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

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:

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.