Covid-19 living Data

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

A table with the general characteristics and risk of bias assessment for all RCTs identified.
A synthesis with forest plots and summary of findings table/evidence profile including phase 2-3 trials. For the vaccine (dose and schedule) evaluated in phase 2-3 trials, results available for the same vaccine (dose and schedule) in phase 1-2 trial will also be included in the synthesis.

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:

Inactivated virus

Non replicating viral vector

Ad26.COV2.S (5×10^10 vp) D0 vs Placebo (Janssen Biotech, Inc.)

ChAdOx1 vs MenACWY (University of Oxford/AstraZeneca )

Gam-COVID-Vac rAd26-S/rAd5-S vs Placebo (Gamaleya Research Institute of Epidemiology and Microbiology)

RNA based vaccine

BNT162b2 vs Placebo (BioNTech/Fosun Pharma/Pfizer )

mRNA-1273 vs Placebo (ModernaTX)

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
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
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
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
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

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.