-clinicaltrials:NCT04368988	clinicaltrials:NCT04368988	clinicaltrials:NCT04368988	Nq0cimEs
-doi:10.1371/journal.pmed.1003769	doi:10.1371/journal.pmed.1003769	doi:10.1371/journal.pmed.1003769	ynvQwwo9
-doi:10.1101/2021.06.09.21258556	doi:10.1101/2021.06.09.21258556	doi:10.1101/2021.06.09.21258556	IUekaKY0
-url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza	url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza	url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza	rclKBvtk
-doi:10.1101/2021.05.05.442782	doi:10.1101/2021.05.05.442782	doi:10.1101/2021.05.05.442782	bOwPRh6q
-10.3389/fimmu.2020.602256	10.3389/fimmu.2020.602256	doi:10.3389/fimmu.2020.602256	7RHpaAHu
-doi:10.1038/nature12005	doi:10.1038/nature12005	doi:10.1038/nature12005	yoFGwkUO
-doi:10.1038/nature12328	doi:10.1038/nature12328	doi:10.1038/nature12328	KZFnwRIN
-doi:10.1128/JVI.01277-13	doi:10.1128/JVI.01277-13	doi:10.1128/jvi.01277-13	YZcHzPcs
-doi:10.1371/journal.pone.0081587	doi:10.1371/journal.pone.0081587	doi:10.1371/journal.pone.0081587	GFWQw4mi
-doi:10.1038/cmi.2015.03	doi:10.1038/cmi.2015.03	doi:10.1038/cmi.2015.03	SF030Zqn
-doi:10.1038/s41577-020-0285-6	doi:10.1038/s41577-020-0285-6	doi:10.1038/s41577-020-0285-6	103fS7Kz2
-doi:10.1016/j.cell.2020.04.042	doi:10.1016/j.cell.2020.04.042	doi:10.1016/j.cell.2020.04.042	Vu1VILWK
-clinicaltrials:NCT04328441	clinicaltrials:NCT04328441	clinicaltrials:NCT04328441	y9IYdfM3
-clinicaltrials:NCT04350931	clinicaltrials:NCT04350931	clinicaltrials:NCT04350931	962rELVS
-clinicaltrials:NCT04362124	clinicaltrials:NCT04362124	clinicaltrials:NCT04362124	EuwTWcPi
-clinicaltrials:NCT04369794	clinicaltrials:NCT04369794	clinicaltrials:NCT04369794	dQtUeruv
-clinicaltrials:NCT04373291	clinicaltrials:NCT04373291	clinicaltrials:NCT04373291	DjXsPR8O
-clinicaltrials:NCT04379336	clinicaltrials:NCT04379336	clinicaltrials:NCT04379336	10OE6y3Pv
-clinicaltrials:NCT04384549	clinicaltrials:NCT04384549	clinicaltrials:NCT04384549	86OjIybR
-clinicaltrials:NCT04387409	clinicaltrials:NCT04387409	clinicaltrials:NCT04387409	ITO15LIz
-clinicaltrials:NCT04414267	clinicaltrials:NCT04414267	clinicaltrials:NCT04414267	VkZGZxLn
-clinicaltrials:NCT04417335	clinicaltrials:NCT04417335	clinicaltrials:NCT04417335	13JVjMfQI
-clinicaltrials:NCT04435379	clinicaltrials:NCT04435379	clinicaltrials:NCT04435379	nk2MVsld
-clinicaltrials:NCT04439045	clinicaltrials:NCT04439045	clinicaltrials:NCT04439045	1E2t9tr8h
-doi:10.1016/j.chom.2020.04.009	doi:10.1016/j.chom.2020.04.009	doi:10.1016/j.chom.2020.04.009	i5k18bpX
-doi:10.1016/j.chom.2020.05.008	doi:10.1016/j.chom.2020.05.008	doi:10.1016/j.chom.2020.05.008	1228YjPRv
 doi:10.3390/nu12051466	doi:10.3390/nu12051466	doi:10.3390/nu12051466	Lyd8s4Mk
 doi:10.1101/2020.10.19.20214395	doi:10.1101/2020.10.19.20214395	doi:10.1101/2020.10.19.20214395	UFrQw1gC
 doi:10.1093/advances/nmaa125	doi:10.1093/advances/nmaa125	doi:10.1093/advances/nmaa125	Hd5V5Usd
diff --git a/evolution-manuscript.docx b/evolution-manuscript.docx
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@@ -58,7 +58,7 @@
   <meta name="author" content="Jeremy P. Kamil" />
   <meta name="author" content="Jesse G. Meyer" />
   <meta name="author" content="Ariel I. Mundo" />
-  <meta name="dcterms.date" content="2022-08-12" />
+  <meta name="dcterms.date" content="2022-08-17" />
   <meta name="keywords" content="covid-19, coronavirus, pandemic, viral infection" />
   <title>SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics</title>
   <style>
@@ -97,8 +97,8 @@
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   <meta property="og:title" content="SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics" />
   <meta property="twitter:title" content="SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics" />
-  <meta name="dc.date" content="2022-08-12" />
-  <meta name="citation_publication_date" content="2022-08-12" />
+  <meta name="dc.date" content="2022-08-17" />
+  <meta name="citation_publication_date" content="2022-08-17" />
   <meta name="dc.language" content="en-US" />
   <meta name="citation_language" content="en-US" />
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@@ -316,13 +316,13 @@
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+  <link rel="alternate" type="text/html" href="https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/" />
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@@ -337,11 +337,11 @@ <h1 class="title">SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and
 </header>
 <p><small><em>
 This manuscript
-(<a href="https://greenelab.github.io/covid19-review/v/693bc6c9d1173d3d0b699a81b22fa58685b05828/">permalink</a>)
+(<a href="https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/">permalink</a>)
 was automatically generated
-from <a href="https://github.com/greenelab/covid19-review/tree/693bc6c9d1173d3d0b699a81b22fa58685b05828">greenelab/covid19-review@693bc6c</a>
-on August 12, 2022.
-It is also available as a <a href="https://greenelab.github.io/covid19-review/v/693bc6c9d1173d3d0b699a81b22fa58685b05828/manuscript.pdf">PDF</a>.
+from <a href="https://github.com/greenelab/covid19-review/tree/1afb26272649eb73d412aacfd63eab9d3758128b">greenelab/covid19-review@1afb262</a>
+on August 17, 2022.
+It is also available as a <a href="https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/manuscript.pdf">PDF</a>.
 Snapshots of individual sections have been published <span class="citation" data-cites="GdZc4Yyd wgAGKcBj njpLhBui EM9YkiOF">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>,<a href="#ref-wgAGKcBj" role="doc-biblioref">2</a>,<a href="#ref-njpLhBui" role="doc-biblioref">3</a>,<a href="#ref-EM9YkiOF" role="doc-biblioref">4</a>]</span> or posted as preprints <span class="citation" data-cites="hIxvVJ7F">[<a href="#ref-hIxvVJ7F" role="doc-biblioref">5</a>]</span>.
 </em></small></p>
 <!-- include the Font Awesome library, per: https://fontawesome.com/start -->
@@ -1264,6 +1264,17 @@ <h2 data-number="1.12" id="conclusions"><span class="header-section-number">1.12
 <h1 data-number="2" id="evolutionary-perspectives-on-sars-cov-2"><span class="header-section-number">2</span> Evolutionary Perspectives on SARS-CoV-2</h1>
 <h2 data-number="2.1" id="abstract-1"><span class="header-section-number">2.1</span> Abstract</h2>
 <h2 data-number="2.2" id="importance-1"><span class="header-section-number">2.2</span> Importance</h2>
+<!-- Text to incorporate (from vaccines): -->
+<!--Move to evolution ms
+Some of the gene mutations carried by Omicron, of which there are between 30-37 in the spike gene (15 in the RBD), have previously been associated with increased transmission, greater affinity for ACE2, and escape from neutralizing antibodies when they have been detected in other VOC [@doi:10.1101/2021.11.11.21266068; @doi:10.1016/j.cell.2021.06.020; @doi:10.1101/2021.12.12.472269; @url:https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-omicron-variant.html; @doi:10.1101/2021.12.14.21267772; @doi:10.1101/2021.12.12.472269].
+However, multiple animal study preprints suggested that the Omicron variant may not be as severe on the respiratory system as previous SARS-CoV-2 variants as evidenced by reduced lung infectivity, reduced SARS-CoV-2 RNA detection in the lung, and reduced inflammation and pathogenicity in animals [@doi:10.21203/rs.3.rs-1211792/v1; @doi:10.1101/2021.12.26.474085; @doi:10.1101/2021.12.24.474086; @doi:10.1101/2022.01.02.474743; @doi:10.1101/2021.12.17.473248].
+-->
+<!--Move to evolution
+Vaccine efficacy is not the only pharmacological intervention affected by VOC.
+Some existing therapeutics, including monoclonal antibody treatments like Bamlanivimab (AbCellera Biologics/ Eli Lilly), were ineffective against the Omicron variant.
+Indeed, only Sotrovimab (Vir Biotechnology/GSK) and Tixagevimab (AstraZeneca) to a much lesser extent could effectively neutralize the Omicron variant out of 7 tested monoclonal antibodies [@doi:10.1101/2021.12.14.21267772], which has been verified by others [@doi:10.1101/2021.12.12.472269].
+The antigenic shift of the Omicron variant does raise concerns for future VOC and what effects they may have on future vaccines and therapeutics.
+-->
 <h2 data-number="2.3" id="introduction-1"><span class="header-section-number">2.3</span> Introduction</h2>
 <p>The emergence of what is now known to be the pathogen SARS-CoV-2 has dramatically reshaped modern life for the past two years.
 The genomic revolution provided the tools needed to understand the virus in ways that were not feasible during previous pandemics.
@@ -1590,7 +1601,6 @@ <h3 data-number="2.8.1" id="variants-of-concern-and-variants-under-surveillance"
 For now, the consensus appears to be that the FDA-approved vaccines still seem to be generally effective against the genetic variants of SARS-CoV-2 and their accompanying mutations, albeit with a lower neutralizing capacity <span class="citation" data-cites="VxRhUVyl kcOVBUnj xYHivkXH izey3Z40">[<a href="#ref-izey3Z40" role="doc-biblioref">503</a>,<a href="#ref-xYHivkXH" role="doc-biblioref">506</a>,<a href="#ref-kcOVBUnj" role="doc-biblioref">507</a>,<a href="#ref-VxRhUVyl" role="doc-biblioref">511</a>]</span>, though select VOCs may present challenges.
 Further research is required to discern the clinical, prophylactic, and therapeutic consequences of these genetic SARS-CoV-2 variants as the pandemic evolves.</p>
 <h2 data-number="2.9" id="sars-cov-2-evolution-and-vaccine-efficacy"><span class="header-section-number">2.9</span> SARS-CoV-2 Evolution and Vaccine Efficacy</h2>
-<!-- This doesn't belong in the vaccines appendix. It seems covered by the evolution manuscript, or should be moved there. -->
 <p>With these vaccines in place, one concern is how the virus’s continued evolution will affect their efficacy.
 Since the start of this pandemic, we have already seen multiple variants emerge: B.1.1.7, which emerged in the UK, B.1.351, which emerged in South Africa, and P.1, which emerged in Brazil.</p>
 <p>Viruses evolve or mutate at different rates.
@@ -1635,7 +1645,7 @@ <h2 data-number="2.10" id="question-6-what-is-next"><span class="header-section-
 Indeed, data from a study in New York City indicated that wastewater SARS-CoV-2 detection correlated with clinical detection of infection <span class="citation" data-cites="1EuKt1ppV">[<a href="#ref-1EuKt1ppV" role="doc-biblioref">532</a>]</span>.
 Similar studies have been conducted in Nevada <span class="citation" data-cites="JwtDsxLy">[<a href="#ref-JwtDsxLy" role="doc-biblioref">533</a>]</span> and Boston <span class="citation" data-cites="8A0XYWq8">[<a href="#ref-8A0XYWq8" role="doc-biblioref">534</a>]</span>.
 To date, studies have shown that factors such as temperature, the travel time of wastewater, and diurnal variability may affect detection of SARS-CoV-2 <span class="citation" data-cites="1DqxOlpHl JwtDsxLy">[<a href="#ref-1DqxOlpHl" role="doc-biblioref">527</a>,<a href="#ref-JwtDsxLy" role="doc-biblioref">533</a>]</span>.
-Additionaly, wastewater surveillance provides a tool to monitor fluctuations in the viral strains present in a community <span class="citation" data-cites="tYFkf9ez 1783YNtiU">[<a href="#ref-tYFkf9ez" role="doc-biblioref">535</a>,<a href="#ref-1783YNtiU" role="doc-biblioref">536</a>]</span>.
+Additionally, wastewater surveillance provides a tool to monitor fluctuations in the viral strains present in a community <span class="citation" data-cites="tYFkf9ez 1783YNtiU">[<a href="#ref-tYFkf9ez" role="doc-biblioref">535</a>,<a href="#ref-1783YNtiU" role="doc-biblioref">536</a>]</span>.
 Due to its demonstrated utility so far, the United States CDC established the National Wastewater Surveillance System (NWSS), which has emerged as an important surveillance tool for SARS-CoV-2 spread <span class="citation" data-cites="8IiPEZuE">[<a href="#ref-8IiPEZuE" role="doc-biblioref">537</a>]</span>.</p>
 <!-- Implications for preventing future pandemics? Vaccine response time?-->
 <p>Knowledge of the evolution of SARS-CoV-2 is imperative to managing it moving forward <span class="citation" data-cites="m99E85qV MicGQlWa">[<a href="#ref-m99E85qV" role="doc-biblioref">523</a>,<a href="#ref-MicGQlWa" role="doc-biblioref">538</a>]</span>.</p>
@@ -2154,9 +2164,9 @@ <h2 data-number="4.3" id="introduction-3"><span class="header-section-number">4.
 <h3 data-number="4.3.1" id="lessons-from-prior-hcov-outbreaks"><span class="header-section-number">4.3.1</span> Lessons from Prior HCoV Outbreaks</h3>
 <div id="fig:csse-deaths" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/5731b89747027f2322595249c7b11b2f237686f6/csse/csse-deaths.png" alt="Figure 3: Cumulative global incidence of COVID-19 and SARS. As of August 10, 2022, 587,493,309 COVID-19 cases and 6,427,446 COVID-19 deaths had been reported worldwide since January 22, 2020. A total of 8,432 cases and 813 deaths were reported for SARS from March 17 to July 11, 2003. SARS-CoV-1 was officially contained on July 5, 2003, within 9 months of its appearance [720]. In contrast, SARS-CoV-2 remains a significant global threat nearly two years after its emergence. COVID-19 data are from the COVID-19 Data Repository by the Center for Systems Science and Engineering at Johns Hopkins University [721,722]. SARS data are from the WHO [723] and were obtained from a dataset on GitHub [724]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/csse/csse-deaths.png" alt="Figure 3: Cumulative global incidence of COVID-19 and SARS. As of August 15, 2022, 591,189,117 COVID-19 cases and 6,437,933 COVID-19 deaths had been reported worldwide since January 22, 2020. A total of 8,432 cases and 813 deaths were reported for SARS from March 17 to July 11, 2003. SARS-CoV-1 was officially contained on July 5, 2003, within 9 months of its appearance [720]. In contrast, SARS-CoV-2 remains a significant global threat nearly two years after its emergence. COVID-19 data are from the COVID-19 Data Repository by the Center for Systems Science and Engineering at Johns Hopkins University [721,722]. SARS data are from the WHO [723] and were obtained from a dataset on GitHub [724]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
 <figcaption aria-hidden="true"><span>Figure 3:</span> <strong>Cumulative global incidence of COVID-19 and SARS.</strong>
-As of August 10, 2022, 587,493,309 COVID-19 cases and 6,427,446 COVID-19 deaths had been reported worldwide since January 22, 2020.
+As of August 15, 2022, 591,189,117 COVID-19 cases and 6,437,933 COVID-19 deaths had been reported worldwide since January 22, 2020.
 A total of 8,432 cases and 813 deaths were reported for SARS from March 17 to July 11, 2003.
 SARS-CoV-1 was officially contained on July 5, 2003, within 9 months of its appearance <span class="citation" data-cites="bOegE5mX">[<a href="#ref-bOegE5mX" role="doc-biblioref">720</a>]</span>.
 In contrast, SARS-CoV-2 remains a significant global threat nearly two years after its emergence.
@@ -2204,7 +2214,7 @@ <h3 data-number="4.3.2" id="potential-approaches-to-the-treatment-of-covid-19"><
 Interventional clinical trials are currently investigating or have investigated a large number of possible therapeutics and combinations of therapeutics for the treatment of COVID-19 (Figure <a href="#fig:ebm-trials">4</a>).</p>
 <div id="fig:ebm-trials" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/5731b89747027f2322595249c7b11b2f237686f6/ebmdatalab/ebmdatalab-trials.png" alt="Figure 4: COVID-19 clinical trials. Trials data are from the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker [729]. As of December 31, 2020, there were 6,987 COVID-19 clinical trials of which 3,962 were interventional. The study types include only types used in at least five trials. Only interventional trials are analyzed in the figures depicting status, phase, and intervention. Of the interventional trials, 98 trials had reported results as of December 31, 2020. Recruitment status and trial phase are shown only for interventional trials in which the status or phase is recorded. Common interventions refers to interventions used in at least ten trials. Combinations of interventions, such as hydroxychloroquine with azithromycin, are tallied separately from the individual interventions. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/ebmdatalab/ebmdatalab-trials.png" alt="Figure 4: COVID-19 clinical trials. Trials data are from the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker [729]. As of December 31, 2020, there were 6,987 COVID-19 clinical trials of which 3,962 were interventional. The study types include only types used in at least five trials. Only interventional trials are analyzed in the figures depicting status, phase, and intervention. Of the interventional trials, 98 trials had reported results as of December 31, 2020. Recruitment status and trial phase are shown only for interventional trials in which the status or phase is recorded. Common interventions refers to interventions used in at least ten trials. Combinations of interventions, such as hydroxychloroquine with azithromycin, are tallied separately from the individual interventions. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
 <figcaption aria-hidden="true"><span>Figure 4:</span> <strong>COVID-19 clinical trials.</strong>
 Trials data are from the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker <span class="citation" data-cites="SSbnPnzT">[<a href="#ref-SSbnPnzT" role="doc-biblioref">729</a>]</span>.
 As of December 31, 2020, there were 6,987 COVID-19 clinical trials of which 3,962 were interventional.
@@ -3260,79 +3270,80 @@ <h2 data-number="5.8" id="potential-avenues-of-interest-for-therapeutic-developm
 <h1 data-number="6" id="application-of-traditional-vaccine-development-strategies-to-sars-cov-2"><span class="header-section-number">6</span> Application of Traditional Vaccine Development Strategies to SARS-CoV-2</h1>
 <h2 data-number="6.1" id="abstract-4"><span class="header-section-number">6.1</span> Abstract</h2>
 <p>Over the past 150 years, vaccines have revolutionized the relationship between people and disease.
-Technologies such as mRNA vaccines have received significant attention in the COVID-19 pandemic due to their novelty and successes.
-However, more traditional vaccine development platforms have also been explored against SARS-CoV-2, yielding important tools in the worldwide fight against the virus.</p>
-<p>A variety of approaches have been used to develop COVID-19 vaccines that are now available in at least one country.
-In this review, we highlight strategies that focus on the virus and its constituent pieces.
+During the COVID-19 pandemic, technologies such as mRNA vaccines have received significant attention due to their novelty and successes.
+However, more traditional vaccine development platforms have also been applied against SARS-CoV-2, yielding important tools in the worldwide fight against the virus.</p>
+<p>A variety of approaches have been used to develop COVID-19 vaccines that are now authorized for use in countries around the world.
+In this review, we highlight strategies that focus on the viral capsid outwards, rather than on the nucleic acids inside.
 Such approaches broadly fall into two categories: whole-virus vaccines and subunit vaccines.
 Whole-virus vaccine approaches use the virus itself, either in an inactivated or attenuated state.
 Subunit vaccines isolate an immunogenic component of the virus using various strategies that is then introduced through vaccination.
 We highlight specific vaccine candidates that utilize these approaches in different ways.
 In a companion manuscript, we review the more recent and novel development of nucleic-acid based vaccine technologies.</p>
-<p>We also seek to contextualize the role that these COVID-19 vaccine development programs have played in providing immunity to people around the world.
-Well-established vaccine technologies are especially important because of their significant impact worldwide on COVID-19 vaccine access.
-Traditional vaccine development programs have been undertaken in a much wider range of countries than those using nucleic-acid-based technologies, which have been led by wealthy countries.
-Therefore, these vaccines, while less cutting-edge on the biotechnology side, are extremely important to the management of SARS-CoV-2.</p>
+<p>We further consider the role that these COVID-19 vaccine development programs have played in providing immunity to people around the world.
+Well-established vaccine technologies have proved especially important because of the significant role they have played in COVID-19 vaccine access at the global scale.
+Vaccine development programs that use established platforms have been undertaken in a much wider range of countries than those using nucleic-acid-based technologies, which have been led by wealthy Western countries.
+Therefore, these vaccine platforms, while less cutting-edge on the biotechnology side, have proven to be extremely important to the management of SARS-CoV-2.</p>
 <h2 data-number="6.2" id="importance-4"><span class="header-section-number">6.2</span> Importance</h2>
-<p>As of August 10, 2022, there have been over 587,493,309 SARS-CoV-2 cases, and it has taken the lives of at least 6,427,446 people globally.
+<p>As of August 15, 2022, there have been over 591,189,117 SARS-CoV-2 cases, and the virus has taken the lives of at least 6,437,933 people globally.
 The development, production, and distribution of vaccines is imperative to saving lives, preventing illness, and reducing the economic and social burdens caused by the COVID-19 pandemic.
 Much emphasis has been placed on vaccines that use cutting-edge biotechnology.
-However, more traditional methods of vaccine development that were refined throughout the twentieth century are critical to producing vaccines that are accessible worldwide.
-Effective deployment is critical to reducing the susceptibility of worldwide populations, especially in light of emerging variants.
-In this review, we evaluate the efficacy of these vaccines as well as patterns in their distribution.
+However, more traditional methods of vaccine development that were refined throughout the twentieth century have been critical in increasing vaccine access worldwide.
+Effective deployment is necessary to reducing the susceptibility of the world’s population, which is especially important in light of emerging variants.
+In this review, we discuss the safety, efficacy, and distribution of vaccines developed using established technologies.
 In a separate review, we describe the vaccines developed using nucleic acid-based vaccine platforms.
 From the current literature, it is clear that the well-established vaccine technologies are also highly effective against SARS-CoV-2 and are being used to address the challenges of COVID-19 globally, including in low- and middle-income countries.
-This worldwide approach is critical for reducing the devastation of SARS-CoV-2.</p>
+This worldwide approach is critical for reducing the devastating impact of SARS-CoV-2.</p>
 <h2 data-number="6.3" id="introduction-4"><span class="header-section-number">6.3</span> Introduction</h2>
 <p>The development of vaccines is widely considered one of the most important medical advances in human history.
 Over the past 150 years, several approaches to vaccines have been developed and refined <span class="citation" data-cites="YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>]</span>.
-The COVID-19 pandemic has generated several unique circumstances relative to past health crises, one of which is the extremely rapid release of the SARS-CoV-2 viral genome.
+The COVID-19 pandemic has generated atypical circumstances compared to past health crises, leading to differences in vaccine development against this pathogen.
+One way in which the COVID-19 pandemic differs from prior global health crises is that the SARS-CoV-2 viral genome was sequenced, assembled, and released very early on (January 2020).
 This genomic information has been important in shaping the biomedical response to this pathogen <span class="citation" data-cites="GdZc4Yyd njpLhBui">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>,<a href="#ref-njpLhBui" role="doc-biblioref">3</a>]</span>.
-However, vaccines have been developed since long before the concept of a virus or a viral genome was known.
-As early as September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development, many of which used more traditional vaccine technologies <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.
-However, media attention has largely focused on vaccine development platforms that have produced vaccine candidates using previously unemployed technologies, especially mRNA vaccines due to their rapid deployment.
+All the same, vaccines have been developed since long before the concept of a virus or a viral genome was known, and as early as September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development, many of which used more traditional vaccine technologies <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.
+However, media attention has largely focused on vaccine development platforms that have produced vaccine candidates using new technologies, especially mRNA vaccines due to their rapid deployment.
 We review vaccine technologies used for SARS-CoV-2 in two parts: here, the application of traditional vaccine development platforms to SARS-CoV-2, and separately, nucleic acid-based approaches <span class="citation" data-cites="nPuLx9h5">[<a href="#ref-nPuLx9h5" role="doc-biblioref">328</a>]</span>.</p>
-<p>Vaccine development using well-established technologies is important for a global perspective on COVID-19.
-As of August 11, 2022, 40 SARS-CoV-2 vaccines have been approved.
-Tracking the administration of 29 vaccines throughout the world indicates that doses have been administered across 223 countries <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span>.
-Of these, 17 were developed using subunit and 11 using whole-virus approaches, which do not require information about the viral genome. <!-- broken template -->
-Many vaccines are available only in a subset of countries, and the types of vaccines available varies widely throughout the world, as the process of developing and deploying a vaccine is complex and often requires coordination between government, industry, academia, and philanthropic entities <span class="citation" data-cites="plfPrQP7">[<a href="#ref-plfPrQP7" role="doc-biblioref">1106</a>]</span>.</p>
-<p>One of the metrics through which a vaccine’s success is measured is efficacy.
-The vaccine efficacy (VE) seeks to quantify the extent to which a vaccine protects against the virus during clinical trials <span class="citation" data-cites="DhPGhZPn">[<a href="#ref-DhPGhZPn" role="doc-biblioref">1107</a>]</span>.
+<p>Understanding vaccine development programs that are using well-established technologies is important for a global perspective on COVID-19.
+As of August 15, 2022, 41 SARS-CoV-2 vaccines have been approved for use in at least one country.
+A resource tracking the distribution of 29 vaccines indicates that, as of August 15, 2022, doses have been administered across 223 countries <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span>.
+Many of these vaccines use platforms that do not require information about the viral genome, with 17 developed using subunit and 11 using whole-virus approaches.
+The types of vaccines available varies widely throughout the world, as the process of developing and deploying a vaccine is complex and often requires coordination between government, industry, academia, and philanthropic entities <span class="citation" data-cites="plfPrQP7">[<a href="#ref-plfPrQP7" role="doc-biblioref">1106</a>]</span>.</p>
+<p>Another difference between prior global health crises and the COVID-19 pandemic is the way that vaccines are evaluated.
+A vaccine’s success is often discussed in terms of vaccine efficacy (VE), which describes the protection conferred during clinical trials <span class="citation" data-cites="DhPGhZPn">[<a href="#ref-DhPGhZPn" role="doc-biblioref">1107</a>]</span>.
 The real-world protection offered by a vaccine is referred to as its effectiveness <span class="citation" data-cites="DhPGhZPn">[<a href="#ref-DhPGhZPn" role="doc-biblioref">1107</a>]</span>.
 Additionally, protection can mean different things in different contexts.
 In general, the goal of a vaccine is to prevent disease, especially severe disease, rather than infection itself.
-Vaccine developers also often test their candidates for serum neutralizing activity, which has been proposed as a biomarker for adaptive immunity in other respiratory illnesses <span class="citation" data-cites="wiGjCZC8">[<a href="#ref-wiGjCZC8" role="doc-biblioref">1108</a>]</span>.
-However, the duration of the COVID-19 pandemic has made it possible to test multiple vaccines in phase 3 trials where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 is evaluated, whereas this has not always been feasible for other infectious diseases that have been controlled more quickly.
-Estimates of VE have been released for many vaccine candidates across a number of technology types based on phase 3 trial data.</p>
+As a proxy for VE, vaccine developers often test their candidates for serum neutralizing activity, which has been proposed as a biomarker for adaptive immunity in other respiratory illnesses <span class="citation" data-cites="wiGjCZC8">[<a href="#ref-wiGjCZC8" role="doc-biblioref">1108</a>]</span>.
+The duration and intensity of the COVID-19 pandemic has made it possible to test multiple vaccines in phase III trials, where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 can be evaluated, whereas this has not always been feasible for other infectious diseases that have been controlled more quickly.
+Estimates of VE have been released for many vaccine candidates across a number of technology types based on phase III trial data.</p>
 <p>However, efficacy is not a static value, and real-world efficacy can vary with location and over time.
-Temporal shifts in efficacy have been an especially heightened topic of concern since late 2021 given the potential for the evolution of SARS-CoV-2 to influence vaccine efficacy.
+Shifts in efficacy have been an especially heightened topic of concern since late 2021 given the potential for variants of SARS-CoV-2 to influence VE.
 Due to viral evolution, vaccine developers are in an arms race with a pathogen that benefits from mutations that reduce its susceptibility to adaptive immunity.
 The evolution of several variants of concern (VOC) presents significant challenges for vaccines developed based on the index strain identified in Wuhan in late 2019.
 We discuss these variants in depth elsewhere <span class="citation" data-cites="17qiILENK">[<a href="#ref-17qiILENK" role="doc-biblioref">327</a>]</span>.
 To date, the most significant VOC identified are Alpha (2020), Beta (2020), Gamma (2020), Delta (2021), and Omicron (2021), with various subvariants of Omicron being the most recently identified (2022).
 The efficacy of vaccines in the context of these variants is discussed where information is available.</p>
 <p>While the relationship between a vaccine and a pathogen is not static, the data clearly demonstrates that a variety of efficacious vaccines have been developed against SARS-CoV-2.
-Here we discuss a selection of programs that use well-established vaccine biotechnology.
-These programs have been undertaken worldwide, in complement to the more cutting-edge approaches in high-income economies like the United States, the European Union, the United Kingdom, and Russia <span class="citation" data-cites="nPuLx9h5">[<a href="#ref-nPuLx9h5" role="doc-biblioref">328</a>]</span>.
-In this review, we discuss the contributions of the traditional and well-established vaccine technologies of whole-virus vaccines and subunit vaccines and their role in the response to the COVID-19 pandemic.</p>
+Here we discuss a selection of programs that use well-established vaccine biotechnologies.
+These programs have been undertaken worldwide, in complement to the more cutting-edge approaches developed and distributed in the United States (U.S.), the European Union (E.U.), the United Kingdom (U.K.), and Russia <span class="citation" data-cites="nPuLx9h5">[<a href="#ref-nPuLx9h5" role="doc-biblioref">328</a>]</span>.
+In this review, we discuss vaccine development using two well-established technologies, whole-virus vaccination and subunit vaccination, and the role these technologies have played in the global response to the COVID-19 pandemic.</p>
 <h2 data-number="6.4" id="whole-virus-vaccines"><span class="header-section-number">6.4</span> Whole-Virus Vaccines</h2>
 <p>Whole-virus vaccines have the longest history among vaccine development approaches.
 Variolation, which is widely considered the first vaccination strategy in human history, is one example <span class="citation" data-cites="Q10m9bJ 1Clt2Bek3">[<a href="#ref-Q10m9bJ" role="doc-biblioref">1109</a>,<a href="#ref-1Clt2Bek3" role="doc-biblioref">1110</a>]</span>.
-Famously employed against smallpox when healthy individuals were exposed to pus from an individual infected with what was believed to be either cowpox or horsepox <span class="citation" data-cites="Q10m9bJ 1Clt2Bek3 ZUHALvLg 1DFnwhtrq">[<a href="#ref-Q10m9bJ" role="doc-biblioref">1109</a>,<a href="#ref-1Clt2Bek3" role="doc-biblioref">1110</a>,<a href="#ref-ZUHALvLg" role="doc-biblioref">1111</a>,<a href="#ref-1DFnwhtrq" role="doc-biblioref">1112</a>]</span>, variolation allowed healthy individuals to be infected with a mild case of a disease.
-While whole-virus vaccines can confer adaptive immunity, they also face safety concerns <span class="citation" data-cites="kC2tx3JC K0Ltu31S ZUHALvLg">[<a href="#ref-ZUHALvLg" role="doc-biblioref">1111</a>,<a href="#ref-kC2tx3JC" role="doc-biblioref">1113</a>,<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
+Famously, variolation was employed against smallpox when healthy individuals were exposed to pus from an individual infected with what was believed to be either cowpox or horsepox <span class="citation" data-cites="Q10m9bJ 1Clt2Bek3 ZUHALvLg 1DFnwhtrq">[<a href="#ref-Q10m9bJ" role="doc-biblioref">1109</a>,<a href="#ref-1Clt2Bek3" role="doc-biblioref">1110</a>,<a href="#ref-ZUHALvLg" role="doc-biblioref">1111</a>,<a href="#ref-1DFnwhtrq" role="doc-biblioref">1112</a>]</span>.
+This approach worked by inducing a mild case of a disease.
+Therefore, while whole-virus vaccines confer adaptive immunity, they also raise safety concerns <span class="citation" data-cites="kC2tx3JC K0Ltu31S ZUHALvLg">[<a href="#ref-ZUHALvLg" role="doc-biblioref">1111</a>,<a href="#ref-kC2tx3JC" role="doc-biblioref">1113</a>,<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
 As of 2005, most vaccines still used whole-virus platforms <span class="citation" data-cites="U9ZIZWkB">[<a href="#ref-U9ZIZWkB" role="doc-biblioref">1115</a>]</span>, and these technologies remain valuable tools in vaccine development today <span class="citation" data-cites="YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>]</span>.
 Whole virus vaccine candidates have been developed for COVID-19 using both live attenuated viruses and inactivated whole viruses.</p>
 <h3 data-number="6.4.1" id="live-attenuated-virus-vaccines"><span class="header-section-number">6.4.1</span> Live-Attenuated Virus Vaccines</h3>
 <p>Live-attenuated virus vaccines (LAV), also known as replication-competent vaccines, use a weakened, living version of a disease-causing virus or a version of a virus that is modified to induce an immune response <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.
-Whether variolation is the first example of a LAV being used to induce immunity is debated <span class="citation" data-cites="kC2tx3JC YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>,<a href="#ref-kC2tx3JC" role="doc-biblioref">1113</a>]</span>, but subsequent efforts to incorporate attenuated viruses relied on either the identification of related viruses that were less virulent in humans (e.g., cowpox/horsepox or rotavirus vaccines) or culture of a virus <em>in vitro</em> <span class="citation" data-cites="ZUHALvLg YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>,<a href="#ref-ZUHALvLg" role="doc-biblioref">1111</a>]</span>.
+Whether variolation is the first example of a LAV being used to induce immunity is debated <span class="citation" data-cites="kC2tx3JC YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>,<a href="#ref-kC2tx3JC" role="doc-biblioref">1113</a>]</span>.
+The first deliberate (albeit pathogen-naïve) attempt to develop an attenuated viral vaccine dates back to Louis Pasteur in 1885.
+The next intentional LAVs were developed against the yellow fever virus in 1935 and influenza in 1936 <span class="citation" data-cites="iX8wXLPW">[<a href="#ref-iX8wXLPW" role="doc-biblioref">1116</a>]</span>.</p>
+<p>Early efforts in LAV development relied on either the identification of a related virus that was less virulent in humans (e.g., cowpox/horsepox or rotavirus vaccines) or the culturing of a virus <em>in vitro</em> <span class="citation" data-cites="ZUHALvLg YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>,<a href="#ref-ZUHALvLg" role="doc-biblioref">1111</a>]</span>.
 Today, a virus can be attenuated by passaging it in a foreign host until, due to selection pressure, the virus loses its efficacy in the original host.
-Alternatively, selective gene deletion or codon deoptimization can be utilized to attenuate the virus <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.
-Foreign antigens can also be integrated into an attenuated viral vector <span class="citation" data-cites="4RuaSyLg">[<a href="#ref-4RuaSyLg" role="doc-biblioref">1116</a>]</span>.
-LAVs are also favored because they tend to be restricted to viral replication in the tissues around the location of inoculation <span class="citation" data-cites="iX8wXLPW">[<a href="#ref-iX8wXLPW" role="doc-biblioref">1117</a>]</span>, and some can be administered intranasally <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.</p>
-<p>The first deliberate (albeit pathogen-naïve) attempt to develop an attenuated viral vaccine dates back to Louis Pasteur in 1885.
-The next intentional LAVs were developed against the yellow fever virus in 1935 and influenza in 1936 <span class="citation" data-cites="iX8wXLPW">[<a href="#ref-iX8wXLPW" role="doc-biblioref">1117</a>]</span>.
-Today, LAVs are used globally to prevent diseases caused by viruses such as measles, rubella, polio, influenza, varicella zoster, and the yellow fever virus <span class="citation" data-cites="wZ2tXSUH">[<a href="#ref-wZ2tXSUH" role="doc-biblioref">1118</a>]</span>.
+Alternatively, selective gene deletion or codon deoptimization can be utilized to attenuate the virus <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>, or foreign antigens can be integrated into an attenuated viral vector <span class="citation" data-cites="4RuaSyLg">[<a href="#ref-4RuaSyLg" role="doc-biblioref">1117</a>]</span>.
+LAVs tend to be restricted to viral replication in the tissues around the location of inoculation <span class="citation" data-cites="iX8wXLPW">[<a href="#ref-iX8wXLPW" role="doc-biblioref">1116</a>]</span>, and some can be administered intranasally <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.</p>
+<p>Today, LAVs are used globally to prevent diseases caused by viruses such as measles, rubella, polio, influenza, varicella zoster, and the yellow fever virus <span class="citation" data-cites="wZ2tXSUH">[<a href="#ref-wZ2tXSUH" role="doc-biblioref">1118</a>]</span>.
 There were attempts to develop LAVs against both SARS-CoV-1 and MERS-CoV <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span>, but no vaccines were approved.
 It is generally recognized that LAVs induce an immune response similar to natural infection, and they are favored because they induce long-lasting and robust immunity that can protect from disease.
 This strong protective effect is induced in part by the immune response to the range of viral antigens available from LAV, which tend to be more immunogenic than those from non-replicating vaccines <span class="citation" data-cites="zLL2yOJK 7RHpaAHu kC2tx3JC">[<a href="#ref-kC2tx3JC" role="doc-biblioref">1113</a>,<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-zLL2yOJK" role="doc-biblioref">1120</a>]</span>.</p>
@@ -3340,73 +3351,63 @@ <h3 data-number="6.4.2" id="application-to-covid-19"><span class="header-section
 <p>To date, LAVs have not been widely deployed against SARS-CoV-2 and COVID-19.
 All the same, there are several COVID-19 LAV candidates in the early (preclinical/phase I) stages of investigation.
 These candidates utilize different approaches.</p>
-<p>One candidate in the preclinical stage is YF-S0, a single-dose LAV developed at Belgium’s Katholieke Universiteit Leuven that uses live-attenuated yellow fever 17D (YF17D) as a vector for a noncleavable prefusion conformation of the SARS-CoV-2 antigen <span class="citation" data-cites="4RuaSyLg">[<a href="#ref-4RuaSyLg" role="doc-biblioref">1116</a>]</span>.
-YF-S0 induced a robust immune response in three animal models and prevented SARS-CoV-2 infection in macaques and hamsters <span class="citation" data-cites="4RuaSyLg">[<a href="#ref-4RuaSyLg" role="doc-biblioref">1116</a>]</span>.</p>
-<p>Other programs are exploring the development of codon deoptimized LAV <span class="citation" data-cites="nwyfEEPl iCUWeMfX xMxJTYge">[<a href="#ref-nwyfEEPl" role="doc-biblioref">1121</a>,<a href="#ref-iCUWeMfX" role="doc-biblioref">1122</a>,<a href="#ref-xMxJTYge" role="doc-biblioref">1123</a>]</span>.
-This approach followed the synthetic attenuated virus engineering (SAVE) strategy to select codon substitutions that are suboptimal for the virus <span class="citation" data-cites="Gnk3ge6D xMxJTYge">[<a href="#ref-xMxJTYge" role="doc-biblioref">1123</a>,<a href="#ref-Gnk3ge6D" role="doc-biblioref">1124</a>]</span>.
+<p>One candidate in the preclinical stage is YF-S0, a single-dose LAV developed at Belgium’s Katholieke Universiteit Leuven that uses live-attenuated yellow fever 17D (YF17D) as a vector for a noncleavable prefusion conformation of the SARS-CoV-2 antigen <span class="citation" data-cites="4RuaSyLg">[<a href="#ref-4RuaSyLg" role="doc-biblioref">1117</a>]</span>.
+YF-S0 induced a robust immune response in three animal models and prevented SARS-CoV-2 infection in macaques and hamsters <span class="citation" data-cites="4RuaSyLg">[<a href="#ref-4RuaSyLg" role="doc-biblioref">1117</a>]</span>.</p>
+<p>Other programs are developing codon deoptimized LAV candidates <span class="citation" data-cites="nwyfEEPl iCUWeMfX xMxJTYge">[<a href="#ref-nwyfEEPl" role="doc-biblioref">1121</a>,<a href="#ref-iCUWeMfX" role="doc-biblioref">1122</a>,<a href="#ref-xMxJTYge" role="doc-biblioref">1123</a>]</span>.
+This approach follows the synthetic attenuated virus engineering (SAVE) strategy to select codon substitutions that are suboptimal for the virus <span class="citation" data-cites="Gnk3ge6D xMxJTYge">[<a href="#ref-xMxJTYge" role="doc-biblioref">1123</a>,<a href="#ref-Gnk3ge6D" role="doc-biblioref">1124</a>]</span>.
 New York-based Codagenix and the Serum Institute of India reported a successful preclinical investigation <span class="citation" data-cites="xMxJTYge">[<a href="#ref-xMxJTYge" role="doc-biblioref">1123</a>]</span> of an intranasally administered deoptimized SARS-CoV-2 LAV known as COVI-VAC, and COVI-VAC entered phase I human trials and dosed its first participants in January 2021 <span class="citation" data-cites="iCUWeMfX bPMpOwp8">[<a href="#ref-iCUWeMfX" role="doc-biblioref">1122</a>,<a href="#ref-bPMpOwp8" role="doc-biblioref">1125</a>]</span>.
 This vaccine is optimized through the removal of the furin cleavage site (see <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span> for a discussion of this site’s importance) and deoptimization of 283 codons <span class="citation" data-cites="2VWtlcwJ">[<a href="#ref-2VWtlcwJ" role="doc-biblioref">1126</a>]</span>.
 The results of the COVI-VAC phase I human trials are expected soon.</p>
-<p>Another company, Meissa Vaccines in Kansas, U.S.A., which also develops vaccines for respiratory syncytial virus (RSV), has developed an intranasal live-attenuated chimeric vaccine.
+<p>Another company, Meissa Vaccines in Kansas, U.S., which also develops vaccines for respiratory syncytial virus (RSV), has developed an intranasal live-attenuated chimeric vaccine.
 Chimeric vaccines integrate genomic content from multiple viruses to create a more stable LAV <span class="citation" data-cites="14GSJSuHC">[<a href="#ref-14GSJSuHC" role="doc-biblioref">1127</a>]</span>.
 Enrollment for phase I human trials began in March 2021 and recruitment is ongoing <span class="citation" data-cites="iCUWeMfX 8ZMg94iW">[<a href="#ref-iCUWeMfX" role="doc-biblioref">1122</a>,<a href="#ref-8ZMg94iW" role="doc-biblioref">1128</a>]</span>.</p>
-<p>Finally, Bacillus Calmette-Guerin (BCG) vaccines that use LAVs are being investigated for the prophylaxis of COVID-19 (see Appendix). <!-- What are we doing with the appendix? Are we submitting it with one of the vaccines manuscripts? Should we link the Manubot version? -->
-The purpose of the BCG vaccine is to prevent tuberculosis, but non-specific effects against other respiratory illnesses have suggested a possible benefit against COVID-19 <span class="citation" data-cites="1CJtdlM6d">[<a href="#ref-1CJtdlM6d" role="doc-biblioref">1129</a>]</span>.
-However, a multicenter trial that randomly assigned participants 60 years and older to vaccination with BCG (n = 1008) or placebo (n = 1006) after 12 months of follow-up found that BCG vaccination had no effect on the incidence of SARS-CoV-2 or other respiratory infections <span class="citation" data-cites="eHrzWQ6D">[<a href="#ref-eHrzWQ6D" role="doc-biblioref">1130</a>]</span>.
+<p>Finally, Bacillus Calmette-Guerin (BCG) vaccines that use LAVs are being investigated for the prophylaxis of COVID-19 (see online Appendix <span class="citation" data-cites="yTsmmAYC">[<a href="#ref-yTsmmAYC" role="doc-biblioref">1129</a>]</span>).
+The purpose of the BCG vaccine is to prevent tuberculosis, but non-specific effects against other respiratory illnesses have suggested a possible benefit against COVID-19 <span class="citation" data-cites="1CJtdlM6d">[<a href="#ref-1CJtdlM6d" role="doc-biblioref">1130</a>]</span>.
+However, a multicenter trial that randomly assigned participants 60 years and older to vaccination with BCG (n = 1,008) or placebo (n = 1,006) found that BCG vaccination had no effect on the incidence of SARS-CoV-2 or other respiratory infections over the course of 12 months <span class="citation" data-cites="eHrzWQ6D">[<a href="#ref-eHrzWQ6D" role="doc-biblioref">1131</a>]</span>.
 Despite these negative findings, BCG vaccination did induce a stronger antibody and cytokine response following COVID-19 infection.
-Currently, investigations of BCG vaccines against COVID-19 are being sponsored by institutes in Australia in collaboration with the Bill and Melinda Gates Foundation <span class="citation" data-cites="9m3rP633">[<a href="#ref-9m3rP633" role="doc-biblioref">1131</a>]</span> and by Texas A&amp;M University in collaboration with numerous other U.S. institutions <span class="citation" data-cites="xdqxBruc">[<a href="#ref-xdqxBruc" role="doc-biblioref">1132</a>]</span>.</p>
-<p>While data is not yet available for human studies, in general, safety concerns previously associated with LAV have been largely mitigated in the modern manufacturing process.
+Currently, investigations of BCG vaccines against COVID-19 are being sponsored by institutes in Australia in collaboration with the Bill and Melinda Gates Foundation <span class="citation" data-cites="9m3rP633">[<a href="#ref-9m3rP633" role="doc-biblioref">1132</a>]</span> and by Texas A&amp;M University in collaboration with numerous other U.S. institutions <span class="citation" data-cites="xdqxBruc">[<a href="#ref-xdqxBruc" role="doc-biblioref">1133</a>]</span>.</p>
+<p>Safety data is not yet available for human studies of LAV COVID-19 vaccines.
+In general, though, safety concerns previously associated with LAV have been largely mitigated in the modern manufacturing process.
 Manufacturers use safe and reliable methods to produce large quantities of vaccines once they have undergone rigorous preclinical studies and clinical trials to evaluate their safety and efficacy.
-However, one remaining safety concern may be contributing to the relatively slow emergence of LAV candidates against COVID-19: they still may present risk to individuals who are immunocompromised <span class="citation" data-cites="bgKUtUIL">[<a href="#ref-bgKUtUIL" role="doc-biblioref">1133</a>]</span>, which is an even greater concern when dealing with a novel virus and disease.
+However, one remaining safety concern may be contributing to the relatively slow emergence of LAV candidates against COVID-19: they still may present risk to individuals who are immunocompromised <span class="citation" data-cites="bgKUtUIL">[<a href="#ref-bgKUtUIL" role="doc-biblioref">1134</a>]</span>, which is an even greater concern when dealing with a novel virus and disease.
 Additional data are needed to ascertain how this technology performs in the case of SARS-CoV-2.
 Despite the long and trusted history of LAV development, this vaccine strategy has not been favored against COVID-19, as other technologies have shown greater expediency and safety compared to the time-consuming nature of developing LAVs for a novel virus.</p>
 <h3 data-number="6.4.3" id="response-to-variants-of-concern"><span class="header-section-number">6.4.3</span> Response to Variants of Concern</h3>
-<p>While no phase 3 trial data is available for LAV vaccine candidates, some manufacturers have proactively sought to respond to the emergence of VOC.
+<p>While no phase III trial data is available for LAV vaccine candidates, some manufacturers have proactively sought to respond to the emergence of VOC.
 For example, a poster reported that Syrian golden hamsters who received COVI-VAC were significantly less likely to lose weight following viral challenge with the Beta VOC <span class="citation" data-cites="2VWtlcwJ">[<a href="#ref-2VWtlcwJ" role="doc-biblioref">1126</a>]</span>.
-Additionally, the protective effect of YF-S0 against VOC has been investigated in hamsters <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-Even for a small number of hamsters that developed breakthrough infections after exposure to the index strain or the Alpha variant, viral loads were very low <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-However, much higher rates of breakthrough infection and higher viral loads were observed when the hamsters were exposed to the Beta variant <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-Reduced seroconversion and nAb titers were also observed against the Beta and Gamma variants <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-As a result, a modified version of YF-S0, called YF-S0*, was developed to include a modified spike protein intended to increase immunogenicity by including the full spectrum of amino acids found in the Gamma VOC as well as stabilizing the S protein’s conformation <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-No breakthrough infections were observed following vaccination with YF-S0 and exposure to the index strain and the Alpha, Beta, Gamma, and Delta variants <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-YF-S0* also reduced viral shedding for several VOC relative to YF-S0 <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>, and it was also observed to produce significantly more nAbs against the Omicron variant <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1134</a>]</span>.
-Therefore, while data from human studies are not available, preclinical results suggest that LAV vaccines likely confer some protection against VOC even when designed with the index strain and that modifications to the design may make this protection more robust as SARS-CoV-2 evolves.</p>
+Additionally, the protective effect of YF-S0 against VOC has been investigated in hamsters <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+Even for a small number of hamsters that developed breakthrough infections after exposure to the index strain or the Alpha variant, viral loads were very low <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+However, much higher rates of breakthrough infection and higher viral loads were observed when the hamsters were exposed to the Beta variant <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+Reduced seroconversion and neutralizing antibody (nAb) titers were also observed against the Beta and Gamma variants <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+As a result, a modified version of YF-S0, called YF-S0*, was developed to include a modified spike protein intended to increase immunogenicity by including the full spectrum of amino acids found in the Gamma VOC as well as stabilizing the S protein’s conformation <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+No breakthrough infections were observed following vaccination with YF-S0 and exposure to the index strain and the Alpha, Beta, Gamma, and Delta variants <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+YF-S0* also reduced viral shedding for several VOC relative to YF-S0 <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>, and it was also observed to produce significantly more nAbs against the Omicron variant <span class="citation" data-cites="z1FVz33g">[<a href="#ref-z1FVz33g" role="doc-biblioref">1135</a>]</span>.
+Therefore, while data from human studies are not available, preclinical results suggest that LAV vaccines likely confer some protection against VOC even when designed with the index strain.
+Modifications to the design may make this protection more robust as SARS-CoV-2 evolves.</p>
 <h2 data-number="6.5" id="inactivated-whole-virus-vaccines"><span class="header-section-number">6.5</span> Inactivated Whole-Virus Vaccines</h2>
 <p>Inactivated whole-virus (IWV) vaccines are another well-established vaccine platform.
-This type of vaccines uses full virus particles generally produced via cell culture that have been rendered non-infectious by chemical (i.e., formaldehyde or β-propiolactone <span class="citation" data-cites="PwjPrwXa">[<a href="#ref-PwjPrwXa" role="doc-biblioref">1135</a>]</span>) or physical (i.e., heat or ultraviolet radiation) means.
+This platform uses full virus particles generally produced via cell culture that have been rendered non-infectious by chemical (i.e., formaldehyde or β-propiolactone <span class="citation" data-cites="PwjPrwXa">[<a href="#ref-PwjPrwXa" role="doc-biblioref">1136</a>]</span>) or physical (i.e., heat or ultraviolet radiation) means.
 In general, these vaccines mimic the key properties of the virus that stimulate a robust immune response, but the risk of adverse reactions is reduced because the virus is inactivated and thus unable to replicate.
 Though these viral particles are inactivated, they retain the capacity to prime the immune system.
-The size of the virus particle makes it ideal for uptake by an antigen-presenting cell, which leads to the stimulation of helper T-cells <span class="citation" data-cites="7Knbo28h">[<a href="#ref-7Knbo28h" role="doc-biblioref">1136</a>]</span>.
-Additionally, the array of epitopes on the surface of the virus increases antibody binding efficiency <span class="citation" data-cites="7Knbo28h">[<a href="#ref-7Knbo28h" role="doc-biblioref">1136</a>]</span>.
-The native conformation of the surface proteins, which is also important for eliciting an immune response, is preserved using these techniques <span class="citation" data-cites="10peSXMZx">[<a href="#ref-10peSXMZx" role="doc-biblioref">1137</a>]</span>.
-Membrane proteins, which support B-cell responses to surface proteins, are also induced by this method <span class="citation" data-cites="iAa7uWOm">[<a href="#ref-iAa7uWOm" role="doc-biblioref">1138</a>]</span>.</p>
+The size of the viral particle makes it ideal for uptake by antigen-presenting cells, which leads to the stimulation of helper T-cells <span class="citation" data-cites="7Knbo28h">[<a href="#ref-7Knbo28h" role="doc-biblioref">1137</a>]</span>.
+Additionally, the array of epitopes on the surface of the virus increases antibody binding efficiency <span class="citation" data-cites="7Knbo28h">[<a href="#ref-7Knbo28h" role="doc-biblioref">1137</a>]</span>.
+The native conformation of the surface proteins, which is also important for eliciting an immune response, is preserved using these techniques <span class="citation" data-cites="10peSXMZx">[<a href="#ref-10peSXMZx" role="doc-biblioref">1138</a>]</span>.
+Membrane proteins, which support B-cell responses to surface proteins, are also induced by this method <span class="citation" data-cites="iAa7uWOm">[<a href="#ref-iAa7uWOm" role="doc-biblioref">1139</a>]</span>.</p>
 <p>IWV vaccines have been a valuable tool in efforts to control many viruses.
 Some targets of IWV vaccines have included influenza viruses, poliovirus, and hepatitis A virus.
-Inactivated vaccines can generally be generated relatively quickly once the pathogenic virus has been isolated and can be passaged in cell culture <span class="citation" data-cites="7RHpaAHu xQSh0vVt">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-xQSh0vVt" role="doc-biblioref">1139</a>]</span>; the fact that these vaccines have not emerged as quickly as nucleic acid vaccines for SARS-CoV-2 may be due to significant investment in the infrastructure for nucleic acid vaccine technologies <span class="citation" data-cites="l28xUYm7">[<a href="#ref-l28xUYm7" role="doc-biblioref">1140</a>]</span>, which are more modular and immunogenic <span class="citation" data-cites="nPuLx9h5">[<a href="#ref-nPuLx9h5" role="doc-biblioref">328</a>]</span>.</p>
+Inactivated vaccines can generally be generated relatively quickly once the pathogenic virus has been isolated and can be passaged in cell culture <span class="citation" data-cites="7RHpaAHu xQSh0vVt">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-xQSh0vVt" role="doc-biblioref">1140</a>]</span>; the fact that these vaccines have not emerged as quickly as nucleic acid vaccines for SARS-CoV-2 may be due to significant investment in the infrastructure for nucleic acid vaccine technologies <span class="citation" data-cites="l28xUYm7">[<a href="#ref-l28xUYm7" role="doc-biblioref">1141</a>]</span>, which are more modular and immunogenic <span class="citation" data-cites="nPuLx9h5">[<a href="#ref-nPuLx9h5" role="doc-biblioref">328</a>]</span>.</p>
 <p>Past applications to human coronaviruses (HCoV) have focused predominantly on SARS-CoV-1.
 Preclinical studies have demonstrated that IWV SARS-CoV-1 vaccine candidates elicited immune responses <em>in vivo</em>.
-These vaccines generated neutralizing antibody titers at concentrations similar to those evoked by recombinant protein vaccines <span class="citation" data-cites="1DymXCWa0 10peSXMZx">[<a href="#ref-10peSXMZx" role="doc-biblioref">1137</a>,<a href="#ref-1DymXCWa0" role="doc-biblioref">1141</a>]</span>.
-Studies in ferrets and non-human primates demonstrated that IWV vaccines can offer protection against infection due to neutralizing antibody and SARS-CoV-1-specific T cell responses <span class="citation" data-cites="4Hh1wpwV">[<a href="#ref-4Hh1wpwV" role="doc-biblioref">1142</a>]</span>.
-However, several attempts to develop IWV vaccines against both SARS-CoV-1 and MERS-CoV were hindered by incidences of vaccine-associated disease enhancement (VADE) in preclinical studies <span class="citation" data-cites="4AwyoMvQ">[<a href="#ref-4AwyoMvQ" role="doc-biblioref">1143</a>]</span>.
-In one example of a study in macaques, an inactivated SARS-CoV-1 vaccine induced even more severe lung damage than the virus due to an enhanced immune reaction <span class="citation" data-cites="ZXAfLbxM">[<a href="#ref-ZXAfLbxM" role="doc-biblioref">1144</a>]</span>.
-Independent studies in mice also demonstrated evidence of lung immunopathology due to VADE in response to MERS-CoV IWV vaccination <span class="citation" data-cites="ihrfEtMq 8qw9OBKX">[<a href="#ref-ihrfEtMq" role="doc-biblioref">1145</a>,<a href="#ref-8qw9OBKX" role="doc-biblioref">1146</a>]</span>.
-The exact mechanisms responsible for VADE remain elusive due to the specificity of the virus-host interactions involved, but VADE is the subject of investigation in preclinical SARS-CoV-2 vaccine studies to ensure the safety of any potential vaccines that may reach phase I trials and beyond <span class="citation" data-cites="4AwyoMvQ">[<a href="#ref-4AwyoMvQ" role="doc-biblioref">1143</a>]</span>.</p>
+These vaccines generated nAb titers at concentrations similar to those evoked by recombinant protein vaccines <span class="citation" data-cites="1DymXCWa0 10peSXMZx">[<a href="#ref-10peSXMZx" role="doc-biblioref">1138</a>,<a href="#ref-1DymXCWa0" role="doc-biblioref">1142</a>]</span>.
+Studies in ferrets and non-human primates demonstrated that IWV vaccines can offer protection against infection due to nAb and SARS-CoV-1-specific T cell responses <span class="citation" data-cites="4Hh1wpwV">[<a href="#ref-4Hh1wpwV" role="doc-biblioref">1143</a>]</span>.
+However, several attempts to develop IWV vaccines against both SARS-CoV-1 and MERS-CoV were hindered by incidences of vaccine-associated disease enhancement (VADE) in preclinical studies <span class="citation" data-cites="4AwyoMvQ">[<a href="#ref-4AwyoMvQ" role="doc-biblioref">1144</a>]</span>.
+In one example of a study in macaques, an inactivated SARS-CoV-1 vaccine induced even more severe lung damage than the virus due to an enhanced immune reaction <span class="citation" data-cites="ZXAfLbxM">[<a href="#ref-ZXAfLbxM" role="doc-biblioref">1145</a>]</span>.
+Independent studies in mice also demonstrated evidence of lung immunopathology due to VADE in response to MERS-CoV IWV vaccination <span class="citation" data-cites="ihrfEtMq 8qw9OBKX">[<a href="#ref-ihrfEtMq" role="doc-biblioref">1146</a>,<a href="#ref-8qw9OBKX" role="doc-biblioref">1147</a>]</span>.
+The exact mechanisms responsible for VADE remain elusive due to the specificity of the virus-host interactions involved, but VADE is the subject of investigation in preclinical SARS-CoV-2 vaccine studies to ensure the safety of any potential vaccines that may reach phase I trials and beyond <span class="citation" data-cites="4AwyoMvQ">[<a href="#ref-4AwyoMvQ" role="doc-biblioref">1144</a>]</span>.</p>
 <h3 data-number="6.5.1" id="application-to-covid-19-1"><span class="header-section-number">6.5.1</span> Application to COVID-19</h3>
-<p>Several whole-virus vaccines have been developed against COVID-19 and are available in countries around the world (Table <a href="#tbl:approved-whole-virus">2</a>).
-As of August 11, 2022, 10 vaccines developed with IWV technology are being distributed in 116 countries (Figure <a href="#fig:iwv-distrib">6</a>).</p>
-<div id="fig:iwv-distrib" class="fignos">
-<figure>
-<img src="https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/inactivated.png" alt="Figure 6: Worldwide availability of vaccines developed using inactivated whole viruses. This figure reflects the number of vaccines based on whole inactivated virus technology that were available in each country as of August 11, 2022. These data are retrieved from Our World in Data [522] and plotted using geopandas [1147]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
-<figcaption aria-hidden="true"><span>Figure 6:</span> <strong>Worldwide availability of vaccines developed using inactivated whole viruses.</strong>
-This figure reflects the number of vaccines based on whole inactivated virus technology that were available in each country as of August 11, 2022.
-These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1147</a>]</span>.
-See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.</figcaption>
-</figure>
-</div>
-<!-- Need to refer to this table in the text somewhere. May make sense to add it to the sentence that refers to the figure to point out how many are distributed and that more are approved (if that is the correct interpretation). -->
 <div id="tbl:approved-whole-virus" class="tablenos">
 <table id="tbl:approved-whole-virus">
-<caption><span>Table 2:</span> Inactivated whole-virus vaccines approved in at least one country <span class="citation" data-cites="jswAyWIs">[<a href="#ref-jswAyWIs" role="doc-biblioref">1148</a>]</span> as of August 10, 2022
+<caption><span>Table 2:</span> Inactivated whole-virus vaccines approved in at least one country <span class="citation" data-cites="jswAyWIs">[<a href="#ref-jswAyWIs" role="doc-biblioref">1148</a>]</span> as of August 15, 2022.
 </caption>
 <colgroup>
 <col style="width: 30%" />
@@ -3466,89 +3467,104 @@ <h3 data-number="6.5.1" id="application-to-covid-19-1"><span class="header-secti
 </tbody>
 </table>
 </div>
+<p>Several whole-virus vaccines have been developed against COVID-19 and are available in countries around the world (Table <a href="#tbl:approved-whole-virus">2</a>).
+As of August 15, 2022, 10 vaccines developed with IWV technology are being distributed in 116 countries (Figure <a href="#fig:iwv-distrib">6</a>).</p>
+<div id="fig:iwv-distrib" class="fignos">
+<figure>
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/inactivated.png" alt="Figure 6: Worldwide availability of vaccines developed using inactivated whole viruses. This figure reflects the number of vaccines based on whole inactivated virus technology that were available in each country as of August 15, 2022. These data are retrieved from Our World in Data [522] and plotted using geopandas [1149]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<figcaption aria-hidden="true"><span>Figure 6:</span> <strong>Worldwide availability of vaccines developed using inactivated whole viruses.</strong>
+This figure reflects the number of vaccines based on whole inactivated virus technology that were available in each country as of August 15, 2022.
+These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1149</a>]</span>.
+See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.</figcaption>
+</figure>
+</div>
 <p>One of those, CoronaVac, was developed by Beijing-based biopharmaceutical company Sinovac.
 The developers inactivated a SARS-CoV-2 strain collected in China with β-propiolactone and propagated it using Vero cells <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span>.
 The vaccine is coupled with an aluminum adjuvant to increase immunogenicity <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span>.
-In phase I and II clinical trials, CoronaVac elicited a strong immunogenic response in animal models and the development of neutralizing antibodies in human participants <span class="citation" data-cites="Ozya5HP5 14fILrRWg N1txjPtt">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1149</a>,<a href="#ref-14fILrRWg" role="doc-biblioref">1150</a>,<a href="#ref-N1txjPtt" role="doc-biblioref">1151</a>]</span>.
-Administration followed a prime-boost regimen using a 0.5 ml dose containing 3 μg of inactivated SARS-CoV-2 virus per dose <span class="citation" data-cites="1A5wiKQAW">[<a href="#ref-1A5wiKQAW" role="doc-biblioref">1152</a>]</span>.
-Results from a two-dose phase III trial following a 14-day prime boost became available in late 2020 <span class="citation" data-cites="1FF7JOwSH">[<a href="#ref-1FF7JOwSH" role="doc-biblioref">1153</a>]</span>, and an interim analysis identified specific IgG neutralizing antibodies against the S1 receptor binding domain (RBD) and a robust IFN-γ secreting T cell response was induced via immunization with CoronaVac <span class="citation" data-cites="UERG6dAd">[<a href="#ref-UERG6dAd" role="doc-biblioref">1154</a>]</span>.
+In phase I and II clinical trials, CoronaVac elicited a strong immunogenic response in animal models and the development of nAbs in human participants <span class="citation" data-cites="Ozya5HP5 14fILrRWg N1txjPtt">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1150</a>,<a href="#ref-14fILrRWg" role="doc-biblioref">1151</a>,<a href="#ref-N1txjPtt" role="doc-biblioref">1152</a>]</span>.
+Administration followed a prime-boost regimen using a 0.5 ml dose containing 3 μg of inactivated SARS-CoV-2 virus per dose <span class="citation" data-cites="1A5wiKQAW">[<a href="#ref-1A5wiKQAW" role="doc-biblioref">1153</a>]</span>.</p>
+<p>Results from a two-dose phase III trial following a 14-day prime boost became available in late 2020 <span class="citation" data-cites="1FF7JOwSH">[<a href="#ref-1FF7JOwSH" role="doc-biblioref">1154</a>]</span>, and an interim analysis identified specific IgG nAbs against the S1 receptor binding domain (RBD) and a robust IFN-γ secreting T cell response was induced via immunization with CoronaVac <span class="citation" data-cites="UERG6dAd">[<a href="#ref-UERG6dAd" role="doc-biblioref">1155</a>]</span>.
 Safety analysis of the CoronaVac vaccine during the phase II trial revealed that most adverse reactions were either mild (grade 1) or moderate (grade 2) in severity.
-In adults aged 18 to 59 years receiving a variety of dosage schedules, site injection pain was consistently the most common symptom reported <span class="citation" data-cites="N1txjPtt">[<a href="#ref-N1txjPtt" role="doc-biblioref">1151</a>]</span>.
-In older adults, the most common local and systemic reactions were pain at the injection site (9%) and fever (3%), respectively <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1149</a>]</span>.
-In phase III trials, minimal side effects were reported <span class="citation" data-cites="1FF7JOwSH">[<a href="#ref-1FF7JOwSH" role="doc-biblioref">1153</a>]</span>.
-CoronaVac was approved for use in China and has been granted emergency use in XX countries, including Brazil, Cambodia, Chile, Colombia, Laos, Malaysia, Mexico, Turkey, Ukraine, and Uruguay <span class="citation" data-cites="wByD9WaX sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>,<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.<!--Add template variable (still need this, ~and [82] is hard-coded~) -->
-As of August 2021, Sinovac had reportedly produced over a billion doses of CoronaVac <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.</p>
+In adults aged 18 to 59 years receiving a variety of dosage schedules, site injection pain was consistently the most common symptom reported <span class="citation" data-cites="N1txjPtt">[<a href="#ref-N1txjPtt" role="doc-biblioref">1152</a>]</span>.
+In older adults, the most common local and systemic reactions were pain at the injection site (9%) and fever (3%), respectively <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1150</a>]</span>.
+In phase III trials, minimal side effects were reported <span class="citation" data-cites="1FF7JOwSH">[<a href="#ref-1FF7JOwSH" role="doc-biblioref">1154</a>]</span>.</p>
+<p>Estimates of CoronaVac’s VE have varied across trials.
+CoronaVac demonstrated an efficacy of a little over 50% in Brazil, which was contested by Turkish officials claiming an efficacy of 91.25%, but ultimately after multiple announcements, the efficacy debate was settled at over 50% <span class="citation" data-cites="18mREgqUz V7MXd4X4">[<a href="#ref-18mREgqUz" role="doc-biblioref">1156</a>,<a href="#ref-V7MXd4X4" role="doc-biblioref">1157</a>]</span>.
+Subsequently, an interim analysis of the phase III randomized placebo-controlled trials conducted in Turkey enrolling 10,214 participants (approximately 2:1 vaccine:placebo) indicated efficacy of 83.5%, with minimal side effects reported <span class="citation" data-cites="1FF7JOwSH">[<a href="#ref-1FF7JOwSH" role="doc-biblioref">1154</a>]</span>, and a prospective national cohort study in Chile reported an adjusted estimated effectiveness of 66% for the prevention of COVID-19 with an estimated 90% and 87% prevention of hospitalization and death, respectively <span class="citation" data-cites="q2wQJULu">[<a href="#ref-q2wQJULu" role="doc-biblioref">1158</a>]</span>.</p>
+<p>CoronaVac was first approved in China and has now been distributed in 63 countries across Africa, Asia, Europe, North America, and South America, including Brazil, Cambodia, Chile, Colombia, Laos, Malaysia, Mexico, Turkey, Ukraine, and Uruguay <span class="citation" data-cites="wByD9WaX sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>,<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.
+As of August 2021, Sinovac had reportedly produced over a billion doses of CoronaVac <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.</p>
 <p>Two additional inactivated vaccine candidates were developed following a similar approach by the state-owned China National Pharmaceutical Group Co., Ltd., more commonly known as Sinopharm CNBG.
-One, known as BBIBP-CorV or Covilo, was developed in Beijing using the HB02 variant of SARS-CoV-2. <!-- We should make these easier to match to the rows in the table above. The name in the Vaccine column isn't similar to what we have in the text here, so we could add a cross-reference or synonym in the text. -->
-At Sinopharm CNBG’s Wuhan Institute, a second vaccine was developed using the WIV04 variant of SARS-CoV-2 <span class="citation" data-cites="miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1156</a>]</span>.
-The viruses were purified, propagated using Vero cells, isolated, and inactivated using β-propiolactone <span class="citation" data-cites="VlnLw2HV miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1156</a>,<a href="#ref-VlnLw2HV" role="doc-biblioref">1157</a>]</span>.
-Both vaccines are adjuvanted with aluminum hydroxide <span class="citation" data-cites="VlnLw2HV miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1156</a>,<a href="#ref-VlnLw2HV" role="doc-biblioref">1157</a>]</span>.
-Preclinical studies indicated that Covilo induced sufficient neutralizing antibody titers in mice, and a prime-boost immunization scheme of 2 μg/dose was sufficient to protect rhesus macaques from disease <span class="citation" data-cites="VlnLw2HV">[<a href="#ref-VlnLw2HV" role="doc-biblioref">1157</a>]</span>.
-For the other vaccine, neutralizing antibodies were detected in all groups 14 days after the final dose in the phase I part of the trial <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1158</a>]</span>, with similar findings reported in interim phase II data <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1158</a>]</span>.
-In phase II trials, the BBIBP-CorV vaccine appeared well-tolerated, with 23% of participants in the vaccine condition (482 total participants, 3:1, vaccine:placebo) reporting at least one adverse reaction characterized as mild to moderate <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1159</a>]</span>.
-In phase III trials, Sinopharm CNBG’s Covilo vaccine made from the WIV04 strain achieved an efficacy of 72.8% and was well tolerated <span class="citation" data-cites="yN5KOfvE">[<a href="#ref-yN5KOfvE" role="doc-biblioref">1160</a>]</span>.
-In July 2021, Covaxin’s overall vaccine efficacy was estimated at 77.8% for the prevention of COVID-19 based on a final enrollment of 25,798 people (approximately 1:1 vaccine:placebo) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1161</a>]</span>.
-However, some discrepancies arose in the reporting of VE.
-Sinopharm affiliates in the UAE in early December 2020 claimed the vaccine had 86% efficacy, which was later at odds with a Sinopharm Beijing affiliate that stated that Covilo had a 79.34% efficacy later that same month <span class="citation" data-cites="w7gO6yGn">[<a href="#ref-w7gO6yGn" role="doc-biblioref">1162</a>]</span>.</p>
-<p>Other programs have been led through industry partnerships with governmental organizations.
-Another IWV vaccine comes from India, where Bharat Biotech International Ltd., which is the biggest producer of vaccines globally, collaborated with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV) to develop Covaxin, also referred to as BBV152.
-Preclinical studies of Covaxin in hamsters <span class="citation" data-cites="bcGxW9fA">[<a href="#ref-bcGxW9fA" role="doc-biblioref">1163</a>]</span> and macaques <span class="citation" data-cites="GgdjKrYi">[<a href="#ref-GgdjKrYi" role="doc-biblioref">1164</a>]</span> indicated that the vaccine induced protective responses deemed sufficient to move forward to human trials.
-Phase I and phase I/II studies indicated that Covaxin adjuvanted with alum and a Toll-like receptor 7/8 (TLR7/8) agonist was safe and immunogenic and that it induced Th1-skewed memory T-cell responses <span class="citation" data-cites="CGuGeB7m GxQSMH5l">[<a href="#ref-CGuGeB7m" role="doc-biblioref">1165</a>,<a href="#ref-GxQSMH5l" role="doc-biblioref">1166</a>]</span>.
-Only mild to moderate side-effects reported upon immunization <span class="citation" data-cites="CGuGeB7m GxQSMH5l">[<a href="#ref-CGuGeB7m" role="doc-biblioref">1165</a>,<a href="#ref-GxQSMH5l" role="doc-biblioref">1166</a>]</span>.
-CoronaVac demonstrated an efficacy of a little over 50% in Brazil, which was contested by Turkish officials claiming an efficacy of 91.25%, but ultimately after multiple announcements, the efficacy debate was settled at over 50% <span class="citation" data-cites="18mREgqUz V7MXd4X4">[<a href="#ref-18mREgqUz" role="doc-biblioref">1167</a>,<a href="#ref-V7MXd4X4" role="doc-biblioref">1168</a>]</span>.
-Subsequently, an interim analysis of the phase III randomized placebo-controlled trials conducted in Turkey enrolling 10,214 participants (approximately 2:1 vaccine:placebo) indicated efficacy of 83.5%, with minimal side effects reported <span class="citation" data-cites="1FF7JOwSH">[<a href="#ref-1FF7JOwSH" role="doc-biblioref">1153</a>]</span>, and a prospective national cohort study in Chile reported an adjusted estimated effectiveness of 66% for the prevention of COVID-19 with an estimated 90% and 87% prevention of hospitalization and death, respectively <span class="citation" data-cites="q2wQJULu">[<a href="#ref-q2wQJULu" role="doc-biblioref">1169</a>]</span>.
-As of September 2021, Covaxin has been approved for emergency use in Guyana, India, Iran, Zimbabwe, Nepal, Mauritius, Mexico, Nepal, Paraguay, and the Philippines <span class="citation" data-cites="19tYVbg8H">[<a href="#ref-19tYVbg8H" role="doc-biblioref">1170</a>]</span>.<!--automate--></p>
-<p>Although IWV vaccine candidates were well-tolerated overall, both SinoVac’s CoronaVac and SinoPharm’s inactivated WIV04 vaccine trials were affected by concerns about adverse events.
-In CoronaVac’s trial of adults 18-59, 2% (n=7) of participants reported severe adverse events <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1149</a>]</span>, causing the trial to be halted for investigation <span class="citation" data-cites="aq22z8M7">[<a href="#ref-aq22z8M7" role="doc-biblioref">1171</a>]</span>.
-They were determined to be unrelated to the vaccine <span class="citation" data-cites="Ozya5HP5 aq22z8M7">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1149</a>,<a href="#ref-aq22z8M7" role="doc-biblioref">1171</a>]</span>, which is now widely distributed.
-Similarly, a trial of the SinoPharm WIV04 vaccine in Peru was briefly paused due to safety concerns in relation to neurological symptoms <span class="citation" data-cites="d09adg1G">[<a href="#ref-d09adg1G" role="doc-biblioref">1172</a>]</span>, but this was later deemed unrelated to the vaccine, and the trial continued <span class="citation" data-cites="nxEJTLGU">[<a href="#ref-nxEJTLGU" role="doc-biblioref">1173</a>]</span>.</p>
+One, known as BBIBP-CorV or Covilo, was developed in Beijing using the HB02 variant of SARS-CoV-2.
+At Sinopharm CNBG’s Wuhan Institute, a second vaccine was developed using the WIV04 variant of SARS-CoV-2 <span class="citation" data-cites="miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1160</a>]</span>.
+The viruses were purified, propagated using Vero cells, isolated, and inactivated using β-propiolactone <span class="citation" data-cites="VlnLw2HV miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1160</a>,<a href="#ref-VlnLw2HV" role="doc-biblioref">1161</a>]</span>.
+Both vaccines are adjuvanted with aluminum hydroxide <span class="citation" data-cites="VlnLw2HV miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1160</a>,<a href="#ref-VlnLw2HV" role="doc-biblioref">1161</a>]</span>.</p>
+<p>Preclinical studies indicated that Covilo induced sufficient nAb titers in mice, and a prime-boost immunization scheme of 2 μg/dose was sufficient to protect rhesus macaques from disease <span class="citation" data-cites="VlnLw2HV">[<a href="#ref-VlnLw2HV" role="doc-biblioref">1161</a>]</span>.
+For the other vaccine, nAbs were detected in all groups 14 days after the final dose in the phase I part of the trial <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1162</a>]</span>, with similar findings reported in interim phase II data <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1162</a>]</span>.
+In phase II trials, the BBIBP-CorV vaccine appeared well-tolerated, with 23% of participants in the vaccine condition (482 total participants, 3:1, vaccine:placebo) reporting at least one adverse reaction characterized as mild to moderate <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1163</a>]</span>.
+In phase III trials, Sinopharm CNBG’s Covilo vaccine made from the WIV04 strain achieved an efficacy of 72.8% and was well tolerated <span class="citation" data-cites="yN5KOfvE">[<a href="#ref-yN5KOfvE" role="doc-biblioref">1164</a>]</span>.
+Sinopharm affiliates in the UAE in early December 2020 claimed the vaccine had 86% efficacy, which was later at odds with a Sinopharm Beijing affiliate that stated that Covilo had a 79.34% efficacy later that same month <span class="citation" data-cites="w7gO6yGn">[<a href="#ref-w7gO6yGn" role="doc-biblioref">1165</a>]</span>.</p>
+<p>Other vaccine development programs have been led through industry partnerships with governmental organizations.
+Bharat Biotech International Ltd., which is the biggest producer of vaccines globally, collaborated with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV) to develop another IWV, Covaxin, which is also known as BBV152.
+Preclinical studies of Covaxin in hamsters <span class="citation" data-cites="bcGxW9fA">[<a href="#ref-bcGxW9fA" role="doc-biblioref">1166</a>]</span> and macaques <span class="citation" data-cites="GgdjKrYi">[<a href="#ref-GgdjKrYi" role="doc-biblioref">1167</a>]</span> indicated that the vaccine induced protective responses deemed sufficient to move forward to human trials.
+Phase I and phase I/II studies indicated that Covaxin adjuvanted with alum and a Toll-like receptor 7/8 (TLR7/8) agonist was safe and immunogenic and that it induced Th1-skewed memory T-cell responses <span class="citation" data-cites="CGuGeB7m GxQSMH5l">[<a href="#ref-CGuGeB7m" role="doc-biblioref">1168</a>,<a href="#ref-GxQSMH5l" role="doc-biblioref">1169</a>]</span>.
+Only mild to moderate side-effects were reported upon immunization <span class="citation" data-cites="CGuGeB7m GxQSMH5l">[<a href="#ref-CGuGeB7m" role="doc-biblioref">1168</a>,<a href="#ref-GxQSMH5l" role="doc-biblioref">1169</a>]</span>.
+In July 2021, Covaxin’s overall vaccine efficacy was estimated at 77.8% for the prevention of COVID-19 based on a final enrollment of 25,798 people (approximately 1:1 vaccine:placebo) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1170</a>]</span>.
+Only mild to moderate side-effects reported upon immunization <span class="citation" data-cites="CGuGeB7m GxQSMH5l">[<a href="#ref-CGuGeB7m" role="doc-biblioref">1168</a>,<a href="#ref-GxQSMH5l" role="doc-biblioref">1169</a>]</span>, and in phase II trials, the BBIBP-CorV vaccine appeared well-tolerated, with 23% of participants in the vaccine condition (482 total participants, 3:1, vaccine:placebo) reporting at least one adverse reaction characterized as mild to moderate <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1163</a>]</span>.
+As of September 2021, Covaxin has been approved for emergency use in 30 countries across Africa, Asia, Europe, and South America, including Guyana, India, Iran, Zimbabwe, Nepal, Mauritius, Mexico, Nepal, Paraguay, and the Philippines <span class="citation" data-cites="19tYVbg8H">[<a href="#ref-19tYVbg8H" role="doc-biblioref">1171</a>]</span>.</p>
+<p>Although IWV vaccine candidates were well-tolerated overall, both Sinovac’s CoronaVac and Sinopharm’s inactivated WIV04 vaccine trials were affected by concerns about adverse events.
+In CoronaVac’s trial of adults 18-59, 2% (n=7) of participants reported severe adverse events <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1150</a>]</span>, causing the trial to be halted for investigation <span class="citation" data-cites="aq22z8M7">[<a href="#ref-aq22z8M7" role="doc-biblioref">1172</a>]</span>.
+They were determined to be unrelated to the vaccine <span class="citation" data-cites="Ozya5HP5 aq22z8M7">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1150</a>,<a href="#ref-aq22z8M7" role="doc-biblioref">1172</a>]</span>, which is now widely distributed.
+Similarly, a trial of the Sinopharm WIV04 vaccine in Peru was briefly paused due to safety concerns in relation to neurological symptoms <span class="citation" data-cites="d09adg1G">[<a href="#ref-d09adg1G" role="doc-biblioref">1173</a>]</span>, but this was later deemed unrelated to the vaccine, and the trial continued <span class="citation" data-cites="nxEJTLGU">[<a href="#ref-nxEJTLGU" role="doc-biblioref">1174</a>]</span>.</p>
 <h3 data-number="6.5.2" id="real-world-safety-and-efficacy"><span class="header-section-number">6.5.2</span> Real-World Safety and Efficacy</h3>
-<p>In the past, problems that arose during the manufacturing of IWV vaccines could present safety issues, but oversight of the manufacturing process has helped to improve IWV vaccine safety <span class="citation" data-cites="1Fybz4oKI">[<a href="#ref-1Fybz4oKI" role="doc-biblioref">1174</a>]</span>.
-Nevertheless, the departure from norms necessitated by the COVID-19 crisis raised concerns about whether oversight would occur at pre-pandemic standards <span class="citation" data-cites="1Fybz4oKI">[<a href="#ref-1Fybz4oKI" role="doc-biblioref">1174</a>]</span>.
+<p>In the past, problems that arose during the manufacturing of IWV vaccines could present safety issues, but oversight of the manufacturing process has helped to improve IWV vaccine safety <span class="citation" data-cites="1Fybz4oKI">[<a href="#ref-1Fybz4oKI" role="doc-biblioref">1175</a>]</span>.
+Nevertheless, the departure from norms necessitated by the COVID-19 crisis raised concerns about whether oversight would occur at pre-pandemic standards <span class="citation" data-cites="1Fybz4oKI">[<a href="#ref-1Fybz4oKI" role="doc-biblioref">1175</a>]</span>.
 In general, the IWV COVID-19 vaccines have reported very few issues with safety.
 Additionally, safety audits have proactively identified concerns.
-For example, in April 2022, the WHO suspended procurement of Covaxin from Bharat Pharmaceuticals due to concerns about deviation from good manufacturing practice in their production facilities <span class="citation" data-cites="19hWVUQQ">[<a href="#ref-19hWVUQQ" role="doc-biblioref">1175</a>]</span>.
+For example, in April 2022, the WHO suspended procurement of Covaxin from Bharat Pharmaceuticals due to concerns about deviation from good manufacturing practice in their production facilities <span class="citation" data-cites="19hWVUQQ">[<a href="#ref-19hWVUQQ" role="doc-biblioref">1176</a>]</span>.
 However, no safety issues had been reported in association with this vaccine.
-Rare cases of VADE have been reported in association with CoronaVac <span class="citation" data-cites="14KuNOjDi">[<a href="#ref-14KuNOjDi" role="doc-biblioref">1176</a>]</span>.</p>
+Rare cases of VADE have been reported in association with CoronaVac <span class="citation" data-cites="14KuNOjDi">[<a href="#ref-14KuNOjDi" role="doc-biblioref">1177</a>]</span>.</p>
 <p>More concern has arisen around the issue of efficacy.
 One of the major limitations of IWV vaccines is their susceptibility to losing efficacy due to mutations in the epitopes of the circulating virus <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
-This loss of specificity over time is likely to be influenced by the evolution of the virus, and specifically by the rate of evolution in the region of the genome that codes for the antigen.</p>
-<p>The Beta variant appears to be more resistant to neutralizing antibodies in sera from individuals immunized with Sinovac than the Alpha variant or wildtype virus, indicating that emerging variants may be of concern <span class="citation" data-cites="s2O5iyCV">[<a href="#ref-s2O5iyCV" role="doc-biblioref">1177</a>]</span>.
-In agreement with previous studies demonstrating sera from individuals vaccinated with Covaxin efficiently neutralized the Alpha variant (B.1.1.7) and the Delta variant (B.1.617.2) <span class="citation" data-cites="lr7INjf6 UYE3NvU4 IvOEe7bV">[<a href="#ref-lr7INjf6" role="doc-biblioref">1178</a>,<a href="#ref-UYE3NvU4" role="doc-biblioref">1179</a>,<a href="#ref-IvOEe7bV" role="doc-biblioref">1180</a>]</span>, the phase III trial reported a 65.2% efficacy against the Delta variant (B.1.617.2) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1161</a>]</span>.
-However, studies suggested the Beta variant was more resistant (compared to the wildtype and Alpha variants) to neutralizing antibodies in sera from individuals immunized with Sinovac <span class="citation" data-cites="s2O5iyCV">[<a href="#ref-s2O5iyCV" role="doc-biblioref">1177</a>]</span>.
-Another preprint determined that sera from individuals immunized with Covaxin had effective neutralizing antibodies against the Delta variant and the so-called Delta plus variant (AY.1) <span class="citation" data-cites="lr7INjf6">[<a href="#ref-lr7INjf6" role="doc-biblioref">1178</a>]</span>.
-Indeed, sera obtained from Covaxin boosted individuals (n = 13) <span class="citation" data-cites="r5HwkOx8">[<a href="#ref-r5HwkOx8" role="doc-biblioref">1181</a>]</span> and those who were vaccinated with Covaxin but recovered from a breakthrough infection (n=31) also neutralized the Omicron variant <span class="citation" data-cites="CqXCzqeS">[<a href="#ref-CqXCzqeS" role="doc-biblioref">1182</a>]</span>.</p>
-<p>Notably, a preprint reported that antisera (i.e., the antibody-contained component of the sera) from 12 people immunized with BBIBP-CorV exhibited neutralizing antibody capacity against the Beta variant (B.1.351), wild type SARS-CoV-2 (NB02), and one of the original variants of SARS-CoV-2 (D614G) <span class="citation" data-cites="w9KwrmQT">[<a href="#ref-w9KwrmQT" role="doc-biblioref">1183</a>]</span>.
-Another preprint including sera from 282 participants used a surrogate neutralizing assay, a test that generally correlates with neutralizing antibodies, to determine that Covilo appears to induce neutralizing antibodies against the binding of the RBD of wild type SARS-CoV-2 and the Alpha, Beta, and Delta variants to ACE2 <span class="citation" data-cites="GZ5Sf8Yd">[<a href="#ref-GZ5Sf8Yd" role="doc-biblioref">1184</a>]</span>.
-Indeed, a study showed that the Alpha variant exhibited very little resistance to neutralization by sera of those immunized with Covilo, but the Beta variant was more resistant to neutralization by almost a factor of 3 <span class="citation" data-cites="s2O5iyCV">[<a href="#ref-s2O5iyCV" role="doc-biblioref">1177</a>]</span>.
-The authors noted that no evidence of VADE was detected using this vaccine in phase II data <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1158</a>]</span>.</p>
-<p>Concern was raised about the efficacy of CoronaVac following reports that over 350 doctors became ill with COVID-19 in Indonesia despite being immunized with CoronaVac <span class="citation" data-cites="fs7G9HyV">[<a href="#ref-fs7G9HyV" role="doc-biblioref">1185</a>]</span>.
+This loss of specificity over time is likely to be influenced by the evolution of the virus, and specifically by the rate of evolution in the region of the genome that codes for the antigen.
+The Beta variant appears to be more resistant to nAbs in sera from individuals immunized with Sinovac than the Alpha variant or wildtype virus, indicating that emerging variants may be of concern <span class="citation" data-cites="s2O5iyCV">[<a href="#ref-s2O5iyCV" role="doc-biblioref">1178</a>]</span>.
+In agreement with previous studies demonstrating sera from individuals vaccinated with Covaxin efficiently neutralized the Alpha variant (B.1.1.7) and the Delta variant (B.1.617.2) <span class="citation" data-cites="lr7INjf6 UYE3NvU4 IvOEe7bV">[<a href="#ref-lr7INjf6" role="doc-biblioref">1179</a>,<a href="#ref-UYE3NvU4" role="doc-biblioref">1180</a>,<a href="#ref-IvOEe7bV" role="doc-biblioref">1181</a>]</span>, the phase III trial reported a 65.2% efficacy against the Delta variant (B.1.617.2) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1170</a>]</span>.
+However, studies suggested the Beta variant was more resistant (compared to the wildtype and Alpha variants) to nAbs in sera from individuals immunized with Sinovac <span class="citation" data-cites="s2O5iyCV">[<a href="#ref-s2O5iyCV" role="doc-biblioref">1178</a>]</span>.
+Another preprint determined that sera from individuals immunized with Covaxin had effective nAbs against the Delta variant and the so-called Delta plus variant (AY.1) <span class="citation" data-cites="lr7INjf6">[<a href="#ref-lr7INjf6" role="doc-biblioref">1179</a>]</span>.
+Indeed, sera obtained from Covaxin boosted individuals (n = 13) <span class="citation" data-cites="r5HwkOx8">[<a href="#ref-r5HwkOx8" role="doc-biblioref">1182</a>]</span> and those who were vaccinated with Covaxin but recovered from a breakthrough infection (n=31) also neutralized the Omicron variant <span class="citation" data-cites="CqXCzqeS">[<a href="#ref-CqXCzqeS" role="doc-biblioref">1183</a>]</span>.</p>
+<p>Notably, a preprint reported that antisera (i.e., the antibody-containing component of the sera) from 12 people immunized with BBIBP-CorV exhibited nAb capacity against the Beta variant (B.1.351), wild type SARS-CoV-2 (NB02), and one of the original variants of SARS-CoV-2 (D614G) <span class="citation" data-cites="w9KwrmQT">[<a href="#ref-w9KwrmQT" role="doc-biblioref">1184</a>]</span>.
+Another preprint including sera from 282 participants used a surrogate neutralizing assay, a test that generally correlates with nAbs, to determine that Covilo appears to induce nAbs against the binding of the RBD of wild type SARS-CoV-2 and the Alpha, Beta, and Delta variants to ACE2 <span class="citation" data-cites="GZ5Sf8Yd">[<a href="#ref-GZ5Sf8Yd" role="doc-biblioref">1185</a>]</span>.
+Indeed, a study showed that the Alpha variant exhibited very little resistance to neutralization by sera of those immunized with Covilo, but the Beta variant was more resistant to neutralization by almost a factor of 3 <span class="citation" data-cites="s2O5iyCV">[<a href="#ref-s2O5iyCV" role="doc-biblioref">1178</a>]</span>.
+The authors noted that no evidence of VADE was detected using this vaccine in phase II data <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1162</a>]</span>.</p>
+<p>Concern was raised about the efficacy of CoronaVac following reports that over 350 doctors became ill with COVID-19 in Indonesia despite being immunized with CoronaVac <span class="citation" data-cites="fs7G9HyV">[<a href="#ref-fs7G9HyV" role="doc-biblioref">1186</a>]</span>.
 In addition to concerns raised by the evolution of SARS-CoV-2, it is important to consider the duration of immunity over time.
-Studies are underway to determine whether a booster immunization is required for several IWV vaccines, including CoronaVac <span class="citation" data-cites="1GcPxd9Bn">[<a href="#ref-1GcPxd9Bn" role="doc-biblioref">1186</a>]</span> and Covaxin <span class="citation" data-cites="s1TGwKbT">[<a href="#ref-s1TGwKbT" role="doc-biblioref">1187</a>]</span>.
-A phase I/II clinical trial of CoronaVac in an elderly cohort (adults 60 years and older) in China determined that by 6 to 8 months following the second dose, neutralizing antibody titers were detected below the seropositive cutoff <span class="citation" data-cites="AcxNwvVQ">[<a href="#ref-AcxNwvVQ" role="doc-biblioref">1188</a>]</span>.
-One preprint has reported that 6 months after the second vaccination, a booster dose of CoronaVac markedly increased geometric mean titers of SARS-CoV-2 neutralizing antibodies <span class="citation" data-cites="1BPnaMPs4">[<a href="#ref-1BPnaMPs4" role="doc-biblioref">1189</a>]</span>.
-However, the reduction of neutralizing antibodies was ameliorated by a booster dose administered 8 months after the second CoronaVac dose.</p>
-<p>A preprint study of healthcare workers in China has since indicated that a booster shot of Covilo elevates B cell and T cell responses and increases neutralizing antibody titers <span class="citation" data-cites="QHtyW0Jz">[<a href="#ref-QHtyW0Jz" role="doc-biblioref">1190</a>]</span>.
-In May 2021, the UAE announced it would consider booster shots for all citizens who had been immunized with Covilo, which was shortly followed by a similar announcement in Bahrain, and by August 29<sup>th</sup>, 2021, the UAE mandated booster shots for all residents who had received Covilo <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.</p>
+Studies are underway to determine whether a booster immunization is required for several IWV vaccines, including CoronaVac <span class="citation" data-cites="1GcPxd9Bn">[<a href="#ref-1GcPxd9Bn" role="doc-biblioref">1187</a>]</span> and Covaxin <span class="citation" data-cites="s1TGwKbT">[<a href="#ref-s1TGwKbT" role="doc-biblioref">1188</a>]</span>.
+A phase I/II clinical trial of CoronaVac in an elderly cohort (adults 60 years and older) in China determined that by 6 to 8 months following the second dose, nAb titers were detected below the seropositive cutoff <span class="citation" data-cites="AcxNwvVQ">[<a href="#ref-AcxNwvVQ" role="doc-biblioref">1189</a>]</span>.
+One preprint has reported that 6 months after the second vaccination, a booster dose of CoronaVac markedly increased geometric mean titers of SARS-CoV-2 nAbs <span class="citation" data-cites="1BPnaMPs4">[<a href="#ref-1BPnaMPs4" role="doc-biblioref">1190</a>]</span>.
+However, the reduction of nAbs was ameliorated by a booster dose administered 8 months after the second CoronaVac dose.
+A preprint study of healthcare workers in China has since indicated that a booster shot of Covilo elevates B cell and T cell responses and increases nAb titers <span class="citation" data-cites="QHtyW0Jz">[<a href="#ref-QHtyW0Jz" role="doc-biblioref">1191</a>]</span>.
+In May 2021, the UAE announced it would consider booster shots for all citizens who had been immunized with Covilo, which was shortly followed by a similar announcement in Bahrain, and by August 29, 2021, the UAE mandated booster shots for all residents who had received Covilo <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.</p>
 <p>Additionally, heterologous vaccine boosters are also being considered in many cases.
-Indeed, Chinese <span class="citation" data-cites="9oJ3sbrk">[<a href="#ref-9oJ3sbrk" role="doc-biblioref">1191</a>]</span> and Chilean <span class="citation" data-cites="uPt61a0E">[<a href="#ref-uPt61a0E" role="doc-biblioref">1192</a>]</span> researchers have opted to investigate options to administer different vaccines (e.g., an mRNA vaccine dose) as a booster dose to individuals who have already received two doses of the IWV vaccine CoronaVac.
-Another study determined that using a viral-vectored vaccine (CanSino’s Convidecia) or an mRNA vaccine (Pfizer/BioNTech’s BNT162b2) instead of CoronaVac in a prime-boost vaccination regimen could induce a more robust immune response <span class="citation" data-cites="hcnFsRig 1Cd41ucny">[<a href="#ref-hcnFsRig" role="doc-biblioref">1193</a>,<a href="#ref-1Cd41ucny" role="doc-biblioref">1194</a>]</span>.
+Indeed, Chinese <span class="citation" data-cites="9oJ3sbrk">[<a href="#ref-9oJ3sbrk" role="doc-biblioref">1192</a>]</span> and Chilean <span class="citation" data-cites="uPt61a0E">[<a href="#ref-uPt61a0E" role="doc-biblioref">1193</a>]</span> researchers have opted to investigate options to administer different vaccines (e.g., an mRNA vaccine dose) as a booster dose to individuals who have already received two doses of the IWV vaccine CoronaVac.
+Another study determined that using a viral-vectored vaccine (CanSino’s Convidecia) or an mRNA vaccine (Pfizer/BioNTech’s BNT162b2) instead of CoronaVac in a prime-boost vaccination regimen could induce a more robust immune response <span class="citation" data-cites="hcnFsRig 1Cd41ucny">[<a href="#ref-hcnFsRig" role="doc-biblioref">1194</a>,<a href="#ref-1Cd41ucny" role="doc-biblioref">1195</a>]</span>.
 Today, booster immunization is suggested for several whole-virus vaccines.</p>
 <h2 data-number="6.6" id="subunit-vaccines"><span class="header-section-number">6.6</span> Subunit Vaccines</h2>
-<p>Efforts to overcome the limitations of live-virus vaccines led to the development of approaches first to inactivate viruses (circa 1900), leading to IWV vaccines, and then to purifying proteins from viruses cultured in eggs (circa 1920) <span class="citation" data-cites="YY3x3bBV dggZoRQD">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>,<a href="#ref-dggZoRQD" role="doc-biblioref">1195</a>]</span>.
+<p>Efforts to overcome the limitations of live-virus vaccines led to the development of approaches first to inactivate viruses (circa 1900), leading to IWV vaccines, and then to purifying proteins from viruses cultured in eggs (circa 1920) <span class="citation" data-cites="YY3x3bBV dggZoRQD">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>,<a href="#ref-dggZoRQD" role="doc-biblioref">1196</a>]</span>.
 The purification of proteins then set the stage for the development of subunit vaccines based on the principle that the immune system can be stimulated by introducing one or more proteins or peptides isolated from the virus.
 Today, such approaches often use antigens isolated from the surface of the viral particle that are key targets of the immune system (protein subunit vaccines).
-Protein subunit vaccines can stimulate antibodies and CD4<sup>+</sup> T-cell responses <span class="citation" data-cites="12eGVhH5I lH2HMMZi">[<a href="#ref-12eGVhH5I" role="doc-biblioref">1196</a>,<a href="#ref-lH2HMMZi" role="doc-biblioref">1197</a>]</span>.
-Advances in biological engineering have also facilitated the development of approaches like viral-like particle (VLP) vaccines, which assemble viral proteins using nanotechnology to induce an immune response <span class="citation" data-cites="99C1xJ2E 1Bxg7Wj6w">[<a href="#ref-99C1xJ2E" role="doc-biblioref">1198</a>,<a href="#ref-1Bxg7Wj6w" role="doc-biblioref">1199</a>]</span>.</p>
-<p>The main advantage of subunit approaches is they are considered very safe, as the antigen alone cannot cause an infection <span class="citation" data-cites="1FfwyYaj7 1Bxg7Wj6w">[<a href="#ref-1Bxg7Wj6w" role="doc-biblioref">1199</a>,<a href="#ref-1FfwyYaj7" role="doc-biblioref">1200</a>]</span>.
+Advances in biological engineering have also facilitated the development of approaches like viral-like particle (VLP) vaccines using nanotechnology <span class="citation" data-cites="99C1xJ2E">[<a href="#ref-99C1xJ2E" role="doc-biblioref">1197</a>]</span>.
+VLPs share the conformation of a virus’s capsid, thereby acting as an antigen, but lack the replication machinery <span class="citation" data-cites="lH2HMMZi">[<a href="#ref-lH2HMMZi" role="doc-biblioref">1198</a>]</span>.
+Both protein subunit and VLP vaccines thus mimic the principle of whole virus vaccines but lack the genetic material required for replication, removing the risk of infection <span class="citation" data-cites="1Bxg7Wj6w">[<a href="#ref-1Bxg7Wj6w" role="doc-biblioref">1199</a>]</span>.</p>
+<p>Unlike whole-virus vaccines, which introduce the whole virus, subunit vaccines stimulate the immune system by introducing one or more proteins or peptides of the virus that have been isolated.
+The main advantage of this platform is that subunit vaccines are considered very safe, as the antigen alone cannot cause an infection <span class="citation" data-cites="1FfwyYaj7">[<a href="#ref-1FfwyYaj7" role="doc-biblioref">1200</a>]</span>.
 Both protein subunit and VLP vaccines thus mimic the principle of whole virus vaccines but lack the genetic material required for replication, removing the risk of infection <span class="citation" data-cites="1Bxg7Wj6w">[<a href="#ref-1Bxg7Wj6w" role="doc-biblioref">1199</a>]</span>.
-The subunit approach is also favored for its consistency in production.
-The components can be designed for a highly targeted immune response to a specific pathogen using synthetic immunogenic particles, allowing the vaccine to be engineered to avoid allergen and reactogenic sequences <span class="citation" data-cites="124bnGvPp">[<a href="#ref-124bnGvPp" role="doc-biblioref">1201</a>]</span>.
-One limitation is that, in the case of protein subunit vaccines, adjuvants are usually required to boost the immune response <span class="citation" data-cites="mv42t1HV">[<a href="#ref-mv42t1HV" role="doc-biblioref">1202</a>]</span> (see Appendix).
-These adjuvants are immunogenic substances, which include, for example, alum (aluminum hydroxide), squalene- or saponin-based adjuvants, and Freund’s incomplete/complete adjuvants <span class="citation" data-cites="rioTBsLc 124bnGvPp">[<a href="#ref-124bnGvPp" role="doc-biblioref">1201</a>,<a href="#ref-rioTBsLc" role="doc-biblioref">1203</a>]</span>.</p>
+Protein subunit vaccines can stimulate antibodies and CD4<sup>+</sup> T-cell responses <span class="citation" data-cites="12eGVhH5I lH2HMMZi">[<a href="#ref-lH2HMMZi" role="doc-biblioref">1198</a>,<a href="#ref-12eGVhH5I" role="doc-biblioref">1201</a>]</span>.</p>
+<p>The subunit approach is also favored for its consistency in production.
+The components can be designed for a highly targeted immune response to a specific pathogen using synthetic immunogenic particles, allowing the vaccine to be engineered to avoid allergen and reactogenic sequences <span class="citation" data-cites="124bnGvPp">[<a href="#ref-124bnGvPp" role="doc-biblioref">1202</a>]</span>.
+One limitation is that, in the case of protein subunit vaccines, adjuvants are usually required to boost the immune response <span class="citation" data-cites="mv42t1HV">[<a href="#ref-mv42t1HV" role="doc-biblioref">1203</a>]</span> (see online Appendix <span class="citation" data-cites="yTsmmAYC">[<a href="#ref-yTsmmAYC" role="doc-biblioref">1129</a>]</span>).
+These adjuvants are immunogenic substances, which include, for example, alum (aluminum hydroxide), squalene- or saponin-based adjuvants, and Freund’s incomplete/complete adjuvants <span class="citation" data-cites="rioTBsLc 124bnGvPp">[<a href="#ref-124bnGvPp" role="doc-biblioref">1202</a>,<a href="#ref-rioTBsLc" role="doc-biblioref">1204</a>]</span>.</p>
 <div id="tbl:approved-subunit" class="tablenos">
 <table id="tbl:approved-subunit">
-<caption><span>Table 3:</span> Subunit vaccines approved for use in at least one country <span class="citation" data-cites="jswAyWIs">[<a href="#ref-jswAyWIs" role="doc-biblioref">1148</a>]</span> as of August 10, 2022.
+<caption><span>Table 3:</span> Subunit vaccines approved for use in at least one country <span class="citation" data-cites="jswAyWIs">[<a href="#ref-jswAyWIs" role="doc-biblioref">1148</a>]</span> as of August 15, 2022.
 </caption>
 <colgroup>
 <col style="width: 35%" />
@@ -3651,88 +3667,86 @@ <h2 data-number="6.6" id="subunit-vaccines"><span class="header-section-number">
 </tbody>
 </table>
 </div>
-<p>Protein subunit vaccine development efforts for both SARS-CoV-1 and MERS-CoV have mostly focused on the immunogenic RBD of the S protein <span class="citation" data-cites="cLAQnckq 1EirBATaN 1AOG59epD">[<a href="#ref-cLAQnckq" role="doc-biblioref">1204</a>,<a href="#ref-1EirBATaN" role="doc-biblioref">1205</a>,<a href="#ref-1AOG59epD" role="doc-biblioref">1206</a>]</span>.
-There have been several approaches investigated in the search for a potential SARS-CoV-1 vaccine, including vaccines targeting the full-length or trimeric S protein <span class="citation" data-cites="Ow2ICHez tzZeWNPV">[<a href="#ref-Ow2ICHez" role="doc-biblioref">1207</a>,<a href="#ref-tzZeWNPV" role="doc-biblioref">1208</a>]</span>, those focused on the RBD protein only <span class="citation" data-cites="1EirBATaN DsfTQFmb 1AOG59epD cLAQnckq">[<a href="#ref-cLAQnckq" role="doc-biblioref">1204</a>,<a href="#ref-1EirBATaN" role="doc-biblioref">1205</a>,<a href="#ref-1AOG59epD" role="doc-biblioref">1206</a>,<a href="#ref-DsfTQFmb" role="doc-biblioref">1209</a>]</span> or non-RBD S protein fragments <span class="citation" data-cites="tzZeWNPV IYjNaaqv">[<a href="#ref-tzZeWNPV" role="doc-biblioref">1208</a>,<a href="#ref-IYjNaaqv" role="doc-biblioref">1210</a>]</span>, as well as the N and M proteins <span class="citation" data-cites="HvO79P9u VUcwpJKL 7hbgOaiE">[<a href="#ref-HvO79P9u" role="doc-biblioref">1211</a>,<a href="#ref-VUcwpJKL" role="doc-biblioref">1212</a>,<a href="#ref-7hbgOaiE" role="doc-biblioref">1213</a>]</span>; these efforts have been thoroughly reviewed elsewhere <span class="citation" data-cites="9Zv0eLa9">[<a href="#ref-9Zv0eLa9" role="doc-biblioref">1214</a>]</span>.
-There have been examples of successful preclinical research including candidate RBD219N-1, a 218-amino-acid residue of the SARS-CoV-1 RBD that, when adjuvanted to aluminum hydroxide, was capable of eliciting a high RBD-specific and neutralizing antibody response in both pseudovirus and live virus infections of immunized mice <span class="citation" data-cites="8723Jsa">[<a href="#ref-8723Jsa" role="doc-biblioref">1215</a>]</span>.
-Other strategies investigating the potential use of the full length S DNA have also been investigated in mice and rhesus macaques, which elicited immune responses <span class="citation" data-cites="GurQD2dO">[<a href="#ref-GurQD2dO" role="doc-biblioref">1216</a>]</span>, but these responses were not as effective as the combination of S DNA and the S1 subunit protein together <span class="citation" data-cites="GurQD2dO T7W7hnB9">[<a href="#ref-GurQD2dO" role="doc-biblioref">1216</a>,<a href="#ref-T7W7hnB9" role="doc-biblioref">1217</a>]</span>.</p>
-<p>Similarly to the SARS-CoV-1 vaccine candidates, the MERS-CoV protein subunit vaccine candidates generally target the RBD <span class="citation" data-cites="9Zv0eLa9 1EirBATaN Mki0DaYb aApaHV1w deUFGhNI sfM5QV3m">[<a href="#ref-1EirBATaN" role="doc-biblioref">1205</a>,<a href="#ref-9Zv0eLa9" role="doc-biblioref">1214</a>,<a href="#ref-Mki0DaYb" role="doc-biblioref">1218</a>,<a href="#ref-aApaHV1w" role="doc-biblioref">1219</a>,<a href="#ref-deUFGhNI" role="doc-biblioref">1220</a>,<a href="#ref-sfM5QV3m" role="doc-biblioref">1221</a>]</span>, with some targeting the full length S protein <span class="citation" data-cites="oghHqZDt">[<a href="#ref-oghHqZDt" role="doc-biblioref">1222</a>]</span>, non-RBD protein fragments such as the SP3 peptide <span class="citation" data-cites="11Zz9H0Dl">[<a href="#ref-11Zz9H0Dl" role="doc-biblioref">1223</a>]</span>, and the recombinant N-terminal domain (rNTD) <span class="citation" data-cites="ZXsnsfvb">[<a href="#ref-ZXsnsfvb" role="doc-biblioref">1224</a>]</span>.
+<p>Protein subunit vaccine development efforts for both SARS-CoV-1 and MERS-CoV usually focused on the immunogenic RBD of the S protein <span class="citation" data-cites="cLAQnckq 1EirBATaN 1AOG59epD">[<a href="#ref-cLAQnckq" role="doc-biblioref">1205</a>,<a href="#ref-1EirBATaN" role="doc-biblioref">1206</a>,<a href="#ref-1AOG59epD" role="doc-biblioref">1207</a>]</span>.
+The search for a potential SARS-CoV-1 vaccine included the development of vaccines targeting the full-length or trimeric S protein <span class="citation" data-cites="Ow2ICHez tzZeWNPV">[<a href="#ref-Ow2ICHez" role="doc-biblioref">1208</a>,<a href="#ref-tzZeWNPV" role="doc-biblioref">1209</a>]</span>, those focused on the RBD protein only <span class="citation" data-cites="1EirBATaN DsfTQFmb 1AOG59epD cLAQnckq">[<a href="#ref-cLAQnckq" role="doc-biblioref">1205</a>,<a href="#ref-1EirBATaN" role="doc-biblioref">1206</a>,<a href="#ref-1AOG59epD" role="doc-biblioref">1207</a>,<a href="#ref-DsfTQFmb" role="doc-biblioref">1210</a>]</span> or non-RBD S protein fragments <span class="citation" data-cites="tzZeWNPV IYjNaaqv">[<a href="#ref-tzZeWNPV" role="doc-biblioref">1209</a>,<a href="#ref-IYjNaaqv" role="doc-biblioref">1211</a>]</span>, and those targeting the N and M proteins <span class="citation" data-cites="HvO79P9u VUcwpJKL 7hbgOaiE">[<a href="#ref-HvO79P9u" role="doc-biblioref">1212</a>,<a href="#ref-VUcwpJKL" role="doc-biblioref">1213</a>,<a href="#ref-7hbgOaiE" role="doc-biblioref">1214</a>]</span>.
+These efforts have been thoroughly reviewed elsewhere <span class="citation" data-cites="9Zv0eLa9">[<a href="#ref-9Zv0eLa9" role="doc-biblioref">1215</a>]</span>.
+There have been examples of successful preclinical research including candidate RBD219N-1, a 218-amino-acid residue of the SARS-CoV-1 RBD that, when adjuvanted to aluminum hydroxide, was capable of eliciting a high RBD-specific and nAb response in both pseudovirus and live virus infections of immunized mice <span class="citation" data-cites="8723Jsa">[<a href="#ref-8723Jsa" role="doc-biblioref">1216</a>]</span>.
+Other strategies investigating the potential use of the full length S DNA have also been investigated in mice and rhesus macaques, which elicited immune responses <span class="citation" data-cites="GurQD2dO">[<a href="#ref-GurQD2dO" role="doc-biblioref">1217</a>]</span>, but these responses were not as effective as the combination of S DNA and the S1 subunit protein together <span class="citation" data-cites="GurQD2dO T7W7hnB9">[<a href="#ref-GurQD2dO" role="doc-biblioref">1217</a>,<a href="#ref-T7W7hnB9" role="doc-biblioref">1218</a>]</span>.</p>
+<p>Similarly to the SARS-CoV-1 vaccine candidates, the MERS-CoV protein subunit vaccine candidates generally target the RBD <span class="citation" data-cites="9Zv0eLa9 1EirBATaN Mki0DaYb aApaHV1w deUFGhNI sfM5QV3m">[<a href="#ref-1EirBATaN" role="doc-biblioref">1206</a>,<a href="#ref-9Zv0eLa9" role="doc-biblioref">1215</a>,<a href="#ref-Mki0DaYb" role="doc-biblioref">1219</a>,<a href="#ref-aApaHV1w" role="doc-biblioref">1220</a>,<a href="#ref-deUFGhNI" role="doc-biblioref">1221</a>,<a href="#ref-sfM5QV3m" role="doc-biblioref">1222</a>]</span>, with some targeting the full length S protein <span class="citation" data-cites="oghHqZDt">[<a href="#ref-oghHqZDt" role="doc-biblioref">1223</a>]</span>, non-RBD protein fragments such as the SP3 peptide <span class="citation" data-cites="11Zz9H0Dl">[<a href="#ref-11Zz9H0Dl" role="doc-biblioref">1224</a>]</span>, and the recombinant N-terminal domain (rNTD) <span class="citation" data-cites="ZXsnsfvb">[<a href="#ref-ZXsnsfvb" role="doc-biblioref">1225</a>]</span>.
 No protein subunit vaccine for MERS-CoV has progressed beyond preclinical research to date.
-VLPs have been investigated for development of vaccines against MERS and SARS <span class="citation" data-cites="oqty7gXw eHe78HXD">[<a href="#ref-oqty7gXw" role="doc-biblioref">1225</a>,<a href="#ref-eHe78HXD" role="doc-biblioref">1226</a>]</span> including testing in animal models <span class="citation" data-cites="cnYnzav2 G87TcArN">[<a href="#ref-cnYnzav2" role="doc-biblioref">1227</a>,<a href="#ref-G87TcArN" role="doc-biblioref">1228</a>]</span>, but once again, only preclinical data against HCoV has been collected <span class="citation" data-cites="jLJEygoA">[<a href="#ref-jLJEygoA" role="doc-biblioref">1229</a>]</span>.
-However, protein subunit vaccines do play a role in public health and have contributed to vaccination against hepatitis B <span class="citation" data-cites="155fGivMy">[<a href="#ref-155fGivMy" role="doc-biblioref">1230</a>]</span> and pertussis <span class="citation" data-cites="CQog2bB7 1CYqHUt3n">[<a href="#ref-CQog2bB7" role="doc-biblioref">1231</a>,<a href="#ref-1CYqHUt3n" role="doc-biblioref">1232</a>]</span> since the 1980s and will likely continue to contribute to public health for the foreseeable future due to ongoing research in vaccines against influenza, SARS-CoV-2, Epstein-Barr virus, dengue virus, and human papillomavirus among others <span class="citation" data-cites="1FQlt5Lqz 8dSIiLCt aAYBP21H">[<a href="#ref-1FQlt5Lqz" role="doc-biblioref">1233</a>,<a href="#ref-8dSIiLCt" role="doc-biblioref">1234</a>,<a href="#ref-aAYBP21H" role="doc-biblioref">1235</a>]</span>.</p>
+VLPs have been investigated for development of vaccines against MERS and SARS <span class="citation" data-cites="oqty7gXw eHe78HXD">[<a href="#ref-oqty7gXw" role="doc-biblioref">1226</a>,<a href="#ref-eHe78HXD" role="doc-biblioref">1227</a>]</span> including testing in animal models <span class="citation" data-cites="cnYnzav2 G87TcArN">[<a href="#ref-cnYnzav2" role="doc-biblioref">1228</a>,<a href="#ref-G87TcArN" role="doc-biblioref">1229</a>]</span>, but once again, only preclinical data against HCoV has been collected <span class="citation" data-cites="jLJEygoA">[<a href="#ref-jLJEygoA" role="doc-biblioref">1230</a>]</span>.
+However, protein subunit vaccines do play a role in public health and have contributed to vaccination against hepatitis B <span class="citation" data-cites="155fGivMy">[<a href="#ref-155fGivMy" role="doc-biblioref">1231</a>]</span> and pertussis <span class="citation" data-cites="CQog2bB7 1CYqHUt3n">[<a href="#ref-CQog2bB7" role="doc-biblioref">1232</a>,<a href="#ref-1CYqHUt3n" role="doc-biblioref">1233</a>]</span> since the 1980s and will likely continue to contribute to public health for the foreseeable future due to ongoing research in vaccines against influenza, SARS-CoV-2, Epstein-Barr virus, dengue virus, and human papillomavirus among others <span class="citation" data-cites="1FQlt5Lqz 8dSIiLCt aAYBP21H">[<a href="#ref-1FQlt5Lqz" role="doc-biblioref">1234</a>,<a href="#ref-8dSIiLCt" role="doc-biblioref">1235</a>,<a href="#ref-aAYBP21H" role="doc-biblioref">1236</a>]</span>.</p>
 <h3 data-number="6.6.1" id="application-to-covid-19-2"><span class="header-section-number">6.6.1</span> Application to COVID-19</h3>
 <p>The development of subunit vaccines against SARS-CoV-2 is a remarkable achievement given the short period of time since the emergence of SARS-CoV-2 in late 2019, particularly considering these types of vaccines have not played a major role in previous pandemics.
-More than 20 protein subunit vaccines from companies such as Sanofi/GlaxoSmithKline, Nanogen, and the Serum Institute of India have entered clinical trials for COVID-19 since the beginning of the pandemic <span class="citation" data-cites="8dSIiLCt">[<a href="#ref-8dSIiLCt" role="doc-biblioref">1234</a>]</span>, 17 have been approved, and at least 10 are being administered worldwide <span class="citation" data-cites="sRy6js2o NdbXBY1h">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>,<a href="#ref-NdbXBY1h" role="doc-biblioref">1236</a>]</span>. <!-- Check template variable -->
-As of August 11, 2022, protein subunit vaccines are being distributed in at least 41 countries (Figure <a href="#fig:ps-distrib">7</a>).</p>
+More than 20 protein subunit vaccines from companies such as Sanofi/GlaxoSmithKline, Nanogen, and the Serum Institute of India have entered clinical trials for COVID-19 since the beginning of the pandemic <span class="citation" data-cites="8dSIiLCt">[<a href="#ref-8dSIiLCt" role="doc-biblioref">1235</a>]</span>, 17 have been approved, and at least 10 are being administered worldwide <span class="citation" data-cites="sRy6js2o NdbXBY1h">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>,<a href="#ref-NdbXBY1h" role="doc-biblioref">1237</a>]</span>.
+As of August 15, 2022, protein subunit vaccines are being distributed in at least 41 countries (Figure <a href="#fig:ps-distrib">7</a>).</p>
 <div id="fig:ps-distrib" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/protein_subunit.png" alt="Figure 7: Worldwide availability of vaccines developed using protein subunit. This figure reflects the number of vaccines based on protein subunit technology that were available in each country as of August 11, 2022. These data are retrieved from Our World in Data [522,1105] and plotted using geopandas [1147]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/protein_subunit.png" alt="Figure 7: Worldwide availability of vaccines developed using protein subunit. This figure reflects the number of vaccines based on protein subunit technology that were available in each country as of August 15, 2022. These data are retrieved from Our World in Data [522,1105] and plotted using geopandas [1149]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
 <figcaption aria-hidden="true"><span>Figure 7:</span> <strong>Worldwide availability of vaccines developed using protein subunit.</strong>
-This figure reflects the number of vaccines based on protein subunit technology that were available in each country as of August 11, 2022.
-These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj sRy6js2o">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>,<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1147</a>]</span>.
+This figure reflects the number of vaccines based on protein subunit technology that were available in each country as of August 15, 2022.
+These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj sRy6js2o">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>,<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1149</a>]</span>.
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.</figcaption>
 </figure>
 </div>
-<p>VLP vaccines have not progressed as rapidly: no data was available for worldwide distribution of VLP vaccines as of August 11, 2022 <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span>.
-Most of these vaccines are designed using either the full-length S protein or the RBD of the S protein specifically as an antigen, although some use several different SARS-CoV-2 proteins <span class="citation" data-cites="1FfwyYaj7">[<a href="#ref-1FfwyYaj7" role="doc-biblioref">1200</a>]</span>.</p>
+<p>VLP vaccines have not progressed as rapidly.
+Programs seeking to develop VLP vaccines have used either the full-length S protein or the RBD of the S protein specifically as an antigen, although some use several different SARS-CoV-2 proteins <span class="citation" data-cites="1FfwyYaj7">[<a href="#ref-1FfwyYaj7" role="doc-biblioref">1200</a>]</span>.
+As of August 15, 2022, only one VLP was available in one country (Canada) <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span>.<!--Canada/Covifenz info is hardcoded--></p>
 <div id="fig:vlp-distrib" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/VLP.png" alt="Figure 8: Worldwide availability of vaccines developed with VLPs. This figure reflects the number of vaccines based on VLP technology that were available in each country as of August 11, 2022. These data are retrieved from Our World in Data [522] and plotted using geopandas [1147]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/VLP.png" alt="Figure 8: Worldwide availability of vaccines developed with VLPs. This figure reflects the number of vaccines based on VLP technology that were available in each country as of August 15, 2022. These data are retrieved from Our World in Data [522] and plotted using geopandas [1149]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
 <figcaption aria-hidden="true"><span>Figure 8:</span> <strong>Worldwide availability of vaccines developed with VLPs.</strong>
-This figure reflects the number of vaccines based on VLP technology that were available in each country as of August 11, 2022.
-These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1147</a>]</span>.
+This figure reflects the number of vaccines based on VLP technology that were available in each country as of August 15, 2022.
+These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1149</a>]</span>.
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.</figcaption>
 </figure>
 </div>
 <h3 data-number="6.6.2" id="nuvaxovid"><span class="header-section-number">6.6.2</span> Nuvaxovid</h3>
 <p>One protein subunit vaccine for SARS-CoV-2 is NVX-CoV2373 or Nuvaxovid, produced by U.S. company Novavax and partners.
 NVX-CoV2373 is a protein nanoparticle vaccine constructed from a mutated prefusion SARS-CoV-2 spike protein in combination with a specialized saponin-based adjuvant to elicit an immune response against SARS-CoV-2.
-The spike protein is recombinantly expressed in Sf9 insect cells <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>]</span>, which have previously been used for several other FDA-approved protein therapeutics <span class="citation" data-cites="RQR2sOmx">[<a href="#ref-RQR2sOmx" role="doc-biblioref">1238</a>]</span>, and contains mutations in the furin cleavage site (682-RRAR-685 to 682-QQAQ-685) along with two proline substitutions (K986P and V987P) that improve thermostability <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>]</span>.</p>
-<p>In preclinical mouse models, Novavax-CoV2373 elicited high anti-spike IgG titers 21 to 28 days post-vaccination that could neutralize the SARS-CoV-2 virus and protect the animals against viral challenge, with particularly strong effects when administered with the proprietary adjuvant Matrix-M<sup>TM</sup> <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>]</span>.
-In a phase I/II trial, a two-dose regimen of NVX-CoV2373 was found to induce anti-spike IgG levels and neutralizing antibody-titers exceeding those observed in convalescent plasma donated by symptomatic patients <span class="citation" data-cites="dMLXxGAI">[<a href="#ref-dMLXxGAI" role="doc-biblioref">1239</a>]</span>.
+The spike protein is recombinantly expressed in Sf9 insect cells <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1238</a>]</span>, which have previously been used for several other FDA-approved protein therapeutics <span class="citation" data-cites="RQR2sOmx">[<a href="#ref-RQR2sOmx" role="doc-biblioref">1239</a>]</span>, and contains mutations in the furin cleavage site (682-RRAR-685 to 682-QQAQ-685) along with two proline substitutions (K986P and V987P) that improve thermostability <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1238</a>]</span>.</p>
+<p>In preclinical mouse models, Novavax-CoV2373 elicited high anti-spike IgG titers 21 to 28 days post-vaccination that could neutralize the SARS-CoV-2 virus and protect the animals against viral challenge, with particularly strong effects when administered with the proprietary adjuvant Matrix-M<sup>TM</sup> <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1238</a>]</span>.
+In a phase I/II trial, a two-dose regimen of NVX-CoV2373 was found to induce anti-spike IgG levels and nAb titers exceeding those observed in convalescent plasma donated by symptomatic patients <span class="citation" data-cites="dMLXxGAI">[<a href="#ref-dMLXxGAI" role="doc-biblioref">1240</a>]</span>.
 In line with the preclinical studies, the use of Matrix-M adjuvant further increased anti-spike immunoglobulin levels and induced a Th1 response.
-In a phase III randomized, observer-blinded, placebo-controlled clinical trial in 14,039 participants, two 5-μg doses of NVX-CoV2373 or placebo were administered 21 days apart in a 1:1 ratio from late September to late November 2020 <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1240</a>]</span>.
-The VE was estimated at 89.7% overall <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1240</a>]</span>.</p>
-<p>In the phase III trial, the efficacy of Novavax’s Nuvaxovid was reported to be 89.7%, with a total of 10 patients developing COVID-19 in the vaccine group versus 96 in the placebo group <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1240</a>]</span>.
+In a phase III randomized, observer-blinded, placebo-controlled clinical trial in 14,039 participants, two 5-μg doses of NVX-CoV2373 or placebo were administered 21 days apart in a 1:1 ratio from late September to late November 2020 <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1241</a>]</span>.</p>
+<p>In the phase III trial, the efficacy of Novavax’s Nuvaxovid was reported to be 89.7%, with a total of 10 patients developing COVID-19 in the vaccine group versus 96 in the placebo group <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1241</a>]</span>.
 No hospitalizations or deaths were reported in the vaccine group.
-An additional phase III randomized, observer-blinded, placebo-controlled trial was conducted in the U.S. and Mexico, enrolling 29,949 participants and administering at least 1 vaccine in a 2:1 ratio from late December 2020 to late February 2021 with the same primary endpoints as the U.K. trial <span class="citation" data-cites="oc5SBo0q">[<a href="#ref-oc5SBo0q" role="doc-biblioref">1241</a>]</span>.
+An additional phase III randomized, observer-blinded, placebo-controlled trial was conducted in the U.S. and Mexico, enrolling 29,949 participants and administering at least 1 vaccine in a 2:1 ratio from late December 2020 to late February 2021 with the same primary endpoints as the U.K. trial <span class="citation" data-cites="oc5SBo0q">[<a href="#ref-oc5SBo0q" role="doc-biblioref">1242</a>]</span>.
 A vaccine efficacy of 90.4% was reported based on 77 cases total, 63 of which occurred in the placebo group.
-All moderate to severe cases of COVID-19 occurred in the placebo group.
-Additionally, in both trials, the vaccine was found to be well-tolerated <span class="citation" data-cites="oc5SBo0q 1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1240</a>,<a href="#ref-oc5SBo0q" role="doc-biblioref">1241</a>]</span>.
-The conclusions of both trials indicate that the NVX-CoV2373 vaccine is safe and effective against COVID-19, and those who received this vaccine through the trials were considered fully vaccinated prior to the vaccine receiving an EUA <span class="citation" data-cites="1COb5Edqu">[<a href="#ref-1COb5Edqu" role="doc-biblioref">1242</a>]</span>.
-The Novavax vaccine has since been authorized for use in several places, including the United Kingdom <span class="citation" data-cites="q3wIcP4d">[<a href="#ref-q3wIcP4d" role="doc-biblioref">1243</a>]</span>, the E.U. <span class="citation" data-cites="P3YhxRob">[<a href="#ref-P3YhxRob" role="doc-biblioref">1244</a>]</span>, and the U.S.A <span class="citation" data-cites="x9xXbzuY">[<a href="#ref-x9xXbzuY" role="doc-biblioref">1245</a>]</span>.
-<!-- Need to indicate it is EUA? What have we been doing elsewhere? Deleted the line below about the June FDA vote, the actual EUA didn't come until July. -->.</p>
+All moderate to severe cases of COVID-19 occurred in the placebo group.</p>
+<p>The conclusions of both trials indicate that the NVX-CoV2373 vaccine is safe and effective against COVID-19.
+In both trials, the vaccine was found to be well-tolerated <span class="citation" data-cites="oc5SBo0q 1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1241</a>,<a href="#ref-oc5SBo0q" role="doc-biblioref">1242</a>]</span>.
+The Novavax vaccine has since been authorized for use in several places, including the United Kingdom <span class="citation" data-cites="q3wIcP4d">[<a href="#ref-q3wIcP4d" role="doc-biblioref">1243</a>]</span>, the E.U. <span class="citation" data-cites="P3YhxRob">[<a href="#ref-P3YhxRob" role="doc-biblioref">1244</a>]</span>, and the U.S. <span class="citation" data-cites="x9xXbzuY">[<a href="#ref-x9xXbzuY" role="doc-biblioref">1245</a>]</span>.</p>
 <h3 data-number="6.6.3" id="covifenz"><span class="header-section-number">6.6.3</span> Covifenz</h3>
 <p>The leading example of a VLP approach applied to COVID-19 comes from Covifenz, developed by Canadian company Medicago <span class="citation" data-cites="pxEbK2Vl">[<a href="#ref-pxEbK2Vl" role="doc-biblioref">1246</a>]</span>.
-This vaccine was developed using plant-based VLP technology <span class="citation" data-cites="18Xmc8WMR">[<a href="#ref-18Xmc8WMR" role="doc-biblioref">1247</a>]</span> that the company had been investigating in order to develop a high-throughput quadrivalent VLP platform to provide protection against influenza <span class="citation" data-cites="WqqE64cZ">[<a href="#ref-WqqE64cZ" role="doc-biblioref">1248</a>]</span>.</p>
-<p>The approach utilizes <em>Nicotiana benthamiana</em>, an Australian relative of the tobacco plant, as an upstream bioreactor <span class="citation" data-cites="WqqE64cZ 18mcJS5j4">[<a href="#ref-WqqE64cZ" role="doc-biblioref">1248</a>,<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
+This vaccine was developed using plant-based VLP technology <span class="citation" data-cites="18Xmc8WMR">[<a href="#ref-18Xmc8WMR" role="doc-biblioref">1247</a>]</span> that the company had been investigating in order to develop a high-throughput quadrivalent VLP platform to provide protection against influenza <span class="citation" data-cites="WqqE64cZ">[<a href="#ref-WqqE64cZ" role="doc-biblioref">1248</a>]</span>.
+The approach utilizes <em>Nicotiana benthamiana</em>, an Australian relative of the tobacco plant, as an upstream bioreactor <span class="citation" data-cites="WqqE64cZ 18mcJS5j4">[<a href="#ref-WqqE64cZ" role="doc-biblioref">1248</a>,<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
 Specifically, the <em>S</em> gene from SARS-CoV-2 in its prefusion conformation is inserted into a bacterial vector (<em>Agrobacterium tumefaciens</em>) that then infects the plant cells <span class="citation" data-cites="WqqE64cZ 18mcJS5j4">[<a href="#ref-WqqE64cZ" role="doc-biblioref">1248</a>,<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
 Expression of the S glycoprotein causes the production of VLPs composed of S trimers anchored in a lipid envelope that accumulate between the plasma membrane and the cell wall of the plant cell <span class="citation" data-cites="18mcJS5j4">[<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
 Because these VLPs do not contain the SARS-CoV-2 genome, they offer similar advantages to whole-virus vaccines while mitigating the risks <span class="citation" data-cites="WqqE64cZ 18mcJS5j4">[<a href="#ref-WqqE64cZ" role="doc-biblioref">1248</a>,<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.</p>
-<p>In the phase I study, Covifenz was administered to 180 Canadian adults 18-55 years old as two doses, 21 days apart, with three different dosages evaluated <span class="citation" data-cites="18mcJS5j4">[<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
-This study reported that when the VLPs were administered with an adjuvant, the vaccine elicited a neutralizing antibody that was significantly (approximately 10 times) higher than that in convalescent sera <span class="citation" data-cites="18mcJS5j4">[<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
-The phase III trial examined 24,141 adults assigned to the treatment and control conditions at a 1:1 ratio between March and September of 2021 <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.
-Similarly, Covifenz was reported to be 71% effective in preventing COVID-19 in the per-protocol analysis <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.
-Efficacy was only slightly lower in the intention-to-treat group at 69%.
-Prevention of moderate-to-severe disease was estimated at 78.8% in the intention-to-treat group.
+<p>In the phase I study, 180 Canadian adults ages 18 to 55 years old were administered Covifenz as two doses, 21 days apart, with three different dosages evaluated <span class="citation" data-cites="18mcJS5j4">[<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
+This study reported that when the VLPs were administered with an adjuvant, the vaccine elicited a nAb that was significantly (approximately 10 times) higher than that in convalescent sera <span class="citation" data-cites="18mcJS5j4">[<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span>.
+The phase III trial examined 24,141 adults assigned to the treatment and control conditions at a 1:1 ratio between March and September of 2021 <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.</p>
+<p>Covifenz was reported to be 71% effective in preventing COVID-19 in the per-protocol analysis <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.
+Efficacy was only slightly lower in the intention-to-treat group at 69%, with the VE for the prevention of moderate-to-severe disease in this group estimated at 78.8%.
 Over 24,000 participants were included in the safety analysis, which reported that 92.3% of vaccine recipients reported local adverse events compared to 45.5% of placebo recipients, with rates for systemic adverse events at 87.3% and 65.0%, respectively.
-However, the adverse effects reported were generally mild to moderate.
+The adverse effects reported were generally mild to moderate, with the most common adverse effects being injection site pain, headache, myalgia, fatigue, and general discomfort.
 Only three patients (two in the vaccine group) reported grade 4 events, all after the second dose.
-The most common adverse effects were injection site pain, headache, myalgia, fatigue, and general discomfort.
 The vaccine was approved for use in adults ages 18 to 65 by Health Canada in February 2022 <span class="citation" data-cites="1JmpfIPn">[<a href="#ref-1JmpfIPn" role="doc-biblioref">1251</a>]</span>.</p>
 <p>Plant-based expression systems such as this are relatively new <span class="citation" data-cites="18mcJS5j4">[<a href="#ref-18mcJS5j4" role="doc-biblioref">1249</a>]</span> but are likely to offer unparalleled feasibility at scale given the speed and low-cost associated with the platform <span class="citation" data-cites="kbvZWBoy">[<a href="#ref-kbvZWBoy" role="doc-biblioref">1252</a>]</span>.
 Additionally, the Covifenz vaccine can be stored at 2 to 8°C.
-However, the worldwide footprint of Covifenz, and of VLP-based technologies against SARS-CoV-2 broadly, remains small, with only 1 VLP vaccine approved for distribution in 1 countries (Figure <a href="#fig:vlp-distrib">8</a>).<!--Grammar needs update if anyone outside of Canada approves or if another VLP becomes active--><!--Check automation-->
+However, the worldwide footprint of Covifenz, and of VLP-based technologies against SARS-CoV-2 broadly, remains small, with only 1 VLP vaccine approved for distribution in 1 countries (Figure <a href="#fig:vlp-distrib">8</a>).
 Approval and administration of Covifenz in countries outside of Canada has been limited by concerns at the WHO about ties between Medicago and the tobacco industry <span class="citation" data-cites="pxEbK2Vl aEJzXfl6">[<a href="#ref-pxEbK2Vl" role="doc-biblioref">1246</a>,<a href="#ref-aEJzXfl6" role="doc-biblioref">1253</a>]</span>.
 While other species of plants have been explored as the upstream bioreactors for plant-derived VLPs, the specific species of tobacco used increased yield dramatically <span class="citation" data-cites="11WYMWwb">[<a href="#ref-11WYMWwb" role="doc-biblioref">1254</a>]</span>.</p>
 <h3 data-number="6.6.4" id="real-world-safety-and-efficacy-1"><span class="header-section-number">6.6.4</span> Real-World Safety and Efficacy</h3>
 <p>To date, data about the effect of viral evolution on the efficacy of subunit vaccines has been limited.
-<em>Post hoc</em> analysis in the phase III trial determined that the NovaVax vaccine had an efficacy of 86.3% against the Alpha variant (identified based on the presence/absence of the 69–70del polymorphism) and 96.4% against other variants <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1240</a>]</span>.
-In the second phase III trial <span class="citation" data-cites="oc5SBo0q">[<a href="#ref-oc5SBo0q" role="doc-biblioref">1241</a>]</span>, whole-genome sequencing was obtained from 61 of the 77 cases, and 79% of infections were identified as a VOC or variant of interest (VOI) that had been characterized at the time of the study.
-Vaccine efficacy against cases caused by VOC, among which the Alpha variant was predominant (88.6%), was reported to be 92.6% <span class="citation" data-cites="oc5SBo0q">[<a href="#ref-oc5SBo0q" role="doc-biblioref">1241</a>]</span>.
+<em>Post hoc</em> analysis in the phase III trial determined that the NovaVax vaccine had an efficacy of 86.3% against the Alpha variant (identified based on the presence/absence of the 69–70del polymorphism) and 96.4% against other variants <span class="citation" data-cites="1D0f8OrG8">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1241</a>]</span>.
+In the second phase III trial <span class="citation" data-cites="oc5SBo0q">[<a href="#ref-oc5SBo0q" role="doc-biblioref">1242</a>]</span>, whole-genome sequencing was obtained from 61 of the 77 cases, and 79% of infections were identified as a VOC or variant of interest (VOI) that had been characterized at the time of the study.
+Vaccine efficacy against cases caused by VOC, among which the Alpha variant was predominant (88.6%), was reported to be 92.6% <span class="citation" data-cites="oc5SBo0q">[<a href="#ref-oc5SBo0q" role="doc-biblioref">1242</a>]</span>.
 In late 2020, an analysis of efficacy in South African adults revealed an overall efficacy of 60.1% and a slightly lower efficacy of 50.1% against B.1.351 in particular <span class="citation" data-cites="14K1ANV1T">[<a href="#ref-14K1ANV1T" role="doc-biblioref">1255</a>]</span>.
 Additionally, an analysis of a booster dose of NVX-CoV2373 administered six months after the primary series revealed a significant increase in neutralizing activity of VOC including Delta and Omicron <span class="citation" data-cites="S28ZsPCI">[<a href="#ref-S28ZsPCI" role="doc-biblioref">1256</a>]</span>.
-It has also been reported that Novavax initiated booster trials in the U.K. <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.</p>
-<p>Because the Covifenz results became available relatively recently (May 4, 2022), limited data is available since the publication of phase III trial results <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.
+It has also been reported that Novavax initiated booster trials in the U.K. <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.</p>
+<p>Because the Covifenz results became available relatively recently (May 2022), limited data is available since the publication of phase III trial results <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.
 However, it should be noted that the Covifenz trials were conducted in 2021, at a time during which the B.1.617.2 (Delta) and P.1 (Gamma) variants were predominant <span class="citation" data-cites="hZr9yVvu">[<a href="#ref-hZr9yVvu" role="doc-biblioref">1250</a>]</span>.
 Genomic analysis of 122 out of 176 cases (165 in the per-protocol population) revealed that none of the COVID-19 cases reported were caused by the original Wuhan strain.
 Instead, 45.9% of cases were identified as the Delta variant, 43.4% as Gamma, 4.9% as Alpha, and 5.8% as VOIs.
@@ -3741,8 +3755,8 @@ <h2 data-number="6.7" id="global-vaccine-status-and-distribution"><span class="h
 <p>The unprecedented deployment of COVID-19 vaccines in under a year from the identification of SARS-CoV-2 led to a new challenge: the formation of rapid global vaccine production and distribution plans.
 The development of vaccines is costly and complicated, but vaccine distribution can be just as challenging.
 Logistical considerations such as transport, storage, equipment (e.g., syringes), the workforce to administer the vaccines, and a continual supply from the manufacturers to meet global demands all must be accounted for and vary globally due to economic, geographic, and sociopolitical reasons <span class="citation" data-cites="RG0vzlcE 19CWe6pdS d0kUYq5Z">[<a href="#ref-RG0vzlcE" role="doc-biblioref">1257</a>,<a href="#ref-19CWe6pdS" role="doc-biblioref">1258</a>,<a href="#ref-d0kUYq5Z" role="doc-biblioref">1259</a>]</span>.
-As of August 11, 2022, at least vaccine doses had been administered in at least 223 countries worldwide using 29 different vaccines <span class="citation" data-cites="3cPwqjhj">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>]</span>.<!--check owid_total_countries variable-->
-The daily global vaccination rate at this time was . <!-- Check template variable --></p>
+As of August 9, 2022, at least 12.0 billion vaccine doses had been administered in at least 223 countries worldwide using 29 different vaccines <span class="citation" data-cites="3cPwqjhj">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>]</span>.&gt;
+The daily global vaccination rate at this time was 745.0 per million.</p>
 <p>However, the distribution of these doses is not uniform around the globe.
 As of May 2022, vaccination rates remained lower in South America (3.1 per 100), Asia (1.9 per 100), Africa (0.3 per 100), and Oceania (0.1 per 100) than in North America, Europe, and Australia <span class="citation" data-cites="dfl5iCJI">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>]</span>.
 Vaccine production and distribution varies from region to region and seems to depend on the availability of the vaccines and potentially a country’s resources and wealth <span class="citation" data-cites="kL8PlRJu">[<a href="#ref-kL8PlRJu" role="doc-biblioref">1261</a>]</span>.</p>
@@ -3753,12 +3767,12 @@ <h2 data-number="6.7" id="global-vaccine-status-and-distribution"><span class="h
 <p>Additionally, the vaccine technologies available differ widely around the globe.
 As we review elsewhere <span class="citation" data-cites="nPuLx9h5">[<a href="#ref-nPuLx9h5" role="doc-biblioref">328</a>]</span>, wealthier nations have invested heavily in mRNA and DNA vaccines.
 In contrast, as we describe above, many countries outside of Europe and North America have developed highly effective vaccines using more traditional approaches.
-As a result, there is a clear relationship between a country’s gross domestic product (GDP) and its access to vaccines (Figure <a href="#fig:gdp-scatter">9</a>).</p>
-<div id="fig:gdp-scatter" class="fignos">
+As a result, there is a clear relationship between a country’s gross domestic product (GDP) and its access to vaccines (Figure <a href="#fig:gdpscatter">9</a>).</p>
+<div id="fig:gdpscatter" class="fignos">
 <figure>
-<img src="%22Distribution%20of%20vaccines%20according%20to%20GDP%22" alt="Figure 9: Vaccine Distribution across Platform Types as a Function of GDP. As of August 11, 2022, the number of doses distributed, by platform type, is shown as a function of GDP. These data are retrieved from Our World in Data [522,1105] and plotted using the Python package plotnine [1266]. Lines show a general trend in the data and are drawn using geom_smooth [1267]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily. Axes are not scaled per capita because both variables would be expected to be modulated by population size." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/OWID_doseTypebyGDP.png" alt="Figure 9: Vaccine Distribution across Platform Types as a Function of GDP. As of August 15, 2022, the number of doses distributed, by platform type, is shown as a function of GDP. These data are retrieved from Our World in Data [522,1105] and plotted using the Python package plotnine [1266]. Lines show a general trend in the data and are drawn using geom_smooth [1267]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily. Axes are not scaled per capita because both variables would be expected to be modulated by population size." />
 <figcaption aria-hidden="true"><span>Figure 9:</span> <strong>Vaccine Distribution across Platform Types as a Function of GDP.</strong>
-As of August 11, 2022, the number of doses distributed, by platform type, is shown as a function of GDP.
+As of August 15, 2022, the number of doses distributed, by platform type, is shown as a function of GDP.
 These data are retrieved from Our World in Data <span class="citation" data-cites="3cPwqjhj sRy6js2o">[<a href="#ref-3cPwqjhj" role="doc-biblioref">522</a>,<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using the Python package plotnine <span class="citation" data-cites="L5wrzuPV">[<a href="#ref-L5wrzuPV" role="doc-biblioref">1266</a>]</span>.
 Lines show a general trend in the data and are drawn using geom_smooth <span class="citation" data-cites="48MbU9B0">[<a href="#ref-48MbU9B0" role="doc-biblioref">1267</a>]</span>.
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
@@ -3768,20 +3782,22 @@ <h2 data-number="6.7" id="global-vaccine-status-and-distribution"><span class="h
 <!-- Figure is not rendering -->
 <p>When vaccines first became available, the wealthy nations of North America and Europe secured most of the limited COVID-19 vaccine stocks <span class="citation" data-cites="1AvwH3T5y">[<a href="#ref-1AvwH3T5y" role="doc-biblioref">1268</a>]</span>.
 Throughout 2021, low- and middle-income countries faced steep competition with high-income countries for vaccines, and the rates of vaccination reflected this unequal distribution <span class="citation" data-cites="JM2MJEBG">[<a href="#ref-JM2MJEBG" role="doc-biblioref">1269</a>]</span>.
-While the wealthiest countries in these regions could compete with each other for vaccines independent of programs such as COVAX <span class="citation" data-cites="JM2MJEBG">[<a href="#ref-JM2MJEBG" role="doc-biblioref">1269</a>]</span>, other countries in these regions have faced challenges in acquiring vaccines developed by the world’s wealthiest nations.</p>
-<p>Fortunately, while mRNA and DNA vaccine development programs are not widespread, vaccine development using whole-virus and subunit technologies has been undertaken worldwide.
-Still, many African nations are reliant on the COVAX Facility, who have promised 600 million doses to the continent <span class="citation" data-cites="1EnpYQzIq">[<a href="#ref-1EnpYQzIq" role="doc-biblioref">1270</a>]</span>.
+While the wealthiest countries in these regions could compete with each other for vaccines independent of programs such as COVAX <span class="citation" data-cites="JM2MJEBG">[<a href="#ref-JM2MJEBG" role="doc-biblioref">1269</a>]</span>, other countries in these regions have faced challenges in acquiring vaccines developed by the world’s wealthiest nations.
+Fortunately, while mRNA and DNA vaccine development programs are not widespread, vaccine development using whole-virus and subunit technologies has been undertaken worldwide.
+China and India, in particular, have developed several vaccines that are now widely available in these densely populated countries (see online Appendix <span class="citation" data-cites="yTsmmAYC">[<a href="#ref-yTsmmAYC" role="doc-biblioref">1129</a>]</span>).</p>
+<p>Still, many nations, especially in Africa, are reliant on the COVAX Facility, who have promised 600 million doses to the continent <span class="citation" data-cites="1EnpYQzIq">[<a href="#ref-1EnpYQzIq" role="doc-biblioref">1270</a>]</span>.
 The COVAX plan seeks to ensure that all participating countries would be allocated vaccines in proportion to their population sizes.
 Once each country has received vaccine doses to account for 20% of their population, the country’s risk profile will determine its place in subsequent phases of vaccine distribution.
 However, several limitations of this framework exist, including that the COVAX scheme seems to go against the WHO’s own ethical principles of human well-being, equal respect, and global equity and that other frameworks might have been more suitable <span class="citation" data-cites="12QaZb4si">[<a href="#ref-12QaZb4si" role="doc-biblioref">1271</a>]</span>.
-Furthermore, COVAX is supposed to allow poorer countries access to affordable vaccines, but the vaccines are driven by publicly traded companies that are required to make a profit <span class="citation" data-cites="kL8PlRJu">[<a href="#ref-kL8PlRJu" role="doc-biblioref">1261</a>]</span>.
-In any case, COVAX provides access to COVID-19 vaccines that may otherwise have been difficult for some countries to obtain.
+Furthermore, COVAX is supposed to allow poorer countries access to affordable vaccines, but the vaccines are driven by publicly traded companies that are required to make a profit <span class="citation" data-cites="kL8PlRJu">[<a href="#ref-kL8PlRJu" role="doc-biblioref">1261</a>]</span>.</p>
+<p>In any case, COVAX provides access to COVID-19 vaccines that may otherwise have been difficult for some countries to obtain.
 COVAX aimed to distribute 2 billion vaccine doses globally by the end of 2021 <span class="citation" data-cites="7dkwQDUf">[<a href="#ref-7dkwQDUf" role="doc-biblioref">1272</a>]</span>.
-According to GAVI, as of January 2022, COVAX had distributed over 1 billion vaccines to 144 participants of the program <span class="citation" data-cites="JNpdOLGo">[<a href="#ref-JNpdOLGo" role="doc-biblioref">1273</a>]</span>, short of its target but still a major global achievement.
+According to Gavi, as of January 2022, COVAX had distributed over 1 billion vaccines to 144 participants of the program <span class="citation" data-cites="JNpdOLGo">[<a href="#ref-JNpdOLGo" role="doc-biblioref">1273</a>]</span>, short of its target but still a major global achievement.
 It is envisaged that COVAX may also receive additional donations of doses from Western nations who purchased surplus vaccines in the race to vaccinate their populations, which will be a welcome boost to the vaccination programs of low- and middle-income countries <span class="citation" data-cites="sr5oRBgc">[<a href="#ref-sr5oRBgc" role="doc-biblioref">1274</a>]</span>.</p>
 <p>In general, deciding on the prioritization and allocation of the COVID-19 vaccines is also a challenging task due to ethical and operational considerations.
 Various frameworks, models, and methods have been proposed to tackle these issues with many countries, regions, or U.S. states devising their own distribution and administration plans <span class="citation" data-cites="S8WhufUV dLbKv1xi jbpdQdOw z5c17nGB s2zZd6pb">[<a href="#ref-S8WhufUV" role="doc-biblioref">1275</a>,<a href="#ref-dLbKv1xi" role="doc-biblioref">1276</a>,<a href="#ref-jbpdQdOw" role="doc-biblioref">1277</a>,<a href="#ref-z5c17nGB" role="doc-biblioref">1278</a>,<a href="#ref-s2zZd6pb" role="doc-biblioref">1279</a>]</span>.
-The majority of the distribution plans prioritized offering vaccines to key workers such as health care workers and those who are clinically vulnerable, such as the elderly, the immunocompromised, and individuals with comorbidities, before targeting the rest of the population, who are less likely to experience severe outcomes from COVID-19 <span class="citation" data-cites="sEyIoYCS">[<a href="#ref-sEyIoYCS" role="doc-biblioref">1280</a>]</span>.</p>
+The majority of the distribution plans prioritized offering vaccines to key workers such as health care workers and those who are clinically vulnerable, such as the elderly, the immunocompromised, and individuals with comorbidities, before targeting the rest of the population, who are less likely to experience severe outcomes from COVID-19 <span class="citation" data-cites="sEyIoYCS">[<a href="#ref-sEyIoYCS" role="doc-biblioref">1280</a>]</span>.
+The availability of vaccines developed in a variety of countries using a variety of platforms is likely to work in favor of worldwide vaccine access.</p>
 <h2 data-number="6.8" id="conclusions-1"><span class="header-section-number">6.8</span> Conclusions</h2>
 <p>Much attention has focused on the most novel vaccine technologies that have been deployed against SARS-CoV-2, but the established vaccine platforms discussed here have all made a significant impact on human health during the twentieth century and in some cases even earlier.
 The COVID-19 pandemic has demonstrated new potential in these established technologies.
@@ -3789,10 +3805,185 @@ <h2 data-number="6.8" id="conclusions-1"><span class="header-section-number">6.8
 Similarly, these technologies were explored for MERS-CoV, but outbreaks were sporadic and difficult to predict, making vaccine testing and the development of a vaccination strategy difficult <span class="citation" data-cites="138O0v19T">[<a href="#ref-138O0v19T" role="doc-biblioref">1284</a>]</span>.
 However, in the COVID-19 pandemic, most of these technologies have been used to accelerate vaccine development programs worldwide.
 Therefore, they are also offering the opportunity to respond quickly to an emergent pathogen.</p>
-<p>While these tried-and-true technologies don’t always produce vaccines with the highly desirable VE reported in mRNA clinical trials (which exceeded &gt;90%), the efficacies are still very high, and these vaccines are extremely effective at preventing severe illness and death.
-As a result, the greater accessibility and stability of these vaccines makes them still valuable at a global level.</p>
-<h1 data-number="7" id="the-coming-of-age-of-nucleic-acid-vaccines-during-covid-19"><span class="header-section-number">7</span> The Coming of Age of Nucleic Acid Vaccines during COVID-19</h1>
-<h2 data-number="7.1" id="abstract-5"><span class="header-section-number">7.1</span> Abstract</h2>
+<p>While these tried-and-true technologies don’t always produce vaccines with the highly desirable VE reported in mRNA clinical trials (which exceeded 90%), the efficacies are still very high, and these vaccines are extremely effective at preventing severe illness and death.
+As a result, the greater accessibility and stability of these vaccines makes them extremely valuable for the global effort to mitigate the loss of life from SARS-CoV-2.</p>
+<h1 data-number="7" id="appendix-additional-information-about-established-vaccine-platforms-for-covid-19"><span class="header-section-number">7</span> Appendix: Additional Information about Established Vaccine Platforms for COVID-19</h1>
+<h2 data-number="7.1" id="sinovacs-coronavac"><span class="header-section-number">7.1</span> Sinovac’s CoronaVac</h2>
+<p>The CoronaVac vaccine was developed by Sinovac, a Beijing-based biopharmaceutical company.
+The vaccine uses an inactivate whole virus with the addition of an aluminum adjuvant <span class="citation" data-cites="RGPoDfHS">[<a href="#ref-RGPoDfHS" role="doc-biblioref">1285</a>]</span>.
+Pre-clinical trials were performed using BALB/c mice and rhesus macaques <span class="citation" data-cites="14fILrRWg">[<a href="#ref-14fILrRWg" role="doc-biblioref">1151</a>]</span>.
+The SARS-CoV-2 strains used in this trial isolated from 11 hospitalized patients (5 from China, 3 from Italy, 1 from the United Kingdom (U.K.), 1 from Spain, 1 from Switzerland).
+A phylogenetic analysis demonstrated that the strains were representative of the variants circulating at the time.
+One of the strains from China, CN2, was used as the inactivated and purified virus while the other 10 strains were used to challenge.
+CN2 was grown in Vero cells.
+The immunogenicity of the vaccine candidate was evaluated with an ELISA assay.
+Ten mice were injected with the vaccine on day 0 and day 7 with varying doses (0, 1.5, 3, or 6 μg), and 10 mice were treated with physiological saline as the control.
+IgG developed in the serum of all vaccinated mice.</p>
+<p>Using the same setup, immunogenicity was also assessed in macaques.
+Four macaques were assigned to each of four groups: treatment with 3 μg at day 0, 7, and 14, treatment with a high dose of 6 μg at day 0, 7, and 14, administration of a placebo vaccine, and administration of only the adjuvant.
+All vaccinated macaques induced IgGs and neutralizing antibodies.
+After challenge with SARS-CoV-2 strain CN1, vaccinated macaques were protected compared to control macaques (placebo or adjuvant only) based on histology and viral loads collected from different regions of the lung.</p>
+<p>Phase I/II clinical trials were conducted in adults 18-59 years old <span class="citation" data-cites="N1txjPtt">[<a href="#ref-N1txjPtt" role="doc-biblioref">1152</a>]</span> and adults over 60 years old <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1150</a>]</span> in China.
+In the case of adults 18-59 years old, a single center, randomized, double-blind, placebo-controlled phase I/II trial was conducted in April 2020.
+Patients in this study were recruited from the community in Suining County of Jiangsu province, China.
+For the phase I trial, 144 (of 185 screened) participants were enrolled, with 72 enrolled in the 14-day interval cohort (i.e., treated on day 0 and day 14) and 72 in the 28-day interval cohort.
+This group of 72 participants was split into 2 blocks for a low-dose (3 μg) and high-dose (6 μg) vaccine.
+Within each block, participants were randomly assigned vaccination with CoronaVac or placebo (aluminum diluent without the virus) at a 2:1 ratio.
+Both the vaccine and placebo were prepared in a Good Manufacturing Practice-accredited facility of Sinovac Life Sciences (Beijing, China).</p>
+<p>The phase II trial followed the same organization of participants, this time using 300 enrolled participants in the 14-day and another 300 enrolled in the 28-day groups.
+One change of note was that the vaccine was produced using a highly automated bioreactor (ReadyToProcess WAVE 25, GE, Umeå, Sweden) to increase vaccine production capacity.
+This change resulted in a higher intact spike protein content.
+The authors of this study were not aware of this antigen-level difference between the vaccine batches for the phase I/II when the ethical approval for the trials occurred.</p>
+<p>To assess adverse responses, participants were asked to record any events up to 7 days post-treatment.
+The reported adverse events were graded according to the China National Medical Products Administration guidelines.
+In the phase I trial, the overall incidence of adverse reactions was 29-38% of patients in the 0 to 14 day group and 13-17% in the 0 to 28 day vaccination group.
+The most common symptom was pain at the injection site, which was reported by 17-21% of patients in the 0 to 14 day cohort and 13% in the 0 to 28 day cohort.
+Most adverse reactions were mild (grade 1), with patients recovering within 48 hours.
+A single case of acute hypersensitivity with manifestation of urticaria 48 hours following the first dose of study drug was reported in the 6 μg group
+Both the 14-day and 28-day cohorts had a strong neutralizing antibody (Ab) response.
+The neutralizing Ab response was measured using a micro cytopathogenic effect assay, which assesses the minimum dilution of neutralizing Ab to be 50% protective against structural changes in host cells in response to viral infection <span class="citation" data-cites="1GUVvcQjL">[<a href="#ref-1GUVvcQjL" role="doc-biblioref">1286</a>]</span>.
+Additionally IgG antibody titers against the receptor binding domain were also measured using ELISA.</p>
+<p>Another phase I/II study was performed with older patients (over 60 years of age) <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1150</a>]</span>.
+The study conducted a single-center, randomized, double-blind, placebo-controlled trial.
+The phase I trial looked at dose escalation using 3 dosages: 1.5, 3, and 6 μg.
+The mean age of participants was 65.8 years (standard deviation = 4.8).
+Of 95 screened participants, 72 were enrolled.
+These 72 participants were split into low (3 μg) and high (6 μg) dose groups.
+Within each group, 24 participants received the treatment and 12 the placebo.
+A neutralizing antibody response against live SARS-CoV-2 was detected compared to baseline using the same micro cytopathogenic effect assay.
+This response was similar across the two dose concentrations.
+Additionally, they did not observe a difference in response between age groups (60–64 years, 65–69 years, and ≥70 years).</p>
+<p>In phase II the mean age was 66.6 years (standard deviation = 4.7).
+499 participants were screened and 350 were enrolled.
+300 were evenly split into 1.5, 3, and 6 μg dose groups, and the remaining 50 were assigned to the placebo group.
+Again, they found a neutralizing antibody response in phase II.
+There wasn’t a significant different between the response to 3 μg versus 6 μg, but the response in both these conditions was higher than in the 1.5 μg condition.</p>
+<p>Participants were required to record adverse reaction events within the first 7 days after each dose.
+The safety results were combined across phase I and II.
+All adverse reactions were either mild (grade 1) or moderate (grade 2) in severity.
+The most common symptom was pain at the injection site (9%) and fever (3%).
+2% (7 participants) reported severe adverse events (4 from the 1.5 μg group, 1 from the 3 μg group, 2 from the 6 μg group), though these were found to be unrelated to the vaccine.</p>
+<p>Overall, the results from the pre-clinical and phase I/II clinical trials were promising, especially the fact that the immune response was consistent in older adults (&gt; 60 years).
+Additional phase III trials were conducted in Brazil in a randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial enrolling nearly 10,000 healthcare workers <span class="citation" data-cites="KewHbkLZ F1lYwPSY">[<a href="#ref-KewHbkLZ" role="doc-biblioref">1287</a>,<a href="#ref-F1lYwPSY" role="doc-biblioref">1288</a>]</span>.
+As of September 2021, CoronaVac trials are now also being held in the Philippines and Hong Kong, bringing the total number of registered phase III trials investigating the safety and efficacy of CoronaVac to 9, with emergency use approval in 40 countries <span class="citation" data-cites="19z4gdhDS">[<a href="#ref-19z4gdhDS" role="doc-biblioref">1289</a>]</span>.
+CoronaVac also appears to be suitable for use in immunocompromised patients such as those with autoimmune rheumatic diseases according to phase IV trials <span class="citation" data-cites="8vzglCry">[<a href="#ref-8vzglCry" role="doc-biblioref">1290</a>]</span>, and the vaccine was also well tolerated and induced humoral responses in phase I trials in children aged 3 to 17 years, which will now be examined in phase II and III clinical trials <span class="citation" data-cites="6EYqf6s7">[<a href="#ref-6EYqf6s7" role="doc-biblioref">1291</a>]</span>.</p>
+<h2 data-number="7.2" id="covaxin"><span class="header-section-number">7.2</span> Covaxin</h2>
+<p>In India, the Covaxin vaccine received emergency authorization on January 3, 2021, despite the lack of phase III data until March 3, 2021, which was communicated via press release <span class="citation" data-cites="Ks3L7qHG">[<a href="#ref-Ks3L7qHG" role="doc-biblioref">1292</a>]</span>.
+Following a press release of the phase III data indicating 80.6% efficacy in 25,800 participants <span class="citation" data-cites="Ks3L7qHG DaDKZXdu">[<a href="#ref-Ks3L7qHG" role="doc-biblioref">1292</a>,<a href="#ref-DaDKZXdu" role="doc-biblioref">1293</a>]</span>, Zimbabwe authorized the use of Covaxin <span class="citation" data-cites="13yEnvOyP">[<a href="#ref-13yEnvOyP" role="doc-biblioref">1294</a>]</span>.
+This was followed by a detailed preprint of the double-blind, randomized, controlled phase III trial that was made available in July 2021, with a final enrollment of 25,798 people (~1:1 vaccine:placebo) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1170</a>]</span>.
+The vaccine was reported as well tolerated, with an overall vaccine efficacy of 77.8% for the prevention of COVID-19.
+Efficacy against severe disease and asymptomatic infection was reported as 93.4% and 63.6% respectively.</p>
+<p>It is not yet clear what level of protection Covaxin offers beyond 6 to 8 months post the second vaccine; consequently, the potential requirement of a booster immunization is being explored <span class="citation" data-cites="s1TGwKbT">[<a href="#ref-s1TGwKbT" role="doc-biblioref">1188</a>]</span>.
+Furthermore, Bharat Biotech is considering other vaccine regimens such as providing one initial immunization with Covaxin followed by two immunizations with its intranasal vaccine (BBV154) <span class="citation" data-cites="UU0pj3ii">[<a href="#ref-UU0pj3ii" role="doc-biblioref">1295</a>]</span>.
+U.S.-based Ocugen Inc., a co-development partner of Bharat Biotech, is leading the application for an Emergency Use Authorization (EUA) for Covaxin intended for the U.S. market.
+It has been reported that Bharat Biotech will soon release its phase II and III pediatric trial results <span class="citation" data-cites="3Q7kvwO3">[<a href="#ref-3Q7kvwO3" role="doc-biblioref">1296</a>]</span>.
+However, the WHO approval of the Covaxin has been delayed <span class="citation" data-cites="AeulXXFm">[<a href="#ref-AeulXXFm" role="doc-biblioref">1297</a>]</span>.</p>
+<h2 data-number="7.3" id="sinopharms-clinical-trials-of-two-vaccine-candidates"><span class="header-section-number">7.3</span> Sinopharm’s Clinical Trials of Two Vaccine Candidates</h2>
+<p>Sinopharm Wuhan Institute developed their SARS-CoV-2 inactivated vaccine using the WIV04 strain isolated from a patient at the Jinyintan Hospital in Wuhan, China <span class="citation" data-cites="miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1160</a>]</span>.
+This vaccine was also passaged in Vero cells, inactivated using β-propiolactone, and was adjuvanted with aluminum hydroxide.
+This vaccine is administered intramuscularly using 5 μg of virus per dose.
+Preclinical data providing supporting evidence for the use of this vaccine is not available publicly.
+Despite the lack of publicly available preclinical results, Sinopharm Wuhan Institute initiated phase I/II trials, which reported on varying dosing and prime-boost regimens.</p>
+<p>A combined phase I/II RCT of Sinopharm’s BBIBP-CorV, also known as Covilo, followed <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1163</a>]</span>.
+In phase I, 192 participants were randomized with varying doses of 2 μg, 4 μg, or 8 μg/dose or a placebo, and they received the same as a second dose 28 days later.
+Approximately 29% of participants reported at least 1 adverse event, most commonly fever, and neutralizing antibody titers were reported for all doses.
+In the phase II trial, 482 participants were enrolled (3:1, vaccine:placebo).
+Participants in the vaccine condition received either a single 8 μg dose or a double immunization of a 4 μg/dose that was administered 14, 21, or 28 days post the prime dose.
+Participants in the placebo condition received the placebo on one of the same four schedules.
+The vaccine appeared well-tolerated, with 23% reporting at least one adverse reaction characterized as mild to moderate.
+It was reported that all participants had a humoral immune response to the vaccines by day 42 but that the double immunization dosing regimen of 4 μg/dose achieved higher neutralizing antibody titers than a single dose of 8 μg and that the highest response was seen in the double-immunization regimen when at least 21 days separated the two doses <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1163</a>]</span>.
+Similar findings were reported in another phase I/II trial published by the same authors <span class="citation" data-cites="yN5KOfvE">[<a href="#ref-yN5KOfvE" role="doc-biblioref">1164</a>]</span>.</p>
+<h2 data-number="7.4" id="novavaxs-nuvaxovid-nvx-cov2373"><span class="header-section-number">7.4</span> Novavax’s Nuvaxovid (NVX-CoV2373)</h2>
+<p>Novavax’s Nuvaxovid is a particularly appealing candidate because the improved stability caused by the proline substitutions is particularly critical to facilitating global distribution, particularly to regions where local refrigerator/freezer capacities are limited.
+Importantly, these amino acid substitutions did not affect the ability of the spike protein to bind the hACE2 receptor (the target receptor of SARS-CoV-2 spike protein).
+The Novavax-CoV2373 vaccine candidate uses a proprietary, saponin-based Matrix-M<sup>TM</sup> adjuvant that contains two different 40nm-sized particles formed by formulating purified saponin with cholesterol and phospholipids <span class="citation" data-cites="1F52Wz7mx">[<a href="#ref-1F52Wz7mx" role="doc-biblioref">1298</a>]</span>.
+In preclinical models, the use of the Matrix-M adjuvant potentiated the cellular and humoral immune responses to influenza vaccines <span class="citation" data-cites="scwOT7dw aD5iMC0Q twmXSpc9 1F52Wz7mx">[<a href="#ref-1F52Wz7mx" role="doc-biblioref">1298</a>,<a href="#ref-scwOT7dw" role="doc-biblioref">1299</a>,<a href="#ref-aD5iMC0Q" role="doc-biblioref">1300</a>,<a href="#ref-twmXSpc9" role="doc-biblioref">1301</a>]</span>.
+Importantly, Matrix-M adjuvant-containing vaccines have shown acceptable safety profiles in human clinical trials <span class="citation" data-cites="jVCL0201">[<a href="#ref-jVCL0201" role="doc-biblioref">1302</a>]</span>.</p>
+<p>Novavax-CoV2373 induced a multifunctional CD4/CD8 T-cell responses and generate high frequencies of follicular helper T-cells and B-cell germinal centers after vaccination.
+These findings were subsequently evaluated in a baboon primate model, in which Novavax-CoV2373 also elicited high antibody titers against the SARS-CoV-2 spike protein, as well as an antigen specific T-cell response.
+Based on this data Novavax initiated a phase I/II clinical trial to evaluate the safety and immunogenicity of Novavax-CoV2373 with Matrix-M <span class="citation" data-cites="Nq0cimEs dMLXxGAI">[<a href="#ref-dMLXxGAI" role="doc-biblioref">1240</a>,<a href="#ref-Nq0cimEs" role="doc-biblioref">1303</a>]</span>.</p>
+<p>The phase I/II trial was a randomized, placebo-controlled study with 131 healthy adult participants in 5 treatment arms <span class="citation" data-cites="dMLXxGAI">[<a href="#ref-dMLXxGAI" role="doc-biblioref">1240</a>]</span>.
+Participants that received the recombinant SARS-CoV-2 vaccine with or without the Matrix-M adjuvant got two injections, 21 days apart.
+Primary outcomes that were assessed include reactogenicity, lab-values (serum chemistry and hematology), and anti-spike IgG levels.
+Secondary outcomes measured included virus neutralization, T-cell responses, and unsolicited adverse events.
+The authors reported that no serious treatment-related adverse events occurred in any of the treatment arms.
+Reactogenicity was mostly absent and of short duration.
+The two-dose vaccine regimen induced anti-spike IgG levels and neutralizing antibody-titers exceeding those in the convalescent plasma of symptomatic patients.
+The outcomes of this trial suggest that Novavax-CoV2373 has an acceptable safety profile and is able to induce a strong immune response with high neutralizing antibody titers.</p>
+<p>The phase II component of the trial was designed to identify the dose regimen for the next clinical trial stage <span class="citation" data-cites="ynvQwwo9">[<a href="#ref-ynvQwwo9" role="doc-biblioref">1304</a>]</span>.
+Both younger (18-59 years) and older patients (60-84 years) were randomly assigned to receive either 5 μg or 25 μg Novavax-CoV2373 or a sodium-chloride placebo in two doses, 21 days apart.
+In line with the phase I data, reactogenicity remained mild to moderate, with no more than 1% of participants in any group reporting grade 3 AEs, and of short duration.
+Both dose levels were able to induce high anti-spike IgG titers as well as neutralizing antibody responses after the second dose.
+Based on both safety and efficacy data, the 5 μg dosing regimen was selected as the optimal dose regimen for the phase III trial.</p>
+<p>Novavax announced an efficacy of 89.3% based on their phase III trial in the U.K. and South Africa <span class="citation" data-cites="1D0f8OrG8 1EWB3hKG 16iOtJ1vE">[<a href="#ref-1D0f8OrG8" role="doc-biblioref">1241</a>,<a href="#ref-1EWB3hKG" role="doc-biblioref">1305</a>,<a href="#ref-16iOtJ1vE" role="doc-biblioref">1306</a>]</span>.
+This trial included over 15,000 participants in the U.K. and 4,000 participants in South Africa.
+The primary endpoint of the trial was the occurrence or absence of PCR-confirmed, symptomatic mild, moderate or severe COVID-19 from 7 days after the second dose onward.
+In the first interim analysis (U.K.), 56 cases of COVID-19 were observed in the placebo group compared to 6 cases in the treatment group.
+Importantly, the vaccine candidate also shows significant clinical efficacy against the prevalent U.K. and South African variants.
+The company has also initiated the development of new constructs to select candidates that can be used as a booster against new strains and plans to initiate clinical trials for these new constructs in the second quarter of 2021.
+Side effects were monitored in 2,310 participants and were generally considered mild, with low incidences of headache, muscle pain, and fatigue.
+A similar efficacy of 90.4% was subsequently estimated in a phase III trial in the United States in Mexico <span class="citation" data-cites="IQOyFnfl">[<a href="#ref-IQOyFnfl" role="doc-biblioref">1307</a>]</span>.</p>
+<p>Given the apparent need for boosters, interest has also emerged in whether vaccines against SARS-CoV-2 can be administered along with annual flu vaccines.
+Early data came from the Novavax NVX-CoV2373 protein subunit vaccine.
+In a subgroup of approximately 400 patients enrolled from the U.K. phase III trial who received either NVX-CoV2373 or placebo 1:1, a concomitant dose of adjuvanted seasonal influenza vaccines (either a trivalent vaccine or a quadrivalent vaccine) was administered <span class="citation" data-cites="IUekaKY0">[<a href="#ref-IUekaKY0" role="doc-biblioref">1308</a>]</span>.
+This study demonstrated that both types of vaccines could be safely administered together.
+While no change to the immune response was noted for the influenza vaccine, a notable reduction of the antibody response for the NVX-CoV2373 was reported, but efficacy was still high at 87.5% <span class="citation" data-cites="IUekaKY0">[<a href="#ref-IUekaKY0" role="doc-biblioref">1308</a>]</span>.
+Novavax has since started phase I/II trials to investigate the administration of its own influenza vaccine, NanoFlu<sup>™</sup>, concomitantly with NVX-CoV2373 <span class="citation" data-cites="rclKBvtk">[<a href="#ref-rclKBvtk" role="doc-biblioref">1309</a>]</span>, which appeared to be safe and effective in preclinical studies <span class="citation" data-cites="bOwPRh6q">[<a href="#ref-bOwPRh6q" role="doc-biblioref">1310</a>]</span>.</p>
+<h2 data-number="7.5" id="protein-subunit-vaccine-development-programs-prior-to-sars-cov-2"><span class="header-section-number">7.5</span> Protein Subunit Vaccine Development Programs Prior to SARS-CoV-2</h2>
+<p>Earlier studies examined the immunogenicity of a SARS-CoV-1 RBD fused with IgG1 Fc.
+This recombinant fusion protein could induce a robust long-lasting neutralizing antibody and cellular immune response that protected mice from SARS-CoV-1 <span class="citation" data-cites="7RHpaAHu 1EirBATaN cLAQnckq">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-cLAQnckq" role="doc-biblioref">1205</a>,<a href="#ref-1EirBATaN" role="doc-biblioref">1206</a>]</span>.
+While there have been other potential protein subunit vaccines for SARS-CoV-1 investigated <em>in vivo</em> <span class="citation" data-cites="7RHpaAHu 9Zv0eLa9">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-9Zv0eLa9" role="doc-biblioref">1215</a>]</span>, none of these candidates have successfully completed clinical trials, more than likely due to the fact that the SARS-CoV-1 epidemic mostly ended by May 2004, and there was thus less of a demand or funding for SARS-CoV-1 vaccine research.</p>
+<p>Similar vaccine candidates have emerged that target the RBD found in the S1 subunit of the trimeric MERS-CoV S protein, which binds to dipeptidyl-peptidase 4 (DPP4 also known as hCD26), the entry point through which MERS-CoV infects cells <span class="citation" data-cites="yoFGwkUO KZFnwRIN YZcHzPcs">[<a href="#ref-yoFGwkUO" role="doc-biblioref">1311</a>,<a href="#ref-KZFnwRIN" role="doc-biblioref">1312</a>,<a href="#ref-YZcHzPcs" role="doc-biblioref">1313</a>]</span>.
+After initially determining that an RBD subunit candidate (S377-588-Fc) could elicit neutralizing antibodies <span class="citation" data-cites="GFWQw4mi">[<a href="#ref-GFWQw4mi" role="doc-biblioref">1314</a>]</span>, a study in mice determined that the administration of three sequential doses of RBD-Fc vaccine coupled with MF59, a squalene immunogenic adjuvant, induced humoral and systemic immunity in mice <span class="citation" data-cites="SF030Zqn">[<a href="#ref-SF030Zqn" role="doc-biblioref">1315</a>]</span>.
+Mice that had been transduced with Ad5-hCD26 and subsequently challenged with MERS-CoV five days later did not show evidence of viral infection in the lungs versus control mice at ten days post vaccination <span class="citation" data-cites="SF030Zqn">[<a href="#ref-SF030Zqn" role="doc-biblioref">1315</a>]</span>.
+Other variations of this vaccine approach include a stable S trimer vaccine whereby proline-substituted variants of S2 can maintain a stable prefusion conformation of the S2 domain <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span>.
+This approach leads to broad and potent neutralizing antibodies <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span></p>
+<h2 data-number="7.6" id="complementary-approaches-to-vaccine-development"><span class="header-section-number">7.6</span> Complementary Approaches to Vaccine Development</h2>
+<p>A complementary approach to other vaccine development programs that is being investigated explores the potential for vaccines that are not made from the SARS-CoV-2 virus to confer what has been termed trained immunity.
+In a recent review <span class="citation" data-cites="103fS7Kz2">[<a href="#ref-103fS7Kz2" role="doc-biblioref">1316</a>]</span>, trained immunity was defined as forms of memory that are temporary (e.g., months or years) and reversible.
+It is induced by exposure to whole-microorganism vaccines or other microbial stimuli that generates heterologous protective effects.
+Trained immunity can be displayed by innate immune cells or innate immune features of other cells, and it is characterized by alterations to immune responsiveness to future immune challenges due to epigenetic and metabolic mechanisms.
+These alterations can take the form of either an increased or decreased response to immune challenge by a pathogen.
+Trained immunity elicited by non-SARS-CoV-2 whole-microorganism vaccines could potentially improve SARS-CoV-2 susceptibility or severity <span class="citation" data-cites="Vu1VILWK">[<a href="#ref-Vu1VILWK" role="doc-biblioref">1317</a>]</span>.</p>
+<p>One type of stimulus which research indicates can induce trained immunity is bacillus Calmette-Guerin (BCG) vaccination.
+BCG is an attenuated form of bacteria <em>Mycobacterium bovis</em>.
+The vaccine is most commonly administered for the prevention of tuberculosis in humans.
+Clinical trials in non-SARS-CoV-2-infected adults have been designed to assess whether BCG vaccination could have prophylactic effects against SARS-CoV-2 by reducing susceptibility, preventing infection, or reducing disease severity.
+A number of trials are now evaluating the effects of the BCG vaccine or the related vaccine VPM1002 <span class="citation" data-cites="Vu1VILWK 9m3rP633 y9IYdfM3 xdqxBruc 962rELVS EuwTWcPi dQtUeruv DjXsPR8O 10OE6y3Pv 86OjIybR ITO15LIz VkZGZxLn 13JVjMfQI nk2MVsld 1E2t9tr8h">[<a href="#ref-9m3rP633" role="doc-biblioref">1132</a>,<a href="#ref-xdqxBruc" role="doc-biblioref">1133</a>,<a href="#ref-Vu1VILWK" role="doc-biblioref">1317</a>,<a href="#ref-y9IYdfM3" role="doc-biblioref">1318</a>,<a href="#ref-962rELVS" role="doc-biblioref">1319</a>,<a href="#ref-EuwTWcPi" role="doc-biblioref">1320</a>,<a href="#ref-dQtUeruv" role="doc-biblioref">1321</a>,<a href="#ref-DjXsPR8O" role="doc-biblioref">1322</a>,<a href="#ref-10OE6y3Pv" role="doc-biblioref">1323</a>,<a href="#ref-86OjIybR" role="doc-biblioref">1324</a>,<a href="#ref-ITO15LIz" role="doc-biblioref">1325</a>,<a href="#ref-VkZGZxLn" role="doc-biblioref">1326</a>,<a href="#ref-13JVjMfQI" role="doc-biblioref">1327</a>,<a href="#ref-nk2MVsld" role="doc-biblioref">1328</a>,<a href="#ref-1E2t9tr8h" role="doc-biblioref">1329</a>]</span>.</p>
+<p>The ongoing trials are using a number of different approaches.
+Some trials enroll healthcare workers, other trials hospitalized elderly adults without immunosuppression who get vaccinated with placebo or BCG at hospital discharge, and yet another set of trials older adults (&gt;50 years) under chronic care for conditions like hypertension and diabetes.
+One set of trials, for example, uses time until first infection as the primary study endpoint; more generally, outcomes measured in some of these trials are related to incidence of disease and disease severity or symptoms.
+Some analyses have suggested a possible correlation at the country level between the frequency of BCG vaccination (or BCG vaccination policies) and the severity of COVID-19 <span class="citation" data-cites="Vu1VILWK">[<a href="#ref-Vu1VILWK" role="doc-biblioref">1317</a>]</span>.
+Currently it is unclear whether this correlation has any connection to trained immunity.
+Many possible confounding factors are also likely to vary among countries, such as age distribution, detection efficiency, stochastic epidemic dynamic effects, differences in healthcare capacity over time in relation to epidemic dynamics, and these have not been adequately accounted for in current analyses. <!-- TO DO: add in study that debunks this-->
+It is unclear whether there is an effect of the timing of BCG vaccination, both during an individual’s life cycle and relative to the COVID-19 pandemic.
+Additionally, given that severe SARS-CoV-2 may be associated with a dysregulated immune response, it is unclear what alterations to the immune response would be most likely to be protective versus pathogenic (e.g., <span class="citation" data-cites="i5k18bpX 1GnFL9zeN Vu1VILWK 1228YjPRv">[<a href="#ref-1GnFL9zeN" role="doc-biblioref">147</a>,<a href="#ref-Vu1VILWK" role="doc-biblioref">1317</a>,<a href="#ref-i5k18bpX" role="doc-biblioref">1330</a>,<a href="#ref-1228YjPRv" role="doc-biblioref">1331</a>]</span>).
+The article <span class="citation" data-cites="Vu1VILWK">[<a href="#ref-Vu1VILWK" role="doc-biblioref">1317</a>]</span> proposes that trained immunity might lead to an earlier and stronger response, which could in turn reduce viremia and the risk of later, detrimental immunopathology.
+While trained immunity is an interesting possible avenue to complement vaccine development efforts through the use of an existing vaccine, additional research is required to assess whether the BCG vaccine is likely to confer trained immunity in the case of SARS-CoV-2.</p>
+<h2 data-number="7.7" id="india-and-chinas-roles-in-vaccine-innovation-and-development"><span class="header-section-number">7.7</span> India and China’s Roles in Vaccine Innovation and Development</h2>
+<p>The nations of China and India have played a major role as COVID-19 vaccination developers and providers.
+Considering India produced approximately 60% of the world’s vaccines prior to the pandemic, it is no surprise that the nation has developed and is developing several COVID-19 vaccine candidates.
+In addition to Covaxin, the Bio E subunit vaccine CORBEVAX is being produced by Biological E in collaboration with U.S.-based Dynavax and the Baylor College of Medicine <span class="citation" data-cites="gsNWcXHn">[<a href="#ref-gsNWcXHn" role="doc-biblioref">1332</a>]</span>.
+These two home-grown vaccines are now approved for adults and children as young as five (CORBEVAX) and six (Covaxin) <span class="citation" data-cites="I9Ha5JL3">[<a href="#ref-I9Ha5JL3" role="doc-biblioref">1333</a>]</span>.</p>
+<p>Other vaccines licensed by India were developed elsewhere but produced in India.
+For example, Novavax (developed in the United States) has signed an agreement with the Serum Institute of India allowing them to produce up to 2 billion doses a year <span class="citation" data-cites="e8pnj0O3">[<a href="#ref-e8pnj0O3" role="doc-biblioref">1334</a>]</span>.
+Similarly, many people within India have been vaccinated with the AstraZeneca-University of Oxford vaccine, known as Covishield in India, which is also produced by the Serum Institute of India <span class="citation" data-cites="gsNWcXHn">[<a href="#ref-gsNWcXHn" role="doc-biblioref">1332</a>]</span>.
+India is also developing vaccines using cutting-edge nucleic-acid-based platforms..
+These include ZyCov-D, a DNA vaccine produced by Zydus Cadila, HGCO19 and India’s first mRNA vaccine, produced by Genova and HDT Biotech Corporation (of the U.S.) <span class="citation" data-cites="gsNWcXHn">[<a href="#ref-gsNWcXHn" role="doc-biblioref">1332</a>]</span>.
+Additionally, in February 2021, Bharat Biotech received approval from Indian officials to commence a phase I study of an intranasal chimpanzee-adenovirus (ChAd) vectored SARS-CoV-2-S vaccine called BBV154 <span class="citation" data-cites="P9mD7Gc9">[<a href="#ref-P9mD7Gc9" role="doc-biblioref">1335</a>]</span>.</p>
+<p>In China, the Sinopharm-Beijing Institute vaccine, the Sinopharm-Wuhan Institute of Biological Products vaccine, the Sinovac Biotech (CoronaVac) vaccine, and CanSino Biologics vaccine are the main vaccines being distributed.
+Sinovac and Sinopharm aimed to produce 2 billion doses by the end of 2021, and they have distributed vaccines as aid to the Philippines and Pakistan <span class="citation" data-cites="gdTtuj5e">[<a href="#ref-gdTtuj5e" role="doc-biblioref">1336</a>]</span>.
+In contrast, the Sinopharm-Wuhan vaccine, which has been approved for use in China since February 25, 2021, has been distributed almost exclusively within China, with limited supplies distributed to the United Arab Emirates <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.
+On the same date, the CanSino vaccine was approved for use in China and has been granted emergency use in several other countries <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.</p>
+<p>However, the vaccine approval and distribution processes in China have come under increased scrutiny from other nations.
+China was criticized for administering vaccines to thousands of government officials and state-owned businesses in September 2020, prior to the completion of phase III clinical trials <span class="citation" data-cites="1Bgnim0gX">[<a href="#ref-1Bgnim0gX" role="doc-biblioref">1337</a>]</span>.
+The behavior of Chinese officials has also come into question due to misinformation campaigns questioning the safety of Western vaccine candidates such as Moderna and Pfizer-BioNTech in a way that is intended to highlight the benefits of their own vaccine candidates <span class="citation" data-cites="gdTtuj5e">[<a href="#ref-gdTtuj5e" role="doc-biblioref">1336</a>]</span>.
+China in particular took aim at mRNA technologies, but Chinese companies have since developed their own mRNA vaccines targeting the omicron variant, one of which is due to begin trials soon in the UAE <span class="citation" data-cites="V2Gz2O9G">[<a href="#ref-V2Gz2O9G" role="doc-biblioref">1338</a>]</span>.
+Furthermore, delays in vaccine distribution have also caused issues, particularly in Turkey where 10 million doses of Sinovac were due to arrive by December 2020, but instead only 3 million were delivered in early January <span class="citation" data-cites="gdTtuj5e">[<a href="#ref-gdTtuj5e" role="doc-biblioref">1336</a>]</span>.
+Similar delays and shortages of doses promised were reported by officials in the Philippines, Egypt, Morocco, and the United Arab Emirates <span class="citation" data-cites="XJmfG8HD 12zVLzkpB">[<a href="#ref-XJmfG8HD" role="doc-biblioref">1339</a>,<a href="#ref-12zVLzkpB" role="doc-biblioref">1340</a>]</span>.
+All the same, Sinovac’s vaccine has since been approved for use in countries around the world <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.</p>
+<h1 data-number="8" id="the-coming-of-age-of-nucleic-acid-vaccines-during-covid-19"><span class="header-section-number">8</span> The Coming of Age of Nucleic Acid Vaccines during COVID-19</h1>
+<h2 data-number="8.1" id="abstract-5"><span class="header-section-number">8.1</span> Abstract</h2>
 <p>In the 21<sup>st</sup> century, several emergent viruses have emphasized the particular value of rapid and scalable vaccine development programs.
 Their importance has been made especially clear by the current pandemic caused by <em>Severe acute respiratory syndrome coronavirus 2</em> (SARS-CoV-2).
 Recent biotechnological advances in vaccine design have facilitated the development and deployment of vaccines against this virus at an unprecedented pace.
@@ -3804,59 +3995,61 @@ <h2 data-number="7.1" id="abstract-5"><span class="header-section-number">7.1</s
 We describe where these candidates currently stand in terms of efficacy, safety, and approval and discuss patterns in worldwide distribution.
 The advances made since early 2020 provide an exceptional illustration of how rapidly vaccine development technology has advanced in the last two decades in particular.
 <!-- Should the abstract say something about this review being about RNA/DNA vaccines? --></p>
-<h2 data-number="7.2" id="importance-5"><span class="header-section-number">7.2</span> Importance</h2>
+<h2 data-number="8.2" id="importance-5"><span class="header-section-number">8.2</span> Importance</h2>
 <p>The SARS-CoV-2 pandemic has caused untold damage globally, presenting unusual demands on but also opportunities for vaccine developers.
-As of August 10, 2022, there have been over 587,493,309 SARS-CoV-2 cases, and it has taken the lives of at least 6,427,446 people globally.
 The development, production, and distribution of vaccines is imperative to saving lives, preventing severe illness, and reducing the economic and social burdens caused by the COVID-19 pandemic.
 Although these vaccine technologies <!-- which ones --> had never previously been approved for use in humans, they have played a leading role in the management of SARS-CoV-2.
 In this review we discuss the history of developing these vaccines and how they have been applied to SARS-CoV-2.
 As the SARS-CoV-2 virus has evolved, they also provide insight into how these technologies have to adapt on incredibly short timescales.</p>
-<h2 data-number="7.3" id="introduction-5"><span class="header-section-number">7.3</span> Introduction</h2>
+<h2 data-number="8.3" id="introduction-5"><span class="header-section-number">8.3</span> Introduction</h2>
 <p>The SARS-CoV-2 virus emerged at the end of 2019 and quickly spread around the world.
 One of the primary approaches available to combat the effects of a virus is vaccination.
 Vaccines bolster the immune response to the virus at the individual and population level, thereby significantly reducing fatalities and severe illness and potentially driving a lower rate of infection even for a highly infectious virus like SARS-CoV-2.
-However, vaccine development has historically been slow.</p>
+However, vaccine development has historically required a lengthy process due to both the experimental and regulatory demands.
+In the present case, the Coalition for Epidemic Preparedness Innovations (CEPI) is coordinating global health agencies and pharmaceutical companies to develop vaccines against SARS-CoV-2.</p>
 <p>As we review in a companion manuscript <span class="citation" data-cites="S1SpDOhi">[<a href="#ref-S1SpDOhi" role="doc-biblioref">344</a>]</span>, vaccine technologies have largely been based on introducing a virus or a component of a virus that is sufficient to induce an immune response without causing the associated illness.
 The past 20 years have seen several previously unknown viruses emerge and rise rapidly to pose a global threat, challenging vaccine developers to explore approaches that would facilitate a rapid response to novel viruses. <!-- Is that specific to the past 20 years? -->
 Unsurprisingly, in the current century, significant advances have been made in vaccine development based on advances in genomics.
 This shift towards nucleic acid-based technologies opens a new frontier in vaccinology, where just the sequence encoding an antigen can be introduced to induce an immune response.
 While other platforms introduce viral components that can in some cases present risks of infection, nucleic acid-based platforms eliminate these risks.
 Additionally, vaccine technologies that require only minor adjustments for novel viral threats are appealing because this modular approach would mean they could enter trials quickly in response to a new pathogen of concern.</p>
-<h2 data-number="7.4" id="honing-a-21st-century-response-to-emergent-viral-threats"><span class="header-section-number">7.4</span> Honing a 21<sup>st</sup> Century Response to Emergent Viral Threats</h2>
+<h2 data-number="8.4" id="honing-a-21st-century-response-to-emergent-viral-threats"><span class="header-section-number">8.4</span> Honing a 21<sup>st</sup> Century Response to Emergent Viral Threats</h2>
 <p>Recently, vaccine technologies have been developed and refined in response to several epidemics that did not reach the level of destruction caused by COVID-19.
 Emergent viral threats of the 21<sup>st</sup> century include severe acute respiratory syndrome (SARS), “swine flu” (H1N1 influenza), Middle East respiratory syndrome (MERS), Ebola virus disease (EVD), COVID-19, and monkeypox, all of which have underscored the importance of a rapid global response to a new infectious virus.
-Because vaccines fail to provide immediate prophylactic protection or treatment of ongoing infections, their application to most of these epidemics has been limited <span class="citation" data-cites="181QWa7HL">[<a href="#ref-181QWa7HL" role="doc-biblioref">1285</a>]</span>. <!-- Aren't vaccines prophylactic? What is meant by immediate? I would think the problem for some of those diseases is that effective vaccines weren't developed quickly enough. --></p>
+Because vaccines fail to provide immediate prophylactic protection or treatment of ongoing infections, their application to most of these epidemics has been limited <span class="citation" data-cites="181QWa7HL">[<a href="#ref-181QWa7HL" role="doc-biblioref">1341</a>]</span>. <!-- Aren't vaccines prophylactic? What is meant by immediate? I would think the problem for some of those diseases is that effective vaccines weren't developed quickly enough. --></p>
 <p>One of the more successful recent vaccine development programs was for H1N1 influenza.
 This program benefited from the strong existing infrastructure for influenza vaccines along with the fact that regulatory agencies had determined that vaccines produced using egg- and cell-based platforms could be licensed under the regulations used for a strain change <span class="citation" data-cites="HyYY2agc">[<a href="#ref-HyYY2agc" role="doc-biblioref">1283</a>]</span>.
 Although a monovalent H1N1 vaccine was not available before the pandemic peaked in the United States of America (U.S.A.) and Europe, it became available soon afterward as a stand-alone vaccine that was eventually incorporated into commercially available seasonal influenza vaccines <span class="citation" data-cites="HyYY2agc">[<a href="#ref-HyYY2agc" role="doc-biblioref">1283</a>]</span>.
 Critiques of the production and distribution of the H1N1 vaccine have stressed the need for alternative development-and-manufacturing platforms that can be readily adapted to new pathogens.</p>
 <p>Efforts to develop such approaches have been undertaken prior to the COVID-19 pandemic.
 DNA vaccine development efforts began for SARS-CoV-1 but did not proceed past animal testing <span class="citation" data-cites="AOGjkjCq">[<a href="#ref-AOGjkjCq" role="doc-biblioref">1282</a>]</span>.
-Likewise, the development of viral-vectored Ebola virus vaccines was undertaken, but the pace of vaccine development was behind the spread of the virus from early on <span class="citation" data-cites="vTrIB9zS">[<a href="#ref-vTrIB9zS" role="doc-biblioref">1286</a>]</span>.
-Although a candidate Ebola vaccine V920 showed promise in preclinical and clinical testing, it did not receive breakthrough therapy designation until the summer of 2016, by which time the Ebola outbreak was winding down <span class="citation" data-cites="8uuVgxzA">[<a href="#ref-8uuVgxzA" role="doc-biblioref">1287</a>]</span>.</p>
+Likewise, the development of viral-vectored Ebola virus vaccines was undertaken, but the pace of vaccine development was behind the spread of the virus from early on <span class="citation" data-cites="vTrIB9zS">[<a href="#ref-vTrIB9zS" role="doc-biblioref">1342</a>]</span>.
+Although a candidate Ebola vaccine V920 showed promise in preclinical and clinical testing, it did not receive breakthrough therapy designation until the summer of 2016, by which time the Ebola outbreak was winding down <span class="citation" data-cites="8uuVgxzA">[<a href="#ref-8uuVgxzA" role="doc-biblioref">1343</a>]</span>.</p>
 <p>The pandemic caused by SARS-CoV-2 has highlighted a confluence of circumstances that positioned vaccine development as a key player in efforts to control the virus and mitigate its damage.
 This virus did not follow the same trajectory as other emergent viruses of recent note, such as SARS-CoV-1, MERS-CoV, and Ebola virus, none of which presented a global threat for such a sustained duration (see visualization in <span class="citation" data-cites="njpLhBui">[<a href="#ref-njpLhBui" role="doc-biblioref">3</a>]</span>).
 Spread of the SARS-CoV-2 virus has remained out of control in many parts of the world into 2022, especially with the emergence of novel variants exhibiting increased rates of transmission <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span>.
 While, for a variety of reasons, SARS-CoV-2 was not controlled as rapidly as the viruses underlying prior 21<sup>st</sup> century epidemics, vaccine development technology had also progressed based on these and other prior viral threats to the point that a rapid international vaccine development response was possible.</p>
-<h2 data-number="7.5" id="development-of-covid-19-vaccines-using-dna-and-rna-platforms"><span class="header-section-number">7.5</span> Development of COVID-19 Vaccines using DNA and RNA Platforms</h2>
+<h2 data-number="8.5" id="development-of-covid-19-vaccines-using-dna-and-rna-platforms"><span class="header-section-number">8.5</span> Development of COVID-19 Vaccines using DNA and RNA Platforms</h2>
 <p>Vaccine development programs for COVID-19 emerged very quickly.
-The first administration of a dose of a COVID-19 vaccine to a human trial participant occurred on March 16, 2020 <span class="citation" data-cites="fQvzeptv 1GA95MF2m">[<a href="#ref-fQvzeptv" role="doc-biblioref">1288</a>,<a href="#ref-1GA95MF2m" role="doc-biblioref">1289</a>]</span>, marking an extremely rapid response to the emergence of SARS-CoV-2.
-Within a few weeks<!-- of what? -->, at least 78 vaccine development programs were active <span class="citation" data-cites="1GA95MF2m">[<a href="#ref-1GA95MF2m" role="doc-biblioref">1289</a>]</span>, and by September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.
-As of August 11, 2022, 40 SARS-CoV-2 vaccines have been approved world wide and 29 are being administered throughout the world, with doses administered across 223 countries.
-The first critical step towards developing a vaccine against SARS-CoV-2 was characterizing the viral target, which happened extremely early in the COVID-19 outbreak with the sequencing and dissemination of the viral genome in early January 2020 <span class="citation" data-cites="vlGP3RAU">[<a href="#ref-vlGP3RAU" role="doc-biblioref">545</a>]</span>.
-This genomic information allowed for an early identification of the sequence of the spike (S) protein (Figure <a href="#fig:virus">10</a>), which is the antigen and induces an immune response <span class="citation" data-cites="Vnbw9o3T 13wCBLnnu">[<a href="#ref-Vnbw9o3T" role="doc-biblioref">1290</a>,<a href="#ref-13wCBLnnu" role="doc-biblioref">1291</a>]</span>.</p>
+The first administration of a dose of a COVID-19 vaccine to a human trial participant occurred on March 16, 2020 <span class="citation" data-cites="fQvzeptv 1GA95MF2m">[<a href="#ref-fQvzeptv" role="doc-biblioref">1344</a>,<a href="#ref-1GA95MF2m" role="doc-biblioref">1345</a>]</span>, marking an extremely rapid response to the emergence of SARS-CoV-2.
+Within a few weeks<!-- of what? -->, at least 78 vaccine development programs were active <span class="citation" data-cites="1GA95MF2m">[<a href="#ref-1GA95MF2m" role="doc-biblioref">1345</a>]</span>, and by September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development <span class="citation" data-cites="dqpEe5Lz">[<a href="#ref-dqpEe5Lz" role="doc-biblioref">1104</a>]</span>.
+As of August 15, 2022, 41 SARS-CoV-2 vaccines have been approved world wide and 29 are being administered throughout the world, with doses administered across 223 countries.
+The first critical step towards developing a vaccine against SARS-CoV-2 was characterizing the viral target, which happened extremely early in the COVID-19 outbreak with the sequencing and dissemination of the viral genome in early January 2020 <span class="citation" data-cites="vlGP3RAU">[<a href="#ref-vlGP3RAU" role="doc-biblioref">545</a>]</span> (Figure <a href="#fig:virus">10</a>).
+This genomic information allowed for an early identification of the sequence of the spike (S) protein (Figure <a href="#fig:virus">10</a>), which is the antigen and induces an immune response <span class="citation" data-cites="Vnbw9o3T 13wCBLnnu">[<a href="#ref-Vnbw9o3T" role="doc-biblioref">1346</a>,<a href="#ref-13wCBLnnu" role="doc-biblioref">1347</a>]</span>.</p>
 <div id="fig:virus" class="fignos">
 <figure>
-<img src="images/SARS_CoV_2.png" alt="Figure 10: Structure of the SARS-CoV-2 virus. The development of vaccines depends on the immune system recognizing the virus. Here, the structure of SARS-CoV-2 is represented both in the abstract and against a visualization of the virion. The abstracted visualization was made using BioRender.com, and the microscopy image is from the National Institute of Allergy and Infectious Diseases Integrated Research Facility [1292]." />
+<img src="images/SARS_CoV_2.png" alt="Figure 10: Structure of the SARS-CoV-2 virus. The development of vaccines depends on the immune system recognizing the virus. Here, the structure of SARS-CoV-2 is represented both in the abstract and against a visualization of the virion. The abstracted visualization was made using BioRender [1348] using the template “Human Coronavirus Structure” by BioRender (August 2020) [1349]. The microscopy was conducted by the National Institute of Allergy and Infectious Diseases [1350]." />
 <figcaption aria-hidden="true"><span>Figure 10:</span> <strong>Structure of the SARS-CoV-2 virus.</strong>
 The development of vaccines depends on the immune system recognizing the virus.
 Here, the structure of SARS-CoV-2 is represented both in the abstract and against a visualization of the virion.
-The abstracted visualization was made using BioRender.com, and the microscopy image is from the National Institute of Allergy and Infectious Diseases Integrated Research Facility <span class="citation" data-cites="Jzj97hJh">[<a href="#ref-Jzj97hJh" role="doc-biblioref">1292</a>]</span>.<!--To Do: Was a template used?--></figcaption>
+The abstracted visualization was made using BioRender <span class="citation" data-cites="14FBejgLM">[<a href="#ref-14FBejgLM" role="doc-biblioref">1348</a>]</span> using the template “Human Coronavirus Structure” by BioRender (August 2020) <span class="citation" data-cites="EAzPxBbg">[<a href="#ref-EAzPxBbg" role="doc-biblioref">1349</a>]</span>.
+The microscopy was conducted by the National Institute of Allergy and Infectious Diseases <span class="citation" data-cites="Jzj97hJh">[<a href="#ref-Jzj97hJh" role="doc-biblioref">1350</a>]</span>.</figcaption>
 </figure>
 </div>
-<p>During the development process, one measure used to assess whether a vaccine candidate is likely to provide protection is serum neutralizing activity <span class="citation" data-cites="wiGjCZC8">[<a href="#ref-wiGjCZC8" role="doc-biblioref">1108</a>]</span>.<!--Would it make sense to have the definition here?-->
-However, unlike in efforts to develop vaccines for prior viral threats, the duration of the COVID-19 pandemic has made it possible to also test vaccines in phase III trials where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 was evaluated.
-The Coalition for Epidemic Preparedness Innovations (CEPI) is coordinating global health agencies and pharmaceutical companies to develop vaccines against SARS-CoV-2.<!--This is an important statement, but seems a little lost here near the VE section--></p>
+<p>During the development process, one measure used to assess whether a vaccine candidate is likely to provide protection is serum neutralizing activity <span class="citation" data-cites="wiGjCZC8">[<a href="#ref-wiGjCZC8" role="doc-biblioref">1108</a>]</span>.
+This assay evaluates the presence of antibodies that can neutralize, or prevent infection by, the virus in question.
+Often, titration is used to determine the extent of neutralization activity.
+However, unlike in efforts to develop vaccines for prior viral threats, the duration of the COVID-19 pandemic has made it possible to also test vaccines in phase III trials where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 was evaluated.</p>
 <!-- This paragraph doesn't really say anything. We have already introduced the manuscript. Do we need it? -->
 <p>With vaccine candidates at all stages of development, including full approval of some vaccines, the vaccine development landscape for COVID-19 includes vaccines produced by a wide array of technologies.
 Examining the vaccine development programs tackling the COVID-19 pandemic alongside other 21<sup>st</sup> century efforts to control emerging viral threats demonstrates the significant biotechnological advances in this field and the importance of modular and adaptable approaches to vaccination.
@@ -3864,62 +4057,62 @@ <h2 data-number="7.5" id="development-of-covid-19-vaccines-using-dna-and-rna-pla
 These programs employ a variety of technologies, ranging from established approaches to novel technologies that had never previously gone to market.<!--Note figure not rendering-->
 Development programs using more established technologies are reviewed in a companion manuscript.
 Here, we review the various technologies being explored for the development of SARS-CoV-2 vaccines that use technologies based on nucleic acids.</p>
-<h2 data-number="7.6" id="cross-platform-considerations-in-vaccine-development"><span class="header-section-number">7.6</span> Cross-Platform Considerations in Vaccine Development</h2>
+<h2 data-number="8.6" id="cross-platform-considerations-in-vaccine-development"><span class="header-section-number">8.6</span> Cross-Platform Considerations in Vaccine Development</h2>
 <p>Certain design decisions are relevant to vaccine development across multiple platforms.
 One applies to the platforms that deliver the antigen, which in the case of SARS-CoV-2 vaccines is the S protein.
-The prefusion conformation of the S protein, which is the structure before the virus fuses to the host cell membrane, is metastable <span class="citation" data-cites="R7Xdh5nH">[<a href="#ref-R7Xdh5nH" role="doc-biblioref">1293</a>]</span>, and the release of energy during membrane fusion drives this process forward following destabilization <span class="citation" data-cites="17DSmRo9H 3uddYea8">[<a href="#ref-17DSmRo9H" role="doc-biblioref">10</a>,<a href="#ref-3uddYea8" role="doc-biblioref">1294</a>]</span>.
-Due to the significant conformational changes that occur during membrane fusion <span class="citation" data-cites="qcVbT0w4 hIc3bKWe zK0rFpz1">[<a href="#ref-qcVbT0w4" role="doc-biblioref">23</a>,<a href="#ref-hIc3bKWe" role="doc-biblioref">1295</a>,<a href="#ref-zK0rFpz1" role="doc-biblioref">1296</a>]</span>, S protein immunogens that are stabilized in the prefusion conformation are of particular interest, especially because a prefusion stabilized <em>Middle East respiratory syndrome-related coronavirus</em> (MERS-CoV) S antigen was found to elicit an improved antibody response <span class="citation" data-cites="oghHqZDt">[<a href="#ref-oghHqZDt" role="doc-biblioref">1222</a>]</span>.
-Moreover, the prefusion conformation offers an opportunity to target S2, a region of the S protein that accumulates mutations at a slower rate <span class="citation" data-cites="13wWdgODZ OVsxrEuX oghHqZDt">[<a href="#ref-13wWdgODZ" role="doc-biblioref">21</a>,<a href="#ref-OVsxrEuX" role="doc-biblioref">22</a>,<a href="#ref-oghHqZDt" role="doc-biblioref">1222</a>]</span> (see also <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span>).
-Vaccine developers can stabilize the prefusion conformer by selecting versions of the S protein containing mutations that lock the position <span class="citation" data-cites="lvq9hGmj">[<a href="#ref-lvq9hGmj" role="doc-biblioref">1297</a>]</span>.
-The immune response to the spike protein when it is stabilized in this conformation is improved over other S structures <span class="citation" data-cites="10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>]</span>.
+The prefusion conformation of the S protein, which is the structure before the virus fuses to the host cell membrane, is metastable <span class="citation" data-cites="R7Xdh5nH">[<a href="#ref-R7Xdh5nH" role="doc-biblioref">1351</a>]</span>, and the release of energy during membrane fusion drives this process forward following destabilization <span class="citation" data-cites="17DSmRo9H 3uddYea8">[<a href="#ref-17DSmRo9H" role="doc-biblioref">10</a>,<a href="#ref-3uddYea8" role="doc-biblioref">1352</a>]</span>.
+Due to the significant conformational changes that occur during membrane fusion <span class="citation" data-cites="qcVbT0w4 hIc3bKWe zK0rFpz1">[<a href="#ref-qcVbT0w4" role="doc-biblioref">23</a>,<a href="#ref-hIc3bKWe" role="doc-biblioref">1353</a>,<a href="#ref-zK0rFpz1" role="doc-biblioref">1354</a>]</span>, S protein immunogens that are stabilized in the prefusion conformation are of particular interest, especially because a prefusion stabilized <em>Middle East respiratory syndrome-related coronavirus</em> (MERS-CoV) S antigen was found to elicit an improved antibody response <span class="citation" data-cites="oghHqZDt">[<a href="#ref-oghHqZDt" role="doc-biblioref">1223</a>]</span>.
+Moreover, the prefusion conformation offers an opportunity to target S2, a region of the S protein that accumulates mutations at a slower rate <span class="citation" data-cites="13wWdgODZ OVsxrEuX oghHqZDt">[<a href="#ref-13wWdgODZ" role="doc-biblioref">21</a>,<a href="#ref-OVsxrEuX" role="doc-biblioref">22</a>,<a href="#ref-oghHqZDt" role="doc-biblioref">1223</a>]</span> (see also <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span>).
+Vaccine developers can stabilize the prefusion conformer by selecting versions of the S protein containing mutations that lock the position <span class="citation" data-cites="lvq9hGmj">[<a href="#ref-lvq9hGmj" role="doc-biblioref">1355</a>]</span>.
+The immune response to the spike protein when it is stabilized in this conformation is improved over other S structures <span class="citation" data-cites="10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>]</span>.
 Thus, vaccines that use this prefusion stabilized conformation are expected to not only offer improved immunogenicity, but also be more resilient to the accumulation of mutations in SARS-CoV-2.</p>
 <p>Another cross-platform consideration is the use of adjuvants.
 Adjuvants include a variety of molecules or larger microbial-related products that affect the immune system broadly or an immune response of interest.
 They can either be comprised of or contain immunostimulants or immunomodulators.
 Adjuvants are sometimes included within vaccines in order to enhance the immune response.
 Different adjuvants can regulate different types of immune responses, so the type or combination of adjuvants used in a vaccine will depend on both the type of vaccine and concern related to efficacy and safety.
-A variety of possible mechanisms for adjuvants have been investigated <span class="citation" data-cites="13bVbfc5h 122h6fIxE uO0uqhxc">[<a href="#ref-13bVbfc5h" role="doc-biblioref">1299</a>,<a href="#ref-122h6fIxE" role="doc-biblioref">1300</a>,<a href="#ref-uO0uqhxc" role="doc-biblioref">1301</a>]</span>.</p>
+A variety of possible mechanisms for adjuvants have been investigated <span class="citation" data-cites="13bVbfc5h 122h6fIxE uO0uqhxc">[<a href="#ref-13bVbfc5h" role="doc-biblioref">1357</a>,<a href="#ref-122h6fIxE" role="doc-biblioref">1358</a>,<a href="#ref-uO0uqhxc" role="doc-biblioref">1359</a>]</span>.</p>
 <p>Due to viral evolution, vaccine developers are in an arms race with a pathogen that benefits from mutations that reduce its susceptibility to adaptive immunity.
 The evolution of several variants of concern (VOC) presents significant challenges for vaccines developed based on the index strain identified in Wuhan in late 2019.
 We discuss these variants in depth elsewhere <span class="citation" data-cites="17qiILENK">[<a href="#ref-17qiILENK" role="doc-biblioref">327</a>]</span>.
 To date, the most significant variants of concern identified are Alpha (2020), Beta (2020), Gamma (2020), Delta (2021), Omicron (2021), and related Omicron subvariants (2022).
 The efficacy of vaccines in the context of these variants is discussed where information is available.</p>
-<h2 data-number="7.7" id="theory-and-implementation-of-nucleic-acid-vaccines"><span class="header-section-number">7.7</span> Theory and Implementation of Nucleic Acid Vaccines</h2>
+<h2 data-number="8.7" id="theory-and-implementation-of-nucleic-acid-vaccines"><span class="header-section-number">8.7</span> Theory and Implementation of Nucleic Acid Vaccines</h2>
 <!-- This section seems more general than the previous section. Switch the order? -->
 <p>Biomedical research in the 21<sup>st</sup> century has been significantly influenced by the genomic revolution.
 While traditional methods of vaccine development, such as inactivated whole viruses are still used today <span class="citation" data-cites="S1SpDOhi">[<a href="#ref-S1SpDOhi" role="doc-biblioref">344</a>]</span>, vaccine development is no exception.
-The shift towards omics-based approaches to vaccine development began to take hold with the meningococcal type B vaccine, which was developed using reverse vaccinology in the early 2010s <span class="citation" data-cites="MCZBJ5sF fw8IwtHq">[<a href="#ref-MCZBJ5sF" role="doc-biblioref">1302</a>,<a href="#ref-fw8IwtHq" role="doc-biblioref">1303</a>]</span>.
+The shift towards omics-based approaches to vaccine development began to take hold with the meningococcal type B vaccine, which was developed using reverse vaccinology in the early 2010s <span class="citation" data-cites="MCZBJ5sF fw8IwtHq">[<a href="#ref-MCZBJ5sF" role="doc-biblioref">1360</a>,<a href="#ref-fw8IwtHq" role="doc-biblioref">1361</a>]</span>.
 In this way, the genomic revolution catalyzed a fundamental shift in the development of vaccines.
-Such technologies could revolutionize the role of vaccines given their potential to address one of the major limitations of vaccines today and facilitate the design of therapeutic, rather than just prophylactic, vaccines <span class="citation" data-cites="kqerKJKY">[<a href="#ref-kqerKJKY" role="doc-biblioref">1304</a>]</span>.</p>
+Such technologies could revolutionize the role of vaccines given their potential to address one of the major limitations of vaccines today and facilitate the design of therapeutic, rather than just prophylactic, vaccines <span class="citation" data-cites="kqerKJKY">[<a href="#ref-kqerKJKY" role="doc-biblioref">1362</a>]</span>.</p>
 <p>Nucleic-acid based approaches share an underlying principle: a vector that delivers the information needed to produce an antigen.
 When the host cells manufacture the antigen, it can then trigger an immune response.
 The fact that no part of the virus is introduced aside from the genetic code of the antigen makes these platforms very safe. <!-- This refers to infection, but there was a lot of discussion about risks of side effects -->
 Such approaches build on subunit vaccination strategies, where a component of a vaccine (e.g., an antigenic protein) is delivered.
 Platforms based on genomic sequencing began to be explored beginning in the 1980s as genetic research became increasingly feasible.
 Advances in genetic engineering allowed for gene sequences of specific viral antigens to be grown <em>in vitro</em> <span class="citation" data-cites="YY3x3bBV">[<a href="#ref-YY3x3bBV" role="doc-biblioref">1103</a>]</span>.
-Studies also demonstrated that model organisms could be induced to construct antigens that would trigger an immune response <span class="citation" data-cites="U9ZIZWkB pWMIo6pD uPszIvSj">[<a href="#ref-U9ZIZWkB" role="doc-biblioref">1115</a>,<a href="#ref-pWMIo6pD" role="doc-biblioref">1305</a>,<a href="#ref-uPszIvSj" role="doc-biblioref">1306</a>]</span>.
+Studies also demonstrated that model organisms could be induced to construct antigens that would trigger an immune response <span class="citation" data-cites="U9ZIZWkB pWMIo6pD uPszIvSj">[<a href="#ref-U9ZIZWkB" role="doc-biblioref">1115</a>,<a href="#ref-pWMIo6pD" role="doc-biblioref">1363</a>,<a href="#ref-uPszIvSj" role="doc-biblioref">1364</a>]</span>.
 These two developments sparked interest in whether it could be possible to identify any or all of the antigens encoded by a virus’s genome and train the immune response to recognize them.</p>
 <p>The delivery and presentation of antigens is fundamental to inducing immunity against a virus.
-Vaccines that deliver nucleic acids allow the introduction of foreign substances to the body to induce both humoral and cellular immune responses <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-Delivering a nucleic acid sequence to host cells allows the host to synthesize an antigen without exposure to a viral threat <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-Host-synthesized antigens can then be presented in complex with major histocompatibility complex (MHC) I and II, which can activate either T- or B-cells <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-While these vaccines encode specific proteins, providing many of the benefits of a protein subunit vaccine, they do not carry any risk of DNA being live, replicating, or spreading, and their manufacturing process lends itself to scalability <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
+Vaccines that deliver nucleic acids allow the introduction of foreign substances to the body to induce both humoral and cellular immune responses <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+Delivering a nucleic acid sequence to host cells allows the host to synthesize an antigen without exposure to a viral threat <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+Host-synthesized antigens can then be presented in complex with major histocompatibility complex (MHC) I and II, which can activate either T- or B-cells <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+While these vaccines encode specific proteins, providing many of the benefits of a protein subunit vaccine, they do not carry any risk of DNA being live, replicating, or spreading, and their manufacturing process lends itself to scalability <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
 Here, opportunities can be framed in terms of the central dogma of genetics: instead of directly providing the proteins from the infectious agents, vaccines developers are exploring the potential for the delivery of DNA or RNA to induce the cell to produce proteins from the virus that in turn induce a host immune response.</p>
 <!-- This paragraph is repetetive. What parts do we need? Delete the rest and move refs doi:10.1358/dot.2018.54.5.2807864 and doi:10.1016/j.coi.2016.05.008. -->
-<p>In nucleic-acid-based approaches, the genome of a pathogen is screened to identify potential vaccine targets <span class="citation" data-cites="fw8IwtHq">[<a href="#ref-fw8IwtHq" role="doc-biblioref">1303</a>]</span>, and pathogens of interest are then expressed <em>in vitro</em> and tested in animal models to determine their immunogenicity <span class="citation" data-cites="fw8IwtHq">[<a href="#ref-fw8IwtHq" role="doc-biblioref">1303</a>]</span>.
-By inducing the host to express the antigen, such vaccines can activate immune pathways via both MHC I and MHC II <span class="citation" data-cites="fwumPoq1">[<a href="#ref-fwumPoq1" role="doc-biblioref">1308</a>]</span> instead of MHC II alone as with prior technologies <span class="citation" data-cites="uPszIvSj">[<a href="#ref-uPszIvSj" role="doc-biblioref">1306</a>]</span>.
-This dual presentation means that both humoral and cellular immunity are activated <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-Thus, in addition to lacking an infectious agent, these approaches are likely to offer several advantages over more traditional immunization platforms because they can stimulate both B- and T-cell responses <span class="citation" data-cites="29LxSWHB BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>,<a href="#ref-29LxSWHB" role="doc-biblioref">1309</a>]</span>.</p>
-<h2 data-number="7.8" id="dna-vaccine-platforms"><span class="header-section-number">7.8</span> DNA Vaccine Platforms</h2>
+<p>In nucleic-acid-based approaches, the genome of a pathogen is screened to identify potential vaccine targets <span class="citation" data-cites="fw8IwtHq">[<a href="#ref-fw8IwtHq" role="doc-biblioref">1361</a>]</span>, and pathogens of interest are then expressed <em>in vitro</em> and tested in animal models to determine their immunogenicity <span class="citation" data-cites="fw8IwtHq">[<a href="#ref-fw8IwtHq" role="doc-biblioref">1361</a>]</span>.
+By inducing the host to express the antigen, such vaccines can activate immune pathways via both MHC I and MHC II <span class="citation" data-cites="fwumPoq1">[<a href="#ref-fwumPoq1" role="doc-biblioref">1366</a>]</span> instead of MHC II alone as with prior technologies <span class="citation" data-cites="uPszIvSj">[<a href="#ref-uPszIvSj" role="doc-biblioref">1364</a>]</span>.
+This dual presentation means that both humoral and cellular immunity are activated <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+Thus, in addition to lacking an infectious agent, these approaches are likely to offer several advantages over more traditional immunization platforms because they can stimulate both B- and T-cell responses <span class="citation" data-cites="29LxSWHB BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>,<a href="#ref-29LxSWHB" role="doc-biblioref">1367</a>]</span>.</p>
+<h2 data-number="8.8" id="dna-vaccine-platforms"><span class="header-section-number">8.8</span> DNA Vaccine Platforms</h2>
 <p>DNA vaccine technologies have developed slowly over the past thirty years.
-DNA vaccines introduce a vector containing a DNA sequence that encodes the antigen(s) necessary to induce a specific immune response into appropriate tissues where <em>in situ</em> expression of the target antigen is induced <span class="citation" data-cites="uPszIvSj">[<a href="#ref-uPszIvSj" role="doc-biblioref">1306</a>]</span>.
-Early attempts revealed issues with low immunogenicity <span class="citation" data-cites="U9ZIZWkB uPszIvSj 12jFcMeQY">[<a href="#ref-U9ZIZWkB" role="doc-biblioref">1115</a>,<a href="#ref-uPszIvSj" role="doc-biblioref">1306</a>,<a href="#ref-12jFcMeQY" role="doc-biblioref">1310</a>]</span>.
-Additionally, initial skepticism about the approach suggested that DNA vaccines might bind to the host genome or induce autoimmune disease <span class="citation" data-cites="fwumPoq1 BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>,<a href="#ref-fwumPoq1" role="doc-biblioref">1308</a>]</span>, but pre-clinical and clinical studies have consistently disproved this hypothesis and indicated DNA vaccines to be safe <span class="citation" data-cites="12jFcMeQY">[<a href="#ref-12jFcMeQY" role="doc-biblioref">1310</a>]</span>.
-These safety concerns were not found to be an issue during preclinical and phase I testing, although antibiotic resistance introduced during the plasmid selection process remained a concern during this initial phase of development <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-While this issue was resolved through strategic vector design <span class="citation" data-cites="Wjtx0VXu 5fcD0JWR">[<a href="#ref-Wjtx0VXu" role="doc-biblioref">1311</a>,<a href="#ref-5fcD0JWR" role="doc-biblioref">1312</a>]</span>, the immunogenicity of these vaccines did not reach expectations <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.</p>
-<p>Several developments during the 2010s led to greater efficacy of DNA vaccines <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-However, no DNA vaccines had been approved for use in humans prior to the COVID-19 pandemic <span class="citation" data-cites="12jFcMeQY yriARFOF">[<a href="#ref-12jFcMeQY" role="doc-biblioref">1310</a>,<a href="#ref-yriARFOF" role="doc-biblioref">1313</a>]</span>.
-As of August 12, 2022, XX <!--8--> vaccines have been approved worldwide (Table <a href="#tbl:approved-DNA">4</a>).<!--Check automation-->
+DNA vaccines introduce a vector containing a DNA sequence that encodes the antigen(s) necessary to induce a specific immune response into appropriate tissues where <em>in situ</em> expression of the target antigen is induced <span class="citation" data-cites="uPszIvSj">[<a href="#ref-uPszIvSj" role="doc-biblioref">1364</a>]</span>.
+Early attempts revealed issues with low immunogenicity <span class="citation" data-cites="U9ZIZWkB uPszIvSj 12jFcMeQY">[<a href="#ref-U9ZIZWkB" role="doc-biblioref">1115</a>,<a href="#ref-uPszIvSj" role="doc-biblioref">1364</a>,<a href="#ref-12jFcMeQY" role="doc-biblioref">1368</a>]</span>.
+Additionally, initial skepticism about the approach suggested that DNA vaccines might bind to the host genome or induce autoimmune disease <span class="citation" data-cites="fwumPoq1 BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>,<a href="#ref-fwumPoq1" role="doc-biblioref">1366</a>]</span>, but pre-clinical and clinical studies have consistently disproved this hypothesis and indicated DNA vaccines to be safe <span class="citation" data-cites="12jFcMeQY">[<a href="#ref-12jFcMeQY" role="doc-biblioref">1368</a>]</span>.
+These safety concerns were not found to be an issue during preclinical and phase I testing, although antibiotic resistance introduced during the plasmid selection process remained a concern during this initial phase of development <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+While this issue was resolved through strategic vector design <span class="citation" data-cites="Wjtx0VXu 5fcD0JWR">[<a href="#ref-Wjtx0VXu" role="doc-biblioref">1369</a>,<a href="#ref-5fcD0JWR" role="doc-biblioref">1370</a>]</span>, the immunogenicity of these vaccines did not reach expectations <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.</p>
+<p>Several developments during the 2010s led to greater efficacy of DNA vaccines <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+However, no DNA vaccines had been approved for use in humans prior to the COVID-19 pandemic <span class="citation" data-cites="12jFcMeQY yriARFOF">[<a href="#ref-12jFcMeQY" role="doc-biblioref">1368</a>,<a href="#ref-yriARFOF" role="doc-biblioref">1371</a>]</span>.
+As of August 15, 2022, 8 vaccines have been approved worldwide (Table <a href="#tbl:approved-DNA">4</a>).
 These vaccines fall into two categories, vaccines that are vectored with a plasmid and those that are vectored with another virus.</p>
 <!-- The traditional vaccines table captions were a bit more descriptive -->
 <div id="tbl:approved-DNA" class="tablenos">
@@ -3982,163 +4175,163 @@ <h2 data-number="7.8" id="dna-vaccine-platforms"><span class="header-section-num
 </tbody>
 </table>
 </div>
-<h3 data-number="7.8.1" id="plasmid-vectored-dna-vaccines"><span class="header-section-number">7.8.1</span> Plasmid-Vectored DNA Vaccines</h3>
+<h3 data-number="8.8.1" id="plasmid-vectored-dna-vaccines"><span class="header-section-number">8.8.1</span> Plasmid-Vectored DNA Vaccines</h3>
 <!-- Should these be another heading level instead of formatted text? -->
 <p><strong>Mechanism:</strong>
-Many DNA vaccines use a plasmid vector-based approach, where the sequence encoding the antigen(s) against which an immune response is sought can be cultivated in a plasmid and delivered directly to an appropriate tissue <span class="citation" data-cites="XnrBoKVk">[<a href="#ref-XnrBoKVk" role="doc-biblioref">1314</a>]</span>.
-Plasmids can also be designed to act as adjuvants by encoding molecules that supplement the immune response, such as immune stimulant molecules <span class="citation" data-cites="fwumPoq1">[<a href="#ref-fwumPoq1" role="doc-biblioref">1308</a>]</span>.
-The DNA itself may also stimulate the innate immune response <span class="citation" data-cites="uPszIvSj 5fcD0JWR">[<a href="#ref-uPszIvSj" role="doc-biblioref">1306</a>,<a href="#ref-5fcD0JWR" role="doc-biblioref">1312</a>]</span>.
-Once the plasmid brings the DNA sequence to an antigen-presenting cell (APC), the host machinery can be used to construct antigen(s) from the transported genetic material, and the body can then synthesize antibodies in response <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-The vectors are edited to remove extra sequences <span class="citation" data-cites="5fcD0JWR">[<a href="#ref-5fcD0JWR" role="doc-biblioref">1312</a>]</span>.
-These types of manufacturing advances have improved the safety and throughput of this platform <span class="citation" data-cites="5fcD0JWR">[<a href="#ref-5fcD0JWR" role="doc-biblioref">1312</a>]</span>.</p>
+Many DNA vaccines use a plasmid vector-based approach, where the sequence encoding the antigen(s) against which an immune response is sought can be cultivated in a plasmid and delivered directly to an appropriate tissue <span class="citation" data-cites="XnrBoKVk">[<a href="#ref-XnrBoKVk" role="doc-biblioref">1372</a>]</span>.
+Plasmids can also be designed to act as adjuvants by encoding molecules that supplement the immune response, such as immune stimulant molecules <span class="citation" data-cites="fwumPoq1">[<a href="#ref-fwumPoq1" role="doc-biblioref">1366</a>]</span>.
+The DNA itself may also stimulate the innate immune response <span class="citation" data-cites="uPszIvSj 5fcD0JWR">[<a href="#ref-uPszIvSj" role="doc-biblioref">1364</a>,<a href="#ref-5fcD0JWR" role="doc-biblioref">1370</a>]</span>.
+Once the plasmid brings the DNA sequence to an antigen-presenting cell (APC), the host machinery can be used to construct antigen(s) from the transported genetic material, and the body can then synthesize antibodies in response <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+The vectors are edited to remove extra sequences <span class="citation" data-cites="5fcD0JWR">[<a href="#ref-5fcD0JWR" role="doc-biblioref">1370</a>]</span>.
+These types of manufacturing advances have improved the safety and throughput of this platform <span class="citation" data-cites="5fcD0JWR">[<a href="#ref-5fcD0JWR" role="doc-biblioref">1370</a>]</span>.</p>
 <p><strong>Prior Applications:</strong>
-In the 1990s and 2000s, DNA vaccines delivered via plasmids sparked significant scientific interest, leading to a large number of preclinical trials <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-Early preclinical trials primarily focused on long-standing disease threats, including viral diseases such as rabies and bacterial diseases such as malaria, and promising results led to phase I testing of the application of this technology to HIV, influenza, malaria, and other diseases of concern during this period <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-Although they were well-tolerated, these early attempts to develop vaccines were generally not very successful in inducing immunity to the target pathogen, with either limited T-cell or limited neutralizing antibody responses observed <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.</p>
-<p>Early plasmid-vectored DNA vaccine trials targeted HIV and subsequently diseases of worldwide importance such as malaria and hepatitis B <span class="citation" data-cites="3EKs730C">[<a href="#ref-3EKs730C" role="doc-biblioref">1315</a>]</span>.
-The concern with these early development projects was immunogenicity, not safety <span class="citation" data-cites="3EKs730C">[<a href="#ref-3EKs730C" role="doc-biblioref">1315</a>]</span>.
-Around the turn of the millennium, a hepatitis B vaccine development program demonstrated that these vaccines can induce both antibody and cellular immune response <span class="citation" data-cites="jPpzjaYO">[<a href="#ref-jPpzjaYO" role="doc-biblioref">1316</a>]</span>.
-As of 2018, however, only two plasmid-vectored DNA vaccines had been approved for commercial use, and both were for veterinary populations <span class="citation" data-cites="fgs4epPY">[<a href="#ref-fgs4epPY" role="doc-biblioref">1317</a>]</span>.</p>
+In the 1990s and 2000s, DNA vaccines delivered via plasmids sparked significant scientific interest, leading to a large number of preclinical trials <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+Early preclinical trials primarily focused on long-standing disease threats, including viral diseases such as rabies and bacterial diseases such as malaria, and promising results led to phase I testing of the application of this technology to HIV, influenza, malaria, and other diseases of concern during this period <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+Although they were well-tolerated, these early attempts to develop vaccines were generally not very successful in inducing immunity to the target pathogen, with either limited T-cell or limited neutralizing antibody responses observed <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.</p>
+<p>Early plasmid-vectored DNA vaccine trials targeted HIV and subsequently diseases of worldwide importance such as malaria and hepatitis B <span class="citation" data-cites="3EKs730C">[<a href="#ref-3EKs730C" role="doc-biblioref">1373</a>]</span>.
+The concern with these early development projects was immunogenicity, not safety <span class="citation" data-cites="3EKs730C">[<a href="#ref-3EKs730C" role="doc-biblioref">1373</a>]</span>.
+Around the turn of the millennium, a hepatitis B vaccine development program demonstrated that these vaccines can induce both antibody and cellular immune response <span class="citation" data-cites="jPpzjaYO">[<a href="#ref-jPpzjaYO" role="doc-biblioref">1374</a>]</span>.
+As of 2018, however, only two plasmid-vectored DNA vaccines had been approved for commercial use, and both were for veterinary populations <span class="citation" data-cites="fgs4epPY">[<a href="#ref-fgs4epPY" role="doc-biblioref">1375</a>]</span>.</p>
 <p><strong>Applications to COVID-19:</strong>
 Several plasmid-vectored DNA vaccines have been developed against COVID-19 (Table <a href="#tbl:approved-DNA">4</a>).
-In fact, the ZyCoV-D vaccines developed by India’s Zydus Cadila is the first plasmid-vectored DNA to receive approval <span class="citation" data-cites="AfMvzFuk eIn1Qf3N">[<a href="#ref-AfMvzFuk" role="doc-biblioref">1318</a>,<a href="#ref-eIn1Qf3N" role="doc-biblioref">1319</a>]</span>.
+In fact, the ZyCoV-D vaccines developed by India’s Zydus Cadila is the first plasmid-vectored DNA to receive approval <span class="citation" data-cites="AfMvzFuk eIn1Qf3N">[<a href="#ref-AfMvzFuk" role="doc-biblioref">1376</a>,<a href="#ref-eIn1Qf3N" role="doc-biblioref">1377</a>]</span>.
 <!--It would be great to go into ZyCoV-D since it made it to approval, but we originally put our effort into covering INO-4800. Consider updating post-submission?--></p>
-<p>Similarly, another plasmid-vectored DNA vaccine, INO-4800 <span class="citation" data-cites="xuzLfS0y">[<a href="#ref-xuzLfS0y" role="doc-biblioref">1320</a>]</span>, was developed by Inovio Pharmaceuticals Technology that uses electroporation as an adjuvant.
-Electroporation was developed as a solution to the issue of limited immunogenicity by increasing the permeability of cell membranes by delivering electrical pulses <span class="citation" data-cites="1Hsm2J1sc">[<a href="#ref-1Hsm2J1sc" role="doc-biblioref">1321</a>]</span>.
-It has been shown that electroporation can enhance vaccine efficacy by up to 100-fold, as measured by increases in antigen-specific antibody titers <span class="citation" data-cites="H6tWVs5R">[<a href="#ref-H6tWVs5R" role="doc-biblioref">1322</a>]</span>.
+<p>Similarly, another plasmid-vectored DNA vaccine, INO-4800 <span class="citation" data-cites="xuzLfS0y">[<a href="#ref-xuzLfS0y" role="doc-biblioref">1378</a>]</span>, was developed by Inovio Pharmaceuticals Technology that uses electroporation as an adjuvant.
+Electroporation was developed as a solution to the issue of limited immunogenicity by increasing the permeability of cell membranes by delivering electrical pulses <span class="citation" data-cites="1Hsm2J1sc">[<a href="#ref-1Hsm2J1sc" role="doc-biblioref">1379</a>]</span>.
+It has been shown that electroporation can enhance vaccine efficacy by up to 100-fold, as measured by increases in antigen-specific antibody titers <span class="citation" data-cites="H6tWVs5R">[<a href="#ref-H6tWVs5R" role="doc-biblioref">1380</a>]</span>.
 The temporary formation of pores through electroporation facilitates the successful transportation of macromolecules into cells, allowing cells to robustly take up INO-4800 for the production of an antibody response.
-For INO-4800, a plasmid-vectored vaccine is delivered through intradermal injection which is then followed by electroporation with a device known as CELLECTRA® <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1323</a>]</span>.
-The safety of the CELLECTRA® device has been studied for over seven years, and these studies support the further development of electroporation as a safe vaccine delivery method <span class="citation" data-cites="1Hsm2J1sc">[<a href="#ref-1Hsm2J1sc" role="doc-biblioref">1321</a>]</span>.</p>
+For INO-4800, a plasmid-vectored vaccine is delivered through intradermal injection which is then followed by electroporation with a device known as CELLECTRA® <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1381</a>]</span>.
+The safety of the CELLECTRA® device has been studied for over seven years, and these studies support the further development of electroporation as a safe vaccine delivery method <span class="citation" data-cites="1Hsm2J1sc">[<a href="#ref-1Hsm2J1sc" role="doc-biblioref">1379</a>]</span>.</p>
 <p>These vaccines therefore represent implementations of a new platform technology.
-In particular, they offer the advantage of a temperature-stable vaccine, facilitating worldwide administration <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1324</a>]</span>.
+In particular, they offer the advantage of a temperature-stable vaccine, facilitating worldwide administration <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1382</a>]</span>.
 Although an exciting development in DNA vaccines, the cost of vaccine manufacturing and electroporation may make scaling the use of this technology for prophylactic use for the general public difficult.</p>
 <p><strong>Trial Safety and Immunogenicity:</strong>
 <!-- Too much trial detail -->
 For INO-4800, the phase I trial began enrolling participants in April 2020 in Philadelphia, PA at the Perelman School of Medicine and at the Center for Pharmaceutical Research in Kansas City, MO.
-This trial examined two different doses administered in a two-dose regimen <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1323</a>]</span>.
-Among the 39 participants, only six AEs were reported and all were grade 1 <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1323</a>]</span>.
-Efficacy was evaluated based on blood samples collected pre- and post-vaccination, and all but three participants of 38 included in the analysis were found to have serum IgG binding titers to the spike protein after vaccination <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1323</a>]</span>.
-Results from the phase II trial were released as a preprint in May 2021 and reported findings based on administering INO-4800 to 401 adult volunteers at high risk of exposure to SARS-CoV-2 <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1324</a>]</span>.
+This trial examined two different doses administered in a two-dose regimen <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1381</a>]</span>.
+Among the 39 participants, only six AEs were reported and all were grade 1 <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1381</a>]</span>.
+Efficacy was evaluated based on blood samples collected pre- and post-vaccination, and all but three participants of 38 included in the analysis were found to have serum IgG binding titers to the spike protein after vaccination <span class="citation" data-cites="4xraQp8j">[<a href="#ref-4xraQp8j" role="doc-biblioref">1381</a>]</span>.
+Results from the phase II trial were released as a preprint in May 2021 and reported findings based on administering INO-4800 to 401 adult volunteers at high risk of exposure to SARS-CoV-2 <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1382</a>]</span>.
 The phase II results supported that the vaccine was safe, with 1,446 treatment-related AEs observed across 281 participants, all but one of which were grade 1 or grade 2.
-The single grade 3 event was joint stiffness <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1324</a>]</span>.
+The single grade 3 event was joint stiffness <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1382</a>]</span>.
 The rates of AEs in the placebo group were not reported.</p>
-<p>To assess the immunogenicity of INO-4800, pre- and post-vaccination blood samples were collected and evaluated for a humoral immune response to the spike protein, and the treatment group was identified to show significantly greater neutralizing activity than the placebo group <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1324</a>]</span>.
-The phase II/III trials are ongoing in several countries, including the United States, Mexico, India, and Colombia <span class="citation" data-cites="pxEE3VEQ R79Wr1hU yraL6YQa Wk6spoae">[<a href="#ref-pxEE3VEQ" role="doc-biblioref">1325</a>,<a href="#ref-R79Wr1hU" role="doc-biblioref">1326</a>,<a href="#ref-yraL6YQa" role="doc-biblioref">1327</a>,<a href="#ref-Wk6spoae" role="doc-biblioref">1328</a>]</span>.
+<p>To assess the immunogenicity of INO-4800, pre- and post-vaccination blood samples were collected and evaluated for a humoral immune response to the spike protein, and the treatment group was identified to show significantly greater neutralizing activity than the placebo group <span class="citation" data-cites="OYnqjMlC">[<a href="#ref-OYnqjMlC" role="doc-biblioref">1382</a>]</span>.
+The phase II/III trials are ongoing in several countries, including the United States, Mexico, India, and Colombia <span class="citation" data-cites="pxEE3VEQ R79Wr1hU yraL6YQa Wk6spoae">[<a href="#ref-pxEE3VEQ" role="doc-biblioref">1383</a>,<a href="#ref-R79Wr1hU" role="doc-biblioref">1384</a>,<a href="#ref-yraL6YQa" role="doc-biblioref">1385</a>,<a href="#ref-Wk6spoae" role="doc-biblioref">1386</a>]</span>.
 Therefore, vaccine efficacy data from a large study population is not yet available.</p>
 <p><strong>Real-World Safety and Efficacy:</strong>
-The efficacy of ZyCoV-D is estimated to be 66.6% <span class="citation" data-cites="3xlXzOoW">[<a href="#ref-3xlXzOoW" role="doc-biblioref">1329</a>]</span>.
+The efficacy of ZyCoV-D is estimated to be 66.6% <span class="citation" data-cites="3xlXzOoW">[<a href="#ref-3xlXzOoW" role="doc-biblioref">1387</a>]</span>.
 Because phase III data is not yet available for INO-4800, the VE is not yet know.</p>
 <p>Studies have examined the ability of INO-4800 to induce an immune response that can neutralize existing VOC.
-They assessed neutralization of several VOC relative to the index strain <span class="citation" data-cites="mbBuH8XY">[<a href="#ref-mbBuH8XY" role="doc-biblioref">1330</a>]</span>.
-They found no difference in neutralization between the index strain and the Gamma VOC (P.1), but neutralization of the Alpha and Beta VOC was significantly lower (approximately two and seven times, respectively) <span class="citation" data-cites="mbBuH8XY">[<a href="#ref-mbBuH8XY" role="doc-biblioref">1330</a>]</span>.
+They assessed neutralization of several VOC relative to the index strain <span class="citation" data-cites="mbBuH8XY">[<a href="#ref-mbBuH8XY" role="doc-biblioref">1388</a>]</span>.
+They found no difference in neutralization between the index strain and the Gamma VOC (P.1), but neutralization of the Alpha and Beta VOC was significantly lower (approximately two and seven times, respectively) <span class="citation" data-cites="mbBuH8XY">[<a href="#ref-mbBuH8XY" role="doc-biblioref">1388</a>]</span>.
 These findings are in line with the shifts in efficacy reported for other vaccines <span class="citation" data-cites="S1SpDOhi">[<a href="#ref-S1SpDOhi" role="doc-biblioref">344</a>]</span>.</p>
 <p>In addition to loss of neutralizing activity due to viral evolution, studies have also evaluated the decline in nAbs induced by INO-4800 over time.
-Levels of nAbs remained statistically significant relative to the pre-vaccination baseline for six months <span class="citation" data-cites="CSlbNoGU">[<a href="#ref-CSlbNoGU" role="doc-biblioref">1331</a>]</span>.
-Administration of a booster dose induced a significant increase of titers relative to their pre-booster levels <span class="citation" data-cites="CSlbNoGU">[<a href="#ref-CSlbNoGU" role="doc-biblioref">1331</a>]</span>.
+Levels of nAbs remained statistically significant relative to the pre-vaccination baseline for six months <span class="citation" data-cites="CSlbNoGU">[<a href="#ref-CSlbNoGU" role="doc-biblioref">1389</a>]</span>.
+Administration of a booster dose induced a significant increase of titers relative to their pre-booster levels <span class="citation" data-cites="CSlbNoGU">[<a href="#ref-CSlbNoGU" role="doc-biblioref">1389</a>]</span>.
 Given the timing of this trial (enrollment between April and July 2020), it is unlikely that participants were exposed to VOC associated with decreased efficacy.</p>
-<p>In light of the emergence of VOC against which many vaccines show lower efficacy, Inovio Pharmaceuticals began to develop a new vaccine with the goal of improving robustness against known and future VOC <span class="citation" data-cites="ysgD4Dcf">[<a href="#ref-ysgD4Dcf" role="doc-biblioref">1332</a>]</span>.
-Known as INO-4802, this vaccine was designed to express a pan-Spike immunogen <span class="citation" data-cites="Aynz3sBj">[<a href="#ref-Aynz3sBj" role="doc-biblioref">1333</a>]</span>.
-Booster studies in rodents <span class="citation" data-cites="12zreC1Tk">[<a href="#ref-12zreC1Tk" role="doc-biblioref">1334</a>]</span> and non-human primates <span class="citation" data-cites="Aynz3sBj">[<a href="#ref-Aynz3sBj" role="doc-biblioref">1333</a>]</span> suggest that it may be more effective than INO-4800 in providing immunity to VOC such as Delta and Omicron when administered as part of a heterologous boost regimen, although boosting with INO-4800 was also very effective in increasing immunity in rhesus macaques <span class="citation" data-cites="Aynz3sBj">[<a href="#ref-Aynz3sBj" role="doc-biblioref">1333</a>]</span>.
+<p>In light of the emergence of VOC against which many vaccines show lower efficacy, Inovio Pharmaceuticals began to develop a new vaccine with the goal of improving robustness against known and future VOC <span class="citation" data-cites="ysgD4Dcf">[<a href="#ref-ysgD4Dcf" role="doc-biblioref">1390</a>]</span>.
+Known as INO-4802, this vaccine was designed to express a pan-Spike immunogen <span class="citation" data-cites="Aynz3sBj">[<a href="#ref-Aynz3sBj" role="doc-biblioref">1391</a>]</span>.
+Booster studies in rodents <span class="citation" data-cites="12zreC1Tk">[<a href="#ref-12zreC1Tk" role="doc-biblioref">1392</a>]</span> and non-human primates <span class="citation" data-cites="Aynz3sBj">[<a href="#ref-Aynz3sBj" role="doc-biblioref">1391</a>]</span> suggest that it may be more effective than INO-4800 in providing immunity to VOC such as Delta and Omicron when administered as part of a heterologous boost regimen, although boosting with INO-4800 was also very effective in increasing immunity in rhesus macaques <span class="citation" data-cites="Aynz3sBj">[<a href="#ref-Aynz3sBj" role="doc-biblioref">1391</a>]</span>.
 Therefore, boosting is likely to be an important strategy for this vaccine, especially as the virus continues to evolve.</p>
-<h3 data-number="7.8.2" id="viral-vectored-dna-vaccines"><span class="header-section-number">7.8.2</span> Viral-Vectored DNA Vaccines</h3>
+<h3 data-number="8.8.2" id="viral-vectored-dna-vaccines"><span class="header-section-number">8.8.2</span> Viral-Vectored DNA Vaccines</h3>
 <p><strong>Mechanism:</strong>
 Plasmids are not the only vector that can be used to deliver sequences associated with viral antigens.
 Genetic material from the target virus can also be delivered using a second virus as a vector.
-Viral vectors have emerged as a safe and efficient method to furnish the nucleotide sequences of an antigen to the immune system <span class="citation" data-cites="1Ff2BDzkT">[<a href="#ref-1Ff2BDzkT" role="doc-biblioref">1335</a>]</span>.
-The genetic content of the vector virus is often altered to prevent it from replicating, but replication-competent viruses can also be used under certain circumstances <span class="citation" data-cites="1FpZkxdl4">[<a href="#ref-1FpZkxdl4" role="doc-biblioref">1336</a>]</span>.
-Once the plasmid or viral vector brings the DNA sequence to an APC, the host machinery can be used to construct antigen(s) from the transported genetic material, and the host can then synthesize antibodies in response <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.</p>
-<p>One of the early viral vectors explored was adenovirus, with serotype 5 (Ad5) being particularly effective <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-This technology rose in popularity during the 2000s due to its being more immunogenic in humans and non-human primates than plasmid-vectored DNA vaccines <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>]</span>.
-In the 2000s, interest also arose in utilizing simian adenoviruses as vectors because of the reduced risk that human vaccine recipients would have prior exposure resulting in adaptive immunity <span class="citation" data-cites="BsrTDzJ2 XRmk1S6R">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>,<a href="#ref-XRmk1S6R" role="doc-biblioref">1337</a>]</span>, and chimpanzee adenoviruses were explored as a potential vector in the development of a vaccine against MERS-CoV <span class="citation" data-cites="Jkm7jfS8">[<a href="#ref-Jkm7jfS8" role="doc-biblioref">1338</a>]</span>.</p>
-<p>Today, various viral-vector platforms including poxviruses <span class="citation" data-cites="8bpbvIro 1AZfAQ5py">[<a href="#ref-8bpbvIro" role="doc-biblioref">1339</a>,<a href="#ref-1AZfAQ5py" role="doc-biblioref">1340</a>]</span>, adenoviruses <span class="citation" data-cites="zX5UKhti">[<a href="#ref-zX5UKhti" role="doc-biblioref">1341</a>]</span>, and vesicular stomatitis viruses <span class="citation" data-cites="SNwg8Qkf lvi4DH2g">[<a href="#ref-SNwg8Qkf" role="doc-biblioref">1342</a>,<a href="#ref-lvi4DH2g" role="doc-biblioref">1343</a>]</span> are being developed,
-Viral-vector vaccines are able to induce both an antibody and cellular response; however, the response is limited due to the immunogenicity of the viral vector used <span class="citation" data-cites="YRgRziXN zX5UKhti">[<a href="#ref-zX5UKhti" role="doc-biblioref">1341</a>,<a href="#ref-YRgRziXN" role="doc-biblioref">1344</a>]</span>.
+Viral vectors have emerged as a safe and efficient method to furnish the nucleotide sequences of an antigen to the immune system <span class="citation" data-cites="1Ff2BDzkT">[<a href="#ref-1Ff2BDzkT" role="doc-biblioref">1393</a>]</span>.
+The genetic content of the vector virus is often altered to prevent it from replicating, but replication-competent viruses can also be used under certain circumstances <span class="citation" data-cites="1FpZkxdl4">[<a href="#ref-1FpZkxdl4" role="doc-biblioref">1394</a>]</span>.
+Once the plasmid or viral vector brings the DNA sequence to an APC, the host machinery can be used to construct antigen(s) from the transported genetic material, and the host can then synthesize antibodies in response <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.</p>
+<p>One of the early viral vectors explored was adenovirus, with serotype 5 (Ad5) being particularly effective <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+This technology rose in popularity during the 2000s due to its being more immunogenic in humans and non-human primates than plasmid-vectored DNA vaccines <span class="citation" data-cites="BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>]</span>.
+In the 2000s, interest also arose in utilizing simian adenoviruses as vectors because of the reduced risk that human vaccine recipients would have prior exposure resulting in adaptive immunity <span class="citation" data-cites="BsrTDzJ2 XRmk1S6R">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>,<a href="#ref-XRmk1S6R" role="doc-biblioref">1395</a>]</span>, and chimpanzee adenoviruses were explored as a potential vector in the development of a vaccine against MERS-CoV <span class="citation" data-cites="Jkm7jfS8">[<a href="#ref-Jkm7jfS8" role="doc-biblioref">1396</a>]</span>.</p>
+<p>Today, various viral-vector platforms including poxviruses <span class="citation" data-cites="8bpbvIro 1AZfAQ5py">[<a href="#ref-8bpbvIro" role="doc-biblioref">1397</a>,<a href="#ref-1AZfAQ5py" role="doc-biblioref">1398</a>]</span>, adenoviruses <span class="citation" data-cites="zX5UKhti">[<a href="#ref-zX5UKhti" role="doc-biblioref">1399</a>]</span>, and vesicular stomatitis viruses <span class="citation" data-cites="SNwg8Qkf lvi4DH2g">[<a href="#ref-SNwg8Qkf" role="doc-biblioref">1400</a>,<a href="#ref-lvi4DH2g" role="doc-biblioref">1401</a>]</span> are being developed,
+Viral-vector vaccines are able to induce both an antibody and cellular response; however, the response is limited due to the immunogenicity of the viral vector used <span class="citation" data-cites="YRgRziXN zX5UKhti">[<a href="#ref-zX5UKhti" role="doc-biblioref">1399</a>,<a href="#ref-YRgRziXN" role="doc-biblioref">1402</a>]</span>.
 An important consideration in identifying potential vectors is the immune response to the vector.
-Both the innate and adaptive immune responses can potentially respond to the vector, limiting the ability of the vaccine to transfer information to the immune system <span class="citation" data-cites="tbs2wD7F">[<a href="#ref-tbs2wD7F" role="doc-biblioref">1345</a>]</span>.
-Different vectors are associated with different levels of reactogenicity; for example, adenoviruses elicit a much stronger innate immune response than replication deficient adeno-associated viruses derived from parvoviruses <span class="citation" data-cites="tbs2wD7F">[<a href="#ref-tbs2wD7F" role="doc-biblioref">1345</a>]</span>.
-Additionally, using a virus circulating widely in human populations as a vector presents additional challenges because vaccine recipients may already have developed an immune response to the vector <span class="citation" data-cites="IUplTKEg">[<a href="#ref-IUplTKEg" role="doc-biblioref">1346</a>]</span>. <!-- So does this also have implications about using the same vector multiple times to develop different vaccines? I recall reading about about that but not the details. --></p>
+Both the innate and adaptive immune responses can potentially respond to the vector, limiting the ability of the vaccine to transfer information to the immune system <span class="citation" data-cites="tbs2wD7F">[<a href="#ref-tbs2wD7F" role="doc-biblioref">1403</a>]</span>.
+Different vectors are associated with different levels of reactogenicity; for example, adenoviruses elicit a much stronger innate immune response than replication deficient adeno-associated viruses derived from parvoviruses <span class="citation" data-cites="tbs2wD7F">[<a href="#ref-tbs2wD7F" role="doc-biblioref">1403</a>]</span>.
+Additionally, using a virus circulating widely in human populations as a vector presents additional challenges because vaccine recipients may already have developed an immune response to the vector <span class="citation" data-cites="IUplTKEg">[<a href="#ref-IUplTKEg" role="doc-biblioref">1404</a>]</span>. <!-- So does this also have implications about using the same vector multiple times to develop different vaccines? I recall reading about about that but not the details. --></p>
 <p><strong>Prior Applications:</strong>
-There are several viral vector vaccines that are available for veterinary use <span class="citation" data-cites="MvKb0qJC BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>,<a href="#ref-MvKb0qJC" role="doc-biblioref">1347</a>]</span>, but prior to the COVID-19 pandemic, only one viral vector vaccine was approved by the United States’ Food and Drug Administration (FDA) for use in humans.
-This vaccine is vectored with a recombinant vesicular stomatitis virus and targeted against the Ebola virus <span class="citation" data-cites="9g5tmszW">[<a href="#ref-9g5tmszW" role="doc-biblioref">1348</a>]</span>.
-Additionally, several phase I and phase II clinical trials for other vaccines are ongoing <span class="citation" data-cites="1Ff2BDzkT">[<a href="#ref-1Ff2BDzkT" role="doc-biblioref">1335</a>]</span>, and the technology is currently being explored for its potential against numerous infectious diseases including malaria <span class="citation" data-cites="OZJWUaDW 3tkGuMXx">[<a href="#ref-OZJWUaDW" role="doc-biblioref">1349</a>,<a href="#ref-3tkGuMXx" role="doc-biblioref">1350</a>]</span>, Ebola <span class="citation" data-cites="AgZwwt5u 9BEMTYn8 PbGQOOI">[<a href="#ref-AgZwwt5u" role="doc-biblioref">1351</a>,<a href="#ref-9BEMTYn8" role="doc-biblioref">1352</a>,<a href="#ref-PbGQOOI" role="doc-biblioref">1353</a>]</span>, and HIV <span class="citation" data-cites="1C8hgfvDF SAIfGNkZ">[<a href="#ref-1C8hgfvDF" role="doc-biblioref">1354</a>,<a href="#ref-SAIfGNkZ" role="doc-biblioref">1355</a>]</span>.</p>
-<p>The threat of MERS and SARS initiated interest in the application of viral vector vaccines to human coronaviruses <span class="citation" data-cites="Jkm7jfS8">[<a href="#ref-Jkm7jfS8" role="doc-biblioref">1338</a>]</span>, but efforts to apply this technology to these pathogens had not yet led to a successful vaccine candidate.
-In the mid-to-late 2000s, adenoviral vectored vaccines against SARS were found to induce SARS-CoV-specific IgA in the lungs of mice <span class="citation" data-cites="umEOWDY5">[<a href="#ref-umEOWDY5" role="doc-biblioref">1356</a>]</span> but were later found to offer incomplete protection in ferret models <span class="citation" data-cites="DGTFML2b">[<a href="#ref-DGTFML2b" role="doc-biblioref">1357</a>]</span>.
-Gamaleya National Center of Epidemiology and Microbiology in Moscow sought to use an adenovirus platform for the development of vaccines for MERS-CoV and Ebola virus, although neither of the previous vaccines were internationally licensed <span class="citation" data-cites="UCI0TCHy">[<a href="#ref-UCI0TCHy" role="doc-biblioref">1358</a>]</span>.</p>
-<p>In 2017, results were published from an initial investigation of two vaccine candidates against MERS-CoV containing the MERS-CoV <em>S</em> gene vectored with chimpanzee adenovirus, Oxford University #1 (ChAdOx1), a replication-deficient chimpanzee adenovirus <span class="citation" data-cites="P94sxWp4">[<a href="#ref-P94sxWp4" role="doc-biblioref">1359</a>]</span>.
+There are several viral vector vaccines that are available for veterinary use <span class="citation" data-cites="MvKb0qJC BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>,<a href="#ref-MvKb0qJC" role="doc-biblioref">1405</a>]</span>, but prior to the COVID-19 pandemic, only one viral vector vaccine was approved by the United States’ Food and Drug Administration (FDA) for use in humans.
+This vaccine is vectored with a recombinant vesicular stomatitis virus and targeted against the Ebola virus <span class="citation" data-cites="9g5tmszW">[<a href="#ref-9g5tmszW" role="doc-biblioref">1406</a>]</span>.
+Additionally, several phase I and phase II clinical trials for other vaccines are ongoing <span class="citation" data-cites="1Ff2BDzkT">[<a href="#ref-1Ff2BDzkT" role="doc-biblioref">1393</a>]</span>, and the technology is currently being explored for its potential against numerous infectious diseases including malaria <span class="citation" data-cites="OZJWUaDW 3tkGuMXx">[<a href="#ref-OZJWUaDW" role="doc-biblioref">1407</a>,<a href="#ref-3tkGuMXx" role="doc-biblioref">1408</a>]</span>, Ebola <span class="citation" data-cites="AgZwwt5u 9BEMTYn8 PbGQOOI">[<a href="#ref-AgZwwt5u" role="doc-biblioref">1409</a>,<a href="#ref-9BEMTYn8" role="doc-biblioref">1410</a>,<a href="#ref-PbGQOOI" role="doc-biblioref">1411</a>]</span>, and HIV <span class="citation" data-cites="1C8hgfvDF SAIfGNkZ">[<a href="#ref-1C8hgfvDF" role="doc-biblioref">1412</a>,<a href="#ref-SAIfGNkZ" role="doc-biblioref">1413</a>]</span>.</p>
+<p>The threat of MERS and SARS initiated interest in the application of viral vector vaccines to human coronaviruses <span class="citation" data-cites="Jkm7jfS8">[<a href="#ref-Jkm7jfS8" role="doc-biblioref">1396</a>]</span>, but efforts to apply this technology to these pathogens had not yet led to a successful vaccine candidate.
+In the mid-to-late 2000s, adenoviral vectored vaccines against SARS were found to induce SARS-CoV-specific IgA in the lungs of mice <span class="citation" data-cites="umEOWDY5">[<a href="#ref-umEOWDY5" role="doc-biblioref">1414</a>]</span> but were later found to offer incomplete protection in ferret models <span class="citation" data-cites="DGTFML2b">[<a href="#ref-DGTFML2b" role="doc-biblioref">1415</a>]</span>.
+Gamaleya National Center of Epidemiology and Microbiology in Moscow sought to use an adenovirus platform for the development of vaccines for MERS-CoV and Ebola virus, although neither of the previous vaccines were internationally licensed <span class="citation" data-cites="UCI0TCHy">[<a href="#ref-UCI0TCHy" role="doc-biblioref">1416</a>]</span>.</p>
+<p>In 2017, results were published from an initial investigation of two vaccine candidates against MERS-CoV containing the MERS-CoV <em>S</em> gene vectored with chimpanzee adenovirus, Oxford University #1 (ChAdOx1), a replication-deficient chimpanzee adenovirus <span class="citation" data-cites="P94sxWp4">[<a href="#ref-P94sxWp4" role="doc-biblioref">1417</a>]</span>.
 This study reported that a candidate containing the complete S protein sequence induced a stronger neutralizing antibody response in mice than candidates vectored with modified vaccinia virus Ankara.</p>
 <p>The candidate was pursued in additional research, and in the summer of 2020 results of two studies were published.
-The first reported that a single dose of ChAdOx1 MERS induced an immune response and inhibited viral replication in macaques <span class="citation" data-cites="3NtMBDMM">[<a href="#ref-3NtMBDMM" role="doc-biblioref">1360</a>]</span>.
-The second reported promising results from a phase I trial that administered the vaccine to adults and measured safety, tolerability, and immune response <span class="citation" data-cites="ERfSJf5B">[<a href="#ref-ERfSJf5B" role="doc-biblioref">1361</a>]</span>.</p>
+The first reported that a single dose of ChAdOx1 MERS induced an immune response and inhibited viral replication in macaques <span class="citation" data-cites="3NtMBDMM">[<a href="#ref-3NtMBDMM" role="doc-biblioref">1418</a>]</span>.
+The second reported promising results from a phase I trial that administered the vaccine to adults and measured safety, tolerability, and immune response <span class="citation" data-cites="ERfSJf5B">[<a href="#ref-ERfSJf5B" role="doc-biblioref">1419</a>]</span>.</p>
 <p><strong>Application to COVID-19:</strong>
 While not all of the above results were available at the time that vaccine development programs against SARS-CoV-2 began, at least three viral vector vaccines have also been developed against SARS-CoV-2.
-First, a collaboration between AstraZeneca and researchers at the University of Oxford successfully applied a viral vector approach to the development of a vaccine against SARS-CoV-2 using the replication-deficient ChAdOx1 vector modified to encode the S protein of SARS-CoV-2 <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1362</a>]</span>.
-In a phase I trial, the immunogenic potential of vaccine candidate ChAdOx1 nCoV-19 was demonstrated through the immune challenge of two animal models, mice and rhesus macaques <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1362</a>]</span>.
-In a phase I/II trial, patients receiving the ChAdOx1 nCoV-19 vaccine developed antibodies to the SARS-CoV-2 spike protein that peaked by day 28, with these levels remaining stable until a second observation at day 56 <span class="citation" data-cites="2bBVSpM">[<a href="#ref-2bBVSpM" role="doc-biblioref">1363</a>]</span>.</p>
+First, a collaboration between AstraZeneca and researchers at the University of Oxford successfully applied a viral vector approach to the development of a vaccine against SARS-CoV-2 using the replication-deficient ChAdOx1 vector modified to encode the S protein of SARS-CoV-2 <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1420</a>]</span>.
+In a phase I trial, the immunogenic potential of vaccine candidate ChAdOx1 nCoV-19 was demonstrated through the immune challenge of two animal models, mice and rhesus macaques <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1420</a>]</span>.
+In a phase I/II trial, patients receiving the ChAdOx1 nCoV-19 vaccine developed antibodies to the SARS-CoV-2 spike protein that peaked by day 28, with these levels remaining stable until a second observation at day 56 <span class="citation" data-cites="2bBVSpM">[<a href="#ref-2bBVSpM" role="doc-biblioref">1421</a>]</span>.</p>
 <p>Second, a viral vector approach was applied by Russia’s Gamaleya Research Institute of Epidemiology and Microbiology to develop Sputnik V, a replication-deficient recombinant adenovirus (rAd) vaccine that combines two adenovirus vectors, rAd26-S and rAd5-S, that express the full-length SARS-CoV-2 spike glycoprotein.
 These vectors are intramuscularly administered individually using two separate vaccines in a prime-boost regimen.
 The rAd26-S is administered first, followed by rAd5-S 21 days later.
 Both vaccines deliver 10<sup>11</sup> viral particles per dose.
-This approach is designed to overcome any potential pre-existing immunity to adenovirus in the population <span class="citation" data-cites="sRAZYY9C">[<a href="#ref-sRAZYY9C" role="doc-biblioref">1364</a>]</span>, as some individuals may possess immunity to Ad5 <span class="citation" data-cites="8jwp261S">[<a href="#ref-8jwp261S" role="doc-biblioref">1365</a>]</span>.
+This approach is designed to overcome any potential pre-existing immunity to adenovirus in the population <span class="citation" data-cites="sRAZYY9C">[<a href="#ref-sRAZYY9C" role="doc-biblioref">1422</a>]</span>, as some individuals may possess immunity to Ad5 <span class="citation" data-cites="8jwp261S">[<a href="#ref-8jwp261S" role="doc-biblioref">1423</a>]</span>.
 Sputnik V is the only recombinant adenovirus vaccine to utilize two vectors.</p>
-<p>Third, Janssen Pharmaceuticals, Inc., a subsidiary of Johnson &amp; Johnson, developed a viral vector vaccine in collaboration with and funded by the United States’ “Operation Warp Speed” <span class="citation" data-cites="D3Px25HN 57BTbcko">[<a href="#ref-D3Px25HN" role="doc-biblioref">1366</a>,<a href="#ref-57BTbcko" role="doc-biblioref">1367</a>]</span>.
-The vaccine candidate JNJ-78436735, formerly known as Ad26.COV2-S, is a monovalent vaccine that is composed of a replication-deficient adenovirus serotype 26 (Ad26) vector expressing the stabilized prefusion S protein of SARS-CoV-2 <span class="citation" data-cites="pWf2T8J8 10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>,<a href="#ref-pWf2T8J8" role="doc-biblioref">1368</a>]</span>.
-Unlike the other two viral vector vaccines available to date, JNJ-78436735 requires only a single dose, a characteristic that was expected to aid in global deployment <span class="citation" data-cites="gOOBv1MD">[<a href="#ref-gOOBv1MD" role="doc-biblioref">1369</a>]</span>.
-JNJ-78436735 was selected from among a number of initial candidate designs <span class="citation" data-cites="10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>]</span> and tested <em>in vivo</em> in Syrian golden hamsters and Rhesus macaques to assess safety and immunogenicity <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1369</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1370</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1371</a>]</span>.
-The JNJ-78436735 candidate was selected for its favorable immunogenicity profile and ease of manufacturability <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1369</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1370</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1371</a>]</span> and was found to confer protection against SARS-CoV-2 in macaques even after six months <span class="citation" data-cites="HGVDPMLm">[<a href="#ref-HGVDPMLm" role="doc-biblioref">1372</a>]</span>.
-The one- versus two-dose regimen was then tested in volunteers through a phase I/IIa trial <span class="citation" data-cites="pWf2T8J8 69GoEX0X">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1368</a>,<a href="#ref-69GoEX0X" role="doc-biblioref">1373</a>]</span>.
+<p>Third, Janssen Pharmaceuticals, Inc., a subsidiary of Johnson &amp; Johnson, developed a viral vector vaccine in collaboration with and funded by the United States’ “Operation Warp Speed” <span class="citation" data-cites="D3Px25HN 57BTbcko">[<a href="#ref-D3Px25HN" role="doc-biblioref">1424</a>,<a href="#ref-57BTbcko" role="doc-biblioref">1425</a>]</span>.
+The vaccine candidate JNJ-78436735, formerly known as Ad26.COV2-S, is a monovalent vaccine that is composed of a replication-deficient adenovirus serotype 26 (Ad26) vector expressing the stabilized prefusion S protein of SARS-CoV-2 <span class="citation" data-cites="pWf2T8J8 10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>,<a href="#ref-pWf2T8J8" role="doc-biblioref">1426</a>]</span>.
+Unlike the other two viral vector vaccines available to date, JNJ-78436735 requires only a single dose, a characteristic that was expected to aid in global deployment <span class="citation" data-cites="gOOBv1MD">[<a href="#ref-gOOBv1MD" role="doc-biblioref">1427</a>]</span>.
+JNJ-78436735 was selected from among a number of initial candidate designs <span class="citation" data-cites="10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>]</span> and tested <em>in vivo</em> in Syrian golden hamsters and Rhesus macaques to assess safety and immunogenicity <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1427</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1428</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1429</a>]</span>.
+The JNJ-78436735 candidate was selected for its favorable immunogenicity profile and ease of manufacturability <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1427</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1428</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1429</a>]</span> and was found to confer protection against SARS-CoV-2 in macaques even after six months <span class="citation" data-cites="HGVDPMLm">[<a href="#ref-HGVDPMLm" role="doc-biblioref">1430</a>]</span>.
+The one- versus two-dose regimen was then tested in volunteers through a phase I/IIa trial <span class="citation" data-cites="pWf2T8J8 69GoEX0X">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1426</a>,<a href="#ref-69GoEX0X" role="doc-biblioref">1431</a>]</span>.
 A major difference between this vaccine and the other two in this category is that the S protein immunogen is stabilized in its prefusion conformation, while in the Sputnik V and AstraZeneca vaccines it is not.</p>
 <p><strong>Trial Estimates of Safety and Efficacy:</strong>
 The first DNA viral-vectored vaccine for which efficacy estimates became available was AstraZeneca’s ChAdOx1 nCoV-19.
-In December 2020, preliminary results of the phase III trial were released detailing randomized control trials conducted in the United Kingdom (U.K.), Brazil, and South Africa between April and November 2020 <span class="citation" data-cites="Vnbw9o3T">[<a href="#ref-Vnbw9o3T" role="doc-biblioref">1290</a>]</span>.
+In December 2020, preliminary results of the phase III trial were released detailing randomized control trials conducted in the United Kingdom (U.K.), Brazil, and South Africa between April and November 2020 <span class="citation" data-cites="Vnbw9o3T">[<a href="#ref-Vnbw9o3T" role="doc-biblioref">1346</a>]</span>.
 These trials compared ChAdOx1 nCoV-19 to a control, but the design of each study varied; pooling data across studies indicated an overall efficacy of 70.4%.
-For Sputnik V, the phase III trial indicated an overall vaccine efficacy of 91.6% for symptomatic COVID-19 <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1374</a>]</span>.
-As for Janssen, in February 2021, the FDA issued an EUA based on interim results from the phase 3 trial <span class="citation" data-cites="iWMHpTBJ 1FcpboRMm">[<a href="#ref-iWMHpTBJ" role="doc-biblioref">1375</a>,<a href="#ref-1FcpboRMm" role="doc-biblioref">1376</a>]</span>.
-The vaccine was well-tolerated, and across all regions studied, it was found to be 66.9% effective after 28 days for the prevention of moderate to severe COVID-19 and to be 81.7% effective for the prevention of laboratory-confirmed severe COVID-19 <span class="citation" data-cites="GOZYHZz0">[<a href="#ref-GOZYHZz0" role="doc-biblioref">1377</a>]</span>.
+For Sputnik V, the phase III trial indicated an overall vaccine efficacy of 91.6% for symptomatic COVID-19 <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1432</a>]</span>.
+As for Janssen, in February 2021, the FDA issued an EUA based on interim results from the phase 3 trial <span class="citation" data-cites="iWMHpTBJ 1FcpboRMm">[<a href="#ref-iWMHpTBJ" role="doc-biblioref">1433</a>,<a href="#ref-1FcpboRMm" role="doc-biblioref">1434</a>]</span>.
+The vaccine was well-tolerated, and across all regions studied, it was found to be 66.9% effective after 28 days for the prevention of moderate to severe COVID-19 and to be 81.7% effective for the prevention of laboratory-confirmed severe COVID-19 <span class="citation" data-cites="GOZYHZz0">[<a href="#ref-GOZYHZz0" role="doc-biblioref">1435</a>]</span>.
 There were no COVID-19-associated deaths in the vaccine group.
-However, the emergence of the Beta variant in the South African trial population was associated with a slightly reduced efficacy (64% two weeks after receipt), and all of the COVID-19-associated deaths in the trial occurred in the South African placebo cohort <span class="citation" data-cites="GOZYHZz0">[<a href="#ref-GOZYHZz0" role="doc-biblioref">1377</a>]</span>.</p>
+However, the emergence of the Beta variant in the South African trial population was associated with a slightly reduced efficacy (64% two weeks after receipt), and all of the COVID-19-associated deaths in the trial occurred in the South African placebo cohort <span class="citation" data-cites="GOZYHZz0">[<a href="#ref-GOZYHZz0" role="doc-biblioref">1435</a>]</span>.</p>
 <p>Two of the three vaccines have faced a number of criticisms surrounding the implementation of their clinical trials.
-In the race to develop vaccines against SARS-CoV-2, President Vladimir Putin of Russia announced the approval of the Sputnik V vaccines on August 11, 2020 in the absence of clinical evidence <span class="citation" data-cites="3KMxmQhV">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1378</a>]</span>.
-A press release on November 11, 2020 indicated positive results from an interim analysis of the phase III Sputnik V trials, which reported 92% efficacy in 16,000 volunteers <span class="citation" data-cites="JSzDvnk6">[<a href="#ref-JSzDvnk6" role="doc-biblioref">1379</a>]</span>.
-However, this release came only two days after both Pfizer and BioNTech reported that their vaccines had an efficacy over 90%, which led to significant skepticism of the Russian findings for a myriad of reasons including the lack of a published protocol and the “reckless” approval of the vaccine in Russia months prior to the publication of the interim results of the phase III trial <span class="citation" data-cites="JSzDvnk6 Yzz3rwqk">[<a href="#ref-JSzDvnk6" role="doc-biblioref">1379</a>,<a href="#ref-Yzz3rwqk" role="doc-biblioref">1380</a>]</span>.
-Consequently, many international scientific agencies and public health bodies expressed concern that due diligence to the clinical trial process was subverted for the sake of expediency, leading many to question the safety and efficacy of Sputnik V <span class="citation" data-cites="15DiM98Ae x4aIj5Fr 3KMxmQhV">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1378</a>,<a href="#ref-15DiM98Ae" role="doc-biblioref">1381</a>,<a href="#ref-x4aIj5Fr" role="doc-biblioref">1382</a>]</span>.
-Despite regulatory, safety, and efficacy concerns, pre-orders for 1 billion doses of the Sputnik V were reported within days of the vaccine’s approval in Russia <span class="citation" data-cites="3KMxmQhV">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1378</a>]</span>.
-Almost a month later, the phase I/II trial data was published <span class="citation" data-cites="PNZEiId1">[<a href="#ref-PNZEiId1" role="doc-biblioref">1383</a>]</span>
-It wasn’t until February 2021, six months after its approval in Russia, that interim results of the phase 3 trial were released <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1374</a>]</span>.</p>
+In the race to develop vaccines against SARS-CoV-2, President Vladimir Putin of Russia announced the approval of the Sputnik V vaccines on August 11, 2020 in the absence of clinical evidence <span class="citation" data-cites="3KMxmQhV">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1436</a>]</span>.
+A press release on November 11, 2020 indicated positive results from an interim analysis of the phase III Sputnik V trials, which reported 92% efficacy in 16,000 volunteers <span class="citation" data-cites="JSzDvnk6">[<a href="#ref-JSzDvnk6" role="doc-biblioref">1437</a>]</span>.
+However, this release came only two days after both Pfizer and BioNTech reported that their vaccines had an efficacy over 90%, which led to significant skepticism of the Russian findings for a myriad of reasons including the lack of a published protocol and the “reckless” approval of the vaccine in Russia months prior to the publication of the interim results of the phase III trial <span class="citation" data-cites="JSzDvnk6 Yzz3rwqk">[<a href="#ref-JSzDvnk6" role="doc-biblioref">1437</a>,<a href="#ref-Yzz3rwqk" role="doc-biblioref">1438</a>]</span>.
+Consequently, many international scientific agencies and public health bodies expressed concern that due diligence to the clinical trial process was subverted for the sake of expediency, leading many to question the safety and efficacy of Sputnik V <span class="citation" data-cites="15DiM98Ae x4aIj5Fr 3KMxmQhV">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1436</a>,<a href="#ref-15DiM98Ae" role="doc-biblioref">1439</a>,<a href="#ref-x4aIj5Fr" role="doc-biblioref">1440</a>]</span>.
+Despite regulatory, safety, and efficacy concerns, pre-orders for 1 billion doses of the Sputnik V were reported within days of the vaccine’s approval in Russia <span class="citation" data-cites="3KMxmQhV">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1436</a>]</span>.
+Almost a month later, the phase I/II trial data was published <span class="citation" data-cites="PNZEiId1">[<a href="#ref-PNZEiId1" role="doc-biblioref">1441</a>]</span>
+It wasn’t until February 2021, six months after its approval in Russia, that interim results of the phase 3 trial were released <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1432</a>]</span>.</p>
 <p>AstraZeneca’s clinical trial also faced criticism.
-The trial was paused in September 2020 following a severe adverse event in one participant <span class="citation" data-cites="vwhmuwto">[<a href="#ref-vwhmuwto" role="doc-biblioref">1384</a>]</span>.
-It was restarted soon after <span class="citation" data-cites="Fz6kXAHy">[<a href="#ref-Fz6kXAHy" role="doc-biblioref">1385</a>]</span>, but it seems that the recent pause was not mentioned to the FDA during a call the morning before the story broke <span class="citation" data-cites="Kt4zFpsF">[<a href="#ref-Kt4zFpsF" role="doc-biblioref">1386</a>]</span>.
+The trial was paused in September 2020 following a severe adverse event in one participant <span class="citation" data-cites="vwhmuwto">[<a href="#ref-vwhmuwto" role="doc-biblioref">1442</a>]</span>.
+It was restarted soon after <span class="citation" data-cites="Fz6kXAHy">[<a href="#ref-Fz6kXAHy" role="doc-biblioref">1443</a>]</span>, but it seems that the recent pause was not mentioned to the FDA during a call the morning before the story broke <span class="citation" data-cites="Kt4zFpsF">[<a href="#ref-Kt4zFpsF" role="doc-biblioref">1444</a>]</span>.
 Additionally, individual sites within the trial employed somewhat different designs but were combined for analysis.
 For example, in South Africa, the trial was double-blinded, whereas in the U.K. and Brazil it was single-blinded, and one of the two trials carried out in the U.K. evaluated two dosing regimens (low dose or standard dose, both followed by standard dose).
 Some of the trials used a meningococcal conjugate vaccine (MenACWY) as a control, while others used saline.
 Data was pooled across countries for analysis, a design decision that was approved by regulators but raised some questions when higher efficacy was reported in a subgroup of patients who received a low-dose followed by a standard dose.
-This group came about because some participants in the U.K. were erroneously primed with a much lower dose, which turned out to have higher efficacy than the intended dose <span class="citation" data-cites="4mDUvRId">[<a href="#ref-4mDUvRId" role="doc-biblioref">1387</a>]</span>.
-Combining the data then led to confusion surrounding the VE, as VE varied widely among conditions (e.g., 62% VE in the standard dose group vs 90% in the group that received a low prime dose <span class="citation" data-cites="Vnbw9o3T">[<a href="#ref-Vnbw9o3T" role="doc-biblioref">1290</a>]</span>).
-Subsequent research, however, suggests that reducing the prime dose may, in fact, elicit a superior immune response in the long-term despite a lower initial response <span class="citation" data-cites="SUGCFKUo">[<a href="#ref-SUGCFKUo" role="doc-biblioref">1388</a>]</span>.
+This group came about because some participants in the U.K. were erroneously primed with a much lower dose, which turned out to have higher efficacy than the intended dose <span class="citation" data-cites="4mDUvRId">[<a href="#ref-4mDUvRId" role="doc-biblioref">1445</a>]</span>.
+Combining the data then led to confusion surrounding the VE, as VE varied widely among conditions (e.g., 62% VE in the standard dose group vs 90% in the group that received a low prime dose <span class="citation" data-cites="Vnbw9o3T">[<a href="#ref-Vnbw9o3T" role="doc-biblioref">1346</a>]</span>).
+Subsequent research, however, suggests that reducing the prime dose may, in fact, elicit a superior immune response in the long-term despite a lower initial response <span class="citation" data-cites="SUGCFKUo">[<a href="#ref-SUGCFKUo" role="doc-biblioref">1446</a>]</span>.
 Therefore, this error may serendipitously improve efficacy of vaccine-vectored vaccines broadly.</p>
 <p><strong>Real-World Safety and Efficacy:</strong>
-As of August 11, 2022, 5 viral-vectored vaccines are being distributed in 202 countries (Figure <a href="#fig:nrvv-distrib">11</a>).
-ChAdOx1 nCoV-19 was first approved for emergency use on December 30, 2020 in the U.K. <span class="citation" data-cites="1A7PjhDDR">[<a href="#ref-1A7PjhDDR" role="doc-biblioref">1389</a>]</span>.
-As early as January 2021, Sputnik V had been administered to 1.5 million Russians <span class="citation" data-cites="X5LkVfY6">[<a href="#ref-X5LkVfY6" role="doc-biblioref">1390</a>]</span>, and doses of Sputnik V have also been distributed to other parts of Europe, such as Belarus, Bosnia-Herzegovina, Hungary, San Marino, Serbia, and Slovakia <span class="citation" data-cites="16LczMwFO Z0V7NK7Y 16GYKbrOq">[<a href="#ref-16LczMwFO" role="doc-biblioref">1391</a>,<a href="#ref-Z0V7NK7Y" role="doc-biblioref">1392</a>,<a href="#ref-16GYKbrOq" role="doc-biblioref">1393</a>]</span>, with the Czech Republic and Austria also having expressed interest in its procurement <span class="citation" data-cites="125VEHWS7">[<a href="#ref-125VEHWS7" role="doc-biblioref">1394</a>]</span>.</p>
+As of August 15, 2022, 5 viral-vectored vaccines are being distributed in 202 countries (Figure <a href="#fig:nrvv-distrib">11</a>).
+ChAdOx1 nCoV-19 was first approved for emergency use on December 30, 2020 in the U.K. <span class="citation" data-cites="1A7PjhDDR">[<a href="#ref-1A7PjhDDR" role="doc-biblioref">1447</a>]</span>.
+As early as January 2021, Sputnik V had been administered to 1.5 million Russians <span class="citation" data-cites="X5LkVfY6">[<a href="#ref-X5LkVfY6" role="doc-biblioref">1448</a>]</span>, and doses of Sputnik V have also been distributed to other parts of Europe, such as Belarus, Bosnia-Herzegovina, Hungary, San Marino, Serbia, and Slovakia <span class="citation" data-cites="16LczMwFO Z0V7NK7Y 16GYKbrOq">[<a href="#ref-16LczMwFO" role="doc-biblioref">1449</a>,<a href="#ref-Z0V7NK7Y" role="doc-biblioref">1450</a>,<a href="#ref-16GYKbrOq" role="doc-biblioref">1451</a>]</span>, with the Czech Republic and Austria also having expressed interest in its procurement <span class="citation" data-cites="125VEHWS7">[<a href="#ref-125VEHWS7" role="doc-biblioref">1452</a>]</span>.</p>
 <div id="fig:nrvv-distrib" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/non_replicating_viral_vector.png" alt="Figure 11: Worldwide availability of vaccines developed using non-replicating viral vectors. This figure reflects the number of vaccines using non-replicating viral vectors that were available in each country as of August 11, 2022. These data are retrieved from Our World in Data [1105] and plotted using geopandas [1147]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/non_replicating_viral_vector.png" alt="Figure 11: Worldwide availability of vaccines developed using non-replicating viral vectors. This figure reflects the number of vaccines using non-replicating viral vectors that were available in each country as of August 15, 2022. These data are retrieved from Our World in Data [1105] and plotted using geopandas [1149]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
 <figcaption aria-hidden="true"><span>Figure 11:</span> <strong>Worldwide availability of vaccines developed using non-replicating viral vectors.</strong><!--As a general comment on the choropleths, is there any way to increase resolution. Hard to see what’s happening in Europe and south east Asia.-->
-This figure reflects the number of vaccines using non-replicating viral vectors that were available in each country as of August 11, 2022.
-These data are retrieved from Our World in Data <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1147</a>]</span>.
+This figure reflects the number of vaccines using non-replicating viral vectors that were available in each country as of August 15, 2022.
+These data are retrieved from Our World in Data <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1149</a>]</span>.
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.</figcaption>
 </figure>
 </div>
 <p>Following the trials, additional concerns have been raised about some of these vaccines.
-Within a few days to a few weeks following their first dose of the AstraZeneca vaccine, three women developed extensive venous sinus thrombosis <span class="citation" data-cites="5gqQwOi6">[<a href="#ref-5gqQwOi6" role="doc-biblioref">1395</a>]</span>.
-In March 2021, administration of the vaccine was paused in several European countries while a possible link to thrombotic events was investigated <span class="citation" data-cites="Q4qW6ARY">[<a href="#ref-Q4qW6ARY" role="doc-biblioref">1396</a>]</span>, as these adverse events had not been observed in clinical trials, but the European Medicine Agency (EMA) soon determined that 25 events were not related to the vaccine <span class="citation" data-cites="xSBGseR">[<a href="#ref-xSBGseR" role="doc-biblioref">1397</a>]</span>.
-The following month, the United States paused administration of the Janssen vaccine for ten days due to 15 similar AEs <span class="citation" data-cites="TtPVfMOL 1F1ma0vMT">[<a href="#ref-TtPVfMOL" role="doc-biblioref">1398</a>,<a href="#ref-1F1ma0vMT" role="doc-biblioref">1399</a>]</span>, but the EMA, CDC, and the FDA’s Advisory Committee on Immunization Practices again identified the events as being very rare and the benefits of the vaccine as likely to outweigh its risks <span class="citation" data-cites="iRvYqPq6 MnBdD0Mr 2uAR3HBq EqBIFx5T">[<a href="#ref-iRvYqPq6" role="doc-biblioref">1400</a>,<a href="#ref-MnBdD0Mr" role="doc-biblioref">1401</a>,<a href="#ref-2uAR3HBq" role="doc-biblioref">1402</a>,<a href="#ref-EqBIFx5T" role="doc-biblioref">1403</a>]</span>.
-In Denmark and Norway, population-based estimates suggested AstraZeneca’s vaccine increased incidence of venous thromboembolic events by 11 cases over baseline per 100,000 doses <span class="citation" data-cites="tTpW7jvQ">[<a href="#ref-tTpW7jvQ" role="doc-biblioref">1404</a>]</span>.
-Estimates of the incidence in other western countries have also been low <span class="citation" data-cites="rWaWz2Yg">[<a href="#ref-rWaWz2Yg" role="doc-biblioref">1405</a>]</span>.
-In the US, thromboembolic events following the Janssen vaccine have also been very rare <span class="citation" data-cites="MnBdD0Mr">[<a href="#ref-MnBdD0Mr" role="doc-biblioref">1401</a>]</span>.
-Subsequently, a potential mechanism was identified: the adenovirus vector binding to platelet factor 4 (PF4) <span class="citation" data-cites="z5vyJuGl XwlVcLVP">[<a href="#ref-z5vyJuGl" role="doc-biblioref">1406</a>,<a href="#ref-XwlVcLVP" role="doc-biblioref">1407</a>]</span>.
-Because this adverse event is so rare, the risk is likely still outweighed by the risks associated with contracting COVID-19 <span class="citation" data-cites="itL8KsXg">[<a href="#ref-itL8KsXg" role="doc-biblioref">1408</a>]</span>, which is also associated with thrombotic events) <span class="citation" data-cites="fcm6ElC0 1F1ma0vMT">[<a href="#ref-1F1ma0vMT" role="doc-biblioref">1399</a>,<a href="#ref-fcm6ElC0" role="doc-biblioref">1409</a>]</span>. <!-- Once vaccines from multiple platforms are widely available, do these calculations change though? It is no longer any vaccine versus COVID in some countries. -->
-Similarly, concerns about Guillain-Barré syndrome arose in connection to the Janssen vaccine, but these events have similarly been determined to be very rare and the benefits to outweigh the risks <span class="citation" data-cites="EqBIFx5T">[<a href="#ref-EqBIFx5T" role="doc-biblioref">1403</a>]</span>.</p>
+Within a few days to a few weeks following their first dose of the AstraZeneca vaccine, three women developed extensive venous sinus thrombosis <span class="citation" data-cites="5gqQwOi6">[<a href="#ref-5gqQwOi6" role="doc-biblioref">1453</a>]</span>.
+In March 2021, administration of the vaccine was paused in several European countries while a possible link to thrombotic events was investigated <span class="citation" data-cites="Q4qW6ARY">[<a href="#ref-Q4qW6ARY" role="doc-biblioref">1454</a>]</span>, as these adverse events had not been observed in clinical trials, but the European Medicine Agency (EMA) soon determined that 25 events were not related to the vaccine <span class="citation" data-cites="xSBGseR">[<a href="#ref-xSBGseR" role="doc-biblioref">1455</a>]</span>.
+The following month, the United States paused administration of the Janssen vaccine for ten days due to 15 similar AEs <span class="citation" data-cites="TtPVfMOL 1F1ma0vMT">[<a href="#ref-TtPVfMOL" role="doc-biblioref">1456</a>,<a href="#ref-1F1ma0vMT" role="doc-biblioref">1457</a>]</span>, but the EMA, CDC, and the FDA’s Advisory Committee on Immunization Practices again identified the events as being very rare and the benefits of the vaccine as likely to outweigh its risks <span class="citation" data-cites="iRvYqPq6 MnBdD0Mr 2uAR3HBq EqBIFx5T">[<a href="#ref-iRvYqPq6" role="doc-biblioref">1458</a>,<a href="#ref-MnBdD0Mr" role="doc-biblioref">1459</a>,<a href="#ref-2uAR3HBq" role="doc-biblioref">1460</a>,<a href="#ref-EqBIFx5T" role="doc-biblioref">1461</a>]</span>.
+In Denmark and Norway, population-based estimates suggested AstraZeneca’s vaccine increased incidence of venous thromboembolic events by 11 cases over baseline per 100,000 doses <span class="citation" data-cites="tTpW7jvQ">[<a href="#ref-tTpW7jvQ" role="doc-biblioref">1462</a>]</span>.
+Estimates of the incidence in other western countries have also been low <span class="citation" data-cites="rWaWz2Yg">[<a href="#ref-rWaWz2Yg" role="doc-biblioref">1463</a>]</span>.
+In the US, thromboembolic events following the Janssen vaccine have also been very rare <span class="citation" data-cites="MnBdD0Mr">[<a href="#ref-MnBdD0Mr" role="doc-biblioref">1459</a>]</span>.
+Subsequently, a potential mechanism was identified: the adenovirus vector binding to platelet factor 4 (PF4) <span class="citation" data-cites="z5vyJuGl XwlVcLVP">[<a href="#ref-z5vyJuGl" role="doc-biblioref">1464</a>,<a href="#ref-XwlVcLVP" role="doc-biblioref">1465</a>]</span>.
+Because this adverse event is so rare, the risk is likely still outweighed by the risks associated with contracting COVID-19 <span class="citation" data-cites="itL8KsXg">[<a href="#ref-itL8KsXg" role="doc-biblioref">1466</a>]</span>, which is also associated with thrombotic events) <span class="citation" data-cites="fcm6ElC0 1F1ma0vMT">[<a href="#ref-1F1ma0vMT" role="doc-biblioref">1457</a>,<a href="#ref-fcm6ElC0" role="doc-biblioref">1467</a>]</span>. <!-- Once vaccines from multiple platforms are widely available, do these calculations change though? It is no longer any vaccine versus COVID in some countries. -->
+Similarly, concerns about Guillain-Barré syndrome arose in connection to the Janssen vaccine, but these events have similarly been determined to be very rare and the benefits to outweigh the risks <span class="citation" data-cites="EqBIFx5T">[<a href="#ref-EqBIFx5T" role="doc-biblioref">1461</a>]</span>.</p>
 <!-- It may not belong here, but do we directly compare the real world efficacy across platforms? In the US there eventually came to be a strong preference for the mRNA vaccines, for instance. -->
-<h2 data-number="7.9" id="rna-vaccines"><span class="header-section-number">7.9</span> RNA Vaccines</h2>
+<h2 data-number="8.9" id="rna-vaccines"><span class="header-section-number">8.9</span> RNA Vaccines</h2>
 <!-- Need to introduce this table and refer to it in text, move it to an appropriate location -->
 <!-- Caption is very short -->
 <div id="tbl:approved-RNA" class="tablenos">
@@ -4157,14 +4350,18 @@ <h2 data-number="7.9" id="rna-vaccines"><span class="header-section-number">7.9<
 <td style="text-align: left;">Gennova Biopharmaceuticals Limited</td>
 </tr>
 <tr class="even">
-<td style="text-align: left;">Spikevax</td>
+<td style="text-align: left;">mRNA-1273.214</td>
 <td style="text-align: left;">Moderna</td>
 </tr>
 <tr class="odd">
+<td style="text-align: left;">Spikevax</td>
+<td style="text-align: left;">Moderna</td>
+</tr>
+<tr class="even">
 <td style="text-align: left;">Comirnaty</td>
 <td style="text-align: left;">Pfizer/BioNTech</td>
 </tr>
-<tr class="even">
+<tr class="odd">
 <td style="text-align: left;">TAK-919 (Moderna formulation)</td>
 <td style="text-align: left;">Takeda</td>
 </tr>
@@ -4173,60 +4370,62 @@ <h2 data-number="7.9" id="rna-vaccines"><span class="header-section-number">7.9<
 </div>
 <p><strong>Mechanism:</strong>
 Building on DNA vaccine technology, RNA vaccines are an even more recent advancement for vaccine development.
-Interest in messenger RNA (mRNA) vaccines emerged around 1990 following <em>in vitro</em> and animal model studies that demonstrated that mRNA could be transferred into cells <span class="citation" data-cites="D7ou3S22 2YZ70C2y">[<a href="#ref-D7ou3S22" role="doc-biblioref">1410</a>,<a href="#ref-2YZ70C2y" role="doc-biblioref">1411</a>]</span>.
-mRNA contains the minimum information needed to create a protein <span class="citation" data-cites="2YZ70C2y">[<a href="#ref-2YZ70C2y" role="doc-biblioref">1411</a>]</span>.
+Interest in messenger RNA (mRNA) vaccines emerged around 1990 following <em>in vitro</em> and animal model studies that demonstrated that mRNA could be transferred into cells <span class="citation" data-cites="D7ou3S22 2YZ70C2y">[<a href="#ref-D7ou3S22" role="doc-biblioref">1468</a>,<a href="#ref-2YZ70C2y" role="doc-biblioref">1469</a>]</span>.
+mRNA contains the minimum information needed to create a protein <span class="citation" data-cites="2YZ70C2y">[<a href="#ref-2YZ70C2y" role="doc-biblioref">1469</a>]</span>.
 RNA vaccines are therefore nucleic-acid based modalities that code for viral antigens against which the human body elicits a humoral and cellular immune response.
 This approach operates one level above the DNA: instead of directly furnishing the gene sequence associated with an antigen to the host, it provides the mRNA transcribed from the DNA sequence.
-Some of the potential advantages of mRNA compared to DNA include safety, as it cannot be integrated by the host and the half life can be regulated, it avoids any issues of a host immune response against the vector, and it holds the potential to dramatically accelerate vaccine manufacturing and development <span class="citation" data-cites="ENBWnhAh 2YZ70C2y">[<a href="#ref-2YZ70C2y" role="doc-biblioref">1411</a>,<a href="#ref-ENBWnhAh" role="doc-biblioref">1412</a>]</span>.<!-- Run on sentence, not sure how to break it up --><!--To Do: Add 10.1056/NEJMcibr2111445 either here or in mRNA section--><!--To Do: address on line 70: Are these just advantages comparing mRNA vs DNA vaccines? The first citations seems to imply that these are advantages over protein-based vaccines as well (subunit and whole inactivated vaccines).--></p>
-<p>The mRNA is transcribed <em>in vitro</em> and delivered to cells via lipid nanoparticles (LNP) <span class="citation" data-cites="HCImhzy8">[<a href="#ref-HCImhzy8" role="doc-biblioref">1413</a>]</span>.
+In addition to the benefits of nucleic acid vaccines broadly, some of the potential advantages of mRNA compared to DNA include safety, as it cannot be integrated by the host and the half life can be regulated, it avoids any issues of a host immune response against the vector, and it holds the potential to dramatically accelerate vaccine manufacturing and development <span class="citation" data-cites="ENBWnhAh 2YZ70C2y vh2AH9sg">[<a href="#ref-2YZ70C2y" role="doc-biblioref">1469</a>,<a href="#ref-ENBWnhAh" role="doc-biblioref">1470</a>,<a href="#ref-vh2AH9sg" role="doc-biblioref">1471</a>]</span>.
+<!-- Run on sentence, not sure how to break it up --><!--To Do: Add 10.1056/NEJMcibr2111445 either here or in mRNA section--></p>
+<p>The mRNA is transcribed <em>in vitro</em> and delivered to cells via lipid nanoparticles (LNP) <span class="citation" data-cites="HCImhzy8">[<a href="#ref-HCImhzy8" role="doc-biblioref">1472</a>]</span>.
 It is recognized by ribosomes <em>in vivo</em> and then translated and modified into functional proteins <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
 The resulting intracellular viral proteins are displayed on surface MHC proteins, provoking a strong CD8+ T cell response as well as a CD4<sup>+</sup> T cell and B cell-associated antibody responses <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
 Naturally, mRNA is not very stable and can degrade quickly in the extracellular environment or the cytoplasm.
-The LNP covering protects the mRNA from enzymatic degradation outside of the cell <span class="citation" data-cites="zNKWlCwE">[<a href="#ref-zNKWlCwE" role="doc-biblioref">1414</a>]</span>.
+The LNP covering protects the mRNA from enzymatic degradation outside of the cell <span class="citation" data-cites="zNKWlCwE">[<a href="#ref-zNKWlCwE" role="doc-biblioref">1473</a>]</span>.
 Codon optimization to prevent secondary structure formation and modifications of the poly-A tail as well as the 5’ untranslated region to promote ribosomal complex binding can increase mRNA expression in cells.
-Furthermore, purifying out double-stranded RNA and immature RNA with fast performance liquid chromatography and high performance liquid chromatography technology will improve translation of the mRNA in the cell <span class="citation" data-cites="K0Ltu31S pRoqjur8">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>,<a href="#ref-pRoqjur8" role="doc-biblioref">1415</a>]</span>.</p>
-<p>There are three types of RNA vaccines: non-replicating, <em>in vivo</em> self-replicating, and <em>in vitro</em> dendritic cell non-replicating <span class="citation" data-cites="1EM5nGaYd">[<a href="#ref-1EM5nGaYd" role="doc-biblioref">1416</a>]</span>.
+Furthermore, purifying out double-stranded RNA and immature RNA with fast performance liquid chromatography and high performance liquid chromatography technology will improve translation of the mRNA in the cell <span class="citation" data-cites="K0Ltu31S pRoqjur8">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>,<a href="#ref-pRoqjur8" role="doc-biblioref">1474</a>]</span>.</p>
+<p>There are three types of RNA vaccines: non-replicating, <em>in vivo</em> self-replicating, and <em>in vitro</em> dendritic cell non-replicating <span class="citation" data-cites="1EM5nGaYd">[<a href="#ref-1EM5nGaYd" role="doc-biblioref">1475</a>]</span>.
 Non-replicating mRNA vaccines consist of a simple open reading frame for the viral antigen flanked by the 5’ UTR and 3’ poly-A tail.
-<em>In vivo</em> self-replicating vaccines encode a modified viral genome derived from single-stranded, positive sense RNA alphaviruses <span class="citation" data-cites="K0Ltu31S pRoqjur8">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>,<a href="#ref-pRoqjur8" role="doc-biblioref">1415</a>]</span>.
+<em>In vivo</em> self-replicating vaccines encode a modified viral genome derived from single-stranded, positive sense RNA alphaviruses <span class="citation" data-cites="K0Ltu31S pRoqjur8">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>,<a href="#ref-pRoqjur8" role="doc-biblioref">1474</a>]</span>.
 The RNA genome encodes the viral antigen along with proteins of the genome replication machinery, including an RNA polymerase.
 Structural proteins required for viral assembly are not included in the engineered genome <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
-Self-replicating vaccines produce more viral antigens over a longer period of time, thereby evoking a more robust immune response <span class="citation" data-cites="1EM5nGaYd">[<a href="#ref-1EM5nGaYd" role="doc-biblioref">1416</a>]</span>.
+Self-replicating vaccines produce more viral antigens over a longer period of time, thereby evoking a more robust immune response <span class="citation" data-cites="1EM5nGaYd">[<a href="#ref-1EM5nGaYd" role="doc-biblioref">1475</a>]</span>.
 Finally, <em>in vitro</em> dendritic cell non-replicating RNA vaccines limit transfection to dendritic cells.
 Dendritic cells are potent antigen-presenting immune cells that easily take up mRNA and present fragments of the translated peptide on their MHC proteins, which can then interact with T cell receptors.
-Ultimately, primed T follicular helper cells can stimulate germinal center B cells that also present the viral antigen to produce antibodies against the virus <span class="citation" data-cites="3LMMW7F0">[<a href="#ref-3LMMW7F0" role="doc-biblioref">1417</a>]</span>.
-These cells are isolated from the patient, then grown and transfected <em>ex vivo</em> <span class="citation" data-cites="ENBWnhAh">[<a href="#ref-ENBWnhAh" role="doc-biblioref">1412</a>]</span>.
-They can then be reintroduced to the patient <span class="citation" data-cites="ENBWnhAh">[<a href="#ref-ENBWnhAh" role="doc-biblioref">1412</a>]</span>.</p>
+Ultimately, primed T follicular helper cells can stimulate germinal center B cells that also present the viral antigen to produce antibodies against the virus <span class="citation" data-cites="3LMMW7F0">[<a href="#ref-3LMMW7F0" role="doc-biblioref">1476</a>]</span>.
+These cells are isolated from the patient, then grown and transfected <em>ex vivo</em> <span class="citation" data-cites="ENBWnhAh">[<a href="#ref-ENBWnhAh" role="doc-biblioref">1470</a>]</span>.
+They can then be reintroduced to the patient <span class="citation" data-cites="ENBWnhAh">[<a href="#ref-ENBWnhAh" role="doc-biblioref">1470</a>]</span>.</p>
 <p>Vaccines based on mRNA delivery confer many advantages over traditional viral vectored vaccines and DNA vaccines.
-In comparison to live attenuated viruses, mRNA vaccines are non-infectious and can be synthetically produced in an egg-free, cell-free environment, thereby reducing the risk of a detrimental immune response in the host <span class="citation" data-cites="wYZ6qJMu">[<a href="#ref-wYZ6qJMu" role="doc-biblioref">1418</a>]</span>.
+In comparison to live attenuated viruses, mRNA vaccines are non-infectious and can be synthetically produced in an egg-free, cell-free environment, thereby reducing the risk of a detrimental immune response in the host <span class="citation" data-cites="wYZ6qJMu">[<a href="#ref-wYZ6qJMu" role="doc-biblioref">1477</a>]</span>.
 Unlike DNA vaccines, mRNA technologies are naturally degradable and non-integrating, and they do not need to cross the nuclear membrane in addition to the plasma membrane for their effects to be seen <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
 Furthermore, mRNA vaccines are easily, affordably, and rapidly scalable. <!-- Does this refer to production? I thought scaling production has been a challenge when talking about a global scale. -->
 Although mRNA vaccines have been developed for therapeutic and prophylactic purposes, none have previously been licensed or commercialized.
 <!-- Some of the below text could go in prior applications -->
-Nevertheless, they have shown promise in animal models and preliminary clinical trials for several indications, including rabies, coronavirus, influenza, and cytomegalovirus <span class="citation" data-cites="3EUiWZdN">[<a href="#ref-3EUiWZdN" role="doc-biblioref">1419</a>]</span>.
-Preclinical data previously identified effective antibody generation against full-length purified influenza hemagglutinin stalk-encoding mRNA in mice, rabbits, and ferrets <span class="citation" data-cites="6wZy2mn8">[<a href="#ref-6wZy2mn8" role="doc-biblioref">1420</a>]</span>.
-Similar immunological responses for mRNA vaccines were observed in humans in phase I and II clinical trials operated by the pharmaceutical-development companies Curevac and Moderna for rabies, flu, and zika <span class="citation" data-cites="pRoqjur8">[<a href="#ref-pRoqjur8" role="doc-biblioref">1415</a>]</span>.
-Positively charged bilayer LNPs carrying the mRNA attract negatively charged cell membranes, endocytose into the cytoplasm <span class="citation" data-cites="zNKWlCwE">[<a href="#ref-zNKWlCwE" role="doc-biblioref">1414</a>]</span>, and facilitate endosomal escape.
-LNPs can be coated with modalities recognized and engulfed by specific cell types, and LNPs that are 150 nm or less effectively enter into lymphatic vessels <span class="citation" data-cites="zNKWlCwE Djz8x39x">[<a href="#ref-zNKWlCwE" role="doc-biblioref">1414</a>,<a href="#ref-Djz8x39x" role="doc-biblioref">1421</a>]</span>.
+Nevertheless, they have shown promise in animal models and preliminary clinical trials for several indications, including rabies, coronavirus, influenza, and cytomegalovirus <span class="citation" data-cites="3EUiWZdN">[<a href="#ref-3EUiWZdN" role="doc-biblioref">1478</a>]</span>.
+Preclinical data previously identified effective antibody generation against full-length purified influenza hemagglutinin stalk-encoding mRNA in mice, rabbits, and ferrets <span class="citation" data-cites="6wZy2mn8">[<a href="#ref-6wZy2mn8" role="doc-biblioref">1479</a>]</span>.
+Similar immunological responses for mRNA vaccines were observed in humans in phase I and II clinical trials operated by the pharmaceutical-development companies Curevac and Moderna for rabies, flu, and zika <span class="citation" data-cites="pRoqjur8">[<a href="#ref-pRoqjur8" role="doc-biblioref">1474</a>]</span>.
+Positively charged bilayer LNPs carrying the mRNA attract negatively charged cell membranes, endocytose into the cytoplasm <span class="citation" data-cites="zNKWlCwE">[<a href="#ref-zNKWlCwE" role="doc-biblioref">1473</a>]</span>, and facilitate endosomal escape.
+LNPs can be coated with modalities recognized and engulfed by specific cell types, and LNPs that are 150 nm or less effectively enter into lymphatic vessels <span class="citation" data-cites="zNKWlCwE Djz8x39x">[<a href="#ref-zNKWlCwE" role="doc-biblioref">1473</a>,<a href="#ref-Djz8x39x" role="doc-biblioref">1480</a>]</span>.
 Therefore, this technology holds great potential for targeted delivery of modified mRNA.</p>
 <p><strong>Prior Applications:</strong>
-mRNA vaccine technology was even slower to develop due to challenges related to the instability of mRNA molecules, the design requirements of an efficient delivery system, and the potential for mRNA to elicit either a very strong immune response or to stimulate the immune system in secondary ways <span class="citation" data-cites="17lluDFcc kqerKJKY">[<a href="#ref-kqerKJKY" role="doc-biblioref">1304</a>,<a href="#ref-17lluDFcc" role="doc-biblioref">1422</a>]</span>.
-As of the 2010s, mRNA was still considered a promising technology for future advances in vaccine development <span class="citation" data-cites="2YZ70C2y">[<a href="#ref-2YZ70C2y" role="doc-biblioref">1411</a>]</span>, but prior to 2020, no mRNA vaccines had been approved for use in humans, despite significant advances in the development of this technology <span class="citation" data-cites="ENBWnhAh">[<a href="#ref-ENBWnhAh" role="doc-biblioref">1412</a>]</span>.
+mRNA vaccine technology was even slower to develop due to challenges related to the instability of mRNA molecules, the design requirements of an efficient delivery system, and the potential for mRNA to elicit either a very strong immune response or to stimulate the immune system in secondary ways <span class="citation" data-cites="17lluDFcc kqerKJKY">[<a href="#ref-kqerKJKY" role="doc-biblioref">1362</a>,<a href="#ref-17lluDFcc" role="doc-biblioref">1481</a>]</span>.
+As of the 2010s, mRNA was still considered a promising technology for future advances in vaccine development <span class="citation" data-cites="2YZ70C2y">[<a href="#ref-2YZ70C2y" role="doc-biblioref">1469</a>]</span>, but prior to 2020, no mRNA vaccines had been approved for use in humans, despite significant advances in the development of this technology <span class="citation" data-cites="ENBWnhAh">[<a href="#ref-ENBWnhAh" role="doc-biblioref">1470</a>]</span>.
 Therefore, while these technologies elegantly capitalize on decades of research in vaccine development as well as the tools of the genomic revolution, it was largely unknown prior to the SARS-CoV-2 pandemic whether this potential could be realized in a real-world vaccination effort.</p>
 <p><strong>Application to COVID-19:</strong>
 Given the potential for this technology to be quickly adapted for a new pathogen, it was favored as a potential vaccine against COVID-19.
-In the vaccines developed under this approach, the mRNA coding for a stabilized prefusion spike protein, which is immunogenic <span class="citation" data-cites="5x25saIz">[<a href="#ref-5x25saIz" role="doc-biblioref">1423</a>]</span>, can be furnished to the immune system in order to train its response.
+In the vaccines developed under this approach, the mRNA coding for a stabilized prefusion spike protein, which is immunogenic <span class="citation" data-cites="5x25saIz">[<a href="#ref-5x25saIz" role="doc-biblioref">1482</a>]</span>, can be furnished to the immune system in order to train its response.
 Two vaccine candidates in this category emerged with promising phase III results at the end of 2020.
 Both require two doses approximately one month apart.
-The first was Pfizer/BioNTech’s BNT162b2, which contains the full prefusion stabilized, membrane-anchored SARS-CoV-2 spike protein in a vaccine formulation based on modified mRNA (modRNA) technology <span class="citation" data-cites="1CsCQi9wT 10VyxCgQU">[<a href="#ref-1CsCQi9wT" role="doc-biblioref">1424</a>,<a href="#ref-10VyxCgQU" role="doc-biblioref">1425</a>]</span>.
-The second mRNA vaccine, mRNA-1273 developed by ModernaTX, is comprised by a conventional LNP-encapsulated RNA encoding a full-length prefusion stabilized S protein for SARS-CoV-2 <span class="citation" data-cites="Biu1CQeQ">[<a href="#ref-Biu1CQeQ" role="doc-biblioref">1426</a>]</span>.
-As of August 11, 2022, 2 mRNA vaccines are available in 168 countries (Figure <a href="#fig:mRNA-distrib">12</a>).</p>
+The first was Pfizer/BioNTech’s BNT162b2, which contains the full prefusion stabilized, membrane-anchored SARS-CoV-2 spike protein in a vaccine formulation based on modified mRNA (modRNA) technology <span class="citation" data-cites="1CsCQi9wT 10VyxCgQU">[<a href="#ref-1CsCQi9wT" role="doc-biblioref">1483</a>,<a href="#ref-10VyxCgQU" role="doc-biblioref">1484</a>]</span>.
+The second mRNA vaccine, mRNA-1273 developed by ModernaTX, is comprised by a conventional LNP-encapsulated RNA encoding a full-length prefusion stabilized S protein for SARS-CoV-2 <span class="citation" data-cites="Biu1CQeQ">[<a href="#ref-Biu1CQeQ" role="doc-biblioref">1485</a>]</span>.
+The vaccine candidates developed against SARS-CoV-2 using mRNA vectors utilize similar principles and technologies, although there are slight differences in implementation among candidates such as the formulation of the platform and the specific components of the spike protein encapsulated (e.g., the full Spike protein vs. the RBD alone) <span class="citation" data-cites="suRY1e0N">[<a href="#ref-suRY1e0N" role="doc-biblioref">1486</a>]</span>.
+As of August 15, 2022, 2 mRNA vaccines are available in 168 countries (Figure <a href="#fig:mRNA-distrib">12</a>).</p>
 <!-- A general comment is that it can be confusing why the number of vaccines in the tables (approve) and figures (available) are different. -->
 <div id="fig:mRNA-distrib" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/RNA.png" alt="Figure 12: Worldwide availability of vaccines developed using mRNA. This figure reflects the number of vaccines based on mRNA technology that were available in each country as of August 11, 2022. These data are retrieved from Our World in Data [1105] and plotted using geopandas [1147]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/RNA.png" alt="Figure 12: Worldwide availability of vaccines developed using mRNA. This figure reflects the number of vaccines based on mRNA technology that were available in each country as of August 15, 2022. These data are retrieved from Our World in Data [1105] and plotted using geopandas [1149]. See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily." />
 <figcaption aria-hidden="true"><span>Figure 12:</span> <strong>Worldwide availability of vaccines developed using mRNA.</strong>
-This figure reflects the number of vaccines based on mRNA technology that were available in each country as of August 11, 2022.
-These data are retrieved from Our World in Data <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1147</a>]</span>.
+This figure reflects the number of vaccines based on mRNA technology that were available in each country as of August 15, 2022.
+These data are retrieved from Our World in Data <span class="citation" data-cites="sRy6js2o">[<a href="#ref-sRy6js2o" role="doc-biblioref">1105</a>]</span> and plotted using geopandas <span class="citation" data-cites="iGEyNO42">[<a href="#ref-iGEyNO42" role="doc-biblioref">1149</a>]</span>.
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.</figcaption>
 </figure>
 </div>
@@ -4234,63 +4433,57 @@ <h2 data-number="7.9" id="rna-vaccines"><span class="header-section-number">7.9<
 The VEs revealed by the Pfizer/BioNTech and Moderna clinical trials exceeded expectations.
 In a phase II/III multinational trial, the Pfizer/BioNTech’s BNT162b2 vaccine was associated with a 95% efficacy against laboratory-confirmed COVID-19 and with mild-to-moderate local and systemic effects but a low risk of serious AEs when the prime-boost doses were administered 21 days apart <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.
 The ModernaTX mRNA-1273 vaccine was the second mRNA vaccine to release phase III results, despite being the first mRNA vaccine to enter phase I clinical trials and publish interim results of their phase III trial a few months later.
-Their study reported a 94.5% vaccine efficacy in preventing symptomatic COVID-19 in adults who received the vaccine at 99 sites around the United States <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
-Similar to BNT162b2, the mRNA-1273 vaccine was associated with mild-to-moderate AEs but with a low risk of serious AEs <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
-In late 2020, both vaccines received approval from the FDA under an emergency use authorization <span class="citation" data-cites="cAaN4Te0 13Ou1UUAd">[<a href="#ref-cAaN4Te0" role="doc-biblioref">1428</a>,<a href="#ref-13Ou1UUAd" role="doc-biblioref">1429</a>]</span>, and these vaccines have been widely distributed, primarily in North America and the European Union <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.
+Their study reported a 94.5% vaccine efficacy in preventing symptomatic COVID-19 in adults who received the vaccine at 99 sites around the United States <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
+Similar to BNT162b2, the mRNA-1273 vaccine was associated with mild-to-moderate AEs but with a low risk of serious AEs <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
+In late 2020, both vaccines received approval from the FDA under an emergency use authorization <span class="citation" data-cites="cAaN4Te0 13Ou1UUAd">[<a href="#ref-cAaN4Te0" role="doc-biblioref">1488</a>,<a href="#ref-13Ou1UUAd" role="doc-biblioref">1489</a>]</span>, and these vaccines have been widely distributed, primarily in North America and the European Union <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.
 As the first mRNA vaccines to make it to market, these two highly efficacious vaccines demonstrate the power of this emerging technology, which has previously attracted scientific interest because of its potential to be used to treat non-infectious as well as infectious diseases.</p>
 <p><strong>Real World Safety and Efficacy:</strong>
-Between December 2020 and April 2021, one prospective cohort study obtained weekly nasal swabs from 3,975 individuals at high risk of SARS-CoV-2 exposure (health care workers, frontline workers, etc.) within the United States <span class="citation" data-cites="D2ZCK63Y">[<a href="#ref-D2ZCK63Y" role="doc-biblioref">1430</a>]</span>.
+Between December 2020 and April 2021, one prospective cohort study obtained weekly nasal swabs from 3,975 individuals at high risk of SARS-CoV-2 exposure (health care workers, frontline workers, etc.) within the United States <span class="citation" data-cites="D2ZCK63Y">[<a href="#ref-D2ZCK63Y" role="doc-biblioref">1490</a>]</span>.
 Among these participants, 3,179 (80%) had received at least one dose of an mRNA vaccine and 2,686 (84%) were fully vaccinated.
 For each vaccinated participant (defined here as having received at least dose 1 more than 7 days ago) whose sample tested positive for SARS-CoV-2, they categorized the viral lineage(s) present in the sample as well as in samples from 3-4 unvaccinated individuals matched by site and testing date.
 Overall efficacy of mRNA vaccines was estimated at 91% with full vaccination, similar to the reports from the clinical trials.
 The occurrence of fevers was also lower in individuals who were partially or fully vaccinated, and the duration of symptoms was approximately 6 days shorter.
-Concerns were also raised about a possible link between mRNA vaccination and myocarditis, especially in young men <span class="citation" data-cites="EqBIFx5T">[<a href="#ref-EqBIFx5T" role="doc-biblioref">1403</a>]</span>. <!-- How valid were these concerns? --></p>
-<h2 data-number="7.10" id="vaccines-and-variants-of-concern"><span class="header-section-number">7.10</span> Vaccines and Variants of Concern</h2>
+Concerns were also raised about a possible link between mRNA vaccination and myocarditis, especially in young men <span class="citation" data-cites="EqBIFx5T">[<a href="#ref-EqBIFx5T" role="doc-biblioref">1461</a>]</span>. <!-- How valid were these concerns? --></p>
+<h2 data-number="8.10" id="vaccines-and-variants-of-concern"><span class="header-section-number">8.10</span> Vaccines and Variants of Concern</h2>
 <p>Efficacy estimates have been released for many vaccine candidates across a number of technology types.
 However, efficacy is not a static value, and real-world efficacy can vary with location and over time.
 COVID-19 vaccines have been challenged by the emergence of VOC.
-These VOC generally carry genetic mutations that code for an altered spike protein, so the antibodies developed resulting from the immunization with the existing vaccines may not be as efficacious, which has caused major concern <span class="citation" data-cites="1B4h40dm5 yqFoGUHl">[<a href="#ref-1B4h40dm5" role="doc-biblioref">1431</a>,<a href="#ref-yqFoGUHl" role="doc-biblioref">1432</a>]</span>.
-Despite some reports of varying and reduced efficacy of the mRNA vaccines against the Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants versus the original SARS-CoV-2 strain or the D614G variant <span class="citation" data-cites="x5yLFKk8 19dwMfMGe 63wnlBQD">[<a href="#ref-x5yLFKk8" role="doc-biblioref">1433</a>,<a href="#ref-19dwMfMGe" role="doc-biblioref">1434</a>,<a href="#ref-63wnlBQD" role="doc-biblioref">1435</a>]</span>, the greatest concern to date has been the Omicron variant (B.1.1.529), which was first identified in November 2021 <span class="citation" data-cites="k7L0WGEM yqFoGUHl">[<a href="#ref-yqFoGUHl" role="doc-biblioref">1432</a>,<a href="#ref-k7L0WGEM" role="doc-biblioref">1436</a>]</span>.
-As of March 2022, the Omicron variant accounted for 95% of all infections sequenced in the United States <span class="citation" data-cites="1Bv67ENp2">[<a href="#ref-1Bv67ENp2" role="doc-biblioref">120</a>]</span> and was linked to an increased risk of SARS-CoV-2 reinfection <span class="citation" data-cites="1B4h40dm5">[<a href="#ref-1B4h40dm5" role="doc-biblioref">1431</a>]</span> and further infection of those who have been vaccinated with the mRNA vaccines <span class="citation" data-cites="lexoTbIa">[<a href="#ref-lexoTbIa" role="doc-biblioref">1437</a>]</span>.</p>
+These VOC generally carry genetic mutations that code for an altered spike protein, so the antibodies developed resulting from the immunization with the existing vaccines may not be as efficacious, which has caused major concern <span class="citation" data-cites="1B4h40dm5 yqFoGUHl">[<a href="#ref-1B4h40dm5" role="doc-biblioref">1491</a>,<a href="#ref-yqFoGUHl" role="doc-biblioref">1492</a>]</span>.
+Despite some reports of varying and reduced efficacy of the mRNA vaccines against the Alpha (B.1.1.7), Beta (B.1.351), and Delta (B.1.617.2) variants versus the original SARS-CoV-2 strain or the D614G variant <span class="citation" data-cites="x5yLFKk8 19dwMfMGe 63wnlBQD">[<a href="#ref-x5yLFKk8" role="doc-biblioref">1493</a>,<a href="#ref-19dwMfMGe" role="doc-biblioref">1494</a>,<a href="#ref-63wnlBQD" role="doc-biblioref">1495</a>]</span>, the greatest concern to date has been the Omicron variant (B.1.1.529), which was first identified in November 2021 <span class="citation" data-cites="k7L0WGEM yqFoGUHl">[<a href="#ref-yqFoGUHl" role="doc-biblioref">1492</a>,<a href="#ref-k7L0WGEM" role="doc-biblioref">1496</a>]</span>.
+As of March 2022, the Omicron variant accounted for 95% of all infections sequenced in the United States <span class="citation" data-cites="1Bv67ENp2">[<a href="#ref-1Bv67ENp2" role="doc-biblioref">120</a>]</span> and was linked to an increased risk of SARS-CoV-2 reinfection <span class="citation" data-cites="1B4h40dm5">[<a href="#ref-1B4h40dm5" role="doc-biblioref">1491</a>]</span> and further infection of those who have been vaccinated with the mRNA vaccines <span class="citation" data-cites="lexoTbIa">[<a href="#ref-lexoTbIa" role="doc-biblioref">1497</a>]</span>.</p>
 <!--Move to evolution ms
 Some of the gene mutations carried by Omicron, of which there are between 30-37 in the spike gene (15 in the RBD), have previously been associated with increased transmission, greater affinity for ACE2, and escape from neutralizing antibodies when they have been detected in other VOC [@doi:10.1101/2021.11.11.21266068; @doi:10.1016/j.cell.2021.06.020; @doi:10.1101/2021.12.12.472269; @url:https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-omicron-variant.html; @doi:10.1101/2021.12.14.21267772; @doi:10.1101/2021.12.12.472269].
 However, multiple animal study preprints suggested that the Omicron variant may not be as severe on the respiratory system as previous SARS-CoV-2 variants as evidenced by reduced lung infectivity, reduced SARS-CoV-2 RNA detection in the lung, and reduced inflammation and pathogenicity in animals [@doi:10.21203/rs.3.rs-1211792/v1; @doi:10.1101/2021.12.26.474085; @doi:10.1101/2021.12.24.474086; @doi:10.1101/2022.01.02.474743; @doi:10.1101/2021.12.17.473248].
 -->
-<p>In spite of vaccination programs, infection rates and hospitalization rates climbed in early 2022 in many Western countries including the United States <span class="citation" data-cites="19qv58Mv3 TkFSco2t">[<a href="#ref-19qv58Mv3" role="doc-biblioref">1438</a>,<a href="#ref-TkFSco2t" role="doc-biblioref">1439</a>]</span>. <!-- Call this out as driven by Omicron? -->
+<p>In spite of vaccination programs, infection rates and hospitalization rates climbed in early 2022 in many Western countries including the United States <span class="citation" data-cites="19qv58Mv3 TkFSco2t">[<a href="#ref-19qv58Mv3" role="doc-biblioref">1498</a>,<a href="#ref-TkFSco2t" role="doc-biblioref">1499</a>]</span>. <!-- Call this out as driven by Omicron? -->
 Studies have reported claims of reduced efficacy of the mRNA vaccines based on the measurement of antibody titers.
-Plasma from individuals double-dosed with Pfizer/BioNTech’s BNT162b2 vaccine had up to a 16-fold reduction in neutralizing capacity against the Omicron variant <span class="citation" data-cites="gZ33CJWT">[<a href="#ref-gZ33CJWT" role="doc-biblioref">1440</a>]</span> and a reduced efficacy (70%) <span class="citation" data-cites="S6RHdOTJ">[<a href="#ref-S6RHdOTJ" role="doc-biblioref">1441</a>]</span>.
-Estimates for the mRNA vaccines range from a 2-fold to over a 20-fold drop in neutralisation titers <span class="citation" data-cites="j172syOP">[<a href="#ref-j172syOP" role="doc-biblioref">1442</a>]</span>, hence the push for third and fourth doses of mRNA vaccines in many Western countries.
-A third mRNA vaccine dose does increase antibody titers, but these levels also wane with time <span class="citation" data-cites="vJlYzFrS">[<a href="#ref-vJlYzFrS" role="doc-biblioref">1443</a>]</span>.
-Notably, immunocompromised individuals such as cancer patients seem to elicit a sufficient protective immune response against the Omicron variant when they have been boosted with a third dose of either mRNA vaccine, albeit a blunted response <span class="citation" data-cites="sNDCRMQ5">[<a href="#ref-sNDCRMQ5" role="doc-biblioref">1444</a>]</span>.
-While antibody titers do correlate with protection <span class="citation" data-cites="J069om3D 1AtNPSzpd QYbPf88B 1HCZbWd9m 4WhXhBth">[<a href="#ref-J069om3D" role="doc-biblioref">1445</a>,<a href="#ref-1AtNPSzpd" role="doc-biblioref">1446</a>,<a href="#ref-QYbPf88B" role="doc-biblioref">1447</a>,<a href="#ref-1HCZbWd9m" role="doc-biblioref">1448</a>,<a href="#ref-4WhXhBth" role="doc-biblioref">1449</a>]</span>, they are not the only mechanisms of immune protection.
+Plasma from individuals double-dosed with Pfizer/BioNTech’s BNT162b2 vaccine had up to a 16-fold reduction in neutralizing capacity against the Omicron variant <span class="citation" data-cites="gZ33CJWT">[<a href="#ref-gZ33CJWT" role="doc-biblioref">1500</a>]</span> and a reduced efficacy (70%) <span class="citation" data-cites="S6RHdOTJ">[<a href="#ref-S6RHdOTJ" role="doc-biblioref">1501</a>]</span>.
+Estimates for the mRNA vaccines range from a 2-fold to over a 20-fold drop in neutralisation titers <span class="citation" data-cites="j172syOP">[<a href="#ref-j172syOP" role="doc-biblioref">1502</a>]</span>, hence the push for third and fourth doses of mRNA vaccines in many Western countries.
+A third mRNA vaccine dose does increase antibody titers, but these levels also wane with time <span class="citation" data-cites="vJlYzFrS">[<a href="#ref-vJlYzFrS" role="doc-biblioref">1503</a>]</span>.
+Notably, immunocompromised individuals such as cancer patients seem to elicit a sufficient protective immune response against the Omicron variant when they have been boosted with a third dose of either mRNA vaccine, albeit a blunted response <span class="citation" data-cites="sNDCRMQ5">[<a href="#ref-sNDCRMQ5" role="doc-biblioref">1504</a>]</span>.
+While antibody titers do correlate with protection <span class="citation" data-cites="J069om3D 1AtNPSzpd QYbPf88B 1HCZbWd9m 4WhXhBth">[<a href="#ref-J069om3D" role="doc-biblioref">1505</a>,<a href="#ref-1AtNPSzpd" role="doc-biblioref">1506</a>,<a href="#ref-QYbPf88B" role="doc-biblioref">1507</a>,<a href="#ref-1HCZbWd9m" role="doc-biblioref">1508</a>,<a href="#ref-4WhXhBth" role="doc-biblioref">1509</a>]</span>, they are not the only mechanisms of immune protection.
 For example, T cell and non-neutralizing antibody responses may be unaffected or less affected by the new VOC, and they warrant further investigation.</p>
-<!--Move to evolution
-Vaccine efficacy is not the only pharmacological intervention affected by VOC.
-Some existing therapeutics, including monoclonal antibody treatments like Bamlanivimab (AbCellera Biologics/ Eli Lilly), were ineffective against the Omicron variant.
-Indeed, only Sotrovimab (Vir Biotechnology/GSK) and Tixagevimab (AstraZeneca) to a much lesser extent could effectively neutralize the Omicron variant out of 7 tested monoclonal antibodies [@doi:10.1101/2021.12.14.21267772], which has been verified by others [@doi:10.1101/2021.12.12.472269].
-The antigenic shift of the Omicron variant does raise concerns for future VOC and what effects they may have on future vaccines and therapeutics.
--->
 <p>The WHO continues to monitor the emergence of variants and their impact on vaccine efficacy <span class="citation" data-cites="lY0XUlUp">[<a href="#ref-lY0XUlUp" role="doc-biblioref">517</a>]</span>.
 Previous research in the computational prediction of the efficacy of vaccines targeting the influenza A virus might complement efforts to monitor these types of viral outbreaks <span class="citation" data-cites="YlAWEwlx">[<a href="#ref-YlAWEwlx" role="doc-biblioref">518</a>]</span>.
 To adapt, booster shots are now recommended in many places, and vaccines in the near future will likely account for multiple variants and strains of SARS-CoV-2 <span class="citation" data-cites="180UFKjJ2">[<a href="#ref-180UFKjJ2" role="doc-biblioref">519</a>]</span>.</p>
-<h2 data-number="7.11" id="booster-doses"><span class="header-section-number">7.11</span> Booster Doses</h2>
+<h2 data-number="8.11" id="booster-doses"><span class="header-section-number">8.11</span> Booster Doses</h2>
 <p>Due to waning neutralizing antibodies and viral evolution, boosters have emerged as an important strategy in retaining the benefits of vaccination over time.
 Homologous booster doses have been investigated for most vaccines.
-For example, over 14,000 adults were administered a booster (second) dose of the Janssen Ad26.COV2.S vaccine <span class="citation" data-cites="Cs2RaaCI">[<a href="#ref-Cs2RaaCI" role="doc-biblioref">1450</a>]</span>.
+For example, over 14,000 adults were administered a booster (second) dose of the Janssen Ad26.COV2.S vaccine <span class="citation" data-cites="Cs2RaaCI">[<a href="#ref-Cs2RaaCI" role="doc-biblioref">1510</a>]</span>.
 The booster dose was highly efficacious, with severe COVID-19 and hospitalization prevented almost completely in the vaccinated group.
-A booster dose was also found to improve immune response for Sputnik V vaccinees <span class="citation" data-cites="WtUhPusE">[<a href="#ref-WtUhPusE" role="doc-biblioref">1451</a>]</span>.
+A booster dose was also found to improve immune response for Sputnik V vaccinees <span class="citation" data-cites="WtUhPusE">[<a href="#ref-WtUhPusE" role="doc-biblioref">1511</a>]</span>.
 For the AstraZeneca vaccine, a different approach was taken.
-In the interest of distributing first doses as widely as possible, the effects of extending the time between the first and second doses was evaluated and <span class="citation" data-cites="17s40tqgW">[<a href="#ref-17s40tqgW" role="doc-biblioref">1452</a>]</span>. <!-- End of sentence missing --></p>
+In the interest of distributing first doses as widely as possible, the effects of extending the time between the first and second doses was evaluated and <span class="citation" data-cites="17s40tqgW">[<a href="#ref-17s40tqgW" role="doc-biblioref">1512</a>]</span>. <!-- End of sentence missing --></p>
 <p>In countries such as Israel, a fourth dose of mRNA vaccines have been introduced in response to the Omicron variant and an initial study in healthcare workers showed that the additional immunization was safe and immunogenic with antibody titers restored to peak-third dose titers.
-No severe illness was reported in the cohort studied (274 versus 426 age-matched controls), and vaccine efficacy against infection was reported at 30% for BNT162b2 and 11% for mRNA-1273 <span class="citation" data-cites="Jv71MaZb">[<a href="#ref-Jv71MaZb" role="doc-biblioref">1453</a>]</span>.
+No severe illness was reported in the cohort studied (274 versus 426 age-matched controls), and vaccine efficacy against infection was reported at 30% for BNT162b2 and 11% for mRNA-1273 <span class="citation" data-cites="Jv71MaZb">[<a href="#ref-Jv71MaZb" role="doc-biblioref">1513</a>]</span>.
 Low efficacy against infection does not undermine the value of vaccination considering the vaccines are intended to prevent severe disease, hospitalization, and death rather than infection generally.</p>
 <p>Many trials have also investigated heterologous boosting approaches.
 In particular, the mRNA vaccines are a popular choice following a primary series of a more traditional platform.
-In general, such approaches have been found to confer favorable immunogenicity relative to homologous boosters (e.g, <span class="citation" data-cites="L0dD93f8 ybtjun8H H6vRjWQg 15rMr9nh7 cNs4cL36 s1xmA2K6 exu6jkTJ">[<a href="#ref-L0dD93f8" role="doc-biblioref">1454</a>,<a href="#ref-ybtjun8H" role="doc-biblioref">1455</a>,<a href="#ref-H6vRjWQg" role="doc-biblioref">1456</a>,<a href="#ref-15rMr9nh7" role="doc-biblioref">1457</a>,<a href="#ref-cNs4cL36" role="doc-biblioref">1458</a>,<a href="#ref-s1xmA2K6" role="doc-biblioref">1459</a>,<a href="#ref-exu6jkTJ" role="doc-biblioref">1460</a>]</span> and many other studies).
-Due to remaining concerns about rare thromboembolic events, vaccinees who received AstraZeneca for their primary course are advised in some countries to seek a heterologous booster <span class="citation" data-cites="EzS3LTYM">[<a href="#ref-EzS3LTYM" role="doc-biblioref">1461</a>]</span>, although such guidances are not supported by the evidence, which indicates that the first dose of AstraZeneca is most likely to be linked to these rare events <span class="citation" data-cites="kFl0x9VR">[<a href="#ref-kFl0x9VR" role="doc-biblioref">1462</a>]</span>.</p>
+In general, such approaches have been found to confer favorable immunogenicity relative to homologous boosters (e.g, <span class="citation" data-cites="L0dD93f8 ybtjun8H H6vRjWQg 15rMr9nh7 cNs4cL36 s1xmA2K6 exu6jkTJ">[<a href="#ref-L0dD93f8" role="doc-biblioref">1514</a>,<a href="#ref-ybtjun8H" role="doc-biblioref">1515</a>,<a href="#ref-H6vRjWQg" role="doc-biblioref">1516</a>,<a href="#ref-15rMr9nh7" role="doc-biblioref">1517</a>,<a href="#ref-cNs4cL36" role="doc-biblioref">1518</a>,<a href="#ref-s1xmA2K6" role="doc-biblioref">1519</a>,<a href="#ref-exu6jkTJ" role="doc-biblioref">1520</a>]</span> and many other studies).
+Due to remaining concerns about rare thromboembolic events, vaccinees who received AstraZeneca for their primary course are advised in some countries to seek a heterologous booster <span class="citation" data-cites="EzS3LTYM">[<a href="#ref-EzS3LTYM" role="doc-biblioref">1521</a>]</span>, although such guidances are not supported by the evidence, which indicates that the first dose of AstraZeneca is most likely to be linked to these rare events <span class="citation" data-cites="kFl0x9VR">[<a href="#ref-kFl0x9VR" role="doc-biblioref">1522</a>]</span>.</p>
 <p>Although the vaccines developed based on the index strain remain highly effective at preventing severe illness and death, they serve much less utility at preventing illness broadly than they did early in the pandemic.
 Therefore, many manufacturers are exploring potential reformulations based on VOC that have emerged since the beginning of the pandemic.
-In June 2022, Moderna released data describing the effect of their bivalent mRNA booster, mRNA-1273.214, designed to protect against the Omicron variant <span class="citation" data-cites="OWsXXUTT">[<a href="#ref-OWsXXUTT" role="doc-biblioref">1463</a>]</span>.
+In June 2022, Moderna released data describing the effect of their bivalent mRNA booster, mRNA-1273.214, designed to protect against the Omicron variant <span class="citation" data-cites="OWsXXUTT">[<a href="#ref-OWsXXUTT" role="doc-biblioref">1523</a>]</span>.
 A 50 μg dose of mRNA-1273.214 was administered to 437 participants.
 One month later, the neutralizing geometric mean titer ratio was assessed against several variants of SARS-CoV-2, including Omicron.
 The immune response was higher against all variants assessed, including Omicron, than for boosting with the original formulation (mRNA-1273).
@@ -4299,7 +4492,7 @@ <h2 data-number="7.11" id="booster-doses"><span class="header-section-number">7.
 Therefore, additional results may provide better insight into the VE of these formulations.
 Given the apparent need for boosters, interest has also emerged in whether updated formulations of SARS-CoV-2 vaccines can be administered along with annual flu vaccines to improve immunity to novel variants.
 <!-- What is our conclusion about this (or will that go in the Conclusion?). The potential of mRNA vaccines was rapid reformulation, but that hasn't really happened in practice (yet). --></p>
-<h2 data-number="7.12" id="effect-of-vaccines-on-community-spread"><span class="header-section-number">7.12</span> Effect of Vaccines on Community Spread</h2>
+<h2 data-number="8.12" id="effect-of-vaccines-on-community-spread"><span class="header-section-number">8.12</span> Effect of Vaccines on Community Spread</h2>
 <!-- I suggest moving this entire section to the appendix. It is well written but long, not directly related to the rest of the sections, and somewhat inconclusive. We could keep the last sentence as part of the conclusions ("Evidence suggests that public health measures ...") and refer to the appendix to support that statement. -->
 <p>The vaccine clinical trial data demonstrate a significant reduction in the likelihood of contracting symptomatic COVID-19, thereby succeeding in the primary goal of vaccination.
 The mRNA vaccines in particular were initially so effective in preventing disease that they were also assumed to have an effect on the likelihood of transmission (e.g., venues requiring proof of vaccination).
@@ -4310,26 +4503,26 @@ <h2 data-number="7.12" id="effect-of-vaccines-on-community-spread"><span class="
 <p>The phase II/III clinical trials evaluating the mRNA vaccines assessed vaccine efficacy based on COVID-19 diagnosis, thereby detecting only patients who received a diagnosis.
 In order to identify patients infected with SARS-CoV-2 who did not receive a diagnosis, for example, potentially those who did not develop symptoms, it would be necessary to conduct routine PCR testing even in the absence of symptoms. <!-- Define PCR? -->
 Prior to the development of vaccines, the evidence suggested that asymptomatic individuals could still spread SARS-CoV-2.
-Investigation of viral dynamics of asymptomatic infection in early 2020 indicated that asymptomatic patients continued to shed the virus for a duration similar to that of symptomatic patients <span class="citation" data-cites="ZU1ZF4SW">[<a href="#ref-ZU1ZF4SW" role="doc-biblioref">1464</a>]</span> (although viral shedding should not be conflated with contagiousness without further investigation <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span>).
-Another study found viral load to be higher in the nasopharyngeal/oropharyngeal samples of asymptomatic patients compared to symptomatic patients hospitalized due to symptoms and/or known exposure <span class="citation" data-cites="whGzxrkn">[<a href="#ref-whGzxrkn" role="doc-biblioref">1465</a>]</span>.
-However, the sample size in both of these studies was small, and a larger study found higher viral load in symptomatic than asymptomatic cases <span class="citation" data-cites="34wAjHW5">[<a href="#ref-34wAjHW5" role="doc-biblioref">1466</a>]</span> along with a systematic review finding a reduced probability of asymptomatic transmission <span class="citation" data-cites="1CA0Sj7dn">[<a href="#ref-1CA0Sj7dn" role="doc-biblioref">1467</a>]</span>.
+Investigation of viral dynamics of asymptomatic infection in early 2020 indicated that asymptomatic patients continued to shed the virus for a duration similar to that of symptomatic patients <span class="citation" data-cites="ZU1ZF4SW">[<a href="#ref-ZU1ZF4SW" role="doc-biblioref">1524</a>]</span> (although viral shedding should not be conflated with contagiousness without further investigation <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span>).
+Another study found viral load to be higher in the nasopharyngeal/oropharyngeal samples of asymptomatic patients compared to symptomatic patients hospitalized due to symptoms and/or known exposure <span class="citation" data-cites="whGzxrkn">[<a href="#ref-whGzxrkn" role="doc-biblioref">1525</a>]</span>.
+However, the sample size in both of these studies was small, and a larger study found higher viral load in symptomatic than asymptomatic cases <span class="citation" data-cites="34wAjHW5">[<a href="#ref-34wAjHW5" role="doc-biblioref">1526</a>]</span> along with a systematic review finding a reduced probability of asymptomatic transmission <span class="citation" data-cites="1CA0Sj7dn">[<a href="#ref-1CA0Sj7dn" role="doc-biblioref">1527</a>]</span>.
 While far from conclusive, these studies suggest that asymptomatic cases still cary a risk of transmitting SARS-CoV-2.</p>
 <p>One important consideration is therefore how likely vaccinated individuals are to develop asymptomatic SARS-CoV-2.
 Considering asymptomatic cases is necessary to establish a more complete picture of efficacy with respect to spread.<!-- To Do: Possible figure indicating pyramid of risk with and without vaccines?-->
-Routine testing of healthcare workers in California who had received an mRNA vaccine revealed slightly higher rates of absolute risk for testing positive than those identified in the phase II/III trials, although the extent to which asymptomatic infection influenced these numbers was not investigated <span class="citation" data-cites="13llzZ2qN">[<a href="#ref-13llzZ2qN" role="doc-biblioref">1468</a>]</span>.
+Routine testing of healthcare workers in California who had received an mRNA vaccine revealed slightly higher rates of absolute risk for testing positive than those identified in the phase II/III trials, although the extent to which asymptomatic infection influenced these numbers was not investigated <span class="citation" data-cites="13llzZ2qN">[<a href="#ref-13llzZ2qN" role="doc-biblioref">1528</a>]</span>.
 Another study analyzed the results of COVID-19 screening tests administered to asymptomatic individuals prior to receiving certain medical services at the Mayo Clinic in several locations across the United States.
-This study found patients who had received two doses of an mRNA vaccine to be 73% less likely to have asymptomatic COVID-19 than patients who had received zero doses <span class="citation" data-cites="dLmXTkx0">[<a href="#ref-dLmXTkx0" role="doc-biblioref">1469</a>]</span>.
-Because this study began on December 17, 2020, a date selected to coincide with the first day vaccines were available at the Mayo Clinic, this number may underestimate the efficacy of the vaccines given that many people eligible for early vaccination were at increased risk for exposure (e.g., healthcare workers and residents of long-term care facilities) <span class="citation" data-cites="dLmXTkx0">[<a href="#ref-dLmXTkx0" role="doc-biblioref">1469</a>]</span>.
-In Israel, a longitudinal study of nearly 12,000 healthcare workers found that of the 5,372 fully vaccinated people with Pfizer/BioNTech BNT162b2, 8 developed symptomatic COVID-19 (BNT162b2 (0.15%) and 19 developed asymptomatic COVID-19 (0.35%) <span class="citation" data-cites="zHE6Quu6">[<a href="#ref-zHE6Quu6" role="doc-biblioref">1470</a>]</span>.
+This study found patients who had received two doses of an mRNA vaccine to be 73% less likely to have asymptomatic COVID-19 than patients who had received zero doses <span class="citation" data-cites="dLmXTkx0">[<a href="#ref-dLmXTkx0" role="doc-biblioref">1529</a>]</span>.
+Because this study began on December 17, 2020, a date selected to coincide with the first day vaccines were available at the Mayo Clinic, this number may underestimate the efficacy of the vaccines given that many people eligible for early vaccination were at increased risk for exposure (e.g., healthcare workers and residents of long-term care facilities) <span class="citation" data-cites="dLmXTkx0">[<a href="#ref-dLmXTkx0" role="doc-biblioref">1529</a>]</span>.
+In Israel, a longitudinal study of nearly 12,000 healthcare workers found that of the 5,372 fully vaccinated people with Pfizer/BioNTech BNT162b2, 8 developed symptomatic COVID-19 (BNT162b2 (0.15%) and 19 developed asymptomatic COVID-19 (0.35%) <span class="citation" data-cites="zHE6Quu6">[<a href="#ref-zHE6Quu6" role="doc-biblioref">1530</a>]</span>.
 While the study itself analyzed the efficacy of the vaccine based on person-days, these findings also suggest that many or even the majority of SARS-CoV-2 infections in vaccinated individuals are likely to be asymptomatic.
 Therefore, in addition to the symptomatic cases reported by the vaccine clinical trials, these findings suggest that asymptomatic cases can also occur in vaccinated people.
 In the absence of symptoms, individuals are less likely to know to self-isolate, and therefore evaluating the effect of the vaccine on viral load is critical to understanding the role vaccinated individuals can play in spreading SARS-CoV-2.</p>
 <p>Another question of interest is therefore whether vaccinated individuals positive for SARS-CoV-2 carry a similar viral load to unvaccinated individuals.
 Viral load is often approximated by cycle threshold (C<sub>t</sub>), or the cycle at which viral presence is detected during RT-qPCR, with a lower C<sub>t</sub> corresponding to a greater viral load.
-A prospective cohort study that evaluated front-line workers in six U.S.A. states from December 2020 to April 2021 reported a 40% reduction in viral load even with just a single dose of an mRNA vaccine <span class="citation" data-cites="D2ZCK63Y">[<a href="#ref-D2ZCK63Y" role="doc-biblioref">1430</a>]</span>.
-The vaccine also appeared to influence the time to viral clearance: the risk of having detectable levels of SARS-CoV-2 for more than one week was reduced by 66% in participants who had received at least one dose <span class="citation" data-cites="D2ZCK63Y">[<a href="#ref-D2ZCK63Y" role="doc-biblioref">1430</a>]</span>.
+A prospective cohort study that evaluated front-line workers in six U.S.A. states from December 2020 to April 2021 reported a 40% reduction in viral load even with just a single dose of an mRNA vaccine <span class="citation" data-cites="D2ZCK63Y">[<a href="#ref-D2ZCK63Y" role="doc-biblioref">1490</a>]</span>.
+The vaccine also appeared to influence the time to viral clearance: the risk of having detectable levels of SARS-CoV-2 for more than one week was reduced by 66% in participants who had received at least one dose <span class="citation" data-cites="D2ZCK63Y">[<a href="#ref-D2ZCK63Y" role="doc-biblioref">1490</a>]</span>.
 However, this study compared the mean viral load across the two groups, meaning that these findings cannot be extrapolated across all points in the disease course.
-Similarly, between December 2020 and February 2021, positive RT-qPCR tests were analyzed for almost 5,000 Israeli patients <span class="citation" data-cites="119cExL0k">[<a href="#ref-119cExL0k" role="doc-biblioref">1471</a>]</span>.
+Similarly, between December 2020 and February 2021, positive RT-qPCR tests were analyzed for almost 5,000 Israeli patients <span class="citation" data-cites="119cExL0k">[<a href="#ref-119cExL0k" role="doc-biblioref">1531</a>]</span>.
 C<sub>t</sub> was analyzed relative to when each patient received the first dose of the Pfizer mRNA vaccine.
 A sharp increase in C<sub>t</sub> (corresponding to reduced viral load) was observed between days 11 and 12, consistent with what is known about the onset of immunity following vaccination.
 This pattern therefore suggested a direct effect of vaccination on viral load.</p>
@@ -4341,7 +4534,7 @@ <h2 data-number="7.12" id="effect-of-vaccines-on-community-spread"><span class="
 A third study investigated viral load (as approximated by C<sub>t</sub>) using samples processed in a single laboratory during the summer of 2021 <span class="citation" data-cites="N5OXLf7V">[<a href="#ref-N5OXLf7V" role="doc-biblioref">521</a>]</span>.
 This study identified no significant differences in C<sub>t</sub> between fully vaccinated and unvaccinated cases, but this study used samples sent for diagnosis and was not longitudinal.
 It offered the additional benefit of culturing samples to assess whether their C<sub>t</sub> threshold was likely to represent contagiousness and found that SARS-CoV-2 could be cultured from 51 of 55 samples with C<sub>t</sub> less than 25 (the cut-off used in many studies).
-Another study of samples collected at two sites in San Francisco, one of which tested only asymptomatic individuals, reported no difference in C<sub>t</sub> between asymptomatic and symptomatic cases regardless of whether vaccination status was included in the model <span class="citation" data-cites="mgscHeDu">[<a href="#ref-mgscHeDu" role="doc-biblioref">1472</a>]</span>.
+Another study of samples collected at two sites in San Francisco, one of which tested only asymptomatic individuals, reported no difference in C<sub>t</sub> between asymptomatic and symptomatic cases regardless of whether vaccination status was included in the model <span class="citation" data-cites="mgscHeDu">[<a href="#ref-mgscHeDu" role="doc-biblioref">1532</a>]</span>.
 Though each of these three studies offers distinct strengths and weaknesses, taken together, they suggest that viral load is likely to be similar in vaccinated and unvaccinated individuals, but that vaccinated individuals clear the virus more rapidly, meaning that the average viral load is lower over time.</p>
 <p>Given the emergence of VOC, especially the Delta and Omicron variants, for which breakthrough infections are more common, the potential for vaccinated individuals to spread SARS-CoV-2 is not static over time.
 In fact, studies reporting reduced viral load in vaccinated individuals collected samples, for the most part, prior to the emergence of the Delta variant’s dominance.
@@ -4352,7 +4545,7 @@ <h2 data-number="7.12" id="effect-of-vaccines-on-community-spread"><span class="
 Therefore, at present, the evidence suggests that vaccinated individuals who are infected can still contribute to community spread.
 The one potential mitigating factor supported at present is that differences in the viral kinetics may result in vaccinated cases infecting fewer individuals over time due to a more rapid decrease in viral load <span class="citation" data-cites="e2Qnnj6R">[<a href="#ref-e2Qnnj6R" role="doc-biblioref">520</a>]</span>, although this study did not examine patterns in secondary transmission.
 Thus, the virological evidence suggests that public health measures such as masking and distancing remain important even in areas with high vaccination rates.</p>
-<h2 data-number="7.13" id="conclusions-2"><span class="header-section-number">7.13</span> Conclusions</h2>
+<h2 data-number="8.13" id="conclusions-2"><span class="header-section-number">8.13</span> Conclusions</h2>
 <p>COVID-19 has seen the coming-of-age of vaccine technologies that have been in development since the late 20<sup>th</sup> century but had never before received approvals.
 Vaccines that employ DNA and RNA eliminate all concerns about potential infection due to the vaccine components.
 The vaccines described above demonstrate the potential for these technologies to facilitate a quick response to an emerging pathogen.
@@ -4360,99 +4553,98 @@ <h2 data-number="7.13" id="conclusions-2"><span class="header-section-number">7.
 These technologies hold significant potential to drive improvements in human health over the coming years.</p>
 <p>Traditional vaccine technologies were built on the principle of using either a weakened version of the virus or a fragment of the virus.
 COVID-19 has highlighted the fact that in recent years, the field has undergone a paradigm shift towards reverse vaccinology.
-Reverse vaccinology emphasizes a hypothesis-free approach to vaccine development <span class="citation" data-cites="jU9YFYvB">[<a href="#ref-jU9YFYvB" role="doc-biblioref">1473</a>]</span>. <!-- What does hypothesis free mean in this context? -->
-This strategy was explored during development of a DNA vaccine against the Zika virus <span class="citation" data-cites="u0dESADU">[<a href="#ref-u0dESADU" role="doc-biblioref">1474</a>]</span>.
-Though the disease was controlled before the vaccine became available <span class="citation" data-cites="HyYY2agc">[<a href="#ref-HyYY2agc" role="doc-biblioref">1283</a>]</span>, the response demonstrated the potential for modular technologies to facilitate a response to emerging viral threats <span class="citation" data-cites="u0dESADU">[<a href="#ref-u0dESADU" role="doc-biblioref">1474</a>]</span>.
-The potential for such vaccines to benefit the field of oncology has encouraged vaccine developers to invest in next-generation approaches, which has spurred the diversification of vaccine development programs <span class="citation" data-cites="wPl93ATP BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1307</a>,<a href="#ref-wPl93ATP" role="doc-biblioref">1475</a>]</span>.
+Reverse vaccinology emphasizes a hypothesis-free approach to vaccine development <span class="citation" data-cites="jU9YFYvB">[<a href="#ref-jU9YFYvB" role="doc-biblioref">1533</a>]</span>. <!-- What does hypothesis free mean in this context? -->
+This strategy was explored during development of a DNA vaccine against the Zika virus <span class="citation" data-cites="u0dESADU">[<a href="#ref-u0dESADU" role="doc-biblioref">1534</a>]</span>.
+Though the disease was controlled before the vaccine became available <span class="citation" data-cites="HyYY2agc">[<a href="#ref-HyYY2agc" role="doc-biblioref">1283</a>]</span>, the response demonstrated the potential for modular technologies to facilitate a response to emerging viral threats <span class="citation" data-cites="u0dESADU">[<a href="#ref-u0dESADU" role="doc-biblioref">1534</a>]</span>.
+The potential for such vaccines to benefit the field of oncology has encouraged vaccine developers to invest in next-generation approaches, which has spurred the diversification of vaccine development programs <span class="citation" data-cites="wPl93ATP BsrTDzJ2">[<a href="#ref-BsrTDzJ2" role="doc-biblioref">1365</a>,<a href="#ref-wPl93ATP" role="doc-biblioref">1535</a>]</span>.
 As a result, during the COVID-19 pandemic, these modular technologies have taken center stage in controlling a viral threat for the first time.</p>
 <p>The large-scale emphasis on vaccine development has led to other advances.
 One example comes from ZyCoV-D, a DNA vaccine developed by the Indian company Cadila Healthcare.
-This vaccine uses a plasmid to deliver the expression-competent Spike protein and IgE signal peptides to the vaccinee <span class="citation" data-cites="1CCmltPec">[<a href="#ref-1CCmltPec" role="doc-biblioref">1476</a>]</span>.
-During the phase I trial, vaccination with a needle versus a needle-free injection system was evaluated, and the vaccine can now be administered without a needle <span class="citation" data-cites="AfMvzFuk eIn1Qf3N">[<a href="#ref-AfMvzFuk" role="doc-biblioref">1318</a>,<a href="#ref-eIn1Qf3N" role="doc-biblioref">1319</a>]</span>.
-This highly portable design offers advantages over traditional vaccines <span class="citation" data-cites="1CCmltPec">[<a href="#ref-1CCmltPec" role="doc-biblioref">1476</a>]</span>, especially as the emergence of variants continues to challenge the efficacy of vaccines.</p>
+This vaccine uses a plasmid to deliver the expression-competent Spike protein and IgE signal peptides to the vaccinee <span class="citation" data-cites="1CCmltPec">[<a href="#ref-1CCmltPec" role="doc-biblioref">1536</a>]</span>.
+During the phase I trial, vaccination with a needle versus a needle-free injection system was evaluated, and the vaccine can now be administered without a needle <span class="citation" data-cites="AfMvzFuk eIn1Qf3N">[<a href="#ref-AfMvzFuk" role="doc-biblioref">1376</a>,<a href="#ref-eIn1Qf3N" role="doc-biblioref">1377</a>]</span>.
+This highly portable design offers advantages over traditional vaccines <span class="citation" data-cites="1CCmltPec">[<a href="#ref-1CCmltPec" role="doc-biblioref">1536</a>]</span>, especially as the emergence of variants continues to challenge the efficacy of vaccines.</p>
 <p>One of the downsides of this leap in vaccine technologies, however, is that they have largely been developed by wealthy countries, including countries in the European Union, the United States, the U.K., and Russia.
 As a result, they are also largely available to residents of wealthy countries, primarily in Europe and North America.<!--Add scatter plot with GDP and RNA doses/population, same for DNA-->
-Although the VE of DNA vaccines tends to be lower than that of mRNA vaccines <span class="citation" data-cites="YTceJugW">[<a href="#ref-YTceJugW" role="doc-biblioref">1477</a>]</span>, they still provide excellent protection against severe illness and are much easier to distribute due to less complex demands for storage.
-Efforts such as COVAX that aim to expand access to vaccines developed by wealthy countries have not been as successful as hoped <span class="citation" data-cites="17V4Lh5uy">[<a href="#ref-17V4Lh5uy" role="doc-biblioref">1478</a>]</span>.
+Although the VE of DNA vaccines tends to be lower than that of mRNA vaccines <span class="citation" data-cites="YTceJugW">[<a href="#ref-YTceJugW" role="doc-biblioref">1537</a>]</span>, they still provide excellent protection against severe illness and are much easier to distribute due to less complex demands for storage.
+Efforts such as COVAX that aim to expand access to vaccines developed by wealthy countries have not been as successful as hoped <span class="citation" data-cites="17V4Lh5uy">[<a href="#ref-17V4Lh5uy" role="doc-biblioref">1538</a>]</span>.
 Fortunately, vaccine development programs using more established technologies have been undertaken in many middle income countries, and those vaccines have been more accessible globally <span class="citation" data-cites="S1SpDOhi">[<a href="#ref-S1SpDOhi" role="doc-biblioref">344</a>]</span>.
-Additionally, efforts to develop new formulations of DNA vaccines in lower- and middle-income countries are increasingly being undertaken <span class="citation" data-cites="4eOROyon">[<a href="#ref-4eOROyon" role="doc-biblioref">1479</a>]</span>.
+Additionally, efforts to develop new formulations of DNA vaccines in lower- and middle-income countries are increasingly being undertaken <span class="citation" data-cites="4eOROyon">[<a href="#ref-4eOROyon" role="doc-biblioref">1539</a>]</span>.
 <!-- Are there some mild concerns about adverse effects or are they too rare to mention here? --></p>
 <p>The modular nature of nucleic acid-based vaccine platforms has opened a new frontier in responding to emerging viral illnesses.
 The RNA vaccines received an EUA in only a few months more than it took to identify the pathogen causing SARS in 2002.
-Given the variety of options available for preventing severe illness and death, it is possible that certain vaccines may be preferable for certain demographics (e.g., young women might choose an mRNA vaccine to entirely mitigate the very low risk of blood clots <span class="citation" data-cites="EqBIFx5T">[<a href="#ref-EqBIFx5T" role="doc-biblioref">1403</a>]</span>).
+Given the variety of options available for preventing severe illness and death, it is possible that certain vaccines may be preferable for certain demographics (e.g., young women might choose an mRNA vaccine to entirely mitigate the very low risk of blood clots <span class="citation" data-cites="EqBIFx5T">[<a href="#ref-EqBIFx5T" role="doc-biblioref">1461</a>]</span>).
 However, this option is likely only available to people in high-income countries.
 In lower-income countries, access to vaccines broadly is a more critical issue.
-Different vaccines may confer advantages in different countries, and vaccine development in a variety of cultural contexts is therefore important <span class="citation" data-cites="hOkTKQ6z">[<a href="#ref-hOkTKQ6z" role="doc-biblioref">1480</a>]</span>.
+Different vaccines may confer advantages in different countries, and vaccine development in a variety of cultural contexts is therefore important <span class="citation" data-cites="hOkTKQ6z">[<a href="#ref-hOkTKQ6z" role="doc-biblioref">1540</a>]</span>.
 Without widespread global availability of vaccines, SARS-CoV-2 will continue presenting a significant threat to people worldwide.</p>
-<h1 data-number="8" id="appendix-vaccine-development-strategies-for-sars-cov-2"><span class="header-section-number">8</span> Appendix: Vaccine Development Strategies for SARS-CoV-2</h1>
-<!-- It would be ideal to loosely organize these sections in the order they appear in the main text, or even split the appendix into a traditional and novel vaccines appendix. -->
-<h2 data-number="8.1" id="rna-vaccines-1"><span class="header-section-number">8.1</span> RNA Vaccines</h2>
+<h1 data-number="9" id="appendix-additional-information-about-novel-vaccine-platforms-for-covid-19"><span class="header-section-number">9</span> Appendix: Additional Information about Novel Vaccine Platforms for COVID-19</h1>
+<h2 data-number="9.1" id="rna-vaccines-1"><span class="header-section-number">9.1</span> RNA Vaccines</h2>
 <p>RNA vaccines are nucleic-acid based modalities that code for viral antigens against which the human body elicits a humoral and cellular immune response.
-The resulting intracellular viral proteins are displayed on surface MHC proteins, provoking a strong CD8+ T cell response as well as a CD4+ T cell and B cell-associated antibody responses <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.</p>
-<p>Similar immunological responses for mRNA vaccines were observed in humans in phase I and II clinical trials operated by the pharmaceutical-development companies Curevac and Moderna for rabies, flu, and zika <span class="citation" data-cites="pRoqjur8">[<a href="#ref-pRoqjur8" role="doc-biblioref">1415</a>]</span>.</p>
+The resulting intracellular viral proteins are displayed on surface MHC proteins, provoking a strong CD8+ T cell response as well as a CD4+ T cell and B cell-associated antibody responses <span class="citation" data-cites="K0Ltu31S">[<a href="#ref-K0Ltu31S" role="doc-biblioref">1114</a>]</span>.
+Similar immunological responses for mRNA vaccines were observed in humans in phase I and II clinical trials operated by the pharmaceutical-development companies Curevac and Moderna for rabies, flu, and zika <span class="citation" data-cites="pRoqjur8">[<a href="#ref-pRoqjur8" role="doc-biblioref">1474</a>]</span>.</p>
 <p>Given the potential for this technology to be quickly adapted for a new pathogen, it has held significant interest for the treatment of COVID-19.
-In the vaccines developed under this approach, the spike protein, which is immunogenic <span class="citation" data-cites="5x25saIz">[<a href="#ref-5x25saIz" role="doc-biblioref">1423</a>]</span>, can be furnished to the immune system in order to train its response.
-The vaccine candidates developed against SARS-CoV-2 using mRNA vectors utilize similar principles and technologies, although there are slight differences in implementation among candidates such as the formulation of the platform and the specific components of the spike protein encapsulated (e.g., the full Spike protein vs. the RBD alone) <span class="citation" data-cites="suRY1e0N">[<a href="#ref-suRY1e0N" role="doc-biblioref">1481</a>]</span>.
+In the vaccines developed under this approach, the spike protein, which is immunogenic <span class="citation" data-cites="5x25saIz">[<a href="#ref-5x25saIz" role="doc-biblioref">1482</a>]</span>, can be furnished to the immune system in order to train its response.
+The vaccine candidates developed against SARS-CoV-2 using mRNA vectors utilize similar principles and technologies, although there are slight differences in implementation among candidates such as the formulation of the platform and the specific components of the spike protein encapsulated (e.g., the full Spike protein vs. the RBD alone) <span class="citation" data-cites="suRY1e0N">[<a href="#ref-suRY1e0N" role="doc-biblioref">1486</a>]</span>.
 The results of the interim analyses of two mRNA vaccine candidates became available at the end of 2020 and provided strong support for this emerging approach to vaccination.
 Below we describe in detail the results available as of February 2021 for two such candidates, mRNA-1273 produced by ModernaTX and BNT162b2 produced by Pfizer, Inc. and BioNTech.
-As of June 2022, the U.S. FDA has issued emergency use authorization of versions of these vaccines for children 6 months and older <span class="citation" data-cites="Ude2jR1F">[<a href="#ref-Ude2jR1F" role="doc-biblioref">1482</a>]</span>.</p>
-<h3 data-number="8.1.1" id="modernatx-mrna-vaccine"><span class="header-section-number">8.1.1</span> ModernaTX mRNA Vaccine</h3>
+As of June 2022, the U.S. FDA has issued emergency use authorization of versions of these vaccines for children 6 months and older <span class="citation" data-cites="Ude2jR1F">[<a href="#ref-Ude2jR1F" role="doc-biblioref">1541</a>]</span>.</p>
+<h3 data-number="9.1.1" id="modernatx-mrna-vaccine"><span class="header-section-number">9.1.1</span> ModernaTX mRNA Vaccine</h3>
 <p>ModernaTX’s mRNA-1273 vaccine was the first COVID-19 vaccine to enter a phase I clinical trial in the United States.
-In this trial, Moderna spearheaded an investigation on the immunogenicity and reactogenicity of mRNA-1273, a conventional lipid nanoparticle encapsulated RNA encoding a full-length prefusion stabilized S protein for SARS-CoV-2 <span class="citation" data-cites="Biu1CQeQ">[<a href="#ref-Biu1CQeQ" role="doc-biblioref">1426</a>]</span>.
+In this trial, Moderna spearheaded an investigation on the immunogenicity and reactogenicity of mRNA-1273, a conventional lipid nanoparticle encapsulated RNA encoding a full-length prefusion stabilized S protein for SARS-CoV-2 <span class="citation" data-cites="Biu1CQeQ">[<a href="#ref-Biu1CQeQ" role="doc-biblioref">1485</a>]</span>.
 An initial report described the results of enrolling forty-five participants who were administered intramuscular injections of mRNA-1273 in their deltoid muscle on day 1 and day 29, with the goal of following patients for the next twelve months <span class="citation" data-cites="wiGjCZC8">[<a href="#ref-wiGjCZC8" role="doc-biblioref">1108</a>]</span>.
 Healthy males and non-pregnant females aged 18-55 years were recruited for this study and divided into three groups receiving 25, 100, or 250 μg of mRNA-1273.
-IgG ELISA assays on patient serology samples were used to examine the immunogenicity of the vaccine <span class="citation" data-cites="Biu1CQeQ">[<a href="#ref-Biu1CQeQ" role="doc-biblioref">1426</a>]</span>.
+IgG ELISA assays on patient serology samples were used to examine the immunogenicity of the vaccine <span class="citation" data-cites="Biu1CQeQ">[<a href="#ref-Biu1CQeQ" role="doc-biblioref">1485</a>]</span>.
 Binding antibodies were observed at two weeks after the first dose at all concentrations.
 At the time point one week after the second dose was administered on day 29, the pseudotyped lentivirus reporter single-round-of-infection neutralization assay, which was used to assess neutralizing activity, reached a median level similar to the median observed in convalescent plasma samples.
 Participants reported mild and moderate systemic adverse events after the day 1 injection, and one severe local event was observed in each of the two highest dose levels.
 The second injection led to severe systemic adverse events for three of the participants at the highest dose levels, with one participant in the group being evaluated at an urgent care center on the day after the second dose.
 The reported localized adverse events from the second dose were similar to those from the first.</p>
-<p>Several months later, a press release from ModernaTX described the results of the first interim analysis of the vaccine <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1483</a>]</span>.
-On November 16, 2020, a report was released describing the initial results from phase III testing, corresponding to the first 95 cases of COVID-19 in the 30,000 enrolled participants <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1483</a>]</span>, with additional data released to the FDA on December 17, 2020 <span class="citation" data-cites="QEdBZMLe">[<a href="#ref-QEdBZMLe" role="doc-biblioref">1484</a>]</span>.
-These results were subsequently published in a peer-reviewed journal (<em>The New England Journal of Medicine</em>) on December 30, 2020 <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
-The first group of 30,420 study participants was randomized to receive the vaccine or a placebo at a ratio of 1:1 <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
-Administration occurred at 99 sites within the United States in two sessions, spaced 28 days apart <span class="citation" data-cites="16kGLLlT8 ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>,<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-Patients reporting COVID-19 symptoms upon follow-up were tested for SARS-CoV-2 using a nasopharyngeal swab that was evaluated with RT-PCR <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
+<p>Several months later, a press release from ModernaTX described the results of the first interim analysis of the vaccine <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1542</a>]</span>.
+On November 16, 2020, a report was released describing the initial results from phase III testing, corresponding to the first 95 cases of COVID-19 in the 30,000 enrolled participants <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1542</a>]</span>, with additional data released to the FDA on December 17, 2020 <span class="citation" data-cites="QEdBZMLe">[<a href="#ref-QEdBZMLe" role="doc-biblioref">1543</a>]</span>.
+These results were subsequently published in a peer-reviewed journal (<em>The New England Journal of Medicine</em>) on December 30, 2020 <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
+The first group of 30,420 study participants was randomized to receive the vaccine or a placebo at a ratio of 1:1 <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
+Administration occurred at 99 sites within the United States in two sessions, spaced 28 days apart <span class="citation" data-cites="16kGLLlT8 ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>,<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+Patients reporting COVID-19 symptoms upon follow-up were tested for SARS-CoV-2 using a nasopharyngeal swab that was evaluated with RT-PCR <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
 The initial preliminary analysis reported the results of the cases observed up until a cut-off date of November 11, 2020.
-Of these first 95 cases reported, 90 occurred in participants receiving the placebo compared to 5 cases in the group receiving the vaccine <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1483</a>]</span>.
+Of these first 95 cases reported, 90 occurred in participants receiving the placebo compared to 5 cases in the group receiving the vaccine <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1542</a>]</span>.
 These results suggested the vaccine is 94.5% effective in preventing COVID-19.
 Additionally, eleven severe cases of COVID-19 were observed, and all eleven occurred in participants receiving the placebo.
-The publication reported the results through an extended cut-off date of November 21, 2020, corresponding to 196 cases <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
+The publication reported the results through an extended cut-off date of November 21, 2020, corresponding to 196 cases <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
 Of these, 11 occurred in the vaccine group and 185 in the placebo group, corresponding to an efficacy of 94.1%.
 Once again, all of the severe cases of COVID-19 observed (n=30) occurred in the placebo group, including one death.
 Thus, as more cases are reported, the efficacy of the vaccine has remained above 90%, and no cases of severe COVID-19 have yet been reported in participants receiving the vaccine.</p>
 <p>These findings suggest the possibility that the vaccine might bolster immune defenses even for subjects who do still develop a SARS-CoV-2 infection.
-The study was designed with an explicit goal of including individuals at high risk for COVID-19, including older adults, people with underlying health conditions, and people of color <span class="citation" data-cites="vkczroFC">[<a href="#ref-vkczroFC" role="doc-biblioref">1486</a>]</span>.
-The phase III trial population was comprised by approximately 25.3% adults over age 65 in the initial report and 24.8% in the publication <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-Among the cases reported by both interim analyses, 16-17% occurred in older adults <span class="citation" data-cites="IMmoqofb ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>,<a href="#ref-IMmoqofb" role="doc-biblioref">1483</a>]</span>.
-Additionally, approximately 10% of participants identified a Black or African-American background and 20% identified Hispanic or Latino ethnicity <span class="citation" data-cites="16kGLLlT8 ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>,<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-Among the first 95 cases, 12.6% occurred in participants identifying a Hispanic or Latino background and 4% in participants reporting a Black or African-American background <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1483</a>]</span>; in the publication, they indicated only that 41 of the cases reported in the placebo group and 1 case in the treatment group occurred in “communities of color”, corresponding to 21.4% of all cases <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
+The study was designed with an explicit goal of including individuals at high risk for COVID-19, including older adults, people with underlying health conditions, and people of color <span class="citation" data-cites="vkczroFC">[<a href="#ref-vkczroFC" role="doc-biblioref">1545</a>]</span>.
+The phase III trial population was comprised by approximately 25.3% adults over age 65 in the initial report and 24.8% in the publication <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+Among the cases reported by both interim analyses, 16-17% occurred in older adults <span class="citation" data-cites="IMmoqofb ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>,<a href="#ref-IMmoqofb" role="doc-biblioref">1542</a>]</span>.
+Additionally, approximately 10% of participants identified a Black or African-American background and 20% identified Hispanic or Latino ethnicity <span class="citation" data-cites="16kGLLlT8 ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>,<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+Among the first 95 cases, 12.6% occurred in participants identifying a Hispanic or Latino background and 4% in participants reporting a Black or African-American background <span class="citation" data-cites="IMmoqofb">[<a href="#ref-IMmoqofb" role="doc-biblioref">1542</a>]</span>; in the publication, they indicated only that 41 of the cases reported in the placebo group and 1 case in the treatment group occurred in “communities of color”, corresponding to 21.4% of all cases <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
 While the sample size in both analyses is small relative to the study population of over 30,000, these results suggest that the vaccine is likely to be effective in people from a variety of backgrounds.</p>
-<p>In-depth safety data was released by ModernaTX as part of their application for an EUA from the FDA and summarized in the associated publication <span class="citation" data-cites="ZYxoabEm 16kGLLlT8">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>,<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
+<p>In-depth safety data was released by ModernaTX as part of their application for an EUA from the FDA and summarized in the associated publication <span class="citation" data-cites="ZYxoabEm 16kGLLlT8">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>,<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
 Because the detail provided in the report is greater than that provided in the publication, here we emphasize the results observed at the time of the first analysis.
-Overall, a large percentage of participants reported adverse effects when solicited, and these reports were higher in the vaccine group than in the placebo group (94.5% versus 59.5%, respectively, at the time of the initial analysis) <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-Some of these events met the criteria for grade 3 (local or systemic) or grade 4 (systemic only) toxicity <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>, but most were grade 1 or grade 2 and lasted 2-3 days <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1427</a>]</span>.
-The most common local adverse reaction was pain at the injection site, reported by 83.7% of participants receiving the first dose of the vaccine and 88.4% upon receiving the second dose, compared to 19.8% and 17.0%, respectively, of patients in the placebo condition <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
+Overall, a large percentage of participants reported adverse effects when solicited, and these reports were higher in the vaccine group than in the placebo group (94.5% versus 59.5%, respectively, at the time of the initial analysis) <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+Some of these events met the criteria for grade 3 (local or systemic) or grade 4 (systemic only) toxicity <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>, but most were grade 1 or grade 2 and lasted 2-3 days <span class="citation" data-cites="ZYxoabEm">[<a href="#ref-ZYxoabEm" role="doc-biblioref">1487</a>]</span>.
+The most common local adverse reaction was pain at the injection site, reported by 83.7% of participants receiving the first dose of the vaccine and 88.4% upon receiving the second dose, compared to 19.8% and 17.0%, respectively, of patients in the placebo condition <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
 Fewer than 5% of vaccine recipients reported grade 3 pain at either administration.
-Other frequent local reactions included erythema, swelling, and lymphadenopathy <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-For systemic adverse reactions, fatigue was the most common <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-Among participants receiving either dose of the vaccine, 68.5% reported fatigue compared to 36.1% participants receiving the placebo <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>.
-The level of fatigue experienced was usually fairly mild, with only 9.6% and 1.3% of participants in the vaccine and placebo conditions, respectively, reporting grade 3 fatigue <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1485</a>]</span>, which corresponds to significant interference with daily activity <span class="citation" data-cites="oJWLuU0h">[<a href="#ref-oJWLuU0h" role="doc-biblioref">1487</a>]</span>.
-Based on the results of the report, an EUA was issued on December 18, 2020 to allow distribution of this vaccine in the United States <span class="citation" data-cites="13Ou1UUAd">[<a href="#ref-13Ou1UUAd" role="doc-biblioref">1429</a>]</span>, and it was shortly followed by an Interim Order authorizing distribution of the vaccine in Canada <span class="citation" data-cites="HwoGQ6DD">[<a href="#ref-HwoGQ6DD" role="doc-biblioref">1488</a>]</span> and a conditional marketing authorization by the European Medicines Agency to facilitate distribution in the European Union <span class="citation" data-cites="4hVgIXyi">[<a href="#ref-4hVgIXyi" role="doc-biblioref">1489</a>]</span>.</p>
-<h3 data-number="8.1.2" id="pfizerbiontech-bnt162b2"><span class="header-section-number">8.1.2</span> Pfizer/BioNTech BNT162b2</h3>
+Other frequent local reactions included erythema, swelling, and lymphadenopathy <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+For systemic adverse reactions, fatigue was the most common <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+Among participants receiving either dose of the vaccine, 68.5% reported fatigue compared to 36.1% participants receiving the placebo <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>.
+The level of fatigue experienced was usually fairly mild, with only 9.6% and 1.3% of participants in the vaccine and placebo conditions, respectively, reporting grade 3 fatigue <span class="citation" data-cites="16kGLLlT8">[<a href="#ref-16kGLLlT8" role="doc-biblioref">1544</a>]</span>, which corresponds to significant interference with daily activity <span class="citation" data-cites="oJWLuU0h">[<a href="#ref-oJWLuU0h" role="doc-biblioref">1546</a>]</span>.
+Based on the results of the report, an EUA was issued on December 18, 2020 to allow distribution of this vaccine in the United States <span class="citation" data-cites="13Ou1UUAd">[<a href="#ref-13Ou1UUAd" role="doc-biblioref">1489</a>]</span>, and it was shortly followed by an Interim Order authorizing distribution of the vaccine in Canada <span class="citation" data-cites="HwoGQ6DD">[<a href="#ref-HwoGQ6DD" role="doc-biblioref">1547</a>]</span> and a conditional marketing authorization by the European Medicines Agency to facilitate distribution in the European Union <span class="citation" data-cites="4hVgIXyi">[<a href="#ref-4hVgIXyi" role="doc-biblioref">1548</a>]</span>.</p>
+<h3 data-number="9.1.2" id="pfizerbiontech-bnt162b2"><span class="header-section-number">9.1.2</span> Pfizer/BioNTech BNT162b2</h3>
 <p>ModernaTX was, in fact, the second company to release news of a successful interim analysis of an mRNA vaccine and receive an EUA.
-The first report came from Pfizer and BioNTech’s mRNA vaccine BNT162b2 on November 9, 2020 <span class="citation" data-cites="16hlR7Xgi">[<a href="#ref-16hlR7Xgi" role="doc-biblioref">1490</a>]</span>, and a preliminary report was published in the <em>New England Journal of Medicine</em> one month later <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.
-The vaccine candidate contains the full prefusion stabilized, membrane-anchored SARS-CoV-2 spike protein in a vaccine formulation based on modified mRNA (modRNA) technology <span class="citation" data-cites="1CsCQi9wT 10VyxCgQU">[<a href="#ref-1CsCQi9wT" role="doc-biblioref">1424</a>,<a href="#ref-10VyxCgQU" role="doc-biblioref">1425</a>]</span>.
-This vaccine candidate should not be confused with a similar candidate from Pfizer/BioNTech, BNT162b1, that delivered only the RBD of the spike protein <span class="citation" data-cites="dlqAfQ7t T3BkYtz2">[<a href="#ref-dlqAfQ7t" role="doc-biblioref">1491</a>,<a href="#ref-T3BkYtz2" role="doc-biblioref">1492</a>]</span>, which was not advanced to a phase III trial because of the improved reactogenicity/immunogenicity profile of BNT162b2 <span class="citation" data-cites="MD2K7MYB">[<a href="#ref-MD2K7MYB" role="doc-biblioref">505</a>]</span>.</p>
+The first report came from Pfizer and BioNTech’s mRNA vaccine BNT162b2 on November 9, 2020 <span class="citation" data-cites="16hlR7Xgi">[<a href="#ref-16hlR7Xgi" role="doc-biblioref">1549</a>]</span>, and a preliminary report was published in the <em>New England Journal of Medicine</em> one month later <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.
+The vaccine candidate contains the full prefusion stabilized, membrane-anchored SARS-CoV-2 spike protein in a vaccine formulation based on modified mRNA (modRNA) technology <span class="citation" data-cites="1CsCQi9wT 10VyxCgQU">[<a href="#ref-1CsCQi9wT" role="doc-biblioref">1483</a>,<a href="#ref-10VyxCgQU" role="doc-biblioref">1484</a>]</span>.
+This vaccine candidate should not be confused with a similar candidate from Pfizer/BioNTech, BNT162b1, that delivered only the RBD of the spike protein <span class="citation" data-cites="dlqAfQ7t T3BkYtz2">[<a href="#ref-dlqAfQ7t" role="doc-biblioref">1550</a>,<a href="#ref-T3BkYtz2" role="doc-biblioref">1551</a>]</span>, which was not advanced to a phase III trial because of the improved reactogenicity/immunogenicity profile of BNT162b2 <span class="citation" data-cites="MD2K7MYB">[<a href="#ref-MD2K7MYB" role="doc-biblioref">505</a>]</span>.</p>
 <p>During the phase III trial of BNT162b2, 43,538 participants were enrolled 1:1 in the placebo and the vaccine candidate and received two 30-μg doses 21 days apart <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.
 Of these enrolled participants, 21,720 received BNT162b2 and 21,728 received a placebo <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.
 Recruitment occurred at 135 sites across six countries: Argentina, Brazil, Germany, South Africa, Turkey, and the United States.
-An initial press release described the first 94 cases, which were consistent with 90% efficacy of the vaccine at 7 days following the second dose <span class="citation" data-cites="16hlR7Xgi">[<a href="#ref-16hlR7Xgi" role="doc-biblioref">1490</a>]</span>.
+An initial press release described the first 94 cases, which were consistent with 90% efficacy of the vaccine at 7 days following the second dose <span class="citation" data-cites="16hlR7Xgi">[<a href="#ref-16hlR7Xgi" role="doc-biblioref">1549</a>]</span>.
 The release of the full trial information covered a longer period and analyzed the first 170 cases occurring at least 7 days after the second dose, 8 of which occurred in patients who had received BNT162b2.
-The press release characterized the study population as diverse, reporting that 42% of the participants worldwide came from non-white backgrounds, including 10% Black and 26% Hispanic or Latino <span class="citation" data-cites="EMWkcH5x">[<a href="#ref-EMWkcH5x" role="doc-biblioref">1493</a>]</span>.
-Within the United States, 10% and 13% of participants, respectively, identified themselves as having Black or Hispanic/Latino backgrounds <span class="citation" data-cites="EMWkcH5x">[<a href="#ref-EMWkcH5x" role="doc-biblioref">1493</a>]</span>.
-Additionally, 41% of participants worldwide were 56 years of age or older <span class="citation" data-cites="EMWkcH5x">[<a href="#ref-EMWkcH5x" role="doc-biblioref">1493</a>]</span>, and they reported that the efficacy of the vaccine in adults over 65 was 94% <span class="citation" data-cites="Ufs4s7hG">[<a href="#ref-Ufs4s7hG" role="doc-biblioref">1494</a>]</span>.
-The primary efficacy analysis of the phase III study was concluded on November 18, 2020 <span class="citation" data-cites="Ufs4s7hG">[<a href="#ref-Ufs4s7hG" role="doc-biblioref">1494</a>]</span>, and the final results indicted 94.6% efficacy of the vaccine <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.</p>
+The press release characterized the study population as diverse, reporting that 42% of the participants worldwide came from non-white backgrounds, including 10% Black and 26% Hispanic or Latino <span class="citation" data-cites="EMWkcH5x">[<a href="#ref-EMWkcH5x" role="doc-biblioref">1552</a>]</span>.
+Within the United States, 10% and 13% of participants, respectively, identified themselves as having Black or Hispanic/Latino backgrounds <span class="citation" data-cites="EMWkcH5x">[<a href="#ref-EMWkcH5x" role="doc-biblioref">1552</a>]</span>.
+Additionally, 41% of participants worldwide were 56 years of age or older <span class="citation" data-cites="EMWkcH5x">[<a href="#ref-EMWkcH5x" role="doc-biblioref">1552</a>]</span>, and they reported that the efficacy of the vaccine in adults over 65 was 94% <span class="citation" data-cites="Ufs4s7hG">[<a href="#ref-Ufs4s7hG" role="doc-biblioref">1553</a>]</span>.
+The primary efficacy analysis of the phase III study was concluded on November 18, 2020 <span class="citation" data-cites="Ufs4s7hG">[<a href="#ref-Ufs4s7hG" role="doc-biblioref">1553</a>]</span>, and the final results indicted 94.6% efficacy of the vaccine <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.</p>
 <p>The safety profile of the vaccine was also assessed <span class="citation" data-cites="CWlYjjIV">[<a href="#ref-CWlYjjIV" role="doc-biblioref">504</a>]</span>.
 A subset of patients were followed for reactogenicity using electronic diaries, with the data collected from these 8,183 participants comprising the solicited safety events analyzed.
 Much like those who received the ModernaTX vaccine candidate, a large proportion of participants reported experiencing site injection pain within 7 days of vaccination.
@@ -4462,20 +4654,20 @@ <h3 data-number="8.1.2" id="pfizerbiontech-bnt162b2"><span class="header-section
 Participants also experienced systemic effects, including fever (in most cases lower than 38.9°C and more common after dose 2), fatigue (25-50% of participants depending on age group and dose), headache (25-50% of participants depending on age group and dose), chills, and muscle or joint pain; more rarely, patients could experience gastrointestinal effects such as vomiting or diarrhea.
 As with the local events, these events were almost always grade 1 or 2.
 While some events were reported by the placebo groups, these events were much rarer than in the treatment group even though compliance was similar.
-Based on the efficacy and safety information released, the vaccine was approved in early December by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency with administration outside of a clinical trial beginning on December 8, 2020 <span class="citation" data-cites="31rsgfCB fhw7l8VO">[<a href="#ref-31rsgfCB" role="doc-biblioref">1495</a>,<a href="#ref-fhw7l8VO" role="doc-biblioref">1496</a>]</span>.
-As of December 11, 2020, the United States FDA approved this vaccine under an emergency use authorization <span class="citation" data-cites="cAaN4Te0">[<a href="#ref-cAaN4Te0" role="doc-biblioref">1428</a>]</span>.</p>
-<h2 data-number="8.2" id="viral-vector-vaccines"><span class="header-section-number">8.2</span> Viral Vector Vaccines</h2>
-<h3 data-number="8.2.1" id="chadox1-ncov-19-astrazeneca"><span class="header-section-number">8.2.1</span> ChAdOx1 nCoV-19 (AstraZeneca)</h3>
+Based on the efficacy and safety information released, the vaccine was approved in early December by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency with administration outside of a clinical trial beginning on December 8, 2020 <span class="citation" data-cites="31rsgfCB fhw7l8VO">[<a href="#ref-31rsgfCB" role="doc-biblioref">1554</a>,<a href="#ref-fhw7l8VO" role="doc-biblioref">1555</a>]</span>.
+As of December 11, 2020, the United States FDA approved this vaccine under an emergency use authorization <span class="citation" data-cites="cAaN4Te0">[<a href="#ref-cAaN4Te0" role="doc-biblioref">1488</a>]</span>.</p>
+<h2 data-number="9.2" id="viral-vector-vaccines"><span class="header-section-number">9.2</span> Viral Vector Vaccines</h2>
+<h3 data-number="9.2.1" id="chadox1-ncov-19-astrazeneca"><span class="header-section-number">9.2.1</span> ChAdOx1 nCoV-19 (AstraZeneca)</h3>
 <p>Prior analyses of viral vector vaccines against hCoV had indicated that this approach showed potential for inducing an immune response, but little information was available about the effect on real-world immunity.
-In the first phase of development, a candidate ChAdOx1 nCoV-19 was evaluated through the immune challenge of two animal models, mice and rhesus macaques <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1362</a>]</span>.
-Animals in the treatment condition were observed to develop neutralizing antibodies specific to SARS-CoV-2 (both macaques and mice) and to show reduced clinical scores when exposed to SARS-CoV-2 (macaques) <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1362</a>]</span>.
-Next, a phase I/II trial was undertaken using a single-blind, randomized controlled design <span class="citation" data-cites="2bBVSpM">[<a href="#ref-2bBVSpM" role="doc-biblioref">1363</a>]</span>.
+In the first phase of development, a candidate ChAdOx1 nCoV-19 was evaluated through the immune challenge of two animal models, mice and rhesus macaques <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1420</a>]</span>.
+Animals in the treatment condition were observed to develop neutralizing antibodies specific to SARS-CoV-2 (both macaques and mice) and to show reduced clinical scores when exposed to SARS-CoV-2 (macaques) <span class="citation" data-cites="1037p4Gvs">[<a href="#ref-1037p4Gvs" role="doc-biblioref">1420</a>]</span>.
+Next, a phase I/II trial was undertaken using a single-blind, randomized controlled design <span class="citation" data-cites="2bBVSpM">[<a href="#ref-2bBVSpM" role="doc-biblioref">1421</a>]</span>.
 ChAdOx1 nCoV-19 and a control, the meningococcal conjugate vaccine MenACWY, were administered intramuscularly to adults ages 18 to 55 at five sites within the United Kingdom (U.K.) at a 1:1 ratio (n=543 and n=534, respectively).
 All but ten participants received a single dose; this small group received a booster 28 days after their first dose of ChAdOx1 nCoV-19.
 Commonly reported local adverse reactions included mild-to-moderate pain and tenderness at the injection site over the course of seven days, while the most common systemic adverse reactions were fatigue and headache; some patients reported severe adverse systemic effects.
 The study also reported that many common reactions could be reduced through the administration of paracetamol (acetaminophen), and paracetamol was not found to reduce immunogenicity.
 Patients receiving the ChAdOx1 nCoV-19 vaccine developed antibodies to the SARS-CoV-2 spike protein that peaked by day 28, with these levels remaining stable until a second observation at day 56 except in the ten patients who received a booster dose at day 28, in whom they increased by day 56.
-Analysis of serum indicated that participants developed antibodies to both S and the RBD and that 100% of them achieved neutralizing titers by day 28.
+Analysis of serum indicated that participants developed antibodies to both S and the RBD, and that 100% of them achieved neutralizing titers by day 28.
 By day 35, the neutralization titers of vaccinated patients was comparable to that observed with plasma from convalescents.
 This initial study therefore suggested that the vaccine was likely to confer protection against SARS-CoV-2, although analysis of its efficacy in preventing COVID-19 was not reported.</p>
 <p>The primary outcome assessed was symptomatic, laboratory-confirmed COVID-19.
@@ -4483,18 +4675,15 @@ <h3 data-number="8.2.1" id="chadox1-ncov-19-astrazeneca"><span class="header-sec
 However, a higher efficacy was reported in the subgroup of patients who received a low-dose followed by a standard dose (90.0%, 95% CI 67.4 to 97·0).
 A total of ten cases of severe COVID-19 resulting in hospitalization were observed among trial participants, and all of these occurred in patients in the control arm of the study.
 In line with the previously reported safety profiling for this vaccine, serious adverse events were reported to be comparable across the two arms of the study, with only three events identified as potentially associated with the vaccine itself.
-The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) approved ChAdOx1 nCoV-19 for emergency use on December 30, 2020 <span class="citation" data-cites="1A7PjhDDR">[<a href="#ref-1A7PjhDDR" role="doc-biblioref">1389</a>]</span>.
-Additional data about the efficacy of this vaccine became available in a preprint released on March 2, 2021 <span class="citation" data-cites="eV6UplSu">[<a href="#ref-eV6UplSu" role="doc-biblioref">1497</a>]</span>.
+Additional data about the efficacy of this vaccine became available in a preprint released on March 2, 2021 <span class="citation" data-cites="eV6UplSu">[<a href="#ref-eV6UplSu" role="doc-biblioref">1556</a>]</span>.
 This report provided data describing the efficacy of ChAdOx1 nCoV-19, along with Pfizer/BioNTech’s BNT162b2, in the U.K. between December 8, 2020 and February 19, 2021 and specifically sought to evaluate the efficacy of the vaccine in the presence of a potentially more contagious variant of concern, B.1.1.7.
 All participants in this study were age 70 or older and the efficacy was estimated to increase from 60% at 28 days after vaccination to 73% at 35 days after vaccination, although the standard error also increased over this time.
 Therefore, preliminary results suggest that in a number of samples, this vaccine confers a high level of protection against SARS-CoV-2.</p>
-<h3 data-number="8.2.2" id="sputnik-v-gam-covid-vac-and-gam-covid-vac-lyo"><span class="header-section-number">8.2.2</span> Sputnik-V (Gam-COVID-Vac and Gam-COVID-Vac-Lyo)</h3>
+<h3 data-number="9.2.2" id="sputnik-v-gam-covid-vac-and-gam-covid-vac-lyo"><span class="header-section-number">9.2.2</span> Sputnik-V (Gam-COVID-Vac and Gam-COVID-Vac-Lyo)</h3>
 <p>The vaccine Gam-COVID-Vac, nicknamed Sputnik V in reference to the space race and “V for vaccine”, was developed by the Gamaleya National Center of Epidemiology and Microbiology in Moscow.
-Gamaleya is an organization with prior experience using the adenovirus platform for the development of vaccines for <em>Middle East respiratory syndrome-related coronavirus</em> and Ebola virus, although neither of the previous vaccines were internationally licensed <span class="citation" data-cites="UCI0TCHy">[<a href="#ref-UCI0TCHy" role="doc-biblioref">1358</a>]</span>.
-The development of Sputnik V was financed by the Russian Direct Investment Fund (RDIF) <span class="citation" data-cites="3KMxmQhV SxiGicKs">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1378</a>,<a href="#ref-SxiGicKs" role="doc-biblioref">1498</a>]</span>.</p>
-<p>Other vaccines, such as the Oxford-AstraZeneca vaccine, utilize the chimpanzee adenovirus vector (ChAdOx1 nCoV-19) for both doses <span class="citation" data-cites="LZ8AtMnD">[<a href="#ref-LZ8AtMnD" role="doc-biblioref">1499</a>]</span>.
-The Sputnik V vaccines are available in both a lyophilized (Gam-COVID-Vac-Lyo) and frozen form (Gam-COVID-Vac), which are stored at 2-8°C and -18°C respectively <span class="citation" data-cites="PNZEiId1">[<a href="#ref-PNZEiId1" role="doc-biblioref">1383</a>]</span>.
-The lyophilized vaccine is convenient for distribution and storage, particularly to remote or disadvantaged areas <span class="citation" data-cites="3KBugyZN">[<a href="#ref-3KBugyZN" role="doc-biblioref">1500</a>]</span>.</p>
+The development of Sputnik V was financed by the Russian Direct Investment Fund (RDIF) <span class="citation" data-cites="3KMxmQhV SxiGicKs">[<a href="#ref-3KMxmQhV" role="doc-biblioref">1436</a>,<a href="#ref-SxiGicKs" role="doc-biblioref">1557</a>]</span>.
+The Sputnik V vaccines are available in both a lyophilized (Gam-COVID-Vac-Lyo) and frozen form (Gam-COVID-Vac), which are stored at 2-8°C and -18°C respectively <span class="citation" data-cites="PNZEiId1">[<a href="#ref-PNZEiId1" role="doc-biblioref">1441</a>]</span>.
+The lyophilized vaccine is convenient for distribution and storage, particularly to remote or disadvantaged areas <span class="citation" data-cites="3KBugyZN">[<a href="#ref-3KBugyZN" role="doc-biblioref">1558</a>]</span>.</p>
 <p>In the phase I/II trial study conducted between late June and early August 2020, 76 participants (18-60 years old) were split into two groups of 38 participants, which were non-randomized in two hospitals in Russia.
 In phase I, 9 patients received rAd26 and 9 patients received rAd5-S to assess safety over 28 days.
 In phase II, at least 5 days after the completion of phase I, 20 patients received a prime-boost vaccination of rAd26-S on day 0 and rAd5-S on day 2, which was administered intramuscularly.
@@ -4504,8 +4693,8 @@ <h3 data-number="8.2.2" id="sputnik-v-gam-covid-vac-and-gam-covid-vac-lyo"><span
 RBD-specific IgG levels were high in both the frozen and lyophilized versions of the vaccine (14,703 and 11,143 respectively), indicating a sufficient immune response to both.
 Three weeks post the second vaccination, the virus-neutralizing geometric mean antibody titers were 49.25 and 45.95 from the frozen and lyophilized vaccines, respectively.
 At 28 days, median cell proliferation of 1.3% CD4<sup>+</sup> and 1.1% CD8<sup>+</sup> were reported for the lyophilized vaccine and 2.5% CD4<sup>+</sup> and 1.3% CD8<sup>+</sup> for the vaccine stored frozen.
-These results indicated that both forms of Sputnik V appeared to be safe and induced a humoral and cellular response in human subjects <span class="citation" data-cites="PNZEiId1">[<a href="#ref-PNZEiId1" role="doc-biblioref">1383</a>]</span>, which may be robust enough to persist and not wane rapidly <span class="citation" data-cites="sRAZYY9C">[<a href="#ref-sRAZYY9C" role="doc-biblioref">1364</a>]</span>.</p>
-<p>In February 2021, the interim results of the phase III randomized, double-blind, placebo-controlled trial were published in <em>The Lancet</em> <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1374</a>]</span>.
+These results indicated that both forms of Sputnik V appeared to be safe and induced a humoral and cellular response in human subjects <span class="citation" data-cites="PNZEiId1">[<a href="#ref-PNZEiId1" role="doc-biblioref">1441</a>]</span>, which may be robust enough to persist and not wane rapidly <span class="citation" data-cites="sRAZYY9C">[<a href="#ref-sRAZYY9C" role="doc-biblioref">1422</a>]</span>.</p>
+<p>In February 2021, the interim results of the phase III randomized, double-blind, placebo-controlled trial were published in <em>The Lancet</em> <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1432</a>]</span>.
 The participants were randomly assigned to receive either a 0.5 mL/dose of vaccine or placebo, which was comprised of the vaccine buffer composition, that was delivered intramuscularly using the same prime-boost regimen as in the phase I/II trials.
 From September 7 to November 24, 19,866 participants completed the trial.
 Of the 14,964 participants who received the vaccine, 16 (0.1%) were confirmed to have COVID-19, whereas 62 of the 4,902 participants (1.3%) in the placebo group were confirmed to have COVID-19.
@@ -4513,45 +4702,45 @@ <h3 data-number="8.2.2" id="sputnik-v-gam-covid-vac-and-gam-covid-vac-lyo"><span
 However, only symptomatic individuals were confirmed for SARS-CoV-2 infection in this trial.
 Therefore, asymptomatic infections were not detected, thus potentially inflating the efficacy estimate.
 Overall, a vaccine efficacy of 91.6% (95% CI 85.6-95.2) was reported, where an efficacy of 91.8% was reported for those over 60 years old and 92.7% for those who were 51-60 years old.
-Indeed, 14 days after the first dose, 87.6% efficacy was achieved and the immunity required to prevent disease occurred within 18 days of vaccination.
-Based on these results, scientists are investigating the potential for a single dose regimen of the rAd26-S sputnik V vaccine <span class="citation" data-cites="wCTVieA3">[<a href="#ref-wCTVieA3" role="doc-biblioref">1501</a>]</span>.
+Indeed, 14 days after the first dose, 87.6% efficacy was achieved and the immunity required to prevent disease occurred within 18 days of vaccination.</p>
+<p>Based on these results, scientists are investigating the potential for a single dose regimen of the rAd26-S sputnik V vaccine <span class="citation" data-cites="wCTVieA3">[<a href="#ref-wCTVieA3" role="doc-biblioref">1559</a>]</span>.
 By the end of the trial, 7,485 participants reported adverse events, of which 94% were grade I.
 Of the 68 participants who experienced serious adverse events during the trial, 45 from the vaccine group and 23 from the placebo groups, none were reported to be associated with the vaccination.
-Likewise, 4 deaths occurred during the trial period that were not related to the vaccine <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1374</a>]</span>.
+Likewise, 4 deaths occurred during the trial period that were not related to the vaccine <span class="citation" data-cites="gLAIyAHm">[<a href="#ref-gLAIyAHm" role="doc-biblioref">1432</a>]</span>.
 The interim findings of the phase III trial indicate that the Sputnik V vaccine regimen appears to be safe with 91.6% efficacy.
 Gamaleya had intended to reach a total of 40,000 participants for the completion of their phase III trial.
-However, the trial has stopped enrolling participants and the numbers have been cut to 31,000 as many individuals in the placebo group dropped out of the study to obtain the vaccine <span class="citation" data-cites="15qYogj0H">[<a href="#ref-15qYogj0H" role="doc-biblioref">1502</a>]</span>.
-Other trials involving Sputnik V are currently underway in Belarus, India, the United Arab Emirates, and Venezuela <span class="citation" data-cites="vrzaW9Gb">[<a href="#ref-vrzaW9Gb" role="doc-biblioref">1503</a>]</span>.</p>
-<p>Preliminary results of a trial of Argentinian healthcare workers in Buenos Aires who were vaccinated with the Sputnik V rAd26-R vector-based vaccine seems to support the short term safety of the first vaccination <span class="citation" data-cites="uOMlbWFc">[<a href="#ref-uOMlbWFc" role="doc-biblioref">1504</a>]</span>.
+However, the trial has stopped enrolling participants and the numbers have been cut to 31,000 as many individuals in the placebo group dropped out of the study to obtain the vaccine <span class="citation" data-cites="15qYogj0H">[<a href="#ref-15qYogj0H" role="doc-biblioref">1560</a>]</span>.
+Other trials involving Sputnik V are currently underway in Belarus, India, the United Arab Emirates, and Venezuela <span class="citation" data-cites="vrzaW9Gb">[<a href="#ref-vrzaW9Gb" role="doc-biblioref">1561</a>]</span>.</p>
+<p>Preliminary results of a trial of Argentinian healthcare workers in Buenos Aires who were vaccinated with the Sputnik V rAd26-R vector-based vaccine seems to support the short term safety of the first vaccination <span class="citation" data-cites="uOMlbWFc">[<a href="#ref-uOMlbWFc" role="doc-biblioref">1562</a>]</span>.
 Of the 707 vaccinated healthcare workers, 71.3% of the 96.6% of respondents reported at least one adverse event attributed to the vaccine.
 Of these individuals, 68% experienced joint and muscle pain, 54% had injection site pain, 11% reported redness and swelling, 40% had a fever, and 5% reported diarrhea.
 Only 5% of the vaccinated participants experienced serious adverse events that required medical attention, of which one was monitored as an inpatient.</p>
-<p>Additionally, an independent assessment of Sputnik V in a phase II clinical trial in India found the vaccine to be effective, but the data is not yet publicly available <span class="citation" data-cites="jv875POj">[<a href="#ref-jv875POj" role="doc-biblioref">1505</a>]</span>.
-On December 21st, 2020, Gamaleya, AstraZeneca, R-Pharm, and the Russian Direct Investment Fund agreed to assess the safety and immunogenicity of the combined use of components of the AstraZeneca and University of Oxford AZD1222 (ChAdOx1) vaccine and the rAd26-S component of the Sputnik V vaccine in clinical trials <span class="citation" data-cites="QzHvKB8C">[<a href="#ref-QzHvKB8C" role="doc-biblioref">1506</a>]</span>.
+<p>Additionally, an independent assessment of Sputnik V in a phase II clinical trial in India found the vaccine to be effective, but the data is not yet publicly available <span class="citation" data-cites="jv875POj">[<a href="#ref-jv875POj" role="doc-biblioref">1563</a>]</span>.
+On December 21st, 2020, Gamaleya, AstraZeneca, R-Pharm, and the Russian Direct Investment Fund agreed to assess the safety and immunogenicity of the combined use of components of the AstraZeneca and University of Oxford AZD1222 (ChAdOx1) vaccine and the rAd26-S component of the Sputnik V vaccine in clinical trials <span class="citation" data-cites="QzHvKB8C">[<a href="#ref-QzHvKB8C" role="doc-biblioref">1564</a>]</span>.
 This agreement hopes to establish scientific and business relations between the entities with an aim to co-develop a vaccine providing long-term immunization.
 The trial, which will begin enrollment soon, will include 100 participants in a phase II open-label study and is hoped to be complete within 6 months.
 Participants will first receive an intramuscular dose of AZD1222 on day 1, followed by a dose of rAd26 on day 29.
 Participants will be monitored from day 1 for 180 days in total.
 The primary outcomes measured will include incidence of serious adverse events post first dose until the end of the study.
-Secondary outcome measures will include incidence of local and systemic adverse events 7 days post each dose, a time course of antibody responses for the Spike protein and the presence of anti-SARS-CoV-2 neutralizing antibodies <span class="citation" data-cites="1G2ROkAsZ">[<a href="#ref-1G2ROkAsZ" role="doc-biblioref">1507</a>]</span>.</p>
+Secondary outcome measures will include incidence of local and systemic adverse events 7 days post each dose, a time course of antibody responses for the Spike protein and the presence of anti-SARS-CoV-2 neutralizing antibodies <span class="citation" data-cites="1G2ROkAsZ">[<a href="#ref-1G2ROkAsZ" role="doc-biblioref">1565</a>]</span>.</p>
 <p>Overall, there is hesitancy surrounding the management of the Sputnik V vaccine approval process and concerns over whether the efficacy data may be inflated due to a lack of asymptomatic testing within the trial.
 However, the interim results of the phase III study were promising and further trials are underway, which will likely shed light on the overall efficacy and safety of the Sputnik V vaccine regimen.
 There may be some advantage to the Sputnik V approach including the favorable storage conditions afforded by choice between a frozen and lyophilized vaccine.
-Furthermore, the producers of Gam-COVID-Vac state that they can produce the vaccine at a cost of less than $10 per dose or less than $20 per patient <span class="citation" data-cites="AfkC38Sh">[<a href="#ref-AfkC38Sh" role="doc-biblioref">1508</a>]</span>.</p>
-<h3 data-number="8.2.3" id="janssens-jnj-78436735"><span class="header-section-number">8.2.3</span> Janssen’s JNJ-78436735</h3>
-<p>The Johnson &amp; Johnson (J&amp;J) vaccine developed by Janssen Pharmaceuticals, Inc., a subsidiary of J&amp;J, was conducted in collaboration with and funded by “Operation Warp Speed” <span class="citation" data-cites="D3Px25HN 57BTbcko pWf2T8J8 10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>,<a href="#ref-D3Px25HN" role="doc-biblioref">1366</a>,<a href="#ref-57BTbcko" role="doc-biblioref">1367</a>,<a href="#ref-pWf2T8J8" role="doc-biblioref">1368</a>]</span>.
-The vaccine was developed using Janssen’s AdVac<sup>®</sup> and PER.C6 platforms that were previously utilized to develop the European Commission-approved Ebola vaccine (Ad26 ZEBOV and MVN-BN-Filo) and their Zika, respiratory syncytial (RSV), and HIV investigational vaccine candidates <span class="citation" data-cites="10uLoe1rR">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1509</a>]</span>.</p>
-<p>The development of a single-dose vaccine was desired by J&amp;J from the outset, with global deployment being a key priority <span class="citation" data-cites="gOOBv1MD">[<a href="#ref-gOOBv1MD" role="doc-biblioref">1369</a>]</span>.
-Using their AdVac<sup>®</sup> technology, the vaccine can remain stable for up to two years between -15℃ and -25℃ and at least three months at 2-8℃ <span class="citation" data-cites="10uLoe1rR">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1509</a>]</span>.
+Furthermore, the producers of Gam-COVID-Vac state that they can produce the vaccine at a cost of less than $10 per dose or less than $20 per patient <span class="citation" data-cites="AfkC38Sh">[<a href="#ref-AfkC38Sh" role="doc-biblioref">1566</a>]</span>.</p>
+<h2 data-number="9.3" id="janssens-jnj-78436735"><span class="header-section-number">9.3</span> Janssen’s JNJ-78436735</h2>
+<p>The Johnson and Johnson (J&amp;J) vaccine developed by Janssen Pharmaceuticals, Inc., a subsidiary of J&amp;J, was conducted in collaboration with and funded by “Operation Warp Speed” <span class="citation" data-cites="D3Px25HN 57BTbcko pWf2T8J8 10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>,<a href="#ref-D3Px25HN" role="doc-biblioref">1424</a>,<a href="#ref-57BTbcko" role="doc-biblioref">1425</a>,<a href="#ref-pWf2T8J8" role="doc-biblioref">1426</a>]</span>.
+The vaccine was developed using Janssen’s AdVac<sup>®</sup> and PER.C6 platforms that were previously utilized to develop the European Commission-approved Ebola vaccine (Ad26 ZEBOV and MVN-BN-Filo) and their Zika, respiratory syncytial (RSV), and HIV investigational vaccine candidates <span class="citation" data-cites="10uLoe1rR">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1567</a>]</span>.</p>
+<p>The development of a single-dose vaccine was desired by J&amp;J from the outset, with global deployment being a key priority <span class="citation" data-cites="gOOBv1MD">[<a href="#ref-gOOBv1MD" role="doc-biblioref">1427</a>]</span>.
+Using their AdVac<sup>®</sup> technology, the vaccine can remain stable for up to two years between -15℃ and -25℃ and at least three months at 2-8℃ <span class="citation" data-cites="10uLoe1rR">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1567</a>]</span>.
 This allows the vaccine to be distributed easily without the requirement for very low temperature storage, unlike many of the other COVID-19 vaccine candidates.
-J&amp;J screened numerous potential vaccine candidates <em>in vitro</em> and in animal models using varying different designs of the S protein, heterologous signal peptides, and prefusion-stabilizing substitutions <span class="citation" data-cites="10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>]</span>.
-A select few candidates were further investigated as a single dose regimen in Syrian golden hamsters, a single dose regimen in rhesus macaques, and a single- and two-dose regimen in both adult and aged rhesus macaques <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1369</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1370</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1371</a>]</span>.
-From these studies, the JNJ-78436735 candidate was selected for its favorable immunogenicity profile and ease of manufacturability <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1298</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1369</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1370</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1371</a>]</span>.
-A SARS-CoV-2 challenge study in rhesus macaques showed that vaccine doses as low as 2 x 10<sup>9</sup> viral particles/mL was sufficient to induce strong protection in bronchoalveolar lavage but that doses higher than 1.125 x 10<sup>10</sup> were required to close achieve close to complete protection in nasal swabs <span class="citation" data-cites="lVoienSE">[<a href="#ref-lVoienSE" role="doc-biblioref">1510</a>]</span>.
-Indeed, six months post-immunization, levels of S-binding and neutralizing antibodies in rhesus macaques indicated that the JNJ-78436735 vaccine conferred durable protection against SARS-CoV-2 <span class="citation" data-cites="HGVDPMLm">[<a href="#ref-HGVDPMLm" role="doc-biblioref">1372</a>]</span>.</p>
+J&amp;J screened numerous potential vaccine candidates <em>in vitro</em> and in animal models using varying different designs of the S protein, heterologous signal peptides, and prefusion-stabilizing substitutions <span class="citation" data-cites="10UC562ga">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>]</span>.
+A select few candidates were further investigated as a single dose regimen in Syrian golden hamsters, a single dose regimen in rhesus macaques, and a single- and two-dose regimen in both adult and aged rhesus macaques <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1427</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1428</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1429</a>]</span>.
+From these studies, the JNJ-78436735 candidate was selected for its favorable immunogenicity profile and ease of manufacturability <span class="citation" data-cites="10UC562ga gOOBv1MD HmMIiIv2 EpOXYGt4">[<a href="#ref-10UC562ga" role="doc-biblioref">1356</a>,<a href="#ref-gOOBv1MD" role="doc-biblioref">1427</a>,<a href="#ref-HmMIiIv2" role="doc-biblioref">1428</a>,<a href="#ref-EpOXYGt4" role="doc-biblioref">1429</a>]</span>.
+A SARS-CoV-2 challenge study in rhesus macaques showed that vaccine doses as low as 2 x 10<sup>9</sup> viral particles/mL was sufficient to induce strong protection in bronchoalveolar lavage but that doses higher than 1.125 x 10<sup>10</sup> were required to close achieve close to complete protection in nasal swabs <span class="citation" data-cites="lVoienSE">[<a href="#ref-lVoienSE" role="doc-biblioref">1568</a>]</span>.
+Indeed, six months post-immunization, levels of S-binding and neutralizing antibodies in rhesus macaques indicated that the JNJ-78436735 vaccine conferred durable protection against SARS-CoV-2 <span class="citation" data-cites="HGVDPMLm">[<a href="#ref-HGVDPMLm" role="doc-biblioref">1430</a>]</span>.</p>
 <p>Following selection of the JNJ-78436735 vaccine, J&amp;J began phase I/IIa trials.
-The interim phase I/IIa data was placed on the <em>medRxiv</em> preprint server on September 25th, 2020 <span class="citation" data-cites="14g52GtO3">[<a href="#ref-14g52GtO3" role="doc-biblioref">1511</a>]</span> and was later published in the <em>New England Journal of Medicine</em> on January 13th, 2021 <span class="citation" data-cites="pWf2T8J8">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1368</a>]</span>.
-The phase I/IIa multi-center, randomized, placebo-controlled trial enrolled 402 healthy participants between 18-55 years old and a further 403 healthy older participants ≥ 65 years old <span class="citation" data-cites="pWf2T8J8">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1368</a>]</span>.
+The interim phase I/IIa data was placed on the <em>medRxiv</em> preprint server on September 25th, 2020 <span class="citation" data-cites="14g52GtO3">[<a href="#ref-14g52GtO3" role="doc-biblioref">1569</a>]</span> and was later published in the <em>New England Journal of Medicine</em> on January 13th, 2021 <span class="citation" data-cites="pWf2T8J8">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1426</a>]</span>.
+The phase I/IIa multi-center, randomized, placebo-controlled trial enrolled 402 healthy participants between 18-55 years old and a further 403 healthy older participants ≥ 65 years old <span class="citation" data-cites="pWf2T8J8">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1426</a>]</span>.
 Patients were administered either a placebo, a low dose (5 x 10<sup>10</sup> viral particles per mL), or a high dose (1 X 10<sup>11</sup> viral particles per mL) intramuscularly as part of either a single- or two-dose regimen.
 All patients received injections 56 days apart, but participants in the single-dose condition received the placebo at the second appointment.
 Those who received only one dose of either vaccine received a placebo dose at their second vaccination visit.
@@ -4559,7 +4748,7 @@ <h3 data-number="8.2.3" id="janssens-jnj-78436735"><span class="header-section-n
 Fatigue, headache, myalgia, and pain at the injection site were the most frequent solicited adverse events reported by participants.
 Although less common, particularly for those in the elderly cohort and those on the low dose regimen, the most frequent systemic adverse effect was fever.
 Overall, immunization was well tolerated, particularly at the lower dose concentration.
-In terms of reactogenicity, over 90% of those who received either the low or high dose demonstrated seroconversion in a neutralization assay using wild-type SARS-CoV-2, 29 days after immunization <span class="citation" data-cites="pWf2T8J8">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1368</a>]</span>.
+In terms of reactogenicity, over 90% of those who received either the low or high dose demonstrated seroconversion in a neutralization assay using wild-type SARS-CoV-2, 29 days after immunization <span class="citation" data-cites="pWf2T8J8">[<a href="#ref-pWf2T8J8" role="doc-biblioref">1426</a>]</span>.
 Neutralizing geometric mean ratio of antibody titers (GMT) between 224-354 were detected regardless of age.
 By day 57, 100% of the 18-55 year old participants had neutralizing GMT (288-488), which remained stable until day 71.
 In the ≥ 65 years old cohort, the incidence of seroconversion for the low- and high-dose was 96% and 88% respectively by day 29.</p>
@@ -4567,18 +4756,18 @@ <h3 data-number="8.2.3" id="janssens-jnj-78436735"><span class="header-section-n
 Seroconversion of the S antibodies was detected in 99% of individuals between 18-55 years old for the low and high doses (GMTs 528 and 695 respectively), with similar findings reported for the ≥ 65 years old.
 Indeed, both dose concentrations also induced robust Th1 cytokine-producing S-specific CD4<sup>+</sup> T cells and CD8<sup>+</sup> T cell responses in both age groups.
 The findings of the phase I/IIa study supported further investigation of a single immunization using the low dose vaccine.
-Therefore, 25 patients were enrolled for a second randomized double-blind, placebo-controlled phase I clinical trial currently being conducted in Boston, Massachusetts for 2 years <span class="citation" data-cites="1CBMCD5I2">[<a href="#ref-1CBMCD5I2" role="doc-biblioref">1512</a>]</span>.
+Therefore, 25 patients were enrolled for a second randomized double-blind, placebo-controlled phase I clinical trial currently being conducted in Boston, Massachusetts for 2 years <span class="citation" data-cites="1CBMCD5I2">[<a href="#ref-1CBMCD5I2" role="doc-biblioref">1570</a>]</span>.
 Participants received either a single dose followed by a placebo, or a double dose of either a low dose (5 x 10<sup>10</sup> viral particles/mL) or a high dose (1 x 10<sup>11</sup> viral particles/mL) vaccine administered intramuscularly on day 1 or day 57.
 Placebo-only recipients received a placebo dose on day 1 and 57.
 Interim analyses conducted on day 71 indicated that binding and neutralizing antibodies developed 8 days after administration in 90% and 25% of vaccine recipients, respectively.
 Binding and neutralizing antibodies were detected in 100% of vaccine recipients by day 57 after a single dose immunization.
 Spike-specific antibodies were highly prevalent (GMT 2432 to 5729) as were neutralizing antibodies (GMT 242 to 449) in the vaccinated groups.
-Indeed, CD4<sup>+</sup> and CD8<sup>+</sup> T-cell responses were also induced, which may provide additional protection, particularly if antibodies wane or poorly respond to infection <span class="citation" data-cites="1GRYnvF01">[<a href="#ref-1GRYnvF01" role="doc-biblioref">1513</a>]</span>.</p>
-<p>On September 23rd, 2020, J&amp;J launched its phase III trial ENSEMBLE and released the study protocol to the public <span class="citation" data-cites="10uLoe1rR 7n6WEkK8">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1509</a>,<a href="#ref-7n6WEkK8" role="doc-biblioref">1514</a>]</span>.
-The trial intended to enroll 60,000 volunteers to assess the safety and efficacy of the single vaccine dose versus placebo with primary endpoints of 14 and 28 days post-immunization <span class="citation" data-cites="10uLoe1rR">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1509</a>]</span>.
+Indeed, CD4<sup>+</sup> and CD8<sup>+</sup> T-cell responses were also induced, which may provide additional protection, particularly if antibodies wane or poorly respond to infection <span class="citation" data-cites="1GRYnvF01">[<a href="#ref-1GRYnvF01" role="doc-biblioref">1571</a>]</span>.</p>
+<p>On September 23rd, 2020, J&amp;J launched its phase III trial ENSEMBLE and released the study protocol to the public <span class="citation" data-cites="10uLoe1rR 7n6WEkK8">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1567</a>,<a href="#ref-7n6WEkK8" role="doc-biblioref">1572</a>]</span>.
+The trial intended to enroll 60,000 volunteers to assess the safety and efficacy of the single vaccine dose versus placebo with primary endpoints of 14 and 28 days post-immunization <span class="citation" data-cites="10uLoe1rR">[<a href="#ref-10uLoe1rR" role="doc-biblioref">1567</a>]</span>.
 The trial was conducted in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the U.S.
-The trial was paused briefly in October 2020 to investigate a “serious medical event”, but resumed shortly after <span class="citation" data-cites="5BTmfe4Y">[<a href="#ref-5BTmfe4Y" role="doc-biblioref">1515</a>]</span>.</p>
-<p>An interim analysis was reported via press release on January 29th, 2021 <span class="citation" data-cites="iWMHpTBJ 1FcpboRMm">[<a href="#ref-iWMHpTBJ" role="doc-biblioref">1375</a>,<a href="#ref-1FcpboRMm" role="doc-biblioref">1376</a>]</span>.
+The trial was paused briefly in October 2020 to investigate a “serious medical event”, but resumed shortly after <span class="citation" data-cites="5BTmfe4Y">[<a href="#ref-5BTmfe4Y" role="doc-biblioref">1573</a>]</span>.</p>
+<p>An interim analysis was reported via press release on January 29th, 2021 <span class="citation" data-cites="iWMHpTBJ 1FcpboRMm">[<a href="#ref-iWMHpTBJ" role="doc-biblioref">1433</a>,<a href="#ref-1FcpboRMm" role="doc-biblioref">1434</a>]</span>.
 The interim data included 43,783 participants who accrued 468 symptomatic cases of COVID-19.
 It was reported that the JNJ-78436735 vaccine was 66% effective across all regions studied for the prevention of moderate to severe COVID-19 28 days post-vaccination in those aged 18 years and older.
 Notably, JNJ-78436735 was 85% effective for the prevention of laboratory-confirmed severe COVID-19 and 100% protection against COVID-19-related hospitalization and death 28 days post-vaccination across all study sites.
@@ -4586,268 +4775,65 @@ <h3 data-number="8.2.3" id="janssens-jnj-78436735"><span class="header-section-n
 The trial also determined that the vaccine candidate has a favorable safety profile as determined by an independent Data and Safety Monitoring Board.
 The vaccine was well tolerated, consistent with previous vaccines produced using the AdVac<sup>®</sup> platform.
 Fever occurred in 9% of vaccine recipients, with grade 3 fever occurring in only 0.2% of recipients.
-Serious adverse events were reportedly higher in the placebo group than the vaccine group, and no anaphylaxis was reported <span class="citation" data-cites="1FcpboRMm">[<a href="#ref-1FcpboRMm" role="doc-biblioref">1376</a>]</span>.</p>
+Serious adverse events were reportedly higher in the placebo group than the vaccine group, and no anaphylaxis was reported <span class="citation" data-cites="1FcpboRMm">[<a href="#ref-1FcpboRMm" role="doc-biblioref">1434</a>]</span>.</p>
 <p>At the time the phase III trial was being conducted, several concerning variants, including B.1.1.7 <span class="citation" data-cites="m9qtrWft">[<a href="#ref-m9qtrWft" role="doc-biblioref">470</a>]</span> and B.1.351 <span class="citation" data-cites="sqhvCTIL">[<a href="#ref-sqhvCTIL" role="doc-biblioref">229</a>]</span>, were spreading across the globe.
 In particular, B.1.351 was first identified in South Africa, which was one of the JNJ-78436735 vaccine trial sites.
 Therefore, the J&amp;J investigators also analyzed the efficacy of the JNJ-78436735 vaccine associated with their various trial sites to determine any potential risk of reduced efficacy as a result of the novel variants.
 It was determined that JNJ-78436735 was 72% effective in the U.S., 66% effective in Latin America, and 57% effective in South Africa 28 days post-vaccination.
 These findings underpin the importance of monitoring for the emergence of novel SARS-CoV-2 variants and determining their effects on vaccine efficacy.</p>
 <p>Looking forward, Janssen are also running a phase III randomized, double-blind, placebo-controlled clinical trial, Ensemble 2, which aims to assess the efficacy, safety, and immunogenicity of a two-dose regimen of JNJ-78436735 administered 57 days apart.
-This trial will enroll 30,000 participants ≥ 18 years old from Belgium, Colombia, France, Germany, Philippines, South Africa, Spain, U.K., and the U.S. <span class="citation" data-cites="sx7F1ktj">[<a href="#ref-sx7F1ktj" role="doc-biblioref">1516</a>]</span>.
+This trial will enroll 30,000 participants ≥ 18 years old from Belgium, Colombia, France, Germany, Philippines, South Africa, Spain, U.K., and the U.S. <span class="citation" data-cites="sx7F1ktj">[<a href="#ref-sx7F1ktj" role="doc-biblioref">1574</a>]</span>.
 This trial will also include participants with and without comorbidities associated with an increased risk of COVID-19.</p>
-<!--To Do: Suggestion to move some of the Sputnik controversy here, along with describing the issues with the AstraZeneca trial-->
-<!--Additionally, though the vaccines are built using similar principles, there are some differences that might influence their efficacy as SARS-CoV-2 evolves.-->
-<!--To Do: suggestion to discuss prefusion conformation (J&J) vs not (the other two)-->
-<h2 data-number="8.3" id="global-vaccine-status-and-distribution-1"><span class="header-section-number">8.3</span> Global Vaccine Status and Distribution</h2>
+<h2 data-number="9.4" id="global-vaccine-status-and-distribution-1"><span class="header-section-number">9.4</span> Global Vaccine Status and Distribution</h2>
 <p>In North America, the majority of vaccines distributed until March 2021 have been produced by Pfizer-BioNTech and Moderna.
 In Canada, the vaccine approval process is conducted by Health Canada, which uses a fast-tracked process whereby vaccine producers can submit data as it becomes available to allow for rapid review.
 An approval may be granted following reviews of the available phase III clinical data.
-This is followed by a period of pharmacovigilance in the population using their post-market surveillance system, which will monitor the long-term safety and efficacy of any vaccines <span class="citation" data-cites="41tJkg7h YPaDf9jp">[<a href="#ref-41tJkg7h" role="doc-biblioref">1517</a>,<a href="#ref-YPaDf9jp" role="doc-biblioref">1518</a>]</span>.
-Health Canada has authorized the use of the Pfizer (December 9th, 2020), Moderna (December 23rd, 2020), Oxford-AstraZeneca (February 26th, 2021), and the Janssen (March 5th, 2021) vaccines, and the Novavax Inc vaccine is also under consideration <span class="citation" data-cites="15t1ePH1z">[<a href="#ref-15t1ePH1z" role="doc-biblioref">1519</a>]</span>.
-While Canada initially projected that by the end of September 2021 a vaccine would be available for all Canadian adults, they now predict that it may be possible earlier as more vaccines have been approved and become available <span class="citation" data-cites="fQM1moSe">[<a href="#ref-fQM1moSe" role="doc-biblioref">1520</a>]</span>.</p>
+This is followed by a period of pharmacovigilance in the population using their post-market surveillance system, which will monitor the long-term safety and efficacy of any vaccines <span class="citation" data-cites="41tJkg7h YPaDf9jp">[<a href="#ref-41tJkg7h" role="doc-biblioref">1575</a>,<a href="#ref-YPaDf9jp" role="doc-biblioref">1576</a>]</span>.
+Health Canada has authorized the use of the Pfizer (December 9th, 2020), Moderna (December 23rd, 2020), Oxford-AstraZeneca (February 26th, 2021), and the Janssen (March 5th, 2021) vaccines, and the Novavax Inc vaccine is also under consideration <span class="citation" data-cites="15t1ePH1z">[<a href="#ref-15t1ePH1z" role="doc-biblioref">1577</a>]</span>.
+While Canada initially projected that by the end of September 2021 a vaccine would be available for all Canadian adults, they now predict that it may be possible earlier as more vaccines have been approved and become available <span class="citation" data-cites="fQM1moSe">[<a href="#ref-fQM1moSe" role="doc-biblioref">1578</a>]</span>.</p>
 <p>In the U.S., vaccines are required to have demonstrated safety and efficacy in phase III trials before manufacturers apply for an emergency use authorization (EUA) from the FDA.
 If an EUA is granted, an additional evaluation of the safety and efficacy of the vaccines is conducted by the CDC’s Advisory Committee on Immunization Practices (ACIP) who also provide guidance on vaccine prioritization.
-On December 1st, 2020, ACIP provided an interim phase 1a recommendation that healthcare workers and long-term care facility residents should be the first to be offered any vaccine approved <span class="citation" data-cites="18BMz232x">[<a href="#ref-18BMz232x" role="doc-biblioref">1521</a>]</span>.
-This was shortly followed by an EUA on December 11th, 2020 for the use of the Pfizer-BioNTech COVID vaccine <span class="citation" data-cites="17wU8KTSP">[<a href="#ref-17wU8KTSP" role="doc-biblioref">1522</a>]</span>, which was distributed and administered to the first healthcare workers on December 14th, 2020 <span class="citation" data-cites="123cVqUNO">[<a href="#ref-123cVqUNO" role="doc-biblioref">1523</a>]</span>.
-Shortly thereafter, an EUA for the Moderna vaccine was issued on December 18th, 2020 <span class="citation" data-cites="7yAHeCqZ">[<a href="#ref-7yAHeCqZ" role="doc-biblioref">1524</a>]</span>.
-On December 20th, 2020, ACIP updated their initial recommendations to suggest that vaccinations should be offered to people aged 75 years old and older and to non-healthcare frontline workers in phase 1b <span class="citation" data-cites="Y3jvGtR9">[<a href="#ref-Y3jvGtR9" role="doc-biblioref">1525</a>]</span>.
-On the same date, it was recommended that phase 1c should include people aged 65-74 years old, individuals between the ages of 16-74 years old at high-risk due to health conditions, and essential workers ineligible in phase 1b <span class="citation" data-cites="Y3jvGtR9">[<a href="#ref-Y3jvGtR9" role="doc-biblioref">1525</a>]</span>.
-On the following day, December 21st, 2020, the first Moderna vaccines used outside of clinical trials were administered to American healthcare workers, which was the same day that President-elect Biden and Dr. Biden received their first doses of the Pfizer-BioNTech vaccine live on television to instill confidence in the approval and vaccination process <span class="citation" data-cites="f5yIh2Xp">[<a href="#ref-f5yIh2Xp" role="doc-biblioref">1526</a>]</span>.</p>
-<p>On February 27th, 2020, the FDA issued an EUA for the Janssen COVID-19 Vaccine <span class="citation" data-cites="BG7N9ETs">[<a href="#ref-BG7N9ETs" role="doc-biblioref">1527</a>]</span>.
-This was followed by an update on recommendations by ACIP for the use of the Janssen COVID-19 vaccine for those over 18 years old <span class="citation" data-cites="yNaiGtW1">[<a href="#ref-yNaiGtW1" role="doc-biblioref">1528</a>]</span>.
+On December 1st, 2020, ACIP provided an interim phase 1a recommendation that healthcare workers and long-term care facility residents should be the first to be offered any vaccine approved <span class="citation" data-cites="18BMz232x">[<a href="#ref-18BMz232x" role="doc-biblioref">1579</a>]</span>.
+This was shortly followed by an EUA on December 11th, 2020 for the use of the Pfizer-BioNTech COVID vaccine <span class="citation" data-cites="17wU8KTSP">[<a href="#ref-17wU8KTSP" role="doc-biblioref">1580</a>]</span>, which was distributed and administered to the first healthcare workers on December 14th, 2020 <span class="citation" data-cites="123cVqUNO">[<a href="#ref-123cVqUNO" role="doc-biblioref">1581</a>]</span>.
+Shortly thereafter, an EUA for the Moderna vaccine was issued on December 18th, 2020 <span class="citation" data-cites="7yAHeCqZ">[<a href="#ref-7yAHeCqZ" role="doc-biblioref">1582</a>]</span>.
+On December 20th, 2020, ACIP updated their initial recommendations to suggest that vaccinations should be offered to people aged 75 years old and older and to non-healthcare frontline workers in phase 1b <span class="citation" data-cites="Y3jvGtR9">[<a href="#ref-Y3jvGtR9" role="doc-biblioref">1583</a>]</span>.
+On the same date, it was recommended that phase 1c should include people aged 65-74 years old, individuals between the ages of 16-74 years old at high-risk due to health conditions, and essential workers ineligible in phase 1b <span class="citation" data-cites="Y3jvGtR9">[<a href="#ref-Y3jvGtR9" role="doc-biblioref">1583</a>]</span>.
+On the following day, December 21st, 2020, the first Moderna vaccines used outside of clinical trials were administered to American healthcare workers, which was the same day that President-elect Biden and Dr. Biden received their first doses of the Pfizer-BioNTech vaccine live on television to instill confidence in the approval and vaccination process <span class="citation" data-cites="f5yIh2Xp">[<a href="#ref-f5yIh2Xp" role="doc-biblioref">1584</a>]</span>.</p>
+<p>On February 27th, 2020, the FDA issued an EUA for the Janssen COVID-19 Vaccine <span class="citation" data-cites="BG7N9ETs">[<a href="#ref-BG7N9ETs" role="doc-biblioref">1585</a>]</span>.
+This was followed by an update on recommendations by ACIP for the use of the Janssen COVID-19 vaccine for those over 18 years old <span class="citation" data-cites="yNaiGtW1">[<a href="#ref-yNaiGtW1" role="doc-biblioref">1586</a>]</span>.
 The Janssen vaccine was first distributed to healthcare facilities on March 1st, 2021.
-On March 12, 2021, the WHO added the Janssen vaccine to the list of safe and effective emergency tools for COVID-19 <span class="citation" data-cites="Vd1wOy6d">[<a href="#ref-Vd1wOy6d" role="doc-biblioref">1529</a>]</span>.
-While the CDC’s ACIP can provide recommendations, it is up to the public health authorities of each state, territory, and tribe to interpret the guidance and determine who will be vaccinated first <span class="citation" data-cites="1CcsUnCiw">[<a href="#ref-1CcsUnCiw" role="doc-biblioref">1530</a>]</span>.
+On March 12, 2021, the WHO added the Janssen vaccine to the list of safe and effective emergency tools for COVID-19 <span class="citation" data-cites="Vd1wOy6d">[<a href="#ref-Vd1wOy6d" role="doc-biblioref">1587</a>]</span>.
+While the CDC’s ACIP can provide recommendations, it is up to the public health authorities of each state, territory, and tribe to interpret the guidance and determine who will be vaccinated first <span class="citation" data-cites="1CcsUnCiw">[<a href="#ref-1CcsUnCiw" role="doc-biblioref">1588</a>]</span>.
 Prior to distribution of the Janssen vaccine, over 103 million doses of the Moderna and Pfizer-BioNTech vaccines were delivered across the U.S., with almost 79 million doses administered.
-Of the total population, 15.6% have received at least one dose and 7.9% have received a second dose of either the Moderna (~38.3 million) or the Pfizer-BioNTech (~40.2 million) vaccines by February 28th, 2021 <span class="citation" data-cites="iiTciwn1">[<a href="#ref-iiTciwn1" role="doc-biblioref">1531</a>]</span>.
-President Biden’s administration has predicted that by the end of May 2021 there may be enough vaccine supply available for all adults in the U.S. <span class="citation" data-cites="ZkZ6ToLh 13bndHWdk">[<a href="#ref-ZkZ6ToLh" role="doc-biblioref">1532</a>,<a href="#ref-13bndHWdk" role="doc-biblioref">1533</a>]</span>.
-However, vaccine production, approval, and distribution was not straightforward in the U.S., as information was initially sparse and the rollout of vaccines was complicated by poor planning and leadership due to political activities prior to the change of administration in January 2021 <span class="citation" data-cites="XOLE6iJT">[<a href="#ref-XOLE6iJT" role="doc-biblioref">1534</a>]</span>.
-These political complications highlight the importance of the transparent vaccine approval process conducted by the FDA <span class="citation" data-cites="1Bgnim0gX">[<a href="#ref-1Bgnim0gX" role="doc-biblioref">1535</a>]</span>.</p>
+Of the total population, 15.6% have received at least one dose and 7.9% have received a second dose of either the Moderna (~38.3 million) or the Pfizer-BioNTech (~40.2 million) vaccines by February 28th, 2021 <span class="citation" data-cites="iiTciwn1">[<a href="#ref-iiTciwn1" role="doc-biblioref">1589</a>]</span>.
+President Biden’s administration has predicted that by the end of May 2021 there may be enough vaccine supply available for all adults in the U.S. <span class="citation" data-cites="ZkZ6ToLh 13bndHWdk">[<a href="#ref-ZkZ6ToLh" role="doc-biblioref">1590</a>,<a href="#ref-13bndHWdk" role="doc-biblioref">1591</a>]</span>.
+However, vaccine production, approval, and distribution was not straightforward in the U.S., as information was initially sparse and the rollout of vaccines was complicated by poor planning and leadership due to political activities prior to the change of administration in January 2021 <span class="citation" data-cites="XOLE6iJT">[<a href="#ref-XOLE6iJT" role="doc-biblioref">1592</a>]</span>.
+These political complications highlight the importance of the transparent vaccine approval process conducted by the FDA <span class="citation" data-cites="1Bgnim0gX">[<a href="#ref-1Bgnim0gX" role="doc-biblioref">1337</a>]</span>.</p>
 <p>Outside the U.S., the Moderna and Pfizer-BioNTech vaccines have been administered in 29 and 69 other countries, respectively, mainly in Europe and North America <span class="citation" data-cites="dfl5iCJI">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>]</span>.
-The Janssen vaccine has so far only been administered in South Africa and the U.S. <span class="citation" data-cites="dfl5iCJI I0vakLIc">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>,<a href="#ref-I0vakLIc" role="doc-biblioref">1536</a>]</span>, but it has also been approved in Bahrain, the European Union (E.U.), Iceland, Liechtenstein, and Norway <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.
-On March 11th, 2021, Johnson &amp; Johnson received approval from the European Medicines Agency (EMA) for conditional marketing authorization of their vaccine <span class="citation" data-cites="17BEDzTkD">[<a href="#ref-17BEDzTkD" role="doc-biblioref">1537</a>]</span>.
-Notably, on March 2nd, 2021, rivals Johnson &amp; Johnson and Merck announced that they entered an agreement to increase production of the Janssen vaccine to meet global demand <span class="citation" data-cites="hHW8U8rE">[<a href="#ref-hHW8U8rE" role="doc-biblioref">1538</a>]</span>.</p>
-<p>The U.K. was the first country to approve use of the Pfizer-BioNTech vaccine on December 2nd, 2020 <span class="citation" data-cites="133HGZMEL">[<a href="#ref-133HGZMEL" role="doc-biblioref">1539</a>]</span>, and it was later approved by EMA on December 21st, 2020 <span class="citation" data-cites="G6V3FR6V">[<a href="#ref-G6V3FR6V" role="doc-biblioref">1540</a>]</span>.
+The Janssen vaccine has so far only been administered in South Africa and the U.S. <span class="citation" data-cites="dfl5iCJI I0vakLIc">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>,<a href="#ref-I0vakLIc" role="doc-biblioref">1593</a>]</span>, but it has also been approved in Bahrain, the European Union (E.U.), Iceland, Liechtenstein, and Norway <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1159</a>]</span>.
+On March 11th, 2021, Johnson &amp; Johnson received approval from the European Medicines Agency (EMA) for conditional marketing authorization of their vaccine <span class="citation" data-cites="17BEDzTkD">[<a href="#ref-17BEDzTkD" role="doc-biblioref">1594</a>]</span>.
+Notably, on March 2nd, 2021, rivals Johnson &amp; Johnson and Merck announced that they entered an agreement to increase production of the Janssen vaccine to meet global demand <span class="citation" data-cites="hHW8U8rE">[<a href="#ref-hHW8U8rE" role="doc-biblioref">1595</a>]</span>.</p>
+<p>The U.K. was the first country to approve use of the Pfizer-BioNTech vaccine on December 2nd, 2020 <span class="citation" data-cites="133HGZMEL">[<a href="#ref-133HGZMEL" role="doc-biblioref">1596</a>]</span>, and it was later approved by EMA on December 21st, 2020 <span class="citation" data-cites="G6V3FR6V">[<a href="#ref-G6V3FR6V" role="doc-biblioref">1597</a>]</span>.
 The U.K. was also the first to administer the Pfizer-BioNTech vaccine, making it the first COVID-19 vaccine supported by phase III data to be administered outside of clinical trials on December 8th, 2020.
-The Oxford-AstraZeneca vaccine, was approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. and by EMA in the E.U. on December 30th (2020) <span class="citation" data-cites="1HIxYDTsj">[<a href="#ref-1HIxYDTsj" role="doc-biblioref">1541</a>]</span> and January 29th (2021) <span class="citation" data-cites="bbw8sMvc">[<a href="#ref-bbw8sMvc" role="doc-biblioref">1542</a>]</span> respectively.
-The Oxford-AstraZeneca vaccine was first administered in the UK on January 4th, 2021 <span class="citation" data-cites="q1Ui5Fm8">[<a href="#ref-q1Ui5Fm8" role="doc-biblioref">1543</a>]</span>, and it is now being used in 53 countries in total, including Brazil, India, Pakistan, Mexico, and spanning most of Europe <span class="citation" data-cites="dfl5iCJI">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>]</span>.
-The Moderna vaccine was authorized for use in the E.U. by EMA on January 6th, 2021 <span class="citation" data-cites="JPSLcRBY">[<a href="#ref-JPSLcRBY" role="doc-biblioref">1544</a>]</span> and in the U.K. by MHRA on January 8th, 2021 <span class="citation" data-cites="k9X9pXJe">[<a href="#ref-k9X9pXJe" role="doc-biblioref">1545</a>]</span>.
-As of March 5th, 2021, 22 million people in the U.K. had received at least one vaccine dose <span class="citation" data-cites="cWMPXfju">[<a href="#ref-cWMPXfju" role="doc-biblioref">1546</a>]</span>.</p>
+The Oxford-AstraZeneca vaccine, was approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. and by EMA in the E.U. on December 30th (2020) <span class="citation" data-cites="1HIxYDTsj">[<a href="#ref-1HIxYDTsj" role="doc-biblioref">1598</a>]</span> and January 29th (2021) <span class="citation" data-cites="bbw8sMvc">[<a href="#ref-bbw8sMvc" role="doc-biblioref">1599</a>]</span> respectively.
+The Oxford-AstraZeneca vaccine was first administered in the UK on January 4th, 2021 <span class="citation" data-cites="q1Ui5Fm8">[<a href="#ref-q1Ui5Fm8" role="doc-biblioref">1600</a>]</span>, and it is now being used in 53 countries in total, including Brazil, India, Pakistan, Mexico, and spanning most of Europe <span class="citation" data-cites="dfl5iCJI">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>]</span>.
+The Moderna vaccine was authorized for use in the E.U. by EMA on January 6th, 2021 <span class="citation" data-cites="JPSLcRBY">[<a href="#ref-JPSLcRBY" role="doc-biblioref">1601</a>]</span> and in the U.K. by MHRA on January 8th, 2021 <span class="citation" data-cites="k9X9pXJe">[<a href="#ref-k9X9pXJe" role="doc-biblioref">1602</a>]</span>.
+As of March 5th, 2021, 22 million people in the U.K. had received at least one vaccine dose <span class="citation" data-cites="cWMPXfju">[<a href="#ref-cWMPXfju" role="doc-biblioref">1603</a>]</span>.</p>
 <p>While the Pfizer-BioNTech vaccine was the first to be distributed following phase III clinical trials, the first COVID-19 vaccine to be widely administered to people prior to the completion of phase III clinical trials was Sputnik V.
-Sputnik V was administered to as many as 1.5 million Russians by early January <span class="citation" data-cites="X5LkVfY6">[<a href="#ref-X5LkVfY6" role="doc-biblioref">1390</a>]</span> due to the establishment of mass vaccination clinics in December 2020, prior to which only approximately 100,000 Russians had already been vaccinated <span class="citation" data-cites="uvQMgFXB bXdr5Gyu">[<a href="#ref-uvQMgFXB" role="doc-biblioref">1547</a>,<a href="#ref-bXdr5Gyu" role="doc-biblioref">1548</a>]</span>.
-Doses of Sputnik V have also been distributed to other parts of Europe <span class="citation" data-cites="16LczMwFO Z0V7NK7Y 16GYKbrOq">[<a href="#ref-16LczMwFO" role="doc-biblioref">1391</a>,<a href="#ref-Z0V7NK7Y" role="doc-biblioref">1392</a>,<a href="#ref-16GYKbrOq" role="doc-biblioref">1393</a>]</span>.
-Hungary was the first E.U. member country to approve and distribute Sputnik V outside of Russia <span class="citation" data-cites="125VEHWS7">[<a href="#ref-125VEHWS7" role="doc-biblioref">1394</a>]</span>, despite the EMA stating that they had neither approved nor received a request for approval of Sputnik V <span class="citation" data-cites="P6x0Qy6s">[<a href="#ref-P6x0Qy6s" role="doc-biblioref">1549</a>]</span>.
-Hungary is also in talks with China to procure the Sinopharm vaccines, which have been approved by Hungarian health authorities but also have not received approval by EMA in the E.U. <span class="citation" data-cites="125VEHWS7">[<a href="#ref-125VEHWS7" role="doc-biblioref">1394</a>]</span>.
-In Latin America, production facilities in both Brazil and Argentina will allow for increased production capacity of Sputnik V and doses have been distributed to Mexico, Argentina, Bolivia, Nicaragua, Paraguay, and Venezuela <span class="citation" data-cites="ID8IywJM">[<a href="#ref-ID8IywJM" role="doc-biblioref">1550</a>]</span>.
-Guinea was the first African nation to administer Sputnik V in December 2020, and the Central African Republic, Zimbabwe, and the Ivory Coast have all registered their interest in purchasing doses of the vaccine <span class="citation" data-cites="ID8IywJM">[<a href="#ref-ID8IywJM" role="doc-biblioref">1550</a>]</span>.
-In the Middle East, Iran has received its first doses of Sputnik V and the United Arab Emirates is conducting phase III trials <span class="citation" data-cites="ID8IywJM">[<a href="#ref-ID8IywJM" role="doc-biblioref">1550</a>]</span>.
-In Asia, while China’s vaccine candidates are favored, the Philippines, Nepal, and Uzbekistan have sought Sputnik V doses <span class="citation" data-cites="37uTx4hs">[<a href="#ref-37uTx4hs" role="doc-biblioref">1551</a>]</span>.
-In total, the RDIF claims to have received orders totalling 1.2 billion doses by over 50 countries worldwide <span class="citation" data-cites="37uTx4hs">[<a href="#ref-37uTx4hs" role="doc-biblioref">1551</a>]</span> and at least 18 countries are currently administering Sputnik V around the globe <span class="citation" data-cites="dfl5iCJI">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>]</span>.
+Sputnik V was administered to as many as 1.5 million Russians by early January <span class="citation" data-cites="X5LkVfY6">[<a href="#ref-X5LkVfY6" role="doc-biblioref">1448</a>]</span> due to the establishment of mass vaccination clinics in December 2020, prior to which only approximately 100,000 Russians had already been vaccinated <span class="citation" data-cites="uvQMgFXB Vwv7l7Hd">[<a href="#ref-uvQMgFXB" role="doc-biblioref">1604</a>,<a href="#ref-Vwv7l7Hd" role="doc-biblioref">1605</a>]</span>.
+Doses of Sputnik V have also been distributed to other parts of Europe <span class="citation" data-cites="16LczMwFO Z0V7NK7Y 16GYKbrOq">[<a href="#ref-16LczMwFO" role="doc-biblioref">1449</a>,<a href="#ref-Z0V7NK7Y" role="doc-biblioref">1450</a>,<a href="#ref-16GYKbrOq" role="doc-biblioref">1451</a>]</span>.
+Hungary was the first E.U. member country to approve and distribute Sputnik V outside of Russia <span class="citation" data-cites="125VEHWS7">[<a href="#ref-125VEHWS7" role="doc-biblioref">1452</a>]</span>, despite the EMA stating that they had neither approved nor received a request for approval of Sputnik V <span class="citation" data-cites="P6x0Qy6s">[<a href="#ref-P6x0Qy6s" role="doc-biblioref">1606</a>]</span>.
+Hungary is also in talks with China to procure the Sinopharm vaccines, which have been approved by Hungarian health authorities but also have not received approval by EMA in the E.U. <span class="citation" data-cites="125VEHWS7">[<a href="#ref-125VEHWS7" role="doc-biblioref">1452</a>]</span>.
+In Latin America, production facilities in both Brazil and Argentina will allow for increased production capacity of Sputnik V and doses have been distributed to Mexico, Argentina, Bolivia, Nicaragua, Paraguay, and Venezuela <span class="citation" data-cites="ID8IywJM">[<a href="#ref-ID8IywJM" role="doc-biblioref">1607</a>]</span>.
+Guinea was the first African nation to administer Sputnik V in December 2020, and the Central African Republic, Zimbabwe, and the Ivory Coast have all registered their interest in purchasing doses of the vaccine <span class="citation" data-cites="ID8IywJM">[<a href="#ref-ID8IywJM" role="doc-biblioref">1607</a>]</span>.
+In the Middle East, Iran has received its first doses of Sputnik V and the United Arab Emirates is conducting phase III trials <span class="citation" data-cites="ID8IywJM">[<a href="#ref-ID8IywJM" role="doc-biblioref">1607</a>]</span>.
+In Asia, while China’s vaccine candidates are favored, the Philippines, Nepal, and Uzbekistan have sought Sputnik V doses <span class="citation" data-cites="37uTx4hs">[<a href="#ref-37uTx4hs" role="doc-biblioref">1608</a>]</span>.
+In total, the RDIF claims to have received orders totalling 1.2 billion doses by over 50 countries worldwide <span class="citation" data-cites="37uTx4hs">[<a href="#ref-37uTx4hs" role="doc-biblioref">1608</a>]</span> and at least 18 countries are currently administering Sputnik V around the globe <span class="citation" data-cites="dfl5iCJI">[<a href="#ref-dfl5iCJI" role="doc-biblioref">1260</a>]</span>.
 Sputnik V has been an attractive vaccine for many countries due to its relatively low price, high efficacy, and its favorable storage conditions.
-For some countries, Russia and China have also been more palatable politically than vaccine suppliers in the West <span class="citation" data-cites="ID8IywJM FAQXPsyc">[<a href="#ref-ID8IywJM" role="doc-biblioref">1550</a>,<a href="#ref-FAQXPsyc" role="doc-biblioref">1552</a>]</span>.
-For others, the delays in the distribution of the other, more-favored candidates has been a motivating factor for pursuing the Sputnik V and Chinese alternatives <span class="citation" data-cites="FAQXPsyc Z0V7NK7Y">[<a href="#ref-Z0V7NK7Y" role="doc-biblioref">1392</a>,<a href="#ref-FAQXPsyc" role="doc-biblioref">1552</a>]</span>.
-Additionally, Germany has stated that if Sputnik V were approved by EMA, it would be considered by the E.U. <span class="citation" data-cites="zCPl6A82">[<a href="#ref-zCPl6A82" role="doc-biblioref">1553</a>]</span>.
-Russia is developing other vaccine candidates and has approved a third vaccine, CoviVac, which is an inactivated vaccine produced by the Chumakov Centre in Moscow, despite the fact the clinical trials have yet to begin <span class="citation" data-cites="hpScvlYg">[<a href="#ref-hpScvlYg" role="doc-biblioref">1554</a>]</span>.</p>
-<h2 data-number="8.4" id="asias-role-in-vaccine-development"><span class="header-section-number">8.4</span> Asia’s Role in Vaccine Development</h2>
-<p>The Asian nations of China and India have played a major role as COVID-19 vaccination developers and providers.
-Iran has also developed several vaccines.
-Considering India produced approximately 60% of the world’s vaccines prior to the pandemic, it is no surprise that the nation has developed and is developing several COVID-19 vaccine candidates.
-In addition to COVAXIN, the Bio E subunit vaccine CORBEVAX is being produced by Biological E in collaboration with U.S.-based Dynavax and the Baylor College of Medicine <span class="citation" data-cites="gsNWcXHn">[<a href="#ref-gsNWcXHn" role="doc-biblioref">1555</a>]</span>.
-These two home-grown vaccines are now approved for adults and children as young as five (CORBEVAX) and six (COVAXIN) <span class="citation" data-cites="I9Ha5JL3">[<a href="#ref-I9Ha5JL3" role="doc-biblioref">1556</a>]</span>.
-Other vaccines licensed by India were developed elsewhere but produced in India.
-For example, Novavax (developed in the United States) has signed an agreement with the Serum Institute of India allowing them to produce up to 2 billion doses a year <span class="citation" data-cites="e8pnj0O3">[<a href="#ref-e8pnj0O3" role="doc-biblioref">1557</a>]</span>.
-Similarly, many people within India have been vaccinated with the AstraZeneca-University of Oxford vaccine, known as Covishield in India, which is also produced by the Serum Institute of India <span class="citation" data-cites="gsNWcXHn">[<a href="#ref-gsNWcXHn" role="doc-biblioref">1555</a>]</span>.
-India is also developing vaccines using cutting-edge nucleic-acid-based platforms.
-These include ZyCov-D, a DNA vaccine produced by Zydus Cadila, HGCO19 and India’s first mRNA vaccine, produced by Genova and HDT Biotech Corporation (of the U.S.) <span class="citation" data-cites="gsNWcXHn">[<a href="#ref-gsNWcXHn" role="doc-biblioref">1555</a>]</span>.
-Additionally, in February 2021, Bharat Biotech received approval from Indian officials to commence a phase I study of an intranasal chimpanzee-adenovirus (ChAd) vectored SARS-CoV-2-S vaccine called BBV154 <span class="citation" data-cites="P9mD7Gc9">[<a href="#ref-P9mD7Gc9" role="doc-biblioref">1558</a>]</span>.</p>
-<p>In China, the Sinopharm-Beijing Institute vaccine, the Sinopharm-Wuhan Institute of Biological Products vaccine, the Sinovac Biotech (CoronaVac) vaccine, and CanSino Biologics vaccine are the main vaccines being distributed.
-The Sinopharm-Beijing vaccine has been distributed to at least 16 countries.<!--automate-->
-Indeed, Sinovac and Sinopharm aimed to produce 2 billion doses by the end of 2021, and they have distributed vaccines as aid to the Philippines and Pakistan <span class="citation" data-cites="gdTtuj5e">[<a href="#ref-gdTtuj5e" role="doc-biblioref">1559</a>]</span>.
-In contrast, the Sinopharm-Wuhan vaccine, which has been approved for use in China since February 25, 2021, has been distributed almost exclusively within China, with limited supplies distributed to the United Arab Emirates <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.
-On the same date, the CanSino vaccine was approved for use in China and has been granted emergency use in several other countries <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.</p>
-<p>However, the vaccine approval and distribution processes in China have come under increased scrutiny from other nations.
-China was criticized for administering vaccines to thousands of government officials and state-owned businesses in September 2020, prior to the completion of phase III clinical trials <span class="citation" data-cites="1Bgnim0gX">[<a href="#ref-1Bgnim0gX" role="doc-biblioref">1535</a>]</span>.
-The behavior of Chinese officials has also come into question due to misinformation campaigns questioning the safety of Western vaccine candidates such as Moderna and Pfizer-BioNTech in a way that is intended to highlight the benefits of their own vaccine candidates <span class="citation" data-cites="gdTtuj5e">[<a href="#ref-gdTtuj5e" role="doc-biblioref">1559</a>]</span>.
-China in particular took aim at mRNA technologies, but Chinese companies have since developed their own mRNA vaccines targeting the omicron variant, one of which is due to begin trials soon in the UAE <span class="citation" data-cites="V2Gz2O9G">[<a href="#ref-V2Gz2O9G" role="doc-biblioref">1560</a>]</span>.
-Furthermore, delays in vaccine distribution have also caused issues, particularly in Turkey where 10 million doses of Sinovac were due to arrive by December 2020, but instead only 3 million were delivered in early January <span class="citation" data-cites="gdTtuj5e">[<a href="#ref-gdTtuj5e" role="doc-biblioref">1559</a>]</span>.
-Similar delays and shortages of doses promised were reported by officials in the Philippines, Egypt, Morocco, and the United Arab Emirates <span class="citation" data-cites="XJmfG8HD 12zVLzkpB">[<a href="#ref-XJmfG8HD" role="doc-biblioref">1561</a>,<a href="#ref-12zVLzkpB" role="doc-biblioref">1562</a>]</span>.
-All the same, Sinovac’s vaccine has since been approved for use in countries around the world <span class="citation" data-cites="wByD9WaX">[<a href="#ref-wByD9WaX" role="doc-biblioref">1155</a>]</span>.</p>
-<h1 data-number="9" id="appendix"><span class="header-section-number">9</span> Appendix</h1>
-<h2 data-number="9.1" id="sinovacs-coronavac"><span class="header-section-number">9.1</span> Sinovac’s CoronaVac</h2>
-<p>Pre-clinical trials were performed using BALB/c mice and rhesus macaques <span class="citation" data-cites="14fILrRWg">[<a href="#ref-14fILrRWg" role="doc-biblioref">1150</a>]</span>.
-The SARS-CoV-2 strains used in this trial isolated from 11 hospitalized patients (5 from China, 3 from Italy, 1 from the UK, 1 from Spain, 1 from Switzerland).
-A phylogenetic analysis demonstrated that the strains were representative of the variants circulating at the time.
-One of the strains from China, CN2, was used as the inactivated and purified virus while the other 10 strains were used to challenge.
-The CN2 was grown in Vero cells.
-An ELISA assay was used to assess the immunogenicity of the vaccine.
-10 mice were injected with the vaccine on day 0 and day 7 with varying doses (0, 1.5, 3, or 6 μg), and 10 mice were treated with physiological saline as the control.
-IgG developed in the serum of all vaccinated mice.
-Using the same setup, immunogenicity was also assessed in macaques.
-Four macaques were assigned to each of four groups: treatment with 3 μg at day 0, 7 and 14, treatment with a high dose of 6 μg at day 0, 7, and 14, administration of a placebo vaccine, and administration of only the adjuvant.
-All vaccinated macaques induced IgGs and neutralizing antibodies.
-After challenge with SARS-CoV-2 strain CN1, vaccinated macaques were protected compared to control macaques (placebo or adjuvant only) based on histology and viral loads collected from different regions of the lung.</p>
-<p>Phase I/II clinical trials were conducted in adults 18-59 years old <span class="citation" data-cites="N1txjPtt">[<a href="#ref-N1txjPtt" role="doc-biblioref">1151</a>]</span> and adults over 60 years old <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1149</a>]</span> in China.
-In the case of adults 18-59 years old, a single center, randomized, double-blind, placebo-controlled phase I/II trial was conducted in April 2020.
-Patients in this study were recruited from the community in Suining County of Jiangsu province, China.
-For the phase I trial, 144 (of 185 screened) participants were enrolled, with 72 enrolled in the 14-day interval cohort (i.e., treated on day 0 and day 14) and 72 in the 28-day interval cohort.
-This group of 72 participants was split into 2 blocks for a low-dose (3 μg) and high-dose (6 μg) vaccine.
-Within each block, participants were randomly assigned vaccination with CoronaVac or placebo (aluminum diluent without the virus) at a 2:1 ratio.
-Both the vaccine and placebo were prepared in a Good Manufacturing Practice-accredited facility of Sinovac Life Sciences (Beijing, China).</p>
-<p>The phase II trial followed the same organization of participants, this time using 300 enrolled participants in the 14-day and another 300 enrolled in the 28-day groups.
-One change of note was that the vaccine was produced using a highly automated bioreactor (ReadyToProcess WAVE 25, GE, Umeå, Sweden) to increase vaccine production capacity.
-This change resulted in a higher intact spike protein content.
-The authors of this study were not aware of this antigen-level difference between the vaccine batches for the phase I/II when the ethical approval for the trials occurred.</p>
-<p>To assess adverse responses, participants were asked to record any events up to 7 days post-treatment.
-The reported adverse events were graded according to the China National Medical Products Administration guidelines.
-In the phase I trial, the overall incidence of adverse reactions was 29-38% of patients in the 0 to 14 day group and 13-17% in the 0 to 28 day vaccination group.
-The most common symptom was pain at the injection site, which was reported by 17-21% of patients in the 0 to 14 day cohort and 13% in the 0 to 28 day cohort.
-Most adverse reactions were mild (grade 1) where patients recovered within 48 hours.
-A single case of acute hypersensitivity with manifestation of urticaria 48 hours following the first dose of study drug was reported in the 6 μg group.
-Most of the adverse reactions reported were characterized as mild and resolved within 48 hours, with a single participant experiencing a serious adverse event that could have been related to vaccination (acute hypersensitivity with manifestation of urticaria 48 hours after their first dose in the 6-μg condition).
-Both the 14-day and 28-day cohorts had a strong neutralizing Ab response.
-The neutralizing Ab response was measured using a micro cytopathogenic effect assay, which assesses the minimum dilution of neutralizing Ab to be 50% protective against structural changes in host cells in response to viral infection <span class="citation" data-cites="1GUVvcQjL">[<a href="#ref-1GUVvcQjL" role="doc-biblioref">1563</a>]</span>.
-Additionally IgG antibody titers against the receptor binding domain were also measured using ELISA.</p>
-<p>Another phase I/II study was performed with older patients (older than 60 years) <span class="citation" data-cites="Ozya5HP5">[<a href="#ref-Ozya5HP5" role="doc-biblioref">1149</a>]</span>.
-The study conducted a single-center, randomized, double-blind, placebo-controlled trial.
-The phase I trial looked at dose escalation using 3 dosages: 1.5, 3 and 6 μg.
-The mean age of participants was 65.8 years (std = 4.8).
-Of 95 screened participants, 72 were enrolled.
-These 72 participants were split into low (3 μg) and high (6 μg) dose groups.
-Within each group, 24 participants received the treatment and 12 the placebo.
-A neutralizing antibody response against live SARS-CoV-2 was detected compared to baseline using the same micro cytopathogenic effect assay.
-This response was similar across the two dose concentrations.
-Additionally, they did not observe a difference in response between age groups (60–64 years, 65–69 years, and ≥70 years).</p>
-<p>In phase II the mean age was 66.6 years (standard deviation = 4.7).
-499 participants were screened and 350 were enrolled.
-300 were evenly split into 1.5, 3, and 6 μg dose groups, and the remaining 50 were assigned to the placebo group.
-Again, they found a neutralizing antibody response in phase II.
-There wasn’t a significant different between the response to 3 μg versus 6 μg, but the response was higher than that to 1.5 μg.</p>
-<p>Participants were required to record adverse reaction events within the first 7 days after each dose.
-The safety results were combined across phase I and II.
-All adverse reactions were either mild (grade 1) or moderate (grade 2) in severity.
-The most common symptom was pain at the injection site (9%) and fever (3%).
-2% (7 participants) reported severe adverse events (4 from the 1.5 μg group, 1 from the 3 μg group, 2 from the 6 μg group), though these were found to be unrelated to the vaccine.</p>
-<p>Overall, the results from the pre-clinical and phase I/II clinical trials are promising.
-It was also very hopeful to see that the immune response was consistent in older adults (&gt; 60 years).
-Phase III trials are being conducted in Brazil <span class="citation" data-cites="KewHbkLZ">[<a href="#ref-KewHbkLZ" role="doc-biblioref">1564</a>]</span>.
-This is a randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial.
-They are expecting 13,060 participants with 11,800 ages 18 to 59 years and 1,260 age 60+.
-Participants will be health care professionals.
-As of September 2021, CoronaVac trials are now also being held in the Philippines and Hong Kong, bringing the total number of registered phase III trials investigating the safety and efficacy of CoronaVac to 9, with emergency use approval in 40 countries <span class="citation" data-cites="19z4gdhDS">[<a href="#ref-19z4gdhDS" role="doc-biblioref">1565</a>]</span>.</p>
-<h2 data-number="9.2" id="covaxin"><span class="header-section-number">9.2</span> COVAXIN</h2>
-<p>In India, the COVAXIN<sup>®</sup> vaccine received emergency authorization on January 3, 2021, despite the lack of phase III data until March 3, which was communicated via press release <span class="citation" data-cites="Ks3L7qHG">[<a href="#ref-Ks3L7qHG" role="doc-biblioref">1566</a>]</span>.
-Following a press release of the phase III data indicating 80.6% efficacy in 25,800 participants <span class="citation" data-cites="Ks3L7qHG DaDKZXdu">[<a href="#ref-Ks3L7qHG" role="doc-biblioref">1566</a>,<a href="#ref-DaDKZXdu" role="doc-biblioref">1567</a>]</span>, Zimbabwe authorized the use of COVAXIN<sup>®</sup> <span class="citation" data-cites="13yEnvOyP">[<a href="#ref-13yEnvOyP" role="doc-biblioref">1568</a>]</span>.
-This was followed by a detailed preprint of the double-blind, randomized, controlled phase III trial that was made available in July 2021, with a final enrollment of 25,798 people (~1:1 vaccine:placebo) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1161</a>]</span>.
-The vaccine was reported as well tolerated, with an overall vaccine efficacy of 77.8% for the prevention of COVID-19.
-Efficacy against severe disease and asymptomatic infection was reported as 93.4% and 63.6% respectively.
-In agreement with previous studies demonstrating sera from individuals vaccinated with COVAXIN<sup>®</sup> efficiently neutralized the alpha variant (B.1.1.7) and the delta variant (B.1.617.2) <span class="citation" data-cites="UYE3NvU4 IvOEe7bV">[<a href="#ref-UYE3NvU4" role="doc-biblioref">1179</a>,<a href="#ref-IvOEe7bV" role="doc-biblioref">1180</a>]</span>, the phase III trial reported a 65.2% efficacy against the delta variant (B.1.617.2) <span class="citation" data-cites="n7BupOQ6">[<a href="#ref-n7BupOQ6" role="doc-biblioref">1161</a>]</span>.
-Indeed, another preprint determined that sera from individuals immunized with COVAXIN<sup>®</sup> had effective neutralizing antibodies against the delta variant and the so-called delta plus variant (AY.1) <span class="citation" data-cites="lr7INjf6">[<a href="#ref-lr7INjf6" role="doc-biblioref">1178</a>]</span>.
-It is not yet clear what level of protection COVAXIN<sup>®</sup> offers beyond 6 to 8 months post the second vaccine; consequently, the potential requirement of a booster immunization is being explored <span class="citation" data-cites="s1TGwKbT">[<a href="#ref-s1TGwKbT" role="doc-biblioref">1187</a>]</span>.
-Furthermore, Bharat Biotech is considering other vaccine regimens such as providing one initial immunization with COVAXIN<sup>®</sup> followed by two immunizations with its intranasal vaccine (BBV154) <span class="citation" data-cites="UU0pj3ii">[<a href="#ref-UU0pj3ii" role="doc-biblioref">1569</a>]</span>.
-U.S.-based Ocugen Inc., a co-development partner of Bharat Biotech, is leading the application for an Emergency Use Authorization (EUA) for COVAXIN<sup>®</sup> intended for the U.S. market.
-As of September 2021 COVAXIN<sup>®</sup> has been approved for emergency use in Guyana, India, Iran, Zimbabwe, and Nepal, Mauritius, Mexico, Nepal, Paraguay, and the Philippines <span class="citation" data-cites="19tYVbg8H">[<a href="#ref-19tYVbg8H" role="doc-biblioref">1170</a>]</span>.
-It has been reported that Bharat Biotech will soon release its phase II and III pediatric trial results <span class="citation" data-cites="3Q7kvwO3">[<a href="#ref-3Q7kvwO3" role="doc-biblioref">1570</a>]</span>.
-However, the WHO approval of the COVAXIN<sup>®</sup> has been delayed <span class="citation" data-cites="AeulXXFm">[<a href="#ref-AeulXXFm" role="doc-biblioref">1571</a>]</span>.</p>
-<h2 data-number="9.3" id="sinopharm-candidates"><span class="header-section-number">9.3</span> Sinopharm Candidates</h2>
-<!--- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561304/ BBIBP-CorV --->
-<!--- https://pubmed.ncbi.nlm.nih.gov/32778225/ --->
-<p>Sinopharm Wuhan Institute also developed their SARS-CoV-2 inactivated vaccine using the WIV04 strain isolated from a patient at the Jinyintan Hospital in Wuhan, China <span class="citation" data-cites="miMRIMwa">[<a href="#ref-miMRIMwa" role="doc-biblioref">1156</a>]</span>.
-This vaccine was also passaged in Vero cells, inactivated using β-propiolactone, and was adjuvanted with aluminum hydroxide.
-This vaccine is administered intramuscularly using 5 μg of virus per dose.
-Preclinical data providing supporting evidence for the use of this vaccine is not available publicly.
-Despite the lack of publicly available preclinical results, Sinopharm Wuhan Institute initiated phase I/II trials, which reported on varying dosing and prime-boost regimens.
-Neutralizing antibodies were detected in all groups 14 days after the final dose in the phase I part of the trial <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1158</a>]</span>.
-Similar findings were reported in the interim phase II data <span class="citation" data-cites="T3MYavsH">[<a href="#ref-T3MYavsH" role="doc-biblioref">1158</a>]</span>.</p>
-<p>A combined phase I/II RCT of Sinopharm’s BBIBP-CorV followed <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1159</a>]</span>.
-In phase I, 192 participants were randomized with varying doses of 2 μg, 4 μg, or 8 μg/dose or a placebo, and they received the same as a second dose 28 days later.
-Approximately 29% of participants reported at least 1 adverse event, most commonly fever, and neutralizing antibody titers were reported for all doses.
-In the phase II trial, 482 participants were enrolled (3:1, vaccine:placebo).
-Participants in the vaccine condition received either a single 8 μg dose or a double immunization of a 4 μg/dose that was administered 14, 21, or 28 days post the prime dose.
-Participants in the placebo condition received the placebo on one of the same four schedules.
-The vaccine appeared well-tolerated, with 23% reporting at least one adverse reaction characterized as mild to moderate.
-It was reported that all participants had a humoral immune response to the vaccines by day 42 but that the double immunization dosing regimen of 4 μg/dose achieved higher neutralizing antibody titers than a single dose of 8 μg and that the highest response was seen in the double-immunization regimen when at least 21 days separated the two doses <span class="citation" data-cites="fPGgVKYL">[<a href="#ref-fPGgVKYL" role="doc-biblioref">1159</a>]</span>.
-Similar findings were reported in another phase I/II trial published by the same authors <span class="citation" data-cites="yN5KOfvE">[<a href="#ref-yN5KOfvE" role="doc-biblioref">1160</a>]</span>.</p>
-<h2 data-number="9.4" id="protein-subunit-vaccines"><span class="header-section-number">9.4</span> Protein Subunit Vaccines</h2>
-<p>Several different technologies are used to develop vaccines in this category.
-Proteins can be grown in yeast and then harvested, as they are culturable devoid of animal-derived growth factors.
-Indeed, the vaccine industry has previously mostly used Pichia pastoris yeast as the expression system <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span>.
-However, in recent years insect cells have also been utilized <span class="citation" data-cites="Qk33ZrIC 2Lol7zTw 1FfwyYaj7">[<a href="#ref-1FfwyYaj7" role="doc-biblioref">1200</a>,<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>,<a href="#ref-2Lol7zTw" role="doc-biblioref">1572</a>]</span>.
-Other protein subunit vaccines utilize virus-like particles (VLPs), which share the conformation of a virus’s capsid, thereby acting as an antigen, but lack the replication machinery <span class="citation" data-cites="lH2HMMZi">[<a href="#ref-lH2HMMZi" role="doc-biblioref">1197</a>]</span>.
-VLPs are often synthesized using nanotechnology <span class="citation" data-cites="OoS5TU81">[<a href="#ref-OoS5TU81" role="doc-biblioref">1573</a>]</span>.</p>
-<h3 data-number="9.4.1" id="novavax-nvx-cov2373"><span class="header-section-number">9.4.1</span> Novavax NVX-CoV2373</h3>
-<p>Novavax-CoV2373 is a protein nanoparticle vaccine candidate against SARS-CoV-2.
-The vaccine is constructed from a mutated SARS-CoV-2 spike protein in combination with a specialized adjuvant to elicit an immune response against SARS-CoV-2.
-The spike protein is recombinantly expressed in Sf9 insect cells <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>]</span>, which have previously been used for several other FDA-approved protein therapeutics <span class="citation" data-cites="RQR2sOmx">[<a href="#ref-RQR2sOmx" role="doc-biblioref">1238</a>]</span>.
-The expressed spike protein contains mutations in the furin cleavage site (682-RRAR-685 to 682-QQAQ-685) to avoid cleavage of the spike protein as well as two proline substitutions (K986P and V987P) to improve thermostability <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>]</span>.
-The improved stability caused by the proline substitutions is particularly critical to facilitating global distribution, particularly to regions where local refrigerator/freezer capacities are limited.
-Importantly, these amino acid substitutions did not affect the ability of the spike protein to bind the hACE2 receptor (the target receptor of SARS-CoV-2 spike protein).
-The Novavax-CoV2373 vaccine candidate uses a proprietary, saponin-based Matrix-M<sup>TM</sup> adjuvant that contains two different 40nm-sized particles formed by formulating purified saponin with cholesterol and phospholipids <span class="citation" data-cites="1F52Wz7mx">[<a href="#ref-1F52Wz7mx" role="doc-biblioref">1574</a>]</span>.
-In preclinical models, the use of the Matrix-M adjuvant potentiated the cellular and humoral immune responses to influenza vaccines <span class="citation" data-cites="scwOT7dw aD5iMC0Q twmXSpc9 1F52Wz7mx">[<a href="#ref-1F52Wz7mx" role="doc-biblioref">1574</a>,<a href="#ref-scwOT7dw" role="doc-biblioref">1575</a>,<a href="#ref-aD5iMC0Q" role="doc-biblioref">1576</a>,<a href="#ref-twmXSpc9" role="doc-biblioref">1577</a>]</span>.
-Importantly, Matrix-M adjuvant-containing vaccines have shown acceptable safety profiles in human clinical trials <span class="citation" data-cites="jVCL0201">[<a href="#ref-jVCL0201" role="doc-biblioref">1578</a>]</span>.</p>
-<p>In preclinical mouse models, Novavax-CoV2373 elicited high anti-spike IgG titers 21-28 days post-vaccination that could neutralize the SARS-CoV-2 virus and protect the animals against virus challenge <span class="citation" data-cites="Qk33ZrIC">[<a href="#ref-Qk33ZrIC" role="doc-biblioref">1237</a>]</span>.
-Antibody titers were significantly elevated in groups receiving the vaccine with the Matrix-M adjuvant compared to the groups without adjuvant.
-Novavax-CoV2373 was able to induce a multifunctional CD4/CD8 T-cell responses and generate high frequencies of follicular helper T-cells and B-cell germinal centers after vaccination.
-These findings were subsequently evaluated in a baboon primate model, in which Novavax-CoV2373 also elicited high antibody titers against the SARS-CoV-2 spike protein, as well as an antigen specific T-cell response.
-Based on this data Novavax initiated a phase I/II clinical trial to evaluate the safety and immunogenicity of Novavax-CoV2373 with Matrix-M <span class="citation" data-cites="Nq0cimEs dMLXxGAI">[<a href="#ref-dMLXxGAI" role="doc-biblioref">1239</a>,<a href="#ref-Nq0cimEs" role="doc-biblioref">1579</a>]</span>.</p>
-<p>The phase I/II trial was a randomized, placebo-controlled study with 131 healthy adult participants in 5 treatment arms <span class="citation" data-cites="dMLXxGAI">[<a href="#ref-dMLXxGAI" role="doc-biblioref">1239</a>]</span>.
-Participants that received the recombinant SARS-CoV-2 vaccine with or without the Matrix-M adjuvant got two injections, 21 days apart.
-Primary outcomes that were assessed include reactogenicity, lab-values (serum chemistry and hematology), and anti-spike IgG levels.
-Secondary outcomes measured included virus neutralization, T-cell responses, and unsolicited adverse events.
-The authors reported that no serious treatment-related adverse events occurred in any of the treatment arms.
-Reactogenicity was mostly absent and of short duration.
-The two-dose vaccine regimen induced anti-spike IgG levels and neutralizing antibody-titers exceeding those in the convalescent plasma of symptomatic patients.
-In line with the preclinical studies, the use of Matrix-M adjuvant further increased anti-spike immunoglobulin levels and induced a Th1 response.
-The outcomes of this trial suggest that Novavax-CoV2373 has an acceptable safety profile and is able to induce a strong immune response with high neutralizing antibody titers.
-The phase II component of the trial was designed to identify the dose regimen for the next clinical trial stage <span class="citation" data-cites="ynvQwwo9">[<a href="#ref-ynvQwwo9" role="doc-biblioref">1580</a>]</span>.
-Both younger (18-59 years) and older patients (60-84 years) were randomly assigned to receive either 5 μg or 25 μg Novavax-CoV2373 or placebo in two doses, 21 days apart.<!--To Do: What is placebo?-->
-In line with the phase I data, reactogenicity remained mild to moderate and of short duration.
-Both dose levels were able to induce high anti-spike IgG titers as well as neutralizing antibody responses after the second dose.
-Based on both safety and efficacy data, the 5 μg dosing regimen was selected as the optimal dose regiment for the phase III trial.
-Although the phase III trial data has not been published yet, Novavax announced an efficacy of 89.3% based on their phase III trial in the UK and South Africa.
-This trial included over 15,000 participants in the UK and 4,000 participants in South Africa with occurrence of a PCR-confirmed symptomatic case as the primary endpoint.
-In the first interim analysis (U.K.), 56 cases of COVID-19 were observed in the placebo group compared to 6 cases in the treatment group.
-Importantly, the vaccine candidate also shows significant clinical efficacy against the prevalent UK and South African variants.
-The company has also initiated the development of new constructs to select candidates that can be used as a booster against new strains and plans to initiate clinical trials for these new constructs in the second quarter of 2021.</p>
-<!-- Phase III trial results are published. Need to update text above if they are included. -->
-<!--The primary endpoint of the phase III trial was the occurrence or absence of PCR-confirmed, symptomatic mild, moderate or severe COVID-19 from 7 days after the second dose onward [@doi:10.1056/NEJMoa2107659].
-Side effects were monitored in 2,310 participants and were generally considered mild, with low incidences of headache, muscle pain, and fatigue.-->
-<p>Given the apparent need for boosters, interest has also emerged in whether vaccines against SARS-CoV-2 can be administered along with annual flu vaccines.
-Early data came from the Novavax NVX-CoV2373 protein subunit vaccine.
-In a subgroup of approximately 400 patients enrolled from the U.K. phase III trial who received either NVX-CoV2373 or placebo 1:1, a concomitant dose of adjuvanted seasonal influenza vaccines (either a trivalent vaccine or a quadrivalent vaccine) was administered <span class="citation" data-cites="IUekaKY0">[<a href="#ref-IUekaKY0" role="doc-biblioref">1581</a>]</span>.
-This study demonstrated that both types of vaccines could be safely administered together.
-While no change to the immune response was noted for the influenza vaccine, a notable reduction of the antibody response for the NVX-CoV2373 was reported, but efficacy was still high at 87.5% <span class="citation" data-cites="IUekaKY0">[<a href="#ref-IUekaKY0" role="doc-biblioref">1581</a>]</span>.
-Novavax has since started phase I/II trials to investigate the administration of its own influenza vaccine, NanoFlu<sup>™</sup>, concomitantly with NVX-CoV2373 <span class="citation" data-cites="rclKBvtk">[<a href="#ref-rclKBvtk" role="doc-biblioref">1582</a>]</span>, which appeared to be safe and effective in preclinical studies <span class="citation" data-cites="bOwPRh6q">[<a href="#ref-bOwPRh6q" role="doc-biblioref">1583</a>]</span>.</p>
-<h3 data-number="9.4.2" id="protein-subunit-vaccine-development-programs-prior-to-sars-cov-2"><span class="header-section-number">9.4.2</span> Protein Subunit Vaccine Development Programs Prior to SARS-CoV-2</h3>
-<p>Earlier studies examined the immunogenicity of a SARS-CoV-1 RBD fused with IgG1 Fc.
-This recombinant fusion protein could induce a robust long-lasting neutralizing antibody and cellular immune response that protected mice from SARS-CoV-1 <span class="citation" data-cites="7RHpaAHu 1EirBATaN cLAQnckq">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-cLAQnckq" role="doc-biblioref">1204</a>,<a href="#ref-1EirBATaN" role="doc-biblioref">1205</a>]</span>.
-While there have been other potential protein subunit vaccines for SARS-CoV-1 investigated <em>in vivo</em> <span class="citation" data-cites="7RHpaAHu 9Zv0eLa9">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>,<a href="#ref-9Zv0eLa9" role="doc-biblioref">1214</a>]</span>, none of these candidates have successfully completed clinical trials, more than likely due to the fact that the SARS-CoV-1 epidemic mostly ended by May 2004, and there was thus less of a demand or funding for SARS-CoV-1 vaccine research.</p>
-<p>Similar vaccine candidates have emerged that target the RBD found in the S1 subunit of the trimeric MERS-CoV S protein, which binds to dipeptidyl-peptidase 4 (DPP4 also known as hCD26), the entry point through which MERS-CoV infects cells <span class="citation" data-cites="yoFGwkUO KZFnwRIN YZcHzPcs">[<a href="#ref-yoFGwkUO" role="doc-biblioref">1584</a>,<a href="#ref-KZFnwRIN" role="doc-biblioref">1585</a>,<a href="#ref-YZcHzPcs" role="doc-biblioref">1586</a>]</span>.
-After initially determining that an RBD subunit candidate (S377-588-Fc) could elicit neutralizing antibodies <span class="citation" data-cites="GFWQw4mi">[<a href="#ref-GFWQw4mi" role="doc-biblioref">1587</a>]</span>, a study in mice determined that the administration of three sequential doses of RBD-Fc vaccine coupled with MF59, a squalene immunogenic adjuvant, induced humoral and systemic immunity in mice <span class="citation" data-cites="SF030Zqn">[<a href="#ref-SF030Zqn" role="doc-biblioref">1588</a>]</span>.
-Mice that had been transduced with Ad5-hCD26 and subsequently challenged with MERS-CoV five days later did not show evidence of viral infection in the lungs versus control mice at ten days post vaccination <span class="citation" data-cites="SF030Zqn">[<a href="#ref-SF030Zqn" role="doc-biblioref">1588</a>]</span>.
-Other variations of this vaccine approach include a stable S trimer vaccine whereby proline-substituted variants of S2 can maintain a stable prefusion conformation of the S2 domain <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span>.
-This approach leads to broad and potent neutralizing antibodies <span class="citation" data-cites="7RHpaAHu">[<a href="#ref-7RHpaAHu" role="doc-biblioref">1119</a>]</span></p>
-<h2 data-number="9.5" id="complementary-approaches-to-vaccine-development"><span class="header-section-number">9.5</span> Complementary Approaches to Vaccine Development</h2>
-<p>A complementary approach to other vaccine development programs that is being investigated explores the potential for vaccines that are not made from the SARS-CoV-2 virus to confer what has been termed trained immunity.
-In a recent review <span class="citation" data-cites="103fS7Kz2">[<a href="#ref-103fS7Kz2" role="doc-biblioref">1589</a>]</span>, trained immunity was defined as forms of memory that are temporary (e.g., months or years) and reversible.
-It is induced by exposure to whole-microorganism vaccines or other microbial stimuli that generates heterologous protective effects.
-Trained immunity can be displayed by innate immune cells or innate immune features of other cells, and it is characterized by alterations to immune responsiveness to future immune challenges due to epigenetic and metabolic mechanisms.
-These alterations can take the form of either an increased or decreased response to immune challenge by a pathogen.
-Trained immunity elicited by non-SARS-CoV-2 whole-microorganism vaccines could potentially improve SARS-CoV-2 susceptibility or severity <span class="citation" data-cites="Vu1VILWK">[<a href="#ref-Vu1VILWK" role="doc-biblioref">1590</a>]</span>.</p>
-<p>One type of stimulus which research indicates can induce trained immunity is bacillus Calmette-Guerin (BCG) vaccination.
-BCG is an attenuated form of bacteria <em>Mycobacterium bovis</em>.
-The vaccine is most commonly administered for the prevention of tuberculosis in humans.
-Clinical trials in non-SARS-CoV-2-infected adults have been designed to assess whether BCG vaccination could have prophylactic effects against SARS-CoV-2 by reducing susceptibility, preventing infection, or reducing disease severity.
-A number of trials are now evaluating the effects of the BCG vaccine or the related vaccine VPM1002 <span class="citation" data-cites="Vu1VILWK 9m3rP633 y9IYdfM3 xdqxBruc 962rELVS EuwTWcPi dQtUeruv DjXsPR8O 10OE6y3Pv 86OjIybR ITO15LIz VkZGZxLn 13JVjMfQI nk2MVsld 1E2t9tr8h">[<a href="#ref-9m3rP633" role="doc-biblioref">1131</a>,<a href="#ref-xdqxBruc" role="doc-biblioref">1132</a>,<a href="#ref-Vu1VILWK" role="doc-biblioref">1590</a>,<a href="#ref-y9IYdfM3" role="doc-biblioref">1591</a>,<a href="#ref-962rELVS" role="doc-biblioref">1592</a>,<a href="#ref-EuwTWcPi" role="doc-biblioref">1593</a>,<a href="#ref-dQtUeruv" role="doc-biblioref">1594</a>,<a href="#ref-DjXsPR8O" role="doc-biblioref">1595</a>,<a href="#ref-10OE6y3Pv" role="doc-biblioref">1596</a>,<a href="#ref-86OjIybR" role="doc-biblioref">1597</a>,<a href="#ref-ITO15LIz" role="doc-biblioref">1598</a>,<a href="#ref-VkZGZxLn" role="doc-biblioref">1599</a>,<a href="#ref-13JVjMfQI" role="doc-biblioref">1600</a>,<a href="#ref-nk2MVsld" role="doc-biblioref">1601</a>,<a href="#ref-1E2t9tr8h" role="doc-biblioref">1602</a>]</span>.</p>
-<p>The ongoing trials are using a number of different approaches.
-Some trials enroll healthcare workers, other trials hospitalized elderly adults without immunosuppression who get vaccinated with placebo or BCG at hospital discharge, and yet another set of trials older adults (&gt;50 years) under chronic care for conditions like hypertension and diabetes.
-One set of trials, for example, uses time until first infection as the primary study endpoint; more generally, outcomes measured in some of these trials are related to incidence of disease and disease severity or symptoms.
-Some analyses have suggested a possible correlation at the country level between the frequency of BCG vaccination (or BCG vaccination policies) and the severity of COVID-19 <span class="citation" data-cites="Vu1VILWK">[<a href="#ref-Vu1VILWK" role="doc-biblioref">1590</a>]</span>.
-Currently it is unclear whether this correlation has any connection to trained immunity.
-Many possible confounding factors are also likely to vary among countries, such as age distribution, detection efficiency, stochastic epidemic dynamic effects, differences in healthcare capacity over time in relation to epidemic dynamics, and these have not been adequately accounted for in current analyses. <!-- TO DO: add in study that debunks this-->
-It is unclear whether there is an effect of the timing of BCG vaccination, both during an individual’s life cycle and relative to the COVID-19 pandemic.
-Additionally, given that severe SARS-CoV-2 may be associated with a dysregulated immune response, it is unclear what alterations to the immune response would be most likely to be protective versus pathogenic (e.g., <span class="citation" data-cites="i5k18bpX 1GnFL9zeN Vu1VILWK 1228YjPRv">[<a href="#ref-1GnFL9zeN" role="doc-biblioref">147</a>,<a href="#ref-Vu1VILWK" role="doc-biblioref">1590</a>,<a href="#ref-i5k18bpX" role="doc-biblioref">1603</a>,<a href="#ref-1228YjPRv" role="doc-biblioref">1604</a>]</span>).
-The article <span class="citation" data-cites="Vu1VILWK">[<a href="#ref-Vu1VILWK" role="doc-biblioref">1590</a>]</span> proposes that trained immunity might lead to an earlier and stronger response, which could in turn reduce viremia and the risk of later, detrimental immunopathology.
-While trained immunity is an interesting possible avenue to complement vaccine development efforts through the use of an existing vaccine, additional research is required to assess whether the BCG vaccine is likely to confer trained immunity in the case of SARS-CoV-2.</p>
+For some countries, Russia and China have also been more palatable politically than vaccine suppliers in the West <span class="citation" data-cites="ID8IywJM FAQXPsyc">[<a href="#ref-ID8IywJM" role="doc-biblioref">1607</a>,<a href="#ref-FAQXPsyc" role="doc-biblioref">1609</a>]</span>.
+For others, the delays in the distribution of the other, more-favored candidates has been a motivating factor for pursuing the Sputnik V and Chinese alternatives <span class="citation" data-cites="FAQXPsyc Z0V7NK7Y">[<a href="#ref-Z0V7NK7Y" role="doc-biblioref">1450</a>,<a href="#ref-FAQXPsyc" role="doc-biblioref">1609</a>]</span>.
+Additionally, Germany has stated that if Sputnik V were approved by EMA, it would be considered by the E.U. <span class="citation" data-cites="zCPl6A82">[<a href="#ref-zCPl6A82" role="doc-biblioref">1610</a>]</span>.
+Russia is developing other vaccine candidates and has approved a third vaccine, CoviVac, which is an inactivated vaccine produced by the Chumakov Centre in Moscow, despite the fact the clinical trials have yet to begin <span class="citation" data-cites="hpScvlYg">[<a href="#ref-hpScvlYg" role="doc-biblioref">1611</a>]</span>.</p>
 <h1 data-number="10" id="dietary-supplements-and-nutraceuticals-under-investigation-for-covid-19-prevention-and-treatment"><span class="header-section-number">10</span> Dietary Supplements and Nutraceuticals Under Investigation for COVID-19 Prevention and Treatment</h1>
 <h2 data-number="10.1" id="abstract-6"><span class="header-section-number">10.1</span> Abstract</h2>
 <p>Coronavirus disease 2019 (COVID-19) has caused global disruption and a significant loss of life.
@@ -4872,141 +4858,141 @@ <h2 data-number="10.3" id="introduction-6"><span class="header-section-number">1
 This rapid effort led to the identification of some promising pharmaceutical therapies for hospitalized patients, such as remdesivir and dexamethasone.
 Furthermore, most societies have adopted non-pharmacological preventative measures such as utilizing public health strategies that reduce the transmission of SARS-CoV-2.
 However, during this time, many individuals sought additional protections via the consumption of various dietary supplements and nutraceuticals that they believed to confer beneficial effects.
-While a patient’s nutritional status does seem to play a role in COVID-19 susceptibility and outcomes <span class="citation" data-cites="Lyd8s4Mk UFrQw1gC Hd5V5Usd 1FAOfFx5A 5tHMedSi">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1605</a>,<a href="#ref-UFrQw1gC" role="doc-biblioref">1606</a>,<a href="#ref-Hd5V5Usd" role="doc-biblioref">1607</a>,<a href="#ref-1FAOfFx5A" role="doc-biblioref">1608</a>,<a href="#ref-5tHMedSi" role="doc-biblioref">1609</a>]</span>, the beginning of the pandemic saw sales of vitamins and other supplements soar despite a lack of any evidence supporting their use against COVID-19.
-In the United States, for example, dietary supplement and nutraceutical sales have shown modest annual growth in recent years (approximately 5%, or a $345 million increase in 2019), but during the six-week period preceding April 5, 2020, they increased by 44% ($435 million) relative to the same period in 2019 <span class="citation" data-cites="A225e05z">[<a href="#ref-A225e05z" role="doc-biblioref">1610</a>]</span>.
-While growth subsequently leveled off, sales continued to boom, with a further 16% ($151 million) increase during the six weeks preceding May 17, 2020 relative to 2019 <span class="citation" data-cites="A225e05z">[<a href="#ref-A225e05z" role="doc-biblioref">1610</a>]</span>.
-In France, New Zealand, India, and China, similar trends in sales were reported <span class="citation" data-cites="LMkJA6Ke puD7Ydak 1FjpTy3Dd 5NJabJny">[<a href="#ref-LMkJA6Ke" role="doc-biblioref">1611</a>,<a href="#ref-puD7Ydak" role="doc-biblioref">1612</a>,<a href="#ref-1FjpTy3Dd" role="doc-biblioref">1613</a>,<a href="#ref-5NJabJny" role="doc-biblioref">1614</a>]</span>.
-The increase in sales was driven by a consumer perception that dietary supplements and nutraceuticals would protect consumers from infection and/or mitigate the impact of infection due to the various “immune-boosting” claims of these products <span class="citation" data-cites="10JmgRgZG 18NItmm1M">[<a href="#ref-10JmgRgZG" role="doc-biblioref">1615</a>,<a href="#ref-18NItmm1M" role="doc-biblioref">1616</a>]</span>.</p>
+While a patient’s nutritional status does seem to play a role in COVID-19 susceptibility and outcomes <span class="citation" data-cites="Lyd8s4Mk UFrQw1gC Hd5V5Usd 1FAOfFx5A 5tHMedSi">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1612</a>,<a href="#ref-UFrQw1gC" role="doc-biblioref">1613</a>,<a href="#ref-Hd5V5Usd" role="doc-biblioref">1614</a>,<a href="#ref-1FAOfFx5A" role="doc-biblioref">1615</a>,<a href="#ref-5tHMedSi" role="doc-biblioref">1616</a>]</span>, the beginning of the pandemic saw sales of vitamins and other supplements soar despite a lack of any evidence supporting their use against COVID-19.
+In the United States, for example, dietary supplement and nutraceutical sales have shown modest annual growth in recent years (approximately 5%, or a $345 million increase in 2019), but during the six-week period preceding April 5, 2020, they increased by 44% ($435 million) relative to the same period in 2019 <span class="citation" data-cites="A225e05z">[<a href="#ref-A225e05z" role="doc-biblioref">1617</a>]</span>.
+While growth subsequently leveled off, sales continued to boom, with a further 16% ($151 million) increase during the six weeks preceding May 17, 2020 relative to 2019 <span class="citation" data-cites="A225e05z">[<a href="#ref-A225e05z" role="doc-biblioref">1617</a>]</span>.
+In France, New Zealand, India, and China, similar trends in sales were reported <span class="citation" data-cites="LMkJA6Ke puD7Ydak 1FjpTy3Dd 5NJabJny">[<a href="#ref-LMkJA6Ke" role="doc-biblioref">1618</a>,<a href="#ref-puD7Ydak" role="doc-biblioref">1619</a>,<a href="#ref-1FjpTy3Dd" role="doc-biblioref">1620</a>,<a href="#ref-5NJabJny" role="doc-biblioref">1621</a>]</span>.
+The increase in sales was driven by a consumer perception that dietary supplements and nutraceuticals would protect consumers from infection and/or mitigate the impact of infection due to the various “immune-boosting” claims of these products <span class="citation" data-cites="10JmgRgZG 18NItmm1M">[<a href="#ref-10JmgRgZG" role="doc-biblioref">1622</a>,<a href="#ref-18NItmm1M" role="doc-biblioref">1623</a>]</span>.</p>
 <p>Due to the significant interest from the general public in dietary additives, whether and to what extent nutraceuticals or dietary supplements can provide any prophylactic or therapeutic benefit remains a topic of interest for the scientific community.
 Nutraceuticals and dietary supplements are related but distinct non-pharmaceutical products.
-Nutraceuticals are classified as supplements with health benefits beyond their basic nutritional value <span class="citation" data-cites="xLPeszeO 2Us0gNMr">[<a href="#ref-xLPeszeO" role="doc-biblioref">1617</a>,<a href="#ref-2Us0gNMr" role="doc-biblioref">1618</a>]</span>.
-The key difference between a dietary supplement and a nutraceutical is that nutraceuticals should not only supplement the diet, but also aid in the prophylaxis and/or treatment of a disorder or disease <span class="citation" data-cites="X0jEogv4">[<a href="#ref-X0jEogv4" role="doc-biblioref">1619</a>]</span>.
+Nutraceuticals are classified as supplements with health benefits beyond their basic nutritional value <span class="citation" data-cites="xLPeszeO 2Us0gNMr">[<a href="#ref-xLPeszeO" role="doc-biblioref">1624</a>,<a href="#ref-2Us0gNMr" role="doc-biblioref">1625</a>]</span>.
+The key difference between a dietary supplement and a nutraceutical is that nutraceuticals should not only supplement the diet, but also aid in the prophylaxis and/or treatment of a disorder or disease <span class="citation" data-cites="X0jEogv4">[<a href="#ref-X0jEogv4" role="doc-biblioref">1626</a>]</span>.
 However, dietary supplements and nutraceuticals, unlike pharmaceuticals, are not subject to the same regulatory protocols that protect consumers of medicines.
-Indeed, nutraceuticals do not entirely fall under the responsibility of the Food and Drug Administration (FDA), but they are monitored as dietary supplements according to the Dietary Supplement, Health and Education Act 1994 (DSHEA) <span class="citation" data-cites="10Tnnl6nF">[<a href="#ref-10Tnnl6nF" role="doc-biblioref">1620</a>]</span> and the Food and Drug Administration Modernization Act 1997 (FDAMA) <span class="citation" data-cites="16eEQf0HM">[<a href="#ref-16eEQf0HM" role="doc-biblioref">1621</a>]</span>.
+Indeed, nutraceuticals do not entirely fall under the responsibility of the Food and Drug Administration (FDA), but they are monitored as dietary supplements according to the Dietary Supplement, Health and Education Act 1994 (DSHEA) <span class="citation" data-cites="10Tnnl6nF">[<a href="#ref-10Tnnl6nF" role="doc-biblioref">1627</a>]</span> and the Food and Drug Administration Modernization Act 1997 (FDAMA) <span class="citation" data-cites="16eEQf0HM">[<a href="#ref-16eEQf0HM" role="doc-biblioref">1628</a>]</span>.
 Due to increases in sales of dietary supplements and nutraceuticals, in 1996 the FDA established the Office of Dietary Supplement Programs (ODSP) to increase surveillance.
 Novel products or nutraceuticals must now submit a new dietary ingredient notification to the ODSP for review.
-There are significant concerns that these legislations do not adequately protect the consumer as they ascribe responsibility to the manufacturers to ensure the safety of the product before manufacturing or marketing <span class="citation" data-cites="5TmtJWVQ">[<a href="#ref-5TmtJWVQ" role="doc-biblioref">1622</a>]</span>.
+There are significant concerns that these legislations do not adequately protect the consumer as they ascribe responsibility to the manufacturers to ensure the safety of the product before manufacturing or marketing <span class="citation" data-cites="5TmtJWVQ">[<a href="#ref-5TmtJWVQ" role="doc-biblioref">1629</a>]</span>.
 Manufacturers are not required to register or even seek approval from the FDA to produce or sell food supplements or nutraceuticals.
-Health or nutrient content claims for labeling purposes are approved based on an authoritative statement from the Academy of Sciences or relevant federal authorities once the FDA has been notified and on the basis that the information is known to be true and not deceptive <span class="citation" data-cites="5TmtJWVQ">[<a href="#ref-5TmtJWVQ" role="doc-biblioref">1622</a>]</span>.
+Health or nutrient content claims for labeling purposes are approved based on an authoritative statement from the Academy of Sciences or relevant federal authorities once the FDA has been notified and on the basis that the information is known to be true and not deceptive <span class="citation" data-cites="5TmtJWVQ">[<a href="#ref-5TmtJWVQ" role="doc-biblioref">1629</a>]</span>.
 Therefore, there is often a gap between perceptions by the American public about a nutraceutical or dietary supplement and the actual clinical evidence surrounding its effects.</p>
 <p>Despite differences in regulations, similar challenges exist outside of the United States.
-In Europe, where the safety of supplements is monitored by the European Union (EU) under Directive 2002/46/EC <span class="citation" data-cites="CWdgoTUe">[<a href="#ref-CWdgoTUe" role="doc-biblioref">1623</a>/?uri=celex%3A32002L0046]</span>.
+In Europe, where the safety of supplements is monitored by the European Union (EU) under Directive 2002/46/EC <span class="citation" data-cites="CWdgoTUe">[<a href="#ref-CWdgoTUe" role="doc-biblioref">1630</a>/?uri=celex%3A32002L0046]</span>.
 However, nutraceuticals are not directly mentioned.
-Consequently, nutraceuticals can be generally described as either a medicinal product under Directive 2004/27/EC <span class="citation" data-cites="G7TnkK6t">[<a href="#ref-G7TnkK6t" role="doc-biblioref">1624</a>/?uri=CELEX:32004L0027]</span> or as a ‘foodstuff’ under Directive 2002/46/EC of the European council.
+Consequently, nutraceuticals can be generally described as either a medicinal product under Directive 2004/27/EC <span class="citation" data-cites="G7TnkK6t">[<a href="#ref-G7TnkK6t" role="doc-biblioref">1631</a>/?uri=CELEX:32004L0027]</span> or as a ‘foodstuff’ under Directive 2002/46/EC of the European council.
 In order to synchronize the various existing legislations, Regulation EC 1924/2006 on nutrition and health claims was put into effect to assure customers of safety and efficacy of products and to deliver understandable information to consumers.
 However, specific legislation for nutraceuticals is still elusive.
-Health claims are permitted on a product label only following compliance and authorization according to the European Food Safety Authority (EFSA) guidelines on nutrition and health claims <span class="citation" data-cites="dzOveIQY">[<a href="#ref-dzOveIQY" role="doc-biblioref">1625</a>]</span>.
-EFSA does not currently distinguish between food supplements and nutraceuticals for health claim applications of new products, as claim authorization is dependent on the availability of clinical data in order to substantiate efficacy <span class="citation" data-cites="MhvDTmeu">[<a href="#ref-MhvDTmeu" role="doc-biblioref">1626</a>]</span>.
-These guidelines seem to provide more protection to consumers than the FDA regulations but potentially at the cost of innovation in the sector <span class="citation" data-cites="LBf0kxOm">[<a href="#ref-LBf0kxOm" role="doc-biblioref">1627</a>]</span>.
-The situation becomes even more complicated when comparing regulations at a global level, as countries such as China and India have existing regulatory frameworks for traditional medicines and phytomedicines not commonly consumed in Western society <span class="citation" data-cites="jovk0AV9">[<a href="#ref-jovk0AV9" role="doc-biblioref">1628</a>]</span>.
-Currently, there is debate among scientists and regulatory authorities surrounding the development of a widespread regulatory framework to deal with the challenges of safety and health claim substantiation for nutraceuticals <span class="citation" data-cites="MhvDTmeu 5TmtJWVQ">[<a href="#ref-5TmtJWVQ" role="doc-biblioref">1622</a>,<a href="#ref-MhvDTmeu" role="doc-biblioref">1626</a>]</span>, as these products do not necessarily follow the same rigorous clinical trial frameworks used to approve the use of pharmaceuticals.
+Health claims are permitted on a product label only following compliance and authorization according to the European Food Safety Authority (EFSA) guidelines on nutrition and health claims <span class="citation" data-cites="dzOveIQY">[<a href="#ref-dzOveIQY" role="doc-biblioref">1632</a>]</span>.
+EFSA does not currently distinguish between food supplements and nutraceuticals for health claim applications of new products, as claim authorization is dependent on the availability of clinical data in order to substantiate efficacy <span class="citation" data-cites="MhvDTmeu">[<a href="#ref-MhvDTmeu" role="doc-biblioref">1633</a>]</span>.
+These guidelines seem to provide more protection to consumers than the FDA regulations but potentially at the cost of innovation in the sector <span class="citation" data-cites="LBf0kxOm">[<a href="#ref-LBf0kxOm" role="doc-biblioref">1634</a>]</span>.
+The situation becomes even more complicated when comparing regulations at a global level, as countries such as China and India have existing regulatory frameworks for traditional medicines and phytomedicines not commonly consumed in Western society <span class="citation" data-cites="jovk0AV9">[<a href="#ref-jovk0AV9" role="doc-biblioref">1635</a>]</span>.
+Currently, there is debate among scientists and regulatory authorities surrounding the development of a widespread regulatory framework to deal with the challenges of safety and health claim substantiation for nutraceuticals <span class="citation" data-cites="MhvDTmeu 5TmtJWVQ">[<a href="#ref-5TmtJWVQ" role="doc-biblioref">1629</a>,<a href="#ref-MhvDTmeu" role="doc-biblioref">1633</a>]</span>, as these products do not necessarily follow the same rigorous clinical trial frameworks used to approve the use of pharmaceuticals.
 Such regulatory disparities have been highlighted by the pandemic, as many individuals and companies have attempted to profit from the vulnerabilities of others by overstating claims in relation to the treatment of COVID-19 using supplements and nutraceuticals.
-The FDA has written several letters to prevent companies marketing or selling products based on false hyperbolic promises about preventing SARS-CoV-2 infection or treating COVID-19 <span class="citation" data-cites="l2tEuVtb Qo0C93P6 133nfCM4l">[<a href="#ref-l2tEuVtb" role="doc-biblioref">1629</a>,<a href="#ref-Qo0C93P6" role="doc-biblioref">1630</a>,<a href="#ref-133nfCM4l" role="doc-biblioref">1631</a>]</span>.
-These letters came in response to efforts to market nutraceutical prophylactics against COVID-19, some of which charged the consumer as much as $23,000 <span class="citation" data-cites="7B3shLSx">[<a href="#ref-7B3shLSx" role="doc-biblioref">1632</a>]</span>.
-There have even been some incidents highlighted in the media because of their potentially life threatening consequences; for example, the use of oleandrin was touted as a potential “cure” by individuals close to the former President of the United States despite its high toxicity <span class="citation" data-cites="Ssmsdskt">[<a href="#ref-Ssmsdskt" role="doc-biblioref">1633</a>]</span>.
+The FDA has written several letters to prevent companies marketing or selling products based on false hyperbolic promises about preventing SARS-CoV-2 infection or treating COVID-19 <span class="citation" data-cites="l2tEuVtb Qo0C93P6 133nfCM4l">[<a href="#ref-l2tEuVtb" role="doc-biblioref">1636</a>,<a href="#ref-Qo0C93P6" role="doc-biblioref">1637</a>,<a href="#ref-133nfCM4l" role="doc-biblioref">1638</a>]</span>.
+These letters came in response to efforts to market nutraceutical prophylactics against COVID-19, some of which charged the consumer as much as $23,000 <span class="citation" data-cites="7B3shLSx">[<a href="#ref-7B3shLSx" role="doc-biblioref">1639</a>]</span>.
+There have even been some incidents highlighted in the media because of their potentially life threatening consequences; for example, the use of oleandrin was touted as a potential “cure” by individuals close to the former President of the United States despite its high toxicity <span class="citation" data-cites="Ssmsdskt">[<a href="#ref-Ssmsdskt" role="doc-biblioref">1640</a>]</span>.
 Thus, heterogeneous and at times relaxed regulatory standards have permitted high-profile cases of the sale of nutraceuticals and dietary supplements that are purported to provide protection against COVID-19, despite a lack of research into these compounds.</p>
 <p>Notwithstanding the issues of poor safety, efficacy, and regulatory oversight, some dietary supplements and nutraceuticals have exhibited therapeutic and prophylactic potential.
-Some have been linked with reduced immunopathology, antiviral and anti-inflammatory activities, or even the prevention of acute respiratory distress syndrome (ARDS) <span class="citation" data-cites="GT7yDBjv 10JmgRgZG EEa0SZCF">[<a href="#ref-10JmgRgZG" role="doc-biblioref">1615</a>,<a href="#ref-GT7yDBjv" role="doc-biblioref">1634</a>,<a href="#ref-EEa0SZCF" role="doc-biblioref">1635</a>]</span>.
+Some have been linked with reduced immunopathology, antiviral and anti-inflammatory activities, or even the prevention of acute respiratory distress syndrome (ARDS) <span class="citation" data-cites="GT7yDBjv 10JmgRgZG EEa0SZCF">[<a href="#ref-10JmgRgZG" role="doc-biblioref">1622</a>,<a href="#ref-GT7yDBjv" role="doc-biblioref">1641</a>,<a href="#ref-EEa0SZCF" role="doc-biblioref">1642</a>]</span>.
 A host of potential candidates have been highlighted in the literature that target various aspects of the COVID-19 viral pathology, while others are thought to prime the host immune system.
-These candidates include vitamins and minerals along with extracts and omega-3 polyunsaturated fatty acids (n-3 PUFA) <span class="citation" data-cites="2hMFPQJR">[<a href="#ref-2hMFPQJR" role="doc-biblioref">1636</a>]</span>.
-<em>In vitro</em> and <em>in vivo</em> studies suggest that nutraceuticals containing phycocyanobilin, N-acetylcysteine, glucosamine, selenium or phase 2 inductive nutraceuticals (e.g. ferulic acid, lipoic acid, or sulforaphane) can prevent or modulate RNA virus infections via amplification of the signaling activity of mitochondrial antiviral-signaling protein (MAVS) and activation of Toll-like receptor 7 <span class="citation" data-cites="eyBAUUCl">[<a href="#ref-eyBAUUCl" role="doc-biblioref">1637</a>]</span>.
+These candidates include vitamins and minerals along with extracts and omega-3 polyunsaturated fatty acids (n-3 PUFA) <span class="citation" data-cites="2hMFPQJR">[<a href="#ref-2hMFPQJR" role="doc-biblioref">1643</a>]</span>.
+<em>In vitro</em> and <em>in vivo</em> studies suggest that nutraceuticals containing phycocyanobilin, N-acetylcysteine, glucosamine, selenium or phase 2 inductive nutraceuticals (e.g. ferulic acid, lipoic acid, or sulforaphane) can prevent or modulate RNA virus infections via amplification of the signaling activity of mitochondrial antiviral-signaling protein (MAVS) and activation of Toll-like receptor 7 <span class="citation" data-cites="eyBAUUCl">[<a href="#ref-eyBAUUCl" role="doc-biblioref">1644</a>]</span>.
 Phase 2 inductive molecules used in the production of nutraceuticals are known to activate nuclear factor erythroid 2–related factor 2 (Nrf2), which is a protein regulator of antioxidant enzymes that leads to the induction of several antioxidant enzymes, such as gamma-glutamylcysteine synthetase.
 While promising, further animal and human studies are required to assess the therapeutic potential of these various nutrients and nutraceuticals against COVID-19.
 For the purpose of this review, we have highlighted some of the main dietary supplements and nutraceuticals that are currently under investigation for their potential prophylactic and therapeutic applications.
 These include n-3 PUFA, zinc, vitamins C and D, and probiotics.</p>
 <h2 data-number="10.4" id="n-3-pufa"><span class="header-section-number">10.4</span> n-3 PUFA</h2>
-<p>One category of supplements that has been explored for beneficial effects against various viral infections are the n-3 PUFAs <span class="citation" data-cites="2hMFPQJR">[<a href="#ref-2hMFPQJR" role="doc-biblioref">1636</a>]</span>, commonly referred to as omega-3 fatty acids, which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
-EPA and DHA intake can come from a diet high in fish or through dietary supplementation with fish oils or purified oils <span class="citation" data-cites="Ufvsmc3N">[<a href="#ref-Ufvsmc3N" role="doc-biblioref">1638</a>]</span>.
-Other, more sustainable sources of EPA and DHA include algae <span class="citation" data-cites="Gzqj7Okm Txn1mlRl">[<a href="#ref-Gzqj7Okm" role="doc-biblioref">1639</a>,<a href="#ref-Txn1mlRl" role="doc-biblioref">1640</a>]</span>, which can also be exploited for their rich abundance of other bioactive compounds such as angiotensin converting enzyme inhibitor peptides and antiviral agents including phycobiliproteins, sulfated polysaccharides, and calcium-spirulan <span class="citation" data-cites="S1A3WazG">[<a href="#ref-S1A3WazG" role="doc-biblioref">1641</a>]</span>.
-n-3 PUFAs have been investigated for many years for their therapeutic potential <span class="citation" data-cites="4xymCvKH">[<a href="#ref-4xymCvKH" role="doc-biblioref">1642</a>]</span>.
-Supplementation with fish oils is generally well tolerated <span class="citation" data-cites="4xymCvKH">[<a href="#ref-4xymCvKH" role="doc-biblioref">1642</a>]</span>, and intake of n-3 PUFAs through dietary sources or supplementation is specifically encouraged for vulnerable groups such as pregnant and lactating women <span class="citation" data-cites="17CHOdNbe g4dU6DMd">[<a href="#ref-17CHOdNbe" role="doc-biblioref">1643</a>,<a href="#ref-g4dU6DMd" role="doc-biblioref">1644</a>]</span>.
+<p>One category of supplements that has been explored for beneficial effects against various viral infections are the n-3 PUFAs <span class="citation" data-cites="2hMFPQJR">[<a href="#ref-2hMFPQJR" role="doc-biblioref">1643</a>]</span>, commonly referred to as omega-3 fatty acids, which include eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
+EPA and DHA intake can come from a diet high in fish or through dietary supplementation with fish oils or purified oils <span class="citation" data-cites="Ufvsmc3N">[<a href="#ref-Ufvsmc3N" role="doc-biblioref">1645</a>]</span>.
+Other, more sustainable sources of EPA and DHA include algae <span class="citation" data-cites="Gzqj7Okm Txn1mlRl">[<a href="#ref-Gzqj7Okm" role="doc-biblioref">1646</a>,<a href="#ref-Txn1mlRl" role="doc-biblioref">1647</a>]</span>, which can also be exploited for their rich abundance of other bioactive compounds such as angiotensin converting enzyme inhibitor peptides and antiviral agents including phycobiliproteins, sulfated polysaccharides, and calcium-spirulan <span class="citation" data-cites="S1A3WazG">[<a href="#ref-S1A3WazG" role="doc-biblioref">1648</a>]</span>.
+n-3 PUFAs have been investigated for many years for their therapeutic potential <span class="citation" data-cites="4xymCvKH">[<a href="#ref-4xymCvKH" role="doc-biblioref">1649</a>]</span>.
+Supplementation with fish oils is generally well tolerated <span class="citation" data-cites="4xymCvKH">[<a href="#ref-4xymCvKH" role="doc-biblioref">1649</a>]</span>, and intake of n-3 PUFAs through dietary sources or supplementation is specifically encouraged for vulnerable groups such as pregnant and lactating women <span class="citation" data-cites="17CHOdNbe g4dU6DMd">[<a href="#ref-17CHOdNbe" role="doc-biblioref">1650</a>,<a href="#ref-g4dU6DMd" role="doc-biblioref">1651</a>]</span>.
 As a result, these well-established compounds have drawn significant interest for their potential immune effects and therapeutic potential.</p>
 <p>Particular interest has arisen in n-3 PUFAs as potential therapeutics against diseases associated with inflammation.
-n-3 PUFAs have been found to modulate inflammation by influencing processes such as leukocyte chemotaxis, adhesion molecule expression, and the production of eicosanoids <span class="citation" data-cites="JNyhLAfe cvX4fl0q">[<a href="#ref-JNyhLAfe" role="doc-biblioref">1645</a>,<a href="#ref-cvX4fl0q" role="doc-biblioref">1646</a>]</span>.
-This and other evidence indicates that n-3 PUFAs may have the capacity to modulate the adaptive immune response <span class="citation" data-cites="JNyhLAfe Ufvsmc3N 2Us0gNMr">[<a href="#ref-2Us0gNMr" role="doc-biblioref">1618</a>,<a href="#ref-Ufvsmc3N" role="doc-biblioref">1638</a>,<a href="#ref-JNyhLAfe" role="doc-biblioref">1645</a>]</span>; for example, they have been found to influence antigen presentation and the production of CD4(+) Th1 cells, among other relevant effects <span class="citation" data-cites="165UR0Ipw">[<a href="#ref-165UR0Ipw" role="doc-biblioref">1647</a>]</span>.
-Certainly, preliminary evidence from banked blood samples from 100 COVID-19 patients suggests that patients with a higher omega-3 index, a measure of the amount of EPA and DHA in red blood cells, had a lower risk of death due to COVID-19 <span class="citation" data-cites="TTfh7mb9">[<a href="#ref-TTfh7mb9" role="doc-biblioref">1648</a>]</span>.
-Interest has also arisen as to whether nutritional status related to n-3 PUFAs can also affect inflammation associated with severe disease, such as ARDS or sepsis <span class="citation" data-cites="FtxL59jJ 12vyTsM9W">[<a href="#ref-FtxL59jJ" role="doc-biblioref">1649</a>,<a href="#ref-12vyTsM9W" role="doc-biblioref">1650</a>]</span>.
+n-3 PUFAs have been found to modulate inflammation by influencing processes such as leukocyte chemotaxis, adhesion molecule expression, and the production of eicosanoids <span class="citation" data-cites="JNyhLAfe cvX4fl0q">[<a href="#ref-JNyhLAfe" role="doc-biblioref">1652</a>,<a href="#ref-cvX4fl0q" role="doc-biblioref">1653</a>]</span>.
+This and other evidence indicates that n-3 PUFAs may have the capacity to modulate the adaptive immune response <span class="citation" data-cites="JNyhLAfe Ufvsmc3N 2Us0gNMr">[<a href="#ref-2Us0gNMr" role="doc-biblioref">1625</a>,<a href="#ref-Ufvsmc3N" role="doc-biblioref">1645</a>,<a href="#ref-JNyhLAfe" role="doc-biblioref">1652</a>]</span>; for example, they have been found to influence antigen presentation and the production of CD4(+) Th1 cells, among other relevant effects <span class="citation" data-cites="165UR0Ipw">[<a href="#ref-165UR0Ipw" role="doc-biblioref">1654</a>]</span>.
+Certainly, preliminary evidence from banked blood samples from 100 COVID-19 patients suggests that patients with a higher omega-3 index, a measure of the amount of EPA and DHA in red blood cells, had a lower risk of death due to COVID-19 <span class="citation" data-cites="TTfh7mb9">[<a href="#ref-TTfh7mb9" role="doc-biblioref">1655</a>]</span>.
+Interest has also arisen as to whether nutritional status related to n-3 PUFAs can also affect inflammation associated with severe disease, such as ARDS or sepsis <span class="citation" data-cites="FtxL59jJ 12vyTsM9W">[<a href="#ref-FtxL59jJ" role="doc-biblioref">1656</a>,<a href="#ref-12vyTsM9W" role="doc-biblioref">1657</a>]</span>.
 ARDS and sepsis hold particular concern in the treatment of severe COVID-19; an analysis of 82 deceased COVID-19 patients in Wuhan during January to February 2020 reported that respiratory failure (associated with ARDS) was the cause of death in 69.5% of cases, and sepsis or multi-organ failure accounted for 28.0% of deaths <span class="citation" data-cites="16mSlRgM3">[<a href="#ref-16mSlRgM3" role="doc-biblioref">732</a>]</span>.
 Research in ARDS prior to current pandemic suggests that n-3 PUFAs may hold some therapeutic potential.
-One study randomized 16 consecutive ARDS patients to receive either a fish oil-enriched lipid emulsion or a control lipid emulsion (comprised of 100% long-chain triglycerides) under a double-blinded design <span class="citation" data-cites="LmdFoxGc">[<a href="#ref-LmdFoxGc" role="doc-biblioref">1651</a>]</span>.
+One study randomized 16 consecutive ARDS patients to receive either a fish oil-enriched lipid emulsion or a control lipid emulsion (comprised of 100% long-chain triglycerides) under a double-blinded design <span class="citation" data-cites="LmdFoxGc">[<a href="#ref-LmdFoxGc" role="doc-biblioref">1658</a>]</span>.
 They reported a statistically significant reduction in leukotriene B4 levels in the group receiving the fish oil-enriched emulsion, suggesting that the fish oil supplementation may have reduced inflammation.
 However, they also reported that most of their tests were not statistically significant, and therefore it seems that additional research using larger sample sizes is required.
-A recent meta-analysis of 10 randomized controlled trials (RCTs) examining the effects of n-3 PUFAs on ARDS patients did not find evidence of any effect on mortality, although the effect on secondary outcomes could not be determined due to a low quality of evidence <span class="citation" data-cites="q9FzffQx">[<a href="#ref-q9FzffQx" role="doc-biblioref">1652</a>]</span>.
-However, another meta-analysis that examined 24 RCTs studying the effects of n-3 fatty acids on sepsis, including ARDS-induced sepsis, did find support for an effect on mortality when n-3 fatty acids were administered via enteral nutrition, although a paucity of high-quality evidence again limited conclusions <span class="citation" data-cites="EwajTsK5">[<a href="#ref-EwajTsK5" role="doc-biblioref">1653</a>]</span>.
+A recent meta-analysis of 10 randomized controlled trials (RCTs) examining the effects of n-3 PUFAs on ARDS patients did not find evidence of any effect on mortality, although the effect on secondary outcomes could not be determined due to a low quality of evidence <span class="citation" data-cites="q9FzffQx">[<a href="#ref-q9FzffQx" role="doc-biblioref">1659</a>]</span>.
+However, another meta-analysis that examined 24 RCTs studying the effects of n-3 fatty acids on sepsis, including ARDS-induced sepsis, did find support for an effect on mortality when n-3 fatty acids were administered via enteral nutrition, although a paucity of high-quality evidence again limited conclusions <span class="citation" data-cites="EwajTsK5">[<a href="#ref-EwajTsK5" role="doc-biblioref">1660</a>]</span>.
 Therefore, despite theoretical support for an immunomodulatory effect of n-3 PUFAs in COVID-19, evidence from existing RCTs is insufficient to determine whether supplementation offers an advantage in a clinical setting that would be relevant to COVID-19.</p>
-<p>Another potential mechanism that has led to interest in n-3 PUFAs as protective against viral infections including COVID-19 is its potential as a precursor molecule for the biosynthesis of endogenous specialized proresolving mediators (SPM), such as protectins and resolvins, that actively resolve inflammation and infection <span class="citation" data-cites="BIVORG2X">[<a href="#ref-BIVORG2X" role="doc-biblioref">1654</a>]</span>.
-SPM have exhibited beneficial effects against a variety of lung infections, including some caused by RNA viruses <span class="citation" data-cites="uPOTvvjR sxgmhJ68">[<a href="#ref-uPOTvvjR" role="doc-biblioref">1655</a>,<a href="#ref-sxgmhJ68" role="doc-biblioref">1656</a>]</span>.
-Several mechanisms for SPM have been proposed, including preventing the release of pro-inflammatory cytokines and chemokines or increasing phagocytosis of cellular debris by macrophages <span class="citation" data-cites="OSEnHt6H">[<a href="#ref-OSEnHt6H" role="doc-biblioref">1657</a>]</span>.
-In influenza, SPM promote antiviral B lymphocytic activities <span class="citation" data-cites="MK0GQ55y">[<a href="#ref-MK0GQ55y" role="doc-biblioref">1658</a>]</span>, and protectin D1 has been shown to increase survival from H1N1 viral infection in mice by affecting the viral replication machinery <span class="citation" data-cites="fIo3ESPM">[<a href="#ref-fIo3ESPM" role="doc-biblioref">1659</a>]</span>.
-It has thus been hypothesized that SPM could aid in the resolution of the cytokine storm and pulmonary inflammation associated with COVID-19 <span class="citation" data-cites="14LjKv9ZH PRLlghQS">[<a href="#ref-14LjKv9ZH" role="doc-biblioref">1660</a>,<a href="#ref-PRLlghQS" role="doc-biblioref">1661</a>]</span>.
-Another theory is that some comorbidities, such as obesity, could lead to deficiencies of SPM, which could in turn be related to the occurrence of adverse outcomes for COVID-19 <span class="citation" data-cites="oLunKkIG">[<a href="#ref-oLunKkIG" role="doc-biblioref">1662</a>]</span>.
-However, not all studies are in agreement that n-3 PUFAs or their resulting SPM are effective against infections <span class="citation" data-cites="B8toe6Mr">[<a href="#ref-B8toe6Mr" role="doc-biblioref">1663</a>]</span>.
-At a minimum, the effectiveness of n-3 PUFAs against infections would be dependent on the dosage, timing, and the specific pathogens responsible <span class="citation" data-cites="3Xht24k3">[<a href="#ref-3Xht24k3" role="doc-biblioref">1664</a>]</span>.
-On another level, there is still the question of whether fish oils can raise the levels of SPM levels upon ingestion and in response to acute inflammation in humans <span class="citation" data-cites="Ge00xeR3">[<a href="#ref-Ge00xeR3" role="doc-biblioref">1665</a>]</span>.
-Currently, Karolinska University Hospital is running a trial that will measure the levels of SPM as a secondary outcome following intravenous supplementation of n-3 PUFAs in hospitalized COVID-19 patients to determine whether n-3 PUFAs provides therapeutic value <span class="citation" data-cites="n93SvQ2p pIfWCVkv">[<a href="#ref-n93SvQ2p" role="doc-biblioref">1666</a>,<a href="#ref-pIfWCVkv" role="doc-biblioref">1667</a>]</span>.
+<p>Another potential mechanism that has led to interest in n-3 PUFAs as protective against viral infections including COVID-19 is its potential as a precursor molecule for the biosynthesis of endogenous specialized proresolving mediators (SPM), such as protectins and resolvins, that actively resolve inflammation and infection <span class="citation" data-cites="BIVORG2X">[<a href="#ref-BIVORG2X" role="doc-biblioref">1661</a>]</span>.
+SPM have exhibited beneficial effects against a variety of lung infections, including some caused by RNA viruses <span class="citation" data-cites="uPOTvvjR sxgmhJ68">[<a href="#ref-uPOTvvjR" role="doc-biblioref">1662</a>,<a href="#ref-sxgmhJ68" role="doc-biblioref">1663</a>]</span>.
+Several mechanisms for SPM have been proposed, including preventing the release of pro-inflammatory cytokines and chemokines or increasing phagocytosis of cellular debris by macrophages <span class="citation" data-cites="OSEnHt6H">[<a href="#ref-OSEnHt6H" role="doc-biblioref">1664</a>]</span>.
+In influenza, SPM promote antiviral B lymphocytic activities <span class="citation" data-cites="MK0GQ55y">[<a href="#ref-MK0GQ55y" role="doc-biblioref">1665</a>]</span>, and protectin D1 has been shown to increase survival from H1N1 viral infection in mice by affecting the viral replication machinery <span class="citation" data-cites="fIo3ESPM">[<a href="#ref-fIo3ESPM" role="doc-biblioref">1666</a>]</span>.
+It has thus been hypothesized that SPM could aid in the resolution of the cytokine storm and pulmonary inflammation associated with COVID-19 <span class="citation" data-cites="14LjKv9ZH PRLlghQS">[<a href="#ref-14LjKv9ZH" role="doc-biblioref">1667</a>,<a href="#ref-PRLlghQS" role="doc-biblioref">1668</a>]</span>.
+Another theory is that some comorbidities, such as obesity, could lead to deficiencies of SPM, which could in turn be related to the occurrence of adverse outcomes for COVID-19 <span class="citation" data-cites="oLunKkIG">[<a href="#ref-oLunKkIG" role="doc-biblioref">1669</a>]</span>.
+However, not all studies are in agreement that n-3 PUFAs or their resulting SPM are effective against infections <span class="citation" data-cites="B8toe6Mr">[<a href="#ref-B8toe6Mr" role="doc-biblioref">1670</a>]</span>.
+At a minimum, the effectiveness of n-3 PUFAs against infections would be dependent on the dosage, timing, and the specific pathogens responsible <span class="citation" data-cites="3Xht24k3">[<a href="#ref-3Xht24k3" role="doc-biblioref">1671</a>]</span>.
+On another level, there is still the question of whether fish oils can raise the levels of SPM levels upon ingestion and in response to acute inflammation in humans <span class="citation" data-cites="Ge00xeR3">[<a href="#ref-Ge00xeR3" role="doc-biblioref">1672</a>]</span>.
+Currently, Karolinska University Hospital is running a trial that will measure the levels of SPM as a secondary outcome following intravenous supplementation of n-3 PUFAs in hospitalized COVID-19 patients to determine whether n-3 PUFAs provides therapeutic value <span class="citation" data-cites="n93SvQ2p pIfWCVkv">[<a href="#ref-n93SvQ2p" role="doc-biblioref">1673</a>,<a href="#ref-pIfWCVkv" role="doc-biblioref">1674</a>]</span>.
 Therefore, while this mechanism provides theoretical support for a role for n-3 PUFAs against COVID-19, experimental support is still needed.</p>
-<p>A third possible mechanism by which n-3 PUFAs could benefit COVID-19 patients arises from the fact that some COVID-19 patients, particularly those with comorbidities, are at a significant risk of thrombotic complications including arterial and venous thrombosis <span class="citation" data-cites="17jegDTvF PyKMLraw">[<a href="#ref-PyKMLraw" role="doc-biblioref">103</a>,<a href="#ref-17jegDTvF" role="doc-biblioref">1668</a>]</span>.
-Therefore, the use of prophylactic and therapeutic anticoagulants and antithrombotic agents is under consideration <span class="citation" data-cites="SxPCbOB1 rWVL91jq">[<a href="#ref-SxPCbOB1" role="doc-biblioref">1669</a>,<a href="#ref-rWVL91jq" role="doc-biblioref">1670</a>]</span>.
-Considering that there is significant evidence that n-3 fatty acids and other fish oil-derived lipids possess antithrombotic properties and anti-inflammatory properties <span class="citation" data-cites="umzPtQG7 V9MDMfpj Ufvsmc3N">[<a href="#ref-Ufvsmc3N" role="doc-biblioref">1638</a>,<a href="#ref-umzPtQG7" role="doc-biblioref">1671</a>,<a href="#ref-V9MDMfpj" role="doc-biblioref">1672</a>]</span>, they may have therapeutic value against the prothrombotic complications of COVID-19.
-In particular, concerns have been raised within the medical community about using investigational therapeutics on COVID-19 patients who are already on antiplatelet therapies due to pre-existing comorbidities because the introduction of such therapeutics could lead to issues with dosing and drug choice and/or negative drug-drug interactions <span class="citation" data-cites="SxPCbOB1">[<a href="#ref-SxPCbOB1" role="doc-biblioref">1669</a>]</span>.
+<p>A third possible mechanism by which n-3 PUFAs could benefit COVID-19 patients arises from the fact that some COVID-19 patients, particularly those with comorbidities, are at a significant risk of thrombotic complications including arterial and venous thrombosis <span class="citation" data-cites="17jegDTvF PyKMLraw">[<a href="#ref-PyKMLraw" role="doc-biblioref">103</a>,<a href="#ref-17jegDTvF" role="doc-biblioref">1675</a>]</span>.
+Therefore, the use of prophylactic and therapeutic anticoagulants and antithrombotic agents is under consideration <span class="citation" data-cites="SxPCbOB1 rWVL91jq">[<a href="#ref-SxPCbOB1" role="doc-biblioref">1676</a>,<a href="#ref-rWVL91jq" role="doc-biblioref">1677</a>]</span>.
+Considering that there is significant evidence that n-3 fatty acids and other fish oil-derived lipids possess antithrombotic properties and anti-inflammatory properties <span class="citation" data-cites="umzPtQG7 V9MDMfpj Ufvsmc3N">[<a href="#ref-Ufvsmc3N" role="doc-biblioref">1645</a>,<a href="#ref-umzPtQG7" role="doc-biblioref">1678</a>,<a href="#ref-V9MDMfpj" role="doc-biblioref">1679</a>]</span>, they may have therapeutic value against the prothrombotic complications of COVID-19.
+In particular, concerns have been raised within the medical community about using investigational therapeutics on COVID-19 patients who are already on antiplatelet therapies due to pre-existing comorbidities because the introduction of such therapeutics could lead to issues with dosing and drug choice and/or negative drug-drug interactions <span class="citation" data-cites="SxPCbOB1">[<a href="#ref-SxPCbOB1" role="doc-biblioref">1676</a>]</span>.
 In such cases, dietary sources of n-3 fatty acids or other nutraceuticals with antiplatelet activities could hold particular value for reducing the risk of thrombotic complications in patients already receiving pharmaceutical antiplatelet therapies.
-A new clinical trial <span class="citation" data-cites="QKHdIx2w">[<a href="#ref-QKHdIx2w" role="doc-biblioref">1673</a>]</span> is currently recruiting COVID-19 positive patients to investigate the anti-inflammatory activity of a recently developed, highly purified nutraceutical derivative of EPA known as icosapent ethyl (Vascepa<sup>TM</sup>) <span class="citation" data-cites="12Q4bY0vF">[<a href="#ref-12Q4bY0vF" role="doc-biblioref">1674</a>]</span>.
-Other randomized controlled trials that are in the preparatory stages intend to investigate the administration of EPA and other bioactive compounds to COVID-19 positive patients in order to observe whether anti-inflammatory effects or disease state improvements occur <span class="citation" data-cites="8lPjdnE7 1AGVAbQuf">[<a href="#ref-8lPjdnE7" role="doc-biblioref">1675</a>,<a href="#ref-1AGVAbQuf" role="doc-biblioref">1676</a>]</span>.
-Finally, while there have been studies investigating the therapeutic value of n-3 fatty acids against ARDS in humans, there is still limited evidence of their effectiveness <span class="citation" data-cites="XHtzuR5c">[<a href="#ref-XHtzuR5c" role="doc-biblioref">1677</a>]</span>.
+A new clinical trial <span class="citation" data-cites="QKHdIx2w">[<a href="#ref-QKHdIx2w" role="doc-biblioref">1680</a>]</span> is currently recruiting COVID-19 positive patients to investigate the anti-inflammatory activity of a recently developed, highly purified nutraceutical derivative of EPA known as icosapent ethyl (Vascepa<sup>TM</sup>) <span class="citation" data-cites="12Q4bY0vF">[<a href="#ref-12Q4bY0vF" role="doc-biblioref">1681</a>]</span>.
+Other randomized controlled trials that are in the preparatory stages intend to investigate the administration of EPA and other bioactive compounds to COVID-19 positive patients in order to observe whether anti-inflammatory effects or disease state improvements occur <span class="citation" data-cites="8lPjdnE7 1AGVAbQuf">[<a href="#ref-8lPjdnE7" role="doc-biblioref">1682</a>,<a href="#ref-1AGVAbQuf" role="doc-biblioref">1683</a>]</span>.
+Finally, while there have been studies investigating the therapeutic value of n-3 fatty acids against ARDS in humans, there is still limited evidence of their effectiveness <span class="citation" data-cites="XHtzuR5c">[<a href="#ref-XHtzuR5c" role="doc-biblioref">1684</a>]</span>.
 It should be noted that the overall lack of human studies in this area means there is limited evidence as to whether these supplements could affect COVID-19 infection.
 Consequently, the clinical trials that are underway and those that have been proposed will provide valuable insight into whether the anti-inflammatory potential of n-3 PUFAs and their derivatives can be beneficial to the treatment of COVID-19.
 All the same, while the evidence is not present to draw conclusions about whether n-3 PUFAs will be useful in treating COVID-19, there is likely little harm associated with a diet rich in fish oils, and interest in n-3 PUFA supplementation by the general public is unlikely to have negative effects.</p>
 <h2 data-number="10.5" id="zinc"><span class="header-section-number">10.5</span> Zinc</h2>
 <p>Zinc is nutrient supplement that may exhibit some benefits against RNA viral infections.
-Zinc is a trace metal obtained from dietary sources or supplementation and is important for the maintenance of immune cells involved in adaptive and innate immunity <span class="citation" data-cites="VMI1lOFR">[<a href="#ref-VMI1lOFR" role="doc-biblioref">1678</a>]</span>.
+Zinc is a trace metal obtained from dietary sources or supplementation and is important for the maintenance of immune cells involved in adaptive and innate immunity <span class="citation" data-cites="VMI1lOFR">[<a href="#ref-VMI1lOFR" role="doc-biblioref">1685</a>]</span>.
 Supplements can be administered orally as a tablet or as a lozenge and are available in many forms, such as zinc picolinate, zinc acetate, and zinc citrate.
 Zinc is also available from dietary sources including meat, seafood, nuts, seeds, legumes, and dairy.
-The role of zinc in immune function has been extensively reviewed <span class="citation" data-cites="VMI1lOFR">[<a href="#ref-VMI1lOFR" role="doc-biblioref">1678</a>]</span>.
+The role of zinc in immune function has been extensively reviewed <span class="citation" data-cites="VMI1lOFR">[<a href="#ref-VMI1lOFR" role="doc-biblioref">1685</a>]</span>.
 Zinc is an important signaling molecule, and zinc levels can alter host defense systems.
-In inflammatory situations such as an infection, zinc can regulate leukocyte immune responses and modulate the nuclear factor kappa-light-chain-enhancer of activated B cells, thus altering cytokine production <span class="citation" data-cites="Qif5U0Ig 1CEzU1G34">[<a href="#ref-Qif5U0Ig" role="doc-biblioref">1679</a>,<a href="#ref-1CEzU1G34" role="doc-biblioref">1680</a>]</span>.
-In particular, zinc supplementation can increase natural killer cell levels, which are important cells for host defense against viral infections <span class="citation" data-cites="7ElRN12v VMI1lOFR">[<a href="#ref-VMI1lOFR" role="doc-biblioref">1678</a>,<a href="#ref-7ElRN12v" role="doc-biblioref">1681</a>]</span>.
+In inflammatory situations such as an infection, zinc can regulate leukocyte immune responses and modulate the nuclear factor kappa-light-chain-enhancer of activated B cells, thus altering cytokine production <span class="citation" data-cites="Qif5U0Ig 1CEzU1G34">[<a href="#ref-Qif5U0Ig" role="doc-biblioref">1686</a>,<a href="#ref-1CEzU1G34" role="doc-biblioref">1687</a>]</span>.
+In particular, zinc supplementation can increase natural killer cell levels, which are important cells for host defense against viral infections <span class="citation" data-cites="7ElRN12v VMI1lOFR">[<a href="#ref-VMI1lOFR" role="doc-biblioref">1685</a>,<a href="#ref-7ElRN12v" role="doc-biblioref">1688</a>]</span>.
 As a result of these immune-related functions, zinc is also under consideration for possible benefits against COVID-19.</p>
-<p>Adequate zinc intake has been associated with reduced incidence of infection <span class="citation" data-cites="kxuSwrCI">[<a href="#ref-kxuSwrCI" role="doc-biblioref">1682</a>]</span> and antiviral immunity <span class="citation" data-cites="IAOnO0Gj">[<a href="#ref-IAOnO0Gj" role="doc-biblioref">1683</a>]</span>.
-A randomized, double-blind, placebo-controlled trial that administered zinc supplementation to elderly subjects over the course of a year found that zinc supplementation decreased susceptibility to infection and that zinc deficiency was associated with increased susceptibility to infection <span class="citation" data-cites="kxuSwrCI">[<a href="#ref-kxuSwrCI" role="doc-biblioref">1682</a>]</span>.
-Clinical trial data supports the utility of zinc to diminish the duration and severity of symptoms associated with common colds when it is provided within 24 hours of the onset of symptoms <span class="citation" data-cites="sgr0mlJK lPexOhy6">[<a href="#ref-sgr0mlJK" role="doc-biblioref">1684</a>,<a href="#ref-lPexOhy6" role="doc-biblioref">1685</a>]</span>.
-An observational study showed that COVID-19 patients had significantly lower zinc levels in comparison to healthy controls and that zinc-deficient COVID-19 patients (those with levels less than 80 μg/dl) tended to have more complications (70.4% vs 30.0%, <em>p</em> = 0.009) and potentially prolonged hospital stays (7.9 vs 5.7 days, <em>p</em> = 0.048) relative to patients who were not zinc deficient <span class="citation" data-cites="1BU6jG2lv">[<a href="#ref-1BU6jG2lv" role="doc-biblioref">1686</a>]</span>.
-In coronaviruses specifically, <em>in vitro</em> evidence has demonstrated that the combination of zinc (Zn<sup>2+</sup>) and zinc ionophores (pyrithione) can interrupt the replication mechanisms of SARS-CoV-GFP (a fluorescently tagged SARS-CoV-1) and a variety of other RNA viruses <span class="citation" data-cites="6aOUJdHa NB1udFHF">[<a href="#ref-6aOUJdHa" role="doc-biblioref">1687</a>,<a href="#ref-NB1udFHF" role="doc-biblioref">1688</a>]</span>.
+<p>Adequate zinc intake has been associated with reduced incidence of infection <span class="citation" data-cites="kxuSwrCI">[<a href="#ref-kxuSwrCI" role="doc-biblioref">1689</a>]</span> and antiviral immunity <span class="citation" data-cites="IAOnO0Gj">[<a href="#ref-IAOnO0Gj" role="doc-biblioref">1690</a>]</span>.
+A randomized, double-blind, placebo-controlled trial that administered zinc supplementation to elderly subjects over the course of a year found that zinc supplementation decreased susceptibility to infection and that zinc deficiency was associated with increased susceptibility to infection <span class="citation" data-cites="kxuSwrCI">[<a href="#ref-kxuSwrCI" role="doc-biblioref">1689</a>]</span>.
+Clinical trial data supports the utility of zinc to diminish the duration and severity of symptoms associated with common colds when it is provided within 24 hours of the onset of symptoms <span class="citation" data-cites="sgr0mlJK lPexOhy6">[<a href="#ref-sgr0mlJK" role="doc-biblioref">1691</a>,<a href="#ref-lPexOhy6" role="doc-biblioref">1692</a>]</span>.
+An observational study showed that COVID-19 patients had significantly lower zinc levels in comparison to healthy controls and that zinc-deficient COVID-19 patients (those with levels less than 80 μg/dl) tended to have more complications (70.4% vs 30.0%, <em>p</em> = 0.009) and potentially prolonged hospital stays (7.9 vs 5.7 days, <em>p</em> = 0.048) relative to patients who were not zinc deficient <span class="citation" data-cites="1BU6jG2lv">[<a href="#ref-1BU6jG2lv" role="doc-biblioref">1693</a>]</span>.
+In coronaviruses specifically, <em>in vitro</em> evidence has demonstrated that the combination of zinc (Zn<sup>2+</sup>) and zinc ionophores (pyrithione) can interrupt the replication mechanisms of SARS-CoV-GFP (a fluorescently tagged SARS-CoV-1) and a variety of other RNA viruses <span class="citation" data-cites="6aOUJdHa NB1udFHF">[<a href="#ref-6aOUJdHa" role="doc-biblioref">1694</a>,<a href="#ref-NB1udFHF" role="doc-biblioref">1695</a>]</span>.
 Currently, there are over twenty clinical trials registered with the intention to use zinc in a preventative or therapeutic manner for COVID-19.
-However, many of these trials proposed the use of zinc in conjunction with hydroxychloroquine and azithromycin <span class="citation" data-cites="XJrj3MiZ 1EqFW3G4X Hc9mjVB2 T0aXNTIp">[<a href="#ref-XJrj3MiZ" role="doc-biblioref">1689</a>,<a href="#ref-1EqFW3G4X" role="doc-biblioref">1690</a>,<a href="#ref-Hc9mjVB2" role="doc-biblioref">1691</a>,<a href="#ref-T0aXNTIp" role="doc-biblioref">1692</a>]</span>, and it is not known how the lack of evidence supporting the use of hydroxychloroquine will affect investigation of zinc.
+However, many of these trials proposed the use of zinc in conjunction with hydroxychloroquine and azithromycin <span class="citation" data-cites="XJrj3MiZ 1EqFW3G4X Hc9mjVB2 T0aXNTIp">[<a href="#ref-XJrj3MiZ" role="doc-biblioref">1696</a>,<a href="#ref-1EqFW3G4X" role="doc-biblioref">1697</a>,<a href="#ref-Hc9mjVB2" role="doc-biblioref">1698</a>,<a href="#ref-T0aXNTIp" role="doc-biblioref">1699</a>]</span>, and it is not known how the lack of evidence supporting the use of hydroxychloroquine will affect investigation of zinc.
 One retrospective observational study of New York University Langone hospitals in New York compared outcomes among hospitalized COVID-19 patients administered hydroxychloroquine and azithromycin with zinc sulfate (n = 411) versus hydroxychloroquine and azithromycin alone (n = 521).
-Notably, zinc is the only treatment that was used in this trial that is still under consideration as a therapeutic agent due to the lack of efficacy and potential adverse events associated with hydroxychloroquine and azithromycin against COVID-19 <span class="citation" data-cites="SmqHOsyB T94OBz6q 1F4wtzwpV">[<a href="#ref-SmqHOsyB" role="doc-biblioref">1693</a>,<a href="#ref-T94OBz6q" role="doc-biblioref">1694</a>,<a href="#ref-1F4wtzwpV" role="doc-biblioref">1695</a>]</span>.
-While the addition of zinc sulfate did not affect the duration of hospitalization, the length of ICU stays or patient ventilation duration, univariate analyses indicated that zinc did increase the frequency of patients discharged and decreased the requirement for ventilation, referrals to the ICU, and mortality <span class="citation" data-cites="Xi9zDqwZ">[<a href="#ref-Xi9zDqwZ" role="doc-biblioref">1696</a>]</span>.
-However, a smaller retrospective study at Hoboken University Medical Center New Jersey failed to find an association between zinc supplementation and survival of hospitalized patients <span class="citation" data-cites="110pLAjkl">[<a href="#ref-110pLAjkl" role="doc-biblioref">1697</a>]</span>.
+Notably, zinc is the only treatment that was used in this trial that is still under consideration as a therapeutic agent due to the lack of efficacy and potential adverse events associated with hydroxychloroquine and azithromycin against COVID-19 <span class="citation" data-cites="SmqHOsyB T94OBz6q 1F4wtzwpV">[<a href="#ref-SmqHOsyB" role="doc-biblioref">1700</a>,<a href="#ref-T94OBz6q" role="doc-biblioref">1701</a>,<a href="#ref-1F4wtzwpV" role="doc-biblioref">1702</a>]</span>.
+While the addition of zinc sulfate did not affect the duration of hospitalization, the length of ICU stays or patient ventilation duration, univariate analyses indicated that zinc did increase the frequency of patients discharged and decreased the requirement for ventilation, referrals to the ICU, and mortality <span class="citation" data-cites="Xi9zDqwZ">[<a href="#ref-Xi9zDqwZ" role="doc-biblioref">1703</a>]</span>.
+However, a smaller retrospective study at Hoboken University Medical Center New Jersey failed to find an association between zinc supplementation and survival of hospitalized patients <span class="citation" data-cites="110pLAjkl">[<a href="#ref-110pLAjkl" role="doc-biblioref">1704</a>]</span>.
 Therefore, whether zinc contributes to COVID-19 recovery remains unclear.
-Other trials are now investigating zinc in conjunction with other supplements such as vitamin C or n-3 PUFA <span class="citation" data-cites="1GGbb9IZt 1AGVAbQuf">[<a href="#ref-1AGVAbQuf" role="doc-biblioref">1676</a>,<a href="#ref-1GGbb9IZt" role="doc-biblioref">1698</a>]</span>.
+Other trials are now investigating zinc in conjunction with other supplements such as vitamin C or n-3 PUFA <span class="citation" data-cites="1GGbb9IZt 1AGVAbQuf">[<a href="#ref-1AGVAbQuf" role="doc-biblioref">1683</a>,<a href="#ref-1GGbb9IZt" role="doc-biblioref">1705</a>]</span>.
 Though there is, overall, encouraging data for zinc supplementation against the common cold and viral infections, there is currently limited evidence to suggest zinc supplementation has any beneficial effects against the current novel COVID-19; thus, the clinical trials that are currently underway will provide vital information on the efficacious use of zinc in COVID-19 prevention and/or treatment.
 However, given the limited risk and the potential association between zinc deficiency and illness, maintaining a healthy diet to ensure an adequate zinc status may be advisable for individuals seeking to reduce their likelihood of infection.</p>
 <h2 data-number="10.6" id="vitamin-c"><span class="header-section-number">10.6</span> Vitamin C</h2>
-<p>Vitamins B, C, D, and E have also been suggested as potential nutrient supplement interventions for COVID-19 <span class="citation" data-cites="2hMFPQJR 3RCeQRRc">[<a href="#ref-2hMFPQJR" role="doc-biblioref">1636</a>,<a href="#ref-3RCeQRRc" role="doc-biblioref">1699</a>]</span>.
-In particular vitamin C has been proposed as a potential therapeutic agent against COVID-19 due to its long history of use against the common cold and other respiratory infections <span class="citation" data-cites="190FMJu3y EbAGaMxL">[<a href="#ref-190FMJu3y" role="doc-biblioref">1700</a>,<a href="#ref-EbAGaMxL" role="doc-biblioref">1701</a>]</span>.
+<p>Vitamins B, C, D, and E have also been suggested as potential nutrient supplement interventions for COVID-19 <span class="citation" data-cites="2hMFPQJR 3RCeQRRc">[<a href="#ref-2hMFPQJR" role="doc-biblioref">1643</a>,<a href="#ref-3RCeQRRc" role="doc-biblioref">1706</a>]</span>.
+In particular vitamin C has been proposed as a potential therapeutic agent against COVID-19 due to its long history of use against the common cold and other respiratory infections <span class="citation" data-cites="190FMJu3y EbAGaMxL">[<a href="#ref-190FMJu3y" role="doc-biblioref">1707</a>,<a href="#ref-EbAGaMxL" role="doc-biblioref">1708</a>]</span>.
 Vitamin C can be obtained via dietary sources such as fruits and vegetables or via supplementation.
 Vitamin C plays a significant role in promoting immune function due to its effects on various immune cells.
-It affects inflammation by modulating cytokine production, decreasing histamine levels, enhancing the differentiation and proliferation of T- and B-lymphocytes, increasing antibody levels, and protecting against the negative effects of reactive oxygen species, among other effects related to COVID-19 pathology <span class="citation" data-cites="9czQt5cR RjFxOURM 13M3VAfY9">[<a href="#ref-9czQt5cR" role="doc-biblioref">1702</a>,<a href="#ref-RjFxOURM" role="doc-biblioref">1703</a>,<a href="#ref-13M3VAfY9" role="doc-biblioref">1704</a>]</span>.
+It affects inflammation by modulating cytokine production, decreasing histamine levels, enhancing the differentiation and proliferation of T- and B-lymphocytes, increasing antibody levels, and protecting against the negative effects of reactive oxygen species, among other effects related to COVID-19 pathology <span class="citation" data-cites="9czQt5cR RjFxOURM 13M3VAfY9">[<a href="#ref-9czQt5cR" role="doc-biblioref">1709</a>,<a href="#ref-RjFxOURM" role="doc-biblioref">1710</a>,<a href="#ref-13M3VAfY9" role="doc-biblioref">1711</a>]</span>.
 Vitamin C is utilized by the body during viral infections, as evinced by lower concentrations in leukocytes and lower concentrations of urinary vitamin C.
-Post-infection, these levels return to baseline ranges <span class="citation" data-cites="uQFCDDIy 10nBT1HbX 1Bj8VMlSk aEEZ8Pq9 gZRPoTM9">[<a href="#ref-uQFCDDIy" role="doc-biblioref">1705</a>,<a href="#ref-10nBT1HbX" role="doc-biblioref">1706</a>,<a href="#ref-1Bj8VMlSk" role="doc-biblioref">1707</a>,<a href="#ref-aEEZ8Pq9" role="doc-biblioref">1708</a>,<a href="#ref-gZRPoTM9" role="doc-biblioref">1709</a>]</span>.
-It has been shown that as little as 0.1 g/d of vitamin C can maintain normal plasma levels of vitamin C in healthy individuals, but higher doses of at least 1-3 g/d are required for critically ill patients in ICUs <span class="citation" data-cites="DPhRTQw0">[<a href="#ref-DPhRTQw0" role="doc-biblioref">1710</a>]</span>.
-Indeed, vitamin C deficiency appears to be common among COVID-19 patients <span class="citation" data-cites="WEWGGYKl Zrm5dyM1">[<a href="#ref-WEWGGYKl" role="doc-biblioref">1711</a>,<a href="#ref-Zrm5dyM1" role="doc-biblioref">1712</a>]</span>.
-COVID-19 is also associated with the formation of microthrombi and coagulopathy <span class="citation" data-cites="17y6YeJ6R">[<a href="#ref-17y6YeJ6R" role="doc-biblioref">105</a>]</span> that contribute to its characteristic lung pathology <span class="citation" data-cites="19taZjxIT">[<a href="#ref-19taZjxIT" role="doc-biblioref">1713</a>]</span>, but these symptoms can be ameliorated by early infusions of vitamin C to inhibit endothelial surface P-selectin expression and platelet-endothelial adhesion <span class="citation" data-cites="WKBgtN6W">[<a href="#ref-WKBgtN6W" role="doc-biblioref">1714</a>]</span>.
-Intravenous vitamin C also reduced D-dimer levels in a case study of 17 COVID-19 patients <span class="citation" data-cites="d9353XOW">[<a href="#ref-d9353XOW" role="doc-biblioref">1715</a>]</span>.
+Post-infection, these levels return to baseline ranges <span class="citation" data-cites="uQFCDDIy 10nBT1HbX 1Bj8VMlSk aEEZ8Pq9 gZRPoTM9">[<a href="#ref-uQFCDDIy" role="doc-biblioref">1712</a>,<a href="#ref-10nBT1HbX" role="doc-biblioref">1713</a>,<a href="#ref-1Bj8VMlSk" role="doc-biblioref">1714</a>,<a href="#ref-aEEZ8Pq9" role="doc-biblioref">1715</a>,<a href="#ref-gZRPoTM9" role="doc-biblioref">1716</a>]</span>.
+It has been shown that as little as 0.1 g/d of vitamin C can maintain normal plasma levels of vitamin C in healthy individuals, but higher doses of at least 1-3 g/d are required for critically ill patients in ICUs <span class="citation" data-cites="DPhRTQw0">[<a href="#ref-DPhRTQw0" role="doc-biblioref">1717</a>]</span>.
+Indeed, vitamin C deficiency appears to be common among COVID-19 patients <span class="citation" data-cites="WEWGGYKl Zrm5dyM1">[<a href="#ref-WEWGGYKl" role="doc-biblioref">1718</a>,<a href="#ref-Zrm5dyM1" role="doc-biblioref">1719</a>]</span>.
+COVID-19 is also associated with the formation of microthrombi and coagulopathy <span class="citation" data-cites="17y6YeJ6R">[<a href="#ref-17y6YeJ6R" role="doc-biblioref">105</a>]</span> that contribute to its characteristic lung pathology <span class="citation" data-cites="19taZjxIT">[<a href="#ref-19taZjxIT" role="doc-biblioref">1720</a>]</span>, but these symptoms can be ameliorated by early infusions of vitamin C to inhibit endothelial surface P-selectin expression and platelet-endothelial adhesion <span class="citation" data-cites="WKBgtN6W">[<a href="#ref-WKBgtN6W" role="doc-biblioref">1721</a>]</span>.
+Intravenous vitamin C also reduced D-dimer levels in a case study of 17 COVID-19 patients <span class="citation" data-cites="d9353XOW">[<a href="#ref-d9353XOW" role="doc-biblioref">1722</a>]</span>.
 D-dimer levels are an important indicator of thrombus formation and breakdown and are notably elevated in COVID-19 patients <span class="citation" data-cites="18AiyvhO8 v1EIzwfx">[<a href="#ref-v1EIzwfx" role="doc-biblioref">101</a>,<a href="#ref-18AiyvhO8" role="doc-biblioref">102</a>]</span>.
 There is therefore preliminary evidence suggesting that vitamin C status and vitamin C administration may be relevant to COVID-19 outcomes.</p>
 <p>Larger-scale studies of vitamin C, however, have provided mixed results.
-A recent meta-analysis found consistent support for regular vitamin C supplementation reducing the duration of the common cold, but that supplementation with vitamin C (&gt; 200 mg) failed to reduce the incidence of colds <span class="citation" data-cites="Pb5PCH7y">[<a href="#ref-Pb5PCH7y" role="doc-biblioref">1716</a>]</span>.
-Individual studies have found Vitamin C to reduce the susceptibility of patients to lower respiratory tract infections, such as pneumonia <span class="citation" data-cites="JARvpqRw">[<a href="#ref-JARvpqRw" role="doc-biblioref">1717</a>]</span>.
+A recent meta-analysis found consistent support for regular vitamin C supplementation reducing the duration of the common cold, but that supplementation with vitamin C (&gt; 200 mg) failed to reduce the incidence of colds <span class="citation" data-cites="Pb5PCH7y">[<a href="#ref-Pb5PCH7y" role="doc-biblioref">1723</a>]</span>.
+Individual studies have found Vitamin C to reduce the susceptibility of patients to lower respiratory tract infections, such as pneumonia <span class="citation" data-cites="JARvpqRw">[<a href="#ref-JARvpqRw" role="doc-biblioref">1724</a>]</span>.
 Another meta-analysis demonstrated that in twelve trials, vitamin C supplementation reduced the length of stay of patients in intensive care units (ICUs) by 7.8% (95% CI: 4.2% to 11.2%; <em>p</em> = 0.00003).
 Furthermore, high doses (1-3 g/day) significantly reduced the length of an ICU stay by 8.6% in six trials (<em>p</em> = 0.003).
-Vitamin C also shortened the duration of mechanical ventilation by 18.2% in three trials in which patients required intervention for over 24 hours (95% CI 7.7% to 27%; p = 0.001) <span class="citation" data-cites="DPhRTQw0">[<a href="#ref-DPhRTQw0" role="doc-biblioref">1710</a>]</span>.
-Despite these findings, an RCT of 167 patients known as CITRUS ALI failed to show a benefit of a 96-hour infusion of vitamin C to treat ARDS <span class="citation" data-cites="Rt5Aik4p">[<a href="#ref-Rt5Aik4p" role="doc-biblioref">1718</a>]</span>.
-Clinical trials specifically investigating vitamin C in the context of COVID-19 have now begun, as highlighted by Carr et al. <span class="citation" data-cites="EbAGaMxL">[<a href="#ref-EbAGaMxL" role="doc-biblioref">1701</a>]</span>.
+Vitamin C also shortened the duration of mechanical ventilation by 18.2% in three trials in which patients required intervention for over 24 hours (95% CI 7.7% to 27%; p = 0.001) <span class="citation" data-cites="DPhRTQw0">[<a href="#ref-DPhRTQw0" role="doc-biblioref">1717</a>]</span>.
+Despite these findings, an RCT of 167 patients known as CITRUS ALI failed to show a benefit of a 96-hour infusion of vitamin C to treat ARDS <span class="citation" data-cites="Rt5Aik4p">[<a href="#ref-Rt5Aik4p" role="doc-biblioref">1725</a>]</span>.
+Clinical trials specifically investigating vitamin C in the context of COVID-19 have now begun, as highlighted by Carr et al. <span class="citation" data-cites="EbAGaMxL">[<a href="#ref-EbAGaMxL" role="doc-biblioref">1708</a>]</span>.
 These trials intend to investigate the use of intravenous vitamin C in hospitalized COVID-19 patients.
-The first trial to report initial results took place in Wuhan, China <span class="citation" data-cites="nwa7WdNM">[<a href="#ref-nwa7WdNM" role="doc-biblioref">1719</a>]</span>.
-These initial results indicated that the administration of 12 g/12 hr of intravenous vitamin C for 7 days in 56 critically ill COVID-19 patients resulted in a promising reduction of 28-day mortality (<em>p</em> = 0.06) in univariate survival analysis <span class="citation" data-cites="ZX7LDDp0">[<a href="#ref-ZX7LDDp0" role="doc-biblioref">1720</a>]</span>.
-Indeed, the same study reported a significant decrease in IL-6 levels by day 7 of vitamin C infusion (<em>p</em> = 0.04) <span class="citation" data-cites="RM8v7Y7H">[<a href="#ref-RM8v7Y7H" role="doc-biblioref">1721</a>]</span>.
+The first trial to report initial results took place in Wuhan, China <span class="citation" data-cites="nwa7WdNM">[<a href="#ref-nwa7WdNM" role="doc-biblioref">1726</a>]</span>.
+These initial results indicated that the administration of 12 g/12 hr of intravenous vitamin C for 7 days in 56 critically ill COVID-19 patients resulted in a promising reduction of 28-day mortality (<em>p</em> = 0.06) in univariate survival analysis <span class="citation" data-cites="ZX7LDDp0">[<a href="#ref-ZX7LDDp0" role="doc-biblioref">1727</a>]</span>.
+Indeed, the same study reported a significant decrease in IL-6 levels by day 7 of vitamin C infusion (<em>p</em> = 0.04) <span class="citation" data-cites="RM8v7Y7H">[<a href="#ref-RM8v7Y7H" role="doc-biblioref">1728</a>]</span>.
 Additional studies that are being conducted in Canada, China, Iran, and the USA will provide additional insight into whether vitamin C supplementation affects COVID-19 outcomes on a larger scale.</p>
 <p>Even though evidence supporting the use of vitamin C is beginning to emerge, we will not know how effective vitamin C is as a therapeutic for quite some time.
 Currently (as of January 2021) over fifteen trials are registered with clinicaltrials.gov that are either recruiting, active or are currently in preparation.
@@ -5014,123 +5000,123 @@ <h2 data-number="10.6" id="vitamin-c"><span class="header-section-number">10.6</
 However, the majority of supplementation studies investigate the intravenous infusion of vitamin C in severe patients.
 Therefore, there is a lack of studies investigating the potential prophylactic administration of vitamin C via oral supplementation for healthy individuals or potentially asymptomatic SARS-CoV-2 positive patients.
 Once again, vitamin C intake is part of a healthy diet and the vitamin likely presents minimal risk, but its potential prophylactic or therapeutic effects against COVID-19 are yet to be determined.
-To maintain vitamin C status, it would be prudent for individuals to ensure that they consume the recommended dietary allowance of vitamin C to maintain a healthy immune system <span class="citation" data-cites="Lyd8s4Mk">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1605</a>]</span>.
-The recommended dietary allowance according to the FDA is 75-90 mg/d, whereas EFSA recommends 110 mg/d <span class="citation" data-cites="hhf96MB1">[<a href="#ref-hhf96MB1" role="doc-biblioref">1722</a>]</span>.</p>
+To maintain vitamin C status, it would be prudent for individuals to ensure that they consume the recommended dietary allowance of vitamin C to maintain a healthy immune system <span class="citation" data-cites="Lyd8s4Mk">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1612</a>]</span>.
+The recommended dietary allowance according to the FDA is 75-90 mg/d, whereas EFSA recommends 110 mg/d <span class="citation" data-cites="hhf96MB1">[<a href="#ref-hhf96MB1" role="doc-biblioref">1729</a>]</span>.</p>
 <h2 data-number="10.7" id="vitamin-d"><span class="header-section-number">10.7</span> Vitamin D</h2>
 <p>Of all of the supplements currently under investigation, vitamin D has become a leading prophylactic and therapeutic candidate against SARS-CoV-2.
-Vitamin D can modulate both the adaptive and innate immune system and is associated with various aspects of immune health and antiviral defense <span class="citation" data-cites="3Nyo3kmR SKP7JCfL 15xVUSQRH 15ESVyKi0 npPvtBLw">[<a href="#ref-3Nyo3kmR" role="doc-biblioref">1723</a>,<a href="#ref-SKP7JCfL" role="doc-biblioref">1724</a>,<a href="#ref-15xVUSQRH" role="doc-biblioref">1725</a>,<a href="#ref-15ESVyKi0" role="doc-biblioref">1726</a>,<a href="#ref-npPvtBLw" role="doc-biblioref">1727</a>]</span>.
+Vitamin D can modulate both the adaptive and innate immune system and is associated with various aspects of immune health and antiviral defense <span class="citation" data-cites="3Nyo3kmR SKP7JCfL 15xVUSQRH 15ESVyKi0 npPvtBLw">[<a href="#ref-3Nyo3kmR" role="doc-biblioref">1730</a>,<a href="#ref-SKP7JCfL" role="doc-biblioref">1731</a>,<a href="#ref-15xVUSQRH" role="doc-biblioref">1732</a>,<a href="#ref-15ESVyKi0" role="doc-biblioref">1733</a>,<a href="#ref-npPvtBLw" role="doc-biblioref">1734</a>]</span>.
 Vitamin D can be sourced through diet or supplementation, but it is mainly biosynthesized by the body on exposure to ultraviolet light (UVB) from sunlight.
-Vitamin D deficiency is associated with an increased susceptibility to infection <span class="citation" data-cites="n3v9Thlz">[<a href="#ref-n3v9Thlz" role="doc-biblioref">1728</a>]</span>.
-In particular, vitamin D deficient patients are at risk of developing acute respiratory infections <span class="citation" data-cites="iWLsflrG">[<a href="#ref-iWLsflrG" role="doc-biblioref">1729</a>]</span> and ARDS <span class="citation" data-cites="iWLsflrG">[<a href="#ref-iWLsflrG" role="doc-biblioref">1729</a>]</span>.
+Vitamin D deficiency is associated with an increased susceptibility to infection <span class="citation" data-cites="n3v9Thlz">[<a href="#ref-n3v9Thlz" role="doc-biblioref">1735</a>]</span>.
+In particular, vitamin D deficient patients are at risk of developing acute respiratory infections <span class="citation" data-cites="iWLsflrG">[<a href="#ref-iWLsflrG" role="doc-biblioref">1736</a>]</span> and ARDS <span class="citation" data-cites="iWLsflrG">[<a href="#ref-iWLsflrG" role="doc-biblioref">1736</a>]</span>.
 1,25-dihydroxyvitamin D3 is the active form of vitamin D that is involved in adaptive and innate responses; however, due to its low concentration and a short half life of a few hours, vitamin D levels are typically measured by the longer lasting and more abundant precursor 25-hydroxyvitamin D.
-The vitamin D receptor is expressed in various immune cells, and vitamin D is an immunomodulator of antigen presenting cells, dendritic cells, macrophages, monocytes, and T- and B-lymphocytes <span class="citation" data-cites="n3v9Thlz nwEQBjV4">[<a href="#ref-n3v9Thlz" role="doc-biblioref">1728</a>,<a href="#ref-nwEQBjV4" role="doc-biblioref">1730</a>]</span>.
+The vitamin D receptor is expressed in various immune cells, and vitamin D is an immunomodulator of antigen presenting cells, dendritic cells, macrophages, monocytes, and T- and B-lymphocytes <span class="citation" data-cites="n3v9Thlz nwEQBjV4">[<a href="#ref-n3v9Thlz" role="doc-biblioref">1735</a>,<a href="#ref-nwEQBjV4" role="doc-biblioref">1737</a>]</span>.
 Due to its potential immunomodulating properties, vitamin D supplementation may be advantageous to maintain a healthy immune system.</p>
-<p>Early in the pandemic it was postulated that an individual’s vitamin D status could significantly affect their risk of developing COVID-19 <span class="citation" data-cites="9ac0GYir">[<a href="#ref-9ac0GYir" role="doc-biblioref">1731</a>]</span>.
+<p>Early in the pandemic it was postulated that an individual’s vitamin D status could significantly affect their risk of developing COVID-19 <span class="citation" data-cites="9ac0GYir">[<a href="#ref-9ac0GYir" role="doc-biblioref">1738</a>]</span>.
 This hypothesis was derived from the fact that the current pandemic emerged in Wuhan China during winter, when 25-hydroxyvitamin D concentrations are at their lowest due to a lack of sunlight, whereas in the Southern Hemisphere, where it was nearing the end of the summer and higher 25-hydroxyvitamin D concentrations would be higher, the number of cases was low.
-This led researchers to question whether there was a seasonal component to the SARS-CoV-2 pandemic and whether vitamin D levels might play a role <span class="citation" data-cites="9ac0GYir LpqYmd4C 1EEHgnhPC CS8krfan">[<a href="#ref-9ac0GYir" role="doc-biblioref">1731</a>,<a href="#ref-LpqYmd4C" role="doc-biblioref">1732</a>,<a href="#ref-1EEHgnhPC" role="doc-biblioref">1733</a>,<a href="#ref-CS8krfan" role="doc-biblioref">1734</a>]</span>.
+This led researchers to question whether there was a seasonal component to the SARS-CoV-2 pandemic and whether vitamin D levels might play a role <span class="citation" data-cites="9ac0GYir LpqYmd4C 1EEHgnhPC CS8krfan">[<a href="#ref-9ac0GYir" role="doc-biblioref">1738</a>,<a href="#ref-LpqYmd4C" role="doc-biblioref">1739</a>,<a href="#ref-1EEHgnhPC" role="doc-biblioref">1740</a>,<a href="#ref-CS8krfan" role="doc-biblioref">1741</a>]</span>.
 Though it is assumed that COVID-19 is seasonal, multiple other factors that can affect vitamin D levels should also be considered.
 These factors include an individual’s nutritional status, their age, their occupation, skin pigmentation, potential comorbidities, and the variation of exposure to sunlight due to latitude amongst others.
-Indeed, it has been estimated that each degree of latitude north of 28 degrees corresponded to a 4.4% increase of COVID-19 mortality, indirectly linking a persons vitamin D levels via exposure to UVB light to COVID-19 mortality <span class="citation" data-cites="LpqYmd4C">[<a href="#ref-LpqYmd4C" role="doc-biblioref">1732</a>]</span>.</p>
-<p>As the pandemic has evolved, additional research of varying quality has investigated some of the potential links identified early in the pandemic <span class="citation" data-cites="9ac0GYir">[<a href="#ref-9ac0GYir" role="doc-biblioref">1731</a>]</span> between vitamin D and COVID-19.
+Indeed, it has been estimated that each degree of latitude north of 28 degrees corresponded to a 4.4% increase of COVID-19 mortality, indirectly linking a persons vitamin D levels via exposure to UVB light to COVID-19 mortality <span class="citation" data-cites="LpqYmd4C">[<a href="#ref-LpqYmd4C" role="doc-biblioref">1739</a>]</span>.</p>
+<p>As the pandemic has evolved, additional research of varying quality has investigated some of the potential links identified early in the pandemic <span class="citation" data-cites="9ac0GYir">[<a href="#ref-9ac0GYir" role="doc-biblioref">1738</a>]</span> between vitamin D and COVID-19.
 Indeed, studies are beginning to investigate whether there is any prophylactic and/or therapeutic relationship between vitamin D and COVID-19.
-A study in Switzerland demonstrated that 27 SARS-CoV-2 positive patients exhibited 25-hydroxyvitamin D plasma concentrations that were significantly lower (11.1 ng/ml) than those of SARS-CoV-2 negative patients (24.6 ng/ml; <em>p</em> = 0.004), an association that held when stratifying patients greater than 70 years old <span class="citation" data-cites="1Gy7Svl72">[<a href="#ref-1Gy7Svl72" role="doc-biblioref">1735</a>]</span>.
-These findings seem to be supported by a Belgian observational study of 186 SARS-CoV-2 positive patients exhibiting symptoms of pneumonia, where 25-hydroxyvitamin D plasma concentrations were measured and CT scans of the lungs were obtained upon hospitalization <span class="citation" data-cites="GMAEaWD1">[<a href="#ref-GMAEaWD1" role="doc-biblioref">1736</a>]</span>.
+A study in Switzerland demonstrated that 27 SARS-CoV-2 positive patients exhibited 25-hydroxyvitamin D plasma concentrations that were significantly lower (11.1 ng/ml) than those of SARS-CoV-2 negative patients (24.6 ng/ml; <em>p</em> = 0.004), an association that held when stratifying patients greater than 70 years old <span class="citation" data-cites="1Gy7Svl72">[<a href="#ref-1Gy7Svl72" role="doc-biblioref">1742</a>]</span>.
+These findings seem to be supported by a Belgian observational study of 186 SARS-CoV-2 positive patients exhibiting symptoms of pneumonia, where 25-hydroxyvitamin D plasma concentrations were measured and CT scans of the lungs were obtained upon hospitalization <span class="citation" data-cites="GMAEaWD1">[<a href="#ref-GMAEaWD1" role="doc-biblioref">1743</a>]</span>.
 A significant difference in 25-hydroxyvitamin D levels was observed between the SARS-CoV-2 patients and 2,717 season-matched hospitalized controls.
 It is not clear from the study which diseases caused the control subjects to be admitted at the time of their 25-hydroxyvitamin D measurement, which makes it difficult to assess the observations reported.
 Both female and male patients possessed lower median 25-hydroxyvitamin D concentrations than the control group as a whole (18.6 ng/ml versus 21.5 ng/ml; <em>p</em> = 0.0016) and a higher rate of vitamin D deficiency (58.6% versus 42.5%).
 However, when comparisons were stratified by sex, evidence of sexual dimorphism became apparent, as female patients had equivalent levels of 25-hydroxyvitamin D to females in the control group, whereas male patients were deficient in 25-hydroxyvitamin D relative to male controls (67% versus 49%; <em>p</em> = 0.0006).
 Notably, vitamin D deficiency was progressively lower in males with advancing radiological disease stages (<em>p</em> = 0.001).
-However, these studies are supported by several others that indicate that vitamin D status may be an independent risk factor for the severity of COVID-19 <span class="citation" data-cites="GM9W6HPG kN3eqnZW 5MvUc8IL 18O6t6Jo">[<a href="#ref-GM9W6HPG" role="doc-biblioref">1737</a>,<a href="#ref-kN3eqnZW" role="doc-biblioref">1738</a>,<a href="#ref-5MvUc8IL" role="doc-biblioref">1739</a>,<a href="#ref-18O6t6Jo" role="doc-biblioref">1740</a>]</span> and in COVID-19 patients relative to population-based controls <span class="citation" data-cites="8ZxZKpYS">[<a href="#ref-8ZxZKpYS" role="doc-biblioref">1741</a>]</span>.
-Indeed, serum concentrations of 25-hydroxyvitamin D above 30 ng/ml, which indicate vitamin D sufficiency, seems to be associated with a reduction in serum C-reactive protein, an inflammatory marker, along with increased lymphocyte levels, which suggests that vitamin D levels may modulate the immune response by reducing risk for cytokine storm in response to SARS-CoV-2 infection <span class="citation" data-cites="8ZxZKpYS">[<a href="#ref-8ZxZKpYS" role="doc-biblioref">1741</a>]</span>.
-A study in India determined that COVID-19 fatality was higher in patients with severe COVID-19 and low serum 25-hydroxyvitamin D (mean level 6.2 ng/ml; 97% vitamin D deficient) levels versus asymptomatic non-severe patients with higher levels of vitamin D (mean level 27.9 ng/ml; 33% vitamin D deficient) <span class="citation" data-cites="QAEcHBzN">[<a href="#ref-QAEcHBzN" role="doc-biblioref">1742</a>]</span>.
+However, these studies are supported by several others that indicate that vitamin D status may be an independent risk factor for the severity of COVID-19 <span class="citation" data-cites="GM9W6HPG kN3eqnZW 5MvUc8IL 18O6t6Jo">[<a href="#ref-GM9W6HPG" role="doc-biblioref">1744</a>,<a href="#ref-kN3eqnZW" role="doc-biblioref">1745</a>,<a href="#ref-5MvUc8IL" role="doc-biblioref">1746</a>,<a href="#ref-18O6t6Jo" role="doc-biblioref">1747</a>]</span> and in COVID-19 patients relative to population-based controls <span class="citation" data-cites="8ZxZKpYS">[<a href="#ref-8ZxZKpYS" role="doc-biblioref">1748</a>]</span>.
+Indeed, serum concentrations of 25-hydroxyvitamin D above 30 ng/ml, which indicate vitamin D sufficiency, seems to be associated with a reduction in serum C-reactive protein, an inflammatory marker, along with increased lymphocyte levels, which suggests that vitamin D levels may modulate the immune response by reducing risk for cytokine storm in response to SARS-CoV-2 infection <span class="citation" data-cites="8ZxZKpYS">[<a href="#ref-8ZxZKpYS" role="doc-biblioref">1748</a>]</span>.
+A study in India determined that COVID-19 fatality was higher in patients with severe COVID-19 and low serum 25-hydroxyvitamin D (mean level 6.2 ng/ml; 97% vitamin D deficient) levels versus asymptomatic non-severe patients with higher levels of vitamin D (mean level 27.9 ng/ml; 33% vitamin D deficient) <span class="citation" data-cites="QAEcHBzN">[<a href="#ref-QAEcHBzN" role="doc-biblioref">1749</a>]</span>.
 In the same study, vitamin D deficiency was associated with higher levels of inflammatory markers including IL-6, ferritin, and tumor necrosis factor α.
-Collectively, these studies add to a multitude of observational studies reporting potential associations between low levels of 25-hydroxyvitamin D and COVID-19 incidence and severity <span class="citation" data-cites="1Gy7Svl72 EhakYR7D xv6TOhJg 8ZxZKpYS ZheSCcim pNuUm1NE 5aqg2qxi 18O6t6Jo 10kobTskt Tcc0pGgI">[<a href="#ref-1Gy7Svl72" role="doc-biblioref">1735</a>,<a href="#ref-18O6t6Jo" role="doc-biblioref">1740</a>,<a href="#ref-8ZxZKpYS" role="doc-biblioref">1741</a>,<a href="#ref-EhakYR7D" role="doc-biblioref">1743</a>,<a href="#ref-xv6TOhJg" role="doc-biblioref">1744</a>,<a href="#ref-ZheSCcim" role="doc-biblioref">1745</a>,<a href="#ref-pNuUm1NE" role="doc-biblioref">1746</a>,<a href="#ref-5aqg2qxi" role="doc-biblioref">1747</a>,<a href="#ref-10kobTskt" role="doc-biblioref">1748</a>,<a href="#ref-Tcc0pGgI" role="doc-biblioref">1749</a>]</span>.</p>
-<p>Despite the large number of studies establishing a link between vitamin D status and COVID-19 severity, an examination of data from the UK Biobank did not support this thesis <span class="citation" data-cites="FZ8yXmxQ 7goCwNjQ">[<a href="#ref-FZ8yXmxQ" role="doc-biblioref">1750</a>,<a href="#ref-7goCwNjQ" role="doc-biblioref">1751</a>]</span>.
+Collectively, these studies add to a multitude of observational studies reporting potential associations between low levels of 25-hydroxyvitamin D and COVID-19 incidence and severity <span class="citation" data-cites="1Gy7Svl72 EhakYR7D xv6TOhJg 8ZxZKpYS ZheSCcim pNuUm1NE 5aqg2qxi 18O6t6Jo 10kobTskt Tcc0pGgI">[<a href="#ref-1Gy7Svl72" role="doc-biblioref">1742</a>,<a href="#ref-18O6t6Jo" role="doc-biblioref">1747</a>,<a href="#ref-8ZxZKpYS" role="doc-biblioref">1748</a>,<a href="#ref-EhakYR7D" role="doc-biblioref">1750</a>,<a href="#ref-xv6TOhJg" role="doc-biblioref">1751</a>,<a href="#ref-ZheSCcim" role="doc-biblioref">1752</a>,<a href="#ref-pNuUm1NE" role="doc-biblioref">1753</a>,<a href="#ref-5aqg2qxi" role="doc-biblioref">1754</a>,<a href="#ref-10kobTskt" role="doc-biblioref">1755</a>,<a href="#ref-Tcc0pGgI" role="doc-biblioref">1756</a>]</span>.</p>
+<p>Despite the large number of studies establishing a link between vitamin D status and COVID-19 severity, an examination of data from the UK Biobank did not support this thesis <span class="citation" data-cites="FZ8yXmxQ 7goCwNjQ">[<a href="#ref-FZ8yXmxQ" role="doc-biblioref">1757</a>,<a href="#ref-7goCwNjQ" role="doc-biblioref">1758</a>]</span>.
 These analyses examined 25-hydroxyvitamin D concentrations alongside SARS-CoV-2 positivity and COVID-19 mortality in over 340,000 UK Biobank participants.
-However, these studies have caused considerable debate that will likely be settled following further studies <span class="citation" data-cites="EtCW6lkq ClClnlJb">[<a href="#ref-EtCW6lkq" role="doc-biblioref">1752</a>,<a href="#ref-ClClnlJb" role="doc-biblioref">1753</a>]</span>.
-Overall, while the evidence suggests that there is likely an association between low serum 25-hydroxyvitamin D and COVID-19 incidence, these studies must be interpreted with caution, as there is the potential for reverse causality, bias, and other confounding factors including that vitamin D deficiency is also associated with numerous pre-existing conditions and risk factors that can increase the risk for severe COVID-19 <span class="citation" data-cites="Lyd8s4Mk 1F2cyuTqD LpqYmd4C F4hC9qly">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1605</a>,<a href="#ref-LpqYmd4C" role="doc-biblioref">1732</a>,<a href="#ref-1F2cyuTqD" role="doc-biblioref">1754</a>,<a href="#ref-F4hC9qly" role="doc-biblioref">1755</a>]</span>.</p>
+However, these studies have caused considerable debate that will likely be settled following further studies <span class="citation" data-cites="EtCW6lkq ClClnlJb">[<a href="#ref-EtCW6lkq" role="doc-biblioref">1759</a>,<a href="#ref-ClClnlJb" role="doc-biblioref">1760</a>]</span>.
+Overall, while the evidence suggests that there is likely an association between low serum 25-hydroxyvitamin D and COVID-19 incidence, these studies must be interpreted with caution, as there is the potential for reverse causality, bias, and other confounding factors including that vitamin D deficiency is also associated with numerous pre-existing conditions and risk factors that can increase the risk for severe COVID-19 <span class="citation" data-cites="Lyd8s4Mk 1F2cyuTqD LpqYmd4C F4hC9qly">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1612</a>,<a href="#ref-LpqYmd4C" role="doc-biblioref">1739</a>,<a href="#ref-1F2cyuTqD" role="doc-biblioref">1761</a>,<a href="#ref-F4hC9qly" role="doc-biblioref">1762</a>]</span>.</p>
 <p>While these studies inform us of the potential importance of vitamin D sufficiency and the risk of SARS-CoV-2 infection and severe COVID-19, they fail to conclusively determine whether vitamin D supplementation can therapeutically affect the clinical course of COVID-19.
 In one study, 40 vitamin D deficient asymptomatic or mildly symptomatic participants patients were either randomized to receive 60,000 IU of cholecalciferol daily for at least 7 days (n = 16) or a placebo (n = 24) with a target serum 25-hydroxyvitamin D level &gt;50 ng/ml.
 At day 7, 10 patients achieved &gt;50 ng/ml, followed by another 2 by day 14.
-By the end of the study, the treatment group had a greater proportion of vitamin D-deficient participants that tested negative for SARS-CoV-2 RNA, and they had a significantly lower fibrinogen levels, potentially indicating a beneficial effect <span class="citation" data-cites="kurM6Av7">[<a href="#ref-kurM6Av7" role="doc-biblioref">1756</a>]</span>.
-A pilot study in Spain determined that early administration of high dose calcifediol (~21,000 IU days 1-2 and ~11,000 IU days 3-7 of hospital admission) with hydroxychloroquine and azithromycin to 50 hospitalized COVID-19 patients significantly reduced ICU admissions and may have reduced disease severity versus hydroxychloroquine and azithromycin alone <span class="citation" data-cites="rYXmRFCk">[<a href="#ref-rYXmRFCk" role="doc-biblioref">1757</a>]</span>.
-Although this study received significant criticism from the National Institute for Health and Care Excellence (NICE) in the UK <span class="citation" data-cites="OAzFPABw">[<a href="#ref-OAzFPABw" role="doc-biblioref">1758</a>]</span>, an independent follow-up statistical analysis supported the findings of the study with respect to the results of cholecalciferol treatment <span class="citation" data-cites="1FHsBdDVU">[<a href="#ref-1FHsBdDVU" role="doc-biblioref">1759</a>]</span>.
-Another trial of 986 patients hospitalized for COVID-19 in three UK hospitals administered cholecalciferol (≥ 280,000 IU in a time period of 7 weeks) to 151 patients and found an association with a reduced risk of COVID-19 mortality, regardless of baseline 25-hydroxyvitamin D levels <span class="citation" data-cites="UlHOCdfk">[<a href="#ref-UlHOCdfk" role="doc-biblioref">1760</a>]</span>.
+By the end of the study, the treatment group had a greater proportion of vitamin D-deficient participants that tested negative for SARS-CoV-2 RNA, and they had a significantly lower fibrinogen levels, potentially indicating a beneficial effect <span class="citation" data-cites="kurM6Av7">[<a href="#ref-kurM6Av7" role="doc-biblioref">1763</a>]</span>.
+A pilot study in Spain determined that early administration of high dose calcifediol (~21,000 IU days 1-2 and ~11,000 IU days 3-7 of hospital admission) with hydroxychloroquine and azithromycin to 50 hospitalized COVID-19 patients significantly reduced ICU admissions and may have reduced disease severity versus hydroxychloroquine and azithromycin alone <span class="citation" data-cites="rYXmRFCk">[<a href="#ref-rYXmRFCk" role="doc-biblioref">1764</a>]</span>.
+Although this study received significant criticism from the National Institute for Health and Care Excellence (NICE) in the UK <span class="citation" data-cites="OAzFPABw">[<a href="#ref-OAzFPABw" role="doc-biblioref">1765</a>]</span>, an independent follow-up statistical analysis supported the findings of the study with respect to the results of cholecalciferol treatment <span class="citation" data-cites="1FHsBdDVU">[<a href="#ref-1FHsBdDVU" role="doc-biblioref">1766</a>]</span>.
+Another trial of 986 patients hospitalized for COVID-19 in three UK hospitals administered cholecalciferol (≥ 280,000 IU in a time period of 7 weeks) to 151 patients and found an association with a reduced risk of COVID-19 mortality, regardless of baseline 25-hydroxyvitamin D levels <span class="citation" data-cites="UlHOCdfk">[<a href="#ref-UlHOCdfk" role="doc-biblioref">1767</a>]</span>.
 However, a double-blind, randomized, placebo-controlled trial of 240 hospitalized COVID-19 patients in São Paulo, Brazil administered a single 200,000 IU oral dose of vitamin D.
 At the end of the study, there was a 24 ng/mL difference of 25-hydroxyvitamin D levels in the treatment group versus the placebo group (<em>p</em> = 0.001), and 87% of the treatment group were vitamin D sufficient versus ~11% in the placebo group.
 Supplementation was well tolerated.
-However, there was no reduction in the length of hospital stay or mortality, and no change to any other relevant secondary outcomes were reported <span class="citation" data-cites="1GjnSzUKx">[<a href="#ref-1GjnSzUKx" role="doc-biblioref">1761</a>]</span>.
+However, there was no reduction in the length of hospital stay or mortality, and no change to any other relevant secondary outcomes were reported <span class="citation" data-cites="1GjnSzUKx">[<a href="#ref-1GjnSzUKx" role="doc-biblioref">1768</a>]</span>.
 These early findings are thus still inconclusive with regards to the therapeutic value of vitamin D supplementation.
-However, other trials are underway, including one trial that is investigating the utility of vitamin D as an immune-modulating agent by monitoring whether administration of vitamin D precipitates an improvement of health status in non-severe symptomatic COVID-19 patients and whether vitamin D prevents patient deterioration <span class="citation" data-cites="162t7zdGv">[<a href="#ref-162t7zdGv" role="doc-biblioref">1762</a>]</span>.
-Other trials are examining various factors including mortality, symptom recovery, severity of disease, rates of ventilation, inflammatory markers such as C-reactive protein and IL-6, blood cell counts, and the prophylactic capacity of vitamin D administration <span class="citation" data-cites="2K0jV5Bn 162t7zdGv rBiojRHk 6kLoX5qT">[<a href="#ref-162t7zdGv" role="doc-biblioref">1762</a>,<a href="#ref-2K0jV5Bn" role="doc-biblioref">1763</a>,<a href="#ref-rBiojRHk" role="doc-biblioref">1764</a>,<a href="#ref-6kLoX5qT" role="doc-biblioref">1765</a>]</span>.
-Concomitant administration of vitamin D with pharmaceuticals such as aspirin <span class="citation" data-cites="32C2erIe">[<a href="#ref-32C2erIe" role="doc-biblioref">1766</a>]</span> and bioactive molecules such as resveratrol <span class="citation" data-cites="tLVliODQ">[<a href="#ref-tLVliODQ" role="doc-biblioref">1767</a>]</span> is also under investigation.</p>
+However, other trials are underway, including one trial that is investigating the utility of vitamin D as an immune-modulating agent by monitoring whether administration of vitamin D precipitates an improvement of health status in non-severe symptomatic COVID-19 patients and whether vitamin D prevents patient deterioration <span class="citation" data-cites="162t7zdGv">[<a href="#ref-162t7zdGv" role="doc-biblioref">1769</a>]</span>.
+Other trials are examining various factors including mortality, symptom recovery, severity of disease, rates of ventilation, inflammatory markers such as C-reactive protein and IL-6, blood cell counts, and the prophylactic capacity of vitamin D administration <span class="citation" data-cites="2K0jV5Bn 162t7zdGv rBiojRHk 6kLoX5qT">[<a href="#ref-162t7zdGv" role="doc-biblioref">1769</a>,<a href="#ref-2K0jV5Bn" role="doc-biblioref">1770</a>,<a href="#ref-rBiojRHk" role="doc-biblioref">1771</a>,<a href="#ref-6kLoX5qT" role="doc-biblioref">1772</a>]</span>.
+Concomitant administration of vitamin D with pharmaceuticals such as aspirin <span class="citation" data-cites="32C2erIe">[<a href="#ref-32C2erIe" role="doc-biblioref">1773</a>]</span> and bioactive molecules such as resveratrol <span class="citation" data-cites="tLVliODQ">[<a href="#ref-tLVliODQ" role="doc-biblioref">1774</a>]</span> is also under investigation.</p>
 <p>The effectiveness of vitamin D supplementation against COVID-19 remains open for debate.
-All the same, there is no doubt that vitamin D deficiency is a widespread issue and should be addressed not only because of its potential link to SARS-CoV-2 incidence <span class="citation" data-cites="Btt5H6f1">[<a href="#ref-Btt5H6f1" role="doc-biblioref">1768</a>]</span>, but also due to its importance for overall health.
+All the same, there is no doubt that vitamin D deficiency is a widespread issue and should be addressed not only because of its potential link to SARS-CoV-2 incidence <span class="citation" data-cites="Btt5H6f1">[<a href="#ref-Btt5H6f1" role="doc-biblioref">1775</a>]</span>, but also due to its importance for overall health.
 There is a possibility that safe exposure to sunlight could improve endogenous synthesis of vitamin D, potentially strengthening the immune system.
 However, sun exposure is not sufficient on its own, particularly in the winter months.
 Indeed, while the possible link between vitamin D status and COVID-19 is further investigated, preemptive supplementation of vitamin D and encouraging people to maintain a healthy diet for optimum vitamin D status is likely to raise serum levels of 25-hydroxyvitamin D while being unlikely to carry major health risks.
 These principles seem to be the basis of a number of guidelines issued by some countries and scientific organizations that have advised supplementation of vitamin D during the pandemic.
 The Académie Nationale de Médecine in France recommends rapid testing of 25-hydroxyvitamin D for people over 60 years old to identify those most at risk of vitamin D deficiency and advises them to obtain a bolus dose of 50,000 to 100,000 IU vitamin D to limit respiratory complications.
-It has also recommended that those under 60 years old should take 800 to 1,000 IU daily if they receive a SARS-CoV-2 positive test <span class="citation" data-cites="llQ4v7QI">[<a href="#ref-llQ4v7QI" role="doc-biblioref">1769</a>/]</span>.
-In Slovenia, doctors have been advised to provide nursing home patients with vitamin D <span class="citation" data-cites="M4v2N83p">[<a href="#ref-M4v2N83p" role="doc-biblioref">1770</a>]</span>.
-Both Public Health England and Public Health Scotland have advised members of the Black, Asian, and minority ethnic communities to supplement for vitamin D in light of evidence that they may be at higher risk for vitamin D deficiency along with other COVID-19 risk factors, a trend that has also been observed in the United States <span class="citation" data-cites="yoAwg53u StktHVeV">[<a href="#ref-yoAwg53u" role="doc-biblioref">1771</a>,<a href="#ref-StktHVeV" role="doc-biblioref">1772</a>]</span>.
+It has also recommended that those under 60 years old should take 800 to 1,000 IU daily if they receive a SARS-CoV-2 positive test <span class="citation" data-cites="llQ4v7QI">[<a href="#ref-llQ4v7QI" role="doc-biblioref">1776</a>/]</span>.
+In Slovenia, doctors have been advised to provide nursing home patients with vitamin D <span class="citation" data-cites="M4v2N83p">[<a href="#ref-M4v2N83p" role="doc-biblioref">1777</a>]</span>.
+Both Public Health England and Public Health Scotland have advised members of the Black, Asian, and minority ethnic communities to supplement for vitamin D in light of evidence that they may be at higher risk for vitamin D deficiency along with other COVID-19 risk factors, a trend that has also been observed in the United States <span class="citation" data-cites="yoAwg53u StktHVeV">[<a href="#ref-yoAwg53u" role="doc-biblioref">1778</a>,<a href="#ref-StktHVeV" role="doc-biblioref">1779</a>]</span>.
 However, other UK scientific bodies including the NICE recommend that individuals supplement for vitamin D as per usual UK government advice but warn that people should not supplement for vitamin D solely to prevent COVID-19.
-All the same, the NICE has provided guidelines for research to investigate the supplementation of vitamin D in the context of COVID-19 <span class="citation" data-cites="4DE4ljR9">[<a href="#ref-4DE4ljR9" role="doc-biblioref">1773</a>]</span>.
-Despite vitamin D deficiency being a widespread issue in the United States <span class="citation" data-cites="lhYw2CB">[<a href="#ref-lhYw2CB" role="doc-biblioref">1774</a>]</span>, the National Institutes of Health have stated that there is “insufficient data to recommend either for or against the use of vitamin D for the prevention or treatment of COVID-19” <span class="citation" data-cites="KNwYH6Y4">[<a href="#ref-KNwYH6Y4" role="doc-biblioref">1775</a>/]</span>.
+All the same, the NICE has provided guidelines for research to investigate the supplementation of vitamin D in the context of COVID-19 <span class="citation" data-cites="4DE4ljR9">[<a href="#ref-4DE4ljR9" role="doc-biblioref">1780</a>]</span>.
+Despite vitamin D deficiency being a widespread issue in the United States <span class="citation" data-cites="lhYw2CB">[<a href="#ref-lhYw2CB" role="doc-biblioref">1781</a>]</span>, the National Institutes of Health have stated that there is “insufficient data to recommend either for or against the use of vitamin D for the prevention or treatment of COVID-19” <span class="citation" data-cites="KNwYH6Y4">[<a href="#ref-KNwYH6Y4" role="doc-biblioref">1782</a>/]</span>.
 These are just some examples of how public health guidance has responded to the emerging evidence regarding vitamin D and COVID-19.
-Outside of official recommendations, there is also evidence that individuals may be paying increased attention to their vitamin D levels, as a survey of Polish consumers showed that 56% of respondents used vitamin D during the pandemic <span class="citation" data-cites="19yy9SHf1">[<a href="#ref-19yy9SHf1" role="doc-biblioref">1776</a>]</span>.
-However, some companies have used the emerging evidence surrounding vitamin D to sell products that claim to prevent and treat COVID-19, which in one incident required a federal court to intervene and issue an injunction barring the sale of vitamin-D-related products due to the lack of clinical data supporting these claims <span class="citation" data-cites="xkewCiC9">[<a href="#ref-xkewCiC9" role="doc-biblioref">1777</a>]</span>.
+Outside of official recommendations, there is also evidence that individuals may be paying increased attention to their vitamin D levels, as a survey of Polish consumers showed that 56% of respondents used vitamin D during the pandemic <span class="citation" data-cites="19yy9SHf1">[<a href="#ref-19yy9SHf1" role="doc-biblioref">1783</a>]</span>.
+However, some companies have used the emerging evidence surrounding vitamin D to sell products that claim to prevent and treat COVID-19, which in one incident required a federal court to intervene and issue an injunction barring the sale of vitamin-D-related products due to the lack of clinical data supporting these claims <span class="citation" data-cites="xkewCiC9">[<a href="#ref-xkewCiC9" role="doc-biblioref">1784</a>]</span>.
 It is clear that further studies and clinical trials are required to conclusively determine the prophylactic and therapeutic potential of vitamin D supplementation against COVID-19.
 Until such time that sufficient evidence emerges, individuals should follow their national guidelines surrounding vitamin D intake to achieve vitamin D sufficiency.</p>
 <h2 data-number="10.8" id="probiotics"><span class="header-section-number">10.8</span> Probiotics</h2>
-<p>Probiotics are “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host” <span class="citation" data-cites="1FyHVZ9yx">[<a href="#ref-1FyHVZ9yx" role="doc-biblioref">1778</a>]</span>.
-Some studies suggest that probiotics are beneficial against common viral infections, and there is modest evidence to suggest that they can modulate the immune response <span class="citation" data-cites="pvZU55k9 HKeroTXj">[<a href="#ref-pvZU55k9" role="doc-biblioref">1779</a>,<a href="#ref-HKeroTXj" role="doc-biblioref">1780</a>]</span>.
-As a result, it has been hypothesized that probiotics may have therapeutic value worthy of investigation against SARS-CoV-2 <span class="citation" data-cites="10e8cHDs8">[<a href="#ref-10e8cHDs8" role="doc-biblioref">1781</a>]</span>.
-Probiotics and next-generation probiotics, which are more akin to pharmacological-grade supplements, have been associated with multiple potential beneficial effects for allergies, digestive tract disorders, and even metabolic diseases through their anti-inflammatory and immunomodulatory effects <span class="citation" data-cites="5fU7dexB 1GCrGCp5P">[<a href="#ref-5fU7dexB" role="doc-biblioref">1782</a>,<a href="#ref-1GCrGCp5P" role="doc-biblioref">1783</a>]</span>.
-However, the mechanisms by which probiotics affect these various conditions would likely differ among strains, with the ultimate effect of the probiotic depending on the heterogeneous set of bacteria present <span class="citation" data-cites="1GCrGCp5P">[<a href="#ref-1GCrGCp5P" role="doc-biblioref">1783</a>]</span>.
-Some of the beneficial effects of probiotics include reducing inflammation by promoting the expression of anti-inflammatory mediators, inhibiting Toll-like receptors 2 and 4, competing directly with pathogens, synthesizing antimicrobial substances or other metabolites, improving intestinal barrier function, and/or favorably altering the gut microbiota and the brain-gut axis <span class="citation" data-cites="B2GeSSQo 1GCrGCp5P nmXF8vkS">[<a href="#ref-1GCrGCp5P" role="doc-biblioref">1783</a>,<a href="#ref-B2GeSSQo" role="doc-biblioref">1784</a>,<a href="#ref-nmXF8vkS" role="doc-biblioref">1785</a>]</span>.
-It is also thought that lactobacilli such as <em>Lactobacillus paracasei, Lactobacillus plantarum</em> and <em>Lactobacillus rhamnosus</em> have the capacity to bind to and inactivate some viruses via adsorptive and/or trapping mechanisms <span class="citation" data-cites="sX7GyWpV">[<a href="#ref-sX7GyWpV" role="doc-biblioref">1786</a>]</span>.
-Other probiotic lactobacilli and even non-viable bacterium-like particles have been shown to reduce both viral attachment to host cells and viral titers, along with reducing cytokine synthesis, enhancing the antiviral IFN-α response, and inducing various other antiviral mechanisms <span class="citation" data-cites="IkuChxSp 8gQnAy2v zGORHhOM sX7GyWpV g0qfbA7l DNbZomOZ p9eKMfO2 x46F06Fr uU3GXiaf">[<a href="#ref-sX7GyWpV" role="doc-biblioref">1786</a>,<a href="#ref-IkuChxSp" role="doc-biblioref">1787</a>,<a href="#ref-8gQnAy2v" role="doc-biblioref">1788</a>,<a href="#ref-zGORHhOM" role="doc-biblioref">1789</a>,<a href="#ref-g0qfbA7l" role="doc-biblioref">1790</a>,<a href="#ref-DNbZomOZ" role="doc-biblioref">1791</a>,<a href="#ref-p9eKMfO2" role="doc-biblioref">1792</a>,<a href="#ref-x46F06Fr" role="doc-biblioref">1793</a>,<a href="#ref-uU3GXiaf" role="doc-biblioref">1794</a>]</span>.
-These antiviral and immunobiotic mechanisms and others have been reviewed in detail elsewhere <span class="citation" data-cites="EEa0SZCF Sp05opqA 10e8cHDs8">[<a href="#ref-EEa0SZCF" role="doc-biblioref">1635</a>,<a href="#ref-10e8cHDs8" role="doc-biblioref">1781</a>,<a href="#ref-Sp05opqA" role="doc-biblioref">1795</a>]</span>.
-However, there is also a bi-directional relationship between the lungs and gut microbiota known as the gut-lung axis <span class="citation" data-cites="13AWoYvqB">[<a href="#ref-13AWoYvqB" role="doc-biblioref">1796</a>]</span>, whereby gut microbial metabolites and endotoxins may affect the lungs via the circulatory system and the lung microbiota in return may affect the gut <span class="citation" data-cites="Smqu1EYN">[<a href="#ref-Smqu1EYN" role="doc-biblioref">1797</a>]</span>.
-Therefore, the gut-lung axis may play role in our future understanding of COVID-19 pathogenesis and become a target for probiotic treatments <span class="citation" data-cites="d27mQ4kO">[<a href="#ref-d27mQ4kO" role="doc-biblioref">1798</a>]</span>.
-Moreover, as microbial dysbiosis of the respiratory tract and gut may play a role in some viral infections, it has been suggested that SARS-CoV-2 may interact with our commensal microbiota [<span class="citation" data-cites="EEa0SZCF">[<a href="#ref-EEa0SZCF" role="doc-biblioref">1635</a>]</span>; <span class="citation" data-cites="HOd4nJPq">[<a href="#ref-HOd4nJPq" role="doc-biblioref">1799</a>]</span>; 10.3389/fmicb.2020.01840] and that the lung microbiome could play a role in developing immunity to viral infections <span class="citation" data-cites="OwqHmSrX">[<a href="#ref-OwqHmSrX" role="doc-biblioref">1800</a>]</span>.
+<p>Probiotics are “live microorganisms that, when administered in adequate amounts, confer a health benefit on the host” <span class="citation" data-cites="1FyHVZ9yx">[<a href="#ref-1FyHVZ9yx" role="doc-biblioref">1785</a>]</span>.
+Some studies suggest that probiotics are beneficial against common viral infections, and there is modest evidence to suggest that they can modulate the immune response <span class="citation" data-cites="pvZU55k9 HKeroTXj">[<a href="#ref-pvZU55k9" role="doc-biblioref">1786</a>,<a href="#ref-HKeroTXj" role="doc-biblioref">1787</a>]</span>.
+As a result, it has been hypothesized that probiotics may have therapeutic value worthy of investigation against SARS-CoV-2 <span class="citation" data-cites="10e8cHDs8">[<a href="#ref-10e8cHDs8" role="doc-biblioref">1788</a>]</span>.
+Probiotics and next-generation probiotics, which are more akin to pharmacological-grade supplements, have been associated with multiple potential beneficial effects for allergies, digestive tract disorders, and even metabolic diseases through their anti-inflammatory and immunomodulatory effects <span class="citation" data-cites="5fU7dexB 1GCrGCp5P">[<a href="#ref-5fU7dexB" role="doc-biblioref">1789</a>,<a href="#ref-1GCrGCp5P" role="doc-biblioref">1790</a>]</span>.
+However, the mechanisms by which probiotics affect these various conditions would likely differ among strains, with the ultimate effect of the probiotic depending on the heterogeneous set of bacteria present <span class="citation" data-cites="1GCrGCp5P">[<a href="#ref-1GCrGCp5P" role="doc-biblioref">1790</a>]</span>.
+Some of the beneficial effects of probiotics include reducing inflammation by promoting the expression of anti-inflammatory mediators, inhibiting Toll-like receptors 2 and 4, competing directly with pathogens, synthesizing antimicrobial substances or other metabolites, improving intestinal barrier function, and/or favorably altering the gut microbiota and the brain-gut axis <span class="citation" data-cites="B2GeSSQo 1GCrGCp5P nmXF8vkS">[<a href="#ref-1GCrGCp5P" role="doc-biblioref">1790</a>,<a href="#ref-B2GeSSQo" role="doc-biblioref">1791</a>,<a href="#ref-nmXF8vkS" role="doc-biblioref">1792</a>]</span>.
+It is also thought that lactobacilli such as <em>Lactobacillus paracasei, Lactobacillus plantarum</em> and <em>Lactobacillus rhamnosus</em> have the capacity to bind to and inactivate some viruses via adsorptive and/or trapping mechanisms <span class="citation" data-cites="sX7GyWpV">[<a href="#ref-sX7GyWpV" role="doc-biblioref">1793</a>]</span>.
+Other probiotic lactobacilli and even non-viable bacterium-like particles have been shown to reduce both viral attachment to host cells and viral titers, along with reducing cytokine synthesis, enhancing the antiviral IFN-α response, and inducing various other antiviral mechanisms <span class="citation" data-cites="IkuChxSp 8gQnAy2v zGORHhOM sX7GyWpV g0qfbA7l DNbZomOZ p9eKMfO2 x46F06Fr uU3GXiaf">[<a href="#ref-sX7GyWpV" role="doc-biblioref">1793</a>,<a href="#ref-IkuChxSp" role="doc-biblioref">1794</a>,<a href="#ref-8gQnAy2v" role="doc-biblioref">1795</a>,<a href="#ref-zGORHhOM" role="doc-biblioref">1796</a>,<a href="#ref-g0qfbA7l" role="doc-biblioref">1797</a>,<a href="#ref-DNbZomOZ" role="doc-biblioref">1798</a>,<a href="#ref-p9eKMfO2" role="doc-biblioref">1799</a>,<a href="#ref-x46F06Fr" role="doc-biblioref">1800</a>,<a href="#ref-uU3GXiaf" role="doc-biblioref">1801</a>]</span>.
+These antiviral and immunobiotic mechanisms and others have been reviewed in detail elsewhere <span class="citation" data-cites="EEa0SZCF Sp05opqA 10e8cHDs8">[<a href="#ref-EEa0SZCF" role="doc-biblioref">1642</a>,<a href="#ref-10e8cHDs8" role="doc-biblioref">1788</a>,<a href="#ref-Sp05opqA" role="doc-biblioref">1802</a>]</span>.
+However, there is also a bi-directional relationship between the lungs and gut microbiota known as the gut-lung axis <span class="citation" data-cites="13AWoYvqB">[<a href="#ref-13AWoYvqB" role="doc-biblioref">1803</a>]</span>, whereby gut microbial metabolites and endotoxins may affect the lungs via the circulatory system and the lung microbiota in return may affect the gut <span class="citation" data-cites="Smqu1EYN">[<a href="#ref-Smqu1EYN" role="doc-biblioref">1804</a>]</span>.
+Therefore, the gut-lung axis may play role in our future understanding of COVID-19 pathogenesis and become a target for probiotic treatments <span class="citation" data-cites="d27mQ4kO">[<a href="#ref-d27mQ4kO" role="doc-biblioref">1805</a>]</span>.
+Moreover, as microbial dysbiosis of the respiratory tract and gut may play a role in some viral infections, it has been suggested that SARS-CoV-2 may interact with our commensal microbiota [<span class="citation" data-cites="EEa0SZCF">[<a href="#ref-EEa0SZCF" role="doc-biblioref">1642</a>]</span>; <span class="citation" data-cites="HOd4nJPq">[<a href="#ref-HOd4nJPq" role="doc-biblioref">1806</a>]</span>; 10.3389/fmicb.2020.01840] and that the lung microbiome could play a role in developing immunity to viral infections <span class="citation" data-cites="OwqHmSrX">[<a href="#ref-OwqHmSrX" role="doc-biblioref">1807</a>]</span>.
 These postulations, if correct, could lead to the development of novel probiotic and prebiotic treatments.
 However, significant research is required to confirm these associations and their relevance to patient care, if any.</p>
 <p>Probiotic therapies and prophylactics may also confer some advantages for managing symptoms of COVID-19 or risks associated with its treatment.
-Probiotics have tentatively been associated with the reduction of risk and duration of viral upper respiratory tract infections <span class="citation" data-cites="1MIGrWIP 58eXvYEV kjavvCzp">[<a href="#ref-1MIGrWIP" role="doc-biblioref">1801</a>,<a href="#ref-58eXvYEV" role="doc-biblioref">1802</a>,<a href="#ref-kjavvCzp" role="doc-biblioref">1803</a>]</span>.
-Some meta-analyses that have assessed the efficacy of probiotics in viral respiratory infections have reported moderate reductions in the incidence and duration of infection <span class="citation" data-cites="58eXvYEV dJIGDt4k">[<a href="#ref-58eXvYEV" role="doc-biblioref">1802</a>,<a href="#ref-dJIGDt4k" role="doc-biblioref">1804</a>]</span>.
-Indeed, randomized controlled trials have shown that administering <em>Bacillus subtilis</em> and <em>Enterococcus faecalis</em> <span class="citation" data-cites="AJav6c61">[<a href="#ref-AJav6c61" role="doc-biblioref">1805</a>]</span>, <em>Lactobacillus rhamnosus GG</em> <span class="citation" data-cites="1E2aDJp4T">[<a href="#ref-1E2aDJp4T" role="doc-biblioref">1806</a>]</span>, or <em>Lactobacillus casei</em> and <em>Bifidobacterium breve</em> with galactooligosaccharides <span class="citation" data-cites="zccFgajh">[<a href="#ref-zccFgajh" role="doc-biblioref">1807</a>]</span> via the nasogastric tube to ventilated patients reduced the occurrence of ventilator-associated pneumonia in comparison to the respective control groups in studies of viral infections and sepsis.
-These findings were also supported by a recent meta-analysis <span class="citation" data-cites="1DI06gFPc">[<a href="#ref-1DI06gFPc" role="doc-biblioref">1808</a>]</span>.
-Additionally, COVID-19 patients carry a significant risk of ventilator-associated bacterial pneumonia <span class="citation" data-cites="164mVBFZx">[<a href="#ref-164mVBFZx" role="doc-biblioref">1809</a>]</span>, but it can be challenging for clinicians to diagnose this infection due to the fact that severe COVID-19 infection presents with the symptoms of pneumonia <span class="citation" data-cites="w2VFo0h1">[<a href="#ref-w2VFo0h1" role="doc-biblioref">1810</a>]</span>.
+Probiotics have tentatively been associated with the reduction of risk and duration of viral upper respiratory tract infections <span class="citation" data-cites="1MIGrWIP 58eXvYEV kjavvCzp">[<a href="#ref-1MIGrWIP" role="doc-biblioref">1808</a>,<a href="#ref-58eXvYEV" role="doc-biblioref">1809</a>,<a href="#ref-kjavvCzp" role="doc-biblioref">1810</a>]</span>.
+Some meta-analyses that have assessed the efficacy of probiotics in viral respiratory infections have reported moderate reductions in the incidence and duration of infection <span class="citation" data-cites="58eXvYEV dJIGDt4k">[<a href="#ref-58eXvYEV" role="doc-biblioref">1809</a>,<a href="#ref-dJIGDt4k" role="doc-biblioref">1811</a>]</span>.
+Indeed, randomized controlled trials have shown that administering <em>Bacillus subtilis</em> and <em>Enterococcus faecalis</em> <span class="citation" data-cites="AJav6c61">[<a href="#ref-AJav6c61" role="doc-biblioref">1812</a>]</span>, <em>Lactobacillus rhamnosus GG</em> <span class="citation" data-cites="1E2aDJp4T">[<a href="#ref-1E2aDJp4T" role="doc-biblioref">1813</a>]</span>, or <em>Lactobacillus casei</em> and <em>Bifidobacterium breve</em> with galactooligosaccharides <span class="citation" data-cites="zccFgajh">[<a href="#ref-zccFgajh" role="doc-biblioref">1814</a>]</span> via the nasogastric tube to ventilated patients reduced the occurrence of ventilator-associated pneumonia in comparison to the respective control groups in studies of viral infections and sepsis.
+These findings were also supported by a recent meta-analysis <span class="citation" data-cites="1DI06gFPc">[<a href="#ref-1DI06gFPc" role="doc-biblioref">1815</a>]</span>.
+Additionally, COVID-19 patients carry a significant risk of ventilator-associated bacterial pneumonia <span class="citation" data-cites="164mVBFZx">[<a href="#ref-164mVBFZx" role="doc-biblioref">1816</a>]</span>, but it can be challenging for clinicians to diagnose this infection due to the fact that severe COVID-19 infection presents with the symptoms of pneumonia <span class="citation" data-cites="w2VFo0h1">[<a href="#ref-w2VFo0h1" role="doc-biblioref">1817</a>]</span>.
 Therefore, an effective prophylactic therapy for ventilator-associated pneumonia in severe COVID-19 patients would carry significant therapeutic value.
-Additionally, in recent years, probiotics have become almost synonymous with the treatment of gastrointestinal issues due to their supposed anti-inflammatory and immunomodulatory effects <span class="citation" data-cites="gcyQ73v7">[<a href="#ref-gcyQ73v7" role="doc-biblioref">1811</a>]</span>.
-Notably, gastrointestinal symptoms commonly occur in COVID-19 patients <span class="citation" data-cites="67ihxDiV">[<a href="#ref-67ihxDiV" role="doc-biblioref">1812</a>]</span>, and angiotensin-converting enzyme 2, the portal by which SARS-CoV-2 enters human cells, is highly expressed in enterocytes of the ileum and colon, suggesting that these organs may be a potential route of infection <span class="citation" data-cites="8Hvgbl3n Nhxoefru">[<a href="#ref-8Hvgbl3n" role="doc-biblioref">1813</a>,<a href="#ref-Nhxoefru" role="doc-biblioref">1814</a>]</span>.
-Indeed, SARS-CoV-2 viral RNA has been detected in human feces <span class="citation" data-cites="TPWaxApy PmE9xedP">[<a href="#ref-PmE9xedP" role="doc-biblioref">77</a>,<a href="#ref-TPWaxApy" role="doc-biblioref">530</a>]</span>, and fecal-oral transmission of the virus has not yet been ruled out <span class="citation" data-cites="r9HNMqTS">[<a href="#ref-r9HNMqTS" role="doc-biblioref">1815</a>]</span>.
-Rectal swabs of some SARS-CoV-2 positive pediatric patients persistently tested positive for several days despite negative nasopharyngeal tests, indicating the potential for fecal viral shedding <span class="citation" data-cites="eOcc1BUx">[<a href="#ref-eOcc1BUx" role="doc-biblioref">1816</a>]</span>.
-However, there is conflicting evidence for the therapeutic value of various probiotics against the incidence or severity of gastrointestinal symptoms in viral or bacterial infections such as gastroenteritis <span class="citation" data-cites="VwStn9Ps UtAKolza">[<a href="#ref-VwStn9Ps" role="doc-biblioref">1817</a>,<a href="#ref-UtAKolza" role="doc-biblioref">1818</a>]</span>.
-Nevertheless, it has been proposed that the administration of probiotics to COVID-19 patients and healthcare workers may prevent or ameliorate the gastrointestinal symptoms of COVID-19, a hypothesis that several clinical trials are now preparing to investigate <span class="citation" data-cites="1AqF1ESKq 9UYsmETk">[<a href="#ref-1AqF1ESKq" role="doc-biblioref">1819</a>,<a href="#ref-9UYsmETk" role="doc-biblioref">1820</a>]</span>.
-Other studies are investigating whether probiotics may affect patient outcomes following SARS-CoV-2 infection <span class="citation" data-cites="15pDlYtom">[<a href="#ref-15pDlYtom" role="doc-biblioref">1821</a>]</span>.</p>
+Additionally, in recent years, probiotics have become almost synonymous with the treatment of gastrointestinal issues due to their supposed anti-inflammatory and immunomodulatory effects <span class="citation" data-cites="gcyQ73v7">[<a href="#ref-gcyQ73v7" role="doc-biblioref">1818</a>]</span>.
+Notably, gastrointestinal symptoms commonly occur in COVID-19 patients <span class="citation" data-cites="67ihxDiV">[<a href="#ref-67ihxDiV" role="doc-biblioref">1819</a>]</span>, and angiotensin-converting enzyme 2, the portal by which SARS-CoV-2 enters human cells, is highly expressed in enterocytes of the ileum and colon, suggesting that these organs may be a potential route of infection <span class="citation" data-cites="8Hvgbl3n Nhxoefru">[<a href="#ref-8Hvgbl3n" role="doc-biblioref">1820</a>,<a href="#ref-Nhxoefru" role="doc-biblioref">1821</a>]</span>.
+Indeed, SARS-CoV-2 viral RNA has been detected in human feces <span class="citation" data-cites="TPWaxApy PmE9xedP">[<a href="#ref-PmE9xedP" role="doc-biblioref">77</a>,<a href="#ref-TPWaxApy" role="doc-biblioref">530</a>]</span>, and fecal-oral transmission of the virus has not yet been ruled out <span class="citation" data-cites="r9HNMqTS">[<a href="#ref-r9HNMqTS" role="doc-biblioref">1822</a>]</span>.
+Rectal swabs of some SARS-CoV-2 positive pediatric patients persistently tested positive for several days despite negative nasopharyngeal tests, indicating the potential for fecal viral shedding <span class="citation" data-cites="eOcc1BUx">[<a href="#ref-eOcc1BUx" role="doc-biblioref">1823</a>]</span>.
+However, there is conflicting evidence for the therapeutic value of various probiotics against the incidence or severity of gastrointestinal symptoms in viral or bacterial infections such as gastroenteritis <span class="citation" data-cites="VwStn9Ps UtAKolza">[<a href="#ref-VwStn9Ps" role="doc-biblioref">1824</a>,<a href="#ref-UtAKolza" role="doc-biblioref">1825</a>]</span>.
+Nevertheless, it has been proposed that the administration of probiotics to COVID-19 patients and healthcare workers may prevent or ameliorate the gastrointestinal symptoms of COVID-19, a hypothesis that several clinical trials are now preparing to investigate <span class="citation" data-cites="1AqF1ESKq 9UYsmETk">[<a href="#ref-1AqF1ESKq" role="doc-biblioref">1826</a>,<a href="#ref-9UYsmETk" role="doc-biblioref">1827</a>]</span>.
+Other studies are investigating whether probiotics may affect patient outcomes following SARS-CoV-2 infection <span class="citation" data-cites="15pDlYtom">[<a href="#ref-15pDlYtom" role="doc-biblioref">1828</a>]</span>.</p>
 <p>Generally, the efficacy of probiotic use is a controversial topic among scientists.
-In Europe, EFSA has banned the term probiotics on products labels, which has elicited either criticism for EFSA or support for probiotics from researchers in the field <span class="citation" data-cites="m3SexO9F 5FTOk7ol 1FyHVZ9yx">[<a href="#ref-1FyHVZ9yx" role="doc-biblioref">1778</a>,<a href="#ref-m3SexO9F" role="doc-biblioref">1822</a>,<a href="#ref-5FTOk7ol" role="doc-biblioref">1823</a>]</span>.
+In Europe, EFSA has banned the term probiotics on products labels, which has elicited either criticism for EFSA or support for probiotics from researchers in the field <span class="citation" data-cites="m3SexO9F 5FTOk7ol 1FyHVZ9yx">[<a href="#ref-1FyHVZ9yx" role="doc-biblioref">1785</a>,<a href="#ref-m3SexO9F" role="doc-biblioref">1829</a>,<a href="#ref-5FTOk7ol" role="doc-biblioref">1830</a>]</span>.
 This regulation is due to the hyperbolic claims placed on the labels of various probiotic products, which lack rigorous scientific data to support their efficacy.
-Overall, the data supporting probiotics in the treatment or prevention of many different disorders and diseases is not conclusive, as the quality of the evidence is generally considered low <span class="citation" data-cites="1MIGrWIP">[<a href="#ref-1MIGrWIP" role="doc-biblioref">1801</a>]</span>.
+Overall, the data supporting probiotics in the treatment or prevention of many different disorders and diseases is not conclusive, as the quality of the evidence is generally considered low <span class="citation" data-cites="1MIGrWIP">[<a href="#ref-1MIGrWIP" role="doc-biblioref">1808</a>]</span>.
 However, in the case of probiotics and respiratory infections, the evidence seems to be supportive of their potential therapeutic value.
 Consequently, several investigations are underway to investigate the prophylactic and therapeutic potential of probiotics for COVID-19.
-The blind use of conventional probiotics for COVID-19 is currently cautioned against until the pathogenesis of SARS-CoV-2 can be further established <span class="citation" data-cites="kv94VRLF">[<a href="#ref-kv94VRLF" role="doc-biblioref">1824</a>]</span>.
+The blind use of conventional probiotics for COVID-19 is currently cautioned against until the pathogenesis of SARS-CoV-2 can be further established <span class="citation" data-cites="kv94VRLF">[<a href="#ref-kv94VRLF" role="doc-biblioref">1831</a>]</span>.
 Until clinical trials investigating the prophylactic and therapeutic potential of probiotics for COVID-19 are complete, it is not possible to provide an evidence-based recommendation for their use.
 Despite these concerns, complementary use of probiotics as an adjuvant therapeutic has been proposed by the Chinese National Health Commission and National Administration of Traditional Chinese Medicine <span class="citation" data-cites="3Ak4Mata">[<a href="#ref-3Ak4Mata" role="doc-biblioref">78</a>]</span>.
-While supply issues prevented the probiotics market from showing the same rapid response to the COVID-19 as some other supplements, many suppliers are reporting growth during the pandemic <span class="citation" data-cites="3Hg8dHMg">[<a href="#ref-3Hg8dHMg" role="doc-biblioref">1825</a>]</span>.
+While supply issues prevented the probiotics market from showing the same rapid response to the COVID-19 as some other supplements, many suppliers are reporting growth during the pandemic <span class="citation" data-cites="3Hg8dHMg">[<a href="#ref-3Hg8dHMg" role="doc-biblioref">1832</a>]</span>.
 Therefore, the public response once again seems to have adopted supplements promoted as bolstering the immune response despite a lack of evidence suggesting they are beneficial for preventing or mitigating COVID-19.</p>
 <h2 data-number="10.9" id="discussion"><span class="header-section-number">10.9</span> Discussion</h2>
 <p>In this review, we report the findings to date of analyses of several dietary supplements and nutraceuticals.
 While existing evidence suggests potential benefits of n-3 PUFA and probiotic supplementation for COVID-19 treatment and prophylaxis, clinical data is still lacking, although trials are underway.
 Both zinc and vitamin C supplementation in hospitalized patients seem to be associated with positive outcomes; however, further clinical trials are required.
 In any case, vitamin C and zinc intake are part of a healthy diet and likely present minimal risk when supplemented, though their potential prophylactic or therapeutic effects against COVID-19 are yet to be determined.
-On the other hand, mounting evidence from observational studies indicates that there is an association between vitamin D deficiency and COVID-19 incidence has also been supported by meta-analysis <span class="citation" data-cites="sWzpGBil">[<a href="#ref-sWzpGBil" role="doc-biblioref">1826</a>]</span>.
+On the other hand, mounting evidence from observational studies indicates that there is an association between vitamin D deficiency and COVID-19 incidence has also been supported by meta-analysis <span class="citation" data-cites="sWzpGBil">[<a href="#ref-sWzpGBil" role="doc-biblioref">1833</a>]</span>.
 Indeed, scientists are working to confirm these findings and to determine whether a patient’s serum 25-hydroxyvitamin D levels are also associated with COVID-19 severity.
 Clinical trials are required to determine whether preemptive vitamin D supplementation may mitigate against severe COVID-19.
-In terms of the therapeutic potential of vitamin D, initial evidence from clinical trials is conflicting but seems to indicate that vitamin D supplementation may reduce COVID-19 severity <span class="citation" data-cites="rYXmRFCk">[<a href="#ref-rYXmRFCk" role="doc-biblioref">1757</a>]</span>.
+In terms of the therapeutic potential of vitamin D, initial evidence from clinical trials is conflicting but seems to indicate that vitamin D supplementation may reduce COVID-19 severity <span class="citation" data-cites="rYXmRFCk">[<a href="#ref-rYXmRFCk" role="doc-biblioref">1764</a>]</span>.
 The various clinical trials currently underway will be imperative to provide information on the efficacious use of vitamin D supplementation for COVID-19 prevention and/or treatment.</p>
 <p>The purported prophylactic and therapeutic benefits of dietary supplements and nutraceuticals for multiple disorders, diseases, and infections has been the subject of significant research and debate for the last few decades.
 Inevitably, scientists are also investigating the potential for these various products to treat or prevent COVID-19.
@@ -5138,45 +5124,45 @@ <h2 data-number="10.9" id="discussion"><span class="header-section-number">10.9<
 The nutraceuticals discussed in this review, namely vitamin C, vitamin D, n-3 PUFA, zinc, and probiotics, were selected because of potential biological mechanisms that could beneficially affect viral and respiratory infections and because they are currently under clinical investigation.
 Specifically, these compounds have all been found to influence cellular processes related to inflammation.
 Inflammation is particularly relevant to COVID-19 because of the negative outcomes (often death) observed in a large number of patients whose immune response becomes hyperactive in response to SARS-CoV-2, leading to severe outcomes such as ARDS and sepsis <span class="citation" data-cites="nCVMwr28">[<a href="#ref-nCVMwr28" role="doc-biblioref">734</a>]</span>.
-Additionally, there is a well-established link between diet and inflammation <span class="citation" data-cites="1HHbyV6d">[<a href="#ref-1HHbyV6d" role="doc-biblioref">1827</a>]</span>, potentially mediated in part by the microbiome <span class="citation" data-cites="ViPBMxtf">[<a href="#ref-ViPBMxtf" role="doc-biblioref">1828</a>]</span>.
+Additionally, there is a well-established link between diet and inflammation <span class="citation" data-cites="1HHbyV6d">[<a href="#ref-1HHbyV6d" role="doc-biblioref">1834</a>]</span>, potentially mediated in part by the microbiome <span class="citation" data-cites="ViPBMxtf">[<a href="#ref-ViPBMxtf" role="doc-biblioref">1835</a>]</span>.
 Thus, the idea that dietary modifications or supplementation could be used to modify the inflammatory response is tied to a broader view of how diet and the immune system are interconnected.
-The supplements and nutraceuticals discussed here therefore lie in sharp contrast to other alleged nutraceutical or dietary supplements that have attracted during the pandemic, such as colloidal silver <span class="citation" data-cites="wtYA1GbG">[<a href="#ref-wtYA1GbG" role="doc-biblioref">1829</a>]</span>, which have no known nutritional function and can be harmful.
+The supplements and nutraceuticals discussed here therefore lie in sharp contrast to other alleged nutraceutical or dietary supplements that have attracted during the pandemic, such as colloidal silver <span class="citation" data-cites="wtYA1GbG">[<a href="#ref-wtYA1GbG" role="doc-biblioref">1836</a>]</span>, which have no known nutritional function and can be harmful.
 Importantly, while little clinical evidence is available about the effects of any supplements against COVID-19, the risks associated with those discussed above are likely to be low, and in some cases, they can be obtained from dietary sources alone.</p>
 <p>There are various other products and molecules that have garnered scientific interest and could merit further investigation.
-These include polyphenols, lipid extracts, and tomato-based nutraceuticals, all of which have been suggested for the potential prevention of cardiovascular complications of COVID-19 such as thrombosis <span class="citation" data-cites="rWVL91jq EEa0SZCF">[<a href="#ref-EEa0SZCF" role="doc-biblioref">1635</a>,<a href="#ref-rWVL91jq" role="doc-biblioref">1670</a>]</span>.
-Melatonin is another supplement that has been identified as a potential antiviral agent against SARS-CoV-2 using computational methods <span class="citation" data-cites="TDa7cEUV">[<a href="#ref-TDa7cEUV" role="doc-biblioref">1830</a>]</span>, and it has also been highlighted as a potential therapeutic agent for COVID-19 due to its documented antioxidant, anti-apoptotic, immunomodulatory, and anti-inflammatory effects <span class="citation" data-cites="rWVL91jq GJAYfMR0 2CXoItPz">[<a href="#ref-rWVL91jq" role="doc-biblioref">1670</a>,<a href="#ref-GJAYfMR0" role="doc-biblioref">1831</a>,<a href="#ref-2CXoItPz" role="doc-biblioref">1832</a>]</span>.
-Notably, melatonin, vitamin D and zinc have attracted public attention because they were included in the treatment plan of the former President of the United States upon his hospitalization due to COVID-19 <span class="citation" data-cites="MNWnrcz6">[<a href="#ref-MNWnrcz6" role="doc-biblioref">1833</a>]</span>.
+These include polyphenols, lipid extracts, and tomato-based nutraceuticals, all of which have been suggested for the potential prevention of cardiovascular complications of COVID-19 such as thrombosis <span class="citation" data-cites="rWVL91jq EEa0SZCF">[<a href="#ref-EEa0SZCF" role="doc-biblioref">1642</a>,<a href="#ref-rWVL91jq" role="doc-biblioref">1677</a>]</span>.
+Melatonin is another supplement that has been identified as a potential antiviral agent against SARS-CoV-2 using computational methods <span class="citation" data-cites="TDa7cEUV">[<a href="#ref-TDa7cEUV" role="doc-biblioref">1837</a>]</span>, and it has also been highlighted as a potential therapeutic agent for COVID-19 due to its documented antioxidant, anti-apoptotic, immunomodulatory, and anti-inflammatory effects <span class="citation" data-cites="rWVL91jq GJAYfMR0 2CXoItPz">[<a href="#ref-rWVL91jq" role="doc-biblioref">1677</a>,<a href="#ref-GJAYfMR0" role="doc-biblioref">1838</a>,<a href="#ref-2CXoItPz" role="doc-biblioref">1839</a>]</span>.
+Notably, melatonin, vitamin D and zinc have attracted public attention because they were included in the treatment plan of the former President of the United States upon his hospitalization due to COVID-19 <span class="citation" data-cites="MNWnrcz6">[<a href="#ref-MNWnrcz6" role="doc-biblioref">1840</a>]</span>.
 These are just some of the many substances and supplements that are currently under investigation but as of yet lack evidence to support their use for the prevention or treatment of COVID-19.
-While there is plenty of skepticism put forward by physicians and scientists surrounding the use of supplements, these statements have not stopped consumers from purchasing these products, with one study reporting that online searches for dietary supplements in Poland began trending with the start of the pandemic <span class="citation" data-cites="19yy9SHf1">[<a href="#ref-19yy9SHf1" role="doc-biblioref">1776</a>]</span>.
+While there is plenty of skepticism put forward by physicians and scientists surrounding the use of supplements, these statements have not stopped consumers from purchasing these products, with one study reporting that online searches for dietary supplements in Poland began trending with the start of the pandemic <span class="citation" data-cites="19yy9SHf1">[<a href="#ref-19yy9SHf1" role="doc-biblioref">1783</a>]</span>.
 Additionally, supplement usage increased between the first and second wave of the pandemic.
 Participants reported various reasons for their use of supplements, including to improve immunity (60%), to improve overall health (57%), and to fill nutrient gaps in their diet (53%).
 Other efforts to collect large datasets regarding such behavior have also sought to explore a possible association between vitamin or supplement consumption and COVID-19.
-An observational analysis of survey responses from 327,720 users of the COVID Symptom Study App found that the consumption of n-3 PUFA supplements, probiotics, multivitamins, and vitamin D was associated with a lower risk of SARS-CoV-2 infection in women but not men after adjusting for potential confounders <span class="citation" data-cites="RJfF7BYs">[<a href="#ref-RJfF7BYs" role="doc-biblioref">1834</a>]</span>.
-According to the authors, the sexual dimorphism observed may in part be because supplements may better support females due to known differences between the male and female immune systems, or it could be due to behavioral and health consciousness differences between the sexes <span class="citation" data-cites="RJfF7BYs">[<a href="#ref-RJfF7BYs" role="doc-biblioref">1834</a>]</span>.
+An observational analysis of survey responses from 327,720 users of the COVID Symptom Study App found that the consumption of n-3 PUFA supplements, probiotics, multivitamins, and vitamin D was associated with a lower risk of SARS-CoV-2 infection in women but not men after adjusting for potential confounders <span class="citation" data-cites="RJfF7BYs">[<a href="#ref-RJfF7BYs" role="doc-biblioref">1841</a>]</span>.
+According to the authors, the sexual dimorphism observed may in part be because supplements may better support females due to known differences between the male and female immune systems, or it could be due to behavioral and health consciousness differences between the sexes <span class="citation" data-cites="RJfF7BYs">[<a href="#ref-RJfF7BYs" role="doc-biblioref">1841</a>]</span>.
 Certainly, randomized controlled trials are required to investigate these findings further.</p>
-<p>Finally, it is known that a patient’s nutritional status affects health outcomes in various infectious diseases <span class="citation" data-cites="5tHMedSi">[<a href="#ref-5tHMedSi" role="doc-biblioref">1609</a>]</span>, and COVID-19 is no different <span class="citation" data-cites="pQxCF4GH Hd5V5Usd d6c8mjAk">[<a href="#ref-Hd5V5Usd" role="doc-biblioref">1607</a>,<a href="#ref-pQxCF4GH" role="doc-biblioref">1835</a>,<a href="#ref-d6c8mjAk" role="doc-biblioref">1836</a>]</span>.
-Some of the main risk factors for severe COVID-19, which also happen to be linked to poor nutritional status, include obesity, hypertension, cardiovascular diseases, type II diabetes mellitus, and indeed age-related malnutrition <span class="citation" data-cites="Hd5V5Usd Lyd8s4Mk 1HL90Mz7X">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1605</a>,<a href="#ref-Hd5V5Usd" role="doc-biblioref">1607</a>,<a href="#ref-1HL90Mz7X" role="doc-biblioref">1837</a>]</span>.
+<p>Finally, it is known that a patient’s nutritional status affects health outcomes in various infectious diseases <span class="citation" data-cites="5tHMedSi">[<a href="#ref-5tHMedSi" role="doc-biblioref">1616</a>]</span>, and COVID-19 is no different <span class="citation" data-cites="pQxCF4GH Hd5V5Usd d6c8mjAk">[<a href="#ref-Hd5V5Usd" role="doc-biblioref">1614</a>,<a href="#ref-pQxCF4GH" role="doc-biblioref">1842</a>,<a href="#ref-d6c8mjAk" role="doc-biblioref">1843</a>]</span>.
+Some of the main risk factors for severe COVID-19, which also happen to be linked to poor nutritional status, include obesity, hypertension, cardiovascular diseases, type II diabetes mellitus, and indeed age-related malnutrition <span class="citation" data-cites="Hd5V5Usd Lyd8s4Mk 1HL90Mz7X">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1612</a>,<a href="#ref-Hd5V5Usd" role="doc-biblioref">1614</a>,<a href="#ref-1HL90Mz7X" role="doc-biblioref">1844</a>]</span>.
 Although not the main focus of this review, it is important to consider the nutritional challenges associated with severe COVID-19 patients.
-Hospitalized COVID-19 patients tend to report an unusually high loss of appetite preceding admission, some suffer diarrhea and gastrointestinal symptoms that result in significantly lower food intake, and patients with poorer nutritional status were more likely to have worse outcomes and require nutrition therapy <span class="citation" data-cites="179QIwE1l">[<a href="#ref-179QIwE1l" role="doc-biblioref">1838</a>]</span>.
-Dysphagia also seems to be a significant problem in pediatric patients that suffered multisystem inflammatory syndrome <span class="citation" data-cites="ARM0HdR3">[<a href="#ref-ARM0HdR3" role="doc-biblioref">1839</a>]</span> and rehabilitating COVID-19 patients, potentially contributing to poor nutritional status <span class="citation" data-cites="1DmkRczqw">[<a href="#ref-1DmkRczqw" role="doc-biblioref">1840</a>]</span>.
-Almost two-thirds of discharged COVID-19 ICU patients exhibit significant weight loss, of which 26% had weight loss greater than 10% <span class="citation" data-cites="d6c8mjAk">[<a href="#ref-d6c8mjAk" role="doc-biblioref">1836</a>]</span>.
-As investigated in this review, hospitalized patients also tend to exhibit vitamin D deficiency or insufficiency, which may be associated with greater disease severity <span class="citation" data-cites="sWzpGBil">[<a href="#ref-sWzpGBil" role="doc-biblioref">1826</a>]</span>.
+Hospitalized COVID-19 patients tend to report an unusually high loss of appetite preceding admission, some suffer diarrhea and gastrointestinal symptoms that result in significantly lower food intake, and patients with poorer nutritional status were more likely to have worse outcomes and require nutrition therapy <span class="citation" data-cites="179QIwE1l">[<a href="#ref-179QIwE1l" role="doc-biblioref">1845</a>]</span>.
+Dysphagia also seems to be a significant problem in pediatric patients that suffered multisystem inflammatory syndrome <span class="citation" data-cites="ARM0HdR3">[<a href="#ref-ARM0HdR3" role="doc-biblioref">1846</a>]</span> and rehabilitating COVID-19 patients, potentially contributing to poor nutritional status <span class="citation" data-cites="1DmkRczqw">[<a href="#ref-1DmkRczqw" role="doc-biblioref">1847</a>]</span>.
+Almost two-thirds of discharged COVID-19 ICU patients exhibit significant weight loss, of which 26% had weight loss greater than 10% <span class="citation" data-cites="d6c8mjAk">[<a href="#ref-d6c8mjAk" role="doc-biblioref">1843</a>]</span>.
+As investigated in this review, hospitalized patients also tend to exhibit vitamin D deficiency or insufficiency, which may be associated with greater disease severity <span class="citation" data-cites="sWzpGBil">[<a href="#ref-sWzpGBil" role="doc-biblioref">1833</a>]</span>.
 Therefore, further research is required to determine how dietary supplements and nutraceuticals may contribute to the treatment of severely ill and rehabilitating patients, who often rely on enteral nutrition.</p>
 <h2 data-number="10.10" id="conclusions-3"><span class="header-section-number">10.10</span> Conclusions</h2>
 <p>Despite all the potential benefits of nutraceutical and dietary supplement interventions presented, currently there is a paucity of clinical evidence to support their use for the prevention or mitigation of COVID-19 infection.
-Nevertheless, optimal nutritional status can prime an individual’s immune system to protect against the effects of acute respiratory viral infections by supporting normal maintenance of the immune system <span class="citation" data-cites="5tHMedSi Lyd8s4Mk">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1605</a>,<a href="#ref-5tHMedSi" role="doc-biblioref">1609</a>]</span>.
-Nutritional strategies can also play a role in the treatment of hospitalized patients, as malnutrition is a risk to COVID-19 patients <span class="citation" data-cites="1DmkRczqw">[<a href="#ref-1DmkRczqw" role="doc-biblioref">1840</a>]</span>.
+Nevertheless, optimal nutritional status can prime an individual’s immune system to protect against the effects of acute respiratory viral infections by supporting normal maintenance of the immune system <span class="citation" data-cites="5tHMedSi Lyd8s4Mk">[<a href="#ref-Lyd8s4Mk" role="doc-biblioref">1612</a>,<a href="#ref-5tHMedSi" role="doc-biblioref">1616</a>]</span>.
+Nutritional strategies can also play a role in the treatment of hospitalized patients, as malnutrition is a risk to COVID-19 patients <span class="citation" data-cites="1DmkRczqw">[<a href="#ref-1DmkRczqw" role="doc-biblioref">1847</a>]</span>.
 Overall, supplementation of vitamin C, vitamin D, and zinc may be an effective method of ensuring their adequate intake to maintain optimal immune function, which may also convey beneficial effects against viral infections due to their immunomodulatory effects.
 Individuals should pay attention to their nutritional status, particularly their intake of vitamin D, considering that vitamin D deficiency is widespread.
-The prevailing evidence seems to indicate an association between vitamin D deficiency with COVID-19 incidence and, potentially, severity <span class="citation" data-cites="LpqYmd4C">[<a href="#ref-LpqYmd4C" role="doc-biblioref">1732</a>]</span>.
+The prevailing evidence seems to indicate an association between vitamin D deficiency with COVID-19 incidence and, potentially, severity <span class="citation" data-cites="LpqYmd4C">[<a href="#ref-LpqYmd4C" role="doc-biblioref">1739</a>]</span>.
 As a result, some international authorities have advised the general public, particularly those at high risk of infection, to consider vitamin D supplementation.
 However, further well-controlled clinical trials are required to confirm these observations.</p>
-<p>Many supplements and nutraceuticals designed for various ailments that are available in the United States and beyond are not strictly regulated <span class="citation" data-cites="lMhFSIiF">[<a href="#ref-lMhFSIiF" role="doc-biblioref">1841</a>]</span>.
+<p>Many supplements and nutraceuticals designed for various ailments that are available in the United States and beyond are not strictly regulated <span class="citation" data-cites="lMhFSIiF">[<a href="#ref-lMhFSIiF" role="doc-biblioref">1848</a>]</span>.
 Consequently, there can be safety and efficacy concerns associated with many of these products.
 Often, the vulnerable members of society can be exploited in this regard and, unfortunately, the COVID-19 pandemic has proven no different.
-As mentioned above, the FDA has issued warnings to several companies for advertising falsified claims in relation to the preventative and therapeutic capabilities of their products against COVID-19 <span class="citation" data-cites="fez8aZAu">[<a href="#ref-fez8aZAu" role="doc-biblioref">1842</a>]</span>.
+As mentioned above, the FDA has issued warnings to several companies for advertising falsified claims in relation to the preventative and therapeutic capabilities of their products against COVID-19 <span class="citation" data-cites="fez8aZAu">[<a href="#ref-fez8aZAu" role="doc-biblioref">1849</a>]</span>.
 Further intensive investigation is required to establish the effects of these nutraceuticals, if any, against COVID-19.
-Until more effective therapeutics are established, the most effective mitigation strategies consist of encouraging standard public health practices such as regular hand washing with soap, wearing a face mask, and covering a cough with your elbow <span class="citation" data-cites="2Xu90WtD">[<a href="#ref-2Xu90WtD" role="doc-biblioref">1843</a>]</span>, along with following social distancing measures, “stay at home” guidelines, expansive testing, and contact tracing <span class="citation" data-cites="EhbZIMo0 12Met0WvX">[<a href="#ref-EhbZIMo0" role="doc-biblioref">1844</a>,<a href="#ref-12Met0WvX" role="doc-biblioref">1845</a>]</span>.
+Until more effective therapeutics are established, the most effective mitigation strategies consist of encouraging standard public health practices such as regular hand washing with soap, wearing a face mask, and covering a cough with your elbow <span class="citation" data-cites="2Xu90WtD">[<a href="#ref-2Xu90WtD" role="doc-biblioref">1850</a>]</span>, along with following social distancing measures, “stay at home” guidelines, expansive testing, and contact tracing <span class="citation" data-cites="EhbZIMo0 12Met0WvX">[<a href="#ref-EhbZIMo0" role="doc-biblioref">1851</a>,<a href="#ref-12Met0WvX" role="doc-biblioref">1852</a>]</span>.
 Indeed, in light of this review, it would also be pertinent to adopt a healthy diet and lifestyle following national guidelines in order to maintain optimal immune health.
 Because of the broad public appeal of dietary supplements and nutraceuticals, it is important to evaluate the evidence regarding the use of such products.
 We will continue to update this review as more findings become available.</p>
@@ -5185,83 +5171,83 @@ <h2 data-number="11.1" id="social-factors-influencing-covid-19-outcomes"><span c
 <p>In addition to understanding the fundamental biology of the SARS-CoV-2 virus and COVID-19, it is critical to consider how the broader environment can influence both COVID-19 outcomes and efforts to develop and implement treatments for the disease.
 The evidence clearly indicates that social environmental factors are critical determinants of individuals’ and communities’ risks related to COVID-19.
 There are distinct components to COVID-19 susceptibility, and an individual’s risk can be elevated at one or all stages from exposure to recovery/mortality: an individual may be more likely to be exposed to the virus, more likely to get infected once exposed, more likely to have serious complications once infected, and be less likely to receive adequate care once they are seriously ill.
-The fact that differences in survival between Black and white patients were no longer significant after controlling for comorbidities and socioeconomic status (type of insurance, neighborhood deprivation score, and hospital where treatment was received) in addition to sex and age <span class="citation" data-cites="hrOv770z">[<a href="#ref-hrOv770z" role="doc-biblioref">1846</a>]</span> underscores the relevance of social factors to understanding mortality differences between racial and ethnic groups.
-Moreover, the Black patients were younger and more likely to be female than white patients, yet still had a higher mortality rate without correction for the other variables <span class="citation" data-cites="hrOv770z">[<a href="#ref-hrOv770z" role="doc-biblioref">1846</a>]</span>.
+The fact that differences in survival between Black and white patients were no longer significant after controlling for comorbidities and socioeconomic status (type of insurance, neighborhood deprivation score, and hospital where treatment was received) in addition to sex and age <span class="citation" data-cites="hrOv770z">[<a href="#ref-hrOv770z" role="doc-biblioref">1853</a>]</span> underscores the relevance of social factors to understanding mortality differences between racial and ethnic groups.
+Moreover, the Black patients were younger and more likely to be female than white patients, yet still had a higher mortality rate without correction for the other variables <span class="citation" data-cites="hrOv770z">[<a href="#ref-hrOv770z" role="doc-biblioref">1853</a>]</span>.
 Here, we outline a few systemic reasons that may exacerbate the COVID-19 pandemic in communities of color.</p>
 <h2 data-number="11.2" id="factors-observed-to-be-associated-with-susceptibility"><span class="header-section-number">11.2</span> Factors Observed to be Associated with Susceptibility</h2>
 <p>As COVID-19 has spread into communities around the globe, it has become clear that the risks associated with this disease are not equally shared by all individuals or all communities.
 Significant disparities in outcomes have led to interest in the demographic, biomedical, and social factors that influence COVID-19 severity.
 Untangling the factors influencing COVID-19 susceptibility is a complex undertaking.
-Among patients who are admitted to the hospital, outcomes have generally been poor, with rates of admission to the intensive care unit (ICU) upwards of 15% in both Wuhan, China and Italy <span class="citation" data-cites="15IDA5kX6 11xfoqpEl qlJ8hCUs">[<a href="#ref-15IDA5kX6" role="doc-biblioref">80</a>,<a href="#ref-11xfoqpEl" role="doc-biblioref">1847</a>,<a href="#ref-qlJ8hCUs" role="doc-biblioref">1848</a>]</span>.
-However, hospitalization rates vary by location <span class="citation" data-cites="xZBEFXiG">[<a href="#ref-xZBEFXiG" role="doc-biblioref">1849</a>]</span>.
+Among patients who are admitted to the hospital, outcomes have generally been poor, with rates of admission to the intensive care unit (ICU) upwards of 15% in both Wuhan, China and Italy <span class="citation" data-cites="15IDA5kX6 11xfoqpEl qlJ8hCUs">[<a href="#ref-15IDA5kX6" role="doc-biblioref">80</a>,<a href="#ref-11xfoqpEl" role="doc-biblioref">1854</a>,<a href="#ref-qlJ8hCUs" role="doc-biblioref">1855</a>]</span>.
+However, hospitalization rates vary by location <span class="citation" data-cites="xZBEFXiG">[<a href="#ref-xZBEFXiG" role="doc-biblioref">1856</a>]</span>.
 This variation may be influenced by demographic (e.g., average age in the area), medical (e.g., the prevalence of comorbid conditions such as diabetes), and social (e.g., income or healthcare availability) factors that vary geographically.
 Additionally, some of the same factors may influence an individual’s probability of exposure to SARS-CoV-2, their risk of developing a more serious case of COVID-19 that would require hospitalization, and their access to medical support.
 As a result, quantifying or comparing susceptibility among individuals, communities, or other groups requires consideration of a number of complex phenomena that intersect across many disciplines of research.
 In this section, the term “risk factor” is used to refer to variables that are statistically associated with more severe COVID-19 outcomes.
 Some are intrinsic characteristics that have been observed to carry an association with variation in outcomes, whereas others may be more functionally linked to the pathophysiology of COVID-19.</p>
 <h3 data-number="11.2.1" id="patient-traits-associated-with-increased-risk"><span class="header-section-number">11.2.1</span> Patient Traits Associated with Increased Risk</h3>
-<p>Two traits that have been consistently associated with more severe COVID-19 outcomes are male sex and advanced age (typically defined as 60 or older, with the greatest risk among those 85 and older <span class="citation" data-cites="aZlVFn2R">[<a href="#ref-aZlVFn2R" role="doc-biblioref">1850</a>]</span>).
-In the United States, males and older individuals diagnosed with COVID-19 were found to be more likely to require hospitalization <span class="citation" data-cites="1D6lVXWbJ Zk5CfYeW">[<a href="#ref-1D6lVXWbJ" role="doc-biblioref">1851</a>,<a href="#ref-Zk5CfYeW" role="doc-biblioref">1852</a>]</span>.
-A retrospective study of hospitalized Chinese patients <span class="citation" data-cites="10THxyeCg">[<a href="#ref-10THxyeCg" role="doc-biblioref">81</a>]</span> found that a higher probability of mortality was associated with older age, and world-wide, population age structure has been found to be an important variable for explaining differences in outbreak severity <span class="citation" data-cites="BQ4pZGxJ">[<a href="#ref-BQ4pZGxJ" role="doc-biblioref">1853</a>]</span>.
-The CFR for adults over 80 has been estimated upwards of 14% or even 20% <span class="citation" data-cites="1DnayDKc4">[<a href="#ref-1DnayDKc4" role="doc-biblioref">1854</a>]</span>.
-Male sex has also been identified as a risk factor for severe COVID-19 outcomes, including death <span class="citation" data-cites="gObtnWSD DqBeNrR5 ConBOYBB">[<a href="#ref-gObtnWSD" role="doc-biblioref">1855</a>,<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>,<a href="#ref-ConBOYBB" role="doc-biblioref">1857</a>/]</span>.
-Early reports from China and Europe indicated that even though the case rates were similar across males and females, males were at elevated risk for hospital admission, ICU admission, and death <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>]</span>, although data from some US states indicates more cases among females, potentially due to gender representation in care-taking professions <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>]</span>.
-In older age groups (e.g., age 60 and older), comparable absolute numbers of male and female cases actually suggests a higher rate of occurrence in males, due to increased skew in the sex ratio <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>]</span>.
-Current estimates based on worldwide data suggest that, compared to females, males may be 30% more likely to be hospitalized, 80% more likely to be admitted to the ICU, and 40% more likely to die as a result of COVID-19 <span class="citation" data-cites="ConBOYBB">[<a href="#ref-ConBOYBB" role="doc-biblioref">1857</a>/]</span>.
-There also may be a compounding effect of advanced age and male sex, with differences time to recovery worst for males over 60 years old relative to female members of their age cohort <span class="citation" data-cites="RcYBFjm1">[<a href="#ref-RcYBFjm1" role="doc-biblioref">1859</a>]</span>.</p>
+<p>Two traits that have been consistently associated with more severe COVID-19 outcomes are male sex and advanced age (typically defined as 60 or older, with the greatest risk among those 85 and older <span class="citation" data-cites="aZlVFn2R">[<a href="#ref-aZlVFn2R" role="doc-biblioref">1857</a>]</span>).
+In the United States, males and older individuals diagnosed with COVID-19 were found to be more likely to require hospitalization <span class="citation" data-cites="1D6lVXWbJ Zk5CfYeW">[<a href="#ref-1D6lVXWbJ" role="doc-biblioref">1858</a>,<a href="#ref-Zk5CfYeW" role="doc-biblioref">1859</a>]</span>.
+A retrospective study of hospitalized Chinese patients <span class="citation" data-cites="10THxyeCg">[<a href="#ref-10THxyeCg" role="doc-biblioref">81</a>]</span> found that a higher probability of mortality was associated with older age, and world-wide, population age structure has been found to be an important variable for explaining differences in outbreak severity <span class="citation" data-cites="BQ4pZGxJ">[<a href="#ref-BQ4pZGxJ" role="doc-biblioref">1860</a>]</span>.
+The CFR for adults over 80 has been estimated upwards of 14% or even 20% <span class="citation" data-cites="1DnayDKc4">[<a href="#ref-1DnayDKc4" role="doc-biblioref">1861</a>]</span>.
+Male sex has also been identified as a risk factor for severe COVID-19 outcomes, including death <span class="citation" data-cites="gObtnWSD DqBeNrR5 ConBOYBB">[<a href="#ref-gObtnWSD" role="doc-biblioref">1862</a>,<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>,<a href="#ref-ConBOYBB" role="doc-biblioref">1864</a>/]</span>.
+Early reports from China and Europe indicated that even though the case rates were similar across males and females, males were at elevated risk for hospital admission, ICU admission, and death <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>]</span>, although data from some US states indicates more cases among females, potentially due to gender representation in care-taking professions <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>]</span>.
+In older age groups (e.g., age 60 and older), comparable absolute numbers of male and female cases actually suggests a higher rate of occurrence in males, due to increased skew in the sex ratio <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>]</span>.
+Current estimates based on worldwide data suggest that, compared to females, males may be 30% more likely to be hospitalized, 80% more likely to be admitted to the ICU, and 40% more likely to die as a result of COVID-19 <span class="citation" data-cites="ConBOYBB">[<a href="#ref-ConBOYBB" role="doc-biblioref">1864</a>/]</span>.
+There also may be a compounding effect of advanced age and male sex, with differences time to recovery worst for males over 60 years old relative to female members of their age cohort <span class="citation" data-cites="RcYBFjm1">[<a href="#ref-RcYBFjm1" role="doc-biblioref">1866</a>]</span>.</p>
 <p>Both of these risk factors can be approached through the lens of biology.
-The biological basis for greater susceptibility with age is likely linked to the prevalence of extenuating health conditions such as heart failure or diabetes <span class="citation" data-cites="1DnayDKc4">[<a href="#ref-1DnayDKc4" role="doc-biblioref">1854</a>]</span>.
+The biological basis for greater susceptibility with age is likely linked to the prevalence of extenuating health conditions such as heart failure or diabetes <span class="citation" data-cites="1DnayDKc4">[<a href="#ref-1DnayDKc4" role="doc-biblioref">1861</a>]</span>.
 Several hypotheses have been proposed to account for differences in severity between males and females.
-For example, some evidence suggests that female sex hormones may be protective <span class="citation" data-cites="DqBeNrR5 fH3qecwy">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>,<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>]</span>.
-ACE2 expression in the kidneys of male mice was observed to be twice as high as that of females, and a regulatory effect of estradiol on ACE2 expression was demonstrated by removing the gonads and then supplementing with estradiol <span class="citation" data-cites="OJvjTsWz fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>,<a href="#ref-OJvjTsWz" role="doc-biblioref">1860</a>]</span>.
-Other work in mice has shown an inverse association between mortality due to SARS-CoV-1 and estradiol, suggesting a protective role for the sex hormone <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>]</span>.
+For example, some evidence suggests that female sex hormones may be protective <span class="citation" data-cites="DqBeNrR5 fH3qecwy">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>,<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>]</span>.
+ACE2 expression in the kidneys of male mice was observed to be twice as high as that of females, and a regulatory effect of estradiol on ACE2 expression was demonstrated by removing the gonads and then supplementing with estradiol <span class="citation" data-cites="OJvjTsWz fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>,<a href="#ref-OJvjTsWz" role="doc-biblioref">1867</a>]</span>.
+Other work in mice has shown an inverse association between mortality due to SARS-CoV-1 and estradiol, suggesting a protective role for the sex hormone <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>]</span>.
 Similarly, evidence suggests that similar patterns might be found in other tissues.
-A preliminary analysis identified higher levels of ACE2 expression in the myocardium of male patients with aortic valve stenosis showed than female patients, although this pattern was not found in controls <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>]</span>.
-Additionally, research has indicated that females respond to lower doses than males of heart medications that act on the Renin angiotensin aldosterone system (RAAS) pathway, which is shared with ACE2 <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>]</span>.
-Additionally, several components of the immune response, including the inflammatory response, may differ in intensity and timing between males and females <span class="citation" data-cites="fH3qecwy OJvjTsWz">[<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>,<a href="#ref-OJvjTsWz" role="doc-biblioref">1860</a>]</span>.
-This hypothesis is supported by some preliminary evidence showing that female patients who recovered from severe COVID-19 had higher antibody titers than males <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>]</span>.
-Sex steroids can also bind to immune cell receptors to influence cytokine production <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>]</span>.
-Additionally, social factors may influence risks related to both age and sex: for example, older adults are more likely to live in care facilities, which have been a source for a large number of outbreaks <span class="citation" data-cites="ujWsdPdH">[<a href="#ref-ujWsdPdH" role="doc-biblioref">1861</a>]</span>, and gender roles may also influence exposure and/or susceptibility due to differences in care-taking and/or risky behaviors (e.g., caring for elder relatives and smoking, respectively) <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1856</a>]</span> among men and women (however, it should be noted that both transgender men and women are suspected to be at heightened risk <span class="citation" data-cites="agpMLmxt">[<a href="#ref-agpMLmxt" role="doc-biblioref">1862</a>]</span>.)</p>
+A preliminary analysis identified higher levels of ACE2 expression in the myocardium of male patients with aortic valve stenosis showed than female patients, although this pattern was not found in controls <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>]</span>.
+Additionally, research has indicated that females respond to lower doses than males of heart medications that act on the Renin angiotensin aldosterone system (RAAS) pathway, which is shared with ACE2 <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>]</span>.
+Additionally, several components of the immune response, including the inflammatory response, may differ in intensity and timing between males and females <span class="citation" data-cites="fH3qecwy OJvjTsWz">[<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>,<a href="#ref-OJvjTsWz" role="doc-biblioref">1867</a>]</span>.
+This hypothesis is supported by some preliminary evidence showing that female patients who recovered from severe COVID-19 had higher antibody titers than males <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>]</span>.
+Sex steroids can also bind to immune cell receptors to influence cytokine production <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>]</span>.
+Additionally, social factors may influence risks related to both age and sex: for example, older adults are more likely to live in care facilities, which have been a source for a large number of outbreaks <span class="citation" data-cites="ujWsdPdH">[<a href="#ref-ujWsdPdH" role="doc-biblioref">1868</a>]</span>, and gender roles may also influence exposure and/or susceptibility due to differences in care-taking and/or risky behaviors (e.g., caring for elder relatives and smoking, respectively) <span class="citation" data-cites="DqBeNrR5">[<a href="#ref-DqBeNrR5" role="doc-biblioref">1863</a>]</span> among men and women (however, it should be noted that both transgender men and women are suspected to be at heightened risk <span class="citation" data-cites="agpMLmxt">[<a href="#ref-agpMLmxt" role="doc-biblioref">1869</a>]</span>.)</p>
 <h3 data-number="11.2.2" id="comorbid-health-conditions"><span class="header-section-number">11.2.2</span> Comorbid Health Conditions</h3>
 <p>A number of pre-existing or comorbid conditions have repeatedly been identified as risk factors for more severe COVID-19 outcomes.
-Several underlying health conditions were identified at high prevalence among hospitalized patients, including obesity, diabetes, hypertension, lung disease, and cardiovascular disease <span class="citation" data-cites="xZBEFXiG">[<a href="#ref-xZBEFXiG" role="doc-biblioref">1849</a>]</span>.
-Higher Sequential Organ Failure Assessment (SOFA) scores have been associated with a higher probability of mortality <span class="citation" data-cites="10THxyeCg">[<a href="#ref-10THxyeCg" role="doc-biblioref">81</a>]</span>, and comorbid conditions such as cardiovascular and lung disease as well as obesity were also associated with an increased risk of hospitalization and death, even when correcting for age and sex <span class="citation" data-cites="gObtnWSD">[<a href="#ref-gObtnWSD" role="doc-biblioref">1855</a>]</span>.
-Diabetes may increase the risk of lengthy hospitalization <span class="citation" data-cites="9NfXSHjH">[<a href="#ref-9NfXSHjH" role="doc-biblioref">1863</a>]</span> or of death <span class="citation" data-cites="9NfXSHjH 13BpwZaaq">[<a href="#ref-9NfXSHjH" role="doc-biblioref">1863</a>,<a href="#ref-13BpwZaaq" role="doc-biblioref">1864</a>]</span>.
-<span class="citation" data-cites="UkCdtLwF">[<a href="#ref-UkCdtLwF" role="doc-biblioref">1865</a>]</span> and <span class="citation" data-cites="OT5GEOej">[<a href="#ref-OT5GEOej" role="doc-biblioref">1866</a>]</span> discuss possible ways in which COVID-19 and diabetes may interact.
-Obesity also appears to be associated with higher risk of severe outcomes from SARS-CoV-2 <span class="citation" data-cites="ZLmNMDrD 2Ahpn6R2">[<a href="#ref-ZLmNMDrD" role="doc-biblioref">1867</a>,<a href="#ref-2Ahpn6R2" role="doc-biblioref">1868</a>]</span>.
-Obesity is considered an underlying risk factor for other health problems, and the mechanism for its contributions to COVID-19 hospitalization or mortality is not yet clear <span class="citation" data-cites="1AmBg80Un">[<a href="#ref-1AmBg80Un" role="doc-biblioref">1869</a>]</span>.
-Dementia and cancer were also associated with the risk of death in an analysis of a large number (more than 20,000) COVID-19 patients in the United Kingdom <span class="citation" data-cites="gObtnWSD">[<a href="#ref-gObtnWSD" role="doc-biblioref">1855</a>]</span>.
-It should be noted that comorbid conditions are inextricably tied to age, as conditions tend to be accumulated over time, but that the prevalence of individual comorbidities or of population health overall can vary regionally <span class="citation" data-cites="1GakM8xhV">[<a href="#ref-1GakM8xhV" role="doc-biblioref">1870</a>]</span>.
-Several comorbidities that are highly prevalent in older adults, such as COPD, hypertension, cardiovascular disease, and diabetes, have been associated with CFRs upwards of 8% compared to an estimate of 1.4% in people without comorbidities <span class="citation" data-cites="1DnayDKc4 H6dfv6Wv">[<a href="#ref-1DnayDKc4" role="doc-biblioref">1854</a>,<a href="#ref-H6dfv6Wv" role="doc-biblioref">1871</a>]</span>. <!-- will this url work for Manubot?-->
-Therefore, both age and health are important considerations when predicting the impact of COVID-19 on a population <span class="citation" data-cites="1GakM8xhV">[<a href="#ref-1GakM8xhV" role="doc-biblioref">1870</a>]</span>.
-However, other associations may exist, such as patients with sepsis having higher SOFA scores – in fact, SOFA was developed for the assessment of organ failure in the context of sepsis, and the acronym originally stood for Sepsis-Related Organ Failure Assessment <span class="citation" data-cites="TuzwDCPt a0h975P6">[<a href="#ref-TuzwDCPt" role="doc-biblioref">1872</a>,<a href="#ref-a0h975P6" role="doc-biblioref">1873</a>]</span>.
+Several underlying health conditions were identified at high prevalence among hospitalized patients, including obesity, diabetes, hypertension, lung disease, and cardiovascular disease <span class="citation" data-cites="xZBEFXiG">[<a href="#ref-xZBEFXiG" role="doc-biblioref">1856</a>]</span>.
+Higher Sequential Organ Failure Assessment (SOFA) scores have been associated with a higher probability of mortality <span class="citation" data-cites="10THxyeCg">[<a href="#ref-10THxyeCg" role="doc-biblioref">81</a>]</span>, and comorbid conditions such as cardiovascular and lung disease as well as obesity were also associated with an increased risk of hospitalization and death, even when correcting for age and sex <span class="citation" data-cites="gObtnWSD">[<a href="#ref-gObtnWSD" role="doc-biblioref">1862</a>]</span>.
+Diabetes may increase the risk of lengthy hospitalization <span class="citation" data-cites="9NfXSHjH">[<a href="#ref-9NfXSHjH" role="doc-biblioref">1870</a>]</span> or of death <span class="citation" data-cites="9NfXSHjH 13BpwZaaq">[<a href="#ref-9NfXSHjH" role="doc-biblioref">1870</a>,<a href="#ref-13BpwZaaq" role="doc-biblioref">1871</a>]</span>.
+<span class="citation" data-cites="UkCdtLwF">[<a href="#ref-UkCdtLwF" role="doc-biblioref">1872</a>]</span> and <span class="citation" data-cites="OT5GEOej">[<a href="#ref-OT5GEOej" role="doc-biblioref">1873</a>]</span> discuss possible ways in which COVID-19 and diabetes may interact.
+Obesity also appears to be associated with higher risk of severe outcomes from SARS-CoV-2 <span class="citation" data-cites="ZLmNMDrD 2Ahpn6R2">[<a href="#ref-ZLmNMDrD" role="doc-biblioref">1874</a>,<a href="#ref-2Ahpn6R2" role="doc-biblioref">1875</a>]</span>.
+Obesity is considered an underlying risk factor for other health problems, and the mechanism for its contributions to COVID-19 hospitalization or mortality is not yet clear <span class="citation" data-cites="1AmBg80Un">[<a href="#ref-1AmBg80Un" role="doc-biblioref">1876</a>]</span>.
+Dementia and cancer were also associated with the risk of death in an analysis of a large number (more than 20,000) COVID-19 patients in the United Kingdom <span class="citation" data-cites="gObtnWSD">[<a href="#ref-gObtnWSD" role="doc-biblioref">1862</a>]</span>.
+It should be noted that comorbid conditions are inextricably tied to age, as conditions tend to be accumulated over time, but that the prevalence of individual comorbidities or of population health overall can vary regionally <span class="citation" data-cites="1GakM8xhV">[<a href="#ref-1GakM8xhV" role="doc-biblioref">1877</a>]</span>.
+Several comorbidities that are highly prevalent in older adults, such as COPD, hypertension, cardiovascular disease, and diabetes, have been associated with CFRs upwards of 8% compared to an estimate of 1.4% in people without comorbidities <span class="citation" data-cites="1DnayDKc4 H6dfv6Wv">[<a href="#ref-1DnayDKc4" role="doc-biblioref">1861</a>,<a href="#ref-H6dfv6Wv" role="doc-biblioref">1878</a>]</span>. <!-- will this url work for Manubot?-->
+Therefore, both age and health are important considerations when predicting the impact of COVID-19 on a population <span class="citation" data-cites="1GakM8xhV">[<a href="#ref-1GakM8xhV" role="doc-biblioref">1877</a>]</span>.
+However, other associations may exist, such as patients with sepsis having higher SOFA scores – in fact, SOFA was developed for the assessment of organ failure in the context of sepsis, and the acronym originally stood for Sepsis-Related Organ Failure Assessment <span class="citation" data-cites="TuzwDCPt a0h975P6">[<a href="#ref-TuzwDCPt" role="doc-biblioref">1879</a>,<a href="#ref-a0h975P6" role="doc-biblioref">1880</a>]</span>.
 Additionally, certain conditions are likely to be more prevalent under or exacerbated by social conditions, especially poverty, as is discussed further below.</p>
 <h3 data-number="11.2.3" id="ancestry"><span class="header-section-number">11.2.3</span> Ancestry</h3>
 <p>A number of studies have suggested associations between individuals’ racial and ethnic backgrounds and their COVID-19 risk.
-In particular, Black Americans are consistently identified as carrying a higher burden of COVID-19 than white Americans <span class="citation" data-cites="1D6lVXWbJ Zk5CfYeW">[<a href="#ref-1D6lVXWbJ" role="doc-biblioref">1851</a>,<a href="#ref-Zk5CfYeW" role="doc-biblioref">1852</a>]</span>, with differences in the rates of kidney complications from COVID-19 particularly pronounced <span class="citation" data-cites="17hdoiBo9">[<a href="#ref-17hdoiBo9" role="doc-biblioref">87</a>]</span>.
-Statistics from a number of cities indicate significant discrepancies between the proportion of COVID-19 cases and deaths in Black Americans relative to their representation in the general population <span class="citation" data-cites="jKKxa9Yy">[<a href="#ref-jKKxa9Yy" role="doc-biblioref">1874</a>]</span>.
-In addition to Black Americans, disproportionate harm and mortality from COVID-19 has also been noted in Latino/Hispanic Americans and in Native American and Alaskan Native communities, including the Navajo nation [<span class="citation" data-cites="yK5bczRb">[<a href="#ref-yK5bczRb" role="doc-biblioref">1875</a>]</span>; <span class="citation" data-cites="u4MMV8aJ">[<a href="#ref-u4MMV8aJ" role="doc-biblioref">1876</a>]</span>; <span class="citation" data-cites="JAo2QxY">[<a href="#ref-JAo2QxY" role="doc-biblioref">1877</a>]</span>; https://www.nytimes.com/2020/04/09/us/coronavirus-navajo-nation.html?searchResultPosition=10; <span class="citation" data-cites="12WZObWRf">[<a href="#ref-12WZObWRf" role="doc-biblioref">1878</a>]</span>; <span class="citation" data-cites="Pp8GWnQm">[<a href="#ref-Pp8GWnQm" role="doc-biblioref">1879</a>]</span>; <span class="citation" data-cites="J9T8eR5H">[<a href="#ref-J9T8eR5H" role="doc-biblioref">1880</a>]</span>].
-In Brazil, indigenous communities likewise carry an increased burden of COVID-19 <span class="citation" data-cites="ODm1CaEq">[<a href="#ref-ODm1CaEq" role="doc-biblioref">1881</a>]</span>.
-In the United Kingdom, nonwhite ethnicity (principally Black or South Asian) was one of several factors found to be associated with a higher risk of death from COVID-19 <span class="citation" data-cites="17gnxmOnf">[<a href="#ref-17gnxmOnf" role="doc-biblioref">1882</a>]</span>.</p>
+In particular, Black Americans are consistently identified as carrying a higher burden of COVID-19 than white Americans <span class="citation" data-cites="1D6lVXWbJ Zk5CfYeW">[<a href="#ref-1D6lVXWbJ" role="doc-biblioref">1858</a>,<a href="#ref-Zk5CfYeW" role="doc-biblioref">1859</a>]</span>, with differences in the rates of kidney complications from COVID-19 particularly pronounced <span class="citation" data-cites="17hdoiBo9">[<a href="#ref-17hdoiBo9" role="doc-biblioref">87</a>]</span>.
+Statistics from a number of cities indicate significant discrepancies between the proportion of COVID-19 cases and deaths in Black Americans relative to their representation in the general population <span class="citation" data-cites="jKKxa9Yy">[<a href="#ref-jKKxa9Yy" role="doc-biblioref">1881</a>]</span>.
+In addition to Black Americans, disproportionate harm and mortality from COVID-19 has also been noted in Latino/Hispanic Americans and in Native American and Alaskan Native communities, including the Navajo nation [<span class="citation" data-cites="yK5bczRb">[<a href="#ref-yK5bczRb" role="doc-biblioref">1882</a>]</span>; <span class="citation" data-cites="u4MMV8aJ">[<a href="#ref-u4MMV8aJ" role="doc-biblioref">1883</a>]</span>; <span class="citation" data-cites="JAo2QxY">[<a href="#ref-JAo2QxY" role="doc-biblioref">1884</a>]</span>; https://www.nytimes.com/2020/04/09/us/coronavirus-navajo-nation.html?searchResultPosition=10; <span class="citation" data-cites="12WZObWRf">[<a href="#ref-12WZObWRf" role="doc-biblioref">1885</a>]</span>; <span class="citation" data-cites="Pp8GWnQm">[<a href="#ref-Pp8GWnQm" role="doc-biblioref">1886</a>]</span>; <span class="citation" data-cites="J9T8eR5H">[<a href="#ref-J9T8eR5H" role="doc-biblioref">1887</a>]</span>].
+In Brazil, indigenous communities likewise carry an increased burden of COVID-19 <span class="citation" data-cites="ODm1CaEq">[<a href="#ref-ODm1CaEq" role="doc-biblioref">1888</a>]</span>.
+In the United Kingdom, nonwhite ethnicity (principally Black or South Asian) was one of several factors found to be associated with a higher risk of death from COVID-19 <span class="citation" data-cites="17gnxmOnf">[<a href="#ref-17gnxmOnf" role="doc-biblioref">1889</a>]</span>.</p>
 <p>From a genetic standpoint, it is highly unlikely that ancestry itself predisposes individuals to contracting COVID-19 or to experiencing severe COVID-19 outcomes.
-Examining human genetic diversity indicates variation over a geographic continuum, and that most human genetic variation is associated with the African continent <span class="citation" data-cites="pwbrxYv8">[<a href="#ref-pwbrxYv8" role="doc-biblioref">1883</a>]</span>.
-African-Americans are also a more genetically diverse group relative to European-Americans, with a large number of rare alleles and a much smaller fraction of common alleles identified in African-Americans <span class="citation" data-cites="CMAPEmTp">[<a href="#ref-CMAPEmTp" role="doc-biblioref">1884</a>]</span>.
-Therefore, the idea that African ancestry (at the continent level) might convey some sort of genetic risk for severe COVID-19 contrasts with what is known about worldwide human genetic diversity <span class="citation" data-cites="q4yhes98">[<a href="#ref-q4yhes98" role="doc-biblioref">1885</a>]</span>.
+Examining human genetic diversity indicates variation over a geographic continuum, and that most human genetic variation is associated with the African continent <span class="citation" data-cites="pwbrxYv8">[<a href="#ref-pwbrxYv8" role="doc-biblioref">1890</a>]</span>.
+African-Americans are also a more genetically diverse group relative to European-Americans, with a large number of rare alleles and a much smaller fraction of common alleles identified in African-Americans <span class="citation" data-cites="CMAPEmTp">[<a href="#ref-CMAPEmTp" role="doc-biblioref">1891</a>]</span>.
+Therefore, the idea that African ancestry (at the continent level) might convey some sort of genetic risk for severe COVID-19 contrasts with what is known about worldwide human genetic diversity <span class="citation" data-cites="q4yhes98">[<a href="#ref-q4yhes98" role="doc-biblioref">1892</a>]</span>.
 The possibility for genetic variants that confer some risk or some protection remains possible, but has not been widely explored, especially at a global level.
 Research in Beijing of a small number (n=80) hospitalized COVID-19 patients revealed an association between severe COVID-19 outcomes and homozygosity for an allele in the interferon-induced transmembrane protein 3 (IFITM3) gene, which was selected as a candidate because it was previously found to be associated with influenza outcomes in Chinese patients <span class="citation" data-cites="FbeY1L1s">[<a href="#ref-FbeY1L1s" role="doc-biblioref">423</a>]</span>.
-Genetic factors may also play a role in the risk of respiratory failure for COVID-19 <span class="citation" data-cites="owevcpwb nn67UTjV I2mIU0wn">[<a href="#ref-owevcpwb" role="doc-biblioref">452</a>,<a href="#ref-nn67UTjV" role="doc-biblioref">1886</a>,<a href="#ref-I2mIU0wn" role="doc-biblioref">1887</a>]</span>.
+Genetic factors may also play a role in the risk of respiratory failure for COVID-19 <span class="citation" data-cites="owevcpwb nn67UTjV I2mIU0wn">[<a href="#ref-owevcpwb" role="doc-biblioref">452</a>,<a href="#ref-nn67UTjV" role="doc-biblioref">1893</a>,<a href="#ref-I2mIU0wn" role="doc-biblioref">1894</a>]</span>.
 However, genetic variants associated with outcomes within ancestral groups are far less surprising than genetic variants explaining outcomes between groups.
-Alleles in <em>ACE2</em> and <em>TMPRSS2</em> have been identified that vary in frequency among ancestral groups <span class="citation" data-cites="KbDdcSgo">[<a href="#ref-KbDdcSgo" role="doc-biblioref">1888</a>]</span>, but whether these variants are associated with COVID-19 susceptibility has not been explored.</p>
+Alleles in <em>ACE2</em> and <em>TMPRSS2</em> have been identified that vary in frequency among ancestral groups <span class="citation" data-cites="KbDdcSgo">[<a href="#ref-KbDdcSgo" role="doc-biblioref">1895</a>]</span>, but whether these variants are associated with COVID-19 susceptibility has not been explored.</p>
 <p>Instead, examining patterns of COVID-19 susceptibility on a global scale that suggest that social factors are of primary importance in predicting mortality.
 Reports from several sub-Saharan African countries have indicated that the effects of the COVID-19 pandemic have been less severe than expected based on the outbreaks in China and Italy.
-In Kenya, for example, estimates of national prevalence based on testing blood donors for SARS-CoV-2 antibodies were consistent with 5% of Kenyan adults having recovered from COVID-19 <span class="citation" data-cites="4SqaP0Ub">[<a href="#ref-4SqaP0Ub" role="doc-biblioref">1889</a>]</span>.
-This high seroprevalence of antibodies lies in sharp contrast to the low number of COVID-19 fatalities in Kenya, which at the time was 71 out of 2093 known cases <span class="citation" data-cites="4SqaP0Ub">[<a href="#ref-4SqaP0Ub" role="doc-biblioref">1889</a>]</span>.
-Likewise, a serosurvey of health care workers in Blantyre City, Malawi reported an adjusted antibody prevalence of 12.3%, suggesting that the virus had been circulating more widely than thought and that the death rate was up eight times lower than models had predicted <span class="citation" data-cites="eWIOKa0u">[<a href="#ref-eWIOKa0u" role="doc-biblioref">1890</a>]</span>.
-While several possible hypotheses for the apparent reduced impact of COVID-19 on the African continent are being explored, such as young demographics in many places <span class="citation" data-cites="p4AYZss0">[<a href="#ref-p4AYZss0" role="doc-biblioref">1891</a>]</span>, these reports present a stark contrast to the severity of COVID-19 in Americans and Europeans of African descent.
-Additionally, ethnic minorities in the United Kingdom also tend to be younger than white British living in the same areas, yet the burden of COVID-19 is still more serious for minorities, especially people of Black Caribbean ancestry, both in absolute numbers and when controlling for age and location <span class="citation" data-cites="xFKmPg6l">[<a href="#ref-xFKmPg6l" role="doc-biblioref">1892</a>/]</span>.
+In Kenya, for example, estimates of national prevalence based on testing blood donors for SARS-CoV-2 antibodies were consistent with 5% of Kenyan adults having recovered from COVID-19 <span class="citation" data-cites="4SqaP0Ub">[<a href="#ref-4SqaP0Ub" role="doc-biblioref">1896</a>]</span>.
+This high seroprevalence of antibodies lies in sharp contrast to the low number of COVID-19 fatalities in Kenya, which at the time was 71 out of 2093 known cases <span class="citation" data-cites="4SqaP0Ub">[<a href="#ref-4SqaP0Ub" role="doc-biblioref">1896</a>]</span>.
+Likewise, a serosurvey of health care workers in Blantyre City, Malawi reported an adjusted antibody prevalence of 12.3%, suggesting that the virus had been circulating more widely than thought and that the death rate was up eight times lower than models had predicted <span class="citation" data-cites="eWIOKa0u">[<a href="#ref-eWIOKa0u" role="doc-biblioref">1897</a>]</span>.
+While several possible hypotheses for the apparent reduced impact of COVID-19 on the African continent are being explored, such as young demographics in many places <span class="citation" data-cites="p4AYZss0">[<a href="#ref-p4AYZss0" role="doc-biblioref">1898</a>]</span>, these reports present a stark contrast to the severity of COVID-19 in Americans and Europeans of African descent.
+Additionally, ethnic minorities in the United Kingdom also tend to be younger than white British living in the same areas, yet the burden of COVID-19 is still more serious for minorities, especially people of Black Caribbean ancestry, both in absolute numbers and when controlling for age and location <span class="citation" data-cites="xFKmPg6l">[<a href="#ref-xFKmPg6l" role="doc-biblioref">1899</a>/]</span>.
 Furthermore, the groups in the United States and United Kingdom that have been identified as carrying elevated COVID-19 burden, namely Black American, indigenous American, and Black and South Asian British, are quite distinct in their position on the human ancestral tree.
 What is shared across these groups is instead a history of disenfranchisement under colonialism and ongoing systematic racism.
-A large analysis of over 11,000 COVID-19 patients hospitalized in 92 hospitals across U.S. states revealed that Black patients were younger, more often female, more likely to be on Medicaid, more likely to have comorbidities, and came from neighborhoods identified as more economically deprived than white patients <span class="citation" data-cites="hrOv770z">[<a href="#ref-hrOv770z" role="doc-biblioref">1846</a>]</span>.
+A large analysis of over 11,000 COVID-19 patients hospitalized in 92 hospitals across U.S. states revealed that Black patients were younger, more often female, more likely to be on Medicaid, more likely to have comorbidities, and came from neighborhoods identified as more economically deprived than white patients <span class="citation" data-cites="hrOv770z">[<a href="#ref-hrOv770z" role="doc-biblioref">1853</a>]</span>.
 This study reported that when these factors were accounted for, the differences in mortality between Black and white patients were no longer significant.
 Thus, the current evidence suggests that the apparent correlations between ancestry and health outcomes must be examined in the appropriate social context.</p>
 <h2 data-number="11.3" id="environmental-influences-on-susceptibility"><span class="header-section-number">11.3</span> Environmental Influences on Susceptibility</h2>
@@ -5269,83 +5255,83 @@ <h3 data-number="11.3.1" id="exposure-to-covid-19"><span class="header-section-n
 <p>Social distancing has emerged as one of the main social policies used to manage the COVID-19 epidemic in many countries.
 Many governments issued stay-at-home orders, especially in the initial months of the crisis.
 However, data clearly indicates that these orders impacted different socioeconomic groups differently.
-In U.S. counties with and without stay-at-home orders, smartphone tracking indicated a significant decrease in the general population’s mobility in April relative to February through March of 2020 (-52.3% and -60.8%, respectively) <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1893</a>]</span>.
-A linear relationship was observed between counties’ reduction in mobility and their wealth and health, as measured by access to health care, food security, income, space, and other factors <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1893</a>]</span>.
-Counties with greater reductions in mobility were also found to have much lower child poverty and household crowding and to be more racially segregated, and to have fewer youth and more elderly residents <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1893</a>]</span>.
-Similar associations between wealth and decreased mobility were observed in cellphone GPS data from Colombia, Indonesia, and Mexico collected between January and May 2020 <span class="citation" data-cites="RdnghmVU">[<a href="#ref-RdnghmVU" role="doc-biblioref">1894</a>]</span>, as well as in a very large data set from several US cities <span class="citation" data-cites="9OksxLmM">[<a href="#ref-9OksxLmM" role="doc-biblioref">1895</a>]</span>.
+In U.S. counties with and without stay-at-home orders, smartphone tracking indicated a significant decrease in the general population’s mobility in April relative to February through March of 2020 (-52.3% and -60.8%, respectively) <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1900</a>]</span>.
+A linear relationship was observed between counties’ reduction in mobility and their wealth and health, as measured by access to health care, food security, income, space, and other factors <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1900</a>]</span>.
+Counties with greater reductions in mobility were also found to have much lower child poverty and household crowding and to be more racially segregated, and to have fewer youth and more elderly residents <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1900</a>]</span>.
+Similar associations between wealth and decreased mobility were observed in cellphone GPS data from Colombia, Indonesia, and Mexico collected between January and May 2020 <span class="citation" data-cites="RdnghmVU">[<a href="#ref-RdnghmVU" role="doc-biblioref">1901</a>]</span>, as well as in a very large data set from several US cities <span class="citation" data-cites="9OksxLmM">[<a href="#ref-9OksxLmM" role="doc-biblioref">1902</a>]</span>.
 These disparities in mobility are likely to be related to the role that essential workers have played during the pandemic.
-Essential workers are disproportionately likely to be female, people of color, immigrants, and to have an income below 200% of the poverty line <span class="citation" data-cites="15qfRPnUG">[<a href="#ref-15qfRPnUG" role="doc-biblioref">1896</a>]</span>.
-Black Americans in particular are over-represented among front-line workers and in professions where social distancing is infeasible <span class="citation" data-cites="HihYbn6k">[<a href="#ref-HihYbn6k" role="doc-biblioref">1897</a>]</span>.
-Health care work in particular presents an increased risk of exposure to SARS-CoV-2 <span class="citation" data-cites="HihYbn6k F4laSOXM hAYohR8m DOyiuaup 13qkVV6eN">[<a href="#ref-HihYbn6k" role="doc-biblioref">1897</a>,<a href="#ref-F4laSOXM" role="doc-biblioref">1898</a>,<a href="#ref-hAYohR8m" role="doc-biblioref">1899</a>,<a href="#ref-DOyiuaup" role="doc-biblioref">1900</a>,<a href="#ref-13qkVV6eN" role="doc-biblioref">1901</a>]</span>.
-In the United Kingdom, (South) Asians are more likely than their white counterparts to be medical professionals <span class="citation" data-cites="xFKmPg6l">[<a href="#ref-xFKmPg6l" role="doc-biblioref">1892</a>/]</span>, although BAME medical professionals are still disproportionately represented in the proportion of National Health Service staff deaths <span class="citation" data-cites="4zjepZ8T">[<a href="#ref-4zjepZ8T" role="doc-biblioref">1902</a>]</span>.
-Similar trends have been reported for nurses, especially nurses of color, in the United States <span class="citation" data-cites="2gxJPENM">[<a href="#ref-2gxJPENM" role="doc-biblioref">1903</a>/-/files/graphics/0920_Covid19_SinsOfOmission_Data_Report.pdf]</span>.
-Furthermore, beyond the risks associated with work itself, use of public transportation may also impact COVID-19 risk <span class="citation" data-cites="Moc3BREQ">[<a href="#ref-Moc3BREQ" role="doc-biblioref">1904</a>]</span>.
+Essential workers are disproportionately likely to be female, people of color, immigrants, and to have an income below 200% of the poverty line <span class="citation" data-cites="15qfRPnUG">[<a href="#ref-15qfRPnUG" role="doc-biblioref">1903</a>]</span>.
+Black Americans in particular are over-represented among front-line workers and in professions where social distancing is infeasible <span class="citation" data-cites="HihYbn6k">[<a href="#ref-HihYbn6k" role="doc-biblioref">1904</a>]</span>.
+Health care work in particular presents an increased risk of exposure to SARS-CoV-2 <span class="citation" data-cites="HihYbn6k F4laSOXM hAYohR8m DOyiuaup 13qkVV6eN">[<a href="#ref-HihYbn6k" role="doc-biblioref">1904</a>,<a href="#ref-F4laSOXM" role="doc-biblioref">1905</a>,<a href="#ref-hAYohR8m" role="doc-biblioref">1906</a>,<a href="#ref-DOyiuaup" role="doc-biblioref">1907</a>,<a href="#ref-13qkVV6eN" role="doc-biblioref">1908</a>]</span>.
+In the United Kingdom, (South) Asians are more likely than their white counterparts to be medical professionals <span class="citation" data-cites="xFKmPg6l">[<a href="#ref-xFKmPg6l" role="doc-biblioref">1899</a>/]</span>, although BAME medical professionals are still disproportionately represented in the proportion of National Health Service staff deaths <span class="citation" data-cites="4zjepZ8T">[<a href="#ref-4zjepZ8T" role="doc-biblioref">1909</a>]</span>.
+Similar trends have been reported for nurses, especially nurses of color, in the United States <span class="citation" data-cites="2gxJPENM">[<a href="#ref-2gxJPENM" role="doc-biblioref">1910</a>/-/files/graphics/0920_Covid19_SinsOfOmission_Data_Report.pdf]</span>.
+Furthermore, beyond the risks associated with work itself, use of public transportation may also impact COVID-19 risk <span class="citation" data-cites="Moc3BREQ">[<a href="#ref-Moc3BREQ" role="doc-biblioref">1911</a>]</span>.
 The socioeconomic and racial/ethnic gaps in who is working on the front lines of the pandemic make it clear that socioeconomic privilege is likely to decrease the probability of exposure to SARS-CoV-2.</p>
 <p>Increased risk of exposure can also arise outside the workplace.
-Nursing homes and skilled nursing facilities received attention early on as high-risk locations for COVID-19 outbreaks <span class="citation" data-cites="aM2XPE3J">[<a href="#ref-aM2XPE3J" role="doc-biblioref">1905</a>]</span>.
-Prisons and detention centers also confer a high risk of exposure or infection <span class="citation" data-cites="BeedQx3I 2uUcva6Y">[<a href="#ref-BeedQx3I" role="doc-biblioref">1906</a>,<a href="#ref-2uUcva6Y" role="doc-biblioref">1907</a>]</span>.
-Populations in care facilities are largely older adults, and in the United States, incarcerated people are more likely to be male and persons of color, especially Black <span class="citation" data-cites="zuipD7ZP">[<a href="#ref-zuipD7ZP" role="doc-biblioref">1908</a>]</span>.
-Additionally, multi-generational households are less common among non-Hispanic white Americans than people of other racial and ethnic backgrounds <span class="citation" data-cites="OzhmHOxJ">[<a href="#ref-OzhmHOxJ" role="doc-biblioref">1909</a>]</span>, increasing the risk of exposure for more susceptible family members.
-Analysis suggests that household crowding may also be associated with increased risk of COVID-19 exposure <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1893</a>]</span>, and household crowding is associated with poverty <span class="citation" data-cites="13wfXDXqr">[<a href="#ref-13wfXDXqr" role="doc-biblioref">1910</a>]</span>.
-Forms of economic insecurity like housing insecurity, which is associated with poverty and more pronounced in communities subjected to racism <span class="citation" data-cites="1Axz3a1Hj 64YOO3yt">[<a href="#ref-1Axz3a1Hj" role="doc-biblioref">1911</a>,<a href="#ref-64YOO3yt" role="doc-biblioref">1912</a>]</span>, would be likely to increase household crowding and other possible sources of exposure.
+Nursing homes and skilled nursing facilities received attention early on as high-risk locations for COVID-19 outbreaks <span class="citation" data-cites="aM2XPE3J">[<a href="#ref-aM2XPE3J" role="doc-biblioref">1912</a>]</span>.
+Prisons and detention centers also confer a high risk of exposure or infection <span class="citation" data-cites="BeedQx3I 2uUcva6Y">[<a href="#ref-BeedQx3I" role="doc-biblioref">1913</a>,<a href="#ref-2uUcva6Y" role="doc-biblioref">1914</a>]</span>.
+Populations in care facilities are largely older adults, and in the United States, incarcerated people are more likely to be male and persons of color, especially Black <span class="citation" data-cites="zuipD7ZP">[<a href="#ref-zuipD7ZP" role="doc-biblioref">1915</a>]</span>.
+Additionally, multi-generational households are less common among non-Hispanic white Americans than people of other racial and ethnic backgrounds <span class="citation" data-cites="OzhmHOxJ">[<a href="#ref-OzhmHOxJ" role="doc-biblioref">1916</a>]</span>, increasing the risk of exposure for more susceptible family members.
+Analysis suggests that household crowding may also be associated with increased risk of COVID-19 exposure <span class="citation" data-cites="bDNDEYNn">[<a href="#ref-bDNDEYNn" role="doc-biblioref">1900</a>]</span>, and household crowding is associated with poverty <span class="citation" data-cites="13wfXDXqr">[<a href="#ref-13wfXDXqr" role="doc-biblioref">1917</a>]</span>.
+Forms of economic insecurity like housing insecurity, which is associated with poverty and more pronounced in communities subjected to racism <span class="citation" data-cites="1Axz3a1Hj 64YOO3yt">[<a href="#ref-1Axz3a1Hj" role="doc-biblioref">1918</a>,<a href="#ref-64YOO3yt" role="doc-biblioref">1919</a>]</span>, would be likely to increase household crowding and other possible sources of exposure.
 As a result, facets of systemic inequality such as mass incarceration of Black Americans and poverty are likely to increase the risk of exposure outside of the workplace.</p>
 <h3 data-number="11.3.2" id="severity-of-covid-19-following-exposure"><span class="header-section-number">11.3.2</span> Severity of COVID-19 Following Exposure</h3>
 <p>Following exposure to SARS-CoV-2, the likelihood that an individual develops COVID-19 and the severity of the disease presentation can be influenced by a number of social factors.
 As discussed above, a number of patient characteristics are associated with the likelihood of severe COVID-19 symptoms.
-In some cases, these trends run counter to those expected given rates of exposure: for example, although women are more likely to be exposed, men are more likely to be diagnosed with, hospitalized from, or die from COVID-19 <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1858</a>]</span>.
+In some cases, these trends run counter to those expected given rates of exposure: for example, although women are more likely to be exposed, men are more likely to be diagnosed with, hospitalized from, or die from COVID-19 <span class="citation" data-cites="fH3qecwy">[<a href="#ref-fH3qecwy" role="doc-biblioref">1865</a>]</span>.
 In the case of comorbid conditions and racial/ethnic demographics, however, social factors are highly likely to modulate or at least influence the apparent association between these traits and the increased risk from COVID-19.
 In particular, the comorbidities and racial/ethnic correlates of severe COVID-19 outcomes suggest that poverty confers additional risk for COVID-19.</p>
 <p>In order to explore the relationship between poverty and COVID-19 outcomes, it is necessary to consider how poverty impacts biology.
 In particular, we focus on the United States and the United Kingdom.
-Comorbidities that increase risk for COVID-19, including obesity, type II diabetes, hypertension, and cardiovascular disease, are known to be intercorrelated <span class="citation" data-cites="sRZCzj6j">[<a href="#ref-sRZCzj6j" role="doc-biblioref">1913</a>]</span>.
-Metabolic conditions related to heightened inflammation, like obesity, type II diabetes, and hypertension, are more strongly associated with negative COVID-19 outcomes than other comorbid conditions, such as chronic heart disease <span class="citation" data-cites="JizR1ocj">[<a href="#ref-JizR1ocj" role="doc-biblioref">1914</a>]</span>.
+Comorbidities that increase risk for COVID-19, including obesity, type II diabetes, hypertension, and cardiovascular disease, are known to be intercorrelated <span class="citation" data-cites="sRZCzj6j">[<a href="#ref-sRZCzj6j" role="doc-biblioref">1920</a>]</span>.
+Metabolic conditions related to heightened inflammation, like obesity, type II diabetes, and hypertension, are more strongly associated with negative COVID-19 outcomes than other comorbid conditions, such as chronic heart disease <span class="citation" data-cites="JizR1ocj">[<a href="#ref-JizR1ocj" role="doc-biblioref">1921</a>]</span>.
 As discussed above, dysregulated inflammation characteristic of cytokine release syndrome is one of the greatest concerns for COVID-19-related death.
-Therefore, it is possible that chronic inflammation characteristic of these metabolic conditions predisposes patients to COVID-19-related death <span class="citation" data-cites="JizR1ocj">[<a href="#ref-JizR1ocj" role="doc-biblioref">1914</a>]</span>.
-The association between these diseases and severe COVID-19 outcomes is a concern from a health equity perspective because poverty exposes people to “obesogenic” conditions <span class="citation" data-cites="nYLB9EMw">[<a href="#ref-nYLB9EMw" role="doc-biblioref">1915</a>]</span> and is therefore unsurprisingly associated with higher incidence of obesity and associated disorders <span class="citation" data-cites="h1e9QTlK">[<a href="#ref-h1e9QTlK" role="doc-biblioref">1916</a>]</span>.
-Furthermore, cell phone GPS data suggests that lower socioeconomic status may also be associated with decreased access to healthy food choices during the COVID-19 pandemic <span class="citation" data-cites="94eOAGnA 5G5UozXd">[<a href="#ref-94eOAGnA" role="doc-biblioref">1917</a>,<a href="#ref-5G5UozXd" role="doc-biblioref">1918</a>]</span>, suggesting that health-related risk factors for COVID-19 may be exacerbated as the pandemic continues <span class="citation" data-cites="17yfPiYAS">[<a href="#ref-17yfPiYAS" role="doc-biblioref">1919</a>]</span>.
-Chronic inflammation is a known outcome of chronic stress (e.g., <span class="citation" data-cites="Hu7PyNNp P2wUkjrR 109EtOYzw 11oGPv27i">[<a href="#ref-Hu7PyNNp" role="doc-biblioref">1920</a>,<a href="#ref-P2wUkjrR" role="doc-biblioref">1921</a>,<a href="#ref-109EtOYzw" role="doc-biblioref">1922</a>,<a href="#ref-11oGPv27i" role="doc-biblioref">1923</a>]</span>).
-Therefore, the chronic stress of poverty is likely to influence health broadly (as summarized in <span class="citation" data-cites="KZSJklnl">[<a href="#ref-KZSJklnl" role="doc-biblioref">1924</a>]</span>) and especially during the stress of the ongoing pandemic.</p>
-<p>A preprint <span class="citation" data-cites="5BMDcXz3">[<a href="#ref-5BMDcXz3" role="doc-biblioref">1925</a>]</span> provided observational evidence that geographical areas in the United States that suffer from worse air pollution by fine particulate matter have also suffered more COVID-19 deaths per capita, after adjusting for demographic covariates.
-Although lack of individual-level exposure data and the impossibility of randomization make it difficult to elucidate the exact causal mechanism, this finding would be consistent with similar findings for all-cause mortality (e.g., <span class="citation" data-cites="vImXUPNS">[<a href="#ref-vImXUPNS" role="doc-biblioref">1926</a>]</span>).
-Exposure to air pollution is associated with both poverty (e.g., <span class="citation" data-cites="6ACdDJOV">[<a href="#ref-6ACdDJOV" role="doc-biblioref">1927</a>]</span>) and chronic inflammation <span class="citation" data-cites="11Ift2eIl">[<a href="#ref-11Ift2eIl" role="doc-biblioref">1928</a>]</span>.
-Other outcomes of environmental racism, such as the proximity of abandoned uranium mines to Navajo land, can also cause respiratory illnesses and other health issues <span class="citation" data-cites="J9T8eR5H">[<a href="#ref-J9T8eR5H" role="doc-biblioref">1880</a>]</span>.
-Similarly, preliminary findings indicate that nutritional status (e.g., vitamin D deficiency <span class="citation" data-cites="8ZxZKpYS">[<a href="#ref-8ZxZKpYS" role="doc-biblioref">1741</a>]</span>) may be associated with COVID-19 outcomes, and reduced access to grocery stores and fresh food often co-occurs with environmental racism <span class="citation" data-cites="J9T8eR5H aHM6WZzd">[<a href="#ref-J9T8eR5H" role="doc-biblioref">1880</a>,<a href="#ref-aHM6WZzd" role="doc-biblioref">1929</a>]</span>.
+Therefore, it is possible that chronic inflammation characteristic of these metabolic conditions predisposes patients to COVID-19-related death <span class="citation" data-cites="JizR1ocj">[<a href="#ref-JizR1ocj" role="doc-biblioref">1921</a>]</span>.
+The association between these diseases and severe COVID-19 outcomes is a concern from a health equity perspective because poverty exposes people to “obesogenic” conditions <span class="citation" data-cites="nYLB9EMw">[<a href="#ref-nYLB9EMw" role="doc-biblioref">1922</a>]</span> and is therefore unsurprisingly associated with higher incidence of obesity and associated disorders <span class="citation" data-cites="h1e9QTlK">[<a href="#ref-h1e9QTlK" role="doc-biblioref">1923</a>]</span>.
+Furthermore, cell phone GPS data suggests that lower socioeconomic status may also be associated with decreased access to healthy food choices during the COVID-19 pandemic <span class="citation" data-cites="94eOAGnA 5G5UozXd">[<a href="#ref-94eOAGnA" role="doc-biblioref">1924</a>,<a href="#ref-5G5UozXd" role="doc-biblioref">1925</a>]</span>, suggesting that health-related risk factors for COVID-19 may be exacerbated as the pandemic continues <span class="citation" data-cites="17yfPiYAS">[<a href="#ref-17yfPiYAS" role="doc-biblioref">1926</a>]</span>.
+Chronic inflammation is a known outcome of chronic stress (e.g., <span class="citation" data-cites="Hu7PyNNp P2wUkjrR 109EtOYzw 11oGPv27i">[<a href="#ref-Hu7PyNNp" role="doc-biblioref">1927</a>,<a href="#ref-P2wUkjrR" role="doc-biblioref">1928</a>,<a href="#ref-109EtOYzw" role="doc-biblioref">1929</a>,<a href="#ref-11oGPv27i" role="doc-biblioref">1930</a>]</span>).
+Therefore, the chronic stress of poverty is likely to influence health broadly (as summarized in <span class="citation" data-cites="KZSJklnl">[<a href="#ref-KZSJklnl" role="doc-biblioref">1931</a>]</span>) and especially during the stress of the ongoing pandemic.</p>
+<p>A preprint <span class="citation" data-cites="5BMDcXz3">[<a href="#ref-5BMDcXz3" role="doc-biblioref">1932</a>]</span> provided observational evidence that geographical areas in the United States that suffer from worse air pollution by fine particulate matter have also suffered more COVID-19 deaths per capita, after adjusting for demographic covariates.
+Although lack of individual-level exposure data and the impossibility of randomization make it difficult to elucidate the exact causal mechanism, this finding would be consistent with similar findings for all-cause mortality (e.g., <span class="citation" data-cites="vImXUPNS">[<a href="#ref-vImXUPNS" role="doc-biblioref">1933</a>]</span>).
+Exposure to air pollution is associated with both poverty (e.g., <span class="citation" data-cites="6ACdDJOV">[<a href="#ref-6ACdDJOV" role="doc-biblioref">1934</a>]</span>) and chronic inflammation <span class="citation" data-cites="11Ift2eIl">[<a href="#ref-11Ift2eIl" role="doc-biblioref">1935</a>]</span>.
+Other outcomes of environmental racism, such as the proximity of abandoned uranium mines to Navajo land, can also cause respiratory illnesses and other health issues <span class="citation" data-cites="J9T8eR5H">[<a href="#ref-J9T8eR5H" role="doc-biblioref">1887</a>]</span>.
+Similarly, preliminary findings indicate that nutritional status (e.g., vitamin D deficiency <span class="citation" data-cites="8ZxZKpYS">[<a href="#ref-8ZxZKpYS" role="doc-biblioref">1748</a>]</span>) may be associated with COVID-19 outcomes, and reduced access to grocery stores and fresh food often co-occurs with environmental racism <span class="citation" data-cites="J9T8eR5H aHM6WZzd">[<a href="#ref-J9T8eR5H" role="doc-biblioref">1887</a>,<a href="#ref-aHM6WZzd" role="doc-biblioref">1936</a>]</span>.
 Taken together, the evidence suggests that low-income workers who face greater exposure to SARS-CoV-2 due to their home or work conditions are also more likely to face environmental and social stressors associated with increased inflammation, and therefore with increased risk from COVID-19.
 In particular, structural racism can play an important role on disease severity after SARS-CoV-2 exposure, due to consequences of racism which include an increased likelihood of poverty and its associated food and housing instability.
-COVID-19 can thus be considered a “syndemic”, or a synergistic interaction between several epidemics <span class="citation" data-cites="11Ldf3Ch3">[<a href="#ref-11Ldf3Ch3" role="doc-biblioref">1930</a>]</span>.
-As a result, it is not surprising that people from minoritized backgrounds and/or with certain pre-existing conditions are more likely to suffer severe effects of COVID-19, but these “risk factors” are likely to be causally linked to poverty <span class="citation" data-cites="XtKjlYFF">[<a href="#ref-XtKjlYFF" role="doc-biblioref">1931</a>]</span>.</p>
+COVID-19 can thus be considered a “syndemic”, or a synergistic interaction between several epidemics <span class="citation" data-cites="11Ldf3Ch3">[<a href="#ref-11Ldf3Ch3" role="doc-biblioref">1937</a>]</span>.
+As a result, it is not surprising that people from minoritized backgrounds and/or with certain pre-existing conditions are more likely to suffer severe effects of COVID-19, but these “risk factors” are likely to be causally linked to poverty <span class="citation" data-cites="XtKjlYFF">[<a href="#ref-XtKjlYFF" role="doc-biblioref">1938</a>]</span>.</p>
 <h3 data-number="11.3.3" id="access-to-treatment"><span class="header-section-number">11.3.3</span> Access to Treatment</h3>
 <p>Finally, COVID-19 outcomes can be influenced by access to healthcare.
 Receiving care for COVID-19 can, but does not always, include receiving a positive test for the SARS-CoV-2 virus.
-For example, it is common to see treatment guidelines for suspected cases regardless of whether the presence of SARS-CoV-2 has been confirmed (e.g., <span class="citation" data-cites="cSA2h9hO">[<a href="#ref-cSA2h9hO" role="doc-biblioref">1932</a>]</span>).
+For example, it is common to see treatment guidelines for suspected cases regardless of whether the presence of SARS-CoV-2 has been confirmed (e.g., <span class="citation" data-cites="cSA2h9hO">[<a href="#ref-cSA2h9hO" role="doc-biblioref">1939</a>]</span>).
 Whether and where a patient is diagnosed can depend on their access to testing, which can vary both between and within countries.
-In the United States, it is not always clear whether an individual will have access to free testing <span class="citation" data-cites="1Intrlax jc9vc7ws">[<a href="#ref-1Intrlax" role="doc-biblioref">1933</a>,<a href="#ref-jc9vc7ws" role="doc-biblioref">1934</a>]</span>.
-The concern has been raised that more economic privilege is likely to correspond to increased access to testing, at least within the United States <span class="citation" data-cites="13MGsHBtw">[<a href="#ref-13MGsHBtw" role="doc-biblioref">1935</a>]</span>.
-This is supported by the fact that African Americans seem to be more likely to be diagnosed in the hospital, while individuals from other groups were more likely to have been diagnosed in ambulatory settings in the community <span class="citation" data-cites="1D6lVXWbJ">[<a href="#ref-1D6lVXWbJ" role="doc-biblioref">1851</a>]</span>.
-Any delays in treatment are a cause for concern <span class="citation" data-cites="13MGsHBtw">[<a href="#ref-13MGsHBtw" role="doc-biblioref">1935</a>]</span>, which could potentially be increased by an inability to acquire testing because in the United States, insurance coverage for care received can depend on a positive test <span class="citation" data-cites="P8VNkYTE">[<a href="#ref-P8VNkYTE" role="doc-biblioref">1936</a>]</span>.</p>
+In the United States, it is not always clear whether an individual will have access to free testing <span class="citation" data-cites="1Intrlax jc9vc7ws">[<a href="#ref-1Intrlax" role="doc-biblioref">1940</a>,<a href="#ref-jc9vc7ws" role="doc-biblioref">1941</a>]</span>.
+The concern has been raised that more economic privilege is likely to correspond to increased access to testing, at least within the United States <span class="citation" data-cites="13MGsHBtw">[<a href="#ref-13MGsHBtw" role="doc-biblioref">1942</a>]</span>.
+This is supported by the fact that African Americans seem to be more likely to be diagnosed in the hospital, while individuals from other groups were more likely to have been diagnosed in ambulatory settings in the community <span class="citation" data-cites="1D6lVXWbJ">[<a href="#ref-1D6lVXWbJ" role="doc-biblioref">1858</a>]</span>.
+Any delays in treatment are a cause for concern <span class="citation" data-cites="13MGsHBtw">[<a href="#ref-13MGsHBtw" role="doc-biblioref">1942</a>]</span>, which could potentially be increased by an inability to acquire testing because in the United States, insurance coverage for care received can depend on a positive test <span class="citation" data-cites="P8VNkYTE">[<a href="#ref-P8VNkYTE" role="doc-biblioref">1943</a>]</span>.</p>
 <p>Another important question is whether patients with moderate to severe cases are able to access hospital facilities and treatments, to the extent that they have been identified.
-Early findings from China as of February 2020 suggested the COVID-19 mortality rate to be much lower in the most developed regions of the country <span class="citation" data-cites="tLVYjfMk">[<a href="#ref-tLVYjfMk" role="doc-biblioref">1937</a>]</span>, although reported mortality is generally an estimate of CFR, which is dependent on rates of testing.
-Efforts to make treatment accessible for all confirmed and suspected cases of COVID-19 in China are credited with expanding care to people with fewer economic resources <span class="citation" data-cites="cOQK0zNa">[<a href="#ref-cOQK0zNa" role="doc-biblioref">1938</a>]</span>.
-In the United States, access to healthcare varies widely, with certain sectors of the workforce less likely to have health insurance; many essential workers in transportation, food service, and other frontline fields are among those likely to be uninsured or underinsured <span class="citation" data-cites="13MGsHBtw">[<a href="#ref-13MGsHBtw" role="doc-biblioref">1935</a>]</span>.
-As of 2018, Hispanic Americans of all races were much less likely to have health insurance than people from non-Hispanic backgrounds <span class="citation" data-cites="gOiB5HDd">[<a href="#ref-gOiB5HDd" role="doc-biblioref">1939</a>]</span>.
+Early findings from China as of February 2020 suggested the COVID-19 mortality rate to be much lower in the most developed regions of the country <span class="citation" data-cites="tLVYjfMk">[<a href="#ref-tLVYjfMk" role="doc-biblioref">1944</a>]</span>, although reported mortality is generally an estimate of CFR, which is dependent on rates of testing.
+Efforts to make treatment accessible for all confirmed and suspected cases of COVID-19 in China are credited with expanding care to people with fewer economic resources <span class="citation" data-cites="cOQK0zNa">[<a href="#ref-cOQK0zNa" role="doc-biblioref">1945</a>]</span>.
+In the United States, access to healthcare varies widely, with certain sectors of the workforce less likely to have health insurance; many essential workers in transportation, food service, and other frontline fields are among those likely to be uninsured or underinsured <span class="citation" data-cites="13MGsHBtw">[<a href="#ref-13MGsHBtw" role="doc-biblioref">1942</a>]</span>.
+As of 2018, Hispanic Americans of all races were much less likely to have health insurance than people from non-Hispanic backgrounds <span class="citation" data-cites="gOiB5HDd">[<a href="#ref-gOiB5HDd" role="doc-biblioref">1946</a>]</span>.
 Therefore, access to diagnostics and care prior to the development of severe COVID-19 is likely to vary depending on socioeconomic and social factors, many of which overlap with the risks of exposure and of developing more severe COVID-19 symptoms.
 This discrepancy ties into concerns about broad infrastructural challenges imposed by COVID-19.
 A major concern in many countries has been the saturation of healthcare systems due to the volume of COVID-19 hospitalizations (e.g., <span class="citation" data-cites="NCcssjLV">[<a href="#ref-NCcssjLV" role="doc-biblioref">318</a>]</span>).
-Similarly, there have been shortages of supplies such as ventilators that are critical to the survival of many COVID-19 patients, leading to extensive ethical discussions about how to allocate limited resources among patients <span class="citation" data-cites="15Yaf3fc8 1As9kWVvA FaGAJ7AI B3awlFvs">[<a href="#ref-15Yaf3fc8" role="doc-biblioref">1940</a>,<a href="#ref-1As9kWVvA" role="doc-biblioref">1941</a>,<a href="#ref-FaGAJ7AI" role="doc-biblioref">1942</a>,<a href="#ref-B3awlFvs" role="doc-biblioref">1943</a>]</span>.
-Although it is generally considered unethical to consider demographic factors such as age, sex, race, or ethnicity while making such decisions, and ideally this information would not be shared with triage teams tasked with allocating limited resources among patients <span class="citation" data-cites="2i1Y7SYn">[<a href="#ref-2i1Y7SYn" role="doc-biblioref">1944</a>]</span>, there are substantial concerns about implicit and explicit biases against older adults <span class="citation" data-cites="GTL02UT6">[<a href="#ref-GTL02UT6" role="doc-biblioref">1945</a>]</span>, premature infants <span class="citation" data-cites="KQfJ4llw">[<a href="#ref-KQfJ4llw" role="doc-biblioref">1946</a>]</span>, and people with disabilities or comorbidities <span class="citation" data-cites="K6yc6elC 1EaLRFk21 2i1Y7SYn">[<a href="#ref-2i1Y7SYn" role="doc-biblioref">1944</a>,<a href="#ref-K6yc6elC" role="doc-biblioref">1947</a>,<a href="#ref-1EaLRFk21" role="doc-biblioref">1948</a>]</span>.
-Because of the greater burden of chronic disease in populations subjected to systemic racism, algorithms intended to be blind to race and ethnicity could, in fact, reinforce systemic inequalities caused by structural racism <span class="citation" data-cites="cPsuWT7U 1D1FX4zQZ LrqhFVIz">[<a href="#ref-cPsuWT7U" role="doc-biblioref">1949</a>,<a href="#ref-1D1FX4zQZ" role="doc-biblioref">1950</a>,<a href="#ref-LrqhFVIz" role="doc-biblioref">1951</a>]</span>.
-Because of this inequality, it has been argued that groups facing health disparities should be prioritized by these algorithms <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1952</a>]</span>.
-This approach would carry its own ethical concerns, including the fact that many resources that need to be distributed do not have well-established risks and benefits <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1952</a>]</span>.</p>
-<p>As the pandemic has progressed, it has become clear that ICU beds and ventilators are not the only limited resources that needs to be allocated, and, in fact, the survival rate for patients who receive mechanical ventilation is lower than these discussions would suggest <span class="citation" data-cites="1ExRX1x4C">[<a href="#ref-1ExRX1x4C" role="doc-biblioref">1953</a>]</span>.
-Allocation of interventions that may reduce suffering, including palliative care, has become critically important <span class="citation" data-cites="1ExRX1x4C ztTunmqF">[<a href="#ref-1ExRX1x4C" role="doc-biblioref">1953</a>,<a href="#ref-ztTunmqF" role="doc-biblioref">1954</a>]</span>.
-The ambiguities surrounding the risks and benefits associated with therapeutics that have been approved under emergency use authorizations also present ethical concerns related to the distribution of resources <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1952</a>]</span>.
-For example, remdesivir, discussed above, is currently available for the treatment of COVID-19 under compassionate use guidelines and through expanded access programs, and in many cases has been donated to hospitals by Gilead <span class="citation" data-cites="18et5lcBc 11gslRJJU">[<a href="#ref-18et5lcBc" role="doc-biblioref">1955</a>,<a href="#ref-11gslRJJU" role="doc-biblioref">1956</a>]</span>.
-Regulations guiding the distribution of drugs in situations like these typically do not address how to determine which patients receive them <span class="citation" data-cites="11gslRJJU">[<a href="#ref-11gslRJJU" role="doc-biblioref">1956</a>]</span>.
-Prioritizing marginalized groups for treatment with a drug like remdesivir would also be unethical because it would entail disproportionately exposing these groups to a therapeutic that may or not be beneficial <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1952</a>]</span>.
+Similarly, there have been shortages of supplies such as ventilators that are critical to the survival of many COVID-19 patients, leading to extensive ethical discussions about how to allocate limited resources among patients <span class="citation" data-cites="15Yaf3fc8 1As9kWVvA FaGAJ7AI B3awlFvs">[<a href="#ref-15Yaf3fc8" role="doc-biblioref">1947</a>,<a href="#ref-1As9kWVvA" role="doc-biblioref">1948</a>,<a href="#ref-FaGAJ7AI" role="doc-biblioref">1949</a>,<a href="#ref-B3awlFvs" role="doc-biblioref">1950</a>]</span>.
+Although it is generally considered unethical to consider demographic factors such as age, sex, race, or ethnicity while making such decisions, and ideally this information would not be shared with triage teams tasked with allocating limited resources among patients <span class="citation" data-cites="2i1Y7SYn">[<a href="#ref-2i1Y7SYn" role="doc-biblioref">1951</a>]</span>, there are substantial concerns about implicit and explicit biases against older adults <span class="citation" data-cites="GTL02UT6">[<a href="#ref-GTL02UT6" role="doc-biblioref">1952</a>]</span>, premature infants <span class="citation" data-cites="KQfJ4llw">[<a href="#ref-KQfJ4llw" role="doc-biblioref">1953</a>]</span>, and people with disabilities or comorbidities <span class="citation" data-cites="K6yc6elC 1EaLRFk21 2i1Y7SYn">[<a href="#ref-2i1Y7SYn" role="doc-biblioref">1951</a>,<a href="#ref-K6yc6elC" role="doc-biblioref">1954</a>,<a href="#ref-1EaLRFk21" role="doc-biblioref">1955</a>]</span>.
+Because of the greater burden of chronic disease in populations subjected to systemic racism, algorithms intended to be blind to race and ethnicity could, in fact, reinforce systemic inequalities caused by structural racism <span class="citation" data-cites="cPsuWT7U 1D1FX4zQZ LrqhFVIz">[<a href="#ref-cPsuWT7U" role="doc-biblioref">1956</a>,<a href="#ref-1D1FX4zQZ" role="doc-biblioref">1957</a>,<a href="#ref-LrqhFVIz" role="doc-biblioref">1958</a>]</span>.
+Because of this inequality, it has been argued that groups facing health disparities should be prioritized by these algorithms <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1959</a>]</span>.
+This approach would carry its own ethical concerns, including the fact that many resources that need to be distributed do not have well-established risks and benefits <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1959</a>]</span>.</p>
+<p>As the pandemic has progressed, it has become clear that ICU beds and ventilators are not the only limited resources that needs to be allocated, and, in fact, the survival rate for patients who receive mechanical ventilation is lower than these discussions would suggest <span class="citation" data-cites="1ExRX1x4C">[<a href="#ref-1ExRX1x4C" role="doc-biblioref">1960</a>]</span>.
+Allocation of interventions that may reduce suffering, including palliative care, has become critically important <span class="citation" data-cites="1ExRX1x4C ztTunmqF">[<a href="#ref-1ExRX1x4C" role="doc-biblioref">1960</a>,<a href="#ref-ztTunmqF" role="doc-biblioref">1961</a>]</span>.
+The ambiguities surrounding the risks and benefits associated with therapeutics that have been approved under emergency use authorizations also present ethical concerns related to the distribution of resources <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1959</a>]</span>.
+For example, remdesivir, discussed above, is currently available for the treatment of COVID-19 under compassionate use guidelines and through expanded access programs, and in many cases has been donated to hospitals by Gilead <span class="citation" data-cites="18et5lcBc 11gslRJJU">[<a href="#ref-18et5lcBc" role="doc-biblioref">1962</a>,<a href="#ref-11gslRJJU" role="doc-biblioref">1963</a>]</span>.
+Regulations guiding the distribution of drugs in situations like these typically do not address how to determine which patients receive them <span class="citation" data-cites="11gslRJJU">[<a href="#ref-11gslRJJU" role="doc-biblioref">1963</a>]</span>.
+Prioritizing marginalized groups for treatment with a drug like remdesivir would also be unethical because it would entail disproportionately exposing these groups to a therapeutic that may or not be beneficial <span class="citation" data-cites="PFHCN5ep">[<a href="#ref-PFHCN5ep" role="doc-biblioref">1959</a>]</span>.
 On the other hand, given that the drug is one of the most promising treatments available for many patients, using a framework that tacitly feeds into structural biases would also be unethical.
-At present, the report prepared for the Director of the CDC by Ethics Subcommittee of the CDC fails to address the complexity of this ethical question given the state of structural racism in the United States, instead stating that “prioritizing individuals according to their chances for short-term survival also avoids ethically irrelevant considerations, such as race or socioeconomic status” <span class="citation" data-cites="ugEOYgfx">[<a href="#ref-ugEOYgfx" role="doc-biblioref">1957</a>]</span>.
-In many cases, experimental therapeutics are made available only through participation in clinical trials <span class="citation" data-cites="1A5E2TkBS">[<a href="#ref-1A5E2TkBS" role="doc-biblioref">1958</a>]</span>.
-However, given the history of medical trials abusing minority communities, especially Black Americans, there is a history of unequal representation in clinical trial enrollment <span class="citation" data-cites="1A5E2TkBS">[<a href="#ref-1A5E2TkBS" role="doc-biblioref">1958</a>]</span>.
+At present, the report prepared for the Director of the CDC by Ethics Subcommittee of the CDC fails to address the complexity of this ethical question given the state of structural racism in the United States, instead stating that “prioritizing individuals according to their chances for short-term survival also avoids ethically irrelevant considerations, such as race or socioeconomic status” <span class="citation" data-cites="ugEOYgfx">[<a href="#ref-ugEOYgfx" role="doc-biblioref">1964</a>]</span>.
+In many cases, experimental therapeutics are made available only through participation in clinical trials <span class="citation" data-cites="1A5E2TkBS">[<a href="#ref-1A5E2TkBS" role="doc-biblioref">1965</a>]</span>.
+However, given the history of medical trials abusing minority communities, especially Black Americans, there is a history of unequal representation in clinical trial enrollment <span class="citation" data-cites="1A5E2TkBS">[<a href="#ref-1A5E2TkBS" role="doc-biblioref">1965</a>]</span>.
 As a result, the standard practice of requiring enrollment in a clinical trial in order to receive experimental treatment may also reinforce patterns established by systemic racism.
 <!--Risk of comorbid health conditions associated with more severe outcomes may be influenced by long-term damage caused by chronic stress related to traumatic social experiences [@doi:10.1007/s12170-013-0338-5], perhaps mediated by cardiovascular risk factors [@doi:10.1101/2020.05.10.20097253], although the effects of chronic stress have not yet been researched in the specific case of COVID-19 disparities.--></p>
 <h3 data-number="11.3.4" id="access-to-and-representation-in-clinical-trials"><span class="header-section-number">11.3.4</span> Access to and Representation in Clinical Trials</h3>
@@ -5362,14 +5348,14 @@ <h3 data-number="11.3.4" id="access-to-and-representation-in-clinical-trials"><s
 The advantage to a patient of participation in a clinical trial is that they may receive an experimental treatment they would not have been able to access otherwise.
 The potential downsides of participation include that the efficacy and side effects of such treatments are often poorly characterized and that patients who enroll in clinical trials will in some cases run the risk of being assigned to a placebo condition where they do not receive the treatment but miss out on opportunities to receive other treatments.
 The benefits and burdens of clinical trials therefore need to be weighed carefully to ensure that they don’t reinforce existing health disparities.
-The WHO Director‐General Tedros Adhanom Ghebreyesus stated his condemnation of utilizing low and middle income countries as test subjects for clinical trials, yet having highly developed countries as the majority of clinical trial representation is also not the answer <span class="citation" data-cites="TFKtmAIg">[<a href="#ref-TFKtmAIg" role="doc-biblioref">1959</a>]</span>.
+The WHO Director‐General Tedros Adhanom Ghebreyesus stated his condemnation of utilizing low and middle income countries as test subjects for clinical trials, yet having highly developed countries as the majority of clinical trial representation is also not the answer <span class="citation" data-cites="TFKtmAIg">[<a href="#ref-TFKtmAIg" role="doc-biblioref">1966</a>]</span>.
 Figure <a href="#fig:ebm-map">13</a> showcases two choropleths detailing COVID-19 clinical trial recruitment by country.
 China, the United States, and France are among the countries with the most clinical trial recruiting for trials with single-country enrollment.
 Many countries have little to no clinical trial recruiting, with the continents of Africa and South America much less represented than Asia, Europe, and North America.
 Trials that recruit across multiple countries do appear to broaden geographic representation, but these trials seem to be heavily dominated by the United States and European Union.</p>
 <div id="fig:ebm-map" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/5731b89747027f2322595249c7b11b2f237686f6/ebmdatalab/ebmdatalab-map.png" alt="Figure 13: Geographic distribution of COVID-19 clinical trials. The density of clinical trials is reported at the country level. As of December 31, 2020, there are 6,987 trials in the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker [729], of which 3,962 are interventional. The top figure demonstrates the density of interventional trials recruiting only from a singular country, while the bottom shows the distribution of recruitment for interventional trials that involve more than one country." />
+<img src="https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/ebmdatalab/ebmdatalab-map.png" alt="Figure 13: Geographic distribution of COVID-19 clinical trials. The density of clinical trials is reported at the country level. As of December 31, 2020, there are 6,987 trials in the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker [729], of which 3,962 are interventional. The top figure demonstrates the density of interventional trials recruiting only from a singular country, while the bottom shows the distribution of recruitment for interventional trials that involve more than one country." />
 <figcaption aria-hidden="true"><span>Figure 13:</span> <strong>Geographic distribution of COVID-19 clinical trials.</strong>
 The density of clinical trials is reported at the country level.
 As of December 31, 2020, there are 6,987 trials in the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker <span class="citation" data-cites="SSbnPnzT">[<a href="#ref-SSbnPnzT" role="doc-biblioref">729</a>]</span>, of which 3,962 are interventional.
@@ -5379,39 +5365,39 @@ <h3 data-number="11.3.4" id="access-to-and-representation-in-clinical-trials"><s
 <p>A few different concerns arise from this skewed geographic representation in clinical trial recruitment.
 First, treatments such as remdesivir that are promising but primarily available to clinical trial participants are unlikely to be accessible by people in many countries.
 Second, it raises the concern that the findings of clinical trials will be based on participants from many of the wealthiest countries, which may lead to ambiguity in whether the findings can be extrapolated to COVID-19 patients elsewhere.
-Especially with the global nature of COVID-19, equitable access to therapeutics and vaccines has been a concern at the forefront of many discussions about policy (e.g., <span class="citation" data-cites="MYW3TeXJ">[<a href="#ref-MYW3TeXJ" role="doc-biblioref">1960</a>]</span>, yet data like that shown in Figure <a href="#fig:ebm-map">13</a> demonstrates that accessibility is likely to be a significant issue.
-Another concern with the heterogeneous international distribution of clinical trials is that the governments of countries leading these clinical trials might prioritize their own populations once vaccines are developed, causing unequal health outcomes <span class="citation" data-cites="rh28K8GB">[<a href="#ref-rh28K8GB" role="doc-biblioref">1961</a>]</span>.
-Additionally, even within a single state in the United States (Maryland), geography was found to influence the likelihood of being recruited into or enrolled in a clinical trial, with patients in under-served rural areas less likely to enroll <span class="citation" data-cites="RZiEc6kh">[<a href="#ref-RZiEc6kh" role="doc-biblioref">1962</a>]</span>.
+Especially with the global nature of COVID-19, equitable access to therapeutics and vaccines has been a concern at the forefront of many discussions about policy (e.g., <span class="citation" data-cites="MYW3TeXJ">[<a href="#ref-MYW3TeXJ" role="doc-biblioref">1967</a>]</span>, yet data like that shown in Figure <a href="#fig:ebm-map">13</a> demonstrates that accessibility is likely to be a significant issue.
+Another concern with the heterogeneous international distribution of clinical trials is that the governments of countries leading these clinical trials might prioritize their own populations once vaccines are developed, causing unequal health outcomes <span class="citation" data-cites="rh28K8GB">[<a href="#ref-rh28K8GB" role="doc-biblioref">1968</a>]</span>.
+Additionally, even within a single state in the United States (Maryland), geography was found to influence the likelihood of being recruited into or enrolled in a clinical trial, with patients in under-served rural areas less likely to enroll <span class="citation" data-cites="RZiEc6kh">[<a href="#ref-RZiEc6kh" role="doc-biblioref">1969</a>]</span>.
 Thus, geography both on the global and local levels may influence when treatments and vaccines are available and who is able to access them.
-Efforts such as the African Union’s efforts to coordinate and promote vaccine development <span class="citation" data-cites="BLKtWt4w">[<a href="#ref-BLKtWt4w" role="doc-biblioref">1963</a>]</span> are therefore critical to promoting equity in the COVID-19 response.</p>
+Efforts such as the African Union’s efforts to coordinate and promote vaccine development <span class="citation" data-cites="BLKtWt4w">[<a href="#ref-BLKtWt4w" role="doc-biblioref">1970</a>]</span> are therefore critical to promoting equity in the COVID-19 response.</p>
 <p>Even when patients are located within the geographic recruitment area of clinical trials, however, there can still be demographic inequalities in enrollment.
-When efforts are made to ensure equal opportunity to participate in clinical trials, there is no significant difference in participation among racial/ethnic groups <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1964</a>]</span>.
-However, within the United States, real clinical trial recruitment numbers have indicated for many years that racial minorities, especially African-Americans, tend to be under-represented (e.g., <span class="citation" data-cites="14jpPBgHd GNMGw3Ff ZdYcndGw QNqutuqe">[<a href="#ref-14jpPBgHd" role="doc-biblioref">1965</a>,<a href="#ref-GNMGw3Ff" role="doc-biblioref">1966</a>,<a href="#ref-ZdYcndGw" role="doc-biblioref">1967</a>,<a href="#ref-QNqutuqe" role="doc-biblioref">1968</a>]</span>).
+When efforts are made to ensure equal opportunity to participate in clinical trials, there is no significant difference in participation among racial/ethnic groups <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1971</a>]</span>.
+However, within the United States, real clinical trial recruitment numbers have indicated for many years that racial minorities, especially African-Americans, tend to be under-represented (e.g., <span class="citation" data-cites="14jpPBgHd GNMGw3Ff ZdYcndGw QNqutuqe">[<a href="#ref-14jpPBgHd" role="doc-biblioref">1972</a>,<a href="#ref-GNMGw3Ff" role="doc-biblioref">1973</a>,<a href="#ref-ZdYcndGw" role="doc-biblioref">1974</a>,<a href="#ref-QNqutuqe" role="doc-biblioref">1975</a>]</span>).
 This trend is especially concerning given the disproportionate impact of COVID-19 on African-Americans.
-Early evidence suggests that the proportion of Black, Latinx, and Native American participants in clinical trials for drugs such as remdesivir is much lower than the representation of these groups among COVID-19 patients <span class="citation" data-cites="2DrMhVAo">[<a href="#ref-2DrMhVAo" role="doc-biblioref">1969</a>]</span>.</p>
+Early evidence suggests that the proportion of Black, Latinx, and Native American participants in clinical trials for drugs such as remdesivir is much lower than the representation of these groups among COVID-19 patients <span class="citation" data-cites="2DrMhVAo">[<a href="#ref-2DrMhVAo" role="doc-biblioref">1976</a>]</span>.</p>
 <p>One proposed explanation for differences among racial and ethnic groups in clinical trial enrollment refers to different experiences in healthcare settings.
-While some plausible reasons for the disparity in communication between physicians and patients could be a lack of awareness and education, mistrust in healthcare professionals, and a lack of health insurance <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1964</a>]</span>, a major concern is that patients from certain racial and ethnic groups are marginalized even while seeking healthcare.
-In the United States, many patients experience “othering” from physicians and other medical professionals due to their race or other external characteristics such as gender (e.g., <span class="citation" data-cites="M7sLngTJ">[<a href="#ref-M7sLngTJ" role="doc-biblioref">1970</a>]</span>).
+While some plausible reasons for the disparity in communication between physicians and patients could be a lack of awareness and education, mistrust in healthcare professionals, and a lack of health insurance <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1971</a>]</span>, a major concern is that patients from certain racial and ethnic groups are marginalized even while seeking healthcare.
+In the United States, many patients experience “othering” from physicians and other medical professionals due to their race or other external characteristics such as gender (e.g., <span class="citation" data-cites="M7sLngTJ">[<a href="#ref-M7sLngTJ" role="doc-biblioref">1977</a>]</span>).
 Many studies have sought to characterize implicit biases in healthcare providers and whether they affect their perceptions or treatment of patients.
-A systematic review that examined 37 such studies reported that most (31) identified racial and/or ethnic biases in healthcare providers in many different roles, although the evidence about whether these biases translated to different attitudes towards patients was mixed <span class="citation" data-cites="sDygnf7I">[<a href="#ref-sDygnf7I" role="doc-biblioref">1971</a>]</span>, with similar findings reported by a second systematic review <span class="citation" data-cites="upbPnFPI">[<a href="#ref-upbPnFPI" role="doc-biblioref">1972</a>]</span>.
-However, data about real-world patient outcomes are very limited, with most studies relying on clinical vignette-based exercises <span class="citation" data-cites="sDygnf7I">[<a href="#ref-sDygnf7I" role="doc-biblioref">1971</a>]</span>, and other analyses suggest that physician implicit bias could impact the patient’s perception of the negativity/positivity of the interaction regardless of the physician’s explicit behavior towards the patient <span class="citation" data-cites="AaFVjNFc">[<a href="#ref-AaFVjNFc" role="doc-biblioref">1973</a>]</span>.
-Because racism is a common factor in both, negative patient experiences with medical professionals are likely to compound other issues of systemic inequality, such as a lack of access to adequate care, a lack of insurance, or increased exposure to SARS-CoV-2 <span class="citation" data-cites="smVwFlNn">[<a href="#ref-smVwFlNn" role="doc-biblioref">1974</a>]</span>.
+A systematic review that examined 37 such studies reported that most (31) identified racial and/or ethnic biases in healthcare providers in many different roles, although the evidence about whether these biases translated to different attitudes towards patients was mixed <span class="citation" data-cites="sDygnf7I">[<a href="#ref-sDygnf7I" role="doc-biblioref">1978</a>]</span>, with similar findings reported by a second systematic review <span class="citation" data-cites="upbPnFPI">[<a href="#ref-upbPnFPI" role="doc-biblioref">1979</a>]</span>.
+However, data about real-world patient outcomes are very limited, with most studies relying on clinical vignette-based exercises <span class="citation" data-cites="sDygnf7I">[<a href="#ref-sDygnf7I" role="doc-biblioref">1978</a>]</span>, and other analyses suggest that physician implicit bias could impact the patient’s perception of the negativity/positivity of the interaction regardless of the physician’s explicit behavior towards the patient <span class="citation" data-cites="AaFVjNFc">[<a href="#ref-AaFVjNFc" role="doc-biblioref">1980</a>]</span>.
+Because racism is a common factor in both, negative patient experiences with medical professionals are likely to compound other issues of systemic inequality, such as a lack of access to adequate care, a lack of insurance, or increased exposure to SARS-CoV-2 <span class="citation" data-cites="smVwFlNn">[<a href="#ref-smVwFlNn" role="doc-biblioref">1981</a>]</span>.
 Furthermore, the experience of being othered is not only expected to impact patients’ trust in and comfort with their provider, but also may directly impact whether or not the patient is offered the opportunity to participate in a clinical trial at all.
 Some studies suggest communication between physicians and patients impacts whether or not a physician offers a patient participation in a clinical trial.
-For example, researchers utilized a linguistic analysis to assess mean word count of phrases related to clinical trial enrollment, such as voluntary participation, clinical trial, etc. <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1964</a>]</span>.
+For example, researchers utilized a linguistic analysis to assess mean word count of phrases related to clinical trial enrollment, such as voluntary participation, clinical trial, etc. <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1971</a>]</span>.
 The data indicated that the mean word count of the entire visit was 1.5 times more for white patients in comparison to Black patients.
-In addition, the greatest disparity between white and Black patients’ experience was the discussion of risks, with over 2 times as many risk-related words spoken with white patients than Black patients <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1964</a>]</span>.
+In addition, the greatest disparity between white and Black patients’ experience was the discussion of risks, with over 2 times as many risk-related words spoken with white patients than Black patients <span class="citation" data-cites="FasLN7DR">[<a href="#ref-FasLN7DR" role="doc-biblioref">1971</a>]</span>.
 The trends observed for other clinical trials raise the concern that COVID-19 clinical trial information may not be discussed as thoroughly or as often with Black patients compared to white patients.</p>
 <p>These discrepancies are especially concerning given that many COVID-19 treatments are being or are considered being made available to patients prior to FDA approval through Emergency Use Authorizations.
-In the past, African-Americans have been over-represented relative to national demographics in use of the FDA’s Exception From Informed Consent (EFIC) pathway <span class="citation" data-cites="Vp7KObiA">[<a href="#ref-Vp7KObiA" role="doc-biblioref">1975</a>]</span>.
+In the past, African-Americans have been over-represented relative to national demographics in use of the FDA’s Exception From Informed Consent (EFIC) pathway <span class="citation" data-cites="Vp7KObiA">[<a href="#ref-Vp7KObiA" role="doc-biblioref">1982</a>]</span>.
 Through this pathway, people who are incapacitated can receive an experimental treatment even if they are not able to consent and there is not sufficient time to seek approval from an authorized representative.
-This pathway presents concerns, however, when it is considered in the context of a long history of systematic abuses in medical experimentation where informed consent was not obtained from people of color, such as the Tuskegee syphilis experiments <span class="citation" data-cites="JNha7DEl">[<a href="#ref-JNha7DEl" role="doc-biblioref">1976</a>]</span>.
+This pathway presents concerns, however, when it is considered in the context of a long history of systematic abuses in medical experimentation where informed consent was not obtained from people of color, such as the Tuskegee syphilis experiments <span class="citation" data-cites="JNha7DEl">[<a href="#ref-JNha7DEl" role="doc-biblioref">1983</a>]</span>.
 While the goal of EFIC approval is to provide treatment to patients who urgently need it, the combination of the ongoing legacy of racism in medicine renders this trend concerning.
-With COVID-19, efforts to prioritize people who suffer from systemic racism are often designed with the goal of righting some of these inequalities (e.g., <span class="citation" data-cites="i53Z5Ye8">[<a href="#ref-i53Z5Ye8" role="doc-biblioref">1977</a>]</span>), but particular attention to informed consent will be imperative in ensuring these trials are ethical given that the benefits and risks of emerging treatments are still poorly characterized.
+With COVID-19, efforts to prioritize people who suffer from systemic racism are often designed with the goal of righting some of these inequalities (e.g., <span class="citation" data-cites="i53Z5Ye8">[<a href="#ref-i53Z5Ye8" role="doc-biblioref">1984</a>]</span>), but particular attention to informed consent will be imperative in ensuring these trials are ethical given that the benefits and risks of emerging treatments are still poorly characterized.
 Making a substantial effort to run inclusive clinical trials is also important because of the possibility that racism could impact how a patient responds to a treatment.
 For example, as discussed above, dexamethasone has been identified as a promising treatment for patients experiencing cytokine release syndrome, but the mechanism of action is tied to the stress response.
-A study from 2005 reported that Black asthma patients showed reduced responsiveness to dexamethasone in comparison to white patients and suggested Black patients might therefore require higher doses of the drug <span class="citation" data-cites="GP85Y1Jo">[<a href="#ref-GP85Y1Jo" role="doc-biblioref">1978</a>]</span>.
-In the context of chronic stress caused by systemic racism, this result is not surprising: chronic stress is associated with dysregulated production of glucocorticoids <span class="citation" data-cites="gkEMgdku">[<a href="#ref-gkEMgdku" role="doc-biblioref">1979</a>]</span> and glucocorticoid receptor resistance <span class="citation" data-cites="BlEZu684">[<a href="#ref-BlEZu684" role="doc-biblioref">1980</a>]</span>.
+A study from 2005 reported that Black asthma patients showed reduced responsiveness to dexamethasone in comparison to white patients and suggested Black patients might therefore require higher doses of the drug <span class="citation" data-cites="GP85Y1Jo">[<a href="#ref-GP85Y1Jo" role="doc-biblioref">1985</a>]</span>.
+In the context of chronic stress caused by systemic racism, this result is not surprising: chronic stress is associated with dysregulated production of glucocorticoids <span class="citation" data-cites="gkEMgdku">[<a href="#ref-gkEMgdku" role="doc-biblioref">1986</a>]</span> and glucocorticoid receptor resistance <span class="citation" data-cites="BlEZu684">[<a href="#ref-BlEZu684" role="doc-biblioref">1987</a>]</span>.
 However, it underscores the critical need for treatment guidelines to take into account differences in life experience, which would be facilitated by the recruitment of patients from a wide range of backgrounds.
 Attention to the social aspects of clinical trial enrollment must therefore be an essential component of the medical research community’s response to COVID-19.</p>
 <!--Table for future version: ### Indirect Effects of the Pandemic
@@ -5459,48 +5445,48 @@ <h2 class="unnumbered" id="keywords">KEYWORDS</h2>
 <h2 data-number="12.2" id="introduction-7"><span class="header-section-number">12.2</span> INTRODUCTION</h2>
 <p>Coronavirus Disease 2019 (COVID-19) caused a worldwide public health crisis that has reshaped many aspects of society.
 The scientific community has, in turn, devoted significant attention and resources towards COVID-19 and the associated virus, SARS-CoV-2, resulting in the release of data and publications at a rate and scale never previously seen for a single topic.
-Over 20,000 articles about COVID-19 were released in the first four months of the pandemic <span class="citation" data-cites="7ub6VM4Z">[<a href="#ref-7ub6VM4Z" role="doc-biblioref">1981</a>]</span>, causing an “infodemic” <span class="citation" data-cites="7ub6VM4Z nnfOazAC">[<a href="#ref-7ub6VM4Z" role="doc-biblioref">1981</a>,<a href="#ref-nnfOazAC" role="doc-biblioref">1982</a>]</span>.
-The COVID-19 Open Research Dataset (CORD-19) <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1983</a>]</span>, which was developed in part with the goal of training machine learning algorithms on COVID-19-related text, illustrates the growth of related scholarly literature (Figure <a href="#fig:cord19-growth">14</a>).
-This resource was developed by querying several sources for terms related to SARS-CoV-2 and COVID-19, as well as the coronaviruses SARS-CoV-1 and MERS-CoV and their associated diseases <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1983</a>]</span>.
+Over 20,000 articles about COVID-19 were released in the first four months of the pandemic <span class="citation" data-cites="7ub6VM4Z">[<a href="#ref-7ub6VM4Z" role="doc-biblioref">1988</a>]</span>, causing an “infodemic” <span class="citation" data-cites="7ub6VM4Z nnfOazAC">[<a href="#ref-7ub6VM4Z" role="doc-biblioref">1988</a>,<a href="#ref-nnfOazAC" role="doc-biblioref">1989</a>]</span>.
+The COVID-19 Open Research Dataset (CORD-19) <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1990</a>]</span>, which was developed in part with the goal of training machine learning algorithms on COVID-19-related text, illustrates the growth of related scholarly literature (Figure <a href="#fig:cord19-growth">14</a>).
+This resource was developed by querying several sources for terms related to SARS-CoV-2 and COVID-19, as well as the coronaviruses SARS-CoV-1 and MERS-CoV and their associated diseases <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1990</a>]</span>.
 CORD-19 contained 1056660 manuscripts as of 2022-06-02.
-Additional curation by CoronaCentral <span class="citation" data-cites="Ybg667S0">[<a href="#ref-Ybg667S0" role="doc-biblioref">1984</a>]</span> has produced, at present, a set of over 180,000 publications particularly relevant to COVID-19 and closely related viruses.
+Additional curation by CoronaCentral <span class="citation" data-cites="Ybg667S0">[<a href="#ref-Ybg667S0" role="doc-biblioref">1991</a>]</span> has produced, at present, a set of over 180,000 publications particularly relevant to COVID-19 and closely related viruses.
 Despite many advances in understanding the virus and the disease, there are also downsides to the availability of so much information.
-“Excessive publication” has been recognized as a concern for over forty years <span class="citation" data-cites="DfSr1Ohc">[<a href="#ref-DfSr1Ohc" role="doc-biblioref">1985</a>]</span> and has been discussed with respect to the COVID-19 literature <span class="citation" data-cites="dUvvJvv6">[<a href="#ref-dUvvJvv6" role="doc-biblioref">982</a>]</span>.
+“Excessive publication” has been recognized as a concern for over forty years <span class="citation" data-cites="DfSr1Ohc">[<a href="#ref-DfSr1Ohc" role="doc-biblioref">1992</a>]</span> and has been discussed with respect to the COVID-19 literature <span class="citation" data-cites="dUvvJvv6">[<a href="#ref-dUvvJvv6" role="doc-biblioref">982</a>]</span>.
 Any effort to synthesize, summarize, and contextualize COVID-19 research will face a vast corpus of potentially relevant material.</p>
 <div id="fig:cord19-growth" class="fignos">
 <figure>
-<img src="https://github.com/greenelab/covid19-review/raw/87225c9935edc816c9c6d8d0e049af7b60b36c95/CORD-19/cord19-growth.png" alt="Figure 14: Growth of the CORD-19 dataset. The number of articles has proliferated, with both traditional and preprint manuscripts in the corpus. The first release (March 16, 2020) contained 28,000 documents [1983]. As of 2022-06-02, this had increased to 1056660 articles. Of these, 42343 are preprints from arXiv, medRxiv, and bioRxiv." />
+<img src="https://github.com/greenelab/covid19-review/raw/87225c9935edc816c9c6d8d0e049af7b60b36c95/CORD-19/cord19-growth.png" alt="Figure 14: Growth of the CORD-19 dataset. The number of articles has proliferated, with both traditional and preprint manuscripts in the corpus. The first release (March 16, 2020) contained 28,000 documents [1990]. As of 2022-06-02, this had increased to 1056660 articles. Of these, 42343 are preprints from arXiv, medRxiv, and bioRxiv." />
 <figcaption aria-hidden="true"><span>Figure 14:</span> <strong>Growth of the CORD-19 dataset.</strong>
 The number of articles has proliferated, with both traditional and preprint manuscripts in the corpus.
-The first release (March 16, 2020) contained 28,000 documents <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1983</a>]</span>.
+The first release (March 16, 2020) contained 28,000 documents <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1990</a>]</span>.
 As of 2022-06-02, this had increased to 1056660 articles.
 Of these, 42343 are preprints from <em>arXiv</em>, <em>medRxiv</em>, and <em>bioRxiv</em>.</figcaption>
 </figure>
 </div>
 <p>Information was released rapidly by both traditional publishers and preprint servers, and many papers faced subsequent scrutiny.
-The number of COVID-19 papers retracted may be higher, and potentially much higher, than is typical, although a thorough investigation of this question requires more time to elapse <span class="citation" data-cites="ZUk10707 caxpZEmy">[<a href="#ref-ZUk10707" role="doc-biblioref">1986</a>,<a href="#ref-caxpZEmy" role="doc-biblioref">1987</a>]</span>.
-Many papers and preprints are also associated with corrections or expressions of concern<a href="#fn1" class="footnote-ref" id="fnref1" role="doc-noteref"><sup>1</sup></a> <span class="citation" data-cites="caxpZEmy">[<a href="#ref-caxpZEmy" role="doc-biblioref">1987</a>]</span>.
-Preprints are released prior to peer review, but some traditional publishing venues have fast-tracked COVID-19 papers through peer review, leading to questions about whether they are held to typical standards <span class="citation" data-cites="1Dez1ZOc5">[<a href="#ref-1Dez1ZOc5" role="doc-biblioref">1988</a>]</span>.
+The number of COVID-19 papers retracted may be higher, and potentially much higher, than is typical, although a thorough investigation of this question requires more time to elapse <span class="citation" data-cites="ZUk10707 caxpZEmy">[<a href="#ref-ZUk10707" role="doc-biblioref">1993</a>,<a href="#ref-caxpZEmy" role="doc-biblioref">1994</a>]</span>.
+Many papers and preprints are also associated with corrections or expressions of concern<a href="#fn1" class="footnote-ref" id="fnref1" role="doc-noteref"><sup>1</sup></a> <span class="citation" data-cites="caxpZEmy">[<a href="#ref-caxpZEmy" role="doc-biblioref">1994</a>]</span>.
+Preprints are released prior to peer review, but some traditional publishing venues have fast-tracked COVID-19 papers through peer review, leading to questions about whether they are held to typical standards <span class="citation" data-cites="1Dez1ZOc5">[<a href="#ref-1Dez1ZOc5" role="doc-biblioref">1995</a>]</span>.
 Therefore, evaluating the COVID-19 literature requires not only digesting available information but also monitoring subsequent changes.</p>
 <p>Because of the fast-moving nature of the topic, many efforts to summarize and synthesize the COVID-19 literature have been undertaken.
-These efforts include newsletters<a href="#fn2" class="footnote-ref" id="fnref2" role="doc-noteref"><sup>2</sup></a> <span class="citation" data-cites="JdWiPJCL">[<a href="#ref-JdWiPJCL" role="doc-biblioref">1989</a>]</span>, web portals<a href="#fn3" class="footnote-ref" id="fnref3" role="doc-noteref"><sup>3</sup></a> <span class="citation" data-cites="1CBWvhTdy">[<a href="#ref-1CBWvhTdy" role="doc-biblioref">1990</a>]</span> or the now-defunct http://covidpreprints.com<a href="#fn4" class="footnote-ref" id="fnref4" role="doc-noteref"><sup>4</sup></a>, comments on preprint servers<a href="#fn5" class="footnote-ref" id="fnref5" role="doc-noteref"><sup>5</sup></a> <span class="citation" data-cites="YZ4cHNuH">[<a href="#ref-YZ4cHNuH" role="doc-biblioref">1991</a>]</span>, and even a journal<a href="#fn6" class="footnote-ref" id="fnref6" role="doc-noteref"><sup>6</sup></a>.
+These efforts include newsletters<a href="#fn2" class="footnote-ref" id="fnref2" role="doc-noteref"><sup>2</sup></a> <span class="citation" data-cites="JdWiPJCL">[<a href="#ref-JdWiPJCL" role="doc-biblioref">1996</a>]</span>, web portals<a href="#fn3" class="footnote-ref" id="fnref3" role="doc-noteref"><sup>3</sup></a> <span class="citation" data-cites="1CBWvhTdy">[<a href="#ref-1CBWvhTdy" role="doc-biblioref">1997</a>]</span> or the now-defunct http://covidpreprints.com<a href="#fn4" class="footnote-ref" id="fnref4" role="doc-noteref"><sup>4</sup></a>, comments on preprint servers<a href="#fn5" class="footnote-ref" id="fnref5" role="doc-noteref"><sup>5</sup></a> <span class="citation" data-cites="YZ4cHNuH">[<a href="#ref-YZ4cHNuH" role="doc-biblioref">1998</a>]</span>, and even a journal<a href="#fn6" class="footnote-ref" id="fnref6" role="doc-noteref"><sup>6</sup></a>.
 However, the explosive rate of publication presents challenges for such efforts, many of which are no longer active.
-Similarly, many literature reviews have been written on the available COVID-19 literature <span class="citation" data-cites="I2EsJmfs evtsR3C5 18eCxyLhx SAE5ME3N xOs5ctsW">[<a href="#ref-I2EsJmfs" role="doc-biblioref">1992</a>,<a href="#ref-evtsR3C5" role="doc-biblioref">1993</a>,<a href="#ref-18eCxyLhx" role="doc-biblioref">1994</a>,<a href="#ref-SAE5ME3N" role="doc-biblioref">1995</a>,<a href="#ref-xOs5ctsW" role="doc-biblioref">1996</a>]</span>, but static reviews quickly become outdated as new research is released or existing research is retracted or superseded.
-One example is a review of topics in COVID-19 research including vaccine development <span class="citation" data-cites="xOs5ctsW">[<a href="#ref-xOs5ctsW" role="doc-biblioref">1996</a>]</span>.
+Similarly, many literature reviews have been written on the available COVID-19 literature <span class="citation" data-cites="I2EsJmfs evtsR3C5 18eCxyLhx SAE5ME3N xOs5ctsW">[<a href="#ref-I2EsJmfs" role="doc-biblioref">1999</a>,<a href="#ref-evtsR3C5" role="doc-biblioref">2000</a>,<a href="#ref-18eCxyLhx" role="doc-biblioref">2001</a>,<a href="#ref-SAE5ME3N" role="doc-biblioref">2002</a>,<a href="#ref-xOs5ctsW" role="doc-biblioref">2003</a>]</span>, but static reviews quickly become outdated as new research is released or existing research is retracted or superseded.
+One example is a review of topics in COVID-19 research including vaccine development <span class="citation" data-cites="xOs5ctsW">[<a href="#ref-xOs5ctsW" role="doc-biblioref">2003</a>]</span>.
 This review was published on July 10, 2020, four days before Moderna released the surprisingly promising results of their phase 1 trial <span class="citation" data-cites="wiGjCZC8">[<a href="#ref-wiGjCZC8" role="doc-biblioref">1108</a>]</span> that changed expectations surrounding vaccines.
 Therefore, the COVID-19 publishing climate presented a challenge where curation of the literature by a diverse group of experts in a format that could respond quickly to high-volume, high-velocity information was desirable.</p>
 <p>We therefore sought to develop a platform for scientific discussion and collaboration around COVID-19 by adapting open publishing infrastructure to accommodate the scale of COVID-19 publishing.
-Recent advances in open publishing have created an infrastructure that facilitates distributed, version-controlled collaboration on manuscripts <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">1997</a>]</span>.
-Manubot <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">1997</a>]</span> is a collaborative framework developed to adapt open-source software development techniques and version control for manuscript writing.
+Recent advances in open publishing have created an infrastructure that facilitates distributed, version-controlled collaboration on manuscripts <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">2004</a>]</span>.
+Manubot <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">2004</a>]</span> is a collaborative framework developed to adapt open-source software development techniques and version control for manuscript writing.
 With Manubot, manuscripts are managed and maintained using GitHub, a popular, online version control interface.
-We selected Manubot because it offers several advantages over comparable collaborative writing platforms such as Authorea, Overleaf, Google Docs, Word Online, or wikis <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">1997</a>]</span>.
+We selected Manubot because it offers several advantages over comparable collaborative writing platforms such as Authorea, Overleaf, Google Docs, Word Online, or wikis <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">2004</a>]</span>.
 Citation-by-identifier ensures consistent reference metadata standards that would be difficult to maintain manually in a manuscript with dozens of authors and over 1,500 citations.
 Manubot’s pull request-based contribution model balances the goals of making the project open to everyone and maintaining scientific accuracy.
 All contributions are reviewed, discussed, and formally approved on GitHub before text updates appear in the public-facing manuscript<a href="#fn7" class="footnote-ref" id="fnref7" role="doc-noteref"><sup>7</sup></a>.
 Continuous integration (CI) seamlessly combines author-produced text and figures with automatically generated and updated statistics and figures derived from external data sources and the manuscript’s own content.
 In addition, the authors who initially launched this project included Manubot developers who had prior successes using Manubot for massively open and traditional manuscripts.</p>
-<p>Collaboration via massively open online papers has been identified as a strategy for promoting inclusion and interdisciplinary thought <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">1998</a>]</span>.
-However, the Manubot workflow can be intimidating to contributors who are not well-versed in git <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">1998</a>]</span>.
+<p>Collaboration via massively open online papers has been identified as a strategy for promoting inclusion and interdisciplinary thought <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">2005</a>]</span>.
+However, the Manubot workflow can be intimidating to contributors who are not well-versed in git <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">2005</a>]</span>.
 The synthesis and discussion of the emerging literature by biomedical scientists and clinicians is imperative to a robust interpretation of COVID-19 research.
 Such efforts in biology often rely on What You See Is What You Get tools such as Google Docs, despite the significant limitations of these platforms in the face of excessive publication.
 We recognized that the problem of synthesizing the COVID-19 literature lent itself well to the Manubot platform, but that the potential technical expertise required to work with Manubot presented a barrier to domain experts.</p>
@@ -5508,22 +5494,22 @@ <h2 data-number="12.2" id="introduction-7"><span class="header-section-number">1
 Unlike prior collaborations built on Manubot, most contributors to the COVID-19 collaborative literature review came from biology or medicine.
 The members of the COVID-19 Review Consortium consolidated information about the virus in the context of related viruses and to synthesize rapidly emerging literature.
 Manubot provided the infrastructure to manage contributions from the community and create a living, scholarly document integrating data from multiple sources.
-Its back-end allowed biomedical scientists to sort and distill informative content out of the overwhelming flood of information <span class="citation" data-cites="1HZeeO4Cs">[<a href="#ref-1HZeeO4Cs" role="doc-biblioref">1999</a>]</span> in order to provide a resource that would be useful to the broader scientific community.
+Its back-end allowed biomedical scientists to sort and distill informative content out of the overwhelming flood of information <span class="citation" data-cites="1HZeeO4Cs">[<a href="#ref-1HZeeO4Cs" role="doc-biblioref">2006</a>]</span> in order to provide a resource that would be useful to the broader scientific community.
 This case study demonstrates the value of open collaborative writing tools such as Manubot to emerging challenges.
 Because it is open source software, we were able to adapt and customize Manubot to flexibly meet the needs of COVID-19 review.
 Recording the evolution of information over time and assembling a resource that auto-updated in response to the evolving crisis revealed the particular value that Manubot holds for managing rapid changes in scientific thought.</p>
 <h2 data-number="12.3" id="methods"><span class="header-section-number">12.3</span> METHODS</h2>
 <h3 data-number="12.3.1" id="contributor-recruitment-and-roles"><span class="header-section-number">12.3.1</span> Contributor Recruitment and Roles</h3>
-<p>First, it was necessary to establish Manubot as a platform accessible to researchers with limited experience working version control, given that this is not typically emphasized in biology and medicine <span class="citation" data-cites="1HmO21gZN OO1DuZd 4ny1onB0">[<a href="#ref-1HmO21gZN" role="doc-biblioref">2000</a>,<a href="#ref-OO1DuZd" role="doc-biblioref">2001</a>,<a href="#ref-4ny1onB0" role="doc-biblioref">2002</a>]</span>.
+<p>First, it was necessary to establish Manubot as a platform accessible to researchers with limited experience working version control, given that this is not typically emphasized in biology and medicine <span class="citation" data-cites="1HmO21gZN OO1DuZd 4ny1onB0">[<a href="#ref-1HmO21gZN" role="doc-biblioref">2007</a>,<a href="#ref-OO1DuZd" role="doc-biblioref">2008</a>,<a href="#ref-4ny1onB0" role="doc-biblioref">2009</a>]</span>.
 Contributors were recruited primarily by word of mouth and on Twitter, and we also collaborated with existing efforts to train early-career researchers.
 We invited potential collaborators to contribute a short introduction on a GitHub issue in order to collect information about participants and provide an introduction to working with GitHub issues.
 Interested participants were encouraged to contribute in several ways.
 One option was to catalog articles of interest as issues.
 We developed a standardized set of questions for contributors to consider when evaluating an article following a framework often used for assessing medical literature.
-This approach emphasizes examining the methods used, assignment (whether the study was observational or randomized), assessment, results, interpretation, and how well the study extrapolates <span class="citation" data-cites="17OQtAY4l">[<a href="#ref-17OQtAY4l" role="doc-biblioref">2003</a>]</span>.
+This approach emphasizes examining the methods used, assignment (whether the study was observational or randomized), assessment, results, interpretation, and how well the study extrapolates <span class="citation" data-cites="17OQtAY4l">[<a href="#ref-17OQtAY4l" role="doc-biblioref">2010</a>]</span>.
 Contributors were also invited to contribute or edit text using GitHub’s pull request system.
 These contributions were not strictly defined and could range from minor corrections to punctuation and grammar to large-scale additions of text.
-Finally, a small number of contributors (the authors of this paper) contributed technical expertise, either through the development of standardized approaches to the evaluation of papers based on the MAARIE Framework <span class="citation" data-cites="k1GJLUxP">[<a href="#ref-k1GJLUxP" role="doc-biblioref">2004</a>]</span>, the writing of code to generate manuscript figures, or the addition of features to Manubot.
+Finally, a small number of contributors (the authors of this paper) contributed technical expertise, either through the development of standardized approaches to the evaluation of papers based on the MAARIE Framework <span class="citation" data-cites="k1GJLUxP">[<a href="#ref-k1GJLUxP" role="doc-biblioref">2011</a>]</span>, the writing of code to generate manuscript figures, or the addition of features to Manubot.
 All of these additions were also submitted as pull requests, either to the COVID-19 review repository or to an external repository, as appropriate.</p>
 <p>Each pull request was reviewed and approved by at least one other contributor before being merged into the main branch.
 We tagged potential reviewers based on the introductions they had contributed in order to encourage participation.
@@ -5537,14 +5523,14 @@ <h3 data-number="12.3.2" id="utilization-and-expansion-of-manubot"><span class="
 This approach also allowed us to minimize the demand on authors to curate and sync bibliographic resources.
 Manubot provides the functionality to create a bibliography using digital object identifiers (DOIs), website URLs, or other identifiers such as PubMed identifiers and arXiv IDs.
 The author can insert a citation in-line using a format such as <code>[@doi:10.1371/journal.pcbi.1007128]</code>.
-Manubot then obtains reference metadata, exports the citations as Citation Style Language JSON Data Items, and renders the bibliographic information needed to generate the references section <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">1997</a>]</span>.
+Manubot then obtains reference metadata, exports the citations as Citation Style Language JSON Data Items, and renders the bibliographic information needed to generate the references section <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">2004</a>]</span>.
 This approach allows multiple authors to work on a piece of text without needing to make manual adjustments to the reference lists.</p>
 <p>Due to the needs of this project, several new features were implemented in Manubot.
 Because of the ever-evolving nature of the COVID-19 crisis, figures and statistics in the text quickly became outdated.
 To address this concern, Manubot and GitHub’s CI features were used to create figures that integrated online data sources and to dynamically update information, such as the current number of active COVID-19 clinical trials <span class="citation" data-cites="njpLhBui">[<a href="#ref-njpLhBui" role="doc-biblioref">3</a>]</span>, within the text of the manuscripts (Figure <a href="#fig:manubot-workflow">15</a>).
 GitHub Actions runs a nightly workflow to update these external data and regenerate the statistics and figures for the manuscript.
 The workflow uses the GitHub API to detect and save the latest commit of the external data sources that are GitHub repositories<a href="#fn12" class="footnote-ref" id="fnref12" role="doc-noteref"><sup>12</sup></a>.
-It then downloads versioned data from that snapshot of the external repositories and runs bash and Python scripts to calculate the desired statistics and produce the summary figures using Matplotlib <span class="citation" data-cites="1026Gxdsi">[<a href="#ref-1026Gxdsi" role="doc-biblioref">2005</a>]</span>.
+It then downloads versioned data from that snapshot of the external repositories and runs bash and Python scripts to calculate the desired statistics and produce the summary figures using Matplotlib <span class="citation" data-cites="1026Gxdsi">[<a href="#ref-1026Gxdsi" role="doc-biblioref">2012</a>]</span>.
 The statistics are stored in JSON files that are accessed by Manubot to populate the values of placeholder template variables dynamically every time the manuscript is built.
 For instance, the template variable <code>{{ebm_trials_results}}</code> in the manuscript is replaced by the actual number of clinical trials with results, 98.
 The template variables also include versioned URLs to the dynamically updated figures.
@@ -5576,7 +5562,7 @@ <h3 data-number="12.3.2" id="utilization-and-expansion-of-manubot"><span class="
 Manubot now supports directly citing hundreds of registered Compact Uniform Resource Identifiers<a href="#fn19" class="footnote-ref" id="fnref19" role="doc-noteref"><sup>19</sup></a>, beyond just the <code>clinicaltrials</code> identifier.</p>
 <p>Because of the large number of citations used in this manuscript and the fast-moving nature of COVID-19 research, keeping track of retractions, corrections, and notices of concern also became a challenge.
 We implemented a new Manubot plugin to support “smart citations” in the HTML build of manuscripts.
-The plugin uses the scite <span class="citation" data-cites="14UJbLWf4">[<a href="#ref-14UJbLWf4" role="doc-biblioref">2006</a>]</span> service to display a badge below any citation with a DOI.
+The plugin uses the scite <span class="citation" data-cites="14UJbLWf4">[<a href="#ref-14UJbLWf4" role="doc-biblioref">2013</a>]</span> service to display a badge below any citation with a DOI.
 The badge contains a set of icons and numbers that indicate how many times that source has been mentioned, supported, or disputed and whether there have been any important editorial notices.
 We were thus able to identify references that needed to be reevaluated by an expert.
 This addition was invaluable given the nature of the project, where we were disseminating rapidly evolving information of great consequence from over 1,500 different sources.
@@ -5611,7 +5597,7 @@ <h3 data-number="12.4.1" id="recruitment-and-manuscript-development"><span class
 </figure>
 </div>
 <!--To Do: make the figure URL dynamic and add commas to large numbers-->
-<p>Coverage by <em>Nature Toolbox</em> <span class="citation" data-cites="AE0QcVgJ">[<a href="#ref-AE0QcVgJ" role="doc-biblioref">2007</a>]</span> and an associated tweet<a href="#fn23" class="footnote-ref" id="fnref23" role="doc-noteref"><sup>23</sup></a> about the project on April 1, 2020 attracted the interest of the scientific community (Figure <a href="#fig:projectstats">16</a>).
+<p>Coverage by <em>Nature Toolbox</em> <span class="citation" data-cites="AE0QcVgJ">[<a href="#ref-AE0QcVgJ" role="doc-biblioref">2014</a>]</span> and an associated tweet<a href="#fn23" class="footnote-ref" id="fnref23" role="doc-noteref"><sup>23</sup></a> about the project on April 1, 2020 attracted the interest of the scientific community (Figure <a href="#fig:projectstats">16</a>).
 Because the GitHub issues and comment systems are similar to other common web commenting systems, authors learned these tools quickly.
 The Gitter chat also presented a low barrier to entry.
 The manuscript continued to grow throughout the first year and a half of the project in both word count and the number of references (Figure <a href="#fig:projectstats">16</a>).
@@ -5637,15 +5623,15 @@ <h3 data-number="12.4.1" id="recruitment-and-manuscript-development"><span class
 These manuscripts cover a wide range of topics including the fundamental biology of SARS-CoV-2 (pathogenesis <span class="citation" data-cites="GdZc4Yyd">[<a href="#ref-GdZc4Yyd" role="doc-biblioref">1</a>]</span> and evolution), biomedical advances in responding to the virus and COVID-19 (pharmaceuticals <span class="citation" data-cites="njpLhBui">[<a href="#ref-njpLhBui" role="doc-biblioref">3</a>]</span>, nutraceuticals <span class="citation" data-cites="wgAGKcBj">[<a href="#ref-wgAGKcBj" role="doc-biblioref">2</a>]</span>, vaccines, and diagnostic technologies), and biological and social factors influencing disease transmission and outcomes.
 To date, 52 authors are associated with the consortium (Figure <a href="#fig:projectstats">16</a>).</p>
 <p>More formal recruitment efforts to integrate with existing projects providing support for undergraduate students during COVID-19 were also successful.
-We incorporated summaries written by the students, post-docs, and faculty of the Immunology Institute at the Mount Sinai School of Medicine<a href="#fn25" class="footnote-ref" id="fnref25" role="doc-noteref"><sup>25</sup></a> <span class="citation" data-cites="YZ4cHNuH">[<a href="#ref-YZ4cHNuH" role="doc-biblioref">1991</a>]</span>.
+We incorporated summaries written by the students, post-docs, and faculty of the Immunology Institute at the Mount Sinai School of Medicine<a href="#fn25" class="footnote-ref" id="fnref25" role="doc-noteref"><sup>25</sup></a> <span class="citation" data-cites="YZ4cHNuH">[<a href="#ref-YZ4cHNuH" role="doc-biblioref">1998</a>]</span>.
 Additionally, two of the consortium authors were undergraduate students recruited through the American Physician Scientist Association’s Virtual Summer Research Program.
 Thus, the consortium was successful in providing a venue for researchers across all career stages to continue investigating and publishing at a time when many biomedical researchers were unable to access their laboratory facilities.</p>
 <h3 data-number="12.4.2" id="integrating-data"><span class="header-section-number">12.4.2</span> Integrating Data</h3>
 <p>We integrated data into the manuscripts from several sources (Figure <a href="#fig:manubot-workflow">15</a>).
 Worldwide cases and deaths were tracked by the COVID-19 Data Repository by the Center for Systems Science and Engineering at Johns Hopkins University<a href="#fn26" class="footnote-ref" id="fnref26" role="doc-noteref"><sup>26</sup></a>.
 The clinical trials statistics and figure were generated based on data from the University of Oxford Evidence-Based Medicine Data Lab’s COVID-19 TrialsTracker <span class="citation" data-cites="SSbnPnzT">[<a href="#ref-SSbnPnzT" role="doc-biblioref">729</a>]</span>.
-Information about vaccine distribution was extracted from Our World In Data<a href="#fn27" class="footnote-ref" id="fnref27" role="doc-noteref"><sup>27</sup></a> <span class="citation" data-cites="ZHvhFakW">[<a href="#ref-ZHvhFakW" role="doc-biblioref">2008</a>]</span>.
-(Figure <a href="#fig:cord19-growth">14</a>) integrates data from the CORD-19 dataset <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1983</a>]</span>.</p>
+Information about vaccine distribution was extracted from Our World In Data<a href="#fn27" class="footnote-ref" id="fnref27" role="doc-noteref"><sup>27</sup></a> <span class="citation" data-cites="ZHvhFakW">[<a href="#ref-ZHvhFakW" role="doc-biblioref">2015</a>]</span>.
+(Figure <a href="#fig:cord19-growth">14</a>) integrates data from the CORD-19 dataset <span class="citation" data-cites="CiOwklc6">[<a href="#ref-CiOwklc6" role="doc-biblioref">1990</a>]</span>.</p>
 <p>Manubot’s bibliographic management capabilities were critical because the amount of relevant literature published far outstripped what we had anticipated at the beginning of the project.
 As of September 10, 2021, there were 1676 references (Figure <a href="#fig:projectstats">16</a>).
 The scite plugin provided a way to visually inspect the reference list to identify possible references of concern.
@@ -5653,7 +5639,7 @@ <h3 data-number="12.4.2" id="integrating-data"><span class="header-section-numbe
 Using CI, Manubot now checks that the manuscript was built correctly, runs spell-checking, and cross-references the manuscripts cited in this review.
 In addition, Manubot rootstock now supports citing clinical trial identifiers such as <code>clinicaltrials:NCT04292899</code> <span class="citation" data-cites="yTCAmOyt">[<a href="#ref-yTCAmOyt" role="doc-biblioref">799</a>]</span>.</p>
 <h2 data-number="12.5" id="discussion-1"><span class="header-section-number">12.5</span> DISCUSSION</h2>
-<p>The current project was based in the GitHub repository <code>greenelab/covid19-review</code> using Manubot <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">1997</a>]</span> to continuously generate the manuscript.
+<p>The current project was based in the GitHub repository <code>greenelab/covid19-review</code> using Manubot <span class="citation" data-cites="YuJbg3zO">[<a href="#ref-YuJbg3zO" role="doc-biblioref">2004</a>]</span> to continuously generate the manuscript.
 The Manubot framework facilitated a massive collaborative review on an urgent topic.
 We demonstrated the utility of Manubot to a project where many contributors lacked expertise or even experience working with version control.
 This effort has produced not only seven literature reviews on topics relevant to the COVID-19 pandemic, but has also generated cyberinfrastructure for training novice users in GitHub.
@@ -5719,7 +5705,7 @@ <h2 data-number="12.5" id="discussion-1"><span class="header-section-number">12.
 In turn, by seeking to adapt Manubot to allow for broader participation, we made a number of improvements that are expected to increase its appeal to researchers from all backgrounds.
 Manubot provided a way for contributors from a variety of backgrounds, including early-career researchers, to join a massive collaborative project while demonstrating their individual contributions to the larger work and gaining experience with version control.
 The licensing and infrastructure also provide the basis for individuals to adapt from this project to create their own snapshots of the COVID-19 literature that derive from, but are not wholly identical to, the primary versions of these reviews.
-This project suggests that massive online open publishing efforts can indeed advance scholarship through inclusion <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">1998</a>]</span>, including during the extreme challenges presented by the COVID-19 pandemic.</p>
+This project suggests that massive online open publishing efforts can indeed advance scholarship through inclusion <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">2005</a>]</span>, including during the extreme challenges presented by the COVID-19 pandemic.</p>
 <p>Some challenges did arise in efforts to include an academically diverse set of authors.
 The barriers to entry posed by git and GitHub likely still reduced participation from individuals who might have otherwise been interested.
 Using pull requests as a tool for writing text is also unfamiliar to many or most scientists, and the review process can be slow, which might cause interested contributors to lose interest.
@@ -5727,7 +5713,7 @@ <h2 data-number="12.5" id="discussion-1"><span class="header-section-number">12.
 As a result, some feedback came through email or comments on the DOCX outputs that were then translated into issues or pull requests by the project managers.
 Given that our approach hinged on these version control tools, it is likely that our group of contributors was biased towards those who were interested in or experienced with computational tools.
 The trajectory of the pandemic itself also likely influenced participation: engagement waned over the course of the pandemic as labs opened back up and researchers were able to return to their work, and we recruited very few senior clinicians to the project, which is unsurprising given the load on medical professionals during this time.
-Engagement that waxes and wanes is, however, typical when writing massively open online papers <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">1998</a>]</span>.
+Engagement that waxes and wanes is, however, typical when writing massively open online papers <span class="citation" data-cites="PoDz2q0A">[<a href="#ref-PoDz2q0A" role="doc-biblioref">2005</a>]</span>.
 Adding features such as spell-check did improve usability, and additional features such as automatically checking the formatting of citations could further improve the usability of this tool.
 In the future, a formal study of participation could allow for quantification of these biases and improved efforts to foster inclusion.</p>
 <p>Additional limitations are challenges associated with massively open online papers in general.
@@ -5738,9 +5724,9 @@ <h2 data-number="12.5" id="discussion-1"><span class="header-section-number">12.
 This asynchronicity could potentially introduce incompatibility between the figures and the surrounding text.
 Similarly, in line with the collaboration-related challenges of the project, some authors returned to update their text, while others did not.
 As a result, the lead authors of each paper often spent several weeks prior to journal submission updating the text to reflect new developments in each area.
-In the future, it may be possible to streamline this process through integration with a tool such as CoronaCentral <span class="citation" data-cites="Ybg667S0">[<a href="#ref-Ybg667S0" role="doc-biblioref">1984</a>]</span> to automatically identify relevant, high-impact papers that need to be included, although expertise would still be required to incorporate them.
+In the future, it may be possible to streamline this process through integration with a tool such as CoronaCentral <span class="citation" data-cites="Ybg667S0">[<a href="#ref-Ybg667S0" role="doc-biblioref">1991</a>]</span> to automatically identify relevant, high-impact papers that need to be included, although expertise would still be required to incorporate them.
 Another challenge involves tracking preprints as they are reviewed or critiqued, revised, and potentially published.
-While updating the content of the manuscript would likely fall to human contributors, automatic detection of published versions of preprints <span class="citation" data-cites="pESBLU4c">[<a href="#ref-pESBLU4c" role="doc-biblioref">2009</a>]</span> could be integrated in the future.
+While updating the content of the manuscript would likely fall to human contributors, automatic detection of published versions of preprints <span class="citation" data-cites="pESBLU4c">[<a href="#ref-pESBLU4c" role="doc-biblioref">2016</a>]</span> could be integrated in the future.
 These challenges are exacerbated by the scale of the infodemic, but developing solutions would benefit future projects tracking more typical trends in publication.
 Similarly, outputting machine readable summaries of key information in the COVID-19 review manuscripts could reduce their contribution to the infodemic.
 As it stands, the integration of Compact Uniform Resource Identifier does make a step in this direction.
@@ -5748,7 +5734,7 @@ <h2 data-number="12.5" id="discussion-1"><span class="header-section-number">12.
 Thus, the experience of using Manubot for a massive project has laid the foundation for future additions to enhance user experience and inclusivity.</p>
 <h2 data-number="12.6" id="conclusion"><span class="header-section-number">12.6</span> CONCLUSION</h2>
 <p>With the worldwide scientific community uniting during 2020 and 2021 to investigate COVID-19 from a wide range of perspectives, findings from many disciplines are relevant on a rapid timescale to a broad scientific audience.
-As many other efforts have described, the publishing rate of formal manuscripts and preprints about COVID-19 has been unprecedented <span class="citation" data-cites="7ub6VM4Z">[<a href="#ref-7ub6VM4Z" role="doc-biblioref">1981</a>]</span>, and efforts to review the body of COVID-19 literature are faced with an ever-expanding corpus to evaluate.
+As many other efforts have described, the publishing rate of formal manuscripts and preprints about COVID-19 has been unprecedented <span class="citation" data-cites="7ub6VM4Z">[<a href="#ref-7ub6VM4Z" role="doc-biblioref">1988</a>]</span>, and efforts to review the body of COVID-19 literature are faced with an ever-expanding corpus to evaluate.
 In the case of the seven manuscripts produced by the COVID-19 Review Consortium, Manubot allows for continuous updating of the manuscripts as the pandemic enters its second year and the landscape shifts with the emergence of promising therapeutics and vaccines <span class="citation" data-cites="njpLhBui">[<a href="#ref-njpLhBui" role="doc-biblioref">3</a>]</span>.
 These manuscripts pull data from external sources and update information and visualizations daily using CI.
 By off-loading some updates to computational pipelines, domain experts can focus on the broader implications of new information as it emerges.
@@ -9124,7 +9110,7 @@ <h2 class="page_break_before" data-number="13.4" id="references"><span class="he
 <div class="csl-left-margin">943. </div><div class="csl-right-inline"><strong>Phenotypic screening in cancer drug discovery — past, present and future</strong> <div class="csl-block">John G Moffat, Joachim Rudolph, David Bailey</div> <em>Nature Reviews Drug Discovery</em> (2014-07-18) <a href="https://doi.org/f6cnfw">https://doi.org/f6cnfw</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/nrd4366">10.1038/nrd4366</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/25033736">25033736</a></div></div>
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+<div class="csl-left-margin">1155. </div><div class="csl-right-inline"><strong>Interim report: Safety and immunogenicity of an inactivated vaccine against SARS-CoV-2 in healthy chilean adults in a phase 3 clinical trial</strong> <div class="csl-block">Susan M Bueno, Katia Abarca, Pablo A González, Nicolás MS Gálvez, Jorge A Soto, Luisa F Duarte, Bárbara M Schultz, Gaspar A Pacheco, Liliana A González, Yaneisi Vázquez, … Alexis M Kalergis</div> <em>Cold Spring Harbor Laboratory</em> (2021-04-01) <a href="https://doi.org/gmwn42">https://doi.org/gmwn42</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2021.03.31.21254494">10.1101/2021.03.31.21254494</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35441164">35441164</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9016657">PMC9016657</a></div></div>
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+<div class="csl-left-margin">1159. </div><div class="csl-right-inline"><strong>Coronavirus Vaccine Tracker</strong> <div class="csl-block">Carl Zimmer, Jonathan Corum, Sui-Lee Wee, Matthew Kristoffersen</div> <em>The New York Times</em> (2020-06-10) <a href="https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html">https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html</a></div>
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+<div class="csl-left-margin">1160. </div><div class="csl-right-inline"><strong>SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates</strong> <div class="csl-block">Nikolaos C Kyriakidis, Andrés López-Cortés, Eduardo Vásconez González, Alejandra Barreto Grimaldos, Esteban Ortiz Prado</div> <em>npj Vaccines</em> (2021-02-22) <a href="https://doi.org/gjsgc4">https://doi.org/gjsgc4</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41541-021-00292-w">10.1038/s41541-021-00292-w</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33619260">33619260</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900244">PMC7900244</a></div></div>
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+<div class="csl-left-margin">1161. </div><div class="csl-right-inline"><strong>Development of an Inactivated Vaccine Candidate, BBIBP-CorV, with Potent Protection against SARS-CoV-2</strong> <div class="csl-block">Hui Wang, Yuntao Zhang, Baoying Huang, Wei Deng, Yaru Quan, Wenling Wang, Wenbo Xu, Yuxiu Zhao, Na Li, Jin Zhang, … Xiaoming Yang</div> <em>Cell</em> (2020-08) <a href="https://doi.org/ghms9s">https://doi.org/ghms9s</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.cell.2020.06.008">10.1016/j.cell.2020.06.008</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32778225">32778225</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275151">PMC7275151</a></div></div>
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+<div class="csl-left-margin">1162. </div><div class="csl-right-inline"><strong>Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes</strong> <div class="csl-block">Shengli Xia, Kai Duan, Yuntao Zhang, Dongyang Zhao, Huajun Zhang, Zhiqiang Xie, Xinguo Li, Cheng Peng, Yanbo Zhang, Wei Zhang, … Xiaoming Yang</div> <em>JAMA</em> (2020-09-08) <a href="https://doi.org/gg72mg">https://doi.org/gg72mg</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1001/jama.2020.15543">10.1001/jama.2020.15543</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32789505">32789505</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426884">PMC7426884</a></div></div>
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+<div class="csl-left-margin">1163. </div><div class="csl-right-inline"><strong>Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial</strong> <div class="csl-block">Shengli Xia, Yuntao Zhang, Yanxia Wang, Hui Wang, Yunkai Yang, George Fu Gao, Wenjie Tan, Guizhen Wu, Miao Xu, Zhiyong Lou, … Xiaoming Yang</div> <em>The Lancet Infectious Diseases</em> (2021-01) <a href="https://doi.org/ghjkrf">https://doi.org/ghjkrf</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/s1473-3099(20)30831-8">10.1016/s1473-3099(20)30831-8</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33069281">33069281</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561304">PMC7561304</a></div></div>
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+<div class="csl-left-margin">1164. </div><div class="csl-right-inline"><strong>Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults</strong> <div class="csl-block">Nawal Al Kaabi, Yuntao Zhang, Shengli Xia, Yunkai Yang, Manaf M Al Qahtani, Najiba Abdulrazzaq, Majed Al Nusair, Mohamed Hassany, Jaleela S Jawad, Jehad Abdalla, … Xiaoming Yang</div> <em>JAMA</em> (2021-05-26) <a href="https://doi.org/gj7khd">https://doi.org/gj7khd</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1001/jama.2021.8565">10.1001/jama.2021.8565</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34037666">34037666</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8156175">PMC8156175</a></div></div>
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+<div class="csl-left-margin">1165. </div><div class="csl-right-inline"><strong>Sinopharm's COVID-19 vaccine 79% effective, seeks approval in China</strong> <div class="csl-block">Reuters</div> (2020-12-30) <a href="https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2940CA">https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2940CA</a></div>
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+<div class="csl-left-margin">1166. </div><div class="csl-right-inline"><strong>Immunogenicity and protective efficacy of BBV152: a whole virion inactivated SARS CoV-2 vaccine in the Syrian hamster model</strong> <div class="csl-block">Sreelekshmy Mohandas, Pragya D Yadav, Anita Shete, Priya Abraham, Krishna Mohan, Gajanan Sapkal, Chandrashekhar Mote, Dimpal Nyayanit, Nivedita Gupta, VK Srini, … Balram Bhargava</div> <em>Research Square Platform LLC</em> (2020-09-16) <a href="https://doi.org/gmwn5d">https://doi.org/gmwn5d</a> <div class="csl-block">DOI: <a href="https://doi.org/10.21203/rs.3.rs-76768/v1">10.21203/rs.3.rs-76768/v1</a></div></div>
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+<div class="csl-left-margin">1167. </div><div class="csl-right-inline"><strong>Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques</strong> <div class="csl-block">Pragya D Yadav, Raches Ella, Sanjay Kumar, Dilip R Patil, Sreelekshmy Mohandas, Anita M Shete, Krishna M Vadrevu, Gaurav Bhati, Gajanan Sapkal, Himanshu Kaushal, … Balram Bhargava</div> <em>Nature Communications</em> (2021-03-02) <a href="https://doi.org/gmwn4c">https://doi.org/gmwn4c</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41467-021-21639-w">10.1038/s41467-021-21639-w</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33654090">33654090</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7925524">PMC7925524</a></div></div>
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+<div class="csl-left-margin">1206. </div><div class="csl-right-inline"><strong>Receptor-binding domain of SARS-CoV spike protein induces long-term protective immunity in an animal model</strong> <div class="csl-block">Lanying Du, Guangyu Zhao, Yuxian He, Yan Guo, Bo-Jian Zheng, Shibo Jiang, Yusen Zhou</div> <em>Vaccine</em> (2007-04) <a href="https://doi.org/drpspr">https://doi.org/drpspr</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.vaccine.2006.10.031">10.1016/j.vaccine.2006.10.031</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/17092615">17092615</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7115660">PMC7115660</a></div></div>
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+<div class="csl-left-margin">1207. </div><div class="csl-right-inline"><strong>A 219-mer CHO-Expressing Receptor-Binding Domain of SARS-CoV S Protein Induces Potent Immune Responses and Protective Immunity</strong> <div class="csl-block">Lanying Du, Guangyu Zhao, Chris CS Chan, Lin Li, Yuxian He, Yusen Zhou, Bo-Jian Zheng, Shibo Jiang</div> <em>Viral Immunology</em> (2010-04) <a href="https://doi.org/b5ghkz">https://doi.org/b5ghkz</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1089/vim.2009.0090">10.1089/vim.2009.0090</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/20374001">20374001</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2883479">PMC2883479</a></div></div>
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+<div class="csl-left-margin">1383. </div><div class="csl-right-inline"><strong>INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S.</strong> <a href="https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Receives-U.S.-FDA-Authorization-to-Proceed-with-INNOVATE-Phase-3-Segment-for-its-COVID-19-Vaccine-Candidate-INO-4800-in-the-U.S/default.aspx">https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Receives-U.S.-FDA-Authorization-to-Proceed-with-INNOVATE-Phase-3-Segment-for-its-COVID-19-Vaccine-Candidate-INO-4800-in-the-U.S/default.aspx</a></div>
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+<div class="csl-left-margin">1385. </div><div class="csl-right-inline"><strong>INOVIO Expands INNOVATE Phase 3 for INO-4800, its DNA Vaccine Candidate for COVID-19, to include Colombia following Regulatory Authorization</strong> <a href="https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Expands-INNOVATE-Phase-3-for-INO-4800-its-DNA-Vaccine-Candidate-for-COVID-19-to-include-Colombia-following-Regulatory-Authorization/default.aspx">https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Expands-INNOVATE-Phase-3-for-INO-4800-its-DNA-Vaccine-Candidate-for-COVID-19-to-include-Colombia-following-Regulatory-Authorization/default.aspx</a></div>
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+<div class="csl-left-margin">1388. </div><div class="csl-right-inline"><strong>INO-4800 DNA vaccine induces neutralizing antibodies and T cell activity against global SARS-CoV-2 variants</strong> <div class="csl-block">Viviane M Andrade, Aaron Christensen-Quick, Joseph Agnes, Jared Tur, Charles Reed, Richa Kalia, Idania Marrero, Dustin Elwood, Katherine Schultheis, Mansi Purwar, … Kate E Broderick</div> <em>npj Vaccines</em> (2021-10-14) <a href="https://doi.org/gns5ff">https://doi.org/gns5ff</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41541-021-00384-7">10.1038/s41541-021-00384-7</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34650089">34650089</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8516974">PMC8516974</a></div></div>
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+<div class="csl-left-margin">1390. </div><div class="csl-right-inline"><strong>INOVIO Announces Strategy to Address Omicron (B.1.1.529) and Future SARS-CoV-2 Variants</strong> <div class="csl-block">INOVIO Pharmaceuticals Inc</div> <a href="https://www.prnewswire.com/news-releases/inovio-announces-strategy-to-address-omicron-b1-1-529-and-future-sars-cov-2-variants-301433776.html">https://www.prnewswire.com/news-releases/inovio-announces-strategy-to-address-omicron-b1-1-529-and-future-sars-cov-2-variants-301433776.html</a></div>
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+<div class="csl-left-margin">1454. </div><div class="csl-right-inline"><strong>Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots</strong> <div class="csl-block">Jacqui Wise</div> <em>BMJ</em> (2021-03-11) <a href="https://doi.org/gqbkdq">https://doi.org/gqbkdq</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n699">10.1136/bmj.n699</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33707182">33707182</a></div></div>
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-<div class="csl-left-margin">1397. </div><div class="csl-right-inline"><strong>Covid-19: AstraZeneca vaccine is not linked to increased risk of blood clots, finds European Medicine Agency</strong> <div class="csl-block">Elisabeth Mahase</div> <em>BMJ</em> (2021-03-19) <a href="https://doi.org/gqbkdr">https://doi.org/gqbkdr</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n774">10.1136/bmj.n774</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33741638">33741638</a></div></div>
+<div class="csl-left-margin">1455. </div><div class="csl-right-inline"><strong>Covid-19: AstraZeneca vaccine is not linked to increased risk of blood clots, finds European Medicine Agency</strong> <div class="csl-block">Elisabeth Mahase</div> <em>BMJ</em> (2021-03-19) <a href="https://doi.org/gqbkdr">https://doi.org/gqbkdr</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n774">10.1136/bmj.n774</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33741638">33741638</a></div></div>
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-<div class="csl-left-margin">1398. </div><div class="csl-right-inline"><strong>Covid-19: US suspends Johnson and Johnson vaccine rollout over blood clots</strong> <div class="csl-block">Elisabeth Mahase</div> <em>BMJ</em> (2021-04-13) <a href="https://doi.org/gqbkds">https://doi.org/gqbkds</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n970">10.1136/bmj.n970</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33849896">33849896</a></div></div>
+<div class="csl-left-margin">1456. </div><div class="csl-right-inline"><strong>Covid-19: US suspends Johnson and Johnson vaccine rollout over blood clots</strong> <div class="csl-block">Elisabeth Mahase</div> <em>BMJ</em> (2021-04-13) <a href="https://doi.org/gqbkds">https://doi.org/gqbkds</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n970">10.1136/bmj.n970</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33849896">33849896</a></div></div>
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-<div class="csl-left-margin">1399. </div><div class="csl-right-inline"><strong>Covid-19: US authorises Johnson and Johnson vaccine again, ending pause in rollout</strong> <div class="csl-block">Janice Hopkins Tanne</div> <em>BMJ</em> (2021-04-26) <a href="https://doi.org/gqbkdp">https://doi.org/gqbkdp</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n1079">10.1136/bmj.n1079</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33903130">33903130</a></div></div>
+<div class="csl-left-margin">1457. </div><div class="csl-right-inline"><strong>Covid-19: US authorises Johnson and Johnson vaccine again, ending pause in rollout</strong> <div class="csl-block">Janice Hopkins Tanne</div> <em>BMJ</em> (2021-04-26) <a href="https://doi.org/gqbkdp">https://doi.org/gqbkdp</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n1079">10.1136/bmj.n1079</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33903130">33903130</a></div></div>
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-<div class="csl-left-margin">1400. </div><div class="csl-right-inline"><strong>Covid-19: Unusual blood clots are “very rare side effect” of Janssen vaccine, says EMA</strong> <div class="csl-block">Elisabeth Mahase</div> <em>BMJ</em> (2021-04-21) <a href="https://doi.org/gqbkdn">https://doi.org/gqbkdn</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n1046">10.1136/bmj.n1046</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33883164">33883164</a></div></div>
+<div class="csl-left-margin">1458. </div><div class="csl-right-inline"><strong>Covid-19: Unusual blood clots are “very rare side effect” of Janssen vaccine, says EMA</strong> <div class="csl-block">Elisabeth Mahase</div> <em>BMJ</em> (2021-04-21) <a href="https://doi.org/gqbkdn">https://doi.org/gqbkdn</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n1046">10.1136/bmj.n1046</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33883164">33883164</a></div></div>
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-<div class="csl-left-margin">1401. </div><div class="csl-right-inline"><strong>Use of the Janssen (Johnson &amp; Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices — United States, December 2021</strong> <div class="csl-block">Sara E Oliver, Megan Wallace, Isaac See, Sarah Mbaeyi, Monica Godfrey, Stephen C Hadler, Tara C Jatlaoui, Evelyn Twentyman, Michelle M Hughes, Agam K Rao, … Matthew F Daley</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2022-01-21) <a href="https://doi.org/gn7jws">https://doi.org/gn7jws</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7103a4">10.15585/mmwr.mm7103a4</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35051137">35051137</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8774160">PMC8774160</a></div></div>
+<div class="csl-left-margin">1459. </div><div class="csl-right-inline"><strong>Use of the Janssen (Johnson &amp; Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices — United States, December 2021</strong> <div class="csl-block">Sara E Oliver, Megan Wallace, Isaac See, Sarah Mbaeyi, Monica Godfrey, Stephen C Hadler, Tara C Jatlaoui, Evelyn Twentyman, Michelle M Hughes, Agam K Rao, … Matthew F Daley</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2022-01-21) <a href="https://doi.org/gn7jws">https://doi.org/gn7jws</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7103a4">10.15585/mmwr.mm7103a4</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35051137">35051137</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8774160">PMC8774160</a></div></div>
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-<div class="csl-left-margin">1402. </div><div class="csl-right-inline"><strong>Safety Monitoring of the Janssen (Johnson &amp; Johnson) COVID-19 Vaccine — United States, March–April 2021</strong> <div class="csl-block">David K Shay, Julianne Gee, John R Su, Tanya R Myers, Paige Marquez, Ruiling Liu, Bicheng Zhang, Charles Licata, Thomas A Clark, Tom T Shimabukuro</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2021-04-07) <a href="https://doi.org/gm2nkf">https://doi.org/gm2nkf</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7018e2">10.15585/mmwr.mm7018e2</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33956784">33956784</a></div></div>
+<div class="csl-left-margin">1460. </div><div class="csl-right-inline"><strong>Safety Monitoring of the Janssen (Johnson &amp; Johnson) COVID-19 Vaccine — United States, March–April 2021</strong> <div class="csl-block">David K Shay, Julianne Gee, John R Su, Tanya R Myers, Paige Marquez, Ruiling Liu, Bicheng Zhang, Charles Licata, Thomas A Clark, Tom T Shimabukuro</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2021-04-07) <a href="https://doi.org/gm2nkf">https://doi.org/gm2nkf</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7018e2">10.15585/mmwr.mm7018e2</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33956784">33956784</a></div></div>
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 <div id="ref-EqBIFx5T" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">1403. </div><div class="csl-right-inline"><strong>Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson &amp; Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021</strong> <div class="csl-block">Hannah G Rosenblum, Stephen C Hadler, Danielle Moulia, Tom T Shimabukuro, John R Su, Naomi K Tepper, Kevin C Ess, Emily Jane Woo, Adamma Mba-Jonas, Meghna Alimchandani, … Sara E Oliver</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2021-08-13) <a href="https://doi.org/gm2nsz">https://doi.org/gm2nsz</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7032e4">10.15585/mmwr.mm7032e4</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34383735">34383735</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8360272">PMC8360272</a></div></div>
+<div class="csl-left-margin">1461. </div><div class="csl-right-inline"><strong>Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson &amp; Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021</strong> <div class="csl-block">Hannah G Rosenblum, Stephen C Hadler, Danielle Moulia, Tom T Shimabukuro, John R Su, Naomi K Tepper, Kevin C Ess, Emily Jane Woo, Adamma Mba-Jonas, Meghna Alimchandani, … Sara E Oliver</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2021-08-13) <a href="https://doi.org/gm2nsz">https://doi.org/gm2nsz</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7032e4">10.15585/mmwr.mm7032e4</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34383735">34383735</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8360272">PMC8360272</a></div></div>
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-<div class="csl-left-margin">1404. </div><div class="csl-right-inline"><strong>Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study</strong> <div class="csl-block">Anton Pottegård, Lars Christian Lund, Øystein Karlstad, Jesper Dahl, Morten Andersen, Jesper Hallas, Øjvind Lidegaard, German Tapia, Hanne Løvdal Gulseth, Paz Lopez-Doriga Ruiz, … Anders Hviid</div> <em>BMJ</em> (2021-05-05) <a href="https://doi.org/gk5nh5">https://doi.org/gk5nh5</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n1114">10.1136/bmj.n1114</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33952445">33952445</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097496">PMC8097496</a></div></div>
+<div class="csl-left-margin">1462. </div><div class="csl-right-inline"><strong>Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study</strong> <div class="csl-block">Anton Pottegård, Lars Christian Lund, Øystein Karlstad, Jesper Dahl, Morten Andersen, Jesper Hallas, Øjvind Lidegaard, German Tapia, Hanne Løvdal Gulseth, Paz Lopez-Doriga Ruiz, … Anders Hviid</div> <em>BMJ</em> (2021-05-05) <a href="https://doi.org/gk5nh5">https://doi.org/gk5nh5</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/bmj.n1114">10.1136/bmj.n1114</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33952445">33952445</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8097496">PMC8097496</a></div></div>
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-<div class="csl-left-margin">1405. </div><div class="csl-right-inline"><strong>Risk of Vaccine-Induced Thrombotic Thrombocytopenia (VITT) following the AstraZeneca/COVISHIELD Adenovirus Vector COVID-19 Vaccines</strong> <div class="csl-block">Benjamin Chan, Ayodele Odutayo, Peter Juni, Nathan M Stall, Pavlos Bobos, Adalsteinn D Brown, Allan Grill, Noah Ivers, Antonina Maltsev, Allison McGeer, … Menaka Pai</div> <em>Ontario COVID-19 Science Advisory Table</em> (2021-05-11) <a href="https://doi.org/gqbkdt">https://doi.org/gqbkdt</a> <div class="csl-block">DOI: <a href="https://doi.org/10.47326/ocsat.2021.02.28.1.0">10.47326/ocsat.2021.02.28.1.0</a></div></div>
+<div class="csl-left-margin">1463. </div><div class="csl-right-inline"><strong>Risk of Vaccine-Induced Thrombotic Thrombocytopenia (VITT) following the AstraZeneca/COVISHIELD Adenovirus Vector COVID-19 Vaccines</strong> <div class="csl-block">Benjamin Chan, Ayodele Odutayo, Peter Juni, Nathan M Stall, Pavlos Bobos, Adalsteinn D Brown, Allan Grill, Noah Ivers, Antonina Maltsev, Allison McGeer, … Menaka Pai</div> <em>Ontario COVID-19 Science Advisory Table</em> (2021-05-11) <a href="https://doi.org/gqbkdt">https://doi.org/gqbkdt</a> <div class="csl-block">DOI: <a href="https://doi.org/10.47326/ocsat.2021.02.28.1.0">10.47326/ocsat.2021.02.28.1.0</a></div></div>
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-<div class="csl-left-margin">1406. </div><div class="csl-right-inline"><strong>ChAdOx1 interacts with CAR and PF4 with implications for thrombosis with thrombocytopenia syndrome</strong> <div class="csl-block">Alexander T Baker, Ryan J Boyd, Daipayan Sarkar, Alicia Teijeira-Crespo, Chun Kit Chan, Emily Bates, Kasim Waraich, John Vant, Eric Wilson, Chloe D Truong, … Mitesh J Borad</div> <em>Science Advances</em> (2021-12-03) <a href="https://doi.org/gpvw22">https://doi.org/gpvw22</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1126/sciadv.abl8213">10.1126/sciadv.abl8213</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34851659">34851659</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8635433">PMC8635433</a></div></div>
+<div class="csl-left-margin">1464. </div><div class="csl-right-inline"><strong>ChAdOx1 interacts with CAR and PF4 with implications for thrombosis with thrombocytopenia syndrome</strong> <div class="csl-block">Alexander T Baker, Ryan J Boyd, Daipayan Sarkar, Alicia Teijeira-Crespo, Chun Kit Chan, Emily Bates, Kasim Waraich, John Vant, Eric Wilson, Chloe D Truong, … Mitesh J Borad</div> <em>Science Advances</em> (2021-12-03) <a href="https://doi.org/gpvw22">https://doi.org/gpvw22</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1126/sciadv.abl8213">10.1126/sciadv.abl8213</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34851659">34851659</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8635433">PMC8635433</a></div></div>
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-<div class="csl-left-margin">1407. </div><div class="csl-right-inline"><strong>Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination</strong> <div class="csl-block">Nina H Schultz, Ingvild H Sørvoll, Annika E Michelsen, Ludvig A Munthe, Fridtjof Lund-Johansen, Maria T Ahlen, Markus Wiedmann, Anne-Hege Aamodt, Thor H Skattør, Geir E Tjønnfjord, Pål A Holme</div> <em>New England Journal of Medicine</em> (2021-06-03) <a href="https://doi.org/gjpssx">https://doi.org/gjpssx</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1056/nejmoa2104882">10.1056/nejmoa2104882</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33835768">33835768</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112568">PMC8112568</a></div></div>
+<div class="csl-left-margin">1465. </div><div class="csl-right-inline"><strong>Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination</strong> <div class="csl-block">Nina H Schultz, Ingvild H Sørvoll, Annika E Michelsen, Ludvig A Munthe, Fridtjof Lund-Johansen, Maria T Ahlen, Markus Wiedmann, Anne-Hege Aamodt, Thor H Skattør, Geir E Tjønnfjord, Pål A Holme</div> <em>New England Journal of Medicine</em> (2021-06-03) <a href="https://doi.org/gjpssx">https://doi.org/gjpssx</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1056/nejmoa2104882">10.1056/nejmoa2104882</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33835768">33835768</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8112568">PMC8112568</a></div></div>
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-<div class="csl-left-margin">1408. </div><div class="csl-right-inline"><strong>COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low platelets</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2021-03-18) <a href="https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots">https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots</a></div>
+<div class="csl-left-margin">1466. </div><div class="csl-right-inline"><strong>COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low platelets</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2021-03-18) <a href="https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots">https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots</a></div>
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-<div class="csl-left-margin">1409. </div><div class="csl-right-inline"><strong>COVID-19: Coagulopathy, Risk of Thrombosis, and the Rationale for Anticoagulation</strong> <div class="csl-block">Wolfgang Miesbach, Michael Makris</div> <em>Clinical and Applied Thrombosis/Hemostasis</em> (2020-01-01) <a href="https://doi.org/gjvk4t">https://doi.org/gjvk4t</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1177/1076029620938149">10.1177/1076029620938149</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32677459">32677459</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370334">PMC7370334</a></div></div>
+<div class="csl-left-margin">1467. </div><div class="csl-right-inline"><strong>COVID-19: Coagulopathy, Risk of Thrombosis, and the Rationale for Anticoagulation</strong> <div class="csl-block">Wolfgang Miesbach, Michael Makris</div> <em>Clinical and Applied Thrombosis/Hemostasis</em> (2020-01-01) <a href="https://doi.org/gjvk4t">https://doi.org/gjvk4t</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1177/1076029620938149">10.1177/1076029620938149</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32677459">32677459</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7370334">PMC7370334</a></div></div>
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+<div class="csl-left-margin">1503. </div><div class="csl-right-inline"><strong>Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19–Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance — VISION Network, 10 States, August 2021–January 2022</strong> <div class="csl-block">Jill M Ferdinands, Suchitra Rao, Brian E Dixon, Patrick K Mitchell, Malini B DeSilva, Stephanie A Irving, Ned Lewis, Karthik Natarajan, Edward Stenehjem, Shaun J Grannis, … Bruce Fireman</div> <em>MMWR. Morbidity and Mortality Weekly Report</em> (2022-02-18) <a href="https://doi.org/gpfrkh">https://doi.org/gpfrkh</a> <div class="csl-block">DOI: <a href="https://doi.org/10.15585/mmwr.mm7107e2">10.15585/mmwr.mm7107e2</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35176007">35176007</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8853475">PMC8853475</a></div></div>
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+<div class="csl-left-margin">1504. </div><div class="csl-right-inline"><strong>COVID-19 mRNA booster vaccines elicit strong protection against SARS-CoV-2 Omicron variant in patients with cancer</strong> <div class="csl-block">Cong Zeng, John P Evans, Karthik Chakravarthy, Panke Qu, Sarah Reisinger, No-Joon Song, Mark P Rubinstein, Peter G Shields, Zihai Li, Shan-Lu Liu</div> <em>Cancer Cell</em> (2022-02) <a href="https://doi.org/gn2gcf">https://doi.org/gn2gcf</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.ccell.2021.12.014">10.1016/j.ccell.2021.12.014</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34986328">34986328</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8716174">PMC8716174</a></div></div>
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+<div class="csl-left-margin">1505. </div><div class="csl-right-inline"><strong>Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial</strong> <div class="csl-block">Peter B Gilbert, David C Montefiori, Adrian B McDermott, Youyi Fong, David Benkeser, Weiping Deng, Honghong Zhou, Christopher R Houchens, Karen Martins, Lakshmi Jayashankar, … </div> <em>Science</em> (2022-01-07) <a href="https://doi.org/gpnbff">https://doi.org/gpnbff</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1126/science.abm3425">10.1126/science.abm3425</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34812653">34812653</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9017870">PMC9017870</a></div></div>
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+<div class="csl-left-margin">1506. </div><div class="csl-right-inline"><strong>Towards a population-based threshold of protection for COVID-19 vaccines</strong> <div class="csl-block">David Goldblatt, Andrew Fiore-Gartland, Marina Johnson, Adam Hunt, Christopher Bengt, Dace Zavadska, Hilda Darta Snipe, Jeremy S Brown, Lesley Workman, Heather J Zar, … Donna Ambrosino</div> <em>Vaccine</em> (2022-01) <a href="https://doi.org/gpnbdz">https://doi.org/gpnbdz</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.vaccine.2021.12.006">10.1016/j.vaccine.2021.12.006</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34933765">34933765</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8673730">PMC8673730</a></div></div>
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+<div class="csl-left-margin">1507. </div><div class="csl-right-inline"><strong>Evidence for antibody as a protective correlate for COVID-19 vaccines</strong> <div class="csl-block">Kristen A Earle, Donna M Ambrosino, Andrew Fiore-Gartland, David Goldblatt, Peter B Gilbert, George R Siber, Peter Dull, Stanley A Plotkin</div> <em>Vaccine</em> (2021-07) <a href="https://doi.org/gnr5w7">https://doi.org/gnr5w7</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.vaccine.2021.05.063">10.1016/j.vaccine.2021.05.063</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34210573">34210573</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8142841">PMC8142841</a></div></div>
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+<div class="csl-left-margin">1508. </div><div class="csl-right-inline"><strong>Towards Internationally standardised humoral Immune Correlates of Protection from SARS-CoV-2 infection and COVID-19 disease</strong> <div class="csl-block">Javier Castillo-Olivares, David A Wells, Matteo Ferrari, Andrew Chan, Peter Smith, Angalee Nadesalingam, Minna Paloniemi, George Carnell, Luis Ohlendorf, Diego Cantoni, … Jonathan Heeney</div> <em>Cold Spring Harbor Laboratory</em> (2021-05-23) <a href="https://doi.org/gk7czq">https://doi.org/gk7czq</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2021.05.21.21257572">10.1101/2021.05.21.21257572</a></div></div>
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-<div class="csl-left-margin">1449. </div><div class="csl-right-inline"><strong>A longitudinal study of SARS-CoV-2-infected patients reveals a high correlation between neutralizing antibodies and COVID-19 severity</strong> <div class="csl-block">Vincent Legros, Solène Denolly, Manon Vogrig, Bertrand Boson, Eglantine Siret, Josselin Rigaill, Sylvie Pillet, Florence Grattard, Sylvie Gonzalo, Paul Verhoeven, … Bruno Pozzetto</div> <em>Cellular &amp;amp; Molecular Immunology</em> (2021-01-06) <a href="https://doi.org/gh5qjr">https://doi.org/gh5qjr</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41423-020-00588-2">10.1038/s41423-020-00588-2</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33408342">33408342</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786875">PMC7786875</a></div></div>
+<div class="csl-left-margin">1509. </div><div class="csl-right-inline"><strong>A longitudinal study of SARS-CoV-2-infected patients reveals a high correlation between neutralizing antibodies and COVID-19 severity</strong> <div class="csl-block">Vincent Legros, Solène Denolly, Manon Vogrig, Bertrand Boson, Eglantine Siret, Josselin Rigaill, Sylvie Pillet, Florence Grattard, Sylvie Gonzalo, Paul Verhoeven, … Bruno Pozzetto</div> <em>Cellular &amp;amp; Molecular Immunology</em> (2021-01-06) <a href="https://doi.org/gh5qjr">https://doi.org/gh5qjr</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41423-020-00588-2">10.1038/s41423-020-00588-2</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33408342">33408342</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786875">PMC7786875</a></div></div>
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+<div class="csl-left-margin">1510. </div><div class="csl-right-inline"><strong>Efficacy and Safety of a Booster Regimen of Ad26.COV2.S Vaccine against Covid-19</strong> <div class="csl-block">Karin Hardt, An Vandebosch, Jerry Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, Johan Vingerhoets, Tobias Kamphuis, Gert Scheper, … </div> <em>Cold Spring Harbor Laboratory</em> (2022-01-31) <a href="https://doi.org/gqbkdm">https://doi.org/gqbkdm</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2022.01.28.22270043">10.1101/2022.01.28.22270043</a></div></div>
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-<div class="csl-left-margin">1451. </div><div class="csl-right-inline"><strong>Sputnik Light booster after Sputnik V vaccination induces robust neutralizing antibody response to B.1.1.529 (Omicron) SARS-CoV-2 variant</strong> <div class="csl-block">IV Dolzhikova, AA Iliukhina, AV Kovyrshina, AV Kuzina, VA Gushchin, AE Siniavin, AA Pochtovyi, EV Shidlovskaya, NA Kuznetsova, MM Megeryan, … AL Gintsburg</div> <em>Cold Spring Harbor Laboratory</em> (2021-12-21) <a href="https://doi.org/gqbkdk">https://doi.org/gqbkdk</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2021.12.17.21267976">10.1101/2021.12.17.21267976</a></div></div>
+<div class="csl-left-margin">1511. </div><div class="csl-right-inline"><strong>Sputnik Light booster after Sputnik V vaccination induces robust neutralizing antibody response to B.1.1.529 (Omicron) SARS-CoV-2 variant</strong> <div class="csl-block">IV Dolzhikova, AA Iliukhina, AV Kovyrshina, AV Kuzina, VA Gushchin, AE Siniavin, AA Pochtovyi, EV Shidlovskaya, NA Kuznetsova, MM Megeryan, … AL Gintsburg</div> <em>Cold Spring Harbor Laboratory</em> (2021-12-21) <a href="https://doi.org/gqbkdk">https://doi.org/gqbkdk</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2021.12.17.21267976">10.1101/2021.12.17.21267976</a></div></div>
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+<div class="csl-left-margin">1512. </div><div class="csl-right-inline"><strong>Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)</strong> <div class="csl-block">Amy Flaxman, Natalie G Marchevsky, Daniel Jenkin, Jeremy Aboagye, Parvinder K Aley, Brian Angus, Sandra Belij-Rammerstorfer, Sagida Bibi, Mustapha Bittaye, Federica Cappuccini, … Andy Yao</div> <em>The Lancet</em> (2021-09) <a href="https://doi.org/hx9c">https://doi.org/hx9c</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/s0140-6736(21)01699-8">10.1016/s0140-6736(21)01699-8</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34480858">34480858</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8409975">PMC8409975</a></div></div>
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+<div class="csl-left-margin">1513. </div><div class="csl-right-inline"><strong>4th Dose COVID mRNA Vaccines' Immunogenicity &amp; Efficacy Against Omicron VOC</strong> <div class="csl-block">Gili Regev-Yochay, Tal Gonen, Mayan Gilboa, Michal Mandelboim, Victoria Indenbaum, Sharon Amit, Lilac Meltzer, Keren Asraf, Carmit Cohen, Ronen Fluss, … Yaniv Lustig</div> <em>Cold Spring Harbor Laboratory</em> (2022-02-15) <a href="https://doi.org/gpnbfd">https://doi.org/gpnbfd</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2022.02.15.22270948">10.1101/2022.02.15.22270948</a></div></div>
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+<div class="csl-left-margin">1515. </div><div class="csl-right-inline"><strong>Homologous and Heterologous Covid-19 Booster Vaccinations</strong> <div class="csl-block">Robert L Atmar, Kirsten E Lyke, Meagan E Deming, Lisa A Jackson, Angela R Branche, Hana M El Sahly, Christina A Rostad, Judith M Martin, Christine Johnston, Richard E Rupp, … John H Beigel</div> <em>New England Journal of Medicine</em> (2022-03-17) <a href="https://doi.org/gn9v3v">https://doi.org/gn9v3v</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1056/nejmoa2116414">10.1056/nejmoa2116414</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35081293">35081293</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8820244">PMC8820244</a></div></div>
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+<div class="csl-left-margin">1518. </div><div class="csl-right-inline"><strong>Neutralizing Activities Against the Omicron Variant After a Heterologous Booster in Healthy Adults Receiving Two Doses of CoronaVac Vaccination</strong> <div class="csl-block">Suvichada Assawakosri, Sitthichai Kanokudom, Nungruthai Suntronwong, Chompoonut Auphimai, Pornjarim Nilyanimit, Preeyaporn Vichaiwattana, Thanunrat Thongmee, Thaneeya Duangchinda, Warangkana Chantima, Pattarakul Pakchotanon, … Yong Poovorawan</div> <em>The Journal of Infectious Diseases</em> (2022-03-10) <a href="https://doi.org/gqbkdf">https://doi.org/gqbkdf</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1093/infdis/jiac092">10.1093/infdis/jiac092</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35267040">35267040</a></div></div>
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+<div class="csl-left-margin">1519. </div><div class="csl-right-inline"><strong>Effectiveness of Homologous and Heterologous Covid-19 Boosters against Omicron</strong> <div class="csl-block">Emma K Accorsi, Amadea Britton, Nong Shang, Katherine E Fleming-Dutra, Ruth Link-Gelles, Zachary R Smith, Gordana Derado, Joseph Miller, Stephanie J Schrag, Jennifer R Verani</div> <em>New England Journal of Medicine</em> (2022-06-23) <a href="https://doi.org/gp8d5h">https://doi.org/gp8d5h</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1056/nejmc2203165">10.1056/nejmc2203165</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/35613039">35613039</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9165559">PMC9165559</a></div></div>
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+<div class="csl-left-margin">1520. </div><div class="csl-right-inline"><strong>Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial</strong> <div class="csl-block">Alasdair PS Munro, Leila Janani, Victoria Cornelius, Parvinder K Aley, Gavin Babbage, David Baxter, Marcin Bula, Katrina Cathie, Krishna Chatterjee, Kate Dodd, … Kim Appleby</div> <em>The Lancet</em> (2021-12) <a href="https://doi.org/gnpjxm">https://doi.org/gnpjxm</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/s0140-6736(21)02717-3">10.1016/s0140-6736(21)02717-3</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/34863358">34863358</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8639161">PMC8639161</a></div></div>
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-<div class="csl-left-margin">1463. </div><div class="csl-right-inline"><strong>Moderna Announces Omicron-Containing Bivalent Booster Candidate mRNA-1273.214 Demonstrates Superior Antibody Response Against Omicron</strong> <a href="https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx">https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-Omicron-Containing-Bivalent-Booster-Candidate-mRNA-1273.214-Demonstrates-Superior-Antibody-Response-Against-Omicron/default.aspx</a></div>
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+<div class="csl-left-margin">1566. </div><div class="csl-right-inline"><strong>The first registered COVID-19 vaccine</strong> <a href="https://sputnikvaccine.com/">https://sputnikvaccine.com/</a></div>
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+<div class="csl-left-margin">1587. </div><div class="csl-right-inline"><strong>WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19</strong> <a href="https://www.who.int/news/item/12-03-2021-who-adds-janssen-vaccine-to-list-of-safe-and-effective-emergency-tools-against-covid-19">https://www.who.int/news/item/12-03-2021-who-adds-janssen-vaccine-to-list-of-safe-and-effective-emergency-tools-against-covid-19</a></div>
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+<div class="csl-left-margin">1590. </div><div class="csl-right-inline"><strong>Biden now says US will have enough vaccine for every adult by the end of May</strong> <div class="csl-block">Kevin Liptak CNN Jeff Zeleny and John Harwood</div> <em>CNN</em> <a href="https://www.cnn.com/2021/03/02/politics/biden-merck-johnson--johnson-vaccine/index.html">https://www.cnn.com/2021/03/02/politics/biden-merck-johnson--johnson-vaccine/index.html</a></div>
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+<div class="csl-left-margin">1594. </div><div class="csl-right-inline"><strong>EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2021-02-16) <a href="https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen">https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-vaccine-janssen</a></div>
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+<div class="csl-left-margin">1595. </div><div class="csl-right-inline"><strong>Merck will help make Johnson &amp; Johnson coronavirus vaccine as rivals team up to help Biden accelerate shots</strong> <div class="csl-block">Washington Post</div> <a href="https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership/">https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership/</a></div>
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+<div class="csl-left-margin">1596. </div><div class="csl-right-inline"><strong>The UK has approved a COVID vaccine — here’s what scientists now want to know</strong> <div class="csl-block">Heidi Ledford, David Cyranoski, Richard Van Noorden</div> <em>Nature</em> (2020-12-03) <a href="https://doi.org/gh4xmm">https://doi.org/gh4xmm</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/d41586-020-03441-8">10.1038/d41586-020-03441-8</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33288887">33288887</a></div></div>
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+<div class="csl-left-margin">1597. </div><div class="csl-right-inline"><strong>EMA recommends first COVID-19 vaccine for authorisation in the EU</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2020-12-21) <a href="https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu">https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu</a></div>
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+<div class="csl-left-margin">1598. </div><div class="csl-right-inline"><strong>Regulatory approval of COVID-19 Vaccine AstraZeneca</strong> <div class="csl-block">GOV.UK</div> <a href="https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca">https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca</a></div>
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 <div id="ref-bbw8sMvc" class="csl-entry" role="doc-biblioentry">
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+<div class="csl-left-margin">1599. </div><div class="csl-right-inline"><strong>EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2021-01-29) <a href="https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu">https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu</a></div>
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+<div class="csl-left-margin">1600. </div><div class="csl-right-inline"><strong>Covid: Brian Pinker, 82, first to get Oxford-AstraZeneca vaccine</strong> <div class="csl-block">BBC News</div> (2021-01-04) <a href="https://www.bbc.com/news/uk-55525542">https://www.bbc.com/news/uk-55525542</a></div>
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+<div class="csl-left-margin">1601. </div><div class="csl-right-inline"><strong>Spikevax (previously COVID-19 Vaccine Moderna)</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2021-01-04) <a href="https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax">https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax</a></div>
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 <div id="ref-k9X9pXJe" class="csl-entry" role="doc-biblioentry">
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+<div class="csl-left-margin">1602. </div><div class="csl-right-inline"><strong>Regulatory approval of Spikevax (formerly COVID-19 Vaccine Moderna)</strong> <div class="csl-block">GOV.UK</div> <a href="https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna">https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna</a></div>
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-<div class="csl-left-margin">1546. </div><div class="csl-right-inline"><strong>Coronavirus Pandemic (COVID-19)</strong> <div class="csl-block">Hannah Ritchie, Edouard Mathieu, Lucas Rodés-Guirao, Cameron Appel, Charlie Giattino, Esteban Ortiz-Ospina, Joe Hasell, Bobbie Macdonald, Diana Beltekian, Max Roser</div> <em>Our World in Data</em> (2020-03-05) <a href="https://ourworldindata.org/covid-vaccinations">https://ourworldindata.org/covid-vaccinations</a></div>
+<div class="csl-left-margin">1603. </div><div class="csl-right-inline"><strong>Coronavirus Pandemic (COVID-19)</strong> <div class="csl-block">Hannah Ritchie, Edouard Mathieu, Lucas Rodés-Guirao, Cameron Appel, Charlie Giattino, Esteban Ortiz-Ospina, Joe Hasell, Bobbie Macdonald, Diana Beltekian, Max Roser</div> <em>Our World in Data</em> (2020-03-05) <a href="https://ourworldindata.org/covid-vaccinations">https://ourworldindata.org/covid-vaccinations</a></div>
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-<div class="csl-left-margin">1547. </div><div class="csl-right-inline"><strong>Putin Orders Start of Mass Covid-19 Shots Hours After U.K. News</strong> <div class="csl-block">Ilya Arkhipov, Stepan Kravchenko</div> <em>Bloomberg</em> (2020-12-02) <a href="https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots">https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots</a></div>
+<div class="csl-left-margin">1604. </div><div class="csl-right-inline"><strong>Putin Orders Start of Mass Covid-19 Shots Hours After U.K. News</strong> <div class="csl-block">Ilya Arkhipov, Stepan Kravchenko</div> <em>Bloomberg</em> (2020-12-02) <a href="https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots">https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots</a></div>
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+<div id="ref-Vwv7l7Hd" class="csl-entry" role="doc-biblioentry">
+<div class="csl-left-margin">1605. </div><div class="csl-right-inline"><strong>Facing Record Covid-19 Case Rise, Russia Rolls Out Sputnik V Vaccine</strong> <div class="csl-block">James Rodgers</div> <em>Forbes</em> <a href="https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/">https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/</a></div>
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+<div class="csl-left-margin">1606. </div><div class="csl-right-inline"><strong>Clarification on Sputnik V vaccine in the EU approval process</strong> <div class="csl-block">EMA</div> <em>European Medicines Agency</em> (2021-02-10) <a href="https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process">https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process</a></div>
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-<div class="csl-left-margin">1550. </div><div class="csl-right-inline"><strong>Countries are lining up for Russia's once-scorned Sputnik vaccine after strong efficacy results</strong> <div class="csl-block">Fortune</div> <a href="https://fortune.com/2021/02/08/international-sputnik-russia-demand/">https://fortune.com/2021/02/08/international-sputnik-russia-demand/</a></div>
+<div class="csl-left-margin">1607. </div><div class="csl-right-inline"><strong>Countries are lining up for Russia's once-scorned Sputnik vaccine after strong efficacy results</strong> <div class="csl-block">Fortune</div> <a href="https://fortune.com/2021/02/08/international-sputnik-russia-demand/">https://fortune.com/2021/02/08/international-sputnik-russia-demand/</a></div>
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-<div class="csl-left-margin">1551. </div><div class="csl-right-inline"><strong>RDIF announces delivery of the first batch of Sputnik V vaccine to Venezuela for clinical trials</strong> <a href="https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials/">https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials/</a></div>
+<div class="csl-left-margin">1608. </div><div class="csl-right-inline"><strong>RDIF announces delivery of the first batch of Sputnik V vaccine to Venezuela for clinical trials</strong> <a href="https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials/">https://sputnikvaccine.com/newsroom/pressreleases/rdif-announces-delivery-of-the-first-batch-of-sputnik-v-vaccine-to-venezuela-for-clinical-trials/</a></div>
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-<div class="csl-left-margin">1552. </div><div class="csl-right-inline"><strong>Unable to get U.S. vaccines, world turns to Russia and China</strong> <div class="csl-block">Ryan Heath</div> <em>POLITICO</em> <a href="https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665">https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665</a></div>
+<div class="csl-left-margin">1609. </div><div class="csl-right-inline"><strong>Unable to get U.S. vaccines, world turns to Russia and China</strong> <div class="csl-block">Ryan Heath</div> <em>POLITICO</em> <a href="https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665">https://www.politico.com/news/2021/02/25/global-vaccine-public-relations-war-471665</a></div>
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+<div class="csl-left-margin">1610. </div><div class="csl-right-inline"><strong>Germany moves to bring Russian vaccine into EU orbit</strong> <div class="csl-block">France 24</div> (2021-02-03) <a href="https://www.france24.com/en/live-news/20210203-germany-moves-to-bring-russian-vaccine-into-eu-orbit">https://www.france24.com/en/live-news/20210203-germany-moves-to-bring-russian-vaccine-into-eu-orbit</a></div>
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-<div class="csl-left-margin">1603. </div><div class="csl-right-inline"><strong>Complex Immune Dysregulation in COVID-19 Patients with Severe Respiratory Failure</strong> <div class="csl-block">Evangelos J Giamarellos-Bourboulis, Mihai G Netea, Nikoletta Rovina, Karolina Akinosoglou, Anastasia Antoniadou, Nikolaos Antonakos, Georgia Damoraki, Theologia Gkavogianni, Maria-Evangelia Adami, Paraskevi Katsaounou, … Antonia Koutsoukou</div> <em>Cell Host &amp; Microbe</em> (2020-06) <a href="https://doi.org/ggthxs">https://doi.org/ggthxs</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.chom.2020.04.009">10.1016/j.chom.2020.04.009</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32320677">32320677</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7172841">PMC7172841</a></div></div>
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-<div class="csl-left-margin">1604. </div><div class="csl-right-inline"><strong>Type I and Type III Interferons – Induction, Signaling, Evasion, and Application to Combat COVID-19</strong> <div class="csl-block">Annsea Park, Akiko Iwasaki</div> <em>Cell Host &amp; Microbe</em> (2020-06) <a href="https://doi.org/gg2ccp">https://doi.org/gg2ccp</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.chom.2020.05.008">10.1016/j.chom.2020.05.008</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32464097">32464097</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255347">PMC7255347</a></div></div>
+<div class="csl-left-margin">1611. </div><div class="csl-right-inline"><strong>Russia approves its third COVID-19 vaccine, CoviVac</strong> <div class="csl-block">Reuters</div> (2021-02-20) <a href="https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2AK07H">https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2AK07H</a></div>
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-<div class="csl-left-margin">1605. </div><div class="csl-right-inline"><strong>COVID-19: The Inflammation Link and the Role of Nutrition in Potential Mitigation</strong> <div class="csl-block">Ioannis Zabetakis, Ronan Lordan, Catherine Norton, Alexandros Tsoupras</div> <em>Nutrients</em> (2020-05-19) <a href="https://doi.org/ggxdq3">https://doi.org/ggxdq3</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12051466">10.3390/nu12051466</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32438620">32438620</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284818">PMC7284818</a></div></div>
+<div class="csl-left-margin">1612. </div><div class="csl-right-inline"><strong>COVID-19: The Inflammation Link and the Role of Nutrition in Potential Mitigation</strong> <div class="csl-block">Ioannis Zabetakis, Ronan Lordan, Catherine Norton, Alexandros Tsoupras</div> <em>Nutrients</em> (2020-05-19) <a href="https://doi.org/ggxdq3">https://doi.org/ggxdq3</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12051466">10.3390/nu12051466</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32438620">32438620</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284818">PMC7284818</a></div></div>
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 <div id="ref-UFrQw1gC" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">1606. </div><div class="csl-right-inline"><strong>Could nutrition modulate COVID-19 susceptibility and severity of disease? A systematic review</strong> <div class="csl-block">Philip T James, Zakari Ali, Andrew E Armitage, Ana Bonell, Carla Cerami, Hal Drakesmith, Modou Jobe, Kerry S Jones, Zara Liew, Sophie E Moore, … Andrew M Prentice</div> <em>Cold Spring Harbor Laboratory</em> (2020-10-21) <a href="https://doi.org/ghr94g">https://doi.org/ghr94g</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.10.19.20214395">10.1101/2020.10.19.20214395</a></div></div>
+<div class="csl-left-margin">1613. </div><div class="csl-right-inline"><strong>Could nutrition modulate COVID-19 susceptibility and severity of disease? A systematic review</strong> <div class="csl-block">Philip T James, Zakari Ali, Andrew E Armitage, Ana Bonell, Carla Cerami, Hal Drakesmith, Modou Jobe, Kerry S Jones, Zara Liew, Sophie E Moore, … Andrew M Prentice</div> <em>Cold Spring Harbor Laboratory</em> (2020-10-21) <a href="https://doi.org/ghr94g">https://doi.org/ghr94g</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.10.19.20214395">10.1101/2020.10.19.20214395</a></div></div>
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 <div id="ref-Hd5V5Usd" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">1607. </div><div class="csl-right-inline"><strong>Coronavirus Disease 2019 (COVID-19) and Nutritional Status: The Missing Link?</strong> <div class="csl-block">Renata Silverio, Daniela Caetano Gonçalves, Márcia Fábia Andrade, Marilia Seelaender</div> <em>Advances in Nutrition</em> (2020-09-25) <a href="https://doi.org/ghhqjd">https://doi.org/ghhqjd</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1093/advances/nmaa125">10.1093/advances/nmaa125</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32975565">32975565</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543263">PMC7543263</a></div></div>
+<div class="csl-left-margin">1614. </div><div class="csl-right-inline"><strong>Coronavirus Disease 2019 (COVID-19) and Nutritional Status: The Missing Link?</strong> <div class="csl-block">Renata Silverio, Daniela Caetano Gonçalves, Márcia Fábia Andrade, Marilia Seelaender</div> <em>Advances in Nutrition</em> (2020-09-25) <a href="https://doi.org/ghhqjd">https://doi.org/ghhqjd</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1093/advances/nmaa125">10.1093/advances/nmaa125</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32975565">32975565</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543263">PMC7543263</a></div></div>
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-<div class="csl-left-margin">1608. </div><div class="csl-right-inline"><strong>Nutritional status of patients with COVID-19</strong> <div class="csl-block">Jae Hyoung Im, Young Soo Je, Jihyeon Baek, Moon-Hyun Chung, Hea Yoon Kwon, Jin-Soo Lee</div> <em>International Journal of Infectious Diseases</em> (2020-11) <a href="https://doi.org/gg7t5t">https://doi.org/gg7t5t</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.ijid.2020.08.018">10.1016/j.ijid.2020.08.018</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32795605">32795605</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418699">PMC7418699</a></div></div>
+<div class="csl-left-margin">1615. </div><div class="csl-right-inline"><strong>Nutritional status of patients with COVID-19</strong> <div class="csl-block">Jae Hyoung Im, Young Soo Je, Jihyeon Baek, Moon-Hyun Chung, Hea Yoon Kwon, Jin-Soo Lee</div> <em>International Journal of Infectious Diseases</em> (2020-11) <a href="https://doi.org/gg7t5t">https://doi.org/gg7t5t</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.ijid.2020.08.018">10.1016/j.ijid.2020.08.018</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32795605">32795605</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7418699">PMC7418699</a></div></div>
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-<div class="csl-left-margin">1609. </div><div class="csl-right-inline"><strong>Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect against Viral Infections</strong> <div class="csl-block">Philip Calder, Anitra Carr, Adrian Gombart, Manfred Eggersdorfer</div> <em>Nutrients</em> (2020-04-23) <a href="https://doi.org/gg29hh">https://doi.org/gg29hh</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12041181">10.3390/nu12041181</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32340216">32340216</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7230749">PMC7230749</a></div></div>
+<div class="csl-left-margin">1616. </div><div class="csl-right-inline"><strong>Optimal Nutritional Status for a Well-Functioning Immune System Is an Important Factor to Protect against Viral Infections</strong> <div class="csl-block">Philip Calder, Anitra Carr, Adrian Gombart, Manfred Eggersdorfer</div> <em>Nutrients</em> (2020-04-23) <a href="https://doi.org/gg29hh">https://doi.org/gg29hh</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12041181">10.3390/nu12041181</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32340216">32340216</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7230749">PMC7230749</a></div></div>
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 <div id="ref-A225e05z" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">1610. </div><div class="csl-right-inline"><strong>Peak dietary supplement sales leveling off during COVID-19 pandemic, but growth still remains strong over last year, market researchers report during webcast</strong> <div class="csl-block">Nutritional Outlook</div> <a href="https://www.nutritionaloutlook.com/view/peak-dietary-supplement-sales-leveling-during-covid-19-pandemic-growth-still-remains-strong">https://www.nutritionaloutlook.com/view/peak-dietary-supplement-sales-leveling-during-covid-19-pandemic-growth-still-remains-strong</a></div>
+<div class="csl-left-margin">1617. </div><div class="csl-right-inline"><strong>Peak dietary supplement sales leveling off during COVID-19 pandemic, but growth still remains strong over last year, market researchers report during webcast</strong> <div class="csl-block">Nutritional Outlook</div> <a href="https://www.nutritionaloutlook.com/view/peak-dietary-supplement-sales-leveling-during-covid-19-pandemic-growth-still-remains-strong">https://www.nutritionaloutlook.com/view/peak-dietary-supplement-sales-leveling-during-covid-19-pandemic-growth-still-remains-strong</a></div>
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-<div class="csl-left-margin">1611. </div><div class="csl-right-inline"><strong>Dietary Diversity among Chinese Residents during the COVID-19 Outbreak and Its Associated Factors</strong> <div class="csl-block">Ai Zhao, Zhongyu Li, Yalei Ke, Shanshan Huo, Yidi Ma, Yumei Zhang, Jian Zhang, Zhongxia Ren</div> <em>Nutrients</em> (2020-06-06) <a href="https://doi.org/ghc6d9">https://doi.org/ghc6d9</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12061699">10.3390/nu12061699</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32517210">32517210</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352896">PMC7352896</a></div></div>
+<div class="csl-left-margin">1618. </div><div class="csl-right-inline"><strong>Dietary Diversity among Chinese Residents during the COVID-19 Outbreak and Its Associated Factors</strong> <div class="csl-block">Ai Zhao, Zhongyu Li, Yalei Ke, Shanshan Huo, Yidi Ma, Yumei Zhang, Jian Zhang, Zhongxia Ren</div> <em>Nutrients</em> (2020-06-06) <a href="https://doi.org/ghc6d9">https://doi.org/ghc6d9</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12061699">10.3390/nu12061699</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32517210">32517210</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352896">PMC7352896</a></div></div>
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 <div id="ref-puD7Ydak" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">1612. </div><div class="csl-right-inline"><strong>Lockdown impact: Grocery stores bolstered NZ supplements sales as pharmacies slumped</strong> <div class="csl-block">nutraingredients-asia.com</div> <em>nutraingredients-asia.com</em> <a href="https://www.nutraingredients-asia.com/Article/2020/07/06/Lockdown-impact-Grocery-stores-bolstered-NZ-supplements-sales-as-pharmacies-slumped">https://www.nutraingredients-asia.com/Article/2020/07/06/Lockdown-impact-Grocery-stores-bolstered-NZ-supplements-sales-as-pharmacies-slumped</a></div>
+<div class="csl-left-margin">1619. </div><div class="csl-right-inline"><strong>Lockdown impact: Grocery stores bolstered NZ supplements sales as pharmacies slumped</strong> <div class="csl-block">nutraingredients-asia.com</div> <em>nutraingredients-asia.com</em> <a href="https://www.nutraingredients-asia.com/Article/2020/07/06/Lockdown-impact-Grocery-stores-bolstered-NZ-supplements-sales-as-pharmacies-slumped">https://www.nutraingredients-asia.com/Article/2020/07/06/Lockdown-impact-Grocery-stores-bolstered-NZ-supplements-sales-as-pharmacies-slumped</a></div>
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-<div class="csl-left-margin">1613. </div><div class="csl-right-inline"><strong>COVID-19 temporarily bolsters European interest in supplements</strong><div class="csl-block">.nutritioninsight.com/</div> <a href="https://ni.cnsmedia.com/a/EHHJsDOG2oc=">https://ni.cnsmedia.com/a/EHHJsDOG2oc=</a></div>
+<div class="csl-left-margin">1620. </div><div class="csl-right-inline"><strong>COVID-19 temporarily bolsters European interest in supplements</strong><div class="csl-block">.nutritioninsight.com/</div> <a href="https://ni.cnsmedia.com/a/EHHJsDOG2oc=">https://ni.cnsmedia.com/a/EHHJsDOG2oc=</a></div>
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 <div id="ref-5NJabJny" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">1614. </div><div class="csl-right-inline"><strong>India’s immune health surge: Nation leads APAC in number of new product launches – new data</strong> <div class="csl-block">nutraingredients.com</div> <em>nutraingredients.com</em> <a href="https://www.nutraingredients.com/Article/2020/07/21/India-s-immune-health-surge-Nation-leads-APAC-in-number-of-new-product-launches-new-data">https://www.nutraingredients.com/Article/2020/07/21/India-s-immune-health-surge-Nation-leads-APAC-in-number-of-new-product-launches-new-data</a></div>
+<div class="csl-left-margin">1621. </div><div class="csl-right-inline"><strong>India’s immune health surge: Nation leads APAC in number of new product launches – new data</strong> <div class="csl-block">nutraingredients.com</div> <em>nutraingredients.com</em> <a href="https://www.nutraingredients.com/Article/2020/07/21/India-s-immune-health-surge-Nation-leads-APAC-in-number-of-new-product-launches-new-data">https://www.nutraingredients.com/Article/2020/07/21/India-s-immune-health-surge-Nation-leads-APAC-in-number-of-new-product-launches-new-data</a></div>
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-<div class="csl-left-margin">1615. </div><div class="csl-right-inline"><strong>Food policy, nutrition and nutraceuticals in the prevention and management of COVID-19: Advice for healthcare professionals</strong> <div class="csl-block">Yasemin Ipek Ayseli, Nazli Aytekin, Derya Buyukkayhan, Ismail Aslan, Mehmet Turan Ayseli</div> <em>Trends in Food Science &amp; Technology</em> (2020-11) <a href="https://doi.org/ghjtcp">https://doi.org/ghjtcp</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.tifs.2020.09.001">10.1016/j.tifs.2020.09.001</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33519086">33519086</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834257">PMC7834257</a></div></div>
+<div class="csl-left-margin">1622. </div><div class="csl-right-inline"><strong>Food policy, nutrition and nutraceuticals in the prevention and management of COVID-19: Advice for healthcare professionals</strong> <div class="csl-block">Yasemin Ipek Ayseli, Nazli Aytekin, Derya Buyukkayhan, Ismail Aslan, Mehmet Turan Ayseli</div> <em>Trends in Food Science &amp; Technology</em> (2020-11) <a href="https://doi.org/ghjtcp">https://doi.org/ghjtcp</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.tifs.2020.09.001">10.1016/j.tifs.2020.09.001</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33519086">33519086</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834257">PMC7834257</a></div></div>
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-<div class="csl-left-margin">1616. </div><div class="csl-right-inline"><strong>5 Food and Beverage Trends in Europe During COVID-19</strong> <a href="https://kerry.com/insights/kerrydigest/2020/5-food-and-beverage-trends-in-europe-during-covid-19">https://kerry.com/insights/kerrydigest/2020/5-food-and-beverage-trends-in-europe-during-covid-19</a></div>
+<div class="csl-left-margin">1623. </div><div class="csl-right-inline"><strong>5 Food and Beverage Trends in Europe During COVID-19</strong> <a href="https://kerry.com/insights/kerrydigest/2020/5-food-and-beverage-trends-in-europe-during-covid-19">https://kerry.com/insights/kerrydigest/2020/5-food-and-beverage-trends-in-europe-during-covid-19</a></div>
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-<div class="csl-left-margin">1617. </div><div class="csl-right-inline"><strong>Structural Design Principles for Delivery of Bioactive Components in Nutraceuticals and Functional Foods</strong> <div class="csl-block">David Julian McClements, Eric Andrew Decker, Yeonhwa Park, Jochen Weiss</div> <em>Critical Reviews in Food Science and Nutrition</em> (2009-06-16) <a href="https://doi.org/dt68m4">https://doi.org/dt68m4</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1080/10408390902841529">10.1080/10408390902841529</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/19484636">19484636</a></div></div>
+<div class="csl-left-margin">1624. </div><div class="csl-right-inline"><strong>Structural Design Principles for Delivery of Bioactive Components in Nutraceuticals and Functional Foods</strong> <div class="csl-block">David Julian McClements, Eric Andrew Decker, Yeonhwa Park, Jochen Weiss</div> <em>Critical Reviews in Food Science and Nutrition</em> (2009-06-16) <a href="https://doi.org/dt68m4">https://doi.org/dt68m4</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1080/10408390902841529">10.1080/10408390902841529</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/19484636">19484636</a></div></div>
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+<div class="csl-left-margin">1625. </div><div class="csl-right-inline"><strong>Nutraceutical therapies for atherosclerosis</strong> <div class="csl-block">Joe WE Moss, Dipak P Ramji</div> <em>Nature Reviews Cardiology</em> (2016-07-07) <a href="https://doi.org/f9g389">https://doi.org/f9g389</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/nrcardio.2016.103">10.1038/nrcardio.2016.103</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/27383080">27383080</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5228762">PMC5228762</a></div></div>
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+<div class="csl-left-margin">1626. </div><div class="csl-right-inline"><strong>Nutraceutical-definition and introduction</strong> <div class="csl-block">Ekta K Kalra</div> <em>AAPS PharmSci</em> (2015-07-10) <a href="https://doi.org/cg5wc9">https://doi.org/cg5wc9</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1208/ps050325">10.1208/ps050325</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/14621960">14621960</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2750935">PMC2750935</a></div></div>
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+<div class="csl-left-margin">1753. </div><div class="csl-right-inline"><strong>Impact of Vitamin D Deficiency on COVID-19—A Prospective Analysis from the CovILD Registry</strong> <div class="csl-block">Alex Pizzini, Magdalena Aichner, Sabina Sahanic, Anna Böhm, Alexander Egger, Gregor Hoermann, Katharina Kurz, Gerlig Widmann, Rosa Bellmann-Weiler, Günter Weiss, … Judith Löffler-Ragg</div> <em>Nutrients</em> (2020-09-11) <a href="https://doi.org/ghr95b">https://doi.org/ghr95b</a> <div class="csl-block">DOI: <a href="https://doi.org/10.3390/nu12092775">10.3390/nu12092775</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32932831">32932831</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551662">PMC7551662</a></div></div>
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-<div class="csl-left-margin">1747. </div><div class="csl-right-inline"><strong>Does Serum Vitamin D Level Affect COVID-19 Infection and Its Severity?-A Case-Control Study</strong> <div class="csl-block">Kun Ye, Fen Tang, Xin Liao, Benjamin A Shaw, Meiqiu Deng, Guangyi Huang, Zhiqiang Qin, Xiaomei Peng, Hewei Xiao, Chunxia Chen, … Jianrong Yang</div> <em>Journal of the American College of Nutrition</em> (2020-10-13) <a href="https://doi.org/ghr935">https://doi.org/ghr935</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1080/07315724.2020.1826005">10.1080/07315724.2020.1826005</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33048028">33048028</a></div></div>
+<div class="csl-left-margin">1754. </div><div class="csl-right-inline"><strong>Does Serum Vitamin D Level Affect COVID-19 Infection and Its Severity?-A Case-Control Study</strong> <div class="csl-block">Kun Ye, Fen Tang, Xin Liao, Benjamin A Shaw, Meiqiu Deng, Guangyi Huang, Zhiqiang Qin, Xiaomei Peng, Hewei Xiao, Chunxia Chen, … Jianrong Yang</div> <em>Journal of the American College of Nutrition</em> (2020-10-13) <a href="https://doi.org/ghr935">https://doi.org/ghr935</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1080/07315724.2020.1826005">10.1080/07315724.2020.1826005</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33048028">33048028</a></div></div>
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-<div class="csl-left-margin">1748. </div><div class="csl-right-inline"><strong>Lower levels of vitamin D are associated with SARS-CoV-2 infection and mortality in the Indian population: An observational study</strong> <div class="csl-block">Sunali Padhi, Subham Suvankar, Venketesh K Panda, Abhijit Pati, Aditya K Panda</div> <em>International Immunopharmacology</em> (2020-11) <a href="https://doi.org/ghr93w">https://doi.org/ghr93w</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.intimp.2020.107001">10.1016/j.intimp.2020.107001</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33182040">33182040</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489890">PMC7489890</a></div></div>
+<div class="csl-left-margin">1755. </div><div class="csl-right-inline"><strong>Lower levels of vitamin D are associated with SARS-CoV-2 infection and mortality in the Indian population: An observational study</strong> <div class="csl-block">Sunali Padhi, Subham Suvankar, Venketesh K Panda, Abhijit Pati, Aditya K Panda</div> <em>International Immunopharmacology</em> (2020-11) <a href="https://doi.org/ghr93w">https://doi.org/ghr93w</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.intimp.2020.107001">10.1016/j.intimp.2020.107001</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33182040">33182040</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489890">PMC7489890</a></div></div>
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-<div class="csl-left-margin">1749. </div><div class="csl-right-inline"><strong>Vitamin D Deficiency Is Associated with COVID-19 Incidence and Disease Severity in Chinese People</strong> <div class="csl-block">Xia Luo, Qing Liao, Ying Shen, Huijun Li, Liming Cheng</div> <em>The Journal of Nutrition</em> (2021-01) <a href="https://doi.org/ghr939">https://doi.org/ghr939</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1093/jn/nxaa332">10.1093/jn/nxaa332</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33188401">33188401</a></div></div>
+<div class="csl-left-margin">1756. </div><div class="csl-right-inline"><strong>Vitamin D Deficiency Is Associated with COVID-19 Incidence and Disease Severity in Chinese People</strong> <div class="csl-block">Xia Luo, Qing Liao, Ying Shen, Huijun Li, Liming Cheng</div> <em>The Journal of Nutrition</em> (2021-01) <a href="https://doi.org/ghr939">https://doi.org/ghr939</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1093/jn/nxaa332">10.1093/jn/nxaa332</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33188401">33188401</a></div></div>
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-<div class="csl-left-margin">1750. </div><div class="csl-right-inline"><strong>Vitamin D concentrations and COVID-19 infection in UK Biobank</strong> <div class="csl-block">Claire E Hastie, Daniel F Mackay, Frederick Ho, Carlos A Celis-Morales, Srinivasa Vittal Katikireddi, Claire L Niedzwiedz, Bhautesh D Jani, Paul Welsh, Frances S Mair, Stuart R Gray, … Jill P Pell</div> <em>Diabetes &amp; Metabolic Syndrome: Clinical Research &amp; Reviews</em> (2020-07) <a href="https://doi.org/ggvv72">https://doi.org/ggvv72</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.dsx.2020.04.050">10.1016/j.dsx.2020.04.050</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32413819">32413819</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204679">PMC7204679</a></div></div>
+<div class="csl-left-margin">1757. </div><div class="csl-right-inline"><strong>Vitamin D concentrations and COVID-19 infection in UK Biobank</strong> <div class="csl-block">Claire E Hastie, Daniel F Mackay, Frederick Ho, Carlos A Celis-Morales, Srinivasa Vittal Katikireddi, Claire L Niedzwiedz, Bhautesh D Jani, Paul Welsh, Frances S Mair, Stuart R Gray, … Jill P Pell</div> <em>Diabetes &amp; Metabolic Syndrome: Clinical Research &amp; Reviews</em> (2020-07) <a href="https://doi.org/ggvv72">https://doi.org/ggvv72</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.dsx.2020.04.050">10.1016/j.dsx.2020.04.050</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32413819">32413819</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204679">PMC7204679</a></div></div>
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-<div class="csl-left-margin">1751. </div><div class="csl-right-inline"><strong>Vitamin D and COVID-19 infection and mortality in UK Biobank</strong> <div class="csl-block">Claire E Hastie, Jill P Pell, Naveed Sattar</div> <em>European Journal of Nutrition</em> (2020-08-26) <a href="https://doi.org/ghr93p">https://doi.org/ghr93p</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1007/s00394-020-02372-4">10.1007/s00394-020-02372-4</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32851419">32851419</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7449523">PMC7449523</a></div></div>
+<div class="csl-left-margin">1758. </div><div class="csl-right-inline"><strong>Vitamin D and COVID-19 infection and mortality in UK Biobank</strong> <div class="csl-block">Claire E Hastie, Jill P Pell, Naveed Sattar</div> <em>European Journal of Nutrition</em> (2020-08-26) <a href="https://doi.org/ghr93p">https://doi.org/ghr93p</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1007/s00394-020-02372-4">10.1007/s00394-020-02372-4</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32851419">32851419</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7449523">PMC7449523</a></div></div>
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-<div class="csl-left-margin">1752. </div><div class="csl-right-inline"><strong>Low serum 25‐hydroxyvitamin D (25[OH]D) levels in patients hospitalized with COVID‐19 are associated with greater disease severity</strong> <div class="csl-block">Grigorios Panagiotou, Su Ann Tee, Yasir Ihsan, Waseem Athar, Gabriella Marchitelli, Donna Kelly, Christopher S Boot, Nadia Stock, James Macfarlane, Adrian R Martineau, … Richard Quinton</div> <em>Clinical Endocrinology</em> (2020-08-06) <a href="https://doi.org/gg5gbj">https://doi.org/gg5gbj</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1111/cen.14276">10.1111/cen.14276</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32621392">32621392</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7361912">PMC7361912</a></div></div>
+<div class="csl-left-margin">1759. </div><div class="csl-right-inline"><strong>Low serum 25‐hydroxyvitamin D (25[OH]D) levels in patients hospitalized with COVID‐19 are associated with greater disease severity</strong> <div class="csl-block">Grigorios Panagiotou, Su Ann Tee, Yasir Ihsan, Waseem Athar, Gabriella Marchitelli, Donna Kelly, Christopher S Boot, Nadia Stock, James Macfarlane, Adrian R Martineau, … Richard Quinton</div> <em>Clinical Endocrinology</em> (2020-08-06) <a href="https://doi.org/gg5gbj">https://doi.org/gg5gbj</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1111/cen.14276">10.1111/cen.14276</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32621392">32621392</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7361912">PMC7361912</a></div></div>
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-<div class="csl-left-margin">1753. </div><div class="csl-right-inline"><strong>Letter in response to the article: Vitamin D concentrations and COVID-19 infection in UK biobank (Hastie et al.)</strong> <div class="csl-block">WB Grant, SL McDonnell</div> <em>Diabetes &amp; Metabolic Syndrome: Clinical Research &amp; Reviews</em> (2020-09) <a href="https://doi.org/ghc7p4">https://doi.org/ghc7p4</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.dsx.2020.05.046">10.1016/j.dsx.2020.05.046</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32563941">32563941</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7293469">PMC7293469</a></div></div>
+<div class="csl-left-margin">1760. </div><div class="csl-right-inline"><strong>Letter in response to the article: Vitamin D concentrations and COVID-19 infection in UK biobank (Hastie et al.)</strong> <div class="csl-block">WB Grant, SL McDonnell</div> <em>Diabetes &amp; Metabolic Syndrome: Clinical Research &amp; Reviews</em> (2020-09) <a href="https://doi.org/ghc7p4">https://doi.org/ghc7p4</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.dsx.2020.05.046">10.1016/j.dsx.2020.05.046</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32563941">32563941</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7293469">PMC7293469</a></div></div>
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-<div class="csl-left-margin">1754. </div><div class="csl-right-inline"><strong>Vitamin D deficiency in African Americans is associated with a high risk of severe disease and mortality by SARS-CoV-2</strong> <div class="csl-block">Virna Margarita Martín Giménez, Felipe Inserra, León Ferder, Joxel García, Walter Manucha</div> <em>Journal of Human Hypertension</em> (2020-08-13) <a href="https://doi.org/ghr933">https://doi.org/ghr933</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41371-020-00398-z">10.1038/s41371-020-00398-z</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32792611">32792611</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425793">PMC7425793</a></div></div>
+<div class="csl-left-margin">1761. </div><div class="csl-right-inline"><strong>Vitamin D deficiency in African Americans is associated with a high risk of severe disease and mortality by SARS-CoV-2</strong> <div class="csl-block">Virna Margarita Martín Giménez, Felipe Inserra, León Ferder, Joxel García, Walter Manucha</div> <em>Journal of Human Hypertension</em> (2020-08-13) <a href="https://doi.org/ghr933">https://doi.org/ghr933</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1038/s41371-020-00398-z">10.1038/s41371-020-00398-z</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32792611">32792611</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7425793">PMC7425793</a></div></div>
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-<div class="csl-left-margin">1755. </div><div class="csl-right-inline"><strong>Evidence for possible association of vitamin D status with cytokine storm and unregulated inflammation in COVID-19 patients</strong> <div class="csl-block">Ali Daneshkhah, Vasundhara Agrawal, Adam Eshein, Hariharan Subramanian, Hemant Kumar Roy, Vadim Backman</div> <em>Aging Clinical and Experimental Research</em> (2020-09-02) <a href="https://doi.org/ghr93q">https://doi.org/ghr93q</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1007/s40520-020-01677-y">10.1007/s40520-020-01677-y</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32876941">32876941</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7465887">PMC7465887</a></div></div>
+<div class="csl-left-margin">1762. </div><div class="csl-right-inline"><strong>Evidence for possible association of vitamin D status with cytokine storm and unregulated inflammation in COVID-19 patients</strong> <div class="csl-block">Ali Daneshkhah, Vasundhara Agrawal, Adam Eshein, Hariharan Subramanian, Hemant Kumar Roy, Vadim Backman</div> <em>Aging Clinical and Experimental Research</em> (2020-09-02) <a href="https://doi.org/ghr93q">https://doi.org/ghr93q</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1007/s40520-020-01677-y">10.1007/s40520-020-01677-y</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32876941">32876941</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7465887">PMC7465887</a></div></div>
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-<div class="csl-left-margin">1756. </div><div class="csl-right-inline"><strong>Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)</strong> <div class="csl-block">Ashu Rastogi, Anil Bhansali, Niranjan Khare, Vikas Suri, Narayana Yaddanapudi, Naresh Sachdeva, GD Puri, Pankaj Malhotra</div> <em>Postgraduate Medical Journal</em> (2020-11-12) <a href="https://doi.org/ghnhpq">https://doi.org/ghnhpq</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/postgradmedj-2020-139065">10.1136/postgradmedj-2020-139065</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33184146">33184146</a></div></div>
+<div class="csl-left-margin">1763. </div><div class="csl-right-inline"><strong>Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study)</strong> <div class="csl-block">Ashu Rastogi, Anil Bhansali, Niranjan Khare, Vikas Suri, Narayana Yaddanapudi, Naresh Sachdeva, GD Puri, Pankaj Malhotra</div> <em>Postgraduate Medical Journal</em> (2020-11-12) <a href="https://doi.org/ghnhpq">https://doi.org/ghnhpq</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1136/postgradmedj-2020-139065">10.1136/postgradmedj-2020-139065</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/33184146">33184146</a></div></div>
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-<div class="csl-left-margin">1757. </div><div class="csl-right-inline"><strong>“Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”</strong> <div class="csl-block">Marta Entrenas Castillo, Luis Manuel Entrenas Costa, José Manuel Vaquero Barrios, Juan Francisco Alcalá Díaz, José López Miranda, Roger Bouillon, José Manuel Quesada Gomez</div> <em>The Journal of Steroid Biochemistry and Molecular Biology</em> (2020-10) <a href="https://doi.org/ghd79r">https://doi.org/ghd79r</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.jsbmb.2020.105751">10.1016/j.jsbmb.2020.105751</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32871238">32871238</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456194">PMC7456194</a></div></div>
+<div class="csl-left-margin">1764. </div><div class="csl-right-inline"><strong>“Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study”</strong> <div class="csl-block">Marta Entrenas Castillo, Luis Manuel Entrenas Costa, José Manuel Vaquero Barrios, Juan Francisco Alcalá Díaz, José López Miranda, Roger Bouillon, José Manuel Quesada Gomez</div> <em>The Journal of Steroid Biochemistry and Molecular Biology</em> (2020-10) <a href="https://doi.org/ghd79r">https://doi.org/ghd79r</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1016/j.jsbmb.2020.105751">10.1016/j.jsbmb.2020.105751</a> · PMID: <a href="https://www.ncbi.nlm.nih.gov/pubmed/32871238">32871238</a> · PMCID: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456194">PMC7456194</a></div></div>
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-<div class="csl-left-margin">1759. </div><div class="csl-right-inline"><strong>Mathematical analysis of Córdoba calcifediol trial suggests strong role for Vitamin D in reducing ICU admissions of hospitalized COVID-19 patients</strong> <div class="csl-block">Irwin Jungreis, Manolis Kellis</div> <em>Cold Spring Harbor Laboratory</em> (2020-12-21) <a href="https://doi.org/ghr94h">https://doi.org/ghr94h</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.11.08.20222638">10.1101/2020.11.08.20222638</a></div></div>
+<div class="csl-left-margin">1766. </div><div class="csl-right-inline"><strong>Mathematical analysis of Córdoba calcifediol trial suggests strong role for Vitamin D in reducing ICU admissions of hospitalized COVID-19 patients</strong> <div class="csl-block">Irwin Jungreis, Manolis Kellis</div> <em>Cold Spring Harbor Laboratory</em> (2020-12-21) <a href="https://doi.org/ghr94h">https://doi.org/ghr94h</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.11.08.20222638">10.1101/2020.11.08.20222638</a></div></div>
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+<div class="csl-left-margin">2033. </div><div class="csl-right-inline"><strong>Epidemiological and Clinical Characteristics of 17 Hospitalized Patients with 2019 Novel Coronavirus Infections Outside Wuhan, China</strong> <div class="csl-block">Jie Li, Shilin Li, Yurui Cai, Qin Liu, Xue Li, Zhaoping Zeng, Yanpeng Chu, Fangcheng Zhu, Fanxin Zeng</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-12) <a href="https://doi.org/ggq63c">https://doi.org/ggq63c</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.11.20022053">10.1101/2020.02.11.20022053</a></div></div>
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+<div class="csl-left-margin">2034. </div><div class="csl-right-inline"><strong>ACE2 Expression in Kidney and Testis May Cause Kidney and Testis Damage After 2019-nCoV Infection</strong> <div class="csl-block">Caibin Fan, Kai Li, Yanhong Ding, Wei Lu, Jianqing Wang</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-13) <a href="https://doi.org/ggq63d">https://doi.org/ggq63d</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.12.20022418">10.1101/2020.02.12.20022418</a></div></div>
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+<div class="csl-left-margin">2035. </div><div class="csl-right-inline"><strong>Aberrant pathogenic GM-CSF &lt;sup&gt;+&lt;/sup&gt; T cells and inflammatory CD14 &lt;sup&gt;+&lt;/sup&gt; CD16 &lt;sup&gt;+&lt;/sup&gt; monocytes in severe pulmonary syndrome patients of a new coronavirus</strong> <div class="csl-block">Yonggang Zhou, Binqing Fu, Xiaohu Zheng, Dongsheng Wang, Changcheng Zhao, Yingjie qi, Rui Sun, Zhigang Tian, Xiaoling Xu, Haiming Wei</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-20) <a href="https://doi.org/ggq63f">https://doi.org/ggq63f</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.12.945576">10.1101/2020.02.12.945576</a></div></div>
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+<div class="csl-left-margin">2036. </div><div class="csl-right-inline"><strong>Clinical Characteristics of 2019 Novel Infected Coronavirus Pneumonia: A Systemic Review and Meta-analysis</strong> <div class="csl-block">Kai Qian, Yi Deng, Yong-Hang Tai, Jun Peng, Hao Peng, Li-Hong Jiang</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-17) <a href="https://doi.org/ggrgbq">https://doi.org/ggrgbq</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.14.20021535">10.1101/2020.02.14.20021535</a></div></div>
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+<div class="csl-left-margin">2037. </div><div class="csl-right-inline"><strong>Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients</strong> <div class="csl-block">Jing Liu, Sumeng Li, Jia Liu, Boyun Liang, Xiaobei Wang, Hua Wang, Wei Li, Qiaoxia Tong, Jianhua Yi, Lei Zhao, … Xin Zheng</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-22) <a href="https://doi.org/ggq63g">https://doi.org/ggq63g</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.16.20023671">10.1101/2020.02.16.20023671</a></div></div>
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+<div class="csl-left-margin">2038. </div><div class="csl-right-inline"><strong>Clinical and immunologic features in severe and moderate forms of Coronavirus Disease 2019</strong> <div class="csl-block">Guang Chen, Di Wu, Wei Guo, Yong Cao, Da Huang, Hongwu Wang, Tao Wang, Xiaoyun Zhang, Huilong Chen, Haijing Yu, … Qin Ning</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-19) <a href="https://doi.org/ggq63h">https://doi.org/ggq63h</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.16.20023903">10.1101/2020.02.16.20023903</a></div></div>
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+<div class="csl-left-margin">2039. </div><div class="csl-right-inline"><strong>Protection of Rhesus Macaque from SARS-Coronavirus challenge by recombinant adenovirus vaccine</strong> <div class="csl-block">Yiyou Chen, Qiang Wei, Ruobing Li, Hong Gao, Hua Zhu, Wei Deng, Linlin Bao, Wei Tong, Zhe Cong, Hong Jiang, Chuan Qin</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-21) <a href="https://doi.org/ggq63k">https://doi.org/ggq63k</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.17.951939">10.1101/2020.02.17.951939</a></div></div>
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+<div class="csl-left-margin">2040. </div><div class="csl-right-inline"><strong>Reduction and Functional Exhaustion of T Cells in Patients with Coronavirus Disease 2019 (COVID-19)</strong> <div class="csl-block">Bo Diao, Chenhui Wang, Yingjun Tan, Xiewan Chen, Ying Liu, Lifen Ning, Li Chen, Min Li, Yueping Liu, Gang Wang, … Yongwen Chen</div> <em>Cold Spring Harbor Laboratory</em> (2020-02-20) <a href="https://doi.org/ggq63m">https://doi.org/ggq63m</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.02.18.20024364">10.1101/2020.02.18.20024364</a></div></div>
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-<div class="csl-left-margin">2131. </div><div class="csl-right-inline"><strong>Non-neuronal expression of SARS-CoV-2 entry genes in the olfactory system suggests mechanisms underlying COVID-19-associated anosmia</strong> <div class="csl-block">David H Brann, Tatsuya Tsukahara, Caleb Weinreb, Marcela Lipovsek, Koen Van den Berge, Boying Gong, Rebecca Chance, Iain C Macaulay, Hsin-jung Chou, Russell Fletcher, … Sandeep Robert Datta</div> <em>Cold Spring Harbor Laboratory</em> (2020-05-18) <a href="https://doi.org/ggqr4m">https://doi.org/ggqr4m</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.03.25.009084">10.1101/2020.03.25.009084</a></div></div>
+<div class="csl-left-margin">2138. </div><div class="csl-right-inline"><strong>Non-neuronal expression of SARS-CoV-2 entry genes in the olfactory system suggests mechanisms underlying COVID-19-associated anosmia</strong> <div class="csl-block">David H Brann, Tatsuya Tsukahara, Caleb Weinreb, Marcela Lipovsek, Koen Van den Berge, Boying Gong, Rebecca Chance, Iain C Macaulay, Hsin-jung Chou, Russell Fletcher, … Sandeep Robert Datta</div> <em>Cold Spring Harbor Laboratory</em> (2020-05-18) <a href="https://doi.org/ggqr4m">https://doi.org/ggqr4m</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.03.25.009084">10.1101/2020.03.25.009084</a></div></div>
 </div>
 <div id="ref-t4vofknR" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">2132. </div><div class="csl-right-inline"><strong>Cigarette smoke exposure and inflammatory signaling increase the expression of the SARS-CoV-2 receptor ACE2 in the respiratory tract</strong> <div class="csl-block">Joan C Smith, Erin L Sausville, Vishruth Girish, Monet Lou Yuan, Kristen M John, Jason M Sheltzer</div> <em>Cold Spring Harbor Laboratory</em> (2020-04-26) <a href="https://doi.org/ggq65x">https://doi.org/ggq65x</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.03.28.013672">10.1101/2020.03.28.013672</a></div></div>
+<div class="csl-left-margin">2139. </div><div class="csl-right-inline"><strong>Cigarette smoke exposure and inflammatory signaling increase the expression of the SARS-CoV-2 receptor ACE2 in the respiratory tract</strong> <div class="csl-block">Joan C Smith, Erin L Sausville, Vishruth Girish, Monet Lou Yuan, Kristen M John, Jason M Sheltzer</div> <em>Cold Spring Harbor Laboratory</em> (2020-04-26) <a href="https://doi.org/ggq65x">https://doi.org/ggq65x</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.03.28.013672">10.1101/2020.03.28.013672</a></div></div>
 </div>
 <div id="ref-k1E3DuFN" class="csl-entry" role="doc-biblioentry">
-<div class="csl-left-margin">2133. </div><div class="csl-right-inline"><strong>The comparative superiority of IgM-IgG antibody test to real-time reverse transcriptase PCR detection for SARS-CoV-2 infection diagnosis</strong> <div class="csl-block">Rui Liu, Xinghui Liu, Huan Han, Muhammad Adnan Shereen, Zhili Niu, Dong Li, Fang Liu, Kailang Wu, Zhen Luo, Chengliang Zhu</div> <em>Cold Spring Harbor Laboratory</em> (2020-03-30) <a href="https://doi.org/ggqtp5">https://doi.org/ggqtp5</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.03.28.20045765">10.1101/2020.03.28.20045765</a></div></div>
+<div class="csl-left-margin">2140. </div><div class="csl-right-inline"><strong>The comparative superiority of IgM-IgG antibody test to real-time reverse transcriptase PCR detection for SARS-CoV-2 infection diagnosis</strong> <div class="csl-block">Rui Liu, Xinghui Liu, Huan Han, Muhammad Adnan Shereen, Zhili Niu, Dong Li, Fang Liu, Kailang Wu, Zhen Luo, Chengliang Zhu</div> <em>Cold Spring Harbor Laboratory</em> (2020-03-30) <a href="https://doi.org/ggqtp5">https://doi.org/ggqtp5</a> <div class="csl-block">DOI: <a href="https://doi.org/10.1101/2020.03.28.20045765">10.1101/2020.03.28.20045765</a></div></div>
 </div>
 </div>
 <!-- Define citation tags below -->
@@ -12708,7 +12715,7 @@ <h1 class="page_break_before" data-number="14" id="appendix-a"><span class="head
 <p>This appendix contains reviews produced by the Immunology Institute of the Icahn School of Medicine</p>
 <!-- Appendix source: https://github.com/ismms-himc/covid-19_sinai_reviews/tree/05d387bf10b829dad6bedb4bf313686750b78cc9 -->
 <h2 data-number="14.1" id="potent-binding-of-2019-novel-coronavirus-spike-protein-by-a-sars-coronavirus-specific-human-monoclonal-antibody"><span class="header-section-number">14.1</span> Potent binding of 2019 novel coronavirus spike protein by a SARS coronavirus-specific human monoclonal antibody</h2>
-<p>Tian et al. <em>Emerg Microbes Infect 2020</em> <span class="citation" data-cites="1HLSeqnY8">[<a href="#ref-1HLSeqnY8" role="doc-biblioref">2010</a>]</span></p>
+<p>Tian et al. <em>Emerg Microbes Infect 2020</em> <span class="citation" data-cites="1HLSeqnY8">[<a href="#ref-1HLSeqnY8" role="doc-biblioref">2017</a>]</span></p>
 <h3 data-number="14.1.1" id="keywords-1"><span class="header-section-number">14.1.1</span> Keywords</h3>
 <ul>
 <li>Monoclonal antibody</li>
@@ -12751,7 +12758,7 @@ <h3 data-number="14.1.5" id="credit"><span class="header-section-number">14.1.5<
 at the Immunology Institute of the Icahn School of Medicine, Mount
 Sinai.</em></p>
 <h2 data-number="14.2" id="integrative-bioinformatics-analysis-provides-insight-into-the-molecular-mechanisms-of-2019-ncov"><span class="header-section-number">14.2</span> Integrative Bioinformatics Analysis Provides Insight into the Molecular Mechanisms of 2019-nCoV</h2>
-<p>He et al. <em>medRxiv</em> <span class="citation" data-cites="lOQPScZt">[<a href="#ref-lOQPScZt" role="doc-biblioref">2011</a>]</span></p>
+<p>He et al. <em>medRxiv</em> <span class="citation" data-cites="lOQPScZt">[<a href="#ref-lOQPScZt" role="doc-biblioref">2018</a>]</span></p>
 <h3 data-number="14.2.1" id="keywords-2"><span class="header-section-number">14.2.1</span> Keywords</h3>
 <ul>
 <li>ACE2</li>
@@ -12836,7 +12843,7 @@ <h3 data-number="14.2.3" id="limitations-1"><span class="header-section-number">
 <h3 data-number="14.2.4" id="credit-1"><span class="header-section-number">14.2.4</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.3" id="diarrhea-may-be-underestimated-a-missing-link-in-2019-novel-coronavirus"><span class="header-section-number">14.3</span> Diarrhea may be underestimated: a missing link in 2019 novel coronavirus</h2>
-<p>Liang et al. <em>medRxiv</em> <span class="citation" data-cites="rL9IRhVy">[<a href="#ref-rL9IRhVy" role="doc-biblioref">2012</a>]</span></p>
+<p>Liang et al. <em>medRxiv</em> <span class="citation" data-cites="rL9IRhVy">[<a href="#ref-rL9IRhVy" role="doc-biblioref">2019</a>]</span></p>
 <h3 data-number="14.3.1" id="keywords-3"><span class="header-section-number">14.3.1</span> Keywords</h3>
 <ul>
 <li>SARS-CoV-2</li>
@@ -12891,7 +12898,7 @@ <h3 data-number="14.3.4" id="significance"><span class="header-section-number">1
 <h3 data-number="14.3.5" id="credit-2"><span class="header-section-number">14.3.5</span> Credit</h3>
 <p><em>Summary generated as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.4" id="specific-ace2-expression-in-cholangiocytes-may-cause-liver-damage-after-2019-ncov-infection"><span class="header-section-number">14.4</span> Specific ACE2 Expression in Cholangiocytes May Cause Liver Damage After 2019-nCoV Infection</h2>
-<p>Chai et al. <em>bioRxiv</em> <span class="citation" data-cites="BHQvMYPG">[<a href="#ref-BHQvMYPG" role="doc-biblioref">2013</a>]</span></p>
+<p>Chai et al. <em>bioRxiv</em> <span class="citation" data-cites="BHQvMYPG">[<a href="#ref-BHQvMYPG" role="doc-biblioref">2020</a>]</span></p>
 <h3 data-number="14.4.1" id="keywords-4"><span class="header-section-number">14.4.1</span> Keywords</h3>
 <ul>
 <li>ACE2</li>
@@ -12926,7 +12933,7 @@ <h3 data-number="14.4.5" id="significance-1"><span class="header-section-number"
 patients is more due to inflammatory cytokines than direct infection of
 the liver. Even if cholangiocytes are infectable by SARS-CoV-2 (which
 was demonstrated by human liver ductal organoid study
-(<span class="citation" data-cites="OuDMtCRl">[<a href="#ref-OuDMtCRl" role="doc-biblioref">2014</a>]</span>),
+(<span class="citation" data-cites="OuDMtCRl">[<a href="#ref-OuDMtCRl" role="doc-biblioref">2021</a>]</span>),
 published clinical data show no significant increase in bile duct injury
 related indexes (i.e. alkaline phosphatase, gamma-glutamyl
 transpeptidase and total bilirubin). In sum, it underscores the
@@ -12936,7 +12943,7 @@ <h3 data-number="14.4.5" id="significance-1"><span class="header-section-number"
 <h3 data-number="14.4.6" id="credit-3"><span class="header-section-number">14.4.6</span> Credit</h3>
 <p><em>Summary generated by Chang Moon as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.5" id="ace2-expression-by-colonic-epithelial-cells-is-associated-with-viral-infection-immunity-and-energy-metabolism"><span class="header-section-number">14.5</span> ACE2 expression by colonic epithelial cells is associated with viral infection, immunity and energy metabolism</h2>
-<p>Wang et al. <em>medRxiv</em>. <span class="citation" data-cites="ViWCb8MJ">[<a href="#ref-ViWCb8MJ" role="doc-biblioref">2015</a>]</span></p>
+<p>Wang et al. <em>medRxiv</em>. <span class="citation" data-cites="ViWCb8MJ">[<a href="#ref-ViWCb8MJ" role="doc-biblioref">2022</a>]</span></p>
 <h3 data-number="14.5.1" id="keywords-5"><span class="header-section-number">14.5.1</span> Keywords</h3>
 <ul>
 <li>single cell RNA seq</li>
@@ -12952,7 +12959,7 @@ <h3 data-number="14.5.4" id="significance-2"><span class="header-section-number"
 <h3 data-number="14.5.5" id="credit-4"><span class="header-section-number">14.5.5</span> Credit</h3>
 <p><em>Summary generated as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.6" id="the-pathogenicity-of-2019-novel-coronavirus-in-hace2-transgenic-mice"><span class="header-section-number">14.6</span> The Pathogenicity of 2019 Novel Coronavirus in hACE2 Transgenic Mice</h2>
-<p>Bao et al. <em>bioRxiv</em> <span class="citation" data-cites="MgLBA5m">[<a href="#ref-MgLBA5m" role="doc-biblioref">2016</a>]</span></p>
+<p>Bao et al. <em>bioRxiv</em> <span class="citation" data-cites="MgLBA5m">[<a href="#ref-MgLBA5m" role="doc-biblioref">2023</a>]</span></p>
 <h3 data-number="14.6.1" id="keywords-6"><span class="header-section-number">14.6.1</span> Keywords</h3>
 <ul>
 <li>Covid-19 mouse model</li>
@@ -12988,7 +12995,7 @@ <h3 data-number="14.6.5" id="credit-5"><span class="header-section-number">14.6.
 at the Immunology Institute of the Icahn School of Medicine, Mount
 Sinai.</em></p>
 <h2 data-number="14.7" id="caution-on-kidney-dysfunctions-of-2019-ncov-patients"><span class="header-section-number">14.7</span> Caution on Kidney Dysfunctions of 2019-nCoV Patients</h2>
-<p>Li et al. <em>medRxiv</em>. <span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2017</a>]</span></p>
+<p>Li et al. <em>medRxiv</em>. <span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2024</a>]</span></p>
 <h3 data-number="14.7.1" id="keywords-7"><span class="header-section-number">14.7.1</span> Keywords</h3>
 <p>CoVID-19, 2019-nCoV, SARS-CoV-2, kidney, clinical, creatinine,
 proteinuria, albuminuria, CT</p>
@@ -13018,11 +13025,11 @@ <h3 data-number="14.7.4" id="significance-4"><span class="header-section-number"
 <ul>
 <li><p>Multiple lines of evidence along this study’s finding point to the
 idea that renal impairment/injury is a key risk factor in 2019-nCoV
-patients similar to what has been reported for SARS-CoV<span class="citation" data-cites="DMaiZBE1">[<a href="#ref-DMaiZBE1" role="doc-biblioref">2018</a>]</span>; this
+patients similar to what has been reported for SARS-CoV<span class="citation" data-cites="DMaiZBE1">[<a href="#ref-DMaiZBE1" role="doc-biblioref">2025</a>]</span>; this
 may be one of the major causes of virally-induced damage and
 contribute to multiorgan failure.</p></li>
 <li><p>ACE2 expression in kidney proximal tubule epithelia and bladder
-epithelia <span class="citation" data-cites="16Xj27QYj">[<a href="#ref-16Xj27QYj" role="doc-biblioref">2019</a>]</span> support
+epithelia <span class="citation" data-cites="16Xj27QYj">[<a href="#ref-16Xj27QYj" role="doc-biblioref">2026</a>]</span> support
 these clinical findings.</p></li>
 <li><p>Study argues for closely monitoring kidney function, and applying
 potential interventions including continuous renal replacement
@@ -13032,7 +13039,7 @@ <h3 data-number="14.7.4" id="significance-4"><span class="header-section-number"
 <h3 data-number="14.7.5" id="credit-6"><span class="header-section-number">14.7.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.8" id="profiling-the-immune-vulnerability-landscape-of-the-2019-novel-coronavirus"><span class="header-section-number">14.8</span> Profiling the immune vulnerability landscape of the 2019 Novel Coronavirus</h2>
-<p>Zhu et al. <em>bioRxiv</em> <span class="citation" data-cites="QhE5mVCc">[<a href="#ref-QhE5mVCc" role="doc-biblioref">2020</a>]</span></p>
+<p>Zhu et al. <em>bioRxiv</em> <span class="citation" data-cites="QhE5mVCc">[<a href="#ref-QhE5mVCc" role="doc-biblioref">2027</a>]</span></p>
 <h3 data-number="14.8.1" id="keywords-8"><span class="header-section-number">14.8.1</span> Keywords</h3>
 <ul>
 <li>epitope prediction</li>
@@ -13064,7 +13071,7 @@ <h3 data-number="14.8.4" id="significance-5"><span class="header-section-number"
 <h3 data-number="14.8.5" id="credit-7"><span class="header-section-number">14.8.5</span> Credit</h3>
 <p><em>Summary generated as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.9" id="single-cell-analysis-of-ace2-expression-in-human-kidneys-and-bladders-reveals-a-potential-route-of-2019-ncov-infection"><span class="header-section-number">14.9</span> Single-cell Analysis of ACE2 Expression in Human Kidneys and Bladders Reveals a Potential Route of 2019-nCoV Infection</h2>
-<p>Lin et al. <em>bioRxiv</em> <span class="citation" data-cites="16Xj27QYj">[<a href="#ref-16Xj27QYj" role="doc-biblioref">2019</a>]</span></p>
+<p>Lin et al. <em>bioRxiv</em> <span class="citation" data-cites="16Xj27QYj">[<a href="#ref-16Xj27QYj" role="doc-biblioref">2026</a>]</span></p>
 <h3 data-number="14.9.1" id="keywords-9"><span class="header-section-number">14.9.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -13116,21 +13123,21 @@ <h3 data-number="14.9.4" id="significance-6"><span class="header-section-number"
 contact with viral particles are likely to be highly sensitive to
 viral-induced damage.</p></li>
 <li><p>SARS-CoV and MERS-CoV have been shown to be detected in urine of
-patients and associate with higher mortality <span class="citation" data-cites="DMaiZBE1 iObQU2el">[<a href="#ref-DMaiZBE1" role="doc-biblioref">2018</a>,<a href="#ref-iObQU2el" role="doc-biblioref">2021</a>]</span>, thus worth
+patients and associate with higher mortality <span class="citation" data-cites="DMaiZBE1 iObQU2el">[<a href="#ref-DMaiZBE1" role="doc-biblioref">2025</a>,<a href="#ref-iObQU2el" role="doc-biblioref">2028</a>]</span>, thus worth
 understanding kidney damage and resultant immune response in
 SARS-CoV-2 as well.</p></li>
 <li><p>This study argues for a potential mode of viral infectivity and
 resultant inflammatory responses in these tissue in addition to
 reported infectivity in the lung and digestive system, which is
 supported by clinical data showing acute and early kidney
-complications in 2019-nCoV patients <span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2017</a>]</span>.</p></li>
+complications in 2019-nCoV patients <span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2024</a>]</span>.</p></li>
 <li><p>Clinically, thus very important to track urinary CoVID-19 shedding
 as well as study acute kidney injury-related co-morbidities.</p></li>
 </ul>
 <h3 data-number="14.9.5" id="credit-8"><span class="header-section-number">14.9.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.10" id="neutrophil-to-lymphocyte-ratio-predicts-severe-illness-patients-with-2019-novel-coronavirus-in-the-early-stage"><span class="header-section-number">14.10</span> Neutrophil-to-Lymphocyte Ratio Predicts Severe Illness Patients with 2019 Novel Coronavirus in the Early Stage</h2>
-<p>Liu et al. <em>medRxiv</em> <span class="citation" data-cites="gK5e7Yhl">[<a href="#ref-gK5e7Yhl" role="doc-biblioref">2022</a>]</span></p>
+<p>Liu et al. <em>medRxiv</em> <span class="citation" data-cites="gK5e7Yhl">[<a href="#ref-gK5e7Yhl" role="doc-biblioref">2029</a>]</span></p>
 <h3 data-number="14.10.1" id="keywords-10"><span class="header-section-number">14.10.1</span> Keywords</h3>
 <ul>
 <li>severe disease</li>
@@ -13175,11 +13182,11 @@ <h3 data-number="14.10.3" id="limitations-9"><span class="header-section-number"
 patients). Given the small sample size, the proposed NLR and age cut
 offs might not hold for a slightly different set of patients. For
 example, in a study of &gt;400 patients, ‘non-severe’ and ‘severe’ NLR
-were 3.2 and 5.5, respectively <span class="citation" data-cites="6Y81C4P3">[<a href="#ref-6Y81C4P3" role="doc-biblioref">2023</a>]</span>.</p>
+were 3.2 and 5.5, respectively <span class="citation" data-cites="6Y81C4P3">[<a href="#ref-6Y81C4P3" role="doc-biblioref">2030</a>]</span>.</p>
 <h3 data-number="14.10.4" id="credit-9"><span class="header-section-number">14.10.4</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.11" id="characteristics-of-lymphocyte-subsets-and-cytokines-in-peripheral-blood-of-123-hospitalized-patients-with-2019-novel-coronavirus-pneumonia-ncp"><span class="header-section-number">14.11</span> Characteristics of lymphocyte subsets and cytokines in peripheral blood of 123 hospitalized patients with 2019 novel coronavirus pneumonia (NCP)</h2>
-<p>Wan et. al. <em>medRxiv</em> <span class="citation" data-cites="P4assQHj">[<a href="#ref-P4assQHj" role="doc-biblioref">2024</a>]</span></p>
+<p>Wan et. al. <em>medRxiv</em> <span class="citation" data-cites="P4assQHj">[<a href="#ref-P4assQHj" role="doc-biblioref">2031</a>]</span></p>
 <h3 data-number="14.11.1" id="keywords-11"><span class="header-section-number">14.11.1</span> Keywords</h3>
 <ul>
 <li>Cytokines</li>
@@ -13208,7 +13215,7 @@ <h3 data-number="14.11.3" id="limitations-10"><span class="header-section-number
 individual (Covid-19 Negative) rather used an internal standard value.
 The recently preprint in LANCET shows The degree of lymphopenia and a
 pro-inflammatory cytokine storm is higher in severe COVID-19 patients
-than in mild cases, and is associated with the disease severity <span class="citation" data-cites="zskgSnle">[<a href="#ref-zskgSnle" role="doc-biblioref">2025</a>]</span>.</p>
+than in mild cases, and is associated with the disease severity <span class="citation" data-cites="zskgSnle">[<a href="#ref-zskgSnle" role="doc-biblioref">2032</a>]</span>.</p>
 <h3 data-number="14.11.4" id="significance-7"><span class="header-section-number">14.11.4</span> Significance</h3>
 <p>This translational data identifies key cytokines and lymphopenia
 associated with disease severity although mechanism and key cellular
@@ -13218,7 +13225,7 @@ <h3 data-number="14.11.4" id="significance-7"><span class="header-section-number
 <h3 data-number="14.11.5" id="credit-10"><span class="header-section-number">14.11.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.12" id="epidemiological-and-clinical-characteristics-of-17-hospitalized-patients-with-2019-novel-coronavirus-infections-outside-wuhan-china"><span class="header-section-number">14.12</span> Epidemiological and Clinical Characteristics of 17 Hospitalized Patients with 2019 Novel Coronavirus Infections Outside Wuhan, China</h2>
-<p>Li et al. <em>medRxiv</em> <span class="citation" data-cites="TXlNzmXd">[<a href="#ref-TXlNzmXd" role="doc-biblioref">2026</a>]</span></p>
+<p>Li et al. <em>medRxiv</em> <span class="citation" data-cites="TXlNzmXd">[<a href="#ref-TXlNzmXd" role="doc-biblioref">2033</a>]</span></p>
 <h3 data-number="14.12.1" id="keywords-12"><span class="header-section-number">14.12.1</span> Keywords</h3>
 <ul>
 <li>epidemiology</li>
@@ -13245,7 +13252,7 @@ <h3 data-number="14.12.4" id="significance-8"><span class="header-section-number
 <h3 data-number="14.12.5" id="credit-11"><span class="header-section-number">14.12.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.13" id="ace2-expression-in-kidney-and-testis-may-cause-kidney-and-testis-damage-after-2019-ncov-infection"><span class="header-section-number">14.13</span> ACE2 Expression in Kidney and Testis May Cause Kidney and Testis Damage After 2019-nCoV Infection</h2>
-<p><span class="citation" data-cites="15K5Ovntj">[<a href="#ref-15K5Ovntj" role="doc-biblioref">2027</a>]</span></p>
+<p><span class="citation" data-cites="15K5Ovntj">[<a href="#ref-15K5Ovntj" role="doc-biblioref">2034</a>]</span></p>
 <h3 data-number="14.13.1" id="keywords-13"><span class="header-section-number">14.13.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -13283,10 +13290,10 @@ <h3 data-number="14.13.3" id="limitations-12"><span class="header-section-number
 <h3 data-number="14.13.4" id="significance-9"><span class="header-section-number">14.13.4</span> Significance</h3>
 <ul>
 <li><p>Kidney ACE2 result supports other concurrent sequencing studies
-<span class="citation" data-cites="16Xj27QYj">[<a href="#ref-16Xj27QYj" role="doc-biblioref">2019</a>]</span> and clinical reports
+<span class="citation" data-cites="16Xj27QYj">[<a href="#ref-16Xj27QYj" role="doc-biblioref">2026</a>]</span> and clinical reports
 of abnormal renal function or even kidney damage in patients
 infected with 2019-nCoV
-<span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2017</a>]</span>.</p></li>
+<span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2024</a>]</span>.</p></li>
 <li><p>High ACE2 expression in testis suggests potential tropism of the
 virus to testicular tissues and indicates potential risks for male
 fertility. Viral orchitis reported for SARS-CoV previously [1],
@@ -13296,7 +13303,7 @@ <h3 data-number="14.13.4" id="significance-9"><span class="header-section-number
 <h3 data-number="14.13.5" id="credit-12"><span class="header-section-number">14.13.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.14" id="aberrant-pathogenic-gm-csf-t-cells-and-inflammatory-cd14cd16-monocytes-in-severe-pulmonary-syndrome-patients-of-a-new-coronavirus"><span class="header-section-number">14.14</span> Aberrant pathogenic GM-CSF+ T cells and inflammatory CD14+CD16+ monocytes in severe pulmonary syndrome patients of a new coronavirus</h2>
-<p><span class="citation" data-cites="Bgo7Cmj3">[<a href="#ref-Bgo7Cmj3" role="doc-biblioref">2028</a>]</span></p>
+<p><span class="citation" data-cites="Bgo7Cmj3">[<a href="#ref-Bgo7Cmj3" role="doc-biblioref">2035</a>]</span></p>
 <h3 data-number="14.14.1" id="keywords-14"><span class="header-section-number">14.14.1</span> Keywords</h3>
 <ul>
 <li>immunopathology</li>
@@ -13376,7 +13383,7 @@ <h3 data-number="14.14.5" id="credit-13"><span class="header-section-number">14.
 <p><em>Review by Gabrielle Lubitz as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.15" id="clinical-characteristics-of-2019-novel-infected-coronavirus-pneumoniaa-systemic-review-and-meta-analysis"><span class="header-section-number">14.15</span> Clinical Characteristics of 2019 Novel Infected Coronavirus Pneumonia：A Systemic Review and Meta-analysis</h2>
 <p>Qian et al. <em>medRxiv</em>.
-<span class="citation" data-cites="4Z1pEioX">[<a href="#ref-4Z1pEioX" role="doc-biblioref">2029</a>]</span></p>
+<span class="citation" data-cites="4Z1pEioX">[<a href="#ref-4Z1pEioX" role="doc-biblioref">2036</a>]</span></p>
 <h3 data-number="14.15.1" id="keywords-15"><span class="header-section-number">14.15.1</span> Keywords</h3>
 <ul>
 <li>White Blood Cells</li>
@@ -13416,7 +13423,7 @@ <h3 data-number="14.15.4" id="significance-11"><span class="header-section-numbe
 <h3 data-number="14.15.5" id="credit-14"><span class="header-section-number">14.15.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.16" id="longitudinal-characteristics-of-lymphocyte-responses-and-cytokine-profiles-in-the-peripheral-blood-of-sars-cov-2-infected-patients"><span class="header-section-number">14.16</span> Longitudinal characteristics of lymphocyte responses and cytokine profiles in the peripheral blood of SARS-CoV-2 infected patients</h2>
-<p>Liu et al. <em>medRxiv</em> <span class="citation" data-cites="zTGzuiTI">[<a href="#ref-zTGzuiTI" role="doc-biblioref">2030</a>]</span></p>
+<p>Liu et al. <em>medRxiv</em> <span class="citation" data-cites="zTGzuiTI">[<a href="#ref-zTGzuiTI" role="doc-biblioref">2037</a>]</span></p>
 <h3 data-number="14.16.1" id="keywords-16"><span class="header-section-number">14.16.1</span> Keywords</h3>
 <ul>
 <li>Lymphopenia</li>
@@ -13466,7 +13473,7 @@ <h3 data-number="14.16.4" id="significance-12"><span class="header-section-numbe
 <h3 data-number="14.16.5" id="credit-15"><span class="header-section-number">14.16.5</span> Credit</h3>
 <p><em>Review by Pauline Hamon as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.17" id="clinical-and-immunologic-features-in-severe-and-moderate-forms-of-coronavirus-disease-2019"><span class="header-section-number">14.17</span> Clinical and immunologic features in severe and moderate forms of Coronavirus Disease 2019</h2>
-<p>Chen et al. <em>medRxiv</em> <span class="citation" data-cites="1EIEx8Qe4">[<a href="#ref-1EIEx8Qe4" role="doc-biblioref">2031</a>]</span></p>
+<p>Chen et al. <em>medRxiv</em> <span class="citation" data-cites="1EIEx8Qe4">[<a href="#ref-1EIEx8Qe4" role="doc-biblioref">2038</a>]</span></p>
 <h3 data-number="14.17.1" id="keywords-17"><span class="header-section-number">14.17.1</span> Keywords</h3>
 <ul>
 <li>severe disease</li>
@@ -13574,7 +13581,7 @@ <h3 data-number="14.18.4" id="significance-14"><span class="header-section-numbe
 <h3 data-number="14.18.5" id="credit-17"><span class="header-section-number">14.18.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.19" id="protection-of-rhesus-macaque-from-sars-coronavirus-challenge-by-recombinant-adenovirus-vaccine"><span class="header-section-number">14.19</span> Protection of Rhesus Macaque from SARS-Coronavirus challenge by recombinant adenovirus vaccine</h2>
-<p>Chen et al. <em>bioRxiv</em> <span class="citation" data-cites="NPxs7bbq">[<a href="#ref-NPxs7bbq" role="doc-biblioref">2032</a>]</span></p>
+<p>Chen et al. <em>bioRxiv</em> <span class="citation" data-cites="NPxs7bbq">[<a href="#ref-NPxs7bbq" role="doc-biblioref">2039</a>]</span></p>
 <h3 data-number="14.19.1" id="keywords-19"><span class="header-section-number">14.19.1</span> Keywords</h3>
 <ul>
 <li>SARS-CoV-1</li>
@@ -13613,7 +13620,7 @@ <h3 data-number="14.19.4" id="significance-15"><span class="header-section-numbe
 <h3 data-number="14.19.5" id="credit-18"><span class="header-section-number">14.19.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.20" id="reduction-and-functional-exhaustion-of-t-cells-in-patients-with-coronavirus-disease-2019-covid-19"><span class="header-section-number">14.20</span> Reduction and Functional Exhaustion of T cells in Patients with Coronavirus Disease 2019 (COVID-19)</h2>
-<p><span class="citation" data-cites="f50ahNxF">[<a href="#ref-f50ahNxF" role="doc-biblioref">2033</a>]</span></p>
+<p><span class="citation" data-cites="f50ahNxF">[<a href="#ref-f50ahNxF" role="doc-biblioref">2040</a>]</span></p>
 <h3 data-number="14.20.1" id="keywords-20"><span class="header-section-number">14.20.1</span> Keywords</h3>
 <ul>
 <li>T cell exhaustion</li>
@@ -13662,7 +13669,7 @@ <h3 data-number="14.20.4" id="significance-16"><span class="header-section-numbe
 <h3 data-number="14.20.5" id="credit-19"><span class="header-section-number">14.20.5</span> Credit</h3>
 <p><em>This review by Chang Moon was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.21" id="clinical-characteristics-of-25-death-cases-infected-with-covid-19-pneumonia-a-retrospective-review-of-medical-records-in-a-single-medical-center-wuhan-china"><span class="header-section-number">14.21</span> Clinical Characteristics of 25 death cases infected with COVID-19 pneumonia: a retrospective review of medical records in a single medical center, Wuhan, China</h2>
-<p><span class="citation" data-cites="EwNi3WJq">[<a href="#ref-EwNi3WJq" role="doc-biblioref">2034</a>]</span></p>
+<p><span class="citation" data-cites="EwNi3WJq">[<a href="#ref-EwNi3WJq" role="doc-biblioref">2041</a>]</span></p>
 <h3 data-number="14.21.1" id="keywords-21"><span class="header-section-number">14.21.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -13701,7 +13708,7 @@ <h3 data-number="14.21.4" id="significance-17"><span class="header-section-numbe
 <h3 data-number="14.21.5" id="credit-20"><span class="header-section-number">14.21.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.22" id="sars-cov-2-infection-does-not-significantly-cause-acute-renal-injury-an-analysis-of-116-hospitalized-patients-with-covid-19-in-a-single-hospital-wuhan-china"><span class="header-section-number">14.22</span> SARS-CoV-2 infection does not significantly cause acute renal injury: an analysis of 116 hospitalized patients with COVID-19 in a single hospital, Wuhan, China</h2>
-<p><span class="citation" data-cites="KG5Lg65z">[<a href="#ref-KG5Lg65z" role="doc-biblioref">2035</a>]</span></p>
+<p><span class="citation" data-cites="KG5Lg65z">[<a href="#ref-KG5Lg65z" role="doc-biblioref">2042</a>]</span></p>
 <h3 data-number="14.22.1" id="keywords-22"><span class="header-section-number">14.22.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -13736,7 +13743,7 @@ <h3 data-number="14.22.3" id="limitations-21"><span class="header-section-number
 be useful to correlate how treatment modality influences kidney
 function (and other parameters).</p></li>
 <li><p>Invokes previous clinical-correlation studies that indicate low
-instances of kidney damage<span class="citation" data-cites="VRoblZFJ bgrzawWp">[<a href="#ref-VRoblZFJ" role="doc-biblioref">2036</a>,<a href="#ref-bgrzawWp" role="doc-biblioref">2037</a>]</span>, but those studies did not track
+instances of kidney damage<span class="citation" data-cites="VRoblZFJ bgrzawWp">[<a href="#ref-VRoblZFJ" role="doc-biblioref">2043</a>,<a href="#ref-bgrzawWp" role="doc-biblioref">2044</a>]</span>, but those studies did not track
 longitudinal urine samples for acute renal injury markers and viral
 shedding.</p></li>
 <li><p>CRRT in patients with CRF is standard therapy irrespective of
@@ -13748,7 +13755,7 @@ <h3 data-number="14.22.4" id="significance-18"><span class="header-section-numbe
 <ul>
 <li><p>This study argues that renal impairment is uncommon in CoVID-19 and
 not associated with high mortaility, in stark contrast with a
-concurrent study <span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2017</a>]</span>.
+concurrent study <span class="citation" data-cites="1Acv5UMSt">[<a href="#ref-1Acv5UMSt" role="doc-biblioref">2024</a>]</span>.
 If supported by further studies, this argues kidney impairment is
 secondary to cytokine storm/inflammation-induced organ failure, and
 not due to direct viral replication.</p></li>
@@ -13759,7 +13766,7 @@ <h3 data-number="14.22.4" id="significance-18"><span class="header-section-numbe
 <h3 data-number="14.22.5" id="credit-21"><span class="header-section-number">14.22.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.23" id="potential-t-cell-and-b-cell-epitopes-of-2019-ncov"><span class="header-section-number">14.23</span> Potential T-cell and B-Cell Epitopes of 2019-nCoV</h2>
-<p><span class="citation" data-cites="hdSafq1o">[<a href="#ref-hdSafq1o" role="doc-biblioref">2038</a>]</span></p>
+<p><span class="citation" data-cites="hdSafq1o">[<a href="#ref-hdSafq1o" role="doc-biblioref">2045</a>]</span></p>
 <h3 data-number="14.23.1" id="keywords-23"><span class="header-section-number">14.23.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -13826,7 +13833,7 @@ <h3 data-number="14.23.4" id="significance-19"><span class="header-section-numbe
 <h3 data-number="14.23.5" id="credit-22"><span class="header-section-number">14.23.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.24" id="structure-function-and-antigenicity-of-the-sarscov-2-spike-glycoprotein"><span class="header-section-number">14.24</span> Structure, Function, and Antigenicity of the SARSCoV-2 Spike Glycoprotein</h2>
-<p>Walls et al. <em>bioRxiv</em>. <span class="citation" data-cites="8xnxgpag">[<a href="#ref-8xnxgpag" role="doc-biblioref">2039</a>]</span> now <span class="citation" data-cites="qcVbT0w4">[<a href="#ref-qcVbT0w4" role="doc-biblioref">23</a>]</span></p>
+<p>Walls et al. <em>bioRxiv</em>. <span class="citation" data-cites="8xnxgpag">[<a href="#ref-8xnxgpag" role="doc-biblioref">2046</a>]</span> now <span class="citation" data-cites="qcVbT0w4">[<a href="#ref-qcVbT0w4" role="doc-biblioref">23</a>]</span></p>
 <h3 data-number="14.24.1" id="keywords-24"><span class="header-section-number">14.24.1</span> Keywords</h3>
 <ul>
 <li>binding affinity</li>
@@ -13864,7 +13871,7 @@ <h3 data-number="14.24.4" id="significance-20"><span class="header-section-numbe
 <h3 data-number="14.24.5" id="credit-23"><span class="header-section-number">14.24.5</span> Credit</h3>
 <p><em>Review by postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.25" id="breadth-of-concomitant-immune-responses-underpinning-viral-clearance-and-patient-recovery-in-a-non-severe-case-of-covid-19"><span class="header-section-number">14.25</span> Breadth of concomitant immune responses underpinning viral clearance and patient recovery in a non-severe case of COVID-19</h2>
-<p>Thevarajan et al. <em>medRxiv</em> <span class="citation" data-cites="QdimT8mN">[<a href="#ref-QdimT8mN" role="doc-biblioref">2040</a>]</span></p>
+<p>Thevarajan et al. <em>medRxiv</em> <span class="citation" data-cites="QdimT8mN">[<a href="#ref-QdimT8mN" role="doc-biblioref">2047</a>]</span></p>
 <h3 data-number="14.25.1" id="keywords-25"><span class="header-section-number">14.25.1</span> Keywords</h3>
 <ul>
 <li>IgG</li>
@@ -13897,13 +13904,13 @@ <h3 data-number="14.25.2" id="main-findings-23"><span class="header-section-numb
 <h3 data-number="14.25.3" id="limitations-24"><span class="header-section-number">14.25.3</span> Limitations</h3>
 <p>These results need to be confirmed in additional patients.</p>
 <p>COVID-19 patients have increased infiltration of macrophages in their
-lungs <span class="citation" data-cites="tVkKuIJt">[<a href="#ref-tVkKuIJt" role="doc-biblioref">2041</a>]</span>. Monitoring monocyte proportions in blood earlier in the
+lungs <span class="citation" data-cites="tVkKuIJt">[<a href="#ref-tVkKuIJt" role="doc-biblioref">2048</a>]</span>. Monitoring monocyte proportions in blood earlier in the
 disease might help to evaluate their eventual migration to the lungs.</p>
 <p>The stable concentration of HLA-DR<sup>+</sup> NK cells in blood from day 7 is
 not sufficient to rule out NK cell activation upon SARS-CoV2 infection.
 In response to influenza A virus, NK cells express higher levels of
 activation markers CD69 and CD38, proliferate better and display higher
-cytotoxicity <span class="citation" data-cites="87CJN2CG">[<a href="#ref-87CJN2CG" role="doc-biblioref">2042</a>]</span>. Assessing these parameters in COVID-19 patients is
+cytotoxicity <span class="citation" data-cites="87CJN2CG">[<a href="#ref-87CJN2CG" role="doc-biblioref">2049</a>]</span>. Assessing these parameters in COVID-19 patients is
 required to better understand NK cell role in clearing this infection.</p>
 <p>Neutralization potential of the COVID-19-binding IgG and IgM antibodies
 should be assessed in future studies.</p>
@@ -13915,13 +13922,13 @@ <h3 data-number="14.25.4" id="significance-21"><span class="header-section-numbe
 <p>This study is among the first to describe the appearance of
 COVID-19-binding IgG and IgM antibodies upon infection. The emergence of
 new serological assays might contribute to monitor more precisely the
-seroconversion kinetics of COVID-19 patients <span class="citation" data-cites="yJW1RVQb">[<a href="#ref-yJW1RVQb" role="doc-biblioref">2043</a>]</span>. Further association
+seroconversion kinetics of COVID-19 patients <span class="citation" data-cites="yJW1RVQb">[<a href="#ref-yJW1RVQb" role="doc-biblioref">2050</a>]</span>. Further association
 studies between IFITM3 SNP-rs12252-C/C variant and clinical data might
 help to refine the COVID-19 outcome prediction tools.</p>
 <h3 data-number="14.25.5" id="credit-24"><span class="header-section-number">14.25.5</span> Credit</h3>
 <p><em>Review by Bérengère Salomé as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.26" id="the-landscape-of-lung-bronchoalveolar-immune-cells-in-covid-19-revealed-by-single-cell-rna-sequencing"><span class="header-section-number">14.26</span> The landscape of lung bronchoalveolar immune cells in COVID-19 revealed by single-cell RNA sequencing</h2>
-<p>Liao et al. <em>medRxiv</em> <span class="citation" data-cites="tVkKuIJt">[<a href="#ref-tVkKuIJt" role="doc-biblioref">2041</a>]</span></p>
+<p>Liao et al. <em>medRxiv</em> <span class="citation" data-cites="tVkKuIJt">[<a href="#ref-tVkKuIJt" role="doc-biblioref">2048</a>]</span></p>
 <h3 data-number="14.26.1" id="keywords-26"><span class="header-section-number">14.26.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -13970,10 +13977,10 @@ <h3 data-number="14.26.3" id="limitations-25"><span class="header-section-number
 healthy and diseased lesions.</p>
 <h3 data-number="14.26.4" id="significance-22"><span class="header-section-number">14.26.4</span> Significance</h3>
 <p>COVID-19 induces a robust inflammatory cytokine storm in patients that
-contributes to severe lung tissue damage and ARDS <span class="citation" data-cites="vasHgjGH">[<a href="#ref-vasHgjGH" role="doc-biblioref">2044</a>]</span>. Accumulation of
+contributes to severe lung tissue damage and ARDS <span class="citation" data-cites="vasHgjGH">[<a href="#ref-vasHgjGH" role="doc-biblioref">2051</a>]</span>. Accumulation of
 monocyte-derived inflammatory macrophages at the expense of Alveolar
 macrophages known to play an anti-inflammatory role following
-respiratory viral infection, in part through the PPARγ pathway <span class="citation" data-cites="9GEyqic3 WBN5f37b">[<a href="#ref-9GEyqic3" role="doc-biblioref">2045</a>,<a href="#ref-WBN5f37b" role="doc-biblioref">2046</a>]</span> are
+respiratory viral infection, in part through the PPARγ pathway <span class="citation" data-cites="9GEyqic3 WBN5f37b">[<a href="#ref-9GEyqic3" role="doc-biblioref">2052</a>,<a href="#ref-WBN5f37b" role="doc-biblioref">2053</a>]</span> are
 likely contributing to lung tissue injuries. These data suggest that
 reduction of monocyte accumulation in the lung tissues could help
 modulate COVID-19-induced inflammation. Further analysis of lymphoid
@@ -13982,7 +13989,7 @@ <h3 data-number="14.26.4" id="significance-22"><span class="header-section-numbe
 <h3 data-number="14.26.5" id="credit-25"><span class="header-section-number">14.26.5</span> Credit</h3>
 <p><em>Review by Bérengère Salomé and Assaf Magen as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.27" id="can-routine-laboratory-tests-discriminate-2019-novel-coronavirus-infected-pneumonia-from-other-community-acquired-pneumonia"><span class="header-section-number">14.27</span> Can routine laboratory tests discriminate 2019 novel coronavirus infected pneumonia from other community-acquired pneumonia?</h2>
-<p>Pan et al. <em>medRxiv</em> <span class="citation" data-cites="FOVDaThy">[<a href="#ref-FOVDaThy" role="doc-biblioref">2047</a>]</span></p>
+<p>Pan et al. <em>medRxiv</em> <span class="citation" data-cites="FOVDaThy">[<a href="#ref-FOVDaThy" role="doc-biblioref">2054</a>]</span></p>
 <h3 data-number="14.27.1" id="keywords-27"><span class="header-section-number">14.27.1</span> Keywords</h3>
 <ul>
 <li>Routine laboratory testing</li>
@@ -14017,7 +14024,7 @@ <h3 data-number="14.27.4" id="significance-23"><span class="header-section-numbe
 <h3 data-number="14.27.5" id="credit-26"><span class="header-section-number">14.27.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.28" id="correlation-analysis-between-disease-severity-and-inflammation-related-parameters-in-patients-with-covid-19-pneumonia"><span class="header-section-number">14.28</span> Correlation Analysis Between Disease Severity and Inflammation-related Parameters in Patients with COVID-19 Pneumonia</h2>
-<p><span class="citation" data-cites="1Du40IOOH">[<a href="#ref-1Du40IOOH" role="doc-biblioref">2048</a>]</span></p>
+<p><span class="citation" data-cites="1Du40IOOH">[<a href="#ref-1Du40IOOH" role="doc-biblioref">2055</a>]</span></p>
 <h3 data-number="14.28.1" id="keywords-28"><span class="header-section-number">14.28.1</span> Keywords</h3>
 <ul>
 <li>cytokine</li>
@@ -14068,7 +14075,7 @@ <h3 data-number="14.28.3" id="significance-24"><span class="header-section-numbe
 <h3 data-number="14.28.4" id="credit-27"><span class="header-section-number">14.28.4</span> Credit</h3>
 <p><em>This review by JJF was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.29" id="an-effective-ctl-peptide-vaccine-for-ebola-zaire-based-on-survivors-cd8-targeting-of-a-particular-nucleocapsid-protein-epitope-with-potential-implications-for-covid-19-vaccine-design"><span class="header-section-number">14.29</span> An Effective CTL Peptide Vaccine for Ebola Zaire Based on Survivors’ CD8+ Targeting of a Particular Nucleocapsid Protein Epitope with Potential Implications for COVID-19 Vaccine Design</h2>
-<p>Herst et al. <em>bioRxiv</em> <span class="citation" data-cites="1DTLMIDoM">[<a href="#ref-1DTLMIDoM" role="doc-biblioref">2049</a>]</span></p>
+<p>Herst et al. <em>bioRxiv</em> <span class="citation" data-cites="1DTLMIDoM">[<a href="#ref-1DTLMIDoM" role="doc-biblioref">2056</a>]</span></p>
 <h3 data-number="14.29.1" id="keywords-29"><span class="header-section-number">14.29.1</span> Keywords</h3>
 <ul>
 <li>Peptide vaccine</li>
@@ -14128,7 +14135,7 @@ <h3 data-number="14.29.2" id="main-findings-27"><span class="header-section-numb
 <h3 data-number="14.29.3" id="credit-28"><span class="header-section-number">14.29.3</span> Credit</h3>
 <p><em>Review by Andrew M. Leader as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.30" id="epitope-based-peptide-vaccines-predicted-against-novel-coronavirus-disease-caused-by-sars-cov-2"><span class="header-section-number">14.30</span> Epitope-based peptide vaccines predicted against novel coronavirus disease caused by SARS-CoV-2</h2>
-<p>Li et al. <em>bioRxiv</em>. <span class="citation" data-cites="9spK49tt">[<a href="#ref-9spK49tt" role="doc-biblioref">2050</a>]</span></p>
+<p>Li et al. <em>bioRxiv</em>. <span class="citation" data-cites="9spK49tt">[<a href="#ref-9spK49tt" role="doc-biblioref">2057</a>]</span></p>
 <h3 data-number="14.30.1" id="keywords-30"><span class="header-section-number">14.30.1</span> Keywords</h3>
 <ul>
 <li>SARS-CoV-2</li>
@@ -14181,7 +14188,7 @@ <h3 data-number="14.30.5" id="credit-29"><span class="header-section-number">14.
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.31" id="the-definition-and-risks-of-cytokine-release-syndrome-like-in-11-covid-19-infected-pneumonia-critically-ill-patients-disease-characteristics-and-retrospective-analysis"><span class="header-section-number">14.31</span> The definition and risks of Cytokine Release Syndrome-Like in 11 COVID-19-Infected Pneumonia critically ill patients: Disease Characteristics and Retrospective Analysis</h2>
 <p>Wang Jr. et al. <em>medRxiv</em>.
-<span class="citation" data-cites="qg1bmQng">[<a href="#ref-qg1bmQng" role="doc-biblioref">2051</a>]</span></p>
+<span class="citation" data-cites="qg1bmQng">[<a href="#ref-qg1bmQng" role="doc-biblioref">2058</a>]</span></p>
 <h3 data-number="14.31.1" id="keywords-31"><span class="header-section-number">14.31.1</span> Keywords</h3>
 <ul>
 <li>Cytokine release syndrome (CRS)</li>
@@ -14222,7 +14229,7 @@ <h3 data-number="14.31.4" id="significance-26"><span class="header-section-numbe
 <h3 data-number="14.31.5" id="credit-30"><span class="header-section-number">14.31.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.32" id="clinical-characteristics-of-36-non-survivors-with-covid-19-in-wuhan-china"><span class="header-section-number">14.32</span> Clinical characteristics of 36 non-survivors with COVID-19 in Wuhan, China</h2>
-<p>Huang et al. <em>medRxiv</em>. <span class="citation" data-cites="YODgfrtM">[<a href="#ref-YODgfrtM" role="doc-biblioref">2052</a>]</span></p>
+<p>Huang et al. <em>medRxiv</em>. <span class="citation" data-cites="YODgfrtM">[<a href="#ref-YODgfrtM" role="doc-biblioref">2059</a>]</span></p>
 <h3 data-number="14.32.1" id="keywords-32"><span class="header-section-number">14.32.1</span> Keywords</h3>
 <ul>
 <li>Clinical Characteristics</li>
@@ -14253,7 +14260,7 @@ <h3 data-number="14.32.4" id="significance-27"><span class="header-section-numbe
 <h3 data-number="14.32.5" id="credit-31"><span class="header-section-number">14.32.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.33" id="risk-factors-related-to-hepatic-injury-in-patients-with-corona-virus-disease-2019"><span class="header-section-number">14.33</span> Risk Factors Related to Hepatic Injury in Patients with Corona Virus Disease 2019</h2>
-<p><span class="citation" data-cites="5CGbn9Jj">[<a href="#ref-5CGbn9Jj" role="doc-biblioref">2053</a>]</span></p>
+<p><span class="citation" data-cites="5CGbn9Jj">[<a href="#ref-5CGbn9Jj" role="doc-biblioref">2060</a>]</span></p>
 <h3 data-number="14.33.1" id="keywords-33"><span class="header-section-number">14.33.1</span> Keywords</h3>
 <ul>
 <li>COVID-related Hepatic Injury</li>
@@ -14289,7 +14296,7 @@ <h3 data-number="14.33.4" id="significance-28"><span class="header-section-numbe
 <h3 data-number="14.33.5" id="credit-32"><span class="header-section-number">14.33.5</span> Credit</h3>
 <p><em>Review by Chang Moon as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.34" id="detectable-serum-sars-cov-2-viral-load-rnaaemia-is-closely-associated-with-drastically-elevated-interleukin-6-il-6-level-in-critically-ill-covid-19-patients"><span class="header-section-number">14.34</span> Detectable serum SARS-CoV-2 viral load (RNAaemia) is closely associated with drastically elevated interleukin 6 (IL-6) level in critically ill COVID-19 patients</h2>
-<p><span class="citation" data-cites="T0BDaXkw">[<a href="#ref-T0BDaXkw" role="doc-biblioref">2054</a>]</span></p>
+<p><span class="citation" data-cites="T0BDaXkw">[<a href="#ref-T0BDaXkw" role="doc-biblioref">2061</a>]</span></p>
 <h3 data-number="14.34.1" id="keywords-34"><span class="header-section-number">14.34.1</span> Keywords</h3>
 <ul>
 <li>ARDS</li>
@@ -14327,7 +14334,7 @@ <h3 data-number="14.34.2" id="main-findings-32"><span class="header-section-numb
 marker.</p>
 <h3 data-number="14.34.3" id="limitations-31"><span class="header-section-number">14.34.3</span> Limitations</h3>
 <p>While this group’s report generally confirms some of the major findings
-of a more extensive study, published in early February 2020, <span class="citation" data-cites="vasHgjGH">[<a href="#ref-vasHgjGH" role="doc-biblioref">2044</a>]</span>,
+of a more extensive study, published in early February 2020, <span class="citation" data-cites="vasHgjGH">[<a href="#ref-vasHgjGH" role="doc-biblioref">2051</a>]</span>,
 there are limitations that should be taken into account. First, the
 number of patients enrolled is relatively small; second, interpretation
 of these data would benefit from inclusion of information about study
@@ -14360,11 +14367,11 @@ <h3 data-number="14.34.4" id="significance-29"><span class="header-section-numbe
 (high levels of IL-6, IL-8 and plasma leukotriene were shown to have
 prognostic value at the onset of ARDS ; serum IL-2 and IL-15 have been
 associated with mortality; reviewed by Chen W &amp; Ware L, Clin Transl Med.
-2015 <span class="citation" data-cites="l3CzJ5ni">[<a href="#ref-l3CzJ5ni" role="doc-biblioref">2055</a>]</span>).</p>
+2015 <span class="citation" data-cites="l3CzJ5ni">[<a href="#ref-l3CzJ5ni" role="doc-biblioref">2062</a>]</span>).</p>
 <h3 data-number="14.34.5" id="credit-33"><span class="header-section-number">14.34.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.35" id="lymphopenia-predicts-disease-severity-of-covid-19-a-descriptive-and-predictive-study"><span class="header-section-number">14.35</span> Lymphopenia predicts disease severity of COVID-19: a descriptive and predictive study</h2>
-<p><span class="citation" data-cites="uIwTzZkJ">[<a href="#ref-uIwTzZkJ" role="doc-biblioref">2056</a>]</span></p>
+<p><span class="citation" data-cites="uIwTzZkJ">[<a href="#ref-uIwTzZkJ" role="doc-biblioref">2063</a>]</span></p>
 <h3 data-number="14.35.1" id="keywords-35"><span class="header-section-number">14.35.1</span> Keywords</h3>
 <ul>
 <li>Lymphopenia</li>
@@ -14398,7 +14405,7 @@ <h3 data-number="14.35.4" id="significance-30"><span class="header-section-numbe
 <h3 data-number="14.35.5" id="credit-34"><span class="header-section-number">14.35.5</span> Credit</h3>
 <p><em>Review by Chang Moon as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.36" id="the-potential-role-of-il-6-in-monitoring-severe-case-of-coronavirus-disease-2019"><span class="header-section-number">14.36</span> The potential role of IL-6 in monitoring severe case of coronavirus disease 2019</h2>
-<p>Liu et al. <em>medRxiv</em>. <span class="citation" data-cites="1GMxHWnxN">[<a href="#ref-1GMxHWnxN" role="doc-biblioref">2057</a>]</span></p>
+<p>Liu et al. <em>medRxiv</em>. <span class="citation" data-cites="1GMxHWnxN">[<a href="#ref-1GMxHWnxN" role="doc-biblioref">2064</a>]</span></p>
 <h3 data-number="14.36.1" id="keywords-36"><span class="header-section-number">14.36.1</span> Keywords</h3>
 <ul>
 <li>Cytokine Release Syndrome</li>
@@ -14439,7 +14446,7 @@ <h3 data-number="14.36.4" id="significance-31"><span class="header-section-numbe
 <h3 data-number="14.36.5" id="credit-35"><span class="header-section-number">14.36.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.37" id="clinical-and-laboratory-profiles-of-75-hospitalized-patients-with-novel-coronavirus-disease-2019-in-hefei-china"><span class="header-section-number">14.37</span> Clinical and Laboratory Profiles of 75 Hospitalized Patients with Novel Coronavirus Disease 2019 in Hefei, China</h2>
-<p>Zhao et al. <em>medRxiv</em>. <span class="citation" data-cites="1B0vBwv1q">[<a href="#ref-1B0vBwv1q" role="doc-biblioref">2058</a>]</span></p>
+<p>Zhao et al. <em>medRxiv</em>. <span class="citation" data-cites="1B0vBwv1q">[<a href="#ref-1B0vBwv1q" role="doc-biblioref">2065</a>]</span></p>
 <h3 data-number="14.37.1" id="keywords-37"><span class="header-section-number">14.37.1</span> Keywords</h3>
 <ul>
 <li>Routine laboratory testing</li>
@@ -14475,7 +14482,7 @@ <h3 data-number="14.37.4" id="significance-32"><span class="header-section-numbe
 <h3 data-number="14.37.5" id="credit-36"><span class="header-section-number">14.37.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.38" id="exuberant-elevation-of-ip-10-mcp-3-and-il-1ra-during-sars-cov-2-infection-is-associated-with-disease-severity-and-fatal-outcome"><span class="header-section-number">14.38</span> Exuberant elevation of IP-10, MCP-3 and IL-1ra during SARS-CoV-2 infection is associated with disease severity and fatal outcome</h2>
-<p>Yang et al. <em>medRxiv</em> <span class="citation" data-cites="RyXNw87v">[<a href="#ref-RyXNw87v" role="doc-biblioref">2059</a>]</span></p>
+<p>Yang et al. <em>medRxiv</em> <span class="citation" data-cites="RyXNw87v">[<a href="#ref-RyXNw87v" role="doc-biblioref">2066</a>]</span></p>
 <h3 data-number="14.38.1" id="keywords-38"><span class="header-section-number">14.38.1</span> Keywords</h3>
 <ul>
 <li>cytokine</li>
@@ -14596,7 +14603,7 @@ <h3 data-number="14.38.6" id="significance-33"><span class="header-section-numbe
 <h3 data-number="14.38.7" id="credit-37"><span class="header-section-number">14.38.7</span> Credit</h3>
 <p><em>Review by Natalie Vaninov as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.39" id="antibody-responses-to-sars-cov-2-in-patients-of-novel-coronavirus-disease-2019"><span class="header-section-number">14.39</span> Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019</h2>
-<p>Zhao Jr. et al. <em>medRxiv</em>. <span class="citation" data-cites="5HXuCa5t">[<a href="#ref-5HXuCa5t" role="doc-biblioref">2060</a>]</span></p>
+<p>Zhao Jr. et al. <em>medRxiv</em>. <span class="citation" data-cites="5HXuCa5t">[<a href="#ref-5HXuCa5t" role="doc-biblioref">2067</a>]</span></p>
 <h3 data-number="14.39.1" id="keywords-39"><span class="header-section-number">14.39.1</span> Keywords</h3>
 <ul>
 <li>SARS-CoV-2 IgG</li>
@@ -14663,7 +14670,7 @@ <h3 data-number="14.39.4" id="significance-34"><span class="header-section-numbe
 <h3 data-number="14.39.5" id="credit-38"><span class="header-section-number">14.39.5</span> Credit</h3>
 <p><em>This review was undertaken by Zafar Mahmood and edited by K Alexandropoulos as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.40" id="restoration-of-leukomonocyte-counts-is-associated-with-viral-clearance-in-covid-19-hospitalized-patients"><span class="header-section-number">14.40</span> Restoration of leukomonocyte counts is associated with viral clearance in COVID-19 hospitalized patients</h2>
-<p>Chen et al. <em>medRxiv</em> <span class="citation" data-cites="uCyoHtV3">[<a href="#ref-uCyoHtV3" role="doc-biblioref">2061</a>]</span></p>
+<p>Chen et al. <em>medRxiv</em> <span class="citation" data-cites="uCyoHtV3">[<a href="#ref-uCyoHtV3" role="doc-biblioref">2068</a>]</span></p>
 <h3 data-number="14.40.1" id="keywords-40"><span class="header-section-number">14.40.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -14696,13 +14703,13 @@ <h3 data-number="14.40.3" id="limitations-37"><span class="header-section-number
 <p>73% of the patients who remained positive for SARS-CoV2 after the 1<sup>st</sup>
 treatment, and 43% of all patients who cleared the virus were treated
 with corticosteroids. Corticosteroids have strong effects on the immune
-compartment in blood <span class="citation" data-cites="L6kwccjn">[<a href="#ref-L6kwccjn" role="doc-biblioref">2062</a>]</span>. The authors should have accounted for
+compartment in blood <span class="citation" data-cites="L6kwccjn">[<a href="#ref-L6kwccjn" role="doc-biblioref">2069</a>]</span>. The authors should have accounted for
 corticosteroid treatment when considering changes in T, NK and B cell
 frequencies.</p>
 <p>Assessing if IL-6 concentrations were back to baseline levels following
 treatment would have provided insights into the COVID-19 cytokine storm
 biology. Patients with higher baseline levels of IL-6 have been reported
-to have lower CD8 and CD4 T cell frequencies <span class="citation" data-cites="1B0vBwv1q">[<a href="#ref-1B0vBwv1q" role="doc-biblioref">2058</a>]</span>. Correlating IL-6 with
+to have lower CD8 and CD4 T cell frequencies <span class="citation" data-cites="1B0vBwv1q">[<a href="#ref-1B0vBwv1q" role="doc-biblioref">2065</a>]</span>. Correlating IL-6 with
 cell counts before and after treatment would thus have also been of
 interest. The report of the laboratory measures in table 2 is incomplete
 and should include the frequencies of patients with increased/decreased
@@ -14715,7 +14722,7 @@ <h3 data-number="14.40.3" id="limitations-37"><span class="header-section-number
 <h3 data-number="14.40.4" id="significance-35"><span class="header-section-number">14.40.4</span> Significance</h3>
 <p>Previous reports suggest an association between disease severity and
 elevated IL-6 or pro-calcitonin concentrations in COVID-19
-patients <span class="citation" data-cites="T0BDaXkw K9G9QT8y">[<a href="#ref-T0BDaXkw" role="doc-biblioref">2054</a>,<a href="#ref-K9G9QT8y" role="doc-biblioref">2063</a>]</span>. IL-6 receptor blockade is also being administered to
+patients <span class="citation" data-cites="T0BDaXkw K9G9QT8y">[<a href="#ref-T0BDaXkw" role="doc-biblioref">2061</a>,<a href="#ref-K9G9QT8y" role="doc-biblioref">2070</a>]</span>. IL-6 receptor blockade is also being administered to
 patients enrolled in clinical trials (NCT04317092). This report thus
 contributes to highlight elevated concentrations of these analytes in
 COVID-19 patients. Mechanisms underlying the association between viral
@@ -14725,7 +14732,7 @@ <h3 data-number="14.40.4" id="significance-35"><span class="header-section-numbe
 <h3 data-number="14.40.5" id="credit-39"><span class="header-section-number">14.40.5</span> Credit</h3>
 <p><em>Review by Bérengère Salomé as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.41" id="clinical-findings-in-critically-ill-patients-infected-with-sars-cov-2-in-guangdong-province-china-a-multi-center-retrospective-observational-study"><span class="header-section-number">14.41</span> Clinical findings in critically ill patients infected with SARS-CoV-2 in Guangdong Province, China: a multi-center, retrospective, observational study
</h2>
-<p>Xu et al. <em>medRxiv</em>. <span class="citation" data-cites="USOnp7c0">[<a href="#ref-USOnp7c0" role="doc-biblioref">2064</a>]</span></p>
+<p>Xu et al. <em>medRxiv</em>. <span class="citation" data-cites="USOnp7c0">[<a href="#ref-USOnp7c0" role="doc-biblioref">2071</a>]</span></p>
 <h3 data-number="14.41.1" id="keywords-41"><span class="header-section-number">14.41.1</span> Keywords</h3>
 <ul>
 <li>clinical outcomes</li>
@@ -14770,7 +14777,7 @@ <h3 data-number="14.41.4" id="significance-36"><span class="header-section-numbe
 <h3 data-number="14.41.5" id="credit-40"><span class="header-section-number">14.41.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.42" id="immune-multi-epitope-vaccine-design-using-an-immunoinformatics-approach-for-2019-novel-coronavirus-in-china-sars-cov-2"><span class="header-section-number">14.42</span> Immune Multi-epitope vaccine design using an immunoinformatics approach for 2019 novel coronavirus in China (SARS-CoV-2)</h2>
-<p><span class="citation" data-cites="14OLQIYK0">[<a href="#ref-14OLQIYK0" role="doc-biblioref">2065</a>]</span></p>
+<p><span class="citation" data-cites="14OLQIYK0">[<a href="#ref-14OLQIYK0" role="doc-biblioref">2072</a>]</span></p>
 <h3 data-number="14.42.1" id="keywords-42"><span class="header-section-number">14.42.1</span> Keywords</h3>
 <ul>
 <li>Vaccine</li>
@@ -14806,7 +14813,7 @@ <h3 data-number="14.42.3" id="limitations-39"><span class="header-section-number
 <h3 data-number="14.42.4" id="credit-41"><span class="header-section-number">14.42.4</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.43" id="clinical-features-of-patients-infected-with-the-2019-novel-coronavirus-covid-19-in-shanghai-china"><span class="header-section-number">14.43</span> Clinical Features of Patients Infected with the 2019 Novel Coronavirus (COVID-19) in Shanghai, China</h2>
-<p>Cao et al. <em>medRxiv</em> <span class="citation" data-cites="12ilBRq6I">[<a href="#ref-12ilBRq6I" role="doc-biblioref">2066</a>]</span></p>
+<p>Cao et al. <em>medRxiv</em> <span class="citation" data-cites="12ilBRq6I">[<a href="#ref-12ilBRq6I" role="doc-biblioref">2073</a>]</span></p>
 <h3 data-number="14.43.1" id="keywords-43"><span class="header-section-number">14.43.1</span> Keywords</h3>
 <ul>
 <li>Disease severity</li>
@@ -14847,7 +14854,7 @@ <h3 data-number="14.43.5" id="credit-42"><span class="header-section-number">14.
 faculty at the Immunology Institute of the Icahn School of Medicine at
 Mount Sinai.</em></p>
 <h2 data-number="14.44" id="serological-detection-of-2019-ncov-respond-to-the-epidemic-a-useful-complement-to-nucleic-acid-testing"><span class="header-section-number">14.44</span> Serological detection of 2019-nCoV respond to the epidemic: A useful complement to nucleic acid testing</h2>
-<p>Zhang et al. <em>medRxiv</em>. <span class="citation" data-cites="IPJURDxi">[<a href="#ref-IPJURDxi" role="doc-biblioref">2067</a>]</span></p>
+<p>Zhang et al. <em>medRxiv</em>. <span class="citation" data-cites="IPJURDxi">[<a href="#ref-IPJURDxi" role="doc-biblioref">2074</a>]</span></p>
 <h3 data-number="14.44.1" id="keywords-44"><span class="header-section-number">14.44.1</span> Keywords</h3>
 <ul>
 <li>Immunoassay</li>
@@ -14879,7 +14886,7 @@ <h3 data-number="14.44.4" id="significance-38"><span class="header-section-numbe
 <h3 data-number="14.44.5" id="credit-43"><span class="header-section-number">14.44.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.45" id="human-kidney-is-a-target-for-novel-severe-acute-respiratory-syndrome-coronavirus-2-sars-cov-2-infection"><span class="header-section-number">14.45</span> Human Kidney is a Target for Novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection</h2>
-<p><span class="citation" data-cites="H0nvocJz">[<a href="#ref-H0nvocJz" role="doc-biblioref">2068</a>]</span></p>
+<p><span class="citation" data-cites="H0nvocJz">[<a href="#ref-H0nvocJz" role="doc-biblioref">2075</a>]</span></p>
 <h3 data-number="14.45.1" id="keywords-45"><span class="header-section-number">14.45.1</span> Keywords</h3>
 <ul>
 <li>Kidney/Renal Failure</li>
@@ -14912,7 +14919,7 @@ <h3 data-number="14.45.4" id="significance-39"><span class="header-section-numbe
 <h3 data-number="14.45.5" id="credit-44"><span class="header-section-number">14.45.5</span> Credit</h3>
 <p><em>Review by Dan Fu Ruan, Evan Cody and Venu Pothula as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine at Mount Sinai.</em></p>
 <h2 data-number="14.46" id="covid-19-early-warning-score-a-multi-parameter-screening-tool-to-identify-highly-suspected-patients"><span class="header-section-number">14.46</span> COVID-19 early warning score: a multi-parameter screening tool to identify highly suspected patients</h2>
-<p>Song et al. <em>medRxiv</em>. <span class="citation" data-cites="KHNnjP7M">[<a href="#ref-KHNnjP7M" role="doc-biblioref">2069</a>]</span></p>
+<p>Song et al. <em>medRxiv</em>. <span class="citation" data-cites="KHNnjP7M">[<a href="#ref-KHNnjP7M" role="doc-biblioref">2076</a>]</span></p>
 <h3 data-number="14.46.1" id="keywords-46"><span class="header-section-number">14.46.1</span> Keywords</h3>
 <ul>
 <li>retrospective</li>
@@ -14951,7 +14958,7 @@ <h3 data-number="14.46.4" id="significance-40"><span class="header-section-numbe
 <h3 data-number="14.46.5" id="credit-45"><span class="header-section-number">14.46.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.47" id="ly6e-impairs-coronavirus-fusion-and-confers-immune-control-of-viral-disease"><span class="header-section-number">14.47</span> LY6E impairs coronavirus fusion and confers immune control of viral disease</h2>
-<p>Pfaender et al. <em>bioRxiv</em>. <span class="citation" data-cites="19xwRoatu">[<a href="#ref-19xwRoatu" role="doc-biblioref">2070</a>]</span></p>
+<p>Pfaender et al. <em>bioRxiv</em>. <span class="citation" data-cites="19xwRoatu">[<a href="#ref-19xwRoatu" role="doc-biblioref">2077</a>]</span></p>
 <h3 data-number="14.47.1" id="keywords-47"><span class="header-section-number">14.47.1</span> Keywords</h3>
 <ul>
 <li>interferon-stimulated genes</li>
@@ -15059,7 +15066,7 @@ <h3 data-number="14.47.4" id="significance-41"><span class="header-section-numbe
 <h3 data-number="14.47.5" id="credit-46"><span class="header-section-number">14.47.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.48" id="a-preliminary-study-on-serological-assay-for-severe-acute-respiratory-syndrome-coronavirus-2-sars-cov-2-in-238-admitted-hospital-patients"><span class="header-section-number">14.48</span> A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients</h2>
-<p>Liu et al. <em>medRxiv</em>. <span class="citation" data-cites="574aSa8C">[<a href="#ref-574aSa8C" role="doc-biblioref">2071</a>]</span></p>
+<p>Liu et al. <em>medRxiv</em>. <span class="citation" data-cites="574aSa8C">[<a href="#ref-574aSa8C" role="doc-biblioref">2078</a>]</span></p>
 <h3 data-number="14.48.1" id="keywords-48"><span class="header-section-number">14.48.1</span> Keywords</h3>
 <ul>
 <li>diagnosis</li>
@@ -15093,7 +15100,7 @@ <h3 data-number="14.48.4" id="significance-42"><span class="header-section-numbe
 <h3 data-number="14.48.5" id="credit-47"><span class="header-section-number">14.48.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.49" id="monoclonal-antibodies-for-the-s2-subunit-of-spike-of-sars-cov-cross-react-with-the-newly-emerged-sars-cov-2"><span class="header-section-number">14.49</span> Monoclonal antibodies for the S2 subunit of spike of SARS-CoV cross-react with the newly-emerged SARS-CoV-2</h2>
-<p><span class="citation" data-cites="NT3T9a8H">[<a href="#ref-NT3T9a8H" role="doc-biblioref">2072</a>]</span></p>
+<p><span class="citation" data-cites="NT3T9a8H">[<a href="#ref-NT3T9a8H" role="doc-biblioref">2079</a>]</span></p>
 <h3 data-number="14.49.1" id="keywords-49"><span class="header-section-number">14.49.1</span> Keywords</h3>
 <ul>
 <li>Coronavirus Disease 2019 (COVID-19)</li>
@@ -15132,7 +15139,7 @@ <h3 data-number="14.49.4" id="significance-43"><span class="header-section-numbe
 <h3 data-number="14.49.5" id="credit-48"><span class="header-section-number">14.49.5</span> Credit</h3>
 <p><em>This review was undertaken by Tamar Plitt and Katherine Lindblad as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.50" id="mortality-of-covid-19-is-associated-with-cellular-immune-function-compared-to-immune-function-in-chinese-han-population"><span class="header-section-number">14.50</span> Mortality of COVID-19 is Associated with Cellular Immune Function Compared to Immune Function in Chinese Han Population</h2>
-<p>Zeng et al. <em>medRxiv</em>. <span class="citation" data-cites="1GEbBtBgh">[<a href="#ref-1GEbBtBgh" role="doc-biblioref">2073</a>]</span></p>
+<p>Zeng et al. <em>medRxiv</em>. <span class="citation" data-cites="1GEbBtBgh">[<a href="#ref-1GEbBtBgh" role="doc-biblioref">2080</a>]</span></p>
 <h3 data-number="14.50.1" id="keywords-50"><span class="header-section-number">14.50.1</span> Keywords</h3>
 <ul>
 <li>WBC</li>
@@ -15169,7 +15176,7 @@ <h3 data-number="14.50.4" id="significance-44"><span class="header-section-numbe
 <h3 data-number="14.50.5" id="credit-49"><span class="header-section-number">14.50.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.51" id="retrospective-analysis-of-clinical-features-in-101-death-cases-with-covid-19"><span class="header-section-number">14.51</span> Retrospective Analysis of Clinical Features in 101 Death Cases with COVID-19</h2>
-<p>Chen et al. <em>medRxiv</em>. <span class="citation" data-cites="WuHcOc9T">[<a href="#ref-WuHcOc9T" role="doc-biblioref">2074</a>]</span></p>
+<p>Chen et al. <em>medRxiv</em>. <span class="citation" data-cites="WuHcOc9T">[<a href="#ref-WuHcOc9T" role="doc-biblioref">2081</a>]</span></p>
 <h3 data-number="14.51.1" id="keywords-51"><span class="header-section-number">14.51.1</span> Keywords</h3>
 <ul>
 <li>death biomarkers</li>
@@ -15270,7 +15277,7 @@ <h3 data-number="14.52.4" id="significance-46"><span class="header-section-numbe
 <h3 data-number="14.52.5" id="credit-51"><span class="header-section-number">14.52.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.53" id="the-inhaled-corticosteroid-ciclesonide-blocks-coronavirus-rna-replication-by-targeting-viral-nsp15"><span class="header-section-number">14.53</span> The inhaled corticosteroid ciclesonide blocks coronavirus RNA replication by targeting viral NSP15</h2>
-<p>Matsuyama et al. <em>bioRxiv</em> <span class="citation" data-cites="JwL9G6bd">[<a href="#ref-JwL9G6bd" role="doc-biblioref">2075</a>]</span></p>
+<p>Matsuyama et al. <em>bioRxiv</em> <span class="citation" data-cites="JwL9G6bd">[<a href="#ref-JwL9G6bd" role="doc-biblioref">2082</a>]</span></p>
 <h3 data-number="14.53.1" id="keywords-53"><span class="header-section-number">14.53.1</span> Keywords</h3>
 <ul>
 <li>Corticosteroids</li>
@@ -15415,7 +15422,7 @@ <h3 data-number="14.54.5" id="credit-53"><span class="header-section-number">14.
 and faculty at the Immunology Institute of the Icahn school of medicine,
 Mount Sinai.</em></p>
 <h2 data-number="14.55" id="immune-phenotyping-based-on-neutrophil-to-lymphocyte-ratio-and-igg-predicts-disease-severity-and-outcome-for-patients-with-covid-19"><span class="header-section-number">14.55</span> Immune phenotyping based on neutrophil-to-lymphocyte ratio and IgG predicts disease severity and outcome for patients with COVID-19</h2>
-<p>Zhang et al. <em>medRxiv</em> <span class="citation" data-cites="1CwCTXPqj">[<a href="#ref-1CwCTXPqj" role="doc-biblioref">2076</a>]</span></p>
+<p>Zhang et al. <em>medRxiv</em> <span class="citation" data-cites="1CwCTXPqj">[<a href="#ref-1CwCTXPqj" role="doc-biblioref">2083</a>]</span></p>
 <h3 data-number="14.55.1" id="keywords-55"><span class="header-section-number">14.55.1</span> Keywords</h3>
 <ul>
 <li>Biomarkers</li>
@@ -15460,7 +15467,7 @@ <h3 data-number="14.55.4" id="significance-49"><span class="header-section-numbe
 <h3 data-number="14.55.5" id="credit-54"><span class="header-section-number">14.55.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.56" id="reinfection-could-not-occur-in-sars-2-cov-2-infected-rhesus-macaques"><span class="header-section-number">14.56</span> Reinfection could not occur in SARS-2 CoV-2 infected rhesus macaques</h2>
-<p>Bao et al. <em>bioRxiv</em> <span class="citation" data-cites="3XqFhi8l">[<a href="#ref-3XqFhi8l" role="doc-biblioref">2077</a>]</span></p>
+<p>Bao et al. <em>bioRxiv</em> <span class="citation" data-cites="3XqFhi8l">[<a href="#ref-3XqFhi8l" role="doc-biblioref">2084</a>]</span></p>
 <h3 data-number="14.56.1" id="keywords-56"><span class="header-section-number">14.56.1</span> Keywords</h3>
 <ul>
 <li>SARS-CoV-2</li>
@@ -15512,7 +15519,7 @@ <h3 data-number="14.56.4" id="significance-50"><span class="header-section-numbe
 <h3 data-number="14.56.5" id="credit-55"><span class="header-section-number">14.56.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.57" id="a-highly-conserved-cryptic-epitope-in-the-receptor-binding-domains-of-sars-cov-2-and-sars-cov"><span class="header-section-number">14.57</span> A highly conserved cryptic epitope in the receptor-binding domains of SARS-CoV-2 and SARS-CoV</h2>
-<p><span class="citation" data-cites="6gQxRkWM">[<a href="#ref-6gQxRkWM" role="doc-biblioref">2078</a>]</span></p>
+<p><span class="citation" data-cites="6gQxRkWM">[<a href="#ref-6gQxRkWM" role="doc-biblioref">2085</a>]</span></p>
 <h3 data-number="14.57.1" id="keywords-57"><span class="header-section-number">14.57.1</span> Keywords</h3>
 <ul>
 <li>neutralizing antibody</li>
@@ -15548,7 +15555,7 @@ <h3 data-number="14.57.4" id="significance-51"><span class="header-section-numbe
 <h3 data-number="14.57.5" id="credit-56"><span class="header-section-number">14.57.5</span> Credit</h3>
 <p><em>This review was undertaken by Dan Fu Ruan, Evan Cody and Venu Pothula as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.58" id="highly-accurate-and-sensitive-diagnostic-detection-of-sars-cov-2-by-digital-pcr"><span class="header-section-number">14.58</span> Highly accurate and sensitive diagnostic detection of SARS-CoV-2 by digital PCR</h2>
-<p>Dong et al. <em>medRxiv</em> <span class="citation" data-cites="UYD5T2mp">[<a href="#ref-UYD5T2mp" role="doc-biblioref">2079</a>]</span></p>
+<p>Dong et al. <em>medRxiv</em> <span class="citation" data-cites="UYD5T2mp">[<a href="#ref-UYD5T2mp" role="doc-biblioref">2086</a>]</span></p>
 <h3 data-number="14.58.1" id="keywords-58"><span class="header-section-number">14.58.1</span> Keywords</h3>
 <ul>
 <li>Diagnosis</li>
@@ -15577,7 +15584,7 @@ <h3 data-number="14.58.4" id="significance-52"><span class="header-section-numbe
 <h3 data-number="14.58.5" id="credit-57"><span class="header-section-number">14.58.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.59" id="sars-cov-2-invades-host-cells-via-a-novel-route-cd147-spike-protein"><span class="header-section-number">14.59</span> SARS-CoV-2 invades host cells via a novel route: CD147-spike protein</h2>
-<p>Wang et al. <em>bioRxiv</em> <span class="citation" data-cites="14y8UvAbH">[<a href="#ref-14y8UvAbH" role="doc-biblioref">2080</a>]</span></p>
+<p>Wang et al. <em>bioRxiv</em> <span class="citation" data-cites="14y8UvAbH">[<a href="#ref-14y8UvAbH" role="doc-biblioref">2087</a>]</span></p>
 <h3 data-number="14.59.1" id="keywords-59"><span class="header-section-number">14.59.1</span> Keywords</h3>
 <ul>
 <li>spike protein</li>
@@ -15618,17 +15625,17 @@ <h3 data-number="14.59.4" id="significance-53"><span class="header-section-numbe
 <p>It has been shown in various studies that SARS-CoV-2 binds to the cell
 surface protein ACE2 for cell entry, yet ACE2 is highly expressed in
 heart, kidney, and intestinal cells, raising the concern that blocking
-ACE2 would result in harmful side effects <span class="citation" data-cites="BcOf65BE">[<a href="#ref-BcOf65BE" role="doc-biblioref">2081</a>]</span> CD147 on the other hand
+ACE2 would result in harmful side effects <span class="citation" data-cites="BcOf65BE">[<a href="#ref-BcOf65BE" role="doc-biblioref">2088</a>]</span> CD147 on the other hand
 is highly expressed in various tumor types, inflamed tissues, and
 pathogen infected cells, suggesting that the inhibition of CD147 would
-not result in major side effects <span class="citation" data-cites="34nQJalJ KcThTnsm">[<a href="#ref-34nQJalJ" role="doc-biblioref">2082</a>,<a href="#ref-KcThTnsm" role="doc-biblioref">2083</a>]</span> The research in this paper has
+not result in major side effects <span class="citation" data-cites="34nQJalJ KcThTnsm">[<a href="#ref-34nQJalJ" role="doc-biblioref">2089</a>,<a href="#ref-KcThTnsm" role="doc-biblioref">2090</a>]</span> The research in this paper has
 resulted in an ongoing clinical trail in China to test the safety and
 efficacy of anti-CD147 Meplazumab to treat COVID-19. (ClinicalTrails.gov
 identifier NCT04275245).</p>
 <h3 data-number="14.59.5" id="credit-58"><span class="header-section-number">14.59.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.60" id="blood-single-cell-immune-profiling-reveals-that-interferon-mapk-pathway-mediated-adaptive-immune-response-for-covid-19"><span class="header-section-number">14.60</span> Blood single cell immune profiling reveals that interferon-MAPK pathway mediated adaptive immune response for COVID-19</h2>
-<p>Huang et al. <em>medRxiv</em> <span class="citation" data-cites="18l4l0nLX">[<a href="#ref-18l4l0nLX" role="doc-biblioref">2084</a>]</span></p>
+<p>Huang et al. <em>medRxiv</em> <span class="citation" data-cites="18l4l0nLX">[<a href="#ref-18l4l0nLX" role="doc-biblioref">2091</a>]</span></p>
 <h3 data-number="14.60.1" id="keywords-60"><span class="header-section-number">14.60.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -15696,7 +15703,7 @@ <h3 data-number="14.60.4" id="significance-54"><span class="header-section-numbe
 <h3 data-number="14.60.5" id="credit-59"><span class="header-section-number">14.60.5</span> Credit</h3>
 <p><em>This review was undertaken by Matthew D. Park as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.61" id="cross-reactive-antibody-response-between-sars-cov-2-and-sars-cov-infection."><span class="header-section-number">14.61</span> Cross-reactive antibody response between SARS-CoV-2 and SARS-CoV infection.</h2>
-<p>Lv et al. <em>bioRxiv</em> <span class="citation" data-cites="dM1rOHmH">[<a href="#ref-dM1rOHmH" role="doc-biblioref">2085</a>]</span></p>
+<p>Lv et al. <em>bioRxiv</em> <span class="citation" data-cites="dM1rOHmH">[<a href="#ref-dM1rOHmH" role="doc-biblioref">2092</a>]</span></p>
 <h3 data-number="14.61.1" id="keywords-61"><span class="header-section-number">14.61.1</span> Keywords</h3>
 <p>SARS-CoV-2, SARS-CoV, spike protein, RBD, cross-reactivity,
 cross-neutralization, antibody, human patients, mouse</p>
@@ -15740,7 +15747,7 @@ <h3 data-number="14.61.4" id="significance-55"><span class="header-section-numbe
 <h3 data-number="14.61.5" id="credit-60"><span class="header-section-number">14.61.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.62" id="the-feasibility-of-convalescent-plasma-therapy-in-severe-covid-19-patients-a-pilot-study"><span class="header-section-number">14.62</span> The feasibility of convalescent plasma therapy in severe COVID-19 patients: a pilot study</h2>
-<p>Duan et al. <em>medRxiv</em> <span class="citation" data-cites="UENoLkhz">[<a href="#ref-UENoLkhz" role="doc-biblioref">2086</a>]</span></p>
+<p>Duan et al. <em>medRxiv</em> <span class="citation" data-cites="UENoLkhz">[<a href="#ref-UENoLkhz" role="doc-biblioref">2093</a>]</span></p>
 <h3 data-number="14.62.1" id="keywords-62"><span class="header-section-number">14.62.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -15812,7 +15819,7 @@ <h3 data-number="14.62.4" id="significance-56"><span class="header-section-numbe
 <h3 data-number="14.62.5" id="credit-61"><span class="header-section-number">14.62.5</span> Credit</h3>
 <p><em>Review by Matthew D. Park and revised by Alice O. Kamphorst and Maria A. Curotto de Lafaille as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.63" id="hydroxychloroquine-and-azithromycin-as-a-treatment-of-covid-19-results-of-an-open-label-non-randomized-clinical-trial"><span class="header-section-number">14.63</span> Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open label non-randomized clinical trial</h2>
-<p><span class="citation" data-cites="Xbkby2Jr">[<a href="#ref-Xbkby2Jr" role="doc-biblioref">2087</a>]</span></p>
+<p><span class="citation" data-cites="Xbkby2Jr">[<a href="#ref-Xbkby2Jr" role="doc-biblioref">2094</a>]</span></p>
 <h3 data-number="14.63.1" id="keywords-63"><span class="header-section-number">14.63.1</span> Keywords</h3>
 <ul>
 <li>hydroxychloroquine</li>
@@ -15868,20 +15875,20 @@ <h3 data-number="14.63.3" id="limitations-60"><span class="header-section-number
 <h3 data-number="14.63.4" id="significance-57"><span class="header-section-number">14.63.4</span> Significance</h3>
 <p>Chloroquine is thought to inhibit viral infection,
 including SARS-Cov-2, by increasing pH within endosomes and lysosomes,
-altering the biochemical conditions required for viral fusion <span class="citation" data-cites="IhdcvbzC BIlqPh6M">[<a href="#ref-IhdcvbzC" role="doc-biblioref">796</a>,<a href="#ref-BIlqPh6M" role="doc-biblioref">2088</a>]</span>.
+altering the biochemical conditions required for viral fusion <span class="citation" data-cites="IhdcvbzC BIlqPh6M">[<a href="#ref-IhdcvbzC" role="doc-biblioref">796</a>,<a href="#ref-BIlqPh6M" role="doc-biblioref">2095</a>]</span>.
 However, chloroquine also has immuno-modulatory effects that I think may
 play a role. Chloroquine has been shown to increase CTLA-4 expression at
 the cell surface by decreasing its degradation in the endo-lysosome
 pathway; AP-1 traffics the cytoplasmic tail of CTLA-4 to lysosomes, but
 in conditions of increased pH, the protein machinery required for
-degradation is less functional <span class="citation" data-cites="Q9tXjG1R">[<a href="#ref-Q9tXjG1R" role="doc-biblioref">2089</a>]</span>. As such, more CTLA-4 remains in
+degradation is less functional <span class="citation" data-cites="Q9tXjG1R">[<a href="#ref-Q9tXjG1R" role="doc-biblioref">2096</a>]</span>. As such, more CTLA-4 remains in
 endosomes and is trafficked back to the cell surface. It is possible
 that this may also contribute to patient recovery via reduction of
 cytokine storm, in addition to the direct anti-viral effects of HCQ.</p>
 <h3 data-number="14.63.5" id="credit-62"><span class="header-section-number">14.63.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.64" id="recapitulation-of-sars-cov-2-infection-and-cholangiocyte-damage-with-human-liver-organoids"><span class="header-section-number">14.64</span> Recapitulation of SARS-CoV-2 Infection and Cholangiocyte Damage with Human Liver Organoids</h2>
-<p><span class="citation" data-cites="OuDMtCRl">[<a href="#ref-OuDMtCRl" role="doc-biblioref">2014</a>]</span></p>
+<p><span class="citation" data-cites="OuDMtCRl">[<a href="#ref-OuDMtCRl" role="doc-biblioref">2021</a>]</span></p>
 <h3 data-number="14.64.1" id="keywords-64"><span class="header-section-number">14.64.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -15928,7 +15935,7 @@ <h3 data-number="14.64.4" id="significance-58"><span class="header-section-numbe
 <h3 data-number="14.64.5" id="credit-63"><span class="header-section-number">14.64.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.65" id="the-sequence-of-human-ace2-is-suboptimal-for-binding-the-s-spike-protein-of-sars-coronavirus-2"><span class="header-section-number">14.65</span> The sequence of human ACE2 is suboptimal for binding the S spike protein of SARS coronavirus 2</h2>
-<p><span class="citation" data-cites="3VPi509z">[<a href="#ref-3VPi509z" role="doc-biblioref">2090</a>]</span></p>
+<p><span class="citation" data-cites="3VPi509z">[<a href="#ref-3VPi509z" role="doc-biblioref">2097</a>]</span></p>
 <h3 data-number="14.65.1" id="keywords-65"><span class="header-section-number">14.65.1</span> Keywords</h3>
 <ul>
 <li>Coronavirus Disease 2019 (COVID-19)</li>
@@ -16018,7 +16025,7 @@ <h3 data-number="14.65.5" id="credit-64"><span class="header-section-number">14.
 in this study represent new tools that can be used for further
 applications, including vaccine development.</p>
 <h2 data-number="14.66" id="comparative-pathogenesis-of-covid-19-mers-and-sars-in-a-non-human-primate-model"><span class="header-section-number">14.66</span> COMPARATIVE PATHOGENESIS OF COVID-19, MERS AND SARS IN A NON-HUMAN PRIMATE MODEL</h2>
-<p><span class="citation" data-cites="1EcOLnVXk">[<a href="#ref-1EcOLnVXk" role="doc-biblioref">2091</a>]</span></p>
+<p><span class="citation" data-cites="1EcOLnVXk">[<a href="#ref-1EcOLnVXk" role="doc-biblioref">2098</a>]</span></p>
 <h3 data-number="14.66.1" id="keywords-66"><span class="header-section-number">14.66.1</span> Keywords</h3>
 <ul>
 <li>SARS-CoV2</li>
@@ -16056,14 +16063,14 @@ <h3 data-number="14.66.4" id="significance-60"><span class="header-section-numbe
 Cynomolgus macaques offer an environment in which viral replication can
 happen, albeit in a limited way and without translating into clinically
 relevant symptoms. Other groups are contributing to SARS-CoV2 literature
-using this animal model <span class="citation" data-cites="3XqFhi8l">[<a href="#ref-3XqFhi8l" role="doc-biblioref">2077</a>]</span>, potentially showing protection against
+using this animal model <span class="citation" data-cites="3XqFhi8l">[<a href="#ref-3XqFhi8l" role="doc-biblioref">2084</a>]</span>, potentially showing protection against
 reinfection in cured macaques. Therefore, this platform could be used to
 examine SARS-CoV2 pathophysiology while studies in other animal models
-are also underway <span class="citation" data-cites="NzFgXYvQ MgLBA5m">[<a href="#ref-MgLBA5m" role="doc-biblioref">2016</a>,<a href="#ref-NzFgXYvQ" role="doc-biblioref">2092</a>]</span>.</p>
+are also underway <span class="citation" data-cites="NzFgXYvQ MgLBA5m">[<a href="#ref-MgLBA5m" role="doc-biblioref">2023</a>,<a href="#ref-NzFgXYvQ" role="doc-biblioref">2099</a>]</span>.</p>
 <h3 data-number="14.66.5" id="credit-65"><span class="header-section-number">14.66.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.67" id="investigating-the-impact-of-asymptomatic-carriers-on-covid-19-transmission"><span class="header-section-number">14.67</span> Investigating the Impact of Asymptomatic Carriers on COVID-19 Transmission</h2>
-<p><span class="citation" data-cites="OvFueDLZ">[<a href="#ref-OvFueDLZ" role="doc-biblioref">2093</a>]</span></p>
+<p><span class="citation" data-cites="OvFueDLZ">[<a href="#ref-OvFueDLZ" role="doc-biblioref">2100</a>]</span></p>
 <h3 data-number="14.67.1" id="keywords-67"><span class="header-section-number">14.67.1</span> Keywords</h3>
 <ul>
 <li>Coronavirus Disease 2019 (COVID-19)</li>
@@ -16101,7 +16108,7 @@ <h3 data-number="14.67.4" id="significance-61"><span class="header-section-numbe
 <h3 data-number="14.67.5" id="credit-66"><span class="header-section-number">14.67.5</span> Credit</h3>
 <p><em>This review was undertaken by Tamar Plitt and Katherine Lindblad as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.68" id="antibody-responses-to-sars-cov-2-in-covid-19-patients-the-perspective-application-of-serological-tests-in-clinical-practice"><span class="header-section-number">14.68</span> Antibody responses to SARS-CoV-2 in COVID-19 patients: the perspective application of serological tests in clinical practice</h2>
-<p>Long et al. <em>medRxiv</em> <span class="citation" data-cites="Y9g1sQ1Y">[<a href="#ref-Y9g1sQ1Y" role="doc-biblioref">2094</a>]</span></p>
+<p>Long et al. <em>medRxiv</em> <span class="citation" data-cites="Y9g1sQ1Y">[<a href="#ref-Y9g1sQ1Y" role="doc-biblioref">2101</a>]</span></p>
 <h3 data-number="14.68.1" id="keywords-68"><span class="header-section-number">14.68.1</span> Keywords</h3>
 <ul>
 <li>Serum antibodies</li>
@@ -16150,7 +16157,7 @@ <h3 data-number="14.68.3" id="limitations-65"><span class="header-section-number
 was tested as well as the heat inactivation of serum samples prior to
 testing. It has previously been reported that heat inactivation
 interferes with the level of antibodies to SARS-Cov-2 and their protocol
-may have resulted in diminished quantification of IgM, specifically <span class="citation" data-cites="p1c9Nilh">[<a href="#ref-p1c9Nilh" role="doc-biblioref">2095</a>]</span>.</p>
+may have resulted in diminished quantification of IgM, specifically <span class="citation" data-cites="p1c9Nilh">[<a href="#ref-p1c9Nilh" role="doc-biblioref">2102</a>]</span>.</p>
 <h3 data-number="14.68.4" id="significance-62"><span class="header-section-number">14.68.4</span> Significance</h3>
 <p>Understanding the features of the antibody responses against SARS-CoV is
 useful in the development of a serological test for the diagnosis of
@@ -16165,7 +16172,7 @@ <h3 data-number="14.68.4" id="significance-62"><span class="header-section-numbe
 <h3 data-number="14.68.5" id="credit-67"><span class="header-section-number">14.68.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.69" id="sars-cov-2-specific-antibody-responses-in-covid-19-patients"><span class="header-section-number">14.69</span> SARS-CoV-2 specific antibody responses in COVID-19 patients</h2>
-<p><span class="citation" data-cites="1BLNvgEao">[<a href="#ref-1BLNvgEao" role="doc-biblioref">2096</a>]</span></p>
+<p><span class="citation" data-cites="1BLNvgEao">[<a href="#ref-1BLNvgEao" role="doc-biblioref">2103</a>]</span></p>
 <h3 data-number="14.69.1" id="keywords-69"><span class="header-section-number">14.69.1</span> Keywords</h3>
 <ul>
 <li>immunoassay</li>
@@ -16180,7 +16187,7 @@ <h3 data-number="14.69.3" id="limitations-66"><span class="header-section-number
 <h3 data-number="14.69.4" id="significance-63"><span class="header-section-number">14.69.4</span> Significance</h3>
 <p>Validated serological tests are urgently needed to map the full spread of SARS-CoV-2 in the population and to determine the kinetics of the antibody response to SARS-CoV-2. Furthermore, clinical trials are ongoing using plasma from patients who have recovered from SARS-CoV-2 as a therapeutic option. An assay such as the one described in this study could be used to screen for strong antibody responses in recovered patients. Furthermore, the assay could be used to screen health care workers for antibody responses to SARS-CoV-2 as personal protective equipment continues to dwindle. The challenge going forward will be to standardize and scale-up the various in-house ELISA’s being developed in independent laboratories across the world.</p>
 <h2 data-number="14.70" id="a-brief-review-of-antiviral-drugs-evaluated-in-registered-clinical-trials-for-covid-19"><span class="header-section-number">14.70</span> A brief review of antiviral drugs evaluated in registered clinical trials for COVID-19</h2>
-<p>Belhadi et al. <span class="citation" data-cites="K41YFM2N">[<a href="#ref-K41YFM2N" role="doc-biblioref">2097</a>]</span></p>
+<p>Belhadi et al. <span class="citation" data-cites="K41YFM2N">[<a href="#ref-K41YFM2N" role="doc-biblioref">2104</a>]</span></p>
 <h3 data-number="14.70.1" id="keywords-70"><span class="header-section-number">14.70.1</span> Keywords</h3>
 <ul>
 <li>Clinical trials</li>
@@ -16233,7 +16240,7 @@ <h3 data-number="14.70.4" id="significance-64"><span class="header-section-numbe
 <h3 data-number="14.70.5" id="credit-68"><span class="header-section-number">14.70.5</span> Credit</h3>
 <p><em>This review was undertaken by K Alexandropoulos as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.71" id="ace-2-expression-in-the-small-airway-epithelia-of-smokers-and-copd-patients-implications-for-covid-19"><span class="header-section-number">14.71</span> ACE-2 Expression in the Small Airway Epithelia of Smokers and COPD Patients: Implications for COVID-19</h2>
-<p>Leung et al. <em>medRxiv</em>. <span class="citation" data-cites="eTsOvBVf">[<a href="#ref-eTsOvBVf" role="doc-biblioref">2098</a>]</span></p>
+<p>Leung et al. <em>medRxiv</em>. <span class="citation" data-cites="eTsOvBVf">[<a href="#ref-eTsOvBVf" role="doc-biblioref">2105</a>]</span></p>
 <h3 data-number="14.71.1" id="keywords-71"><span class="header-section-number">14.71.1</span> Keywords</h3>
 <ul>
 <li>chronic obstructive pulmonary disease</li>
@@ -16277,7 +16284,7 @@ <h3 data-number="14.71.4" id="significance-65"><span class="header-section-numbe
 <h3 data-number="14.71.5" id="credit-69"><span class="header-section-number">14.71.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.72" id="dynamic-profile-of-severe-or-critical-covid-19-cases"><span class="header-section-number">14.72</span> Dynamic profile of severe or critical COVID-19 cases</h2>
-<p><span class="citation" data-cites="18KZGwJ0J">[<a href="#ref-18KZGwJ0J" role="doc-biblioref">2099</a>]</span></p>
+<p><span class="citation" data-cites="18KZGwJ0J">[<a href="#ref-18KZGwJ0J" role="doc-biblioref">2106</a>]</span></p>
 <h3 data-number="14.72.1" id="keywords-72"><span class="header-section-number">14.72.1</span> Keywords</h3>
 <ul>
 <li>Coronavirus Disease 2019 (COVID-19)</li>
@@ -16313,7 +16320,7 @@ <h3 data-number="14.72.4" id="significance-66"><span class="header-section-numbe
 <h3 data-number="14.72.5" id="credit-70"><span class="header-section-number">14.72.5</span> Credit</h3>
 <p><em>This review was undertaken by Katherine Lindblad and Tamar Plitt as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.73" id="association-between-clinical-laboratory-and-ct-characteristics-and-rt-pcr-results-in-the-follow-up-of-covid-19-patients"><span class="header-section-number">14.73</span> Association between Clinical, Laboratory and CT Characteristics and RT-PCR Results in the Follow-up of COVID-19 patients</h2>
-<p>Fu et al. <em>medRxiv</em>. <span class="citation" data-cites="1BJXDZ04c">[<a href="#ref-1BJXDZ04c" role="doc-biblioref">2100</a>]</span></p>
+<p>Fu et al. <em>medRxiv</em>. <span class="citation" data-cites="1BJXDZ04c">[<a href="#ref-1BJXDZ04c" role="doc-biblioref">2107</a>]</span></p>
 <h3 data-number="14.73.1" id="keywords-73"><span class="header-section-number">14.73.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -16436,7 +16443,7 @@ <h3 data-number="14.73.6" id="significance-67"><span class="header-section-numbe
 <h3 data-number="14.73.7" id="credit-71"><span class="header-section-number">14.73.7</span> Credit</h3>
 <p><em>This review was undertaken by Natalie Vaninov as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.74" id="an-orally-bioavailable-broad-spectrum-antiviral-inhibits-sars-cov-2-and-multiple-2-endemic-epidemic-and-bat-coronavirus"><span class="header-section-number">14.74</span> An orally bioavailable broad-spectrum antiviral inhibits SARS-CoV-2 and multiple 2 endemic, epidemic and bat coronavirus</h2>
-<p>Sheahan et al. <em>bioRxiv</em>. <span class="citation" data-cites="iMCz5Twj">[<a href="#ref-iMCz5Twj" role="doc-biblioref">2101</a>]</span></p>
+<p>Sheahan et al. <em>bioRxiv</em>. <span class="citation" data-cites="iMCz5Twj">[<a href="#ref-iMCz5Twj" role="doc-biblioref">2108</a>]</span></p>
 <h3 data-number="14.74.1" id="keywords-74"><span class="header-section-number">14.74.1</span> Keywords</h3>
 <ul>
 <li>Treatment</li>
@@ -16488,7 +16495,7 @@ <h3 data-number="14.74.4" id="significance-68"><span class="header-section-numbe
 #### Credit</p>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.75" id="identification-of-antiviral-drug-candidates-against-sars-cov-2-from-fda-approved-drugs"><span class="header-section-number">14.75</span> Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs</h2>
-<p>Sangeun Jeon et al. <span class="citation" data-cites="ZDP9vSpg">[<a href="#ref-ZDP9vSpg" role="doc-biblioref">2102</a>]</span></p>
+<p>Sangeun Jeon et al. <span class="citation" data-cites="ZDP9vSpg">[<a href="#ref-ZDP9vSpg" role="doc-biblioref">2109</a>]</span></p>
 <h3 data-number="14.75.1" id="keywords-75"><span class="header-section-number">14.75.1</span> Keywords</h3>
 <ul>
 <li>COVID-19</li>
@@ -16534,7 +16541,7 @@ <h3 data-number="14.75.3" id="limitations-72"><span class="header-section-number
 <h3 data-number="14.75.4" id="credit-72"><span class="header-section-number">14.75.4</span> Credit</h3>
 <p><em>This review was undertaken by K Alexandropoulos as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.76" id="respiratory-disease-and-virus-shedding-in-rhesus-macaques-inoculated-with-sars-cov-2"><span class="header-section-number">14.76</span> Respiratory disease and virus shedding in rhesus macaques inoculated with SARS-CoV-2</h2>
-<p>Munster et al. <em>bioRxiv</em>. <span class="citation" data-cites="LYFzvlzE">[<a href="#ref-LYFzvlzE" role="doc-biblioref">2103</a>]</span></p>
+<p>Munster et al. <em>bioRxiv</em>. <span class="citation" data-cites="LYFzvlzE">[<a href="#ref-LYFzvlzE" role="doc-biblioref">2110</a>]</span></p>
 <h3 data-number="14.76.1" id="keywords-76"><span class="header-section-number">14.76.1</span> Keywords</h3>
 <p>animal model, pulmonary infiltrates, dynamic
 of antibody response, cytokine</p>
@@ -16576,7 +16583,7 @@ <h3 data-number="14.76.3" id="limitations-73"><span class="header-section-number
 <h3 data-number="14.76.4" id="significance-69"><span class="header-section-number">14.76.4</span> Significance</h3>
 <p>This work confirms that rhesus
 macaques can be a good model to study Covid-19, as it has been shown by
-other groups <span class="citation" data-cites="3XqFhi8l unVgVIfU 1EcOLnVXk">[<a href="#ref-3XqFhi8l" role="doc-biblioref">2077</a>,<a href="#ref-1EcOLnVXk" role="doc-biblioref">2091</a>,<a href="#ref-unVgVIfU" role="doc-biblioref">2104</a>]</span>. While these experiments recapitulate
+other groups <span class="citation" data-cites="3XqFhi8l unVgVIfU 1EcOLnVXk">[<a href="#ref-3XqFhi8l" role="doc-biblioref">2084</a>,<a href="#ref-1EcOLnVXk" role="doc-biblioref">2098</a>,<a href="#ref-unVgVIfU" role="doc-biblioref">2111</a>]</span>. While these experiments recapitulate
 moderate COVID-19 in humans, the mode of inoculation via a combination
 of intratracheal, intranasal, ocular and oral routes, might not
 reproduce how humans get infected and may lead to different dynamics in
@@ -16591,7 +16598,7 @@ <h3 data-number="14.76.4" id="significance-69"><span class="header-section-numbe
 <h3 data-number="14.76.5" id="credit-73"><span class="header-section-number">14.76.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.77" id="ace2-expression-is-increased-in-the-lungs-of-patients-with-comorbidities-associated-with-severe-covid-19"><span class="header-section-number">14.77</span> ACE2 Expression is Increased in the Lungs of Patients with Comorbidities Associated with Severe COVID-19</h2>
-<p><span class="citation" data-cites="wjtVy2v0">[<a href="#ref-wjtVy2v0" role="doc-biblioref">2105</a>]</span></p>
+<p><span class="citation" data-cites="wjtVy2v0">[<a href="#ref-wjtVy2v0" role="doc-biblioref">2112</a>]</span></p>
 <h3 data-number="14.77.1" id="keywords-77"><span class="header-section-number">14.77.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -16651,7 +16658,7 @@ <h3 data-number="14.77.4" id="significance-70"><span class="header-section-numbe
 <h3 data-number="14.77.5" id="credit-74"><span class="header-section-number">14.77.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.78" id="meplazumab-treats-covid-19-pneumonia-an-open-labelled-concurrent-controlled-add-on-clinical-trial"><span class="header-section-number">14.78</span> Meplazumab treats COVID-19 pneumonia: an open-labelled, concurrent controlled add-on clinical trial</h2>
-<p>Bian et al. <em>medRxiv</em>. <span class="citation" data-cites="DFhY5nfb">[<a href="#ref-DFhY5nfb" role="doc-biblioref">2106</a>]</span></p>
+<p>Bian et al. <em>medRxiv</em>. <span class="citation" data-cites="DFhY5nfb">[<a href="#ref-DFhY5nfb" role="doc-biblioref">2113</a>]</span></p>
 <h3 data-number="14.78.1" id="keywords-78"><span class="header-section-number">14.78.1</span> Keywords</h3>
 <ul>
 <li>Meplazumab</li>
@@ -16685,16 +16692,16 @@ <h3 data-number="14.78.3" id="limitations-75"><span class="header-section-number
 <h3 data-number="14.78.4" id="significance-71"><span class="header-section-number">14.78.4</span> Significance</h3>
 <p>These results seem promising as for now there are
 limited treatments for Covid-19 patients, but a larger cohort of patient
-is needed. CD147 has already been described to facilitate HIV <span class="citation" data-cites="yP8TXdq2">[<a href="#ref-yP8TXdq2" role="doc-biblioref">2107</a>]</span>,
-measles virus <span class="citation" data-cites="X8l1n4zY">[<a href="#ref-X8l1n4zY" role="doc-biblioref">2108</a>]</span>, and malaria <span class="citation" data-cites="YcyNaIVC">[<a href="#ref-YcyNaIVC" role="doc-biblioref">2109</a>]</span> entry into host cells. This group was
+is needed. CD147 has already been described to facilitate HIV <span class="citation" data-cites="yP8TXdq2">[<a href="#ref-yP8TXdq2" role="doc-biblioref">2114</a>]</span>,
+measles virus <span class="citation" data-cites="X8l1n4zY">[<a href="#ref-X8l1n4zY" role="doc-biblioref">2115</a>]</span>, and malaria <span class="citation" data-cites="YcyNaIVC">[<a href="#ref-YcyNaIVC" role="doc-biblioref">2116</a>]</span> entry into host cells. This group was
 the first to describe the CD147-spike route of SARS-Cov-2 entry in host
-cells <span class="citation" data-cites="14y8UvAbH">[<a href="#ref-14y8UvAbH" role="doc-biblioref">2080</a>]</span> p147. Indeed, they had previously shown in 2005 that SARS-Cov
-could enter host cells via this transmembrane protein <span class="citation" data-cites="m9yLJ5Da">[<a href="#ref-m9yLJ5Da" role="doc-biblioref">2110</a>]</span>. Further
+cells <span class="citation" data-cites="14y8UvAbH">[<a href="#ref-14y8UvAbH" role="doc-biblioref">2087</a>]</span> p147. Indeed, they had previously shown in 2005 that SARS-Cov
+could enter host cells via this transmembrane protein <span class="citation" data-cites="m9yLJ5Da">[<a href="#ref-m9yLJ5Da" role="doc-biblioref">2117</a>]</span>. Further
 biological understanding of how SARS-CoV-2 can enter host cells and how
 this integrates with ACE2R route of entry is needed. Also, the specific
 cellular targets of the anti-CD147 antibody need to be assessed, as this
 protein can be expressed by many cell types and has been shown to
-involved in leukocytes aggregation <span class="citation" data-cites="J0ibHE3l">[<a href="#ref-J0ibHE3l" role="doc-biblioref">2111</a>]</span>. Lastly, Meplazumab is not a
+involved in leukocytes aggregation <span class="citation" data-cites="J0ibHE3l">[<a href="#ref-J0ibHE3l" role="doc-biblioref">2118</a>]</span>. Lastly, Meplazumab is not a
 commercially-available drug and requires significant health resources to
 generate and administer which might prevent rapid development and use.</p>
 <h3 data-number="14.78.5" id="credit-75"><span class="header-section-number">14.78.5</span> Credit</h3>
@@ -16777,7 +16784,7 @@ <h3 data-number="14.79.4" id="significance-72"><span class="header-section-numbe
 <h3 data-number="14.79.5" id="credit-76"><span class="header-section-number">14.79.5</span> Credit</h3>
 <p><em>Review by Jovani Catalan-Dibene as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.80" id="characterisation-of-the-transcriptome-and-proteome-of-sars-cov-2-using-direct-rna-sequencing-and-tandem-mass-spectrometry-reveals-evidence-for-a-cell-passage-induced-in-frame-deletion-in-the-spike-glycoprotein-that-removes-the-furin-like-cleavage-site."><span class="header-section-number">14.80</span> Characterisation of the transcriptome and proteome of SARS-CoV-2 using direct RNA sequencing and tandem mass spectrometry reveals evidence for a cell passage induced in-frame deletion in the spike glycoprotein that removes the furin-like cleavage site.</h2>
-<p>Davidson et al. <span class="citation" data-cites="bCYYaFKM">[<a href="#ref-bCYYaFKM" role="doc-biblioref">2112</a>]</span></p>
+<p>Davidson et al. <span class="citation" data-cites="bCYYaFKM">[<a href="#ref-bCYYaFKM" role="doc-biblioref">2119</a>]</span></p>
 <h3 data-number="14.80.1" id="keywords-80"><span class="header-section-number">14.80.1</span> Keywords</h3>
 <ul>
 <li>Transcription</li>
@@ -16800,7 +16807,7 @@ <h3 data-number="14.80.2" id="main-findings-76"><span class="header-section-numb
 not SARS-CoV or the closely related bat coronavirus RaTG13, which are
 cleaved at S1 / S2 by other proteases <span class="citation" data-cites="CqQVkaqj">[<a href="#ref-CqQVkaqj" role="doc-biblioref">14</a>]</span>. Furin cleavage sites at
 similar positions in other viruses have been linked to increased
-pathogenicity and greater cell tropism <span class="citation" data-cites="16tHVjVzu">[<a href="#ref-16tHVjVzu" role="doc-biblioref">2113</a>]</span>. Loss of this site in
+pathogenicity and greater cell tropism <span class="citation" data-cites="16tHVjVzu">[<a href="#ref-16tHVjVzu" role="doc-biblioref">2120</a>]</span>. Loss of this site in
 SARS-CoV-2 has also already been shown to increase viral entry into Vero
 but not BHK cells (which are also interferon deficient) <span class="citation" data-cites="qcVbT0w4">[<a href="#ref-qcVbT0w4" role="doc-biblioref">23</a>]</span>. The
 authors therefore make an important contribution in demonstrating that
@@ -16809,7 +16816,7 @@ <h3 data-number="14.80.2" id="main-findings-76"><span class="header-section-numb
 <h3 data-number="14.80.3" id="limitations-77"><span class="header-section-number">14.80.3</span> Limitations</h3>
 <p>As the authors note, a similar study posted earlier by Kim et al., which
 also passaged SARS-CoV-2 in Vero cells, did not identify any loss in the
-S protein furin cleavage site <span class="citation" data-cites="hRVfFbS">[<a href="#ref-hRVfFbS" role="doc-biblioref">2114</a>]</span>. It therefore remains to be
+S protein furin cleavage site <span class="citation" data-cites="hRVfFbS">[<a href="#ref-hRVfFbS" role="doc-biblioref">2121</a>]</span>. It therefore remains to be
 determined how likely it is that this mutation spontaneously arises. A
 quantitative investigation using multiple experimental replicas to
 understand the spontaneous viral mutation rate at this site and
@@ -16847,7 +16854,7 @@ <h3 data-number="14.80.4" id="significance-73"><span class="header-section-numbe
 <h3 data-number="14.80.5" id="credit-77"><span class="header-section-number">14.80.5</span> Credit</h3>
 <p><em>This review was undertaken by Tim O’Donnell, Maria Kuksin as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.81" id="a-sars-cov-2-human-protein-protein-interaction-map-reveals-drug-targets-and-potential-drug--repurposing"><span class="header-section-number">14.81</span> A SARS-CoV-2-Human Protein-Protein Interaction Map Reveals Drug Targets and Potential Drug- Repurposing</h2>
-<p>Gordon et al. <em>bioRxiv</em> <span class="citation" data-cites="phJM8g2Y">[<a href="#ref-phJM8g2Y" role="doc-biblioref">2115</a>]</span></p>
+<p>Gordon et al. <em>bioRxiv</em> <span class="citation" data-cites="phJM8g2Y">[<a href="#ref-phJM8g2Y" role="doc-biblioref">2122</a>]</span></p>
 <h3 data-number="14.81.1" id="keywords-81"><span class="header-section-number">14.81.1</span> Keywords</h3>
 <ul>
 <li>protein-protein interactions</li>
@@ -16884,7 +16891,7 @@ <h3 data-number="14.81.5" id="credit-78"><span class="header-section-number">14.
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.82" id="first-clinical-study-using-hcv-protease-inhibitor-danoprevir-to-treat-naïve-and-experienced-covid-19-patients"><span class="header-section-number">14.82</span> First Clinical Study Using HCV Protease Inhibitor Danoprevir to Treat Naïve and Experienced COVID-19 Patients</h2>
 <p>Chen et al. <em>medRxiv</em>.
-<span class="citation" data-cites="RTIk8DTo">[<a href="#ref-RTIk8DTo" role="doc-biblioref">2116</a>]</span></p>
+<span class="citation" data-cites="RTIk8DTo">[<a href="#ref-RTIk8DTo" role="doc-biblioref">2123</a>]</span></p>
 <h3 data-number="14.82.1" id="keywords-82"><span class="header-section-number">14.82.1</span> Keywords</h3>
 <ul>
 <li>Clinical study</li>
@@ -16895,7 +16902,7 @@ <h3 data-number="14.82.1" id="keywords-82"><span class="header-section-number">1
 </ul>
 <h3 data-number="14.82.2" id="main-findings-78"><span class="header-section-number">14.82.2</span> Main Findings</h3>
 <p>The authors treated 11 Covid-19 patients with Danoprevir, a
-commercialized HCV protease inhibitor <span class="citation" data-cites="YoCPtq6P">[<a href="#ref-YoCPtq6P" role="doc-biblioref">2117</a>]</span><sup>(p4)</sup>, boosted by ritonavir <span class="citation" data-cites="10GnhBctk">[<a href="#ref-10GnhBctk" role="doc-biblioref">2118</a>]</span>, a
+commercialized HCV protease inhibitor <span class="citation" data-cites="YoCPtq6P">[<a href="#ref-YoCPtq6P" role="doc-biblioref">2124</a>]</span><sup>(p4)</sup>, boosted by ritonavir <span class="citation" data-cites="10GnhBctk">[<a href="#ref-10GnhBctk" role="doc-biblioref">2125</a>]</span>, a
 CYP3A4 inhibitor (which enhances the plasma concentration and
 bioavailabilty of Danoprevir). Two patients had never received
 anti-viral therapy before (=naïve), whereas nine patients were on
@@ -16917,10 +16924,10 @@ <h3 data-number="14.82.3" id="limitations-79"><span class="header-section-number
 <h3 data-number="14.82.4" id="significance-75"><span class="header-section-number">14.82.4</span> Significance</h3>
 <p>The authors of the study treated patients with Danoprevir, with the
 rational to that this is an approved and well tolerated drug for HCV
-patients <span class="citation" data-cites="10GnhBctk">[<a href="#ref-10GnhBctk" role="doc-biblioref">2118</a>]</span>, and that it could also target the protease from SARS-CoV-2
+patients <span class="citation" data-cites="10GnhBctk">[<a href="#ref-10GnhBctk" role="doc-biblioref">2125</a>]</span>, and that it could also target the protease from SARS-CoV-2
 (essential for viral replication and transcription). Indeed, homology
 modelling data indicated that HCV protease inhibitors have the highest
-binding affinity to Sars-Cov2 protease among other approved drugs <span class="citation" data-cites="7zBwK1wn">[<a href="#ref-7zBwK1wn" role="doc-biblioref">2119</a>]</span>.</p>
+binding affinity to Sars-Cov2 protease among other approved drugs <span class="citation" data-cites="7zBwK1wn">[<a href="#ref-7zBwK1wn" role="doc-biblioref">2126</a>]</span>.</p>
 <p>While this study shows that the combination of Danoprevir and Ritonavir
 might be beneficial for Covid-19 patients, additional clinical trials
 with more patients and with better methodology (randomization and
@@ -17079,7 +17086,7 @@ <h3 data-number="14.83.6" id="credit-80"><span class="header-section-number">14.
 faculty at the Immunology Institute of the Icahn school of medicine,
 Mount Sinai.</em></p>
 <h2 data-number="14.84" id="serology-characteristics-of-sars-cov-2-infection-since-the-exposure-and-post-symptoms-onset"><span class="header-section-number">14.84</span> Serology characteristics of SARS-CoV-2 infection since the exposure and post symptoms onset</h2>
-<p>Lou et al. <em>medRxiv</em>. <span class="citation" data-cites="lnuNSHEW">[<a href="#ref-lnuNSHEW" role="doc-biblioref">2120</a>]</span></p>
+<p>Lou et al. <em>medRxiv</em>. <span class="citation" data-cites="lnuNSHEW">[<a href="#ref-lnuNSHEW" role="doc-biblioref">2127</a>]</span></p>
 <h3 data-number="14.84.1" id="keywords-84"><span class="header-section-number">14.84.1</span> Keywords</h3>
 <ul>
 <li>Seroconversion rate</li>
@@ -17103,7 +17110,7 @@ <h3 data-number="14.84.2" id="main-findings-80"><span class="header-section-numb
 (d.p.e) or 9, 10- and 12-days post-onset (d.p.o). Seroconversion was
 first detected at day 7d.p.e in 98.9% of the patients. Interestingly
 they found that viral load declined as antibody levels increased. This
-was in contrast to a previous study <span class="citation" data-cites="5HXuCa5t">[<a href="#ref-5HXuCa5t" role="doc-biblioref">2060</a>]</span>, showing that increased antibody
+was in contrast to a previous study <span class="citation" data-cites="5HXuCa5t">[<a href="#ref-5HXuCa5t" role="doc-biblioref">2067</a>]</span>, showing that increased antibody
 titers did not always correlate with RNA clearance (low number of
 patient sample).</p>
 <h3 data-number="14.84.3" id="limitations-82"><span class="header-section-number">14.84.3</span> Limitations</h3>
@@ -17125,7 +17132,7 @@ <h3 data-number="14.84.4" id="significance-76"><span class="header-section-numbe
 <h3 data-number="14.84.5" id="credit-81"><span class="header-section-number">14.84.5</span> Credit</h3>
 <p><em>This review was undertaken and edited by Konstantina A as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.85" id="sars-cov-2-launches-a-unique-transcriptional-signature-from-in-vitro-ex-vivo-and-in-vivo-systems"><span class="header-section-number">14.85</span> SARS-CoV-2 launches a unique transcriptional signature from in vitro, ex vivo, and in vivo systems</h2>
-<p>Blanco-Melo et al. <em>bioRxiv</em>. <span class="citation" data-cites="aNSdARwe">[<a href="#ref-aNSdARwe" role="doc-biblioref">2121</a>]</span></p>
+<p>Blanco-Melo et al. <em>bioRxiv</em>. <span class="citation" data-cites="aNSdARwe">[<a href="#ref-aNSdARwe" role="doc-biblioref">2128</a>]</span></p>
 <h3 data-number="14.85.1" id="keywords-85"><span class="header-section-number">14.85.1</span> Keywords</h3>
 <ul>
 <li>host cellular response</li>
@@ -17180,7 +17187,7 @@ <h3 data-number="14.85.5" id="potential-conflicts-of-interest-disclosure"><span
 <h3 data-number="14.85.6" id="credit-82"><span class="header-section-number">14.85.6</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.86" id="a-new-predictor-of-disease-severity-in-patients-with-covid-19-in-wuhan-china"><span class="header-section-number">14.86</span> A New Predictor of Disease Severity in Patients with COVID-19 in Wuhan, China</h2>
-<p>Zhou et al. <em>bioRxiv</em>. <span class="citation" data-cites="EWZmuLvu">[<a href="#ref-EWZmuLvu" role="doc-biblioref">2122</a>]</span></p>
+<p>Zhou et al. <em>bioRxiv</em>. <span class="citation" data-cites="EWZmuLvu">[<a href="#ref-EWZmuLvu" role="doc-biblioref">2129</a>]</span></p>
 <h3 data-number="14.86.1" id="keywords-86"><span class="header-section-number">14.86.1</span> Keywords</h3>
 <ul>
 <li>disease severity</li>
@@ -17216,20 +17223,20 @@ <h3 data-number="14.86.3" id="limitations-84"><span class="header-section-number
 into moderate and mild disease.</p>
 <p>Also, studying different subset of lymphocytes could lead to a more
 specific predictor. Another study showed that the neutrophils to CD8+ T
-cells ratio was a strong predictor of disease severity <span class="citation" data-cites="zTGzuiTI">[<a href="#ref-zTGzuiTI" role="doc-biblioref">2030</a>]</span>. Another more
+cells ratio was a strong predictor of disease severity <span class="citation" data-cites="zTGzuiTI">[<a href="#ref-zTGzuiTI" role="doc-biblioref">2037</a>]</span>. Another more
 precise study showed that the percentage of helper T cells and
 regulatory T cells decrease but the percentage of naïve helper T cells
-increases in severe cases <span class="citation" data-cites="6Y81C4P3">[<a href="#ref-6Y81C4P3" role="doc-biblioref">2023</a>]</span>. Taking these subpopulations into account
+increases in severe cases <span class="citation" data-cites="6Y81C4P3">[<a href="#ref-6Y81C4P3" role="doc-biblioref">2030</a>]</span>. Taking these subpopulations into account
 might make the predictor more powerful.</p>
 <p>Other studies also noted an inverse correlation between disease severity
-and LDH <span class="citation" data-cites="USOnp7c0">[<a href="#ref-USOnp7c0" role="doc-biblioref">2064</a>]</span> or IL6 <span class="citation" data-cites="1GEbBtBgh">[<a href="#ref-1GEbBtBgh" role="doc-biblioref">2073</a>]</span> levels, but the authors here do not discuss LDH nor
+and LDH <span class="citation" data-cites="USOnp7c0">[<a href="#ref-USOnp7c0" role="doc-biblioref">2071</a>]</span> or IL6 <span class="citation" data-cites="1GEbBtBgh">[<a href="#ref-1GEbBtBgh" role="doc-biblioref">2080</a>]</span> levels, but the authors here do not discuss LDH nor
 IL6 levels, although this could help to strengthen the predictor.</p>
 <p>The study is based on the results obtained on the first day of
 admission, studying the dynamic of the changes in patients might also be
 interesting to better predict disease severity.</p>
 <h3 data-number="14.86.4" id="significance-78"><span class="header-section-number">14.86.4</span> Significance</h3>
 <p>This study confirms that the neutrophil to lymphocyte ratio can be a
-predictor of disease severity as shown by many others <span class="citation" data-cites="6Y81C4P3 VRoblZFJ gK5e7Yhl">[<a href="#ref-gK5e7Yhl" role="doc-biblioref">2022</a>,<a href="#ref-6Y81C4P3" role="doc-biblioref">2023</a>,<a href="#ref-VRoblZFJ" role="doc-biblioref">2036</a>]</span>. The
+predictor of disease severity as shown by many others <span class="citation" data-cites="6Y81C4P3 VRoblZFJ gK5e7Yhl">[<a href="#ref-gK5e7Yhl" role="doc-biblioref">2029</a>,<a href="#ref-6Y81C4P3" role="doc-biblioref">2030</a>,<a href="#ref-VRoblZFJ" role="doc-biblioref">2043</a>]</span>. The
 novelty here is that they show that a combination with other markers can
 enhance the specificity and sensibility of the predictor, although the
 study could be improved by taking into account sub-populations of
@@ -17238,7 +17245,7 @@ <h3 data-number="14.86.4" id="significance-78"><span class="header-section-numbe
 <h3 data-number="14.86.5" id="credit-83"><span class="header-section-number">14.86.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.87" id="metabolic-disturbances-and-inflammatory-dysfunction-predict-severity-of-coronavirus-disease-2019-covid-19-a-retrospective-study"><span class="header-section-number">14.87</span> Metabolic disturbances and inflammatory dysfunction predict severity of coronavirus disease 2019 (COVID-19): a retrospective study</h2>
-<p>Shuke Nie et al. <em>medRxiv</em>. <span class="citation" data-cites="95sQSGzx">[<a href="#ref-95sQSGzx" role="doc-biblioref">2123</a>]</span></p>
+<p>Shuke Nie et al. <em>medRxiv</em>. <span class="citation" data-cites="95sQSGzx">[<a href="#ref-95sQSGzx" role="doc-biblioref">2130</a>]</span></p>
 <h3 data-number="14.87.1" id="keywords-87"><span class="header-section-number">14.87.1</span> Keywords</h3>
 <ul>
 <li>metabolism</li>
@@ -17292,7 +17299,7 @@ <h3 data-number="14.87.4" id="significance-79"><span class="header-section-numbe
 <h3 data-number="14.87.5" id="credit-84"><span class="header-section-number">14.87.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.88" id="viral-kinetics-and-antibody-responses-in-patients-with-covid-19"><span class="header-section-number">14.88</span> Viral Kinetics and Antibody Responses in Patients with COVID-19</h2>
-<p><span class="citation" data-cites="btVuoX6V">[<a href="#ref-btVuoX6V" role="doc-biblioref">2124</a>]</span></p>
+<p><span class="citation" data-cites="btVuoX6V">[<a href="#ref-btVuoX6V" role="doc-biblioref">2131</a>]</span></p>
 <h3 data-number="14.88.1" id="keywords-88"><span class="header-section-number">14.88.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -17336,15 +17343,15 @@ <h3 data-number="14.88.4" id="significance-80"><span class="header-section-numbe
 disease progression and kinetics is useful to stratify patients, and
 for future serological tests.</p></li>
 <li><p>Strong spike-IgG levels often correlate with lymphopenia and
-CoVID-19 disease severity <span class="citation" data-cites="LIf5SSUs">[<a href="#ref-LIf5SSUs" role="doc-biblioref">2125</a>]</span>, similar to macaque
-studies in SARS <span class="citation" data-cites="tC5vJmwj">[<a href="#ref-tC5vJmwj" role="doc-biblioref">2126</a>]</span>. It would be critical to see if anti-NP or
+CoVID-19 disease severity <span class="citation" data-cites="LIf5SSUs">[<a href="#ref-LIf5SSUs" role="doc-biblioref">2132</a>]</span>, similar to macaque
+studies in SARS <span class="citation" data-cites="tC5vJmwj">[<a href="#ref-tC5vJmwj" role="doc-biblioref">2133</a>]</span>. It would be critical to see if anti-NP or
 anti-Spike IgG antibodies for SARS-CoV-2 also elicit similar
 detrimental effects before clinical use.</p></li>
 </ul>
 <h3 data-number="14.88.5" id="credit-85"><span class="header-section-number">14.88.5</span> Credit</h3>
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.89" id="covid-19-infection-induces-readily-detectable-morphological-and-inflammation-related-phenotypic-changes-in-peripheral-blood-monocytes-the-severity-of-which-correlate-with-patient-outcome"><span class="header-section-number">14.89</span> COVID-19 infection induces readily detectable morphological and inflammation-related phenotypic changes in peripheral blood monocytes, the severity of which correlate with patient outcome</h2>
-<p><span class="citation" data-cites="1FZgghazg">[<a href="#ref-1FZgghazg" role="doc-biblioref">2127</a>]</span></p>
+<p><span class="citation" data-cites="1FZgghazg">[<a href="#ref-1FZgghazg" role="doc-biblioref">2134</a>]</span></p>
 <h3 data-number="14.89.1" id="keywords-89"><span class="header-section-number">14.89.1</span> Keywords</h3>
 <ul>
 <li>Monocytes</li>
@@ -17398,7 +17405,7 @@ <h3 data-number="14.89.3" id="limitations-87"><span class="header-section-number
 <h3 data-number="14.89.4" id="significance-81"><span class="header-section-number">14.89.4</span> Significance</h3>
 <p>Despite the limitations of this study, the discovery of
 a FSC-high monocyte population in COVID-19 patients is of great
-interest. With similar implication, a the recent study by Zhou et al. <span class="citation" data-cites="Bgo7Cmj3">[<a href="#ref-Bgo7Cmj3" role="doc-biblioref">2028</a>]</span>
+interest. With similar implication, a the recent study by Zhou et al. <span class="citation" data-cites="Bgo7Cmj3">[<a href="#ref-Bgo7Cmj3" role="doc-biblioref">2035</a>]</span>
 identified a connection between an inflammatory CD14+CD16+ monocyte
 population and pulmonary immunopathology leading to deleterious clinical
 manifestations and even acute mortality after SARS-CoV-2 infections.
@@ -17408,7 +17415,7 @@ <h3 data-number="14.89.4" id="significance-81"><span class="header-section-numbe
 <h3 data-number="14.89.5" id="credit-86"><span class="header-section-number">14.89.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.90" id="correlation-between-universal-bcg-vaccination-policy-and-reduced-morbidity-and-mortality-for-covid-19-an-epidemiological-study"><span class="header-section-number">14.90</span> Correlation between universal BCG vaccination policy and reduced morbidity and mortality for COVID-19: an epidemiological study</h2>
-<p>Miller et al. <em>medRxiv</em>. <span class="citation" data-cites="15gdkEnfn">[<a href="#ref-15gdkEnfn" role="doc-biblioref">2128</a>]</span></p>
+<p>Miller et al. <em>medRxiv</em>. <span class="citation" data-cites="15gdkEnfn">[<a href="#ref-15gdkEnfn" role="doc-biblioref">2135</a>]</span></p>
 <h3 data-number="14.90.1" id="keywords-90"><span class="header-section-number">14.90.1</span> Keywords</h3>
 <ul>
 <li>BCG vaccine</li>
@@ -17458,16 +17465,16 @@ <h3 data-number="14.90.4" id="significance-82"><span class="header-section-numbe
 <p><strong>This study shows that there is a correlation between BCG vaccination
 policy and reduced mortality for Covid-19</strong>. Indeed, BCG vaccine has
 been shown to protect against several viruses and enhance innate
-immunity <span class="citation" data-cites="16FOT89K5">[<a href="#ref-16FOT89K5" role="doc-biblioref">2129</a>]</span>, which could explain why it could protect against SARS-CoV-2
+immunity <span class="citation" data-cites="16FOT89K5">[<a href="#ref-16FOT89K5" role="doc-biblioref">2136</a>]</span>, which could explain why it could protect against SARS-CoV-2
 infection, but the exact mechanism is still unknown. <strong>Moreover, the
 efficiency of adult/older people vaccination and protection against
 Covid-19 still needs to be assessed.</strong> Regarding this, Australian
 researchers are starting a clinical trial of BCG vaccine for healthcare
-workers <span class="citation" data-cites="MCuIRGFE">[<a href="#ref-MCuIRGFE" role="doc-biblioref">2130</a>]</span>, to assess if it can protect them against Covid-19.</p>
+workers <span class="citation" data-cites="MCuIRGFE">[<a href="#ref-MCuIRGFE" role="doc-biblioref">2137</a>]</span>, to assess if it can protect them against Covid-19.</p>
 <h3 data-number="14.90.5" id="credit-87"><span class="header-section-number">14.90.5</span> Credit</h3>
 <p><em>This review was undertaken as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.91" id="non-neural-expression-of-sars-cov-2-entry-genes-in-the-olfactory-epithelium"><span class="header-section-number">14.91</span> Non-neural expression of SARS-CoV-2 entry genes in the olfactory epithelium</h2>
-<p><span class="citation" data-cites="12oDb7aki">[<a href="#ref-12oDb7aki" role="doc-biblioref">2131</a>]</span></p>
+<p><span class="citation" data-cites="12oDb7aki">[<a href="#ref-12oDb7aki" role="doc-biblioref">2138</a>]</span></p>
 <h3 data-number="14.91.1" id="keywords-91"><span class="header-section-number">14.91.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -17650,7 +17657,7 @@ <h3 data-number="14.91.5" id="credit-88"><span class="header-section-number">14.
 patients infected with SARS-CoV-1 further support the potential
 importance and relevance of this study.</p>
 <h2 data-number="14.92" id="cigarette-smoke-triggers-the-expansion-of-a-subpopulation-of-respiratory-epithelial-cells-that-express-the-sars-cov-2-receptor-ace2"><span class="header-section-number">14.92</span> Cigarette smoke triggers the expansion of a subpopulation of respiratory epithelial cells that express the SARS-CoV-2 receptor ACE2</h2>
-<p><span class="citation" data-cites="t4vofknR">[<a href="#ref-t4vofknR" role="doc-biblioref">2132</a>]</span></p>
+<p><span class="citation" data-cites="t4vofknR">[<a href="#ref-t4vofknR" role="doc-biblioref">2139</a>]</span></p>
 <h3 data-number="14.92.1" id="keywords-92"><span class="header-section-number">14.92.1</span> Keywords</h3>
 <ul>
 <li>CoVID-19</li>
@@ -17701,7 +17708,7 @@ <h3 data-number="14.92.4" id="significance-84"><span class="header-section-numbe
 implies CoV-2 susceptibility might be smoking-specific, and not
 fibrosis-specific.</p></li>
 <li><p>Another preprint showed ACE2 expression increases in lung of
-patients with CoV-2 co-morbidities such as hypertension <span class="citation" data-cites="wjtVy2v0">[<a href="#ref-wjtVy2v0" role="doc-biblioref">2105</a>]</span>; these studies
+patients with CoV-2 co-morbidities such as hypertension <span class="citation" data-cites="wjtVy2v0">[<a href="#ref-wjtVy2v0" role="doc-biblioref">2112</a>]</span>; these studies
 collectively paint a better picture of CoV-2 susceptibility before
 actual experiments can be carried out.</p></li>
 </ul>
@@ -17709,7 +17716,7 @@ <h3 data-number="14.92.5" id="credit-89"><span class="header-section-number">14.
 <p><em>Review by Samarth Hegde as part of a project by students, postdocs and faculty at the Immunology Institute of the Icahn School of Medicine, Mount Sinai.</em></p>
 <h2 data-number="14.93" id="the-comparative-superiority-of-igm-igg-antibody-test-to-real-time-reverse-transcriptase-pcr-detection-for-sars-cov-2-infection-diagnosis"><span class="header-section-number">14.93</span> The comparative superiority of IgM-IgG antibody test to real-time reverse transcriptase PCR detection for SARS-CoV-2 infection diagnosis</h2>
 <p>Liu et al. <em>medRxiv</em>.
-<span class="citation" data-cites="k1E3DuFN">[<a href="#ref-k1E3DuFN" role="doc-biblioref">2133</a>]</span></p>
+<span class="citation" data-cites="k1E3DuFN">[<a href="#ref-k1E3DuFN" role="doc-biblioref">2140</a>]</span></p>
 <h3 data-number="14.93.1" id="keywords-93"><span class="header-section-number">14.93.1</span> Keywords</h3>
 <ul>
 <li>IgM/IgG antibody test</li>
diff --git a/manuscript.md b/manuscript.md
index e0addf9a8..c8b7c2b1c 100644
--- a/manuscript.md
+++ b/manuscript.md
@@ -6,7 +6,7 @@ keywords:
 - pandemic
 - viral infection
 lang: en-US
-date-meta: '2022-08-12'
+date-meta: '2022-08-17'
 author-meta:
 - Halie M. Rando
 - Casey S. Greene
@@ -72,8 +72,8 @@ header-includes: |-
   <meta name="citation_title" content="SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics" />
   <meta property="og:title" content="SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics" />
   <meta property="twitter:title" content="SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics" />
-  <meta name="dc.date" content="2022-08-12" />
-  <meta name="citation_publication_date" content="2022-08-12" />
+  <meta name="dc.date" content="2022-08-17" />
+  <meta name="citation_publication_date" content="2022-08-17" />
   <meta name="dc.language" content="en-US" />
   <meta name="citation_language" content="en-US" />
   <meta name="dc.relation.ispartof" content="Manubot" />
@@ -291,13 +291,13 @@ header-includes: |-
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   <meta name="citation_pdf_url" content="https://greenelab.github.io/covid19-review/manuscript.pdf" />
   <link rel="alternate" type="application/pdf" href="https://greenelab.github.io/covid19-review/manuscript.pdf" />
-  <link rel="alternate" type="text/html" href="https://greenelab.github.io/covid19-review/v/693bc6c9d1173d3d0b699a81b22fa58685b05828/" />
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+  <link rel="alternate" type="text/html" href="https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/" />
+  <meta name="manubot_html_url_versioned" content="https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/" />
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   <meta property="og:type" content="article" />
   <meta property="twitter:card" content="summary_large_image" />
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+  <meta property="og:image" content="https://github.com/greenelab/covid19-review/raw/1afb26272649eb73d412aacfd63eab9d3758128b/content/images/thumbnail.png" />
+  <meta property="twitter:image" content="https://github.com/greenelab/covid19-review/raw/1afb26272649eb73d412aacfd63eab9d3758128b/content/images/thumbnail.png" />
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@@ -319,11 +319,11 @@ manubot-clear-requests-cache: false
 
 <small><em>
 This manuscript
-([permalink](https://greenelab.github.io/covid19-review/v/693bc6c9d1173d3d0b699a81b22fa58685b05828/))
+([permalink](https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/))
 was automatically generated
-from [greenelab/covid19-review@693bc6c](https://github.com/greenelab/covid19-review/tree/693bc6c9d1173d3d0b699a81b22fa58685b05828)
-on August 12, 2022.
-It is also available as a [PDF](https://greenelab.github.io/covid19-review/v/693bc6c9d1173d3d0b699a81b22fa58685b05828/manuscript.pdf).
+from [greenelab/covid19-review@1afb262](https://github.com/greenelab/covid19-review/tree/1afb26272649eb73d412aacfd63eab9d3758128b)
+on August 17, 2022.
+It is also available as a [PDF](https://greenelab.github.io/covid19-review/v/1afb26272649eb73d412aacfd63eab9d3758128b/manuscript.pdf).
 Snapshots of individual sections have been published [@individual-pathogenesis; @individual-nutraceuticals; @individual-pharmaceuticals; @individual-methods] or posted as preprints [@individual-diagnostics].
 </em></small>
 
@@ -1396,6 +1396,18 @@ In the future, interdisciplinary work on SARS-CoV-2 and COVID-19 may guide a res
 
 ### Importance
 
+<!-- Text to incorporate (from vaccines): -->
+<!--Move to evolution ms
+Some of the gene mutations carried by Omicron, of which there are between 30-37 in the spike gene (15 in the RBD), have previously been associated with increased transmission, greater affinity for ACE2, and escape from neutralizing antibodies when they have been detected in other VOC [@doi:10.1101/2021.11.11.21266068; @doi:10.1016/j.cell.2021.06.020; @doi:10.1101/2021.12.12.472269; @url:https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/scientific-brief-omicron-variant.html; @doi:10.1101/2021.12.14.21267772; @doi:10.1101/2021.12.12.472269].
+However, multiple animal study preprints suggested that the Omicron variant may not be as severe on the respiratory system as previous SARS-CoV-2 variants as evidenced by reduced lung infectivity, reduced SARS-CoV-2 RNA detection in the lung, and reduced inflammation and pathogenicity in animals [@doi:10.21203/rs.3.rs-1211792/v1; @doi:10.1101/2021.12.26.474085; @doi:10.1101/2021.12.24.474086; @doi:10.1101/2022.01.02.474743; @doi:10.1101/2021.12.17.473248].
+-->
+<!--Move to evolution
+Vaccine efficacy is not the only pharmacological intervention affected by VOC.
+Some existing therapeutics, including monoclonal antibody treatments like Bamlanivimab (AbCellera Biologics/ Eli Lilly), were ineffective against the Omicron variant.
+Indeed, only Sotrovimab (Vir Biotechnology/GSK) and Tixagevimab (AstraZeneca) to a much lesser extent could effectively neutralize the Omicron variant out of 7 tested monoclonal antibodies [@doi:10.1101/2021.12.14.21267772], which has been verified by others [@doi:10.1101/2021.12.12.472269].
+The antigenic shift of the Omicron variant does raise concerns for future VOC and what effects they may have on future vaccines and therapeutics.
+-->
+
 ### Introduction
 
 The emergence of what is now known to be the pathogen SARS-CoV-2 has dramatically reshaped modern life for the past two years.
@@ -1774,7 +1786,6 @@ Further research is required to discern the clinical, prophylactic, and therapeu
 
 ### SARS-CoV-2 Evolution and Vaccine Efficacy
 
-<!-- This doesn't belong in the vaccines appendix. It seems covered by the evolution manuscript, or should be moved there. -->
 With these vaccines in place, one concern is how the virus's continued evolution will affect their efficacy.
 Since the start of this pandemic, we have already seen multiple variants emerge: B.1.1.7, which emerged in the UK, B.1.351, which emerged in South Africa, and P.1, which emerged in Brazil.
 
@@ -1815,8 +1826,6 @@ This study was not longitudinal, but the timing of testing relative to symptom o
 The findings of this study are therefore consistent with the idea that vaccinated people are less likely to contract symptomatic or severe COVID-19, but in cases of breakthrough infection, are still likely to be able to transmit SARS-CoV-2 to others.
 <!--Among 16 Dane County samples sequenced, 14 (88%) were identified as the Delta variant of concern, and 42 of 50 samples (84%) from WI as a whole were consistent with the Delta VOC.-->
 
-
-
 ### Question 6: What is Next?
 
 The SARS-CoV-2 pandemic has presented many unprecedented scientific opportunities.
@@ -1830,7 +1839,7 @@ To date, studies show that wastewater surveillance is an effective tool to monit
 Indeed, data from a study in New York City indicated that wastewater SARS-CoV-2 detection correlated with clinical detection of infection  [@doi:10.1039/D1EW00747E].
 Similar studies have been conducted in Nevada [@doi:10.1016/j.wroa.2020.100086] and Boston [@doi:10.1128/mSystems.00614-20].
 To date, studies have shown that factors such as temperature, the travel time of wastewater, and diurnal variability may affect detection of SARS-CoV-2 [@doi:10.1016/j.scitotenv.2020.138875; @doi:10.1016/j.wroa.2020.100086].
-Additionaly, wastewater surveillance provides a tool to monitor fluctuations in the viral strains present in a community [@doi:10.1101/2022.02.18.22271188 ; @doi:10.1101/2021.12.21.21268077].
+Additionally, wastewater surveillance provides a tool to monitor fluctuations in the viral strains present in a community [@doi:10.1101/2022.02.18.22271188 ; @doi:10.1101/2021.12.21.21268077].
 Due to its demonstrated utility so far, the United States CDC established the National Wastewater Surveillance System (NWSS), which has emerged as an important surveillance tool for SARS-CoV-2 spread [@url:https://www.cdc.gov/healthywater/surveillance/wastewater-surveillance/wastewater-surveillance.html]. 
 
 <!-- Implications for preventing future pandemics? Vaccine response time?-->
@@ -2455,14 +2464,14 @@ The scale of the COVID-19 pandemic has made the repurposing and development of p
 
 ![
 **Cumulative global incidence of COVID-19 and SARS.**
-As of August 10, 2022, 587,493,309 COVID-19 cases and 6,427,446 COVID-19 deaths had been reported worldwide since January 22, 2020.
+As of August 15, 2022, 591,189,117 COVID-19 cases and 6,437,933 COVID-19 deaths had been reported worldwide since January 22, 2020.
 A total of 8,432 cases and 813 deaths were reported for SARS from March 17 to July 11, 2003.
 SARS-CoV-1 was officially contained on July 5, 2003, within 9 months of its appearance [@doi:10.3390/ijerph17113973].
 In contrast, SARS-CoV-2 remains a significant global threat nearly two years after its emergence.
 COVID-19 data are from the COVID-19 Data Repository by the Center for Systems Science and Engineering at Johns Hopkins University [@https://github.com/CSSEGISandData/COVID-19/tree/master/csse_covid_19_data/csse_covid_19_time_series; @doi:10/ggnsjk].
 SARS data are from the WHO [@url:https://www.who.int/health-topics/severe-acute-respiratory-syndrome] and were obtained from a dataset on GitHub [@url:https://github.com/imdevskp/sars-2003-outbreak-data-webscraping-code].
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/5731b89747027f2322595249c7b11b2f237686f6/csse/csse-deaths.png "Global incidence of COVID-19 and SARS"){#fig:csse-deaths secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/csse/csse-deaths.png "Global incidence of COVID-19 and SARS"){#fig:csse-deaths secno=1}
 
 At first, SARS-CoV-2's rapid shift from an unknown virus to a significant worldwide threat closely paralleled the emergence of _Severe acute respiratory syndrome-related coronavirus_ (SARS-CoV-1), which was responsible for the 2002-03 SARS epidemic.
 The first documented case of COVID-19 was reported in Wuhan, China in November 2019, and the disease quickly spread worldwide in the early months of 2020.
@@ -2519,7 +2528,7 @@ Recruitment status and trial phase are shown only for interventional trials in w
 Common interventions refers to interventions used in at least ten trials.
 Combinations of interventions, such as hydroxychloroquine with azithromycin, are tallied separately from the individual interventions.
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/5731b89747027f2322595249c7b11b2f237686f6/ebmdatalab/ebmdatalab-trials.png "COVID-19 clinical trials"){#fig:ebm-trials secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/ebmdatalab/ebmdatalab-trials.png "COVID-19 clinical trials"){#fig:ebm-trials secno=1}
 
 The purpose of this review is to provide an evolving resource tracking the status of efforts to repurpose and develop drugs for the treatment of COVID-19.
 We highlight four strategies that provide different paradigms for the identification of potential pharmaceutical treatments.
@@ -3573,62 +3582,62 @@ Therefore, TLR agonists hold some potential for broad-spectrum prophylaxis.
 ### Abstract
 
 Over the past 150 years, vaccines have revolutionized the relationship between people and disease.
-Technologies such as mRNA vaccines have received significant attention in the COVID-19 pandemic due to their novelty and successes.
-However, more traditional vaccine development platforms have also been explored against SARS-CoV-2, yielding important tools in the worldwide fight against the virus.
+During the COVID-19 pandemic, technologies such as mRNA vaccines have received significant attention due to their novelty and successes.
+However, more traditional vaccine development platforms have also been applied against SARS-CoV-2, yielding important tools in the worldwide fight against the virus.
 
-A variety of approaches have been used to develop COVID-19 vaccines that are now available in at least one country.
-In this review, we highlight strategies that focus on the virus and its constituent pieces.
+A variety of approaches have been used to develop COVID-19 vaccines that are now authorized for use in countries around the world.
+In this review, we highlight strategies that focus on the viral capsid outwards, rather than on the nucleic acids inside.
 Such approaches broadly fall into two categories: whole-virus vaccines and subunit vaccines.
 Whole-virus vaccine approaches use the virus itself, either in an inactivated or attenuated state.
 Subunit vaccines isolate an immunogenic component of the virus using various strategies that is then introduced through vaccination.
 We highlight specific vaccine candidates that utilize these approaches in different ways.
 In a companion manuscript, we review the more recent and novel development of nucleic-acid based vaccine technologies.
 
-We also seek to contextualize the role that these COVID-19 vaccine development programs have played in providing immunity to people around the world.
-Well-established vaccine technologies are especially important because of their significant impact worldwide on COVID-19 vaccine access.
-Traditional vaccine development programs have been undertaken in a much wider range of countries than those using nucleic-acid-based technologies, which have been led by wealthy countries.
-Therefore, these vaccines, while less cutting-edge on the biotechnology side, are extremely important to the management of SARS-CoV-2.
+We further consider the role that these COVID-19 vaccine development programs have played in providing immunity to people around the world.
+Well-established vaccine technologies have proved especially important because of the significant role they have played in COVID-19 vaccine access at the global scale.
+Vaccine development programs that use established platforms have been undertaken in a much wider range of countries than those using nucleic-acid-based technologies, which have been led by wealthy Western countries.
+Therefore, these vaccine platforms, while less cutting-edge on the biotechnology side, have proven to be extremely important to the management of SARS-CoV-2.
 
 ### Importance
 
-As of August 10, 2022, there have been over 587,493,309 SARS-CoV-2 cases, and it has taken the lives of at least 6,427,446 people globally.
+As of August 15, 2022, there have been over 591,189,117 SARS-CoV-2 cases, and the virus has taken the lives of at least 6,437,933 people globally.
 The development, production, and distribution of vaccines is imperative to saving lives, preventing illness, and reducing the economic and social burdens caused by the COVID-19 pandemic.
 Much emphasis has been placed on vaccines that use cutting-edge biotechnology.
-However, more traditional methods of vaccine development that were refined throughout the twentieth century are critical to producing vaccines that are accessible worldwide.
-Effective deployment is critical to reducing the susceptibility of worldwide populations, especially in light of emerging variants.
-In this review, we evaluate the efficacy of these vaccines as well as patterns in their distribution.
+However, more traditional methods of vaccine development that were refined throughout the twentieth century have been critical in increasing vaccine access worldwide.
+Effective deployment is necessary to reducing the susceptibility of the world's population, which is especially important in light of emerging variants.
+In this review, we discuss the safety, efficacy, and distribution of vaccines developed using established technologies.
 In a separate review, we describe the vaccines developed using nucleic acid-based vaccine platforms.
 From the current literature, it is clear that the well-established vaccine technologies are also highly effective against SARS-CoV-2 and are being used to address the challenges of COVID-19 globally, including in low- and middle-income countries.
-This worldwide approach is critical for reducing the devastation of SARS-CoV-2.
+This worldwide approach is critical for reducing the devastating impact of SARS-CoV-2.
 
 ### Introduction
 
 The development of vaccines is widely considered one of the most important medical advances in human history.
 Over the past 150 years, several approaches to vaccines have been developed and refined [@doi:10.1073/pnas.1400472111].
-The COVID-19 pandemic has generated several unique circumstances relative to past health crises, one of which is the extremely rapid release of the SARS-CoV-2 viral genome.
+The COVID-19 pandemic has generated atypical circumstances compared to past health crises, leading to differences in vaccine development against this pathogen.
+One way in which the COVID-19 pandemic differs from prior global health crises is that the SARS-CoV-2 viral genome was sequenced, assembled, and released very early on (January 2020).
 This genomic information has been important in shaping the biomedical response to this pathogen [@individual-pathogenesis; @individual-pharmaceuticals].
-However, vaccines have been developed since long before the concept of a virus or a viral genome was known.
-As early as September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development, many of which used more traditional vaccine technologies [@doi:10.1038/s41586-020-2798-3].
-However, media attention has largely focused on vaccine development platforms that have produced vaccine candidates using previously unemployed technologies, especially mRNA vaccines due to their rapid deployment.
+All the same, vaccines have been developed since long before the concept of a virus or a viral genome was known, and as early as September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development, many of which used more traditional vaccine technologies [@doi:10.1038/s41586-020-2798-3].
+However, media attention has largely focused on vaccine development platforms that have produced vaccine candidates using new technologies, especially mRNA vaccines due to their rapid deployment.
 We review vaccine technologies used for SARS-CoV-2 in two parts: here, the application of traditional vaccine development platforms to SARS-CoV-2, and separately, nucleic acid-based approaches [@individual-vaccines-novel].
 
-Vaccine development using well-established technologies is important for a global perspective on COVID-19.
-As of August 11, 2022, 40 SARS-CoV-2 vaccines have been approved. 
-Tracking the administration of 29 vaccines throughout the world indicates that  doses have been administered across 223 countries [@doi:10.1038/s41562-021-01122-8].
-Of these, 17 were developed using subunit and 11 using whole-virus approaches, which do not require information about the viral genome. <!-- broken template -->
-Many vaccines are available only in a subset of countries, and the types of vaccines available varies widely throughout the world, as the process of developing and deploying a vaccine is complex and often requires coordination between government, industry, academia, and philanthropic entities [@doi:10.1126/science.abc5312].
+Understanding vaccine development programs that are using well-established technologies is important for a global perspective on COVID-19.
+As of August 15, 2022, 41 SARS-CoV-2 vaccines have been approved for use in at least one country.
+A resource tracking the distribution of 29 vaccines indicates that, as of August 15, 2022,  doses have been administered across 223 countries [@doi:10.1038/s41562-021-01122-8].
+Many of these vaccines use platforms that do not require information about the viral genome, with 17 developed using subunit and 11 using whole-virus approaches.
+The types of vaccines available varies widely throughout the world, as the process of developing and deploying a vaccine is complex and often requires coordination between government, industry, academia, and philanthropic entities [@doi:10.1126/science.abc5312].
 
-One of the metrics through which a vaccine's success is measured is efficacy.
-The vaccine efficacy (VE) seeks to quantify the extent to which a vaccine protects against the virus during clinical trials [@url:https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection].
+Another difference between prior global health crises and the COVID-19 pandemic is the way that vaccines are evaluated.
+A vaccine's success is often discussed in terms of vaccine efficacy (VE), which describes the protection conferred during clinical trials [@url:https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection].
 The real-world protection offered by a vaccine is referred to as its effectiveness [@url:https://www.who.int/news-room/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection].
 Additionally, protection can mean different things in different contexts.
 In general, the goal of a vaccine is to prevent disease, especially severe disease, rather than infection itself.
-Vaccine developers also often test their candidates for serum neutralizing activity, which has been proposed as a biomarker for adaptive immunity in other respiratory illnesses [@doi:10.1056/nejmoa2022483].
-However, the duration of the COVID-19 pandemic has made it possible to test multiple vaccines in phase 3 trials where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 is evaluated, whereas this has not always been feasible for other infectious diseases that have been controlled more quickly.
-Estimates of VE have been released for many vaccine candidates across a number of technology types based on phase 3 trial data.
+As a proxy for VE, vaccine developers often test their candidates for serum neutralizing activity, which has been proposed as a biomarker for adaptive immunity in other respiratory illnesses [@doi:10.1056/nejmoa2022483].
+The duration and intensity of the COVID-19 pandemic has made it possible to test multiple vaccines in phase III trials, where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 can be evaluated, whereas this has not always been feasible for other infectious diseases that have been controlled more quickly.
+Estimates of VE have been released for many vaccine candidates across a number of technology types based on phase III trial data.
 
 However, efficacy is not a static value, and real-world efficacy can vary with location and over time.
-Temporal shifts in efficacy have been an especially heightened topic of concern since late 2021 given the potential for the evolution of SARS-CoV-2 to influence vaccine efficacy.
+Shifts in efficacy have been an especially heightened topic of concern since late 2021 given the potential for variants of SARS-CoV-2 to influence VE.
 Due to viral evolution, vaccine developers are in an arms race with a pathogen that benefits from mutations that reduce its susceptibility to adaptive immunity.
 The evolution of several variants of concern (VOC) presents significant challenges for vaccines developed based on the index strain identified in Wuhan in late 2019.
 We discuss these variants in depth elsewhere [@individual-evolution].
@@ -3636,30 +3645,32 @@ To date, the most significant VOC identified are Alpha (2020), Beta (2020), Gamm
 The efficacy of vaccines in the context of these variants is discussed where information is available.
 
 While the relationship between a vaccine and a pathogen is not static, the data clearly demonstrates that a variety of efficacious vaccines have been developed against SARS-CoV-2.
-Here we discuss a selection of programs that use well-established vaccine biotechnology.
-These programs have been undertaken worldwide, in complement to the more cutting-edge approaches in high-income economies like the United States, the European Union, the United Kingdom, and Russia [@individual-vaccines-novel].
-In this review, we discuss the contributions of the traditional and well-established vaccine technologies of whole-virus vaccines and subunit vaccines and their role in the response to the COVID-19 pandemic.
+Here we discuss a selection of programs that use well-established vaccine biotechnologies.
+These programs have been undertaken worldwide, in complement to the more cutting-edge approaches developed and distributed in the United States (U.S.), the European Union (E.U.), the United Kingdom (U.K.), and Russia [@individual-vaccines-novel].
+In this review, we discuss vaccine development using two well-established technologies, whole-virus vaccination and subunit vaccination, and the role these technologies have played in the global response to the COVID-19 pandemic.
 
 ### Whole-Virus Vaccines
 
 Whole-virus vaccines have the longest history among vaccine development approaches.
 Variolation, which is widely considered the first vaccination strategy in human history, is one example [@doi:10.1016/j.jinf.2005.07.021; @doi:10.1007/978-1-4419-1339-5_2].
-Famously employed against smallpox when healthy individuals were exposed to pus from an individual infected with what was believed to be either cowpox or horsepox [@doi:10.1016/j.jinf.2005.07.021; @doi:10.1007/978-1-4419-1339-5_2; @doi:10.1377/hlthaff.24.3.611; @doi:10.1016/j.vaccine.2017.11.003], variolation allowed healthy individuals to be infected with a mild case of a disease.
-While whole-virus vaccines can confer adaptive immunity, they also face safety concerns [@doi:10.1016/j.virol.2015.03.032; @doi:10.3389/fimmu.2019.00594; @doi:10.1377/hlthaff.24.3.611].
+Famously, variolation was employed against smallpox when healthy individuals were exposed to pus from an individual infected with what was believed to be either cowpox or horsepox [@doi:10.1016/j.jinf.2005.07.021; @doi:10.1007/978-1-4419-1339-5_2; @doi:10.1377/hlthaff.24.3.611; @doi:10.1016/j.vaccine.2017.11.003].
+This approach worked by inducing a mild case of a disease.
+Therefore, while whole-virus vaccines confer adaptive immunity, they also raise safety concerns [@doi:10.1016/j.virol.2015.03.032; @doi:10.3389/fimmu.2019.00594; @doi:10.1377/hlthaff.24.3.611].
 As of 2005, most vaccines still used whole-virus platforms [@doi:10/dn299p], and these technologies remain valuable tools in vaccine development today [@doi:10.1073/pnas.1400472111].
 Whole virus vaccine candidates have been developed for COVID-19 using both live attenuated viruses and inactivated whole viruses.
 
 #### Live-Attenuated Virus Vaccines
 
 Live-attenuated virus vaccines (LAV), also known as replication-competent vaccines, use a weakened, living version of a disease-causing virus or a version of a virus that is modified to induce an immune response [@doi:10.1038/s41586-020-2798-3].
-Whether variolation is the first example of a LAV being used to induce immunity is debated [@doi:10.1016/j.virol.2015.03.032; @doi:10.1073/pnas.1400472111], but subsequent efforts to incorporate attenuated viruses relied on either the identification of related viruses that were less virulent in humans (e.g., cowpox/horsepox or rotavirus vaccines) or culture of a virus _in vitro_ [@doi:10.1377/hlthaff.24.3.611; @doi:10.1073/pnas.1400472111].
-Today, a virus can be attenuated by passaging it in a foreign host until, due to selection pressure, the virus loses its efficacy in the original host.
-Alternatively, selective gene deletion or codon deoptimization can be utilized to attenuate the virus [@doi:10.1038/s41586-020-2798-3].
-Foreign antigens can also be integrated into an attenuated viral vector [@doi:10.1038/s41586-020-3035-9].
-LAVs are also favored because they tend to be restricted to viral replication in the tissues around the location of inoculation [@doi:10.1128/9781555818951], and some can be administered intranasally [@doi:10.1038/s41586-020-2798-3].
-
+Whether variolation is the first example of a LAV being used to induce immunity is debated [@doi:10.1016/j.virol.2015.03.032; @doi:10.1073/pnas.1400472111].
 The first deliberate (albeit pathogen-naïve) attempt to develop an attenuated viral vaccine dates back to Louis Pasteur in 1885.
 The next intentional LAVs were developed against the yellow fever virus in 1935 and influenza in 1936 [@doi:10.1128/9781555818951].
+
+Early efforts in LAV development relied on either the identification of a related virus that was less virulent in humans (e.g., cowpox/horsepox or rotavirus vaccines) or the culturing of a virus _in vitro_ [@doi:10.1377/hlthaff.24.3.611; @doi:10.1073/pnas.1400472111].
+Today, a virus can be attenuated by passaging it in a foreign host until, due to selection pressure, the virus loses its efficacy in the original host.
+Alternatively, selective gene deletion or codon deoptimization can be utilized to attenuate the virus [@doi:10.1038/s41586-020-2798-3], or foreign antigens can be integrated into an attenuated viral vector [@doi:10.1038/s41586-020-3035-9].
+LAVs tend to be restricted to viral replication in the tissues around the location of inoculation [@doi:10.1128/9781555818951], and some can be administered intranasally [@doi:10.1038/s41586-020-2798-3].
+
 Today, LAVs are used globally to prevent diseases caused by viruses such as measles, rubella, polio, influenza, varicella zoster, and the yellow fever virus [@doi:10.1016/B978-0-323-35761-6.00002-X].
 There were attempts to develop LAVs against both SARS-CoV-1 and MERS-CoV [@doi:10.3389/fimmu.2020.602256], but no vaccines were approved.
 It is generally recognized that LAVs induce an immune response similar to natural infection, and they are favored because they induce long-lasting and robust immunity that can protect from disease.
@@ -3674,23 +3685,24 @@ These candidates utilize different approaches.
 One candidate in the preclinical stage is YF-S0, a single-dose LAV developed at Belgium's Katholieke Universiteit Leuven that uses live-attenuated yellow fever 17D (YF17D) as a vector for a noncleavable prefusion conformation of the SARS-CoV-2 antigen [@doi:10.1038/s41586-020-3035-9].
 YF-S0 induced a robust immune response in three animal models and prevented SARS-CoV-2 infection in macaques and hamsters [@doi:10.1038/s41586-020-3035-9].
 
-Other programs are exploring the development of codon deoptimized LAV [@url:https://news.griffith.edu.au/2020/04/23/griffith-university-researchers-on-the-road-to-covid-19-vaccine; @url:https://covid-19tracker.milkeninstitute.org; @doi:10.1073/pnas.2102775118].
-This approach followed the synthetic attenuated virus engineering (SAVE) strategy to select codon substitutions that are suboptimal for the virus [@doi:10.1126/science.1155761; @doi:10.1073/pnas.2102775118].
+Other programs are developing codon deoptimized LAV candidates [@url:https://news.griffith.edu.au/2020/04/23/griffith-university-researchers-on-the-road-to-covid-19-vaccine; @url:https://covid-19tracker.milkeninstitute.org; @doi:10.1073/pnas.2102775118].
+This approach follows the synthetic attenuated virus engineering (SAVE) strategy to select codon substitutions that are suboptimal for the virus [@doi:10.1126/science.1155761; @doi:10.1073/pnas.2102775118].
 New York-based Codagenix and the Serum Institute of India reported a successful preclinical investigation [@doi:10.1073/pnas.2102775118] of an intranasally administered deoptimized SARS-CoV-2 LAV known as COVI-VAC, and COVI-VAC entered phase I human trials and dosed its first participants in January 2021 [@url:https://covid-19tracker.milkeninstitute.org; @clinicaltrials:NCT04619628].
 This vaccine is optimized through the removal of the furin cleavage site (see [@individual-pathogenesis] for a discussion of this site's importance) and deoptimization of 283 codons [@pmc:PMC8644885].
 The results of the COVI-VAC phase I human trials are expected soon.
 
-Another company, Meissa Vaccines in Kansas, U.S.A., which also develops vaccines for respiratory syncytial virus (RSV), has developed an intranasal live-attenuated chimeric vaccine.
+Another company, Meissa Vaccines in Kansas, U.S., which also develops vaccines for respiratory syncytial virus (RSV), has developed an intranasal live-attenuated chimeric vaccine.
 Chimeric vaccines integrate genomic content from multiple viruses to create a more stable LAV [@doi:10.3389/fmicb.2019.02881].
 Enrollment for phase I human trials began in March 2021 and recruitment is ongoing [@url:https://covid-19tracker.milkeninstitute.org; @clinicaltrials:NCT04798001].
 
-Finally, Bacillus Calmette-Guerin (BCG) vaccines that use LAVs are being investigated for the prophylaxis of COVID-19 (see Appendix). <!-- What are we doing with the appendix? Are we submitting it with one of the vaccines manuscripts? Should we link the Manubot version? -->
+Finally, Bacillus Calmette-Guerin (BCG) vaccines that use LAVs are being investigated for the prophylaxis of COVID-19 (see online Appendix [@url:https://greenelab.github.io/covid19-review]).
 The purpose of the BCG vaccine is to prevent tuberculosis, but non-specific effects against other respiratory illnesses have suggested a possible benefit against COVID-19 [@doi:10.1038/s41577-020-0337-y].
-However, a multicenter trial that randomly assigned participants 60 years and older to vaccination with BCG (n = 1008) or placebo (n = 1006) after 12 months of follow-up found that BCG vaccination had no effect on the incidence of SARS-CoV-2 or other respiratory infections [@doi:10.1093/cid/ciac182].
+However, a multicenter trial that randomly assigned participants 60 years and older to vaccination with BCG (n = 1,008) or placebo (n = 1,006) found that BCG vaccination had no effect on the incidence of SARS-CoV-2 or other respiratory infections over the course of 12 months [@doi:10.1093/cid/ciac182].
 Despite these negative findings, BCG vaccination did induce a stronger antibody and cytokine response following COVID-19 infection.
 Currently, investigations of BCG vaccines against COVID-19 are being sponsored by institutes in Australia in collaboration with the Bill and Melinda Gates Foundation [@clinicaltrials:NCT04327206] and by Texas A&M University in collaboration with numerous other U.S. institutions [@clinicaltrials:NCT04348370].
 
-While data is not yet available for human studies, in general, safety concerns previously associated with LAV have been largely mitigated in the modern manufacturing process.
+Safety data is not yet available for human studies of LAV COVID-19 vaccines.
+In general, though, safety concerns previously associated with LAV have been largely mitigated in the modern manufacturing process.
 Manufacturers use safe and reliable methods to produce large quantities of vaccines once they have undergone rigorous preclinical studies and clinical trials to evaluate their safety and efficacy.
 However, one remaining safety concern may be contributing to the relatively slow emergence of LAV candidates against COVID-19: they still may present risk to individuals who are immunocompromised [@doi:10.1016/j.copbio.2007.10.010], which is an even greater concern when dealing with a novel virus and disease.
 Additional data are needed to ascertain how this technology performs in the case of SARS-CoV-2.
@@ -3698,24 +3710,25 @@ Despite the long and trusted history of LAV development, this vaccine strategy h
 
 #### Response to Variants of Concern
 
-While no phase 3 trial data is available for LAV vaccine candidates, some manufacturers have proactively sought to respond to the emergence of VOC.
+While no phase III trial data is available for LAV vaccine candidates, some manufacturers have proactively sought to respond to the emergence of VOC.
 For example, a poster reported that Syrian golden hamsters who received COVI-VAC were significantly less likely to lose weight following viral challenge with the Beta VOC [@pmc:PMC8644885].
 Additionally, the protective effect of YF-S0 against VOC has been investigated in hamsters [@doi:10.1101/2021.11.12.468374].
 Even for a small number of hamsters that developed breakthrough infections after exposure to the index strain or the Alpha variant, viral loads were very low [@doi:10.1101/2021.11.12.468374].
 However, much higher rates of breakthrough infection and higher viral loads were observed when the hamsters were exposed to the Beta variant [@doi:10.1101/2021.11.12.468374].
-Reduced seroconversion and nAb titers were also observed against the Beta and Gamma variants [@doi:10.1101/2021.11.12.468374].
+Reduced seroconversion and neutralizing antibody (nAb) titers were also observed against the Beta and Gamma variants [@doi:10.1101/2021.11.12.468374].
 As a result, a modified version of YF-S0, called YF-S0\*, was developed to include a modified spike protein intended to increase immunogenicity by including the full spectrum of amino acids found in the Gamma VOC as well as stabilizing the S protein's conformation [@doi:10.1101/2021.11.12.468374].
 No breakthrough infections were observed following vaccination with YF-S0 and exposure to the index strain and the Alpha, Beta, Gamma, and Delta variants [@doi:10.1101/2021.11.12.468374].
-YF-S0* also reduced viral shedding for several VOC relative to YF-S0 [@doi:10.1101/2021.11.12.468374], and it was also observed to produce significantly more nAbs against the Omicron variant [@doi:10.1101/2021.11.12.468374].
-Therefore, while data from human studies are not available, preclinical results suggest that LAV vaccines likely confer some protection against VOC even when designed with the index strain and that modifications to the design may make this protection more robust as SARS-CoV-2 evolves.
+YF-S0\* also reduced viral shedding for several VOC relative to YF-S0 [@doi:10.1101/2021.11.12.468374], and it was also observed to produce significantly more nAbs against the Omicron variant [@doi:10.1101/2021.11.12.468374].
+Therefore, while data from human studies are not available, preclinical results suggest that LAV vaccines likely confer some protection against VOC even when designed with the index strain.
+Modifications to the design may make this protection more robust as SARS-CoV-2 evolves.
 
 ### Inactivated Whole-Virus Vaccines
 
 Inactivated whole-virus (IWV) vaccines are another well-established vaccine platform.
-This type of vaccines uses full virus particles generally produced via cell culture that have been rendered non-infectious by chemical (i.e., formaldehyde or &beta;-propiolactone [@doi:10.1080/14760584.2017.1357471]) or physical (i.e., heat or ultraviolet radiation) means.
+This platform uses full virus particles generally produced via cell culture that have been rendered non-infectious by chemical (i.e., formaldehyde or &beta;-propiolactone [@doi:10.1080/14760584.2017.1357471]) or physical (i.e., heat or ultraviolet radiation) means.
 In general, these vaccines mimic the key properties of the virus that stimulate a robust immune response, but the risk of adverse reactions is reduced because the virus is inactivated and thus unable to replicate.
 Though these viral particles are inactivated, they retain the capacity to prime the immune system.
-The size of the virus particle makes it ideal for uptake by an antigen-presenting cell, which leads to the stimulation of helper T-cells [@doi:10.1038/nri2868].
+The size of the viral particle makes it ideal for uptake by antigen-presenting cells, which leads to the stimulation of helper T-cells [@doi:10.1038/nri2868].
 Additionally, the array of epitopes on the surface of the virus increases antibody binding efficiency [@doi:10.1038/nri2868].
 The native conformation of the surface proteins, which is also important for eliciting an immune response, is preserved using these techniques [@doi:10.1016/j.virusres.2007.03.025].
 Membrane proteins, which support B-cell responses to surface proteins, are also induced by this method [@doi:10.1084/jem.164.4.1114].
@@ -3726,8 +3739,8 @@ Inactivated vaccines can generally be generated relatively quickly once the path
 
 Past applications to human coronaviruses (HCoV) have focused predominantly on SARS-CoV-1.
 Preclinical studies have demonstrated that IWV SARS-CoV-1 vaccine candidates elicited immune responses _in vivo_.
-These vaccines generated neutralizing antibody titers at concentrations similar to those evoked by recombinant protein vaccines [@doi:10.1002/rmv.492; @doi:10.1016/j.virusres.2007.03.025].
-Studies in ferrets and non-human primates demonstrated that IWV vaccines can offer protection against infection due to neutralizing antibody and SARS-CoV-1-specific T cell responses [@doi:10.1093/intimm/dxh143].
+These vaccines generated nAb titers at concentrations similar to those evoked by recombinant protein vaccines [@doi:10.1002/rmv.492; @doi:10.1016/j.virusres.2007.03.025].
+Studies in ferrets and non-human primates demonstrated that IWV vaccines can offer protection against infection due to nAb and SARS-CoV-1-specific T cell responses [@doi:10.1093/intimm/dxh143].
 However, several attempts to develop IWV vaccines against both SARS-CoV-1 and MERS-CoV were hindered by incidences of vaccine-associated disease enhancement (VADE) in preclinical studies [@doi:10.1038/s41579-020-00462-y].
 In one example of a study in macaques, an inactivated SARS-CoV-1 vaccine induced even more severe lung damage than the virus due to an enhanced immune reaction [@doi:10.1021/acsinfecdis.6b00006].
 Independent studies in mice also demonstrated evidence of lung immunopathology due to VADE in response to MERS-CoV IWV vaccination [@doi:10.1080/21645515.2016.1177688; @doi:10.1128/mBio.00554-20].
@@ -3735,19 +3748,7 @@ The exact mechanisms responsible for VADE remain elusive due to the specificity
 
 #### Application to COVID-19
 
-Several whole-virus vaccines have been developed against COVID-19 and are available in countries around the world (Table @tbl:approved-whole-virus).
-As of August 11, 2022, 10 vaccines developed with IWV technology are being distributed in 116 countries (Figure @fig:iwv-distrib).
-
-![
-**Worldwide availability of vaccines developed using inactivated whole viruses.**
-This figure reflects the number of vaccines based on whole inactivated virus technology that were available in each country as of August 11, 2022.
-These data are retrieved from Our World in Data [@url:https://ourworldindata.org/coronavirus] and plotted using geopandas [@doi:10.5281/zenodo.5573592].
-See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/inactivated.png "Availability of inactivated whole virus vaccines"){#fig:iwv-distrib secno=1}
-
-<!-- Need to refer to this table in the text somewhere. May make sense to add it to the sentence that refers to the figure to point out how many are distributed and that more are approved (if that is the correct interpretation). -->
-
-Table: Inactivated whole-virus vaccines approved in at least one country [@url:https://covid19.trackvaccines.org/types-of-vaccines] as of August 10, 2022
+Table: Inactivated whole-virus vaccines approved in at least one country [@url:https://covid19.trackvaccines.org/types-of-vaccines] as of August 15, 2022.
 {#tbl:approved-whole-virus}
 
 | Vaccine                  | Company                                                   |
@@ -3764,45 +3765,60 @@ Table: Inactivated whole-virus vaccines approved in at least one country [@url:h
 | CoronaVac                | Sinovac                                                   |
 | VLA2001                  | Valneva                                                   |
 
+Several whole-virus vaccines have been developed against COVID-19 and are available in countries around the world (Table @tbl:approved-whole-virus).
+As of August 15, 2022, 10 vaccines developed with IWV technology are being distributed in 116 countries (Figure @fig:iwv-distrib).
+
+![
+**Worldwide availability of vaccines developed using inactivated whole viruses.**
+This figure reflects the number of vaccines based on whole inactivated virus technology that were available in each country as of August 15, 2022.
+These data are retrieved from Our World in Data [@url:https://ourworldindata.org/coronavirus] and plotted using geopandas [@doi:10.5281/zenodo.5573592].
+See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/inactivated.png "Availability of inactivated whole virus vaccines"){#fig:iwv-distrib secno=1}
+
 One of those, CoronaVac, was developed by Beijing-based biopharmaceutical company Sinovac.
 The developers inactivated a SARS-CoV-2 strain collected in China with &beta;-propiolactone and propagated it using Vero cells [@doi:10.3389/fimmu.2020.602256].
 The vaccine is coupled with an aluminum adjuvant to increase immunogenicity [@doi:10.3389/fimmu.2020.602256].
-In phase I and II clinical trials, CoronaVac elicited a strong immunogenic response in animal models and the development of neutralizing antibodies in human participants [@doi:10/fx8z; @doi:10.1126/science.abc1932; @doi:10/fpcx].
+In phase I and II clinical trials, CoronaVac elicited a strong immunogenic response in animal models and the development of nAbs in human participants [@doi:10/fx8z; @doi:10.1126/science.abc1932; @doi:10/fpcx].
 Administration followed a prime-boost regimen using a 0.5 ml dose containing 3 &mu;g of inactivated SARS-CoV-2 virus per dose [@url:https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE_recommendation-Sinovac-CoronaVac-background-2021.1].
-Results from a two-dose phase III trial following a 14-day prime boost became available in late 2020 [@doi:10/gk898z], and an interim analysis identified specific IgG neutralizing antibodies against the S1 receptor binding domain (RBD) and a robust IFN-&gamma; secreting T cell response was induced via immunization with CoronaVac [@doi:10.1101/2021.03.31.21254494].
+
+Results from a two-dose phase III trial following a 14-day prime boost became available in late 2020 [@doi:10/gk898z], and an interim analysis identified specific IgG nAbs against the S1 receptor binding domain (RBD) and a robust IFN-&gamma; secreting T cell response was induced via immunization with CoronaVac [@doi:10.1101/2021.03.31.21254494].
 Safety analysis of the CoronaVac vaccine during the phase II trial revealed that most adverse reactions were either mild (grade 1) or moderate (grade 2) in severity.
 In adults aged 18 to 59 years receiving a variety of dosage schedules, site injection pain was consistently the most common symptom reported [@doi:10/fpcx].
 In older adults, the most common local and systemic reactions were pain at the injection site (9%) and fever (3%), respectively [@doi:10/fx8z].
 In phase III trials, minimal side effects were reported [@doi:10/gk898z].
-CoronaVac was approved for use in China and has been granted emergency use in XX countries, including Brazil, Cambodia, Chile, Colombia, Laos, Malaysia, Mexico, Turkey, Ukraine, and Uruguay [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html; @doi:10.1038/s41562-021-01122-8].<!--Add template variable (still need this, ~and [82] is hard-coded~) -->
+
+Estimates of CoronaVac's VE have varied across trials.
+CoronaVac demonstrated an efficacy of a little over 50% in Brazil, which was contested by Turkish officials claiming an efficacy of 91.25%, but ultimately after multiple announcements, the efficacy debate was settled at over 50% [@url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR; @url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html].
+Subsequently, an interim analysis of the phase III randomized placebo-controlled trials conducted in Turkey enrolling 10,214 participants (approximately 2:1 vaccine:placebo) indicated efficacy of 83.5%, with minimal side effects reported [@doi:10/gk898z], and a prospective national cohort study in Chile reported an adjusted estimated effectiveness of 66% for the prevention of COVID-19 with an estimated 90% and 87% prevention of hospitalization and death, respectively [@doi:10.1056/NEJMoa2107715].
+
+CoronaVac was first approved in China and has now been distributed in 63 countries across Africa, Asia, Europe, North America, and South America, including Brazil, Cambodia, Chile, Colombia, Laos, Malaysia, Mexico, Turkey, Ukraine, and Uruguay [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html; @doi:10.1038/s41562-021-01122-8].
 As of August 2021, Sinovac had reportedly produced over a billion doses of CoronaVac [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
 
 Two additional inactivated vaccine candidates were developed following a similar approach by the state-owned China National Pharmaceutical Group Co., Ltd., more commonly known as Sinopharm CNBG.
-One, known as BBIBP-CorV or Covilo, was developed in Beijing using the HB02 variant of SARS-CoV-2. <!-- We should make these easier to match to the rows in the table above. The name in the Vaccine column isn't similar to what we have in the text here, so we could add a cross-reference or synonym in the text. -->
+One, known as BBIBP-CorV or Covilo, was developed in Beijing using the HB02 variant of SARS-CoV-2.
 At Sinopharm CNBG's Wuhan Institute, a second vaccine was developed using the WIV04 variant of SARS-CoV-2 [@doi:10.1038/s41541-021-00292-w].
 The viruses were purified, propagated using Vero cells, isolated, and inactivated using β-propiolactone [@doi:10.1016/j.cell.2020.06.008; @doi:10.1038/s41541-021-00292-w].
 Both vaccines are adjuvanted with aluminum hydroxide [@doi:10.1016/j.cell.2020.06.008; @doi:10.1038/s41541-021-00292-w].
-Preclinical studies indicated that Covilo induced sufficient neutralizing antibody titers in mice, and a prime-boost immunization scheme of 2 &mu;g/dose was sufficient to protect rhesus macaques from disease [@doi:10.1016/j.cell.2020.06.008].
-For the other vaccine, neutralizing antibodies were detected in all groups 14 days after the final dose in the phase I part of the trial [@doi:10.1001/jama.2020.15543], with similar findings reported in interim phase II data [@doi:10.1001/jama.2020.15543].
+
+Preclinical studies indicated that Covilo induced sufficient nAb titers in mice, and a prime-boost immunization scheme of 2 &mu;g/dose was sufficient to protect rhesus macaques from disease [@doi:10.1016/j.cell.2020.06.008].
+For the other vaccine, nAbs were detected in all groups 14 days after the final dose in the phase I part of the trial [@doi:10.1001/jama.2020.15543], with similar findings reported in interim phase II data [@doi:10.1001/jama.2020.15543].
 In phase II trials, the BBIBP-CorV vaccine appeared well-tolerated, with 23% of participants in the vaccine condition (482 total participants, 3:1, vaccine:placebo) reporting at least one adverse reaction characterized as mild to moderate [@doi:10/ghjkrf].
 In phase III trials, Sinopharm CNBG's Covilo vaccine made from the WIV04 strain achieved an efficacy of 72.8% and was well tolerated [@doi:10.1001/jama.2021.8565].
-In July 2021, Covaxin’s overall vaccine efficacy was estimated at 77.8% for the prevention of COVID-19 based on a final enrollment of 25,798 people (approximately 1:1 vaccine:placebo) [@doi:10/gmns9m].
-However, some discrepancies arose in the reporting of VE.
 Sinopharm affiliates in the UAE in early December 2020 claimed the vaccine had 86% efficacy, which was later at odds with a Sinopharm Beijing affiliate that stated that Covilo had a 79.34% efficacy later that same month [@url:https://www.reuters.com/article/health-coronavirus-china-vaccine-int-idUSKBN2940CA].
 
-Other programs have been led through industry partnerships with governmental organizations.
-Another IWV vaccine comes from India, where Bharat Biotech International Ltd., which is the biggest producer of vaccines globally, collaborated with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV) to develop Covaxin, also referred to as BBV152.
+Other vaccine development programs have been led through industry partnerships with governmental organizations.
+Bharat Biotech International Ltd., which is the biggest producer of vaccines globally, collaborated with the Indian Council of Medical Research (ICMR) National Institute of Virology (NIV) to develop another IWV, Covaxin, which is also known as BBV152.
 Preclinical studies of Covaxin in hamsters [@doi:10.21203/rs.3.rs-76768/v1] and macaques [@doi:10.1038/s41467-021-21639-w] indicated that the vaccine induced protective responses deemed sufficient to move forward to human trials.
 Phase I and phase I/II studies indicated that Covaxin adjuvanted with alum and a Toll-like receptor 7/8 (TLR7/8) agonist was safe and immunogenic and that it induced Th1-skewed memory T-cell responses [@doi:10/gkrthh; @doi:10/gh7597].
-Only mild to moderate side-effects reported upon immunization [@doi:10/gkrthh; @doi:10/gh7597].
-CoronaVac demonstrated an efficacy of a little over 50% in Brazil, which was contested by Turkish officials claiming an efficacy of 91.25%, but ultimately after multiple announcements, the efficacy debate was settled at over 50% [@url:https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil/brazil-institute-says-coronavac-efficacy-above-50-but-delays-full-results-idUSKBN28X2CR; @url:https://www.nytimes.com/2020/12/25/health/turkey-brazil-sinovac-coronavirus-vaccine.html].
-Subsequently, an interim analysis of the phase III randomized placebo-controlled trials conducted in Turkey enrolling 10,214 participants (approximately 2:1 vaccine:placebo) indicated efficacy of 83.5%, with minimal side effects reported [@doi:10/gk898z], and a prospective national cohort study in Chile reported an adjusted estimated effectiveness of 66% for the prevention of COVID-19 with an estimated 90% and 87% prevention of hospitalization and death, respectively [@doi:10.1056/NEJMoa2107715].
-As of September 2021, Covaxin has been approved for emergency use in Guyana, India, Iran, Zimbabwe, Nepal, Mauritius, Mexico, Nepal, Paraguay, and the Philippines [@url:https://covid19.trackvaccines.org/vaccines/9].<!--automate-->
+Only mild to moderate side-effects were reported upon immunization [@doi:10/gkrthh; @doi:10/gh7597].
+In July 2021, Covaxin’s overall vaccine efficacy was estimated at 77.8% for the prevention of COVID-19 based on a final enrollment of 25,798 people (approximately 1:1 vaccine:placebo) [@doi:10/gmns9m].
+Only mild to moderate side-effects reported upon immunization [@doi:10/gkrthh; @doi:10/gh7597], and in phase II trials, the BBIBP-CorV vaccine appeared well-tolerated, with 23% of participants in the vaccine condition (482 total participants, 3:1, vaccine:placebo) reporting at least one adverse reaction characterized as mild to moderate [@doi:10/ghjkrf].
+As of September 2021, Covaxin has been approved for emergency use in 30 countries across Africa, Asia, Europe, and South America, including Guyana, India, Iran, Zimbabwe, Nepal, Mauritius, Mexico, Nepal, Paraguay, and the Philippines [@url:https://covid19.trackvaccines.org/vaccines/9].
 
-Although IWV vaccine candidates were well-tolerated overall, both SinoVac's CoronaVac and SinoPharm's inactivated WIV04 vaccine trials were affected by concerns about adverse events.
+Although IWV vaccine candidates were well-tolerated overall, both Sinovac's CoronaVac and Sinopharm's inactivated WIV04 vaccine trials were affected by concerns about adverse events.
 In CoronaVac’s trial of adults 18-59, 2% (n=7) of participants reported severe adverse events [@doi:10/fx8z], causing the trial to be halted for investigation [@url:https://www.nytimes.com/interactive/2020/health/sinovac-covid-19-vaccine.html].
 They were determined to be unrelated to the vaccine [@doi:10/fx8z; @url:https://www.nytimes.com/interactive/2020/health/sinovac-covid-19-vaccine.html], which is now widely distributed.
-Similarly, a trial of the SinoPharm WIV04 vaccine in Peru was briefly paused due to safety concerns in relation to neurological symptoms [@url:https://www.nytimes.com/live/2020/12/16/world/covid-19-coronavirus], but this was later deemed unrelated to the vaccine, and the trial continued [@clinicaltrials:NCT04612972].
+Similarly, a trial of the Sinopharm WIV04 vaccine in Peru was briefly paused due to safety concerns in relation to neurological symptoms [@url:https://www.nytimes.com/live/2020/12/16/world/covid-19-coronavirus], but this was later deemed unrelated to the vaccine, and the trial continued [@clinicaltrials:NCT04612972].
 
 #### Real-World Safety and Efficacy
 
@@ -3817,27 +3833,25 @@ Rare cases of VADE have been reported in association with CoronaVac [@doi:10.115
 More concern has arisen around the issue of efficacy.
 One of the major limitations of IWV vaccines is their susceptibility to losing efficacy due to mutations in the epitopes of the circulating virus [@doi:10.3389/fimmu.2019.00594].
 This loss of specificity over time is likely to be influenced by the evolution of the virus, and specifically by the rate of evolution in the region of the genome that codes for the antigen.
-
-The Beta variant appears to be more resistant to neutralizing antibodies in sera from individuals immunized with Sinovac than the Alpha variant or wildtype virus, indicating that emerging variants may be of concern [@doi:10.1056/nejmc2103022].
+The Beta variant appears to be more resistant to nAbs in sera from individuals immunized with Sinovac than the Alpha variant or wildtype virus, indicating that emerging variants may be of concern [@doi:10.1056/nejmc2103022].
 In agreement with previous studies demonstrating sera from individuals vaccinated with Covaxin efficiently neutralized the Alpha variant (B.1.1.7) and the Delta variant (B.1.617.2) [@doi:10.1101/2021.07.30.454511; @doi:10.1093/jtm/taab104; @doi:10.1093/jtm/taab051], the phase III trial reported a 65.2% efficacy against the Delta variant (B.1.617.2) [@doi:10.1101/2021.06.30.21259439].
-However, studies suggested the Beta variant was more resistant (compared to the wildtype and Alpha variants) to neutralizing antibodies in sera from individuals immunized with Sinovac [@doi:10.1056/NEJMc2103022].
-Another preprint determined that sera from individuals immunized with Covaxin had effective neutralizing antibodies against the Delta variant and the so-called Delta plus variant (AY.1) [@doi:10.1101/2021.07.30.454511].
+However, studies suggested the Beta variant was more resistant (compared to the wildtype and Alpha variants) to nAbs in sera from individuals immunized with Sinovac [@doi:10.1056/NEJMc2103022].
+Another preprint determined that sera from individuals immunized with Covaxin had effective nAbs against the Delta variant and the so-called Delta plus variant (AY.1) [@doi:10.1101/2021.07.30.454511].
 Indeed, sera obtained from Covaxin boosted individuals (n = 13) [@doi:10.1101/2022.01.24.22269189] and those who were vaccinated with Covaxin but recovered from a breakthrough infection (n=31) also neutralized the Omicron variant [@doi:10.1016/j.jinf.2022.03.016].
 
-Notably, a preprint reported that antisera (i.e., the antibody-contained component of the sera) from 12 people immunized with BBIBP-CorV exhibited neutralizing antibody capacity against the Beta variant (B.1.351), wild type SARS-CoV-2 (NB02), and one of the original variants of SARS-CoV-2 (D614G) [@doi:10.1101/2021.02.01.429069].
-Another preprint including sera from 282 participants used a surrogate neutralizing assay, a test that generally correlates with neutralizing antibodies, to determine that Covilo appears to induce neutralizing antibodies against the binding of the RBD of wild type SARS-CoV-2 and the Alpha, Beta, and Delta variants to ACE2 [@doi:10.1101/2021.07.15.21260621].
+Notably, a preprint reported that antisera (i.e., the antibody-containing component of the sera) from 12 people immunized with BBIBP-CorV exhibited nAb capacity against the Beta variant (B.1.351), wild type SARS-CoV-2 (NB02), and one of the original variants of SARS-CoV-2 (D614G) [@doi:10.1101/2021.02.01.429069].
+Another preprint including sera from 282 participants used a surrogate neutralizing assay, a test that generally correlates with nAbs, to determine that Covilo appears to induce nAbs against the binding of the RBD of wild type SARS-CoV-2 and the Alpha, Beta, and Delta variants to ACE2 [@doi:10.1101/2021.07.15.21260621].
 Indeed, a study showed that the Alpha variant exhibited very little resistance to neutralization by sera of those immunized with Covilo, but the Beta variant was more resistant to neutralization by almost a factor of 3 [@doi:10.1056/NEJMc2103022].
 The authors noted that no evidence of VADE was detected using this vaccine in phase II data [@doi:10.1001/jama.2020.15543].
 
 Concern was raised about the efficacy of CoronaVac following reports that over 350 doctors became ill with COVID-19 in Indonesia despite being immunized with CoronaVac [@url:https://www.nytimes.com/2021/06/22/business/economy/china-vaccines-covid-outbreak.html].
 In addition to concerns raised by the evolution of SARS-CoV-2, it is important to consider the duration of immunity over time.
 Studies are underway to determine whether a booster immunization is required for several IWV vaccines, including CoronaVac [@clinicaltrials:NCT04962308] and Covaxin [@url:https://www.hindustantimes.com/india-news/covaxin-booster-dose-what-is-it-what-does-govt-say-about-this-101625644184446.html].
-A phase I/II clinical trial of CoronaVac in an elderly cohort (adults 60 years and older) in China determined that by 6 to 8 months following the second dose, neutralizing antibody titers were detected below the seropositive cutoff [@doi:10.1101/2021.08.03.21261544].
-One preprint has reported that 6 months after the second vaccination, a booster dose of CoronaVac markedly increased geometric mean titers of SARS-CoV-2 neutralizing antibodies [@doi:10.1101/2021.07.23.21261026].
-However, the reduction of neutralizing antibodies was ameliorated by a booster dose administered 8 months after the second CoronaVac dose.
-
-A preprint study of healthcare workers in China has since indicated that a booster shot of Covilo elevates B cell and T cell responses and increases neutralizing antibody titers [@doi:10.1101/2021.09.12.21263373].
-In May 2021, the UAE announced it would consider booster shots for all citizens who had been immunized with Covilo, which was shortly followed by a similar announcement in Bahrain, and by August 29^th^, 2021, the UAE mandated booster shots for all residents who had received Covilo [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
+A phase I/II clinical trial of CoronaVac in an elderly cohort (adults 60 years and older) in China determined that by 6 to 8 months following the second dose, nAb titers were detected below the seropositive cutoff [@doi:10.1101/2021.08.03.21261544].
+One preprint has reported that 6 months after the second vaccination, a booster dose of CoronaVac markedly increased geometric mean titers of SARS-CoV-2 nAbs [@doi:10.1101/2021.07.23.21261026].
+However, the reduction of nAbs was ameliorated by a booster dose administered 8 months after the second CoronaVac dose.
+A preprint study of healthcare workers in China has since indicated that a booster shot of Covilo elevates B cell and T cell responses and increases nAb titers [@doi:10.1101/2021.09.12.21263373].
+In May 2021, the UAE announced it would consider booster shots for all citizens who had been immunized with Covilo, which was shortly followed by a similar announcement in Bahrain, and by August 29, 2021, the UAE mandated booster shots for all residents who had received Covilo [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
 
 Additionally, heterologous vaccine boosters are also being considered in many cases.
 Indeed, Chinese [@url:https://medicalxpress.com/news/2021-08-china-mixed-vaccine-trial-delta.html] and Chilean [@url:https://clinicaltrials.gov/ct2/show/NCT04992182] researchers have opted to investigate options to administer different vaccines (e.g., an mRNA vaccine dose) as a booster dose to individuals who have already received two doses of the IWV vaccine CoronaVac.
@@ -3849,17 +3863,21 @@ Today, booster immunization is suggested for several whole-virus vaccines.
 Efforts to overcome the limitations of live-virus vaccines led to the development of approaches first to inactivate viruses (circa 1900), leading to IWV vaccines, and then to purifying proteins from viruses cultured in eggs (circa 1920) [@doi:10.1073/pnas.1400472111; @doi:10.1073/pnas.1402981111].
 The purification of proteins then set the stage for the development of subunit vaccines based on the principle that the immune system can be stimulated by introducing one or more proteins or peptides isolated from the virus.
 Today, such approaches often use antigens isolated from the surface of the viral particle that are key targets of the immune system (protein subunit vaccines).
-Protein subunit vaccines can stimulate antibodies and CD4^+^ T-cell responses [@doi:10.1007/978-1-4615-1823-5; @doi:10/dg35hw].
-Advances in biological engineering have also facilitated the development of approaches like viral-like particle (VLP) vaccines, which assemble viral proteins using nanotechnology to induce an immune response [@doi:10.1007/978-1-4939-1417-3_9; @doi:10.1186/s12951-021-00806-7].
+Advances in biological engineering have also facilitated the development of approaches like viral-like particle (VLP) vaccines using nanotechnology [@doi:10.1007/978-1-4939-1417-3_9].
+VLPs share the conformation of a virus's capsid, thereby acting as an antigen, but lack the replication machinery [@doi:10/dg35hw].
+Both protein subunit and VLP vaccines thus mimic the principle of whole virus vaccines but lack the genetic material required for replication, removing the risk of infection [@doi:10.1186/s12951-021-00806-7].
 
-The main advantage of subunit approaches is they are considered very safe, as the antigen alone cannot cause an infection [@doi:10.1016/j.addr.2021.01.001; @doi:10.1186/s12951-021-00806-7].
+Unlike whole-virus vaccines, which introduce the whole virus, subunit vaccines stimulate the immune system by introducing one or more proteins or peptides of the virus that have been isolated.
+The main advantage of this platform is that subunit vaccines are considered very safe, as the antigen alone cannot cause an infection [@doi:10.1016/j.addr.2021.01.001].
 Both protein subunit and VLP vaccines thus mimic the principle of whole virus vaccines but lack the genetic material required for replication, removing the risk of infection [@doi:10.1186/s12951-021-00806-7].
+Protein subunit vaccines can stimulate antibodies and CD4^+^ T-cell responses [@doi:10.1007/978-1-4615-1823-5; @doi:10/dg35hw].
+
 The subunit approach is also favored for its consistency in production.
 The components can be designed for a highly targeted immune response to a specific pathogen using synthetic immunogenic particles, allowing the vaccine to be engineered to avoid allergen and reactogenic sequences [@doi:10.3390/vaccines2030515].
-One limitation is that, in the case of protein subunit vaccines, adjuvants are usually required to boost the immune response [@doi:10.1517/14712598.2011.573624] (see Appendix).
+One limitation is that, in the case of protein subunit vaccines, adjuvants are usually required to boost the immune response [@doi:10.1517/14712598.2011.573624] (see online Appendix [@url:https://greenelab.github.io/covid19-review]).
 These adjuvants are immunogenic substances, which include, for example, alum (aluminum hydroxide), squalene- or saponin-based adjuvants, and Freund’s incomplete/complete adjuvants [@doi:10.1016/j.vaccine.2019.04.055; @doi:10.3390/vaccines2030515].
 
-Table: Subunit vaccines approved for use in at least one country [@url:https://covid19.trackvaccines.org/types-of-vaccines] as of August 10, 2022.
+Table: Subunit vaccines approved for use in at least one country [@url:https://covid19.trackvaccines.org/types-of-vaccines] as of August 15, 2022.
 {#tbl:approved-subunit}
 
 | Vaccine                                   | Company                                                    | Platform        |
@@ -3882,9 +3900,10 @@ Table: Subunit vaccines approved for use in at least one country [@url:https://c
 | Aurora-CoV                                | Vector State Research Center of Virology and Biotechnology | protein subunit |
 | EpiVacCorona                              | Vector State Research Center of Virology and Biotechnology | protein subunit |
 
-Protein subunit vaccine development efforts for both SARS-CoV-1 and MERS-CoV have mostly focused on the immunogenic RBD of the S protein [@doi:10.1016/j.vaccine.2006.06.084; @doi:10.1016/j.vaccine.2006.10.031; @doi:10.1089/vim.2009.0090].
-There have been several approaches investigated in the search for a potential SARS-CoV-1 vaccine, including vaccines targeting the full-length or trimeric S protein [@doi:10.1128/JVI.00083-06; @doi:10.1089/vim.2012.0076], those focused on the RBD protein only [@doi:10.1016/j.vaccine.2006.10.031; @doi:10.1016/j.bbrc.2009.05.003; @doi:10.1089/vim.2009.0090; @doi:10.1016/j.vaccine.2006.06.084] or non-RBD S protein fragments [@doi:10.1089/vim.2012.0076; @doi:10.1089/dna.2005.24.510], as well as the N and M proteins [@doi:10.1128/jcm.43.8.3718-3726.2005; @doi:10.1016/j.vaccine.2009.05.073; @doi:10.1016/j.vaccine.2006.01.058]; these efforts have been thoroughly reviewed elsewhere [@doi:10.3389/fmicb.2020.00298].
-There have been examples of successful preclinical research including candidate RBD219N-1, a 218-amino-acid residue of the SARS-CoV-1 RBD that, when adjuvanted to aluminum hydroxide, was capable of eliciting a high RBD-specific and neutralizing antibody response in both pseudovirus and live virus infections of immunized mice [@doi:10.4161/hv.27464].
+Protein subunit vaccine development efforts for both SARS-CoV-1 and MERS-CoV usually focused on the immunogenic RBD of the S protein [@doi:10.1016/j.vaccine.2006.06.084; @doi:10.1016/j.vaccine.2006.10.031; @doi:10.1089/vim.2009.0090].
+The search for a potential SARS-CoV-1 vaccine included the development of vaccines targeting the full-length or trimeric S protein [@doi:10.1128/JVI.00083-06; @doi:10.1089/vim.2012.0076], those focused on the RBD protein only [@doi:10.1016/j.vaccine.2006.10.031; @doi:10.1016/j.bbrc.2009.05.003; @doi:10.1089/vim.2009.0090; @doi:10.1016/j.vaccine.2006.06.084] or non-RBD S protein fragments [@doi:10.1089/vim.2012.0076; @doi:10.1089/dna.2005.24.510], and those targeting the N and M proteins [@doi:10.1128/jcm.43.8.3718-3726.2005; @doi:10.1016/j.vaccine.2009.05.073; @doi:10.1016/j.vaccine.2006.01.058].
+These efforts have been thoroughly reviewed elsewhere [@doi:10.3389/fmicb.2020.00298].
+There have been examples of successful preclinical research including candidate RBD219N-1, a 218-amino-acid residue of the SARS-CoV-1 RBD that, when adjuvanted to aluminum hydroxide, was capable of eliciting a high RBD-specific and nAb response in both pseudovirus and live virus infections of immunized mice [@doi:10.4161/hv.27464].
 Other strategies investigating the potential use of the full length S DNA have also been investigated in mice and rhesus macaques, which elicited immune responses [@doi:10.1038/ncomms8712], but these responses were not as effective as the combination of S DNA and the S1 subunit protein together [@doi:10.1038/ncomms8712; @doi:10.1016/j.antiviral.2016.07.015].
 
 Similarly to the SARS-CoV-1 vaccine candidates, the MERS-CoV protein subunit vaccine candidates generally target the RBD [@doi:10.3389/fmicb.2020.00298; @doi:10.1016/j.vaccine.2006.10.031; @doi:10.1016/j.ebiom.2015.08.031; @doi:10.1371/journal.pone.0112602; @doi:10.1016/j.vaccine.2018.02.065; @doi:10.1016/j.virol.2016.10.005], with some targeting the full length S protein [@doi:10.1073/pnas.1707304114], non-RBD protein fragments such as the SP3 peptide [@doi:10.1089/vim.2014.0080], and the recombinant N-terminal domain (rNTD) [@doi:10.1016/j.vaccine.2016.11.064].
@@ -3895,25 +3914,26 @@ However, protein subunit vaccines do play a role in public health and have contr
 #### Application to COVID-19
 
 The development of subunit vaccines against SARS-CoV-2 is a remarkable achievement given the short period of time since the emergence of SARS-CoV-2 in late 2019, particularly considering these types of vaccines have not played a major role in previous pandemics.
-More than 20 protein subunit vaccines from companies such as Sanofi/GlaxoSmithKline, Nanogen, and the Serum Institute of India have entered clinical trials for COVID-19 since the beginning of the pandemic [@url:https://covid19.trackvaccines.org/vaccines], 17 have been approved, and at least 10 are being administered worldwide [@doi:10.1038/s41562-021-01122-8; @url:https://covid19.trackvaccines.org]. <!-- Check template variable -->
-As of August 11, 2022, protein subunit vaccines are being distributed in at least 41 countries (Figure @fig:ps-distrib).
+More than 20 protein subunit vaccines from companies such as Sanofi/GlaxoSmithKline, Nanogen, and the Serum Institute of India have entered clinical trials for COVID-19 since the beginning of the pandemic [@url:https://covid19.trackvaccines.org/vaccines], 17 have been approved, and at least 10 are being administered worldwide [@doi:10.1038/s41562-021-01122-8; @url:https://covid19.trackvaccines.org].
+As of August 15, 2022, protein subunit vaccines are being distributed in at least 41 countries (Figure @fig:ps-distrib).
 
 ![
 **Worldwide availability of vaccines developed using protein subunit.**
-This figure reflects the number of vaccines based on protein subunit technology that were available in each country as of August 11, 2022.
+This figure reflects the number of vaccines based on protein subunit technology that were available in each country as of August 15, 2022.
 These data are retrieved from Our World in Data [@url:https://ourworldindata.org/coronavirus; @doi:10.1038/s41562-021-01122-8] and plotted using geopandas [@doi:10.5281/zenodo.5573592].
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/protein_subunit.png "Availability of protein subunit vaccines"){#fig:ps-distrib secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/protein_subunit.png "Availability of protein subunit vaccines"){#fig:ps-distrib secno=1}
 
-VLP vaccines have not progressed as rapidly: no data was available for worldwide distribution of VLP vaccines as of August 11, 2022 [@doi:10.1038/s41562-021-01122-8].
-Most of these vaccines are designed using either the full-length S protein or the RBD of the S protein specifically as an antigen, although some use several different SARS-CoV-2 proteins [@doi:10.1016/j.addr.2021.01.001].
+VLP vaccines have not progressed as rapidly.
+Programs seeking to develop VLP vaccines have used either the full-length S protein or the RBD of the S protein specifically as an antigen, although some use several different SARS-CoV-2 proteins [@doi:10.1016/j.addr.2021.01.001].
+As of August 15, 2022, only one VLP was available in one country (Canada) [@doi:10.1038/s41562-021-01122-8].<!--Canada/Covifenz info is hardcoded-->
 
 ![
 **Worldwide availability of vaccines developed with VLPs.**
-This figure reflects the number of vaccines based on VLP technology that were available in each country as of August 11, 2022.
+This figure reflects the number of vaccines based on VLP technology that were available in each country as of August 15, 2022.
 These data are retrieved from Our World in Data [@url:https://ourworldindata.org/coronavirus] and plotted using geopandas [@doi:10.5281/zenodo.5573592].
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/VLP.png "Availability of protein subunit vaccines"){#fig:vlp-distrib secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/VLP.png "Availability of protein subunit vaccines"){#fig:vlp-distrib secno=1}
 
 #### Nuvaxovid
 
@@ -3922,46 +3942,43 @@ NVX-CoV2373 is a protein nanoparticle vaccine constructed from a mutated prefusi
 The spike protein is recombinantly expressed in Sf9 insect cells [@doi:10.1038/s41467-020-20653-8], which have previously been used for several other FDA-approved protein therapeutics [@doi:10.1021/acs.iecr.8b00985], and contains mutations in the furin cleavage site (682-RRAR-685 to 682-QQAQ-685) along with two proline substitutions (K986P and V987P) that improve thermostability [@doi:10.1038/s41467-020-20653-8].
 
 In preclinical mouse models, Novavax-CoV2373 elicited high anti-spike IgG titers 21 to 28 days post-vaccination that could neutralize the SARS-CoV-2 virus and protect the animals against viral challenge, with particularly strong effects when administered with the proprietary adjuvant Matrix-M^TM^ [@doi:10.1038/s41467-020-20653-8].
-In a phase I/II trial, a two-dose regimen of NVX-CoV2373 was found to induce anti-spike IgG levels and neutralizing antibody-titers exceeding those observed in convalescent plasma donated by symptomatic patients [@doi:10.1056/NEJMoa2026920].
+In a phase I/II trial, a two-dose regimen of NVX-CoV2373 was found to induce anti-spike IgG levels and nAb titers exceeding those observed in convalescent plasma donated by symptomatic patients [@doi:10.1056/NEJMoa2026920].
 In line with the preclinical studies, the use of Matrix-M adjuvant further increased anti-spike immunoglobulin levels and induced a Th1 response.
-In a phase III randomized, observer-blinded, placebo-controlled clinical trial in 14,039 participants, two 5-&mu;g doses of NVX-CoV2373 or placebo were administered 21 days apart in a 1:1 ratio from late September to late November 2020 [@doi:10.1056/nejmoa2107659]. 
-The VE was estimated at 89.7% overall [@doi:10.1056/nejmoa2107659].
+In a phase III randomized, observer-blinded, placebo-controlled clinical trial in 14,039 participants, two 5-&mu;g doses of NVX-CoV2373 or placebo were administered 21 days apart in a 1:1 ratio from late September to late November 2020 [@doi:10.1056/nejmoa2107659].
 
 In the phase III trial, the efficacy of Novavax's Nuvaxovid was reported to be 89.7%, with a total of 10 patients developing COVID-19 in the vaccine group versus 96 in the placebo group [@doi:10.1056/NEJMoa2107659].
 No hospitalizations or deaths were reported in the vaccine group.
 An additional phase III randomized, observer-blinded, placebo-controlled trial was conducted in the U.S. and Mexico, enrolling 29,949 participants and administering at least 1 vaccine in a 2:1 ratio from late December 2020 to late February 2021 with the same primary endpoints as the U.K. trial [@doi:10.1101/2021.10.05.21264567].
 A vaccine efficacy of 90.4% was reported based on 77 cases total, 63 of which occurred in the placebo group.
 All moderate to severe cases of COVID-19 occurred in the placebo group.
-Additionally, in both trials, the vaccine was found to be well-tolerated [@doi:10.1101/2021.10.05.21264567; @doi:10.1056/NEJMoa2107659].
-The conclusions of both trials indicate that the NVX-CoV2373 vaccine is safe and effective against COVID-19, and those who received this vaccine through the trials were considered fully vaccinated prior to the vaccine receiving an EUA [@url:https://ir.novavax.com/Novavax-Statement-on-UK-and-Mexico-Phase-3-Clinical-Trial-Participants-Considered-Fully-Vaccinated-in-the-US].
-The Novavax vaccine has since been authorized for use in several places, including the United Kingdom [@url:https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra], the E.U. [@url:https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu], and the U.S.A [@url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted].
-<!-- Need to indicate it is EUA? What have we been doing elsewhere? Deleted the line below about the June FDA vote, the actual EUA didn't come until July. -->.
+
+The conclusions of both trials indicate that the NVX-CoV2373 vaccine is safe and effective against COVID-19.
+In both trials, the vaccine was found to be well-tolerated [@doi:10.1101/2021.10.05.21264567; @doi:10.1056/NEJMoa2107659].
+The Novavax vaccine has since been authorized for use in several places, including the United Kingdom [@url:https://www.gov.uk/government/news/novavax-covid-19-vaccine-nuvaxovid-approved-by-mhra], the E.U. [@url:https://www.ema.europa.eu/en/news/ema-recommends-nuvaxovid-authorisation-eu], and the U.S. [@url:https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted].
 
 #### Covifenz
 
 The leading example of a VLP approach applied to COVID-19 comes from Covifenz, developed by Canadian company Medicago [@doi:10.1503/cmaj.1095992].
 This vaccine was developed using plant-based VLP technology [@url:https://medicago.com/en/our-products/our-vaccines/covifenz-covid-19-vlp-vaccine] that the company had been investigating in order to develop a high-throughput quadrivalent VLP platform to provide protection against influenza [@doi:10/gjn28x].
-
 The approach utilizes _Nicotiana benthamiana_, an Australian relative of the tobacco plant, as an upstream bioreactor [@doi:10/gjn28x; @doi:10.1038/s41591-021-01370-1].
 Specifically, the _S_ gene from SARS-CoV-2 in its prefusion conformation is inserted into a bacterial vector (_Agrobacterium tumefaciens_) that then infects the plant cells [@doi:10/gjn28x; @doi:10.1038/s41591-021-01370-1].
 Expression of the S glycoprotein causes the production of VLPs composed of S trimers anchored in a lipid envelope that accumulate between the plasma membrane and the cell wall of the plant cell [@doi:10.1038/s41591-021-01370-1].
 Because these VLPs do not contain the SARS-CoV-2 genome, they offer similar advantages to whole-virus vaccines while mitigating the risks [@doi:10/gjn28x; @doi:10.1038/s41591-021-01370-1].
 
-In the phase I study, Covifenz was administered to 180 Canadian adults 18-55 years old as two doses, 21 days apart, with three different dosages evaluated [@doi:10.1038/s41591-021-01370-1].
-This study reported that when the VLPs were administered with an adjuvant, the vaccine elicited a neutralizing antibody that was significantly (approximately 10 times) higher than that in convalescent sera [@doi:10.1038/s41591-021-01370-1].
+In the phase I study, 180 Canadian adults ages 18 to 55 years old were administered Covifenz as two doses, 21 days apart, with three different dosages evaluated [@doi:10.1038/s41591-021-01370-1].
+This study reported that when the VLPs were administered with an adjuvant, the vaccine elicited a nAb that was significantly (approximately 10 times) higher than that in convalescent sera [@doi:10.1038/s41591-021-01370-1].
 The phase III trial examined 24,141 adults assigned to the treatment and control conditions at a 1:1 ratio between March and September of 2021 [@doi:10.1056/NEJMoa2201300].
-Similarly, Covifenz was reported to be 71% effective in preventing COVID-19 in the per-protocol analysis [@doi:10.1056/NEJMoa2201300].
-Efficacy was only slightly lower in the intention-to-treat group at 69%.
-Prevention of moderate-to-severe disease was estimated at 78.8% in the intention-to-treat group.
+
+Covifenz was reported to be 71% effective in preventing COVID-19 in the per-protocol analysis [@doi:10.1056/NEJMoa2201300].
+Efficacy was only slightly lower in the intention-to-treat group at 69%, with the VE for the prevention of moderate-to-severe disease in this group estimated at 78.8%.
 Over 24,000 participants were included in the safety analysis, which reported that 92.3% of vaccine recipients reported local adverse events compared to 45.5% of placebo recipients, with rates for systemic adverse events at 87.3% and 65.0%, respectively.
-However, the adverse effects reported were generally mild to moderate.
+The adverse effects reported were generally mild to moderate, with the most common adverse effects being injection site pain, headache, myalgia, fatigue, and general discomfort.
 Only three patients (two in the vaccine group) reported grade 4 events, all after the second dose.
-The most common adverse effects were injection site pain, headache, myalgia, fatigue, and general discomfort.
 The vaccine was approved for use in adults ages 18 to 65 by Health Canada in February 2022 [@url:https://www.gsk.com/en-gb/media/press-releases/medicago-and-gsk-announce-the-approval-by-health-canada-of-covifenz].
 
 Plant-based expression systems such as this are relatively new [@doi:10.1038/s41591-021-01370-1] but are likely to offer unparalleled feasibility at scale given the speed and low-cost associated with the platform [@doi:10.1111/j.1467-7652.2008.00384.x].
 Additionally, the Covifenz vaccine can be stored at 2 to 8&#176;C.
-However, the worldwide footprint of Covifenz, and of VLP-based technologies against SARS-CoV-2 broadly, remains small, with only 1 VLP vaccine approved for distribution in 1 countries (Figure @fig:vlp-distrib).<!--Grammar needs update if anyone outside of Canada approves or if another VLP becomes active--><!--Check automation-->
+However, the worldwide footprint of Covifenz, and of VLP-based technologies against SARS-CoV-2 broadly, remains small, with only 1 VLP vaccine approved for distribution in 1 countries (Figure @fig:vlp-distrib).
 Approval and administration of Covifenz in countries outside of Canada has been limited by concerns at the WHO about ties between Medicago and the tobacco industry [@doi:10.1503/cmaj.1095992; @doi:10.1136/bmj.o811].
 While other species of plants have been explored as the upstream bioreactors for plant-derived VLPs, the specific species of tobacco used increased yield dramatically [@doi:10.4161/hv.22218].
 
@@ -3975,7 +3992,7 @@ In late 2020, an analysis of efficacy in South African adults revealed an overal
 Additionally, an analysis of a booster dose of NVX-CoV2373 administered six months after the primary series revealed a significant increase in neutralizing activity of VOC including Delta and Omicron [@doi:10.1101/2021.12.23.21267374].
 It has also been reported that Novavax initiated booster trials in the U.K. [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
 
-Because the Covifenz results became available relatively recently (May 4, 2022), limited data is available since the publication of phase III trial results [@doi:10.1056/NEJMoa2201300].
+Because the Covifenz results became available relatively recently (May 2022), limited data is available since the publication of phase III trial results [@doi:10.1056/NEJMoa2201300].
 However, it should be noted that the Covifenz trials were conducted in 2021, at a time during which the B.1.617.2 (Delta) and P.1 (Gamma) variants were predominant [@doi:10.1056/NEJMoa2201300].
 Genomic analysis of 122 out of 176 cases (165 in the per-protocol population) revealed that none of the COVID-19 cases reported were caused by the original Wuhan strain.
 Instead, 45.9% of cases were identified as the Delta variant, 43.4% as Gamma, 4.9% as Alpha, and 5.8% as VOIs.
@@ -3986,8 +4003,8 @@ Therefore, the efficacy data from this phase III trial may be lower than it woul
 The unprecedented deployment of COVID-19 vaccines in under a year from the identification of SARS-CoV-2 led to a new challenge: the formation of rapid global vaccine production and distribution plans.
 The development of vaccines is costly and complicated, but vaccine distribution can be just as challenging.
 Logistical considerations such as transport, storage, equipment (e.g., syringes), the workforce to administer the vaccines, and a continual supply from the manufacturers to meet global demands all must be accounted for and vary globally due to economic, geographic, and sociopolitical reasons [@doi:10.1016/j.eclinm.2020.100674; @doi:10.1126/science.abe2803; @doi:10.1126/sciadv.abf1374].
-As of August 11, 2022, at least  vaccine doses had been administered in at least 223 countries worldwide using 29 different vaccines [@url:https://ourworldindata.org/coronavirus].<!--check owid_total_countries variable-->
-The daily global vaccination rate at this time was . <!-- Check template variable -->
+As of August 9, 2022, at least 12.0 billion vaccine doses had been administered in at least 223 countries worldwide using 29 different vaccines [@url:https://ourworldindata.org/coronavirus].>
+The daily global vaccination rate at this time was 745.0 per million.
 
 However, the distribution of these doses is not uniform around the globe.
 As of May 2022, vaccination rates remained lower in South America (3.1 per 100), Asia (1.9 per 100), Africa (0.3 per 100), and Oceania (0.1 per 100) than in North America, Europe, and Australia [@url:https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html].
@@ -4001,37 +4018,40 @@ However, the initiative has been less successful than was initially hoped due to
 Additionally, the vaccine technologies available differ widely around the globe.
 As we review elsewhere [@individual-vaccines-novel], wealthier nations have invested heavily in mRNA and DNA vaccines.
 In contrast, as we describe above, many countries outside of Europe and North America have developed highly effective vaccines using more traditional approaches.
-As a result, there is a clear relationship between a country's gross domestic product (GDP) and its access to vaccines (Figure @fig:gdp-scatter).
+As a result, there is a clear relationship between a country's gross domestic product (GDP) and its access to vaccines (Figure @fig:gdpscatter).
 
 ![
 **Vaccine Distribution across Platform Types as a Function of GDP.**
-As of August 11, 2022, the number of doses distributed, by platform type, is shown as a function of GDP.
+As of August 15, 2022, the number of doses distributed, by platform type, is shown as a function of GDP.
 These data are retrieved from Our World in Data [@url:https://ourworldindata.org/coronavirus; @doi:10.1038/s41562-021-01122-8] and plotted using the Python package plotnine [@url:https://github.com/has2k1/plotnine].
 Lines show a general trend in the data and are drawn using geom_smooth [@url:https://ggplot2.tidyverse.org/reference/geom_smooth.html].
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
 Axes are not scaled per capita because both variables would be expected to be modulated by population size.
-]( "Distribution of vaccines according to GDP"){#fig:gdp-scatter secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/OWID_doseTypebyGDP.png "Distribution of vaccines according to GDP"){#fig:gdpscatter secno=1}
 
 <!-- Figure is not rendering -->
 
 When vaccines first became available, the wealthy nations of North America and Europe secured most of the limited COVID-19 vaccine stocks [@url:https://www.nytimes.com/2020/12/15/us/coronavirus-vaccine-doses-reserved.html].
 Throughout 2021, low- and middle-income countries faced steep competition with high-income countries for vaccines, and the rates of vaccination reflected this unequal distribution [@doi:10.1002/hpm.3341].
 While the wealthiest countries in these regions could compete with each other for vaccines independent of programs such as COVAX [@doi:10.1002/hpm.3341], other countries in these regions have faced challenges in acquiring vaccines developed by the world's wealthiest nations.
-
 Fortunately, while mRNA and DNA vaccine development programs are not widespread, vaccine development using whole-virus and subunit technologies has been undertaken worldwide.
-Still, many African nations are reliant on the COVAX Facility, who have promised 600 million doses to the continent [@url:https://www.bbc.com/news/56100076].
+China and India, in particular, have developed several vaccines that are now widely available in these densely populated countries (see online Appendix [@url:https://greenelab.github.io/covid19-review]).
+
+Still, many nations, especially in Africa, are reliant on the COVAX Facility, who have promised 600 million doses to the continent [@url:https://www.bbc.com/news/56100076].
 The COVAX plan seeks to ensure that all participating countries would be allocated vaccines in proportion to their population sizes.
 Once each country has received vaccine doses to account for 20% of their population, the country’s risk profile will determine its place in subsequent phases of vaccine distribution.
 However, several limitations of this framework exist, including that the COVAX scheme seems to go against the WHO’s own ethical principles of human well-being, equal respect, and global equity and that other frameworks might have been more suitable [@doi:10.1136/bmj.m4853].
 Furthermore, COVAX is supposed to allow poorer countries access to affordable vaccines, but the vaccines are driven by publicly traded companies that are required to make a profit [@url:https://www.nytimes.com/2020/12/25/business/coronavirus-vaccines-global-economy.html].
+
 In any case, COVAX provides access to COVID-19 vaccines that may otherwise have been difficult for some countries to obtain.
 COVAX aimed to distribute 2 billion vaccine doses globally by the end of 2021 [@url:https://www.who.int/initiatives/act-accelerator/covax].
-According to GAVI, as of January 2022, COVAX had distributed over 1 billion vaccines to 144 participants of the program [@url:https://www.gavi.org/covax-vaccine-roll-out], short of its target but still a major global achievement.
+According to Gavi, as of January 2022, COVAX had distributed over 1 billion vaccines to 144 participants of the program [@url:https://www.gavi.org/covax-vaccine-roll-out], short of its target but still a major global achievement.
 It is envisaged that COVAX may also receive additional donations of doses from Western nations who purchased surplus vaccines in the race to vaccinate their populations, which will be a welcome boost to the vaccination programs of low- and middle-income countries [@doi:10.1126/science.abh4476].
 
 In general, deciding on the prioritization and allocation of the COVID-19 vaccines is also a challenging task due to ethical and operational considerations.
 Various frameworks, models, and methods have been proposed to tackle these issues with many countries, regions, or U.S. states devising their own distribution and administration plans [@doi:10.1126/science.abe6959; @doi:10.1038/s41598-020-78447-3; @doi:10.1016/j.vaccine.2020.12.059; @doi:10.1136/medethics-2020-107036; @doi:10.1101/2021.01.12.21249694].
 The majority of the distribution plans prioritized offering vaccines to key workers such as health care workers and those who are clinically vulnerable, such as the elderly, the immunocompromised, and individuals with comorbidities, before targeting the rest of the population, who are less likely to experience severe outcomes from COVID-19 [@url:https://ourworldindata.org/covid-vaccination-policy].
+The availability of vaccines developed in a variety of countries using a variety of platforms is likely to work in favor of worldwide vaccine access.
 
 ### Conclusions
 
@@ -4042,8 +4062,221 @@ Similarly, these technologies were explored for MERS-CoV, but outbreaks were spo
 However, in the COVID-19 pandemic, most of these technologies have been used to accelerate vaccine development programs worldwide.
 Therefore, they are also offering the opportunity to respond quickly to an emergent pathogen.
 
-While these tried-and-true technologies don't always produce vaccines with the highly desirable VE reported in mRNA clinical trials (which exceeded >90%), the efficacies are still very high, and these vaccines are extremely effective at preventing severe illness and death.
-As a result, the greater accessibility and stability of these vaccines makes them still valuable at a global level.
+While these tried-and-true technologies don't always produce vaccines with the highly desirable VE reported in mRNA clinical trials (which exceeded 90%), the efficacies are still very high, and these vaccines are extremely effective at preventing severe illness and death.
+As a result, the greater accessibility and stability of these vaccines makes them extremely valuable for the global effort to mitigate the loss of life from SARS-CoV-2.
+
+
+## Appendix: Additional Information about Established Vaccine Platforms for COVID-19
+
+### Sinovac's CoronaVac
+
+The CoronaVac vaccine was developed by Sinovac, a Beijing-based biopharmaceutical company.
+The vaccine uses an inactivate whole virus with the addition of an aluminum adjuvant [@doi:10.3389/fimmu.2020.585354].
+Pre-clinical trials were performed using BALB/c mice and rhesus macaques [@doi:10.1126/science.abc1932].
+The SARS-CoV-2 strains used in this trial isolated from 11 hospitalized patients (5 from China, 3 from Italy, 1 from the United Kingdom (U.K.), 1 from Spain, 1 from Switzerland).
+A phylogenetic analysis demonstrated that the strains were representative of the variants circulating at the time.
+One of the strains from China, CN2, was used as the inactivated and purified virus while the other 10 strains were used to challenge.
+CN2 was grown in Vero cells.
+The immunogenicity of the vaccine candidate was evaluated with an ELISA assay.
+Ten mice were injected with the vaccine on day 0 and day 7 with varying doses (0, 1.5, 3, or 6 &mu;g), and 10 mice were treated with physiological saline as the control.
+IgG developed in the serum of all vaccinated mice.
+
+Using the same setup, immunogenicity was also assessed in macaques.
+Four macaques were assigned to each of four groups: treatment with 3 &mu;g at day 0, 7, and 14, treatment with a high dose of 6 &mu;g at day 0, 7, and 14, administration of a placebo vaccine, and administration of only the adjuvant.
+All vaccinated macaques induced IgGs and neutralizing antibodies.
+After challenge with SARS-CoV-2 strain CN1, vaccinated macaques were protected compared to control macaques (placebo or adjuvant only) based on histology and viral loads collected from different regions of the lung.
+
+Phase I/II clinical trials were conducted in adults 18-59 years old [@doi:10/fpcx] and adults over 60 years old [@doi:10/fx8z] in China.
+In the case of adults 18-59 years old, a single center, randomized, double-blind, placebo-controlled phase I/II trial was conducted in April 2020.
+Patients in this study were recruited from the community in Suining County of Jiangsu province, China.
+For the phase I trial, 144 (of 185 screened) participants were enrolled, with 72 enrolled in the 14-day interval cohort (i.e., treated on day 0 and day 14) and 72 in the 28-day interval cohort.
+This group of 72 participants was split into 2 blocks for a low-dose (3 &mu;g) and high-dose (6 &mu;g) vaccine.
+Within each block, participants were randomly assigned vaccination with CoronaVac or placebo (aluminum diluent without the virus) at a 2:1 ratio.
+Both the vaccine and placebo were prepared in a Good Manufacturing Practice-accredited facility of Sinovac Life Sciences (Beijing, China).
+
+The phase II trial followed the same organization of participants, this time using 300 enrolled participants in the 14-day and another 300 enrolled in the 28-day groups.
+One change of note was that the vaccine was produced using a highly automated bioreactor (ReadyToProcess WAVE 25, GE, Ume&aring;, Sweden) to increase vaccine production capacity.
+This change resulted in a higher intact spike protein content.
+The authors of this study were not aware of this antigen-level difference between the vaccine batches for the phase I/II when the ethical approval for the trials occurred.
+
+To assess adverse responses, participants were asked to record any events up to 7 days post-treatment.
+The reported adverse events were graded according to the China National Medical Products Administration guidelines.
+In the phase I trial, the overall incidence of adverse reactions was 29-38% of patients in the 0 to 14 day group and 13-17% in the 0 to 28 day vaccination group.
+The most common symptom was pain at the injection site, which was reported by 17-21% of patients in the 0 to 14 day cohort and 13% in the 0 to 28 day cohort.
+Most adverse reactions were mild (grade 1), with patients recovering within 48 hours.
+A single case of acute hypersensitivity with manifestation of urticaria 48 hours following the first dose of study drug was reported in the 6 &mu;g group
+Both the 14-day and 28-day cohorts had a strong neutralizing antibody (Ab) response.
+The neutralizing Ab response was measured using a micro cytopathogenic effect assay, which assesses the minimum dilution of neutralizing Ab to be 50% protective against structural changes in host cells in response to viral infection [@doi:10.1016/j.vaccine.2012.03.010].
+Additionally IgG antibody titers against the receptor binding domain were also measured using ELISA.
+
+Another phase I/II study was performed with older patients (over 60 years of age) [@doi:10/fx8z].
+The study conducted a single-center, randomized, double-blind, placebo-controlled trial.
+The phase I trial looked at dose escalation using 3 dosages: 1.5, 3, and 6 &mu;g.
+The mean age of participants was 65.8 years (standard deviation = 4.8).
+Of 95 screened participants, 72 were enrolled.
+These 72 participants were split into low (3 &mu;g) and high (6 &mu;g) dose groups.
+Within each group, 24 participants received the treatment and 12 the placebo.
+A neutralizing antibody response against live SARS-CoV-2 was detected compared to baseline using the same micro cytopathogenic effect assay.
+This response was similar across the two dose concentrations.
+Additionally, they did not observe a difference in response between age groups (60–64 years, 65–69 years, and ≥70 years).
+
+In phase II the mean age was 66.6 years (standard deviation = 4.7).
+499 participants were screened and 350 were enrolled.
+300 were evenly split into 1.5, 3, and 6 &mu;g dose groups, and the remaining 50 were assigned to the placebo group.
+Again, they found a neutralizing antibody response in phase II.
+There wasn't a significant different between the response to 3 &mu;g versus 6 &mu;g, but the response in both these conditions was higher than in the 1.5 &mu;g condition.
+
+Participants were required to record adverse reaction events within the first 7 days after each dose.
+The safety results were combined across phase I and II.
+All adverse reactions were either mild (grade 1) or moderate (grade 2) in severity.
+The most common symptom was pain at the injection site (9%) and fever (3%).
+2% (7 participants) reported severe adverse events (4 from the 1.5 &mu;g group, 1 from the 3 &mu;g group, 2 from the 6 &mu;g group), though these were found to be unrelated to the vaccine.
+
+Overall, the results from the pre-clinical and phase I/II clinical trials were promising, especially the fact that the immune response was consistent in older adults (> 60 years).
+Additional phase III trials were conducted in Brazil in a randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial enrolling nearly 10,000 healthcare workers [@doi:10.1186/s13063-020-04775-4; @doi:10.2139/ssrn.3822780].
+As of September 2021, CoronaVac trials are now also being held in the Philippines and Hong Kong, bringing the total number of registered phase III trials investigating the safety and efficacy of CoronaVac to 9, with emergency use approval in 40 countries [@url:https://covid19.trackvaccines.org/vaccines/7].
+CoronaVac also appears to be suitable for use in immunocompromised patients such as those with autoimmune rheumatic diseases according to phase IV trials [@doi:10.1038/s41591-021-01469-5], and the vaccine was also well tolerated and induced humoral responses in phase I trials in children aged 3 to 17 years, which will now be examined in phase II and III clinical trials [@doi:10/gn93].
+
+### Covaxin
+
+In India, the Covaxin vaccine received emergency authorization on January 3, 2021, despite the lack of phase III data until March 3, 2021, which was communicated via press release [@url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf].
+Following a press release of the phase III data indicating 80.6% efficacy in 25,800 participants [@url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf; @url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf], Zimbabwe authorized the use of Covaxin [@url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm].
+This was followed by a detailed preprint of the double-blind, randomized, controlled phase III trial that was made available in July 2021, with a final enrollment of 25,798 people (~1:1 vaccine:placebo) [@doi:10.1101/2021.06.30.21259439].
+The vaccine was reported as well tolerated, with an overall vaccine efficacy of 77.8% for the prevention of COVID-19.
+Efficacy against severe disease and asymptomatic infection was reported as 93.4% and 63.6% respectively.
+
+It is not yet clear what level of protection Covaxin offers beyond 6 to 8 months post the second vaccine; consequently, the potential requirement of a booster immunization is being explored [@url:https://www.hindustantimes.com/india-news/covaxin-booster-dose-what-is-it-what-does-govt-say-about-this-101625644184446.html].
+Furthermore, Bharat Biotech is considering other vaccine regimens such as providing one initial immunization with Covaxin followed by two immunizations with its intranasal vaccine (BBV154) [@url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html].
+U.S.-based Ocugen Inc., a co-development partner of Bharat Biotech, is leading the application for an Emergency Use Authorization (EUA) for Covaxin intended for the U.S. market.
+It has been reported that Bharat Biotech will soon release its phase II and III pediatric trial results [@url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms].
+However, the WHO approval of the Covaxin has been delayed [@url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23].
+
+### Sinopharm's Clinical Trials of Two Vaccine Candidates
+
+Sinopharm Wuhan Institute developed their SARS-CoV-2 inactivated vaccine using the WIV04 strain isolated from a patient at the Jinyintan Hospital in Wuhan, China [@doi:10.1038/s41541-021-00292-w].
+This vaccine was also passaged in Vero cells, inactivated using &beta;-propiolactone, and was adjuvanted with aluminum hydroxide.
+This vaccine is administered intramuscularly using 5 &mu;g of virus per dose.
+Preclinical data providing supporting evidence for the use of this vaccine is not available publicly.
+Despite the lack of publicly available preclinical results, Sinopharm Wuhan Institute initiated phase I/II trials, which reported on varying dosing and prime-boost regimens.
+
+A combined phase I/II RCT of Sinopharm's BBIBP-CorV, also known as Covilo, followed [@doi:10/ghjkrf].
+In phase I, 192 participants were randomized with varying doses of 2 &mu;g, 4 &mu;g, or 8 &mu;g/dose or a placebo, and they received the same as a second dose 28 days later.
+Approximately 29% of participants reported at least 1 adverse event, most commonly fever, and neutralizing antibody titers were reported for all doses.
+In the phase II trial, 482 participants were enrolled (3:1, vaccine:placebo).
+Participants in the vaccine condition received either a single 8 &mu;g dose or a double immunization of a 4 &mu;g/dose that was administered 14, 21, or 28 days post the prime dose.
+Participants in the placebo condition received the placebo on one of the same four schedules.
+The vaccine appeared well-tolerated, with 23% reporting at least one adverse reaction characterized as mild to moderate.
+It was reported that all participants had a humoral immune response to the vaccines by day 42 but that the double immunization dosing regimen of 4 &mu;g/dose achieved higher neutralizing antibody titers than a single dose of 8 &mu;g and that the highest response was seen in the double-immunization regimen when at least 21 days separated the two doses [@doi:10/ghjkrf].
+Similar findings were reported in another phase I/II trial published by the same authors [@doi:10.1001/jama.2021.8565].
+
+### Novavax's Nuvaxovid (NVX-CoV2373)
+
+Novavax's Nuvaxovid is a particularly appealing candidate because the improved stability caused by the proline substitutions is particularly critical to facilitating global distribution, particularly to regions where local refrigerator/freezer capacities are limited.
+Importantly, these amino acid substitutions did not affect the ability of the spike protein to bind the hACE2 receptor (the target receptor of SARS-CoV-2 spike protein).
+The Novavax-CoV2373 vaccine candidate uses a proprietary, saponin-based Matrix-M^TM^ adjuvant that contains two different 40nm-sized particles formed by formulating purified saponin with cholesterol and phospholipids [@doi:10.1007/s12026-018-8991-x].
+In preclinical models, the use of the Matrix-M adjuvant potentiated the cellular and humoral immune responses to influenza vaccines [@doi:10.1016/j.vaccine.2013.01.039; @doi:10.1016/j.vaccine.2009.09.044; @doi:10.1111/j.1750-2659.2011.00256.x; @doi:10.1007/s12026-018-8991-x].
+Importantly, Matrix-M adjuvant-containing vaccines have shown acceptable safety profiles in human clinical trials [@doi:10.1016/j.vaccine.2011.08.042].
+
+Novavax-CoV2373 induced a multifunctional CD4/CD8 T-cell responses and generate high frequencies of follicular helper T-cells and B-cell germinal centers after vaccination.
+These findings were subsequently evaluated in a baboon primate model, in which Novavax-CoV2373 also elicited high antibody titers against the SARS-CoV-2 spike protein, as well as an antigen specific T-cell response.
+Based on this data Novavax initiated a phase I/II clinical trial to evaluate the safety and immunogenicity of Novavax-CoV2373 with Matrix-M [@clinicaltrials:NCT04368988; @doi:10.1056/NEJMoa2026920].
+
+The phase I/II trial was a randomized, placebo-controlled study with 131 healthy adult participants in 5 treatment arms [@doi:10.1056/NEJMoa2026920].
+Participants that received the recombinant SARS-CoV-2 vaccine with or without the Matrix-M adjuvant got two injections, 21 days apart.
+Primary outcomes that were assessed include reactogenicity, lab-values (serum chemistry and hematology), and anti-spike IgG levels.
+Secondary outcomes measured included virus neutralization, T-cell responses, and unsolicited adverse events.
+The authors reported that no serious treatment-related adverse events occurred in any of the treatment arms.
+Reactogenicity was mostly absent and of short duration.
+The two-dose vaccine regimen induced anti-spike IgG levels and neutralizing antibody-titers exceeding those in the convalescent plasma of symptomatic patients.
+The outcomes of this trial suggest that Novavax-CoV2373 has an acceptable safety profile and is able to induce a strong immune response with high neutralizing antibody titers.
+
+The phase II component of the trial was designed to identify the dose regimen for the next clinical trial stage [@doi:10.1371/journal.pmed.1003769].
+Both younger (18-59 years) and older patients (60-84 years) were randomly assigned to receive either 5 &mu;g or 25 &mu;g Novavax-CoV2373 or a sodium-chloride placebo in two doses, 21 days apart.
+In line with the phase I data, reactogenicity remained mild to moderate, with no more than 1% of participants in any group reporting grade 3 AEs, and of short duration.
+Both dose levels were able to induce high anti-spike IgG titers as well as neutralizing antibody responses after the second dose.
+Based on both safety and efficacy data, the 5 &mu;g dosing regimen was selected as the optimal dose regimen for the phase III trial.
+
+Novavax announced an efficacy of 89.3% based on their phase III trial in the U.K. and South Africa [@doi:10.1056/NEJMoa2107659; @url:https://ir.novavax.com/2021-01-28-Novavax-COVID-19-Vaccine-Demonstrates-89-3-Efficacy-in-UK-Phase-3-Trial; @url:https://ir.novavax.com/2021-06-14-Novavax-COVID-19-Vaccine-Demonstrates-90-Overall-Efficacy-and-100-Protection-Against-Moderate-and-Severe-Disease-in-PREVENT-19-Phase-3-Trial].
+This trial included over 15,000 participants in the U.K. and 4,000 participants in South Africa.
+The primary endpoint of the trial was the occurrence or absence of PCR-confirmed, symptomatic mild, moderate or severe COVID-19 from 7 days after the second dose onward.
+In the first interim analysis (U.K.), 56 cases of COVID-19 were observed in the placebo group compared to 6 cases in the treatment group.
+Importantly, the vaccine candidate also shows significant clinical efficacy against the prevalent U.K. and South African variants.
+The company has also initiated the development of new constructs to select candidates that can be used as a booster against new strains and plans to initiate clinical trials for these new constructs in the second quarter of 2021.
+Side effects were monitored in 2,310 participants and were generally considered mild, with low incidences of headache, muscle pain, and fatigue.
+A similar efficacy of 90.4% was subsequently estimated in a phase III trial in the United States in Mexico [@doi:10.1056/NEJMoa2116185].
+
+Given the apparent need for boosters, interest has also emerged in whether vaccines against SARS-CoV-2 can be administered along with annual flu vaccines.
+Early data came from the Novavax NVX-CoV2373 protein subunit vaccine.
+In a subgroup of approximately 400 patients enrolled from the U.K. phase III trial who received either NVX-CoV2373 or placebo 1:1, a concomitant dose of adjuvanted seasonal influenza vaccines (either a trivalent vaccine or a quadrivalent vaccine) was administered [@doi:10.1101/2021.06.09.21258556].
+This study demonstrated that both types of vaccines could be safely administered together.
+While no change to the immune response was noted for the influenza vaccine, a notable reduction of the antibody response for the NVX-CoV2373 was reported, but efficacy was still high at 87.5% [@doi:10.1101/2021.06.09.21258556].
+Novavax has since started phase I/II trials to investigate the administration of its own influenza vaccine, NanoFlu^™^, concomitantly with NVX-CoV2373 [@url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza], which appeared to be safe and effective in preclinical studies [@doi:10.1101/2021.05.05.442782].
+
+### Protein Subunit Vaccine Development Programs Prior to SARS-CoV-2
+
+Earlier studies examined the immunogenicity of a SARS-CoV-1 RBD fused with IgG1 Fc.
+This recombinant fusion protein could induce a robust long-lasting neutralizing antibody and cellular immune response that protected mice from SARS-CoV-1 [@doi:10.3389/fimmu.2020.602256; @doi:10.1016/j.vaccine.2006.10.031; @doi:10.1016/j.vaccine.2006.06.084].
+While there have been other potential protein subunit vaccines for SARS-CoV-1 investigated _in vivo_ [@10.3389/fimmu.2020.602256; @doi:10.3389/fmicb.2020.00298], none of these candidates have successfully completed clinical trials, more than likely due to the fact that the SARS-CoV-1 epidemic mostly ended by May 2004, and there was thus less of a demand or funding for SARS-CoV-1 vaccine research.
+
+Similar vaccine candidates have emerged that target the RBD found in the S1 subunit of the trimeric MERS-CoV S protein, which binds to dipeptidyl-peptidase 4 (DPP4 also known as hCD26), the entry point through which MERS-CoV infects cells [@doi:10.1038/nature12005; @doi:10.1038/nature12328; @doi:10.1128/JVI.01277-13].
+After initially determining that an RBD subunit candidate (S377-588-Fc) could elicit neutralizing antibodies [@doi:10.1371/journal.pone.0081587], a study in mice determined that the administration of three sequential doses of RBD-Fc vaccine coupled with MF59, a squalene immunogenic adjuvant, induced humoral and systemic immunity in mice [@doi:10.1038/cmi.2015.03].
+Mice that had been transduced with Ad5-hCD26 and subsequently challenged with MERS-CoV five days later did not show evidence of viral infection in the lungs versus control mice at ten days post vaccination [@doi:10.1038/cmi.2015.03].
+Other variations of this vaccine approach include a stable S trimer vaccine whereby proline-substituted variants of S2 can maintain a stable prefusion conformation of the S2 domain [@10.3389/fimmu.2020.602256].
+This approach leads to broad and potent neutralizing antibodies [@10.3389/fimmu.2020.602256]
+
+### Complementary Approaches to Vaccine Development
+
+A complementary approach to other vaccine development programs that is being investigated explores the potential for vaccines that are not made from the SARS-CoV-2 virus to confer what has been termed trained immunity.
+In a recent review [@doi:10.1038/s41577-020-0285-6], trained immunity was defined as forms of memory that are temporary (e.g., months or years) and reversible.
+It is induced by exposure to whole-microorganism vaccines or other microbial stimuli that generates heterologous protective effects.
+Trained immunity can be displayed by innate immune cells or innate immune features of other cells, and it is characterized by alterations to immune responsiveness to future immune challenges due to epigenetic and metabolic mechanisms.
+These alterations can take the form of either an increased or decreased response to immune challenge by a pathogen.
+Trained immunity elicited by non-SARS-CoV-2 whole-microorganism vaccines could potentially improve SARS-CoV-2 susceptibility or severity [@doi:10.1016/j.cell.2020.04.042].
+
+One type of stimulus which research indicates can induce trained immunity is bacillus Calmette-Guerin (BCG) vaccination.
+BCG is an attenuated form of bacteria _Mycobacterium bovis_.
+The vaccine is most commonly administered for the prevention of tuberculosis in humans.
+Clinical trials in non-SARS-CoV-2-infected adults have been designed to assess whether BCG vaccination could have prophylactic effects against SARS-CoV-2 by reducing susceptibility, preventing infection, or reducing disease severity.
+A number of trials are now evaluating the effects of the BCG vaccine or the related vaccine VPM1002 [@doi:10.1016/j.cell.2020.04.042; @clinicaltrials:NCT04327206; @clinicaltrials:NCT04328441; @clinicaltrials:NCT04348370; @clinicaltrials:NCT04350931; @clinicaltrials:NCT04362124; @clinicaltrials:NCT04369794; @clinicaltrials:NCT04373291; @clinicaltrials:NCT04379336; @clinicaltrials:NCT04384549; @clinicaltrials:NCT04387409; @clinicaltrials:NCT04414267; @clinicaltrials:NCT04417335; @clinicaltrials:NCT04435379; @clinicaltrials:NCT04439045].
+
+The ongoing trials are using a number of different approaches.
+Some trials enroll healthcare workers, other trials hospitalized elderly adults without immunosuppression who get vaccinated with placebo or BCG at hospital discharge, and yet another set of trials older adults (>50 years) under chronic care for conditions like hypertension and diabetes.
+One set of trials, for example, uses time until first infection as the primary study endpoint; more generally, outcomes measured in some of these trials are related to incidence of disease and disease severity or symptoms.
+Some analyses have suggested a possible correlation at the country level between the frequency of BCG vaccination (or BCG vaccination policies) and the severity of COVID-19 [@doi:10.1016/j.cell.2020.04.042].
+Currently it is unclear whether this correlation has any connection to trained immunity.
+Many possible confounding factors are also likely to vary among countries, such as age distribution, detection efficiency, stochastic epidemic dynamic effects, differences in healthcare capacity over time in relation to epidemic dynamics, and these have not been adequately accounted for in current analyses. <!-- TO DO: add in study that debunks this-->
+It is unclear whether there is an effect of the timing of BCG vaccination, both during an individual's life cycle and relative to the COVID-19 pandemic.
+Additionally, given that severe SARS-CoV-2 may be associated with a dysregulated immune response, it is unclear what alterations to the immune response would be most likely to be protective versus pathogenic (e.g., [@doi:10.1016/j.chom.2020.04.009; @doi:10.1016/j.chom.2020.05.009; @doi:10.1016/j.cell.2020.04.042; @doi:10.1016/j.chom.2020.05.008]).
+The article [@doi:10.1016/j.cell.2020.04.042] proposes that trained immunity might lead to an earlier and stronger response, which could in turn reduce viremia and the risk of later, detrimental immunopathology.
+While trained immunity is an interesting possible avenue to complement vaccine development efforts through the use of an existing vaccine, additional research is required to assess whether the BCG vaccine is likely to confer trained immunity in the case of SARS-CoV-2.
+
+### India and China's Roles in Vaccine Innovation and Development
+
+The nations of China and India have played a major role as COVID-19 vaccination developers and providers.
+Considering India produced approximately 60% of the world's vaccines prior to the pandemic, it is no surprise that the nation has developed and is developing several COVID-19 vaccine candidates.
+In addition to Covaxin, the Bio E subunit vaccine CORBEVAX is being produced by Biological E in collaboration with U.S.-based Dynavax and the Baylor College of Medicine [@url:https://www.bbc.com/news/world-asia-india-55748124].
+These two home-grown vaccines are now approved for adults and children as young as five (CORBEVAX) and six (Covaxin) [@url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581].
+
+Other vaccines licensed by India were developed elsewhere but produced in India.
+For example, Novavax (developed in the United States) has signed an agreement with the Serum Institute of India allowing them to produce up to 2 billion doses a year [@url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI].
+Similarly, many people within India have been vaccinated with the AstraZeneca-University of Oxford vaccine, known as Covishield in India, which is also produced by the Serum Institute of India [@url:https://www.bbc.com/news/world-asia-india-55748124].
+India is also developing vaccines using cutting-edge nucleic-acid-based platforms..
+These include ZyCov-D, a DNA vaccine produced by Zydus Cadila, HGCO19 and India’s first mRNA vaccine, produced by Genova and HDT Biotech Corporation (of the U.S.) [@url:https://www.bbc.com/news/world-asia-india-55748124].
+Additionally, in February 2021, Bharat Biotech received approval from Indian officials to commence a phase I study of an intranasal chimpanzee-adenovirus (ChAd) vectored SARS-CoV-2-S vaccine called BBV154 [@url:https://www.bharatbiotech.com/intranasal-vaccine.html].
+
+In China, the Sinopharm-Beijing Institute vaccine, the Sinopharm-Wuhan Institute of Biological Products vaccine, the Sinovac Biotech (CoronaVac) vaccine, and CanSino Biologics vaccine are the main vaccines being distributed.
+Sinovac and Sinopharm aimed to produce 2 billion doses by the end of 2021, and they have distributed vaccines as aid to the Philippines and Pakistan [@url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html].
+In contrast, the Sinopharm-Wuhan vaccine, which has been approved for use in China since February 25, 2021, has been distributed almost exclusively within China, with limited supplies distributed to the United Arab Emirates [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
+On the same date, the CanSino vaccine was approved for use in China and has been granted emergency use in several other countries [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
+
+However, the vaccine approval and distribution processes in China have come under increased scrutiny from other nations.
+China was criticized for administering vaccines to thousands of government officials and state-owned businesses in September 2020, prior to the completion of phase III clinical trials [@doi:10.1001/jama.2021.1961].
+The behavior of Chinese officials has also come into question due to misinformation campaigns questioning the safety of Western vaccine candidates such as Moderna and Pfizer-BioNTech in a way that is intended to highlight the benefits of their own vaccine candidates [@url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html].
+China in particular took aim at mRNA technologies, but Chinese companies have since developed their own mRNA vaccines targeting the omicron variant, one of which is due to begin trials soon in the UAE [@url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30].
+Furthermore, delays in vaccine distribution have also caused issues, particularly in Turkey where 10 million doses of Sinovac were due to arrive by December 2020, but instead only 3 million were delivered in early January [@url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html].
+Similar delays and shortages of doses promised were reported by officials in the Philippines, Egypt, Morocco, and the United Arab Emirates [@url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594; @url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560].
+All the same, Sinovac's vaccine has since been approved for use in countries around the world [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
+
 
 
 ## The Coming of Age of Nucleic Acid Vaccines during COVID-19
@@ -4065,7 +4298,6 @@ The advances made since early 2020 provide an exceptional illustration of how ra
 ### Importance
 
 The SARS-CoV-2 pandemic has caused untold damage globally, presenting unusual demands on but also opportunities for vaccine developers.
-As of August 10, 2022, there have been over 587,493,309 SARS-CoV-2 cases, and it has taken the lives of at least 6,427,446 people globally.
 The development, production, and distribution of vaccines is imperative to saving lives, preventing severe illness, and reducing the economic and social burdens caused by the COVID-19 pandemic.
 Although these vaccine technologies <!-- which ones --> had never previously been approved for use in humans, they have played a leading role in the management of SARS-CoV-2.
 In this review we discuss the history of developing these vaccines and how they have been applied to SARS-CoV-2.
@@ -4076,7 +4308,8 @@ As the SARS-CoV-2 virus has evolved, they also provide insight into how these te
 The SARS-CoV-2 virus emerged at the end of 2019 and quickly spread around the world.
 One of the primary approaches available to combat the effects of a virus is vaccination.
 Vaccines bolster the immune response to the virus at the individual and population level, thereby significantly reducing fatalities and severe illness and potentially driving a lower rate of infection even for a highly infectious virus like SARS-CoV-2.
-However, vaccine development has historically been slow.
+However, vaccine development has historically required a lengthy process due to both the experimental and regulatory demands.
+In the present case, the Coalition for Epidemic Preparedness Innovations (CEPI) is coordinating global health agencies and pharmaceutical companies to develop vaccines against SARS-CoV-2.
 
 As we review in a companion manuscript [@individual-vaccines-traditional], vaccine technologies have largely been based on introducing a virus or a component of a virus that is sufficient to induce an immune response without causing the associated illness.
 The past 20 years have seen several previously unknown viruses emerge and rise rapidly to pose a global threat, challenging vaccine developers to explore approaches that would facilitate a rapid response to novel viruses. <!-- Is that specific to the past 20 years? -->
@@ -4111,20 +4344,22 @@ While, for a variety of reasons, SARS-CoV-2 was not controlled as rapidly as the
 Vaccine development programs for COVID-19 emerged very quickly.
 The first administration of a dose of a COVID-19 vaccine to a human trial participant occurred on March 16, 2020 [@url:https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19; @doi:10.1038/d41573-020-00073-5], marking an extremely rapid response to the emergence of SARS-CoV-2.
 Within a few weeks<!-- of what? -->, at least 78 vaccine development programs were active [@doi:10.1038/d41573-020-00073-5], and by September 2020, there were over 180 vaccine candidates against SARS-CoV-2 in development [@doi:10.1038/s41586-020-2798-3].
-As of August 11, 2022, 40 SARS-CoV-2 vaccines have been approved world wide and 29 are being administered throughout the world, with  doses administered across 223 countries.
-The first critical step towards developing a vaccine against SARS-CoV-2 was characterizing the viral target, which happened extremely early in the COVID-19 outbreak with the sequencing and dissemination of the viral genome in early January 2020 [@url:https://www.who.int/emergencies/disease-outbreak-news/item/2020-DON233].
+As of August 15, 2022, 41 SARS-CoV-2 vaccines have been approved world wide and 29 are being administered throughout the world, with  doses administered across 223 countries.
+The first critical step towards developing a vaccine against SARS-CoV-2 was characterizing the viral target, which happened extremely early in the COVID-19 outbreak with the sequencing and dissemination of the viral genome in early January 2020 [@url:https://www.who.int/emergencies/disease-outbreak-news/item/2020-DON233] (Figure @fig:virus).
 This genomic information allowed for an early identification of the sequence of the spike (S) protein (Figure @fig:virus), which is the antigen and induces an immune response [@doi:10/fmq2; @doi:10.3389/fimmu.2020.576622].
 
 ![
 **Structure of the SARS-CoV-2 virus.**
 The development of vaccines depends on the immune system recognizing the virus.
 Here, the structure of SARS-CoV-2 is represented both in the abstract and against a visualization of the virion.
-The abstracted visualization was made using BioRender.com, and the microscopy image is from the National Institute of Allergy and Infectious Diseases Integrated Research Facility [@url:https://www.niaid.nih.gov/news-events/novel-coronavirus-sarscov2-images].<!--To Do: Was a template used?-->
+The abstracted visualization was made using BioRender [@url:https://biorender.com] using the template "Human Coronavirus Structure" by BioRender (August 2020) [@url:https://app.biorender.com/biorender-templates/figures/all/t-5f21e90283765600b08fbe9d-human-coronavirus-structure].
+The microscopy was conducted by the National Institute of Allergy and Infectious Diseases [@url:https://www.niaid.nih.gov/news-events/novel-coronavirus-sarscov2-images].
 ](images/SARS_CoV_2.png){#fig:virus secno=1}
 
-During the development process, one measure used to assess whether a vaccine candidate is likely to provide protection is serum neutralizing activity [@doi:10.1056/nejmoa2022483].<!--Would it make sense to have the definition here?-->
+During the development process, one measure used to assess whether a vaccine candidate is likely to provide protection is serum neutralizing activity [@doi:10.1056/nejmoa2022483].
+This assay evaluates the presence of antibodies that can neutralize, or prevent infection by, the virus in question.
+Often, titration is used to determine the extent of neutralization activity.
 However, unlike in efforts to develop vaccines for prior viral threats, the duration of the COVID-19 pandemic has made it possible to also test vaccines in phase III trials where the effect of the vaccines on a cohort’s likelihood of contracting SARS-CoV-2 was evaluated.
-The Coalition for Epidemic Preparedness Innovations (CEPI) is coordinating global health agencies and pharmaceutical companies to develop vaccines against SARS-CoV-2.<!--This is an important statement, but seems a little lost here near the VE section-->
 
 <!-- This paragraph doesn't really say anything. We have already introduced the manuscript. Do we need it? -->
 With vaccine candidates at all stages of development, including full approval of some vaccines, the vaccine development landscape for COVID-19 includes vaccines produced by a wide array of technologies.
@@ -4200,7 +4435,7 @@ While this issue was resolved through strategic vector design [@doi:10.1186/1475
 
 Several developments during the 2010s led to greater efficacy of DNA vaccines [@doi:10.1038/nrg2432].
 However, no DNA vaccines had been approved for use in humans prior to the COVID-19 pandemic [@doi:10.3390/ijms19113605; @doi:10.3390/pharmaceutics12010030].
-As of August 12, 2022, XX <!--8--> vaccines have been approved worldwide (Table @tbl:approved-DNA).<!--Check automation-->
+As of August 15, 2022, 8 vaccines have been approved worldwide (Table @tbl:approved-DNA).
 These vaccines fall into two categories, vaccines that are vectored with a plasmid and those that are vectored with another virus.
 
 <!-- The traditional vaccines table captions were a bit more descriptive -->
@@ -4378,16 +4613,16 @@ Subsequent research, however, suggests that reducing the prime dose may, in fact
 Therefore, this error may serendipitously improve efficacy of vaccine-vectored vaccines broadly.
 
 **Real-World Safety and Efficacy:**
-As of August 11, 2022, 5 viral-vectored vaccines are being distributed in 202 countries (Figure @fig:nrvv-distrib).
+As of August 15, 2022, 5 viral-vectored vaccines are being distributed in 202 countries (Figure @fig:nrvv-distrib).
 ChAdOx1 nCoV-19 was first approved for emergency use on December 30, 2020 in the U.K. [@url:https://www.astrazeneca.com/media-centre/press-releases/2020/astrazenecas-covid-19-vaccine-authorised-in-uk.html].
 As early as January 2021, Sputnik V had been administered to 1.5 million Russians [@url:https://www.brusselstimes.com/news-contents/world/149039/1-5-million-people-have-received-sputnik-v-vaccine-russia-says-russian-direct-investment-fund-mikhail-murashko], and doses of Sputnik V have also been distributed to other parts of Europe, such as Belarus, Bosnia-Herzegovina, Hungary, San Marino, Serbia, and Slovakia [@url:https://www.euronews.com/2021/02/12/hungary-to-begin-using-russia-s-sputnik-v-vaccine-today; @url:https://www.euronews.com/2021/02/24/san-marino-buys-russia-s-sputnik-v-after-eu-vaccine-delivery-delays; @url:https://www.themoscowtimes.com/2020/12/29/belarus-starts-coronavirus-vaccination-with-sputnik-v-a72512], with the Czech Republic and Austria also having expressed interest in its procurement [@url:https://www.cnbc.com/2021/03/02/russias-sputnik-vaccine-is-luring-eastern-europe-worrying-the-eu.html].
 
 ![
 **Worldwide availability of vaccines developed using non-replicating viral vectors.**<!--As a general comment on the choropleths, is there any way to increase resolution. Hard to see what’s happening in Europe and south east Asia.-->
-This figure reflects the number of vaccines using non-replicating viral vectors that were available in each country as of August 11, 2022.
+This figure reflects the number of vaccines using non-replicating viral vectors that were available in each country as of August 15, 2022.
 These data are retrieved from Our World in Data [@doi:10.1038/s41562-021-01122-8] and plotted using geopandas [@doi:10.5281/zenodo.5573592].
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/non_replicating_viral_vector.png "Availability of non-replicating viral-vectored vaccines"){#fig:nrvv-distrib secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/non_replicating_viral_vector.png "Availability of non-replicating viral-vectored vaccines"){#fig:nrvv-distrib secno=1}
 
 Following the trials, additional concerns have been raised about some of these vaccines.
 Within a few days to a few weeks following their first dose of the AstraZeneca vaccine, three women developed extensive venous sinus thrombosis [@doi:10.3390/jcm10081599].
@@ -4412,6 +4647,7 @@ Table: Approved RNA vaccines [@url:https://covid19.trackvaccines.org/types-of-va
 | Vaccine                       | Company                            |
 |:------------------------------|:-----------------------------------|
 | GEMCOVAC-19                   | Gennova Biopharmaceuticals Limited |
+| mRNA-1273.214                 | Moderna                            |
 | Spikevax                      | Moderna                            |
 | Comirnaty                     | Pfizer/BioNTech                    |
 | TAK-919 (Moderna formulation) | Takeda                             |
@@ -4422,7 +4658,8 @@ Interest in messenger RNA (mRNA) vaccines emerged around 1990 following _in vitr
 mRNA contains the minimum information needed to create a protein [@doi:10.4161/rna.22269].
 RNA vaccines are therefore nucleic-acid based modalities that code for viral antigens against which the human body elicits a humoral and cellular immune response.
 This approach operates one level above the DNA: instead of directly furnishing the gene sequence associated with an antigen to the host, it provides the mRNA transcribed from the DNA sequence.
-Some of the potential advantages of mRNA compared to DNA include safety, as it cannot be integrated by the host and the half life can be regulated, it avoids any issues of a host immune response against the vector, and it holds the potential to dramatically accelerate vaccine manufacturing and development [@doi:10.1038/nrd.2017.243; @doi:10.4161/rna.22269].<!-- Run on sentence, not sure how to break it up --><!--To Do: Add 10.1056/NEJMcibr2111445 either here or in mRNA section--><!--To Do: address on line 70: Are these just advantages comparing mRNA vs DNA vaccines? The first citations seems to imply that these are advantages over protein-based vaccines as well (subunit and whole inactivated vaccines).-->
+In addition to the benefits of nucleic acid vaccines broadly, some of the potential advantages of mRNA compared to DNA include safety, as it cannot be integrated by the host and the half life can be regulated, it avoids any issues of a host immune response against the vector, and it holds the potential to dramatically accelerate vaccine manufacturing and development [@doi:10.1038/nrd.2017.243; @doi:10.4161/rna.22269; @doi:10.1056/NEJMcibr2111445].
+<!-- Run on sentence, not sure how to break it up --><!--To Do: Add 10.1056/NEJMcibr2111445 either here or in mRNA section-->
 
 The mRNA is transcribed _in vitro_ and delivered to cells via lipid nanoparticles (LNP) [@doi:10.1002/eji.1830230749].
 It is recognized by ribosomes _in vivo_ and then translated and modified into functional proteins [@doi:10.3389/fimmu.2019.00594].
@@ -4469,16 +4706,17 @@ Two vaccine candidates in this category emerged with promising phase III results
 Both require two doses approximately one month apart.
 The first was Pfizer/BioNTech's BNT162b2, which contains the full prefusion stabilized, membrane-anchored SARS-CoV-2 spike protein in a vaccine formulation based on modified mRNA (modRNA) technology [@doi:10.1101/cshperspect.a014035; @url:https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-early-positive-data-ongoing-0].
 The second mRNA vaccine, mRNA-1273 developed by ModernaTX, is comprised by a conventional LNP-encapsulated RNA encoding a full-length prefusion stabilized S protein for SARS-CoV-2 [@clinicaltrials:NCT04283461].
-As of August 11, 2022, 2 mRNA vaccines are available in 168 countries (Figure @fig:mRNA-distrib).
+The vaccine candidates developed against SARS-CoV-2 using mRNA vectors utilize similar principles and technologies, although there are slight differences in implementation among candidates such as the formulation of the platform and the specific components of the spike protein encapsulated (e.g., the full Spike protein vs. the RBD alone) [@doi:10.3389/fphar.2020.00937].
+As of August 15, 2022, 2 mRNA vaccines are available in 168 countries (Figure @fig:mRNA-distrib).
 
 <!-- A general comment is that it can be confusing why the number of vaccines in the tables (approve) and figures (available) are different. -->
 
 ![
 **Worldwide availability of vaccines developed using mRNA.**
-This figure reflects the number of vaccines based on mRNA technology that were available in each country as of August 11, 2022.
+This figure reflects the number of vaccines based on mRNA technology that were available in each country as of August 15, 2022.
 These data are retrieved from Our World in Data [@doi:10.1038/s41562-021-01122-8] and plotted using geopandas [@doi:10.5281/zenodo.5573592].
 See https://greenelab.github.io/covid19-review/ for the most recent version of this figure, which is updated daily.
-](https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/RNA.png "Availability of mRNA vaccines"){#fig:mRNA-distrib secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/RNA.png "Availability of mRNA vaccines"){#fig:mRNA-distrib secno=1}
 
 **Trial Safety and Immunogenicity:**
 The VEs revealed by the Pfizer/BioNTech and Moderna clinical trials exceeded expectations.
@@ -4520,14 +4758,6 @@ Notably, immunocompromised individuals such as cancer patients seem to elicit a
 While antibody titers do correlate with protection [@doi:10.1126/science.abm3425; @doi:10.1016/j.vaccine.2021.12.006; @doi:10.1016/j.vaccine.2021.05.063; @doi:10.1101/2021.05.21.21257572; @doi:10.1038/s41423-020-00588-2], they are not the only mechanisms of immune protection.
 For example, T cell and non-neutralizing antibody responses may be unaffected or less affected by the new VOC, and they warrant further investigation.
 
-
-<!--Move to evolution
-Vaccine efficacy is not the only pharmacological intervention affected by VOC.
-Some existing therapeutics, including monoclonal antibody treatments like Bamlanivimab (AbCellera Biologics/ Eli Lilly), were ineffective against the Omicron variant.
-Indeed, only Sotrovimab (Vir Biotechnology/GSK) and Tixagevimab (AstraZeneca) to a much lesser extent could effectively neutralize the Omicron variant out of 7 tested monoclonal antibodies [@doi:10.1101/2021.12.14.21267772], which has been verified by others [@doi:10.1101/2021.12.12.472269].
-The antigenic shift of the Omicron variant does raise concerns for future VOC and what effects they may have on future vaccines and therapeutics.
--->
-
 The WHO continues to monitor the emergence of variants and their impact on vaccine efficacy [@url:https://www.who.int/news-room/feature-stories/detail/the-effects-of-virus-variants-on-covid-19-vaccines].
 Previous research in the computational prediction of the efficacy of vaccines targeting the influenza A virus might complement efforts to monitor these types of viral outbreaks [@doi:10.1093/cid/ciy323].
 To adapt, booster shots are now recommended in many places, and vaccines in the near future will likely account for multiple variants and strains of SARS-CoV-2 [@doi:10.1038/s41591-021-01230-y].
@@ -4664,14 +4894,12 @@ Different vaccines may confer advantages in different countries, and vaccine dev
 Without widespread global availability of vaccines, SARS-CoV-2 will continue presenting a significant threat to people worldwide.
 
 
-## Appendix: Vaccine Development Strategies for SARS-CoV-2
-<!-- It would be ideal to loosely organize these sections in the order they appear in the main text, or even split the appendix into a traditional and novel vaccines appendix. -->
+## Appendix: Additional Information about Novel Vaccine Platforms for COVID-19
 
 ### RNA Vaccines
 
 RNA vaccines are nucleic-acid based modalities that code for viral antigens against which the human body elicits a humoral and cellular immune response.
 The resulting intracellular viral proteins are displayed on surface MHC proteins, provoking a strong CD8+ T cell response as well as a CD4+ T cell and B cell-associated antibody responses [@doi:10.3389/fimmu.2019.00594].
-
 Similar immunological responses for mRNA vaccines were observed in humans in phase I and II clinical trials operated by the pharmaceutical-development companies Curevac and Moderna for rabies, flu, and zika [@doi:10.1080/14760584.2017.1355245].
 
 Given the potential for this technology to be quickly adapted for a new pathogen, it has held significant interest for the treatment of COVID-19.
@@ -4771,7 +4999,7 @@ All but ten participants received a single dose; this small group received a boo
 Commonly reported local adverse reactions included mild-to-moderate pain and tenderness at the injection site over the course of seven days, while the most common systemic adverse reactions were fatigue and headache; some patients reported severe adverse systemic effects.
 The study also reported that many common reactions could be reduced through the administration of paracetamol (acetaminophen), and paracetamol was not found to reduce immunogenicity.
 Patients receiving the ChAdOx1 nCoV-19 vaccine developed antibodies to the SARS-CoV-2 spike protein that peaked by day 28, with these levels remaining stable until a second observation at day 56 except in the ten patients who received a booster dose at day 28, in whom they increased by day 56.
-Analysis of serum indicated that participants developed antibodies to both S and the RBD and that 100% of them achieved neutralizing titers by day 28.
+Analysis of serum indicated that participants developed antibodies to both S and the RBD, and that 100% of them achieved neutralizing titers by day 28.
 By day 35, the neutralization titers of vaccinated patients was comparable to that observed with plasma from convalescents.
 This initial study therefore suggested that the vaccine was likely to confer protection against SARS-CoV-2, although analysis of its efficacy in preventing COVID-19 was not reported.
 
@@ -4780,7 +5008,6 @@ There were 131 cases observed among the 11,636 participants eligible for the pri
 However, a higher efficacy was reported in the subgroup of patients who received a low-dose followed by a standard dose (90.0%, 95% CI 67.4 to 97·0).
 A total of ten cases of severe COVID-19 resulting in hospitalization were observed among trial participants, and all of these occurred in patients in the control arm of the study.
 In line with the previously reported safety profiling for this vaccine, serious adverse events were reported to be comparable across the two arms of the study, with only three events identified as potentially associated with the vaccine itself.
-The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) approved ChAdOx1 nCoV-19 for emergency use on December 30, 2020 [@url:https://www.astrazeneca.com/media-centre/press-releases/2020/astrazenecas-covid-19-vaccine-authorised-in-uk.html].
 Additional data about the efficacy of this vaccine became available in a preprint released on March 2, 2021 [@doi:10.1101/2021.03.01.21252652].
 This report provided data describing the efficacy of ChAdOx1 nCoV-19, along with Pfizer/BioNTech's BNT162b2, in the U.K. between December 8, 2020 and February 19, 2021 and specifically sought to evaluate the efficacy of the vaccine in the presence of a potentially more contagious variant of concern, B.1.1.7.
 All participants in this study were age 70 or older and the efficacy was estimated to increase from 60% at 28 days after vaccination to 73% at 35 days after vaccination, although the standard error also increased over this time.
@@ -4789,10 +5016,7 @@ Therefore, preliminary results suggest that in a number of samples, this vaccine
 #### Sputnik-V (Gam-COVID-Vac and Gam-COVID-Vac-Lyo)
 
 The vaccine Gam-COVID-Vac, nicknamed Sputnik V in reference to the space race and "V for vaccine", was developed by the Gamaleya National Center of Epidemiology and Microbiology in Moscow.
-Gamaleya is an organization with prior experience using the adenovirus platform for the development of vaccines for _Middle East respiratory syndrome-related coronavirus_ and Ebola virus, although neither of the previous vaccines were internationally licensed [@url:https://www.who.int/immunization/sage/meetings/2018/october/2_Ebola_SAGE2018Oct_BgDoc_20180919.pdf].
 The development of Sputnik V was financed by the Russian Direct Investment Fund (RDIF) [@doi:10/ft7j; @doi:10/ghs3sn].
-
-Other vaccines, such as the Oxford-AstraZeneca vaccine, utilize the chimpanzee adenovirus vector (ChAdOx1 nCoV-19) for both doses [@doi:10/ghpghz].
 The Sputnik V vaccines are available in both a lyophilized (Gam-COVID-Vac-Lyo) and frozen form (Gam-COVID-Vac), which are stored at 2-8°C and -18°C respectively [@doi:10/gg96hq].
 The lyophilized vaccine is convenient for distribution and storage, particularly to remote or disadvantaged areas [@doi:10.3390/v13010054].
 
@@ -4816,6 +5040,7 @@ However, only symptomatic individuals were confirmed for SARS-CoV-2 infection in
 Therefore, asymptomatic infections were not detected, thus potentially inflating the efficacy estimate.
 Overall, a vaccine efficacy of 91.6% (95% CI 85.6-95.2) was reported, where an efficacy of 91.8% was reported for those over 60 years old and 92.7% for those who were 51-60 years old.
 Indeed, 14 days after the first dose, 87.6% efficacy was achieved and the immunity required to prevent disease occurred within 18 days of vaccination.
+
 Based on these results, scientists are investigating the potential for a single dose regimen of the rAd26-S sputnik V vaccine [@doi:10.1136/bmj.n309].
 By the end of the trial, 7,485 participants reported adverse events, of which 94% were grade I.
 Of the 68 participants who experienced serious adverse events during the trial, 45 from the vaccine group and 23 from the placebo groups, none were reported to be associated with the vaccination.
@@ -4844,21 +5069,21 @@ However, the interim results of the phase III study were promising and further t
 There may be some advantage to the Sputnik V approach including the favorable storage conditions afforded by choice between a frozen and lyophilized vaccine.
 Furthermore, the producers of Gam-COVID-Vac state that they can produce the vaccine at a cost of less than $10 per dose or less than $20 per patient [@url:https://sputnikvaccine.com].
 
-#### Janssen’s JNJ-78436735
+### Janssen’s JNJ-78436735
 
-The Johnson & Johnson (J&J) vaccine developed by Janssen Pharmaceuticals, Inc., a subsidiary of J&J, was conducted in collaboration with and funded by “Operation Warp Speed” [@url:https://www.gao.gov/products/gao-21-319; @url:https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use; @doi:10.1056/NEJMoa2034201;@doi:10.1038/s41541-020-00243-x].
+The Johnson and Johnson (J&amp;J) vaccine developed by Janssen Pharmaceuticals, Inc., a subsidiary of J&amp;J, was conducted in collaboration with and funded by “Operation Warp Speed” [@url:https://www.gao.gov/products/gao-21-319; @url:https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use; @doi:10.1056/NEJMoa2034201;@doi:10.1038/s41541-020-00243-x].
 The vaccine was developed using Janssen’s AdVac^®^ and PER.C6 platforms that were previously utilized to develop the European Commission-approved Ebola vaccine (Ad26 ZEBOV and MVN-BN-Filo) and their Zika, respiratory syncytial (RSV), and HIV investigational vaccine candidates [@url:https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate].
 
-The development of a single-dose vaccine was desired by J&J from the outset, with global deployment being a key priority [@doi:10.1038/s41586-020-2607-z].
+The development of a single-dose vaccine was desired by J&amp;J from the outset, with global deployment being a key priority [@doi:10.1038/s41586-020-2607-z].
 Using their AdVac^®^ technology, the vaccine can remain stable for up to two years between -15℃ and -25℃ and at least three months at 2-8℃ [@url:https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate].
 This allows the vaccine to be distributed easily without the requirement for very low temperature storage, unlike many of the other COVID-19 vaccine candidates.
-J&J screened numerous potential vaccine candidates _in vitro_ and in animal models using varying different designs of the S protein, heterologous signal peptides, and prefusion-stabilizing substitutions [@doi:10.1038/s41541-020-00243-x].
+J&amp;J screened numerous potential vaccine candidates _in vitro_ and in animal models using varying different designs of the S protein, heterologous signal peptides, and prefusion-stabilizing substitutions [@doi:10.1038/s41541-020-00243-x].
 A select few candidates were further investigated as a single dose regimen in Syrian golden hamsters, a single dose regimen in rhesus macaques, and a single- and two-dose regimen in both adult and aged rhesus macaques [@doi:10.1038/s41541-020-00243-x; @doi:10.1038/s41586-020-2607-z; @doi:10.1038/s41591-020-1070-6; @doi:10.1101/2020.11.17.368258].
 From these studies, the JNJ-78436735 candidate was selected for its favorable immunogenicity profile and ease of manufacturability [@doi:10.1038/s41541-020-00243-x; @doi:10.1038/s41586-020-2607-z; @doi:10.1038/s41591-020-1070-6; @doi:10.1101/2020.11.17.368258].
 A SARS-CoV-2 challenge study in rhesus macaques showed that vaccine doses as low as 2 x 10^9^ viral particles/mL was sufficient to induce strong protection in bronchoalveolar lavage but that doses higher than 1.125 x 10^10^ were required to close achieve close to complete protection in nasal swabs [@doi:10.1101/2021.01.27.428380].
 Indeed, six months post-immunization, levels of S-binding and neutralizing antibodies in rhesus macaques indicated that the JNJ-78436735 vaccine conferred durable protection against SARS-CoV-2 [@doi:10.1101/2021.01.30.428921].
 
-Following selection of the JNJ-78436735 vaccine, J&J began phase I/IIa trials.
+Following selection of the JNJ-78436735 vaccine, J&amp;J began phase I/IIa trials.
 The interim phase I/IIa data was placed on the _medRxiv_ preprint server on September 25th, 2020 [@doi:10.1101/2020.09.23.20199604] and was later published in the _New England Journal of Medicine_ on January 13th, 2021 [@doi:10.1056/NEJMoa2034201].
 The phase I/IIa multi-center, randomized, placebo-controlled trial enrolled 402 healthy participants between 18-55 years old and a further 403 healthy older participants ≥ 65 years old [@doi:10.1056/NEJMoa2034201].
 Patients were administered either a placebo, a low dose (5 x 10^10^ viral particles per mL), or a high dose (1 X 10^11^ viral particles per mL) intramuscularly as part of either a single- or two-dose regimen.
@@ -4885,7 +5110,7 @@ Binding and neutralizing antibodies were detected in 100% of vaccine recipients
 Spike-specific antibodies were highly prevalent (GMT 2432 to 5729) as were neutralizing antibodies (GMT 242 to 449) in the vaccinated groups.
 Indeed, CD4^+^ and CD8^+^ T-cell responses were also induced, which may provide additional protection, particularly if antibodies wane or poorly respond to infection [@doi:10.1038/s41586-020-03041-6].
 
-On September 23rd, 2020, J&J launched its phase III trial ENSEMBLE and released the study protocol to the public [@url:https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate; @clinicaltrials:NCT04505722].
+On September 23rd, 2020, J&amp;J launched its phase III trial ENSEMBLE and released the study protocol to the public [@url:https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate; @clinicaltrials:NCT04505722].
 The trial intended to enroll 60,000 volunteers to assess the safety and efficacy of the single vaccine dose versus placebo with primary endpoints of 14 and 28 days post-immunization [@url:https://www.jnj.com/johnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate].
 The trial was conducted in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the U.S.
 The trial was paused briefly in October 2020 to investigate a “serious medical event”, but resumed shortly after [@url:https://www.jnj.com/our-company/johnson-johnson-prepares-to-resume-phase-3-ensemble-trial-of-its-janssen-covid-19-vaccine-candidate-in-the-us].
@@ -4902,7 +5127,7 @@ Serious adverse events were reportedly higher in the placebo group than the vacc
 
 At the time the phase III trial was being conducted, several concerning variants, including B.1.1.7 [@url:https://cov-lineages.org/global_report_B.1.1.7.html] and B.1.351 [@url:https://cov-lineages.org/global_report_B.1.351.html], were spreading across the globe.
 In particular, B.1.351 was first identified in South Africa, which was one of the JNJ-78436735 vaccine trial sites.
-Therefore, the J&J investigators also analyzed the efficacy of the JNJ-78436735 vaccine associated with their various trial sites to determine any potential risk of reduced efficacy as a result of the novel variants.
+Therefore, the J&amp;J investigators also analyzed the efficacy of the JNJ-78436735 vaccine associated with their various trial sites to determine any potential risk of reduced efficacy as a result of the novel variants.
 It was determined that JNJ-78436735 was 72% effective in the U.S., 66% effective in Latin America, and 57% effective in South Africa 28 days post-vaccination.
 These findings underpin the importance of monitoring for the emergence of novel SARS-CoV-2 variants and determining their effects on vaccine efficacy.
 
@@ -4910,11 +5135,6 @@ Looking forward, Janssen are also running a phase III randomized, double-blind,
 This trial will enroll 30,000 participants ≥ 18 years old from Belgium, Colombia, France, Germany, Philippines, South Africa, Spain, U.K., and the U.S. [@url:https://www.jnj.com/johnson-johnson-initiates-second-global-phase-3-clinical-trial-of-its-janssen-covid-19-vaccine-candidate].
 This trial will also include participants with and without comorbidities associated with an increased risk of COVID-19.
 
-<!--To Do: Suggestion to move some of the Sputnik controversy here, along with describing the issues with the AstraZeneca trial-->
-
-<!--Additionally, though the vaccines are built using similar principles, there are some differences that might influence their efficacy as SARS-CoV-2 evolves.-->
-<!--To Do: suggestion to discuss prefusion conformation (J&J) vs not (the other two)-->
-
 ### Global Vaccine Status and Distribution
 
 In North America, the majority of vaccines distributed until March 2021 have been produced by Pfizer-BioNTech and Moderna.
@@ -4957,7 +5177,7 @@ The Moderna vaccine was authorized for use in the E.U. by EMA on January 6th, 20
 As of March 5th, 2021, 22 million people in the U.K. had received at least one vaccine dose [@url:https://ourworldindata.org/covid-vaccinations].
 
 While the Pfizer-BioNTech vaccine was the first to be distributed following phase III clinical trials, the first COVID-19 vaccine to be widely administered to people prior to the completion of phase III clinical trials was Sputnik V.
-Sputnik V was administered to as many as 1.5 million Russians by early January [@url:https://www.brusselstimes.com/news-contents/world/149039/1-5-million-people-have-received-sputnik-v-vaccine-russia-says-russian-direct-investment-fund-mikhail-murashko] due to the establishment of mass vaccination clinics in December 2020, prior to which only approximately 100,000 Russians had already been vaccinated [@url:https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots;@{url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine/}].
+Sputnik V was administered to as many as 1.5 million Russians by early January [@url:https://www.brusselstimes.com/news-contents/world/149039/1-5-million-people-have-received-sputnik-v-vaccine-russia-says-russian-direct-investment-fund-mikhail-murashko] due to the establishment of mass vaccination clinics in December 2020, prior to which only approximately 100,000 Russians had already been vaccinated [@url:https://www.bloomberg.com/news/articles/2020-12-02/within-hours-of-u-k-putin-orders-start-of-mass-covid-19-shots;@{url:https://www.forbes.com/sites/jamesrodgerseurope/2020/12/05/facing-record-covid-19-case-rise-russia-rolls-out-sputnik-v-vaccine}].
 Doses of Sputnik V have also been distributed to other parts of Europe [@url:https://www.euronews.com/2021/02/12/hungary-to-begin-using-russia-s-sputnik-v-vaccine-today; @url:https://www.euronews.com/2021/02/24/san-marino-buys-russia-s-sputnik-v-after-eu-vaccine-delivery-delays; @url:https://www.themoscowtimes.com/2020/12/29/belarus-starts-coronavirus-vaccination-with-sputnik-v-a72512].
 Hungary was the first E.U. member country to approve and distribute Sputnik V outside of Russia [@url:https://www.cnbc.com/2021/03/02/russias-sputnik-vaccine-is-luring-eastern-europe-worrying-the-eu.html], despite the EMA stating that they had neither approved nor received a request for approval of Sputnik V [@url:https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process].
 Hungary is also in talks with China to procure the Sinopharm vaccines, which have been approved by Hungarian health authorities but also have not received approval by EMA in the E.U. [@url:https://www.cnbc.com/2021/03/02/russias-sputnik-vaccine-is-luring-eastern-europe-worrying-the-eu.html].
@@ -4972,241 +5192,6 @@ For others, the delays in the distribution of the other, more-favored candidates
 Additionally, Germany has stated that if Sputnik V were approved by EMA, it would be considered by the E.U. [@url:https://www.france24.com/en/live-news/20210203-germany-moves-to-bring-russian-vaccine-into-eu-orbit].
 Russia is developing other vaccine candidates and has approved a third vaccine, CoviVac, which is an inactivated vaccine produced by the Chumakov Centre in Moscow, despite the fact the clinical trials have yet to begin [@url:https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-idUSKBN2AK07H].
 
-### Asia's Role in Vaccine Development
-
-The Asian nations of China and India have played a major role as COVID-19 vaccination developers and providers.
-Iran has also developed several vaccines.
-Considering India produced approximately 60% of the world's vaccines prior to the pandemic, it is no surprise that the nation has developed and is developing several COVID-19 vaccine candidates.
-In addition to COVAXIN, the Bio E subunit vaccine CORBEVAX is being produced by Biological E in collaboration with U.S.-based Dynavax and the Baylor College of Medicine [@url:https://www.bbc.com/news/world-asia-india-55748124].
-These two home-grown vaccines are now approved for adults and children as young as five (CORBEVAX) and six (COVAXIN) [@url:https://www.tribuneindia.com/news/nation/covaxin-cleared-for-6-12-age-group-by-drugs-regulator-389581].
-Other vaccines licensed by India were developed elsewhere but produced in India.
-For example, Novavax (developed in the United States) has signed an agreement with the Serum Institute of India allowing them to produce up to 2 billion doses a year [@url:https://www.reuters.com/article/health-coronavirus-novavax-idUSKBN2661PI].
-Similarly, many people within India have been vaccinated with the AstraZeneca-University of Oxford vaccine, known as Covishield in India, which is also produced by the Serum Institute of India [@url:https://www.bbc.com/news/world-asia-india-55748124].
-India is also developing vaccines using cutting-edge nucleic-acid-based platforms.
-These include ZyCov-D, a DNA vaccine produced by Zydus Cadila, HGCO19 and India’s first mRNA vaccine, produced by Genova and HDT Biotech Corporation (of the U.S.) [@url:https://www.bbc.com/news/world-asia-india-55748124].
-Additionally, in February 2021, Bharat Biotech received approval from Indian officials to commence a phase I study of an intranasal chimpanzee-adenovirus (ChAd) vectored SARS-CoV-2-S vaccine called BBV154 [@url:https://www.bharatbiotech.com/intranasal-vaccine.html].
-
-In China, the Sinopharm-Beijing Institute vaccine, the Sinopharm-Wuhan Institute of Biological Products vaccine, the Sinovac Biotech (CoronaVac) vaccine, and CanSino Biologics vaccine are the main vaccines being distributed.
-The Sinopharm-Beijing vaccine has been distributed to at least 16 countries.<!--automate-->
-Indeed, Sinovac and Sinopharm aimed to produce 2 billion doses by the end of 2021, and they have distributed vaccines as aid to the Philippines and Pakistan [@url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html].
-In contrast, the Sinopharm-Wuhan vaccine, which has been approved for use in China since February 25, 2021, has been distributed almost exclusively within China, with limited supplies distributed to the United Arab Emirates [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
-On the same date, the CanSino vaccine was approved for use in China and has been granted emergency use in several other countries [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
-
-However, the vaccine approval and distribution processes in China have come under increased scrutiny from other nations.
-China was criticized for administering vaccines to thousands of government officials and state-owned businesses in September 2020, prior to the completion of phase III clinical trials [@doi:10.1001/jama.2021.1961].
-The behavior of Chinese officials has also come into question due to misinformation campaigns questioning the safety of Western vaccine candidates such as Moderna and Pfizer-BioNTech in a way that is intended to highlight the benefits of their own vaccine candidates [@url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html].
-China in particular took aim at mRNA technologies, but Chinese companies have since developed their own mRNA vaccines targeting the omicron variant, one of which is due to begin trials soon in the UAE [@url:https://www.reuters.com/business/healthcare-pharmaceuticals/chinese-omicron-specific-mrna-covid-vaccine-candidate-be-trialed-uae-2022-04-30].
-Furthermore, delays in vaccine distribution have also caused issues, particularly in Turkey where 10 million doses of Sinovac were due to arrive by December 2020, but instead only 3 million were delivered in early January [@url:https://www.nytimes.com/2021/01/25/business/china-covid-19-vaccine-backlash.html].
-Similar delays and shortages of doses promised were reported by officials in the Philippines, Egypt, Morocco, and the United Arab Emirates [@url:https://abcnews.go.com/Health/wireStory/philippines-receive-covid-19-vaccine-delays-76163594; @url:https://www.wsj.com/articles/chinas-covid-19-vaccine-makers-struggle-to-meet-demand-11612958560].
-All the same, Sinovac's vaccine has since been approved for use in countries around the world [@url:https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html].
-
-
-## Appendix
-
-### Sinovac's CoronaVac
-
-Pre-clinical trials were performed using BALB/c mice and rhesus macaques [@doi:10.1126/science.abc1932].
-The SARS-CoV-2 strains used in this trial isolated from 11 hospitalized patients (5 from China, 3 from Italy, 1 from the UK, 1 from Spain, 1 from Switzerland).
-A phylogenetic analysis demonstrated that the strains were representative of the variants circulating at the time.
-One of the strains from China, CN2, was used as the inactivated and purified virus while the other 10 strains were used to challenge.
-The CN2 was grown in Vero cells.
-An ELISA assay was used to assess the immunogenicity of the vaccine.
-10 mice were injected with the vaccine on day 0 and day 7 with varying doses (0, 1.5, 3, or 6 &mu;g), and 10 mice were treated with physiological saline as the control.
-IgG developed in the serum of all vaccinated mice.
-Using the same setup, immunogenicity was also assessed in macaques.
-Four macaques were assigned to each of four groups: treatment with 3 &mu;g at day 0, 7 and 14, treatment with a high dose of 6 &mu;g at day 0, 7, and 14, administration of a placebo vaccine, and administration of only the adjuvant.
-All vaccinated macaques induced IgGs and neutralizing antibodies.
-After challenge with SARS-CoV-2 strain CN1, vaccinated macaques were protected compared to control macaques (placebo or adjuvant only) based on histology and viral loads collected from different regions of the lung.
-
-Phase I/II clinical trials were conducted in adults 18-59 years old [@doi:10/fpcx] and adults over 60 years old [@doi:10/fx8z] in China.
-In the case of adults 18-59 years old, a single center, randomized, double-blind, placebo-controlled phase I/II trial was conducted in April 2020.
-Patients in this study were recruited from the community in Suining County of Jiangsu province, China.
-For the phase I trial, 144 (of 185 screened) participants were enrolled, with 72 enrolled in the 14-day interval cohort (i.e., treated on day 0 and day 14) and 72 in the 28-day interval cohort.
-This group of 72 participants was split into 2 blocks for a low-dose (3 &mu;g) and high-dose (6 &mu;g) vaccine.
-Within each block, participants were randomly assigned vaccination with CoronaVac or placebo (aluminum diluent without the virus) at a 2:1 ratio.
-Both the vaccine and placebo were prepared in a Good Manufacturing Practice-accredited facility of Sinovac Life Sciences (Beijing, China).
-
-The phase II trial followed the same organization of participants, this time using 300 enrolled participants in the 14-day and another 300 enrolled in the 28-day groups.
-One change of note was that the vaccine was produced using a highly automated bioreactor (ReadyToProcess WAVE 25, GE, Ume&aring;, Sweden) to increase vaccine production capacity.
-This change resulted in a higher intact spike protein content.
-The authors of this study were not aware of this antigen-level difference between the vaccine batches for the phase I/II when the ethical approval for the trials occurred.
-
-To assess adverse responses, participants were asked to record any events up to 7 days post-treatment.
-The reported adverse events were graded according to the China National Medical Products Administration guidelines.
-In the phase I trial, the overall incidence of adverse reactions was 29-38% of patients in the 0 to 14 day group and 13-17% in the 0 to 28 day vaccination group.
-The most common symptom was pain at the injection site, which was reported by 17-21% of patients in the 0 to 14 day cohort and 13% in the 0 to 28 day cohort.
-Most adverse reactions were mild (grade 1) where patients recovered within 48 hours.
-A single case of acute hypersensitivity with manifestation of urticaria 48 hours following the first dose of study drug was reported in the 6 &mu;g group.
-Most of the adverse reactions reported were characterized as mild and resolved within 48 hours, with a single participant experiencing a serious adverse event that could have been related to vaccination (acute hypersensitivity with manifestation of urticaria 48 hours after their first dose in the 6-&mu;g condition).
-Both the 14-day and 28-day cohorts had a strong neutralizing Ab response.
-The neutralizing Ab response was measured using a micro cytopathogenic effect assay, which assesses the minimum dilution of neutralizing Ab to be 50% protective against structural changes in host cells in response to viral infection [@doi:10.1016/j.vaccine.2012.03.010].
-Additionally IgG antibody titers against the receptor binding domain were also measured using ELISA.
-
-Another phase I/II study was performed with older patients (older than 60 years) [@doi:10/fx8z].
-The study conducted a single-center, randomized, double-blind, placebo-controlled trial.
-The phase I trial looked at dose escalation using 3 dosages: 1.5, 3 and 6 &mu;g.
-The mean age of participants was 65.8 years (std = 4.8).
-Of 95 screened participants, 72 were enrolled.
-These 72 participants were split into low (3 &mu;g) and high (6 &mu;g) dose groups.
-Within each group, 24 participants received the treatment and 12 the placebo.
-A neutralizing antibody response against live SARS-CoV-2 was detected compared to baseline using the same micro cytopathogenic effect assay.
-This response was similar across the two dose concentrations.
-Additionally, they did not observe a difference in response between age groups (60–64 years, 65–69 years, and ≥70 years).
-
-In phase II the mean age was 66.6 years (standard deviation = 4.7).
-499 participants were screened and 350 were enrolled.
-300 were evenly split into 1.5, 3, and 6 &mu;g dose groups, and the remaining 50 were assigned to the placebo group.
-Again, they found a neutralizing antibody response in phase II.
-There wasn't a significant different between the response to 3 &mu;g versus 6 &mu;g, but the response was higher than that to 1.5 &mu;g.
-
-Participants were required to record adverse reaction events within the first 7 days after each dose.
-The safety results were combined across phase I and II.
-All adverse reactions were either mild (grade 1) or moderate (grade 2) in severity.
-The most common symptom was pain at the injection site (9%) and fever (3%).
-2% (7 participants) reported severe adverse events (4 from the 1.5 &mu;g group, 1 from the 3 &mu;g group, 2 from the 6 &mu;g group), though these were found to be unrelated to the vaccine.
-
-Overall, the results from the pre-clinical and phase I/II clinical trials are promising.
-It was also very hopeful to see that the immune response was consistent in older adults (> 60 years).
-Phase III trials are being conducted in Brazil [@doi:10.1186/s13063-020-04775-4].
-This is a randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial.
-They are expecting 13,060 participants with 11,800 ages 18 to 59 years and 1,260 age 60+.
-Participants will be health care professionals.
-As of September 2021, CoronaVac trials are now also being held in the Philippines and Hong Kong, bringing the total number of registered phase III trials investigating the safety and efficacy of CoronaVac to 9, with emergency use approval in 40 countries [@url:https://covid19.trackvaccines.org/vaccines/7].
-
-### COVAXIN
-
-In India, the COVAXIN^®^ vaccine received emergency authorization on January 3, 2021, despite the lack of phase III data until March 3, which was communicated via press release [@url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf].
-Following a press release of the phase III data indicating 80.6% efficacy in 25,800 participants [@url:https://www.bharatbiotech.com/images/press/covaxin-phase3-efficacy-results.pdf; @url:https://www.biogenetech.co.th/wp-content/uploads/2021/03/5-Ocugen.pdf], Zimbabwe authorized the use of COVAXIN^®^ [@url:http://www.xinhuanet.com/english/2021-03/04/c_139783893.htm].
-This was followed by a detailed preprint of the double-blind, randomized, controlled phase III trial that was made available in July 2021, with a final enrollment of 25,798 people (~1:1 vaccine:placebo) [@doi:10.1101/2021.06.30.21259439].
-The vaccine was reported as well tolerated, with an overall vaccine efficacy of 77.8% for the prevention of COVID-19.
-Efficacy against severe disease and asymptomatic infection was reported as 93.4% and 63.6% respectively.
-In agreement with previous studies demonstrating sera from individuals vaccinated with COVAXIN^®^ efficiently neutralized the alpha variant (B.1.1.7) and the delta variant (B.1.617.2) [@doi:10.1093/jtm/taab104; @doi:10.1093/jtm/taab051], the phase III trial reported a 65.2% efficacy against the delta variant (B.1.617.2) [@doi:10.1101/2021.06.30.21259439].
-Indeed, another preprint determined that sera from individuals immunized with COVAXIN^®^ had effective neutralizing antibodies against the delta variant and the so-called delta plus variant (AY.1) [@doi:10.1101/2021.07.30.454511].
-It is not yet clear what level of protection COVAXIN^®^ offers beyond 6 to 8 months post the second vaccine; consequently, the potential requirement of a booster immunization is being explored [@url:https://www.hindustantimes.com/india-news/covaxin-booster-dose-what-is-it-what-does-govt-say-about-this-101625644184446.html].
-Furthermore, Bharat Biotech is considering other vaccine regimens such as providing one initial immunization with COVAXIN^®^ followed by two immunizations with its intranasal vaccine (BBV154) [@url:https://www.business-standard.com/article/current-affairs/booster-dose-bharat-biotech-s-nasal-vaccine-may-be-used-with-covaxin-121092500034_1.html].
-U.S.-based Ocugen Inc., a co-development partner of Bharat Biotech, is leading the application for an Emergency Use Authorization (EUA) for COVAXIN^®^  intended for the U.S. market.
-As of September 2021 COVAXIN^®^ has been approved for emergency use in Guyana, India, Iran, Zimbabwe, and Nepal, Mauritius, Mexico, Nepal, Paraguay, and the Philippines [@url:https://covid19.trackvaccines.org/vaccines/9].
-It has been reported that Bharat Biotech will soon release its phase II and III pediatric trial results [@url:https://timesofindia.indiatimes.com/india/bharat-biotech-to-submit-covaxin-kids-trials-data-to-dcgi-in-weeks-time/articleshow/86392325.cms].
-However, the WHO approval of the COVAXIN^®^ has been delayed [@url:https://www.indiatoday.in/coronavirus-outbreak/video/who-emergency-approval-for-covaxin-delayed-till-october-5-1856178-2021-09-23].
-
-### Sinopharm Candidates
-
-<!--- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7561304/ BBIBP-CorV --->
-<!--- https://pubmed.ncbi.nlm.nih.gov/32778225/ --->
-Sinopharm Wuhan Institute also developed their SARS-CoV-2 inactivated vaccine using the WIV04 strain isolated from a patient at the Jinyintan Hospital in Wuhan, China [@doi:10.1038/s41541-021-00292-w].
-This vaccine was also passaged in Vero cells, inactivated using &beta;-propiolactone, and was adjuvanted with aluminum hydroxide.
-This vaccine is administered intramuscularly using 5 &mu;g of virus per dose.
-Preclinical data providing supporting evidence for the use of this vaccine is not available publicly.
-Despite the lack of publicly available preclinical results, Sinopharm Wuhan Institute initiated phase I/II trials, which reported on varying dosing and prime-boost regimens.
-Neutralizing antibodies were detected in all groups 14 days after the final dose in the phase I part of the trial [@doi:10.1001/jama.2020.15543].
-Similar findings were reported in the interim phase II data [@doi:10.1001/jama.2020.15543].
-
-A combined phase I/II RCT of Sinopharm's BBIBP-CorV followed [@doi:10/ghjkrf].
-In phase I, 192 participants were randomized with varying doses of 2 &mu;g, 4 &mu;g, or 8 &mu;g/dose or a placebo, and they received the same as a second dose 28 days later.
-Approximately 29% of participants reported at least 1 adverse event, most commonly fever, and neutralizing antibody titers were reported for all doses.
-In the phase II trial, 482 participants were enrolled (3:1, vaccine:placebo).
-Participants in the vaccine condition received either a single 8 &mu;g dose or a double immunization of a 4 &mu;g/dose that was administered 14, 21, or 28 days post the prime dose.
-Participants in the placebo condition received the placebo on one of the same four schedules.
-The vaccine appeared well-tolerated, with 23% reporting at least one adverse reaction characterized as mild to moderate.
-It was reported that all participants had a humoral immune response to the vaccines by day 42 but that the double immunization dosing regimen of 4 &mu;g/dose achieved higher neutralizing antibody titers than a single dose of 8 &mu;g and that the highest response was seen in the double-immunization regimen when at least 21 days separated the two doses [@doi:10/ghjkrf].
-Similar findings were reported in another phase I/II trial published by the same authors [@doi:10.1001/jama.2021.8565].
-
-### Protein Subunit Vaccines
-
-Several different technologies are used to develop vaccines in this category.
-Proteins can be grown in yeast and then harvested, as they are culturable devoid of animal-derived growth factors.
-Indeed, the vaccine industry has previously mostly used Pichia pastoris yeast as the expression system [@doi:10.3389/fimmu.2020.602256].
-However, in recent years insect cells have also been utilized [@doi:10.1038/s41467-020-20653-8; @doi:10.1016/j.vaccine.2012.01.016; @doi:10.1016/j.addr.2021.01.001].
-Other protein subunit vaccines utilize virus-like particles (VLPs), which share the conformation of a virus's capsid, thereby acting as an antigen, but lack the replication machinery [@doi:10/dg35hw].
-VLPs are often synthesized using nanotechnology [@doi:10.1038/nri3488].
-
-#### Novavax NVX-CoV2373
-
-Novavax-CoV2373 is a protein nanoparticle vaccine candidate against SARS-CoV-2.
-The vaccine is constructed from a mutated SARS-CoV-2 spike protein in combination with a specialized adjuvant to elicit an immune response against SARS-CoV-2.
-The spike protein is recombinantly expressed in Sf9 insect cells [@doi:10.1038/s41467-020-20653-8], which have previously been used for several other FDA-approved protein therapeutics [@doi:10.1021/acs.iecr.8b00985].
-The expressed spike protein contains mutations in the furin cleavage site (682-RRAR-685 to 682-QQAQ-685) to avoid cleavage of the spike protein as well as two proline substitutions (K986P and V987P) to improve thermostability [@doi:10.1038/s41467-020-20653-8].
-The improved stability caused by the proline substitutions is particularly critical to facilitating global distribution, particularly to regions where local refrigerator/freezer capacities are limited.
-Importantly, these amino acid substitutions did not affect the ability of the spike protein to bind the hACE2 receptor (the target receptor of SARS-CoV-2 spike protein).
-The Novavax-CoV2373 vaccine candidate uses a proprietary, saponin-based Matrix-M^TM^ adjuvant that contains two different 40nm-sized particles formed by formulating purified saponin with cholesterol and phospholipids [@doi:10.1007/s12026-018-8991-x].
-In preclinical models, the use of the Matrix-M adjuvant potentiated the cellular and humoral immune responses to influenza vaccines [@doi:10.1016/j.vaccine.2013.01.039; @doi:10.1016/j.vaccine.2009.09.044; @doi:10.1111/j.1750-2659.2011.00256.x; @doi:10.1007/s12026-018-8991-x].
-Importantly, Matrix-M adjuvant-containing vaccines have shown acceptable safety profiles in human clinical trials [@doi:10.1016/j.vaccine.2011.08.042].
-
-In preclinical mouse models, Novavax-CoV2373 elicited high anti-spike IgG titers 21-28 days post-vaccination that could neutralize the SARS-CoV-2 virus and protect the animals against virus challenge [@doi:10.1038/s41467-020-20653-8].
-Antibody titers were significantly elevated in groups receiving the vaccine with the Matrix-M adjuvant compared to the groups without adjuvant.
-Novavax-CoV2373 was able to induce a multifunctional CD4/CD8 T-cell responses and generate high frequencies of follicular helper T-cells and B-cell germinal centers after vaccination.
-These findings were subsequently evaluated in a baboon primate model, in which Novavax-CoV2373 also elicited high antibody titers against the SARS-CoV-2 spike protein, as well as an antigen specific T-cell response.
-Based on this data Novavax initiated a phase I/II clinical trial to evaluate the safety and immunogenicity of Novavax-CoV2373 with Matrix-M [@clinicaltrials:NCT04368988; @doi:10.1056/NEJMoa2026920].
-
-The phase I/II trial was a randomized, placebo-controlled study with 131 healthy adult participants in 5 treatment arms [@doi:10.1056/NEJMoa2026920].
-Participants that received the recombinant SARS-CoV-2 vaccine with or without the Matrix-M adjuvant got two injections, 21 days apart.
-Primary outcomes that were assessed include reactogenicity, lab-values (serum chemistry and hematology), and anti-spike IgG levels.
-Secondary outcomes measured included virus neutralization, T-cell responses, and unsolicited adverse events.
-The authors reported that no serious treatment-related adverse events occurred in any of the treatment arms.
-Reactogenicity was mostly absent and of short duration.
-The two-dose vaccine regimen induced anti-spike IgG levels and neutralizing antibody-titers exceeding those in the convalescent plasma of symptomatic patients.
-In line with the preclinical studies, the use of Matrix-M adjuvant further increased anti-spike immunoglobulin levels and induced a Th1 response.
-The outcomes of this trial suggest that Novavax-CoV2373 has an acceptable safety profile and is able to induce a strong immune response with high neutralizing antibody titers.
-The phase II component of the trial was designed to identify the dose regimen for the next clinical trial stage [@doi:10.1371/journal.pmed.1003769].
-Both younger (18-59 years) and older patients (60-84 years) were randomly assigned to receive either 5 &mu;g or 25 &mu;g Novavax-CoV2373 or placebo in two doses, 21 days apart.<!--To Do: What is placebo?-->
-In line with the phase I data, reactogenicity remained mild to moderate and of short duration.
-Both dose levels were able to induce high anti-spike IgG titers as well as neutralizing antibody responses after the second dose.
-Based on both safety and efficacy data, the 5 &mu;g dosing regimen was selected as the optimal dose regiment for the phase III trial.
-Although the phase III trial data has not been published yet, Novavax announced an efficacy of 89.3% based on their phase III trial in the UK and South Africa.
-This trial included over 15,000 participants in the UK and 4,000 participants in South Africa with occurrence of a PCR-confirmed symptomatic case as the primary endpoint.
-In the first interim analysis (U.K.), 56 cases of COVID-19 were observed in the placebo group compared to 6 cases in the treatment group.
-Importantly, the vaccine candidate also shows significant clinical efficacy against the prevalent UK and South African variants.
-The company has also initiated the development of new constructs to select candidates that can be used as a booster against new strains and plans to initiate clinical trials for these new constructs in the second quarter of 2021.
-
-<!-- Phase III trial results are published. Need to update text above if they are included. -->
-<!--The primary endpoint of the phase III trial was the occurrence or absence of PCR-confirmed, symptomatic mild, moderate or severe COVID-19 from 7 days after the second dose onward [@doi:10.1056/NEJMoa2107659].
-Side effects were monitored in 2,310 participants and were generally considered mild, with low incidences of headache, muscle pain, and fatigue.-->
-
-Given the apparent need for boosters, interest has also emerged in whether vaccines against SARS-CoV-2 can be administered along with annual flu vaccines.
-Early data came from the Novavax NVX-CoV2373 protein subunit vaccine.
-In a subgroup of approximately 400 patients enrolled from the U.K. phase III trial who received either NVX-CoV2373 or placebo 1:1, a concomitant dose of adjuvanted seasonal influenza vaccines (either a trivalent vaccine or a quadrivalent vaccine) was administered [@doi:10.1101/2021.06.09.21258556].
-This study demonstrated that both types of vaccines could be safely administered together.
-While no change to the immune response was noted for the influenza vaccine, a notable reduction of the antibody response for the NVX-CoV2373 was reported, but efficacy was still high at 87.5% [@doi:10.1101/2021.06.09.21258556].
-Novavax has since started phase I/II trials to investigate the administration of its own influenza vaccine, NanoFlu^™^, concomitantly with NVX-CoV2373 [@url:https://ir.novavax.com/2021-09-08-Novavax-Initiates-Phase-1-2-Clinical-Trial-of-Combination-Vaccine-for-COVID-19-and-Seasonal-Influenza], which appeared to be safe and effective in preclinical studies [@doi:10.1101/2021.05.05.442782].
-
-#### Protein Subunit Vaccine Development Programs Prior to SARS-CoV-2
-
-Earlier studies examined the immunogenicity of a SARS-CoV-1 RBD fused with IgG1 Fc.
-This recombinant fusion protein could induce a robust long-lasting neutralizing antibody and cellular immune response that protected mice from SARS-CoV-1 [@doi:10.3389/fimmu.2020.602256; @doi:10.1016/j.vaccine.2006.10.031; @doi:10.1016/j.vaccine.2006.06.084].
-While there have been other potential protein subunit vaccines for SARS-CoV-1 investigated _in vivo_ [@10.3389/fimmu.2020.602256; @doi:10.3389/fmicb.2020.00298], none of these candidates have successfully completed clinical trials, more than likely due to the fact that the SARS-CoV-1 epidemic mostly ended by May 2004, and there was thus less of a demand or funding for SARS-CoV-1 vaccine research.
-
-Similar vaccine candidates have emerged that target the RBD found in the S1 subunit of the trimeric MERS-CoV S protein, which binds to dipeptidyl-peptidase 4 (DPP4 also known as hCD26), the entry point through which MERS-CoV infects cells [@doi:10.1038/nature12005; @doi:10.1038/nature12328; @doi:10.1128/JVI.01277-13].
-After initially determining that an RBD subunit candidate (S377-588-Fc) could elicit neutralizing antibodies [@doi:10.1371/journal.pone.0081587], a study in mice determined that the administration of three sequential doses of RBD-Fc vaccine coupled with MF59, a squalene immunogenic adjuvant, induced humoral and systemic immunity in mice [@doi:10.1038/cmi.2015.03].
-Mice that had been transduced with Ad5-hCD26 and subsequently challenged with MERS-CoV five days later did not show evidence of viral infection in the lungs versus control mice at ten days post vaccination [@doi:10.1038/cmi.2015.03].
-Other variations of this vaccine approach include a stable S trimer vaccine whereby proline-substituted variants of S2 can maintain a stable prefusion conformation of the S2 domain [@10.3389/fimmu.2020.602256].
-This approach leads to broad and potent neutralizing antibodies [@10.3389/fimmu.2020.602256]
-
-### Complementary Approaches to Vaccine Development
-
-A complementary approach to other vaccine development programs that is being investigated explores the potential for vaccines that are not made from the SARS-CoV-2 virus to confer what has been termed trained immunity.
-In a recent review [@doi:10.1038/s41577-020-0285-6], trained immunity was defined as forms of memory that are temporary (e.g., months or years) and reversible.
-It is induced by exposure to whole-microorganism vaccines or other microbial stimuli that generates heterologous protective effects.
-Trained immunity can be displayed by innate immune cells or innate immune features of other cells, and it is characterized by alterations to immune responsiveness to future immune challenges due to epigenetic and metabolic mechanisms.
-These alterations can take the form of either an increased or decreased response to immune challenge by a pathogen.
-Trained immunity elicited by non-SARS-CoV-2 whole-microorganism vaccines could potentially improve SARS-CoV-2 susceptibility or severity [@doi:10.1016/j.cell.2020.04.042].
-
-One type of stimulus which research indicates can induce trained immunity is bacillus Calmette-Guerin (BCG) vaccination.
-BCG is an attenuated form of bacteria _Mycobacterium bovis_.
-The vaccine is most commonly administered for the prevention of tuberculosis in humans.
-Clinical trials in non-SARS-CoV-2-infected adults have been designed to assess whether BCG vaccination could have prophylactic effects against SARS-CoV-2 by reducing susceptibility, preventing infection, or reducing disease severity.
-A number of trials are now evaluating the effects of the BCG vaccine or the related vaccine VPM1002 [@doi:10.1016/j.cell.2020.04.042; @clinicaltrials:NCT04327206; @clinicaltrials:NCT04328441; @clinicaltrials:NCT04348370; @clinicaltrials:NCT04350931; @clinicaltrials:NCT04362124; @clinicaltrials:NCT04369794; @clinicaltrials:NCT04373291; @clinicaltrials:NCT04379336; @clinicaltrials:NCT04384549; @clinicaltrials:NCT04387409; @clinicaltrials:NCT04414267; @clinicaltrials:NCT04417335; @clinicaltrials:NCT04435379; @clinicaltrials:NCT04439045].
-
-The ongoing trials are using a number of different approaches.
-Some trials enroll healthcare workers, other trials hospitalized elderly adults without immunosuppression who get vaccinated with placebo or BCG at hospital discharge, and yet another set of trials older adults (>50 years) under chronic care for conditions like hypertension and diabetes.
-One set of trials, for example, uses time until first infection as the primary study endpoint; more generally, outcomes measured in some of these trials are related to incidence of disease and disease severity or symptoms.
-Some analyses have suggested a possible correlation at the country level between the frequency of BCG vaccination (or BCG vaccination policies) and the severity of COVID-19 [@doi:10.1016/j.cell.2020.04.042].
-Currently it is unclear whether this correlation has any connection to trained immunity.
-Many possible confounding factors are also likely to vary among countries, such as age distribution, detection efficiency, stochastic epidemic dynamic effects, differences in healthcare capacity over time in relation to epidemic dynamics, and these have not been adequately accounted for in current analyses. <!-- TO DO: add in study that debunks this-->
-It is unclear whether there is an effect of the timing of BCG vaccination, both during an individual's life cycle and relative to the COVID-19 pandemic.
-Additionally, given that severe SARS-CoV-2 may be associated with a dysregulated immune response, it is unclear what alterations to the immune response would be most likely to be protective versus pathogenic (e.g., [@doi:10.1016/j.chom.2020.04.009; @doi:10.1016/j.chom.2020.05.009; @doi:10.1016/j.cell.2020.04.042; @doi:10.1016/j.chom.2020.05.008]).
-The article [@doi:10.1016/j.cell.2020.04.042] proposes that trained immunity might lead to an earlier and stronger response, which could in turn reduce viremia and the risk of later, detrimental immunopathology.
-While trained immunity is an interesting possible avenue to complement vaccine development efforts through the use of an existing vaccine, additional research is required to assess whether the BCG vaccine is likely to confer trained immunity in the case of SARS-CoV-2.
-
 
 
 ## Dietary Supplements and Nutraceuticals Under Investigation for COVID-19 Prevention and Treatment
@@ -5804,7 +5789,7 @@ Trials that recruit across multiple countries do appear to broaden geographic re
 The density of clinical trials is reported at the country level.
 As of December 31, 2020, there are 6,987 trials in the University of Oxford Evidence-Based Medicine Data Lab's COVID-19 TrialsTracker [@doi:10.5281/zenodo.3732709], of which 3,962 are interventional.
 The top figure demonstrates the density of interventional trials recruiting only from a singular country, while the bottom shows the distribution of recruitment for interventional trials that involve more than one country.
-](https://github.com/greenelab/covid19-review/raw/5731b89747027f2322595249c7b11b2f237686f6/ebmdatalab/ebmdatalab-map.png "COVID-19 clinical trials"){#fig:ebm-map secno=1}
+](https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/ebmdatalab/ebmdatalab-map.png "COVID-19 clinical trials"){#fig:ebm-map secno=1}
 
 A few different concerns arise from this skewed geographic representation in clinical trial recruitment.
 First, treatments such as remdesivir that are promising but primarily available to clinical trial participants are unlikely to be accessible by people in many countries.
diff --git a/manuscript.pdf b/manuscript.pdf
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+    "title": "A Review of the Progress and Challenges of Developing a Vaccine for COVID-19",
+    "volume": "11",
+    "author": [
+      {
+        "given": "Omna",
+        "family": "Sharma"
+      },
+      {
+        "given": "Ali A.",
+        "family": "Sultan"
+      },
+      {
+        "given": "Hong",
+        "family": "Ding"
+      },
+      {
+        "given": "Chris R.",
+        "family": "Triggle"
+      }
+    ],
+    "container-title": "Frontiers in Immunology",
+    "issued": {
+      "date-parts": [
+        [
+          2020,
+          10,
+          14
+        ]
+      ]
+    },
+    "URL": "https://doi.org/gh65wd",
+    "container-title-short": "Front. Immunol.",
+    "PMCID": "PMC7591699",
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+    "id": "RGPoDfHS",
+    "note": "This CSL Item was generated by Manubot v0.5.2 from its persistent identifier (standard_id).\nstandard_id: doi:10.3389/fimmu.2020.585354"
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   {
     "publisher": "Frontiers Media SA",
     "abstract": "<jats:p>Coronavirus Disease 2019 (COVID-19) is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), a newly emerged coronavirus, and has been pandemic since March 2020 and led to many fatalities. Vaccines represent the most efficient means to control and stop the pandemic of COVID-19. However, currently there is no effective COVID-19 vaccine approved to use worldwide except for two human adenovirus vector vaccines, three inactivated vaccines, and one peptide vaccine for early or limited use in China and Russia. Safe and effective vaccines against COVID-19 are in urgent need. Researchers around the world are developing 213 COVID-19 candidate vaccines, among which 44 are in human trials. In this review, we summarize and analyze vaccine progress against SARS-CoV, Middle-East respiratory syndrome Coronavirus (MERS-CoV), and SARS-CoV-2, including inactivated vaccines, live attenuated vaccines, subunit vaccines, virus like particles, nucleic acid vaccines, and viral vector vaccines. As SARS-CoV-2, SARS-CoV, and MERS-CoV share the common genus, <jats:italic>Betacoronavirus</jats:italic>, this review of the major research progress will provide a reference and new insights into the COVID-19 vaccine design and development.</jats:p>",
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+    "language": "en",
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+    "title": "SARS-CoV-2 and COVID-19: An Evolving Review of Diagnostics and Therapeutics",
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+    "source": "greenelab.github.io",
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+      {
+        "family": "Rando",
+        "given": "Halie M."
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+      {
+        "family": "Greene",
+        "given": "Casey S."
+      },
+      {
+        "family": "Robson",
+        "given": "Michael P."
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+        "family": "Boca",
+        "given": "Simina M."
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+        "given": "Sandipan"
+      },
+      {
+        "family": "McGowan",
+        "given": "Lucy D\\'Agostino"
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+        "family": "Dattoli",
+        "given": "Anna Ada"
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+        "given": "Ryan"
+      },
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+        "given": "John P."
+      },
+      {
+        "family": "Field",
+        "given": "Jeffrey M."
+      },
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+      },
+      {
+        "family": "MacLean",
+        "given": "Adam L."
+      },
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+        "family": "Lee",
+        "given": "Alexandra J."
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+        "given": "Immunology Institute of the Icahn School",
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+      },
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+        "given": "Fengling"
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+        "family": "Jadavji",
+        "given": "Nafisa M."
+      },
+      {
+        "family": "Sell",
+        "given": "Elizabeth"
+      },
+      {
+        "family": "Wang",
+        "given": "Jinhui"
+      },
+      {
+        "family": "Rafizadeh",
+        "given": "Diane N."
+      },
+      {
+        "family": "Skelly",
+        "given": "Ashwin N."
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+        "given": "Marouen Ben"
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+        "given": "Likhitha"
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+        "given": "James Brian"
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+        "given": "YoSon"
+      },
+      {
+        "family": "Bansal",
+        "given": "Vikas"
+      },
+      {
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+        "given": "Stephen"
+      },
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+        "family": "Dziak",
+        "given": "John J."
+      },
+      {
+        "family": "Sun",
+        "given": "Yuchen"
+      },
+      {
+        "family": "Qi",
+        "given": "Yanjun"
+      },
+      {
+        "family": "Shinholster",
+        "given": "Lamonica"
+      },
+      {
+        "family": "Lukan",
+        "given": "Temitayo"
+      },
+      {
+        "family": "Knyazev",
+        "given": "Sergey"
+      },
+      {
+        "family": "Perrin",
+        "given": "Dimitri"
+      },
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+        "family": "Mangul",
+        "given": "Serghei"
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+      {
+        "family": "Das",
+        "given": "Shikta"
+      },
+      {
+        "family": "Szeto",
+        "given": "Gregory L."
+      },
+      {
+        "family": "Lubiana",
+        "given": "Tiago"
+      },
+      {
+        "family": "Mai",
+        "given": "David"
+      },
+      {
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+      },
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     "id": "tG2qcJCU",
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   },
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-    "id": "rclKBvtk",
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     "type": "webpage",
-    "abstract": "Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced enrollment of the first...",
+    "abstract": "GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that...",
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+    "title": "Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial",
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   },
   {
-    "id": "1COb5Edqu",
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     "type": "webpage",
-    "abstract": "The US Centers for Disease Control and Prevention (CDC) provided updated guidance (Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United...",
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     "container-title": "Novavax Investor Relations",
     "language": "en",
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-    "URL": "https://ir.novavax.com/Novavax-Statement-on-UK-and-Mexico-Phase-3-Clinical-Trial-Participants-Considered-Fully-Vaccinated-in-the-US",
+    "title": "Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial",
+    "URL": "https://ir.novavax.com/2021-06-14-Novavax-COVID-19-Vaccine-Demonstrates-90-Overall-Efficacy-and-100-Protection-Against-Moderate-and-Severe-Disease-in-PREVENT-19-Phase-3-Trial",
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+    "language": "en",
+    "title": "Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza",
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-    "URL": "https://www.chembridge.com/screening_libraries/diversity_libraries/",
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     "container-title": "CNN",
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-    "title": "Biden now says US will have enough vaccine for every adult by the end of May | CNN Politics",
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     "type": "article-newspaper",
-    "abstract": "More than 5.31 billion people worldwide have received a Covid-19 vaccine, equal to about 69.2 percent of the world population.",
+    "abstract": "More than 5.33 billion people worldwide have received a Covid-19 vaccine, equal to about 69.5 percent of the world population.",
     "container-title": "The New York Times",
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     "container-title": "Reuters",
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-    "section": "Healthcare & Pharma",
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     "container-title": "Reuters",
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-    "section": "Race for a cure",
+    "section": "Healthcare & Pharma",
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diff --git a/spelling-error-locations.txt b/spelling-error-locations.txt
index 607f22a0c..338d65a8e 100644
--- a/spelling-error-locations.txt
+++ b/spelling-error-locations.txt
@@ -1,5 +1,2 @@
-content/09.evolution.md:115:timetree
-content/09.evolution.md:436:reproducibly
-content/09.evolution.md:437:sewersheds
-content/09.evolution.md:441:Additionaly
-content/09.evolution.md:442:NWSS
+content/22.vaccines-trad.md:412:gdpscatter
+content/22.vaccines-trad.md:421:gdpscatter
diff --git a/spelling-errors.txt b/spelling-errors.txt
index ce0624a90..fd81ebe51 100644
--- a/spelling-errors.txt
+++ b/spelling-errors.txt
@@ -1,10 +1,6 @@
-Additionaly
 Agrobacterium
 benthamiana
+gdpscatter
 lococyte
 Nicotiana
-NWSS
-reproducibly
-sewersheds
-timetree
 tumefaciens
diff --git a/vaccines-novel-manuscript.docx b/vaccines-novel-manuscript.docx
index bf98c69c4..6468bba7a 100644
Binary files a/vaccines-novel-manuscript.docx and b/vaccines-novel-manuscript.docx differ
diff --git a/vaccines-trad-manuscript.docx b/vaccines-trad-manuscript.docx
index 0553fff60..b6a94221a 100644
Binary files a/vaccines-trad-manuscript.docx and b/vaccines-trad-manuscript.docx differ
diff --git a/variables.json b/variables.json
index 159e853e3..d799145d2 100644
--- a/variables.json
+++ b/variables.json
@@ -8,7 +8,7 @@
       "viral infection"
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-    "date-meta": "2022-08-12",
+    "date-meta": "2022-08-17",
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-  "ebm_update_time_utc": "2022-08-12T00:19:00.461548",
+  "ebm_update_time_utc": "2022-08-17T00:20:37.983347",
   "Covaxin_continents": "Africa, Asia, Europe, and South America",
   "Covaxin_country_count": "30",
   "Sinovac_continents": "Africa, Asia, Europe, North America, and South America",
   "Sinovac_country_count": "63",
   "owid_RNA_count": "2",
   "owid_RNA_countries": "168",
-  "owid_RNA_map": "https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/RNA.png",
+  "owid_RNA_map": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/RNA.png",
   "owid_VLP_count": "1",
   "owid_VLP_countries": "1",
-  "owid_VLP_map": "https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/VLP.png",
-  "owid_commit_date": "2022-08-12T07:08:37Z",
-  "owid_commit_date_pretty": "August 12, 2022",
-  "owid_commit_sha": "a557597f49d8d89ad78e246651178f31a665990f",
-  "owid_doses_bargraph": "https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/OWID_doseTypebyGDP.png",
+  "owid_VLP_map": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/VLP.png",
+  "owid_commit_date": "2022-08-16T07:05:45Z",
+  "owid_commit_date_pretty": "August 16, 2022",
+  "owid_commit_sha": "19ce9079401686da0f139e16f41aeb90e1506e39",
+  "owid_doses_bargraph": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/OWID_dosesByContinent.png",
+  "owid_doses_scatterplot": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/OWID_doseTypebyGDP.png",
   "owid_inactivated_count": "10",
   "owid_inactivated_countries": "116",
-  "owid_inactivated_map": "https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/inactivated.png",
-  "owid_most_recent_date": "August 11, 2022",
+  "owid_inactivated_map": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/inactivated.png",
+  "owid_most_recent_date": "August 15, 2022",
   "owid_non_replicating_viral_vector_count": "5",
   "owid_non_replicating_viral_vector_countries": "202",
-  "owid_non_replicating_viral_vector_map": "https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/non_replicating_viral_vector.png",
+  "owid_non_replicating_viral_vector_map": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/non_replicating_viral_vector.png",
   "owid_plasmid_vectored_count": "0",
   "owid_plasmid_vectored_countries": "0",
   "owid_protein_subunit_count": "10",
   "owid_protein_subunit_countries": "41",
-  "owid_protein_subunit_map": "https://github.com/greenelab/covid19-review/raw/bb142aed891d5ee92efc88fccc1c3631769d8ddf/owiddata/maps/protein_subunit.png",
+  "owid_protein_subunit_map": "https://github.com/greenelab/covid19-review/raw/eb15d131342eae478f456ef874d560272f8ee451/owiddata/maps/protein_subunit.png",
   "owid_total_countries": "223",
   "owid_vaccine_counts": "29",
-  "owid_worldwide_daily_rate": "846.0 per million",
-  "owid_worldwide_date": "August 5, 2022",
+  "owid_worldwide_daily_rate": "745.0 per million",
+  "owid_worldwide_date": "August 9, 2022",
   "owid_worldwide_total_vaccinations": "12.0 billion",
   "viper_approved_DNA": "| Vaccine                                      | Company                     | Platform                     |\n|:---------------------------------------------|:----------------------------|:-----------------------------|\n| Convidecia                                   | CanSino                     | non replicating viral vector |\n| Gam-COVID-Vac                                | Gamaleya                    | non replicating viral vector |\n| Sputnik Light                                | Gamaleya                    | non replicating viral vector |\n| Sputnik V                                    | Gamaleya                    | non replicating viral vector |\n| Ad26.COV2.S                                  | Janssen (Johnson & Johnson) | non replicating viral vector |\n| Vaxzevria                                    | Oxford/AstraZeneca          | non replicating viral vector |\n| Covishield (Oxford/ AstraZeneca formulation) | Serum Institute of India    | non replicating viral vector |\n| ZyCoV-D                                      | Zydus Cadila                | plasmid vectored             |",
-  "viper_approved_RNA": "| Vaccine                       | Company                            |\n|:------------------------------|:-----------------------------------|\n| GEMCOVAC-19                   | Gennova Biopharmaceuticals Limited |\n| Spikevax                      | Moderna                            |\n| Comirnaty                     | Pfizer/BioNTech                    |\n| TAK-919 (Moderna formulation) | Takeda                             |",
+  "viper_approved_RNA": "| Vaccine                       | Company                            |\n|:------------------------------|:-----------------------------------|\n| GEMCOVAC-19                   | Gennova Biopharmaceuticals Limited |\n| mRNA-1273.214                 | Moderna                            |\n| Spikevax                      | Moderna                            |\n| Comirnaty                     | Pfizer/BioNTech                    |\n| TAK-919 (Moderna formulation) | Takeda                             |",
   "viper_approved_subunit": "| Vaccine                                   | Company                                                    | Platform        |\n|:------------------------------------------|:-----------------------------------------------------------|:----------------|\n| Zifivax                                   | Anhui Zhifei Longcom                                       | protein subunit |\n| Noora vaccine                             | Bagheiat-allah University of Medical Sciences              | protein subunit |\n| Corbevax                                  | Biological E Limited                                       | protein subunit |\n| Abdala                                    | Center for Genetic Engineering and Biotechnology (CIGB)    | protein subunit |\n| Soberana 02                               | Instituto Finlay de Vacunas Cuba                           | protein subunit |\n| Soberana Plus                             | Instituto Finlay de Vacunas Cuba                           | protein subunit |\n| Covifenz                                  | Medicago                                                   | VLP             |\n| MVC-COV1901                               | Medigen                                                    | protein subunit |\n| Recombinant SARS-CoV-2 Vaccine (CHO Cell) | National Vaccine and Serum Institute                       | protein subunit |\n| Nuvaxovid                                 | Novavax                                                    | protein subunit |\n| Razi Cov Pars                             | Razi Vaccine and Serum Research Institute                  | protein subunit |\n| COVOVAX (Novavax formulation)             | Serum Institute of India                                   | protein subunit |\n| SKYCovione                                | SK Bioscience Co Ltd                                       | protein subunit |\n| TAK-019 (Novavax formulation)             | Takeda                                                     | protein subunit |\n| SpikoGen                                  | Vaxine/CinnaGen Co.                                        | protein subunit |\n| Aurora-CoV                                | Vector State Research Center of Virology and Biotechnology | protein subunit |\n| EpiVacCorona                              | Vector State Research Center of Virology and Biotechnology | protein subunit |",
   "viper_approved_whole_virus": "| Vaccine                  | Company                                                   |\n|:-------------------------|:----------------------------------------------------------|\n| Covaxin                  | Bharat Biotech                                            |\n| KoviVac                  | Chumakov Center                                           |\n| Turkovac                 | Health Institutes of Turkey                               |\n| FAKHRAVAC (MIVAC)        | Organization of Defensive Innovation and Research         |\n| QazVac                   | Research Institute for Biological Safety Problems (RIBSP) |\n| KCONVAC                  | Shenzhen Kangtai Biological Products Co                   |\n| COVIran Barekat          | Shifa Pharmed Industrial Co                               |\n| Covilo                   | Sinopharm (Beijing)                                       |\n| Inactivated (Vero Cells) | Sinopharm (Wuhan)                                         |\n| CoronaVac                | Sinovac                                                   |\n| VLA2001                  | Valneva                                                   |",
-  "viper_date_pretty": "August 10, 2022",
+  "viper_date_pretty": "August 15, 2022",
   "viper_num_approved_DNA": 8,
-  "viper_num_approved_RNA": 4,
+  "viper_num_approved_RNA": 5,
   "viper_num_approved_subunit": 17,
   "viper_num_approved_whole_virus": 11,
-  "viper_vaccine_counts": "40",
-  "viper_vax_dev_Africa": "No approved vaccines have been developed in Africa [@url:https://covid19.trackvaccines.org].",
-  "viper_vax_dev_Asia": "Vaccines have been developed in 6 countries in Asia, including China (Convidecia, CanSino; Covilo, Sinopharm (Beijing); CoronaVac, Sinovac; Inactivated (Vero Cells), Sinopharm (Wuhan); nan, nan; KCONVAC, Shenzhen Kangtai Biological Products Co; Zifivax, Anhui Zhifei Longcom), India (Covaxin, Bharat Biotech; Corbevax, Biological E Limited), Iran (COVIran Barekat, Shifa Pharmed Industrial Co; FAKHRAVAC (MIVAC), Organization of Defensive Innovation and Research; Razi Cov Pars, Razi Vaccine and Serum Research Institute), Kazakhstan (QazVac, Research Institute for Biological Safety Problems (RIBSP)), Taiwan (MVC-COV1901, Medigen), and Turkey (Turkovac, Health Institutes of Turkey).",
-  "viper_vax_dev_Europe": "Vaccines have been developed in 4 countries in Europe, including the Netherlands (Ad26.COV2.S, Janssen (Johnson & Johnson)), United Kingdom (Vaxzevria, Oxford/AstraZeneca), Germany (Comirnaty, Pfizer/BioNTech), and Russia (Sputnik Light, Gamaleya; Sputnik V, Gamaleya; EpiVacCorona, Vector State Research Center of Virology and Biotechnology; KoviVac, Chumakov Center).",
-  "viper_vax_dev_North_America": "Vaccines have been developed in 2 countries in North America, including the United States of America (Spikevax, Moderna; Comirnaty, Pfizer/BioNTech; Nuvaxovid, Novavax), and Cuba (Abdala, Center for Genetic Engineering and Biotechnology (CIGB); Soberana Plus, Instituto Finlay de Vacunas Cuba; Soberana 02, Instituto Finlay de Vacunas Cuba).",
-  "viper_vax_dev_Oceania": "The only approved vaccine developed in Oceania is SpikoGen, which was developed by Vaxine/CinnaGen Co. in Australia [@url:https://covid19.trackvaccines.org].",
-  "viper_vax_dev_South_America": "No approved vaccines have been developed in South America [@url:https://covid19.trackvaccines.org].",
+  "viper_vaccine_counts": "41",
   "stats_clean_date": "September 10, 2021",
   "stats_date": "2021-09-10",
   "stats_num_authors": "52",