COVID-19 vaccine effectiveness
(Randomized evidence)

Methods

Protocol

Latest news:Last search date July 30, 2023. No further screening is planned after this date. Extraction is ongoing for all pending studies.

A list of studies pending extraction is available here.

meta-COVID

Perform your own analysis using COVID-NMA data for prime vaccination (last search date 14/12/2022), create and download your forest plots by clicking below:

go to metacovid

Vaccine types

COVID-19 BOOSTER DOSE VACCINATION: updated daily

Vaccine efficacy, immunogenicity and safety of booster vs no booster (tables)

Vaccine efficacy, immunogenicity and safety of booster VS booster (tables)

COVID-19 PRIME VACCINATION: Last search date December 14, 2022.

Vaccine efficacy and safety for vaccine vs placebo / no vaccine (forest plots)

Vaccine efficacy and safety for vaccine vs vaccine (forest plots)

Vaccine efficacy, immunogenicity and safety of heterologous vs homologous vaccination (tables)

Vaccine efficacy and safety against variants of concern (forest plots)

Trials reports under extraction

In addition to the below included trials, we have included and presently extracting 12 new vaccine randomized trials

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 prime vaccination, early phase trials were extracted only when the dose has been selected. Results from phase 1-2 studies are included in forest plots for the chosen vaccine dose and schedule only. List of early phases included but not extracted are detailed on here .

Search studies

Search by Vaccine name Author Registration number

Your research ==> Vaccine name: 1273

Trial Type Comparisons Design Participants Sample size Overall risk
of bias
Highest assessment
Full description
Intervention 1 Intervention 2
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

NCT04796896
Moderna TX
Anderson E, N Engl J Med, 2022 b

Full text
Commentary
RNA based vaccine

mRNA-1273

Placebo

RCT
Phase 2-3
Children 6 to 23 months of age, including healthy and those with stable chronic diseases in 87 centres in USA (79 sites) and Canada (8 sites). N= 2355
Some concerns
Details

Full description

NCT04283461; NCT04785144
Moderna + National Institute of Allergy and Infectious Diseases (NIAID)
Anderson E, SSRN, 2022

Full text
Commentary
Commentary
Homologous booster

mRNA-1273/Boost 50 mcg of mRNA-1273.351

mRNA-1273/Boost mRNA-1273

mRNA-1273/Boost 25 mcg mRNA- 1273.351 and 25 mcg mRNA-1273

RCT
Phase 1
Healthy adult volunteers who were SARS-CoV-2 infection-free in 3 sites in the USA N= 96
Some concerns
Details

Full description

NCT04796896
Moderna TX
Anderson E, N Engl J Med , 2022 a

Full text
Commentary
RNA based vaccine

mRNA-1273

Placebo

RCT
Phase 2-3
Children 2 to 5 years of age, including healthy and those with stable chronic diseases in 87 centres in USA (79 sites) and Canada (8 sites). N= 4048
Some concerns
Details

Full description

TCTR20220112002
Moderna; Pfizer
Assantachai P, J Infect Dis, 2023

Full text
Full text
Commentary
RNA based vaccine

ChAdOx1/Boost mRNA1273-20 mcg ID

ChAdOx1/Boost BNT162b2- 10MCG ID

ChAd/Boost mRNA1273

ChadOx1/boostBNT

RCT
4
Adults 65 years of age or older in a single centre in Thailand N= 210
Some concerns
Details

Full description

EudraCT 2021-002348-57
Pfizer-BioNTech; Moderna; Oxford-AstraZeneca
Bonelli M, Ann Rheum Dis , 2022

Full text
Commentary
Heterologous booster

Boost ChAdOx1/prime vaccination BNT162b2 or mRNA-1273

Boost BNT162b2 or mRNA-1273/prime vaccination BNT162b2 or mRNA-1273

RCT
2
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

NCT05289037
Moderna + National Institute of Allergy and Infections Diseases (NIAID); ModernaTX
Branche A, medRxiv, 2022 a

Full text
Commentary
Commentary
Commentary
RNA based vaccine

Any COVID-19 vaccine prime and 1st boost/2nd boost mRNA-1273 Omicron + mRNA-1273 Beta

Any COVID-19 vaccine prime and 1st boost/2nd boost mRNA-1273Omicron + mRNA-1273 Delta

Any COVID-19 vaccine prime and 1st boost/2nd boost mRNA-1273 Omicron + mRNA-1273

Any COVID-19 vaccine prime and 1st boost/2nd boost mRNA-1273 Omicron

Any COVID-19 vaccine prime and 1st boost/2nd boost mRNA-1273

RCT
Phase 2
Adults with completed primary and booster COVID-19 vaccine series, either homologous or heterologous, and in stable health at 22 centers in USA. N= 602
Some concerns
Details

Full description

TCTR20211102003
Sinovac Research and Development Co., Ltd; Pfizer/BioNTech + Fosun Pharma; Moderna + National Institute of Allergy and Infectious Diseases (NIAID); AstraZeneca + University of Oxford
Bruminhent J, Am J Transplant, 2022

Full text
Full text
Commentary
RNA based vaccine

CoronaVac or ChAdOx1/Boost BNT162b2 or mRNA-1273

CoronaVac or ChAdOx1/Boost ChAdOx1

RCT
Phase 3
Adult kidney transplant recipients without a history of COVID-19 in a single centre in Thailand. N= 85
Some concerns
Details

Full description

NCT05132855
Pfizer/BioNTech+Fosun Pharma; Moderna;Medigen Vaccine Biologics+Dynavax+NIAID
Chuang C-H, J Clin Virol, 2022

Full text
Full text
Commentary
Commentary
Heterologous booster

ChadOx1/Boost BNT162b2

ChadOx1/Boost mRNA-1273 (half dose)

ChadOx1/Boost mRNA-1273

ChadOx1/boost MVC-COV1901

RCT
1-2
Health care worker with no history of COVID-19 who had received 2 prime doses of ChAdOx1 nCoV-19 in a single centre in Taiwan. N= 340
Some concerns
Details

Full description

NCT04796896
ModernaTX
Creech CB, N Engl J Med, 2022
KidCOVE

Full text
Commentary
RNA based vaccine

mRNA-1273 (50 mcg D0/28)

Placebo

RCT
Phase 2-3
Children aged 6-11 years, healthy or with stable chronic conditions and no known recent history of COVID-19 infection, at 87 centers in Canada and USA. N= 4016
Some concerns
Details

Full description

NCT04470427
ModernaTX
El Sahly H, N Engl J Med, 2021
COVE

Full text
Full text
Commentary
Commentary
RNA based vaccine

mRNA-1273 100 mcg D1/28

Placebo D1/28

RCT
Phase 3
Healthy adults with no known history of SARS-CoV-2 infection in 99 centers in the US N= 30415
Some concerns
Details

Full description

NCT05197153
AstraZeneca+University of Oxford; Moderna TX; Medigen Vaccine Biologics+Dynavax+NIAID
Estephan L, Vaccine, 2023 a

Full text
Commentary
Protein subunit

MVC-COV1901/Boost 1/2 MVC-COV1901

MVC-COV1901/Boost mRNA-127

MVC-COV1901/Boost ChAdOx1

MVC-COV1901/Boost MVC-COV1901

RCT
Phase 2
Adults who received ChAdOx1, mRNA-1273, or MVC-COV1901 as prime vaccination with no history of COVID-19 , in 4 centers in Taiwan N= 313
Some concerns
Details

Full description

NCT05197153
AstraZeneca+University of Oxford; Moderna TX; Medigen Vaccine Biologics+Dynavax+NIAID
Estephan L, Vaccine, 2023 b

Full text
Commentary
Protein subunit

ChadOx1/boost MVC-COV1901

ChadOx1/boostmRNA-1273 (half dose)

ChadOx1/boostChadOx1

RCT
Phase 2
Adults who received ChAdOx1, mRNA-1273, or MVC-COV1901 as prime vaccination with no history of COVID-19 , in 4 centers in Taiwan N= 323
Some concerns
Details

Full description

NCT05197153
AstraZeneca+University of Oxford; Moderna TX; Medigen Vaccine Biologics+Dynavax+NIAID
Estephan L, Vaccine, 2023 c

Full text
Commentary
Protein subunit

mRNA-1273/Boost MVC-COV1901

mRNA-1273/Boost ChAdOx1

mRNA-1273/Boost 1/2 MVC-COV1901

mRNA-1273/Boost 1/2 mRNA-1273

RCT
Phase 2
Adults who received ChAdOx1, mRNA-1273, or MVC-COV1901 as prime vaccination with no history of COVID-19 , in 4 centers in Taiwan N= 163
Some concerns
Details

Full description

NCT04885907
ModernaTX
Hall VG, N Engl J Med, 2021

Full text
Commentary
Commentary
RNA based vaccine

mRNA-1273

Placebo

RCT
Phase 4
Solid organ transplant recipients with no previous diagnosis of COVID-19 who has previously received two doses of mRNA-1273 at a single center in Canada N= 120
Some concerns
Details

Full description

NCT04900467; EudraCT: 2021-002174-52
Moderna;Pfizer/BioNTech
Janssen C, EClinicalMedicine, 2022

Full text
Full text
Commentary
Heterologous vaccination scheme

1 dose BNT162b2/1 dose mRNA-1273

1 dose mRNA-1273 /1 dose BNT162b2

2 doses BNT162b2

2 doses mRNA-1273

RCT
Phase 2
Adults with no known or suspected history of SARS-CoV-2 infection at 17 centers in France. N= 414
Some concerns
Details

Full description

NCT05030974
Moderna ; Pfizer/BioNTech + Fosun Pharma ; Janssen Pharmaceutical
Kho M, Lancet Infect Dis, 2022
RECOVAC

Full text
Commentary
Commentary
Heterologous booster

mRNA vaccine/Boost 2 doses mRNA-1273

mRNA vaccine/Boost Ad26.COV2-S

mRNAvaccine/Boost mRNA-1273

RCT
Phase 4
Adult kidney transplant recipients without seroconversion after two doses of an mRNA vaccine and no history of COVID-19 at 4 centers in the Netherlands. N= 230
Some concerns
Details

Full description

EudraCT, 2022-000063-51; NCT05249829
ModernaTX/ National Institute of Allergy and Infectious Diseases (NIAID)
Lee I, medRxiv, 2023 a

Full text
Commentary
Commentary
Heterologous booster

Any prime vaccine/Boost mRNA vaccine/ mRNA-1273.529

Any prime vaccine/Boost mRNA vaccine/ mRNA-1273

RCT
Phase 2-3
Healthy or stable co-morbidities, at least 16 years who had previously received 2 injections of an authorized Covid-19 primary series vaccine with or without an mRNA-based booster as the third dose in 28 centres in UK. N= 724
Some concerns
Details

Full description

EudraCT, 2022-000063-51; NCT05249829
ModernaTX/National Institute of Allergy and Infectious Diseases (NIAID)
Lee l, medRxiv, 2023 b

Full text
Commentary
Commentary
Heterologous booster

Any prime vaccine/Boost mRNA vaccine/ mRNA-1273.214

Any prime vaccine/Boost mRNA vaccine/ mRNA-1273

RCT
Phase 2-3
Healthy or stable co-morbidities, at least 16 years who had previously received 2 injections of an authorized Covid-19 primary series vaccine with or without an mRNA-based booster as the third dose in 28 centres in UK. N= 2,824
Some concerns
Details

Full description

NCT04962906; NCT05027672
Gamaleya Research Institute, AstraZeneca+University of Oxford;Moderna;Sinopharm
Macchia A, Lancet Reg Health Am, 2022

Full text
Commentary
Non replicating viral vector

Gam-COVID-Vac rAd26-S

Gam-COVID-Vac rAd26-S/BBIBP-CorV

RCT
Phase 2
Adults who had received the first dose (rAd26) of the Sputnik V vaccine at least 30 days earlier and no history of SARS-CoV-2 at a single centre in Argentina N= 540
Some concerns
Details

Full description

NCT04677660
ModernaTX
Masuda T, Vaccine, 2022 a

Full text
Commentary
RNA based vaccine

mRNA-1273

Placebo

RCT
Phase 1-2
Healthy adults aged ≥ 20 years with no known history/risk of SARS-CoV-2 infection at 2 centers in Japan. N= 200
Some concerns
Details

Full description

EudraCT 2021-002693-10
Moderna+NIAID; Pfizer/BioNTech+Fosun Pharma; AstraZeneca + University of Oxford
Mrak D, Nat Commun, 2022

Full text
Commentary
Commentary
Homologous booster

BNT162b2 or mRNA-1273/Boost ChAdOx1

mRNA-1273 or BNT162b2/Homologous boost

RCT
Phase 2
Immunosuppressed adults including elderly with no history of COVID-19 in a single centre in Austria. N= 51
Low
Details

Full description

ISRCTN73765130
AstraZeneca + University of Oxford; Janssen Pharmaceutical; Novovax; Moderna + NIAID; Pfizer BioNTech + Fosun Pharma; CureVac AG; Valneva, NIHR, UK
Munro A, Lancet, 2021 e
COV-BOOST

Full text
Commentary
Heterologous booster

ChadOx1/Boost mRNA1273

ChadOx1/Boost CVnCov

ChadOx1/Boost BNT162b2 half dose

ChadOx1/Boost placebo

RCT
Phase 2
Adults aged ≥30 years in good physical health at 18 centers in the UK. N= 2883
Some concerns
Details

Full description

ISRCTN73765130
AstraZeneca + University of Oxford; Janssen Pharmaceutical; Novovax; Moderna + NIAID; Pfizer BioNTech + Fosun Pharma; CureVac AG; Valneva, NIHR, UK
Munro A, Lancet, 2021 b
COV-BOOST

Full text
Commentary
Heterologous booster

BNT162b2/Boost ChAdOx1

BNT162b2/Boost Novavax

BNT162b2/Boost Novavax half dose

BNT162b2/Boost placebo

RCT
Phase 2
Adults aged ≥30 years in good physical health at 18 centers in the UK. N= 2883
Some concerns
Details

Full description

ISRCTN73765130
AstraZeneca + University of Oxford; Janssen Pharmaceutical; Novovax; Moderna + NIAID; Pfizer BioNTech + Fosun Pharma; CureVac AG; Valneva, NIHR, UK
Munro A, Lancet, 2021 f
COV-BOOST

Full text
Commentary
Heterologous booster

BNT162b2/Boost mRNA1273

BNT162b2/Boost CVnCov

BNT162b2/Boost BNT162b2 half dose

BNT162b2/Boos placebo

RCT
Phase 2
Adults aged ≥30 years in good physical health at 18 centers in the UK. N= 2883
Some concerns
Details

Full description

ISRCTN73765130
AstraZeneca + University of Oxford; Janssen Pharmaceutical; Novovax; Moderna + NIAID; Pfizer BioNTech + Fosun Pharma; CureVac AG; Valneva, NIHR, UK
Munro A, Lancet, 2021 c
COV-BOOST

Full text
Commentary
Heterologous booster

ChadOx1/Boost BNT162b2

ChadOx1/Boost VLA2001

ChadOx1/Boost VLA2001 half dose

ChadOx1/Boost Ad26.COV2.S

ChadOx1/Boost placebo

RCT
Phase 2
Adults aged ≥30 years in good physical health at 18 centers in the UK. N= 2883
Some concerns
Details

Full description

ISRCTN73765130
AstraZeneca + University of Oxford; Janssen Pharmaceutical; Novovax; Moderna + NIAID; Pfizer BioNTech + Fosun Pharma; CureVac AG; Valneva, NIHR, UK
Munro A , Lancet, 2021 a
COV-BOOST

Full text
Commentary
Non replicating viral vector

ChadOx1/Boost ChadOx1

ChadOx1/Boost Novavax

ChadOx1/Boost Novavax

ChadOx1/Boost Novavax half dose

ChadOx1/Boost Novavax half dose

ChadOx1/Boost Placebo

ChadOx1/Boost Placebo

ChadOx1/Boost ChadOx1

ChadOx1/Boost ChadOx1

ChadOx1/Boost Placebo

RCT
Phase 2
Adults aged ≥30 years in good physical health at 18 centers in the UK. N= 2883
Some concerns
Details

Full description

ISRCTN73765130
AstraZeneca + University of Oxford; Janssen Pharmaceutical; Novovax; Moderna + NIAID; Pfizer BioNTech + Fosun Pharma; CureVac AG; Valneva, NIHR, UK
Munro A, Lancet, 2021 d
COV-BOOST

Full text
Commentary
RNA based vaccine

BNT162b2/Boost BNT162b2

BNT162b2/Boost VLA2001

BNT162b2/Boost VLA2001 half dose

BNT162b2/Boost Ad26.COV2.S

BNT162b2/Boost placebo

RCT
Phase 2
Adults aged ≥30 years in good physical health at 18 centers in the UK. N= 2883
Some concerns
Details

Full description

ISRCTN73765130 ; EudraCT 2021-002175-19
Pfizer/BioNTech;ModernaTX
Munro APS, Lancet Infect Dis, 2022
COV-BOOST

Full text
Commentary
RNA based vaccine

BNT162b2/1st boost BNT162b2/2nd boost BNT162b2

ChadOx1/1st boost BNT162b2/2nd boost BNT162b2

BNT162b2/1st boost BNT162b2/2nd boost half dose m-RNA 1273

ChadOx1/1st boost BNT162b2/2nd boost half dose m-RNA 1273

RCT
Phase 2
Healthy adults aged 30 years or over, including elderly and those with well controlled or mild-moderate comorbidity, who had received a 2-dose primary schedule of either BNT162b2 or ChAdOx1 and a BNT162b2 booster at 18 centers in the UK N= 166
Some concerns
Details

Full description

NCT05142319
Pfizer/BioNTech+Fosun Pharma; ModernaTX
Poh XY, Clin. Infect. Dis., 2022
PRIBIVAC

Full text
Commentary
RNA based vaccine

BNT162b2/Boost mRNA-1273

BNT162b2/Boost BNT162b2

RCT
3
Adults at a single center in Singapore with no previous history of COVID-19 who had received a primary series of BTN162b2 at least 6 months previously N= 100
Some concerns
Details

Full description

EudraCT021-002927-39
Pfizer/BioNTech+Fosun Pharma/Moderna/Janssen Pharmaceutical Companies
Reindl-Schwaighofer R, JAMA, 2021

Full text
Full text
Commentary
Commentary
RNA based vaccine

mRNA-1273 or BNT162b2/Homologous boost

mRNA-1273 or BNT162b2/Boost Ad26COVS1

RCT
Phase 2
Adult kidney transplant recipients with no history of COVID-19 infection and without an antibody response 4 weeks after a 2-dose mRNA vaccine schedule at a single center in Austria. N= 201
Some concerns
Details

Full description

NCT04927936
Janssen Pharmaceutical;Moderna ;Pfizer/BionTech+Fosun Pharma
Sablerolles R, Clin Infect Dis, 2022
SWITCH

Full text
Full text
Commentary
Commentary
Placebo

Ad26.COV2.S/Boost m-RNA-1273

Ad26.COV2.S/Boost BNT162b2

Ad26.COV2.S/Boost Ad26.COV2.S

RCT
Phase 3
Healthcare workers aged 18-65 years, without severe comorbidities, and no known history of SARS-CoV-2 infection who received a single Ad26.COV2.S primary vaccination at 4 centers in the Netherlands. N= 461
Some concerns
Details

Full description

NCT04805125
Pfizer/BioNTech+Fosun Pharma; ModernaTX
Speich B, Clin Infect Dis, 2022

Full text
Full text
Commentary
Commentary
RNA based vaccine

BNT162b2

mRNA-1273

RCT
Phase 3
Adult patients living with HIV (PLWH) or solid organ transplant recipients who were SARS-CoV-2 infection-free for the last 3 months in 3 centres in Switzerland. N= 430
Some concerns
Details

Full description

ISRCTN27841311; EudraCT 2021-001275-16
AstraZeneca + University of Oxford / Novavax / Moderna + NIAID
Stuart A, Lancet, 2021 a
Com-COV2

Full text
Commentary
Commentary
Protein subunit

1 dose ChAdOx1 followed by 1 dose NVX-CoV2373

1 dose ChAdOx1 followed by 1 dose mRNA-1273

2 doses ChAdOx1

RCT
Phase 2
Healthy adults over 50 years previously vaccinated with one dose of ChAdOx1 nCoV-19 in 9 centres in the UK N= 540
Some concerns
Details

Full description

ISRCTN27841311; EudraCT 2021-001275-16
Pfizer BioNTech + Fosun Pharma / Novavax / Moderna + NIAID
Stuart A, Lancet, 2021 b
Com-COV2

Full text
Commentary
Commentary
Protein subunit

1 dose BNT162b2 followed by 1 dose NVX-CoV2373

1 dose BNT162b2 followed by 1 dose mRNA-1273

2 doses BNT162b2

RCT
Phase 2
Adults over 50 years previously vaccinated with one dose of BNT162b2 at 9 centres in the UK N= 532
Some concerns
Details

Full description