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.

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.

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

KMS-1 D0/28 Adjuvant
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

Ad26.COV2.S 1x10^11vp Placebo
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

ChAdOx1 SD/SD 1/2 doses MenACWY
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.