COVID-19 vaccine effectiveness
(Randomized evidence)

Analyses are updated every two weeks

Methods

Variants of concern

RCTs

Vaccine types

Access all forest plots

Trials reports under extraction

In addition to the below included trials, we have included and presently extracting 9 new vaccine randomized trials:

Halperin SA, Lance, 2021 Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinde
Haranaka M, Nat Commun, 2021 A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults.
Hernandez-Bernal F, medrxiv, 2021 Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike protein vaccine: a randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study).
Li G, SSRN, 2021 Safety and Immunogenicity of the ChadOx1 nCoV-19 (AZD1222) Vaccine in Children Aged 12-17 Years: A Preliminary Report of a Phase 2, Single-Blind, Randomised Controlled Trial (COV006)
Liu J, J Infect Dis, 2021 Immunogenicity and Safety of a Three-Dose Regimen of a SARS-CoV-2 Inactivated Vaccine in Adults: A Randomized, Double-blind, Placebo-controlled Phase 2 Trial.
Mallory R, medrxiv, 2021 Immunogenicity and Safety Following a Homologous Booster Dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): A Phase 2 Randomized Placebo-Controlled Trial
Munro A , Lancet, 2021 Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial
Reindl-Schwaighofer R, JAMA Intern Med, 2021 Comparison of SARS-CoV-2 Antibody Response 4 Weeks After Homologous vs Heterologous Third Vaccine Dose in Kidney Transplant Recipients: A Randomized Clinical Trial.
Stuart A, Lancet, 2021 Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial

Description of primary studies

In this table, we report the main characteristics of the COVID-19 vaccine candidates from RCTs identified, in addition to the overall risk of bias assessment.

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.

Search studies

Search by Vaccine name Author Registration number
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

NCT04649151
ModernaTX
Ali K, N Engl J Med, 2021

Full text
Commentary
RNA based vaccine

mRNA-1273

Placebo

RCT
Phase 2-3
Healthy adolescents in 26 centers in the USA N=3732
Some concerns
Details

Full description

NCT04568031
AstraZeneca+University of Oxford
Asano M, Int J Infect Dis, 2021

Full text
(21)00818-3/fulltextCommentary
Non replicating viral vector

ChAdOx1

Placebo

RCT
Phase 1-2
Adults with or without mild, well-controlled co-morbidities seronegative and PCR negative to SARS-CoV-2 at 5 centres in Japan N=256
Low
Details

Full description

EudraCT 2021-002348-57
Pfizer-BioNTech; Moderna; Oxford-AstraZeneca
Bonelli M, medRxiv, 2021

Full text
Commentary
Commentary
Non replicating viral vector

ChAdOx1 booster

BNT or mRNA booster

RCT
*
Adults under current rituximab therapy who did not develop humoral response against SARS-CoV-2 after their standard vaccination with Biontech/Pfizer or Moderna in a single center in Austria N=60
Some concerns
Details

Full description

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

Full text
Commentary
RNA based vaccine

ChAd/BNT

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, Clin Infect Dis, 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
Some concerns
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

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

Placebo

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

Full description

ISRCTN89951424
AstraZeneca+University of Oxford
Clemens S, Nat. Commun., 2021

Full text
Commentary
Commentary
Non replicating viral vector

ChAdOx1

MenACWY

RCT
Phase 3
Adults that were SARS-CoV-2 seronegative and with no history of COVID-19 in six centers in Brazil. N=10416
Some concerns
Details

Full description

NCT04611802
Novavax
Dunkle L M, medRxiv, 2021

Full text
Commentary
Commentary
Protein subunit

NVX-CoV2373

Placebo

RCT
Phase 3
Healthy adults in 113 sites in the USA and 6 in Mexico N=29949
Some concerns
Details

Full description