COVID-19 vaccine effectiveness
(Randomized evidence)

Analyses are updated every Friday

Methods

Variants of concern

RCTs

Treatment comparisons

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.

For phase 1-2 studies, we report on the general charecteristics and assess the risk of Bias for safety outcomes only. Results from phase1-2 studies are included in forest plots for the chosen vaccine dose and schedule.

The evidence synthesis with forest plots and summary of findings table and evidence profile are provided for the chosen vaccine schedule with results collected from relevant phase 1, 2 and 3 studies.

Results for each vaccine comparisons are the summary of evidence from the latest study report results.

Trial Type Comparisons Design Participants Sample size Overall risk
of bias
Highest assessment
Full description
Intervention 1 Intervention 2
NCT04510207, ChiCTR2000034780
Sinopharm - China National Biotec Group Company Limited
Al Kaabi N, JAMA, 2021

Full text
Commentary
Commentary
Inactivated virus

WIV04

HBO2

Placebo

RCT
Phase 3
Healthy adults free of known COVID-19 or HIV infection at 3 centres in United Arab Emirates and Bahrain N=40411
Some concerns
Details

Full description

NCT04470427
ModernaTX
Baden LR, N Engl J Med, 2020
COVE

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

NCT04860739, EudraCT2021-001978-37
Pfizer/BioNTech + Fosun Pharma
Borobia A M, Lancet, 2021

Full text
Commentary
RNA based vaccine

BNT162b2

No vaccine

RCT
Phase 2
Healthy, or clinically stable, adults (aged ≥18 and ≤60) that were SARS-COV-2 infection free and who had received a prime ChAdOx1-S vaccination between 8 and 12 weeks before the screening visit in 5 centers in Spain. N=676
Some concerns
Details

Full description

NCT04651790
Sinovac Research and Development Co., Ltd
Bueno S, medRxiv, 2021

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, Lancet, 2021

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 D0/28

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 D0/14

RCT
Phase 2
Healthy SARS-CoV-2 serology/DNA negative adults in two centres in China N=750
Some concerns
Details

Full description

NCT04641481
Bharat Biotech
Ella R, medRxiv, 2021
New

Full text
Commentary
Commentary
Inactivated virus

BBV152

Placebo

RCT
3
Adults with no history of SARS-CoV-2 infection who were healthy or had stable chronic medical conditions at 25 centers in India N=25778
Some concerns
Details

Full description

NCT04471519 ; CTRI/2
Bharat Biotech
Ella R, Lancet Infect Dis, 2021

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

NCT04471519 ; CTRI/2
Bharat Biotech
Ella R, Lancet Infect Dis, 2021

Full text
Commentary
Inactivated virus

BBV152 3mcg + Algel-IMDG

BBV152 6mcg + Algel-IMDG

BBV152 6mcg + Algel D0/1

Adjuvant D0/14

RCT
Phase 1
Healthy SARS-CoV-2 serology/PCR negative adults in 11 centres in India N=375
Low
Details

Full description

NCT04400838
AstraZeneca + University of Oxford
Emary K, Lancet, 2021

Full text
Commentary
Non replicating viral vector

ChAdOx1

MenACWY

RCT
Phase 2-3
Adults seronegative at baseline enrolled at 19 study sites in UK N=10673
Some concerns
Details

Full description

NCT04324606; ISRCTN1
University of Oxford/AstraZeneca
Folegatti PM, Lancet, 2020
COV001

Full text
Commentary
; Commentary
(20)31611-1/fulltext
Non replicating viral vector

ChAdOx1 SD

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=1067
Low
Details

Full description

NCT04368988
Novavax
Formica N, medRxiv, 2021

Full text
Commentary
Commentary
Protein subunit

NVX-CoV2373

NVX-CoV2373 5mcg D0

25mcg NVX-CoV2373 D0/D21

25mcg NVX-CoV2373 D0

Placebo

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

NCT04368728
Pfizer/BioNTech + Fosun Pharma
Frenck R, N Engl J Med, 2021

Full text
Commentary
RNA based vaccine

BNT162b2

Placebo

RCT
Phase 3
Adolescents aged 12 to 15 years with no previous Covid-19 diagnosis or SARS-CoV-2 infection in 29 centers in the USA N=2264
Some concerns
Details

Full description

NCT04636697
Medicago Inc
Gobeil P, medRxiv, 2021

Full text
Commentary
Commentary
Virus-Like particle (VLP)

CoVLP 3.75mcg +AS03

Placebo

RCT
Phase 2
Healthy adults and non-institutionalized older adults (seronegative and seropositive) in multiple centers in Canada and the USA N=588 N/A

Full description

NCT04537208
Sanofi Pasteur, GlaxoSmithKline
Goepfert P, Lancet, 2021

Full text
Commentary
Protein subunit

CoV2 preS dTM LD + AFO3

CoV2 preS dTM LD + ASO3

CoV2 preS dTM HD + AFO3

CoV2 preS dTM HD + ASO3

CoV2 preS dTM HD

Placebo

RCT
Phase 1-2
Health adults aged 18 years and older and SARS-CoV-2 infection-free in 10 centres in the USA. N=271
Some concerns
Details

Full description

NCT04551547
Sinovac Research and Development Co., Ltd
Han B, SSRN, 2021

Full text
Commentary
Commentary
Inactivated virus

CoronaVac 1.5 mcg D0/28

Adjuvant D0/28

CoronaVac 3.0 mcg D0/28

RCT
Phase 1/2
Healthy children and adolescents aged 3-17 years with no history of SARS-CoV-2 infection in a single centre in China. N=552
Low
Details

Full description

NCT04583995; EudraCT 2020-004123-16
Novavax
Heath P, N Engl J Med, 2021

Full text
Commentary
Protein subunit

NVX-CoV2373

Placebo

RCT
Phase 3
Adults 18 to 84 years old who were healthy or had stable chronic medical conditions with no history of COVID-19 at 33 centres in the UK. N=15187
Some concerns
Details

Full description

NCT04368988
Novavax
Keech C, N Engl J Med, 2020

Full text
Commentary
Protein subunit

25mcg NVX-D0/21

NVX-CoV2373

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

ChiCTR2000034825 ; NCT04523571
BioNTech RNA Pharmaceuticals
Li J, Nature Medicine, 2021

Full text
Commentary
RNA based vaccine

BNT162b1 10 mcg

BNT162b1 10 mcg

RCT
Phase 1
Healthy young adults between 18 and 55 years of age, and older adults between 65 and 85 that were SARS-COVID-2 infection-free at a single center in China. N=144
Low
Details

Full description

ChiCTR2100045108
Guangdong Provincial Center for Disease Control and Prevention
Liao Y, Emerg Microbes Infec, 2021
New

Full text
Commentary
Protein subunit

V-01 10 mcg

V-01 25 mcg

V-01 50 mcg

Adjuvant

RCT
Phase 1
Healthy seronegative adults with no history of COVID-19 in a single center in China N=180
Some concerns
Details

Full description

ISRCTN69254139, EudraCT: 2020-005085-33
AstraZeneca+University of Oxford; Pfizer/BioNTech+Fosun Pharma
Liu X, SSRN, 2021
Com-COV

Full text
Commentary
Commentary
Commentary
Commentary
RNA based vaccine

ChAd/ChAd-28

BNT/BNT-28

ChAd/BNT-28

BNT/ChAd-28

RCT
Phase 2
Adults 50 years or older with no previous SARS-CoV-2 infection, no or well-controlled mild-moderate comorbidities and HIV-negative in 8 centers in the UK N=463
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

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

Full text
Commentary
Non replicating viral vector

ChAdOx1

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
Some concerns
Details

Full description

NCT04444674, PACTR202006922165132
AstraZeneca + University of Oxford
Madhi S, Research square , 2021

Full text
Commentary
Non replicating viral vector

ChAdOx1 nCoV-19

Placebo D0/28

RCT
Phase 1-2
Adults living with HIV in 7 centers in South Africa N=104
Some concerns
Details

Full description

NCT04642638
Inovio Pharmaceuticals
Mammen Jr M, medRxiv, 2021

Full text
Commentary
Commentary
DNA based vaccine

INO-4800 1mg D0/28

INO-4800 2mg D0/28

Placebo 1 D0/28

Placebo 2 D0/28

RCT
Phase 2
Healthy adult volunteers SARS-CoV-2 seronegative at high risk of infection at 16 locations in the USA. N=201
Some concerns
Details

Full description

NCT04456595
Sinovac Research and Development Co., Ltd
Palacios R, SSRN, 2021
PROFISCOV

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

NCT04758273, ChiCTR2000038804
Shenzhen Kangtai Biological Products and Beijing Minhai Biotechnology
Pan HX, Chin Med J, 2021

Full text
Commentary
Inactivated virus

5mcg KCONVAC

10mcg KCONVAC

RCT
Phase 1
Healthy adult volunteers with no history of COVID-19 and HIV- and SARS-CoV-2 infection-free in a single centre in China. N=60
Low
Details

Full description

NCT04756323, ChiCTR2000039462
Shenzhen Kangtai Biological Products and Beijing Minhai Biotechnology
Pan HX, Chin Med J, 2021

Full text
Commentary
Inactivated virus

KCONVAC 5mcg D0/14

KCONVAC 5mcg D0/14

KCONVAC 5mcg D0/28

KCONVAC 5mcg D0/28

KCONVAC 5mcg D0/14

KCONVAC 10mcg D0/14

KCONVAC 10mcg D0/14

KCONVAC 5mcg D0/14

KCONVAC 10mcg D0/28

Placebo D0/28

Placebo D0/14

Placebo D0/14

RCT
Phase 2
Healthy adult volunteers with no history of COVID-19 and HIV- and SARS-CoV-2 infection-free in a single centre in China. N=500
Low
Details

Full description

NCT04368728
Pfizer/BioNTech + Fosun Pharma
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, Vaccine, 2021

Full text
Commentary
Inactivated virus

KMS-1 100 EU D0/14

KMS-1 100 EU D0/28

Placebo D0/14

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

NCT04527575
EpiVac LLC ; State Scientific Center of Virology and Biotechnology “Vector” of Rospotrebnadzor
Ryzhikov AB, Infektsiia Immun, 2021

Full text
Commentary
Protein subunit

EpiVacCorona

Placebo

RCT
Phase 2
Healthy adult SARS-CoV-2 infection-free volunteers in a single center in Russia. N=86
Some concerns
Details

Full description

NCT04436276
Janssen Pharmaceutical Companies
Sadoff J, N Engl J Med, 2021
ENSEMBLE

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

NCT04505722
Janssen Pharmaceutical Companies
Sadoff J, N Engl J Med, 2021
ENSEMBLE

Full text
Commentary
Non replicating viral vector

Ad26.COV2.S

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

NCT04533399; PACTR202009726132275
Novavax
Shinde V, N Engl J Med, 2021

Full text
Commentary
Protein subunit

NVX-CoV2373

Placebo

RCT
Phase 2a/b
HIV-negative adults (18 to 84 years) and medically stable HIV-positive adults (18 to 64 years) at 16 sites in South Africa N=4406
Some concerns
Details

Full description

NCT04582344
Sinovac Research and Development Co., Ltd
Tanriover M, Lancet , 2021

Full text
Commentary
Commentary
Inactivated virus

CoronaVac

Adjuvant

RCT
Phase 3
Healthy healthcare workers and adults aged 18–59 years with no history of COVID-19 from 24 centres in Turkey N=10218
Some concerns
Details

Full description

ISRCTN89951424
University of Oxford/AstraZeneca
Voysey M, Lancet, 2020
COV003

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

NCT04324606 / EudraC
AstraZeneca + University of Oxford
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

NCT04400838
University of Oxford/AstraZeneca
Voysey M, Lancet, 2020
COV002

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

NCT04368728
BioNTech SE, Pfizer
Walsh E, N Engl J Med, 2020

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 Research and Development Co., Ltd
Wu Z, Lancet Infect Dis, 2021

Full text
Commentary
; Commentary
Inactivated virus

CoronaVac 1.5mcg D0/28

CoronaVac

CoronaVac 6mcg D0/28

Adjuvant

RCT
Phase 1/2
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

ChiCTR2000031809
Wuhan Institute of Biological Products Co Ltd./Sinopharm
Xia S, JAMA, 2020

Full text
Commentary
Inactivated virus

Inactivated 2.5mcg-3doses

Inactivated 5mcg-3doses

Inactivated 10mcg-3doses

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

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

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 Research and Development Co., Ltd
Zhang Y, Lancet Infect Dis, 2020

Full text
Commentary
; Commentary
Inactivated virus

CoronaVac 6 mcg D0/28

CoronaVac 3 mcg D0/28

CoronaVac 6 mcg D0/14

CoronaVac

Adjuvant

RCT
Phase 1
Healthy SARS-CoV-2 serology/DNA negative adults in a single centre in China N=144
Some concerns
Details

Full description

NCT04352608
Sinovac Research and Development Co., Ltd
Zhang Y, Lancet Infect Dis, 2020

Full text
Commentary
; Commentary
Inactivated virus

CoronaVac

CoronaVac 6 mcg D0/14

CoronaVac 3 mcg D0/28

CoronaVac 6 mcg 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

NCT04523571 ; ChiCTR
BioNTech / Pfizer / Fosun Pharma
Zhu F, ResearchSquare, 2021

Full text
Commentary
; Commentary
RNA based vaccine

BNT126b1 10 mcg/0.5 ml 2-

BNT126b1 30 mcg/0.5 ml 2-

Placebo

RCT
Phase 1
Healthy SARS-CoV-2 infection-free adults aged 18-55 and 65-85 at a single center in China N=144
Some concerns
Details

Full description