Covid-19 living Data

Vaccines for covid-19 patients

As part of the COVID-NMA initiative, we are identifying all randomized controlled trials (RCTs) of COVID-19 vaccine.

Below, you can access

A table with the general characteristics and risk of bias assessment for all RCTs identified.
A synthesis with forest plots and summary of findings table/evidence profile including phase 2-3 trials. For the vaccine (dose and schedule) evaluated in phase 2-3 trials, results available for the same vaccine (dose and schedule) in phase 1-2 trial will also be included in the synthesis.

Of note: For risk of bias assessment, we are considering the “effect of assignment to intervention” which might not be the analysis planned and reported by investigators. Consequently, when investigators planned to assess and report the “per-protocol” effect, the risk of bias for domain 2 may be evaluated as “some concerns”. We will contact investigators to obtain the results of the intent-to-treat analysis.

Treatment comparisons

We report below the forest plots for the main treatment comparisons.

Please choose a Treatment Comparison:

Inactivated virus

Non replicating viral vector

ChAdOx1 vs MenACWY (University of Oxford/AstraZeneca )

RNA based vaccine

BNT162b2 vs Placebo (BioNTech/Fosun Pharma/Pfizer )

mRNA-1273 vs Placebo (ModernaTX)

Trials reports under extraction

In addition to the below included trials, we have included and presently extracting 4 new vaccine randomized trials:

Ella R, medRxiv, 2020	Safety and immunogenicity clinical trial of an inactivated SARS-CoV-2 vaccine, BBV152 (a phase 2, double-blind, randomised controlled trial) and the persistence of immune responses from a phase 1 follow-up report
Shilong Y, medRxiv, 2020	Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD protein vaccine against COVID-19 in adults: pooled analysis of two randomized, double-blind, placebo-controlled, phase 1 and 2 trials
Ward BJ, medRxiv, 2020	Phase 1 trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants
Zhu F, ResearchSquare, 2021	First report demonstrating the safety and immunogenicity of the SARS-COV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, observer-blind Phase I study

Description of primary studies

In this table, we report the main characteristics of the COVID-19 vaccine candidates from RCTs identified. The presented data is preliminary and ROB assessment is still under quality control. Please contact us if you notice an inaccuracy.

Risk of bias appears in black for some studies because the assessment data is not available to proceed with the assessment. Non randomized studies are not included in the table.

Last update: 22/01/2021

Trial	Type	Comparisons		Design	Participants	Sample size	Overall risk of bias	Full description
		Intervention 1	Intervention 2
NCT04470427 ModernaTX Baden LR, N Engl J Med, 2020 Full text FDA Briefing Full text Commentary	RNA based vaccine	mRNA-1273	Placebo	RCT Phase 3	Healthy adults with no known history of SARS-CoV-2 infection in 99 centers in the US	N=30351	Some concerns Details	Full description
NCT04412538 Institute of Medical Biology (IMB), Chinese Academy of Medical Sciences (CAMS). Che Y,Clin Infect Dis,2020 Full text Commentary	Inactivated virus	KMS-1 100 EU D0/14	Adjuvant	RCT Phase 2	Healthy SARS-CoV-2 serology/DNA negative adults in two centres in China	N=750	Some concerns Details	Full description
		KMS-1 150 EU D0/14	Adjuvant
		KMS-1 100 EU D0/28	Adjuvant
		KMS-1 150 EU D0/28	Adjuvant
NCT04471519 ; CTRI/2020/07/026300 Bharat Biotech Ella R,medRxiv,2020 Full text ; Full text Commentary ; Commentary	Inactivated virus	3mcg BBV152 + Algel-IMDG	Adjuvant	RCT phase 1	Healthy SARS-CoV-2 serology/PCR negative adults in 11 centres in India	N=375	Some concerns Details	Full description
		6mcg BBV152 + Algel-IMDG	Adjuvant
		6mcg BBV152 + Algel	Adjuvant
NCT04324606; ISRCTN15281137; EudraCT 2020-001072-15 University of Oxford/AstraZeneca Folegatti PM (COV001), Lancet, 2020 Full text Barrett JR, Nature medicine, 2020 Full text Ewer KJ, Nature medicine, 2020 Full text Commentary Commentary	Non replicating viral vector	ChAdOx1	MenACWY	RCT Phase 1/2	Healthy adults with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms in five centres in the UK	N=1077	Low Details	Full description
NCT04368988 Novavax Keech C., N Engl J Med, 2020 Full text Commentary	Non replicating viral vector	2 dose 25mcg NVX-D0/21	Placebo	RCT Phase 1	Healthy adult volunteers, SARS-CoV-2 infection-free and no history of SARS-CoV-2 infection in two centres in Australia.	N=134	Some concerns Details	Full description
		2 dose 5mcg NVX/M1-D0/21	Placebo
		2 dose 25mcg NVX/M1-D0/21	Placebo
		1 dose 25mcg NVX/M1+Placebo-D0/21	Placebo
NCT04368728 BioNTech/Fosun Pharma/Pfizer Polack FP,N Engl J Med,2020 Full text Commentary Commentary Commentary Commentary Commentary	RNA based vaccine	BNT162b2	Placebo	RCT Phase 2/3	Healthy SARS-CoV-2 DNA negative adults in multiple centres in Argentina, Brazil, Germany, South Africa, Turkey, and the USA	N=43548	Some concerns Details	Full description
NCT04412538 The Institute of Medical Biology (IMB), Chinese Academy of Medical Sciences (CAM) Pu J, MedRxiv, 2020 Full text Commentary ; Commentary	Inactivated virus	KMS-1 D0/14	Adjuvant	RCT Phase 1	Healthy adults aged 18 to 59 years, SARS-CoV-2 nucleic acid or antibodies negative in a single centre in China.	N=192	Some concerns Details	Full description
	Inactivated virus	KMS-1 D0/28	Adjuvant	RCT Phase 1		N=192	Some concerns Details	Full description
NCT04405908 Clover Biopharmaceuticals, Chengdu, China Richmond P,MedRxiv,2020 Full text Commentary ; Commentary	Protein subunit	SCB-2019 3 mcg	Placebo	RCT Phase 1	Healthy SARS-CoV-2 serology/DNA negative elderly adults at one study center in Australia	N=151	Some concerns Details	Full description
		SCB-2019 9 mcg	Placebo
		SCB-2019 30 mcg	Placebo
		SCB-2019 3 mcg + AS03	Placebo
		SCB-2019 3 mcg + CpG/Alum	Placebo
		SCB-2019 9 mcg + AS03	Placebo
		SCB-2019 9 mcg + CpG/Alum	Placebo
		SCB-2019 30 mcg + AS03	Placebo
		SCB-2019 30 mcg + CpG/Alum	Placebo
NCT04436276 Janssen Pharmaceutical Companies Sadoff J,MedRxiv,2020 Full text Commentary	Non replicating viral vector	Ad26.COV2.S 5x10^10vp	Placebo	RCT Phase 1	Healthy SARS-CoV-2 nucleic acid negative adults 18-55 years old and elderly >65 years old in multiple centres in Belgium and the US	N=785	High Details	Full description
	Non replicating viral vector	Ad26.COV2.S 1x10^11vp	Placebo	RCT Phase 1		N=785	High Details	Full description
NCT04400838 University of Oxford/AstraZeneca Voysey M (COV002), Lancet, 2020 Full text Commentary	Non replicating viral vector	ChAdOx1 LD/SD	1/2 doses MenACWY	RCT Phase 2/3	Healthy adults in 18 centers in the UK	N=7548	Some concerns Details	Full description
	Non replicating viral vector	ChAdOx1 SD/SD	1/2 doses MenACWY	RCT Phase 2/3	Healthy adults in 18 centers in the UK	N=7548	Some concerns Details	Full description
ISRCTN89951424 University of Oxford/AstraZeneca Voysey M (COV003), Lancet, 2020 Full text Commentary	Non replicating viral vector	ChAdOx1 SD/SD	MenACWY/saline	RCT Phase 3	Healthy SARS-CoV-2 serology/DNA negative adults in six centres in Brazil	N=4088	Some concerns Details	Full description
NCT04444674 University of Oxford/AstraZeneca Voysey M (COV005), Lancet, 2020 Full text Commentary	Non replicating viral vector	ChAdOx1 std 2 doses	Saline	RCT Phase 1/2	Healthy adults from four studies in multiple centres in Brazil, South Africa, and the UK	N=2013	Details	Full description
NCT04368728 BioNTech SE, Pfizer Walsh E, N Engl J Med, 2020 Full text Commentary	RNA based vaccine	BNT162b1 10 mcg D1/21	Placebo	RCT Phase 1	Healthy SARS-CoV-2 serology/DNA negative adults in four centres in USA	N=195	Low Details	Full description
		BNT162b1 20 mcg D1/21	Placebo
		BNT162b1 30 mcg D1/21	Placebo
		BNT162b1 100 mcg D1/21	Placebo
		BNT162b2 10 mcg D1/21	Placebo
		BNT162b2 20 mcg D1/21	Placebo
		BNT162b2 30 mcg D1/21	Placebo
ChiCTR2000031809 Wuhan Institute of Biological Products Co Ltd./Sinopharm Xia S, JAMA, 2020 Full text Commentary	Inactivated virus	Inactivated 2.5mcg-D0/28/56	Adjuvant	RCT Phase 1/2	Healthy adults, aged 18 to 59 years, without history ofSARS-CoV(via on-site inquiry) or SARS-CoV-2 infection (via serologicaland nucleic acid test	N=96	Low Details	Full description
		Inactivated 5mcg-D0/28/56	Adjuvant
		Inactivated 10mcg-D0/28/56	Adjuvant
		Inactivated 5mcg-D0/14	Adjuvant
		Inactivated 5mcg-D0/21	Adjuvant
ChiCTR2000032459 Beijing Institute of Biological Products/Sinopharm Xia S, Lancet Infect Dis, 2020 Full text Commentary	Inactivated virus	BBIBP-CorV 8mcg	Adjuvant	RCT Phase 2	Healthy SARS-CoV-2 serology negative adults 18-59 years old and ?60 years old in a single centre in China	N=112	Some concerns Details	Full description
		BBIBP-CorV 4mcg D0/14	Adjuvant
		BBIBP-CorV 4mcg D0/21	Adjuvant
		BBIBP-CorV 4mcg D0/28	Adjuvant
NCT04352608 Sinovac Zhang Y,Lancet Infect Dis,2020 Full text Commentary	Inactivated virus	CoronaVac 3 mcg D0/14	Adjuvant	RCT Phase 2	Healthy SARS-CoV-2 serology/DNA negative adults in a single centre in China	N=600	Some concerns Details	Full description
		CoronaVac 6 mcg D0/14	Adjuvant
		CoronaVac 3 mcg D0/28	Adjuvant
		CoronaVac 6 mcg D0/28	Adjuvant
NCT04341389 CanSino Biological Inc./Beijing Institute of Biotechnology Zhu F, The Lancet, 2020 Full text Commentary Commentary	Non replicating viral vector	Adenovirus type-5-vectored COVID-19 1 × 10¹¹ vp	Placebo	RCT Phase 2	Healthy adult volunteers with HIV-negative and SARS-CoV-2 infection-free in a single centre in China.	N=508	Some concerns Details	Full description
		Adenovirus type-5-vectored COVID-19 5×10¹° vp	Placebo
		Adenovirus type-5-vectored COVID-19 1 × 10¹¹ vp	Adenovirus type-5-vectored COVID-19 5×10¹° vp

The link in the column "Overall risk of bias" provides access to a complete description of the assessment of each risk of bias domain with supports for judgement produced using the Revised Cochrane risk-of-bias tool for randomized trials RoB 2.

The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review. The link in the column "Full description" provides access to the general characteristics of the study.

We acknowledge that we may have been unable to extract some information from pre-prints, as they represent preliminary forms of scientific communication.