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.

We present the risk of Bias for phase 1-2 studies assessed for safety outcomes only.

Treatment comparisons

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

Please choose a Treatment Comparison:

Inactivated virus

Non replicating viral vector

Ad26.COV2.S (5×10^10 vp) D0 vs Placebo (Janssen Biotech, Inc.)

ChAdOx1 vs MenACWY (University of Oxford/AstraZeneca )

Gam-COVID-Vac rAd26-S/rAd5-S vs Placebo (Gamaleya Research Institute of Epidemiology and Microbiology)

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 6 new vaccine randomized trials:

Bueno S, medRxiv, 2021	Interim Report: Safety And Immunogenicity Of An Inactivated Vaccine Against Sars-Cov-2 In Healthy Chilean Adults In A Phase 3 Clinical Trial
Goepfert P, medRxiv, 2021	Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: a randomised, placebo-controlled, dose-ranging study
Han B, SSRN, 2021	Safety, Tolerability and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Healthy Children and Adolescents: A Randomised, Double-Blind, and Placebo-Controlled, Phase 1/2 Clinical Trial
Palacios R, SSRN, 2021	Efficacy and Safety of a COVID-19 Inactivated Vaccine in Healthcare Professionals in Brazil: The PROFISCOV Study
Pan HX, medRxiv, 2021	Immunogenicity and Safety of a SARS-CoV-2 Inactivated Vaccine (KCONVAC) in Healthy Adults: Two Randomized, Double-blind, and Placebo-controlled Phase 1/2 Clinical Trials
Shinde V, medRxiv, 2021	Preliminary Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant

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.

Press releases

We acknowledged the publication of press release on the findings of the Novavax vaccine: COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial ">Novavax vaccine We will summarize and assess the study results once the full study reports have been published.

Last update: 16/04/2021

Trial	Type	Comparisons		Design	Participants	Sample size	Overall risk of bias Highest assessment	Full description
		Intervention 1	Intervention 2
NCT04470427 ModernaTX Baden LR, N Engl J Med, 2020 COVE New Full text Full text ; Full text 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=30420	Some concerns Details	Full description
NCT04651790 Sinovac Research and Development Co., Ltd Bueno S, medRxiv, 2021 New Full text Commentary Commentary	Inactivated virus	CoronaVac	Placebo	RCT Phase 3	Adult healthcare workers with no history of confirmed symptomatic SARS-CoV-2 infection who were in contact with possible or confirmed cases of COVID-19 in 8 sites in Chile.	N=434	Low Details	Full description
NCT04495933 The University of Queensland; Syneos Health; CSIRO Manufacturing; Seqirus; Coalition for Epidemic Preparedness Innovations Chappell K, SSRN, 2021 New Full text Commentary	Protein subunit	SARS-CoV-2 Sclamp 5-mcg D SARS-CoV-2 Sclamp 15-mcg SARS-CoV-2 Sclamp 45-mcg SARS-CoV-2 Sclamp 45-mcg	Placebo	RCT Phase 1	Healthy SARS-CoV-2 infection-free adults aged 18-55 at one center in Australia.	N=120	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 KMS-1 150 EU D0/14 KMS-1 100 EU D0/28 KMS-1 150 EU D0/28	Adjuvant	RCT Phase 2	Healthy SARS-CoV-2 serology/DNA negative adults in two centres in China	N=750	Some concerns Details	Full description
NCT04471519 ; CTRI/2 Bharat Biotech Ella R, Lancet Infect Dis, 2021 Full text Commentary	Inactivated virus	3mcg BBV152 + Algel-IMDG 6mcg BBV152 + Algel-IMDG 6mcg BBV152 + Algel	Adjuvant	RCT Phase 1	Healthy SARS-CoV-2 serology/PCR negative adults in 11 centres in India	N=375	Low Details	Full description
NCT04471519 ; CTRI/2 Bharat Biotech Ella R, Lancet Infect Dis, 2021 Updated Full text Commentary ; Commentary	Inactivated virus	6mcg BBV152 + Algel-IMDG	3mcg BBV152 + Algel-IMDG	RCT Phase 2	Healthy adults (<65 yo) and children (≥12 yo)volunteers, SARS-CoV-2 infection-free in 9 centres in India	N=380	Some concerns Details	Full description
NCT04505722 Janssen Biotech, Inc. *ENSEMBLE, , 2021 ENSEMBLE** New Full text Stephenson KE, JAMA, 2021 Full text		Ad26.COV2.S (5×10^10 vp)	Placebo	RCT Phase 3	Adults >18 years of age at 213 centers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and USA	N=44325	Some concerns Details	Full description
NCT04368988 Novavax, Inc Formica N, medRxiv, 2021 Full text Commentary Commentary	Protein subunit	NVX-CoV2373 5mcg D0/21 NVX-CoV2373 5mcg D0 25mcg NVX-CoV2373 D0/D21 25mcg NVX-CoV2373 D0	Placebo D0/D21	RCT Phase 2	Healthy adults (stable comorbidities and confirmed COVID-19 with mild symptoms permitted) aged 18-84 years at 17 centers in Australia and USA	N=1288	Some concerns Details	Full description
NCT04368988 Novavax Keech C, N Engl J Med, 2020 Full text Commentary	Non replicating viral vector	25mcg NVX-D0/21 5mcg NVX/M1-D0/21 25mcg NVX/M1-D0/21 25mcg NVX/M1+Placebo-D0/2	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
NCT04530396 Gamaleya Research Institute of Epidemiology and Microbiology Logunov D, Lancet, 2021 RESIST Full text Commentary ; Commentary ; Commentary	Non replicating viral vector	Gam-COVID-Vac rAd26-S/rAd	Placebo	RCT Phase 3	SARS-CoV-2- and HIV infection-free adult volunteers at 25 centers in Russia	N=21977	Some concerns Details	Full description
NCT04444674 University of Oxford/AstraZeneca Madhi S, N Engl J Med, 2021 COV005 Updated Full text Commentary	Non replicating viral vector	ChAdOx1 5X10^10vp D0/D28	Placebo	RCT Phase 1-2	Healthy adult volunteers that were HIV-negative and SARS-CoV-2 infection-free in 7 centres in South Africa	N=2026	N/A	Full description
NCT04456595 Sinovac Biotech Palacios R, SSRN, 2021 PROFISCOV New Full text Commentary	Inactivated virus	CoronaVac	Placebo	RCT Phase 3	Healthcare professionals with or without previous COVID-19 infection caring for COVID-19 patients at 16 centers in Brazil.	N=12408	Some concerns Details	Full description
NCT04368728 BioNTech/Fosun Pharma/Pfizer Polack F, 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=43448	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-1 100 EU D0/14 KMS-1 100 EU D0/28	Placebo	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
NCT04405908 Clover Biopharmaceuticals, Chengdu, China Richmond P, Lancet, 2021 Full text Commentary	Protein subunit	SCB-2019 3 mcg SCB-2019 3 mcg + AS03 SCB-2019 3 mcg + CpG/Alum SCB-2019 9 mcg SCB-2019 9 mcg + AS03 SCB-2019 9 mcg + CpG/Alum SCB-2019 30 mcg SCB-2019 30 mcg + AS03 SCB-2019 30 mcg + CpG/Alu	Placebo	RCT Phase 1	Healthy SARS-CoV-2 serology/DNA negative adults aged 18-75 years at one study center in Australia	N=151	Low Details	Full description
NCT04436276 Janssen Pharmaceutical Companies Sadoff J, N Engl J Med, 2021 Full text Commentary	Non replicating viral vector	Ad26.COV2.S 5x10^10vp Ad26.COV2.S 1x10^11vp	Placebo	RCT Phase 1-2	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=810	Some concerns Details	Full description
ISRCTN89951424 University of Oxford/AstraZeneca Voysey M, Lancet, 2020 COV003 Updated 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=10002	Some concerns Details	Full description
NCT04400838 University of Oxford/AstraZeneca Voysey M, Lancet, 2020 COV002 Updated Full text Commentary	Non replicating viral vector	ChAdOx1 LD/SD ChAdOx1 SD/SD	MenACWY	RCT Phase 2/3	Healthy adults in 18 centres in the UK	N=10673	Some concerns Details	Full description
NCT04324606 / EudraC University of Oxford/AstraZeneca Voysey M, Lancet, 2021 COV001/COV002/COV003/COV005 Full text Commentary ; Commentary ; Commentary	Non replicating viral vector	ChAdOx1	MenACWY/saline	RCT phase 1/2/3	Adults seronegative at baseline from four studies in multiple centres in Brazil, South Africa, and the UK	N=24422	Some concerns Details	Full description
NCT04368728 BioNTech SE, Pfizer Walsh E, N Engl J Med, 2020 New Full text Commentary	RNA based vaccine	BNT162b1 10 mcg D1/21 BNT162b1 20 mcg D1/21 BNT162b1 30 mcg D1/21 BNT162b1 100 mcg D1/21 BNT162b2 10 mcg D1/21 BNT162b2 20 mcg D1/21 BNT162b2 30 mcg D1/21	BNT162b1 30 mcg D1/21	RCT Phase 1	Healthy SARS-CoV-2 serology/DNA negative adults in four centres in USA	N=195	Low Details	Full description
NCT04450004 Medicago Ward B, medRxiv, 2020 Full text Commentary ; Commentary	Virus-Like particle (VLP)	CoVLP 3.75mcg + CpG1018 CoVLP 3.75mcg + AS03 CoVLP 7.5mcg + CpG1018 CoVLP 7.5mcg + AS03 CoVLP 15mcg + CpG1018 CoVLP 15mcg + AS03	CoVLP 3.75mcg CoVLP 3.75mcg CoVLP 7.5mcg CoVLP 7.5mcg CoVLP 15mcg CoVLP 15mcg	RCT Phase 1	Healthy SARS-CoV-2 infection-free adults aged 18-55 years at 2 centers in Canada	N=180	Some concerns Details	Full description
NCT04383574 Sinovac Biotech Wu Z, Lancet Infect Dis, 2021 Full text Commentary ; Commentary	Inactivated virus	CoronaVac 1.5mcg D0/28 CoronaVac 3mcg D0/28 CoronaVac 6mcg D0/28	Adjuvant	RCT Phase 2	Healthy adults aged 60 years and older with no history of SARS-CoV-2 infection in a single centre in China	N=422	Low Details	Full description
ChiCTR2000032459 Beijing Institute of Biological Products/Sinopharm Xia S, Lancet Infect Dis, 2020 Full text Commentary	Inactivated virus	BBIBP-CorV 8mcg once BBIBP-CorV 4mcg D0/14 BBIBP-CorV 4mcg D0/21 BBIBP-CorV 4mcg D0/28	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=448	Some concerns Details	Full description
ChiCTR2000031809 Wuhan Institute of Biological Products Co Ltd./Sinopharm Xia S, JAMA, 2020 Full text Commentary	Inactivated virus	Inactivated 2.5mcg-D0/28/ Inactivated 5mcg-D0/28/56 Inactivated 10mcg-D0/28/5 Inactivated 5mcg-D0/14 Inactivated 5mcg-D0/21	Adjuvant	RCT Phase 1	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=320	Low Details	Full description
NCT04445194 Institute of Microbiology, Chinese Academy of Sciences ; Anhui Zhifei Longcom Biopharmaceutical Co., Ltd Yang S, Lancet, 2021 Full text Commentary	Protein subunit	ZF2001 25 mcg 3 doses ZF2001 50 mcg 3 doses	Adjuvant	RCT Phase 1	Healthy SARS-CoV-2 infection-free adults aged 18-59 at 2 centers in China	N=50	Some concerns Details	Full description
NCT04466085 Institute of Microbiology, Chinese Academy of Sciences ; Anhui Zhifei Longcom Biopharmaceutical Co., Ltd Yang S, Lancet, 2021 Full text Commentary	Protein subunit	ZF2001 25 mcg 2 doses ZF2001 50 mcg 2 doses ZF2001 25 mcg 3 doses ZF2001 50 mcg 3 doses	Adjuvant	RCT Phase 2	Healthy SARS-CoV-2 infection-free adults aged 18-59 at 1 center in China	N=900	Low Details	Full description
NCT04352608 Sinovac Zhang Y, Lancet Infect Dis, 2020 Full text Commentary ; Commentary	Inactivated virus	CoronaVac 3 μg D0/14 CoronaVac 6 μg D0/14 CoronaVac 3 μg D0/28 CoronaVac 6 μg D0/28	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
NCT04341389 CanSino Biological Inc./Beijing Institute of Biotechnology Zhu F, Lancet, 2020 Full text Commentary Commentary	Non replicating viral vector	Ad5-vectored 1×10¹¹ vp Ad5-vectored 1×10¹¹ vp Ad5-vectored 5×10¹⁰ vp	Ad5-vectored 5×10¹⁰ vp Placebo 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

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 risk of bias by domain as well as 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.