Cochrane · systematic review · CD015477

Efficacy and safety of COVID‐19 vaccines

Graña, C, Ghosn, L, Evrenoglou, T, et al. · Cochrane Database of Systematic Reviews · 2022 · Cochrane Library

Emergency and Critical CareAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
119
current version
GRADE rated
84
No studies
35
Included studies
NR
No studies 35 · 29.4%Ungraded 0 · 0%Very low 6 · 5%Low 28 · 23.5%Moderate 19 · 16%High 31 · 26.1%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

BNT162b2 – Pfizer/BioNTech + Fosun Pharma compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionÂ
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
no estimate extracted2 studies · 44077 participantsHigh
Severe or critical COVID‐19e
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
no estimate extracted1 study · 46077 participantsHigh
All‐cause mortalityg
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
RR 1.07 [0.52, 2.22]1 study · 43847 participantsLow
Downgraded: imprecision
Systemic reactogenicity events
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
no estimate extractedNRNo studies
Any adverse eventi
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
no estimate extracted3 studies · 46149 participantsLow
Downgraded: inconsistency
Serious adverse eventsi
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
RR 1.3 [0.55, 3.07]2 studies · 46107 participantsLow
Downgraded: imprecision, inconsistency
Local reactogenicity events
BNT162b2 – Pfizer/BioNTech + Fosun Pharma vs placebo
no estimate extractedNRNo studies

mRNA‐1273 – ModernaTX compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionb
mRNA‐1273 – ModernaTX vs placebo
no estimate extracted2 studies · 31632 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency
Confirmed symptomatic COVID‐19 b
mRNA‐1273 – ModernaTX vs placebo
no estimate extracted2 studies · 31632 participantsHigh
Severe or critical COVID‐19f
mRNA‐1273 – ModernaTX vs placebo
no estimate extracted1 study · 28451 participantsHigh
All‐cause mortalityf
mRNA‐1273 – ModernaTX vs placebo
RR 1.06 [0.54, 2.1]1 study · 30346 participantsLow
Downgraded: risk of bias, imprecision, inconsistency
Systemic reactogenicity eventsi
mRNA‐1273 – ModernaTX vs placebo
RR 1.28 [1.22, 1.34]2 studies · 34037 participantsHigh
Any adverse eventk
mRNA‐1273 – ModernaTX vs placebo
no estimate extracted2 studies · 32995 participantsLow
Downgraded: risk of bias, imprecision, inconsistency
Serious adverse eventsl
mRNA‐1273 – ModernaTX vs placebo
RR 0.92 [0.78, 1.08]2 studies · 34072 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency
Local reactogenicity eventsi
mRNA‐1273 – ModernaTX vs placebo
RR 3.3 [2.02, 5.4]2 studies · 34037 participantsHigh

CVnCoV – CureVac AG compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
CVnCoV – CureVac AG vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
CVnCoV – CureVac AG vs placebo
no estimate extracted1 study · 25062 participantsModerate
Downgraded: risk of bias, indirectness
Severe or critical COVID‐19f
CVnCoV – CureVac AG vs placebo
no estimate extracted1 study · 25062 participantsVery low
Downgraded: risk of bias, imprecision, indirectness
All‐cause mortalityh
CVnCoV – CureVac AG vs placebo
RR 1.33 [0.46, 3.83]1 study · 39529 participantsVery low
Downgraded: imprecision, indirectness
Systemic reactogenicity eventsi
CVnCoV – CureVac AG vs placebo
RR 1.48 [1.43, 1.53]1 study · 3982 participantsHigh
Any adverse eventj
CVnCoV – CureVac AG vs placebo
RR 1.42 [1.38, 1.47]1 study · 3982 participantsModerate
Downgraded: indirectness
Serious adverse eventsk
CVnCoV – CureVac AG vs placebo
RR 1.24 [0.9, 1.71]1 study · 39529 participantsLow
Downgraded: imprecision, indirectness
Local reactogenicity eventsi
CVnCoV – CureVac AG vs placebo
RR 3.51 [3.24, 3.81]1 study · 3982 participantsHigh

ChAdOx1 – AstraZeneca + University of Oxford compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionb
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
no estimate extracted5 studies · 43390 participantsModerate
Downgraded: risk of bias, inconsistency
Confirmed symptomatic COVID‐19b
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
no estimate extracted5 studies · 43390 participantsHigh
Severe or critical COVID‐19
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
no estimate extractedNRNo studies
All‐cause mortalityf
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
RR 0.48 [0.2, 1.14]5 studies · 56727 participantsLow
Downgraded: imprecision
Systemic reactogenicity eventsi
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
RR 3.93 [2.11, 7.29]1 study · 256 participantsModerate
Downgraded: imprecision
Any adverse eventl
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
no estimate extracted7 studies · 57580 participantsLow
Downgraded: inconsistency
Serious adverse eventso
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
RR 0.88 [0.72, 1.07]7 studies · 58182 participantsModerate
Downgraded: imprecision
Local reactogenicity eventsi
ChAdOx1 – AstraZeneca + University of Oxford vs placebo
RR 6.44 [2.98, 13.92]1 study · 256 participantsModerate
Downgraded: risk of bias, imprecision

SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford compared to ChAdOx1 – University of Oxford for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionÂ
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
no estimate extractedNRNo studies
Severe or critical COVID‐19
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
no estimate extractedNRNo studies
All‐cause mortalityÂ
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
no estimate extractedNRNo studies
Systemic reactogenicity eventsb
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
RR 0.73 [0.54, 0.98]1 study · 400 participantsModerate
Downgraded: imprecision
Any adverse evente
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
RR 0.83 [0.52, 1.33]1 study · 400 participantsLow
Downgraded: imprecision
Serious adverse eventsg
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
RR 0.5 [0.08, 2.95]1 study · 400 participantsLow
Downgraded: imprecision
Local reactogenicity eventsb
SII‐ChAdOx1 – Serum Institute of India/AstraZeneca + University of Oxford vs ChAdOx1 – University of Oxford
RR 0.76 [0.55, 1.05]1 study · 400 participantsLow
Downgraded: imprecision

AD26.COV2.S – Janssen Pharmaceutical Companies compared to placebo for vaccination against COVID‐19a

7 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
no estimate extracted1 study · 39058 participantsHigh
Severe or critical COVID‐19b
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
no estimate extracted1 study · 39058 participantsHigh
All‐cause mortalityb
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
RR 0.25 [0.09, 0.67]1 study · 43783 participantsHigh
Serious adverse eventsb
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
RR 0.92 [0.69, 1.22]1 study · 43783 participantsModerate
Downgraded: imprecision
Systemic reactogenicity eventse
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
RR 1.83 [1.29, 2.6]2 studies · 7222 participantsHigh
Any adverse eventh
AD26.COV2.S – Janssen Pharmaceutical Companies vs placebo
no estimate extracted2 studies · 7222 participantsLow
Downgraded: risk of bias, inconsistency

Gam‐COVID‐VAC – Sputnik V compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
Gam‐COVID‐VAC – Sputnik V vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
Gam‐COVID‐VAC – Sputnik V vs placebo
no estimate extracted1 study · 18695 participantsModerate
Downgraded: indirectness
Severe or critical COVID‐19b
Gam‐COVID‐VAC – Sputnik V vs placebo
no estimate extracted1 study · 19866 participantsModerate
Downgraded: indirectness
All‐cause mortalityf
Gam‐COVID‐VAC – Sputnik V vs placebo
RR 0.99 [0.1, 9.54]1 study · 21862 participantsVery low
Downgraded: imprecision, indirectness
Systemic reactogenicity events
Gam‐COVID‐VAC – Sputnik V vs placebo
no estimate extractedNRNo studies
Any adverse event
Gam‐COVID‐VAC – Sputnik V vs placebo
no estimate extractedNRNo studies
Serious adverse eventsf
Gam‐COVID‐VAC – Sputnik V vs placebo
RR 0.65 [0.39, 1.07]1 study · 21862 participantsLow
Downgraded: imprecision, indirectness
Local reactogenicity events
Gam‐COVID‐VAC – Sputnik V vs placebo
no estimate extractedNRNo studies

CoronaVac – Sinovac compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionÂ
CoronaVac – Sinovac vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
CoronaVac – Sinovac vs placebo
no estimate extracted2 studies · 19852 participantsLow
Downgraded: risk of bias, imprecision, inconsistency
Severe or critical COVID‐19b
CoronaVac – Sinovac vs placebo
no estimate extracted2 studies · 19852 participantsLow
Downgraded: risk of bias, imprecision
All‐cause mortalityh
CoronaVac – Sinovac vs placebo
RR 0.5 [0.05, 5.52]2 studies · 22610 participantsLow
Downgraded: imprecision
Systemic reactogenicity eventsj
CoronaVac – Sinovac vs placebo
RR 1.19 [1, 1.42]6 studies · 23966 participantsLow
Downgraded: risk of bias, imprecision, inconsistency
Any adverse evento
CoronaVac – Sinovac vs placebo
RR 1.09 [1.07, 1.11]6 studies · 23367 participantsHigh
Serious adverse eventsr
CoronaVac – Sinovac vs placebo
RR 0.97 [0.62, 1.51]4 studies · 23139 participantsLow
Downgraded: risk of bias, imprecision
Local reactogenicity eventsj
CoronaVac – Sinovac vs placebo
RR 1.76 [1.69, 1.82]6 studies · 23962 participantsHigh

WIBP‐CorV – Sinopharm‐Wuhan compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionb
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
no estimate extracted1 study · 25449 participantsHigh
Confirmed symptomatic COVID‐19b
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
no estimate extracted1 study · 25480 participantsHigh
Severe or critical COVID‐19
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
no estimate extractedNRNo studies
All‐cause mortalityÂ
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
no estimate extractedNRNo studies
Systemic reactogenicity eventse
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
RR 0.99 [0.95, 1.03]2 studies · 27029 participantsHigh
Any adverse eventh
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
RR 0.96 [0.93, 0.98]2 studies · 27029 participantsHigh
Serious adverse eventsi
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
RR 0.83 [0.6, 1.15]2 studies · 27029 participantsLow
Downgraded: risk of bias, imprecision
Local reactogenicity eventsk
WIBP‐CorV – Sinopharm‐Wuhan vs placebo
RR 0.88 [0.85, 0.92]2 studies · 27029 participantsHigh

BBIBP‐CorV – Sinopharm‐Beijing compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionb
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
no estimate extracted1 study · 25435 participantsHigh
Confirmed symptomatic COVID‐19b
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
no estimate extracted1 study · 25463 participantsHigh
Severe or critical COVID‐19
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
no estimate extractedNRNo studies
All‐cause mortality
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
no estimate extractedNRNo studies
Systemic reactogenicity eventse
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
RR 1.05 [0.86, 1.28]3 studies · 27540 participantsModerate
Downgraded: imprecision
Any adverse eventh
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
no estimate extracted3 studies · 26924 participantsLow
Downgraded: imprecision, inconsistency
Serious adverse eventsk
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
RR 0.76 [0.54, 1.06]1 study · 26924 participantsLow
Downgraded: imprecision
Local reactogenicity eventse
BBIBP‐CorV – Sinopharm‐Beijing vs placebo
no estimate extracted3 studies · 26924 participantsLow
Downgraded: imprecision, inconsistency

BBV152 – Bharat Biotech compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infectionb
BBV152 – Bharat Biotech vs placebo
no estimate extracted1 study · 6289 participantsHigh
Confirmed symptomatic COVID‐19b
BBV152 – Bharat Biotech vs placebo
no estimate extracted1 study · 16973 participantsHigh
Severe or critical COVID‐19b
BBV152 – Bharat Biotech vs placebo
no estimate extracted1 study · 16976 participantsHigh
All‐cause mortalitye
BBV152 – Bharat Biotech vs placebo
RR 0.5 [0.17, 1.46]1 study · 25753 participantsLow
Downgraded: imprecision
Systemic reactogenicity eventsg
BBV152 – Bharat Biotech vs placebo
RR 1.34 [1.15, 1.58]2 studies · 25925 participantsHigh
Any adverse eventi
BBV152 – Bharat Biotech vs placebo
RR 1 [0.94, 1.07]1 study · 25753 participantsHigh
Serious adverse eventsi
BBV152 – Bharat Biotech vs placebo
RR 0.65 [0.43, 0.97]1 study · 25928 participantsHigh
Local reactogenicity eventsg
BBV152 – Bharat Biotech vs placebo
RR 1.08 [0.95, 1.24]2 studies · 25750 participantsHigh

NVX‐CoV2373 – Novavax compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
NVX‐CoV2373 – Novavax vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
NVX‐CoV2373 – Novavax vs placebo
no estimate extracted3 studies · 42175 participantsModerate
Downgraded: risk of bias, inconsistency
Severe or critical COVID‐19
NVX‐CoV2373 – Novavax vs placebo
no estimate extracted1 study · 25452 participantsModerate
Downgraded: risk of bias, indirectness
All‐cause mortalityh
NVX‐CoV2373 – Novavax vs placebo
RR 0.9 [0.3, 2.68]1 study · 29582 participantsLow
Downgraded: risk of bias, imprecision
Systemic reactogenicity eventsj
NVX‐CoV2373 – Novavax vs placebo
RR 1.21 [1.17, 1.25]3 studies · 31063 participantsHigh
Any adverse eventm
NVX‐CoV2373 – Novavax vs placebo
RR 1.15 [1.05, 1.26]5 studies · 46231 participantsModerate
Downgraded: risk of bias, inconsistency
Serious adverse eventsm
NVX‐CoV2373 – Novavax vs placebo
RR 0.92 [0.74, 1.14]4 studies · 38802 participantsLow
Downgraded: risk of bias, imprecision
Local reactogenicity eventsj
NVX‐CoV2373 – Novavax vs placebo
RR 2.78 [1.99, 3.88]3 studies · 31063 participantsHigh

FINLAY‐FR‐2 – Instituto Finlay de Vacunas compared to placebo for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19b
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extracted1 study · 28674 participantsModerate
Downgraded: risk of bias
Severe or critical COVID‐19
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extractedNRNo studies
All‐cause mortalitye
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
RR 0.37 [0.17, 0.8]1 study · 28674 participantsModerate
Downgraded: risk of bias
Systemic reactogenicity events
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extractedNRNo studies
Any adverse event
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extractedNRNo studies
Serious adverse events
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extractedNRNo studies
Local reactogenicity events
FINLAY‐FR‐2 – Instituto Finlay de Vacunas vs placebo
no estimate extractedNRNo studies

Heterologous vaccination scheme compared to homologous vaccination scheme for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
Heterologous vaccination scheme vs homologous vaccination scheme
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19
Heterologous vaccination scheme vs homologous vaccination scheme
no estimate extractedNRNo studies
Severe or critical COVID‐19
Heterologous vaccination scheme vs homologous vaccination scheme
no estimate extractedNRNo studies
All‐cause mortalityÂ
Heterologous vaccination scheme vs homologous vaccination scheme
no estimate extractedNRNo studies
Systemic reactogenicity eventsb
Heterologous vaccination scheme vs homologous vaccination scheme
RR 1.96 [0.52, 7.41]1 study · 101 participantsLow
Downgraded: risk of bias, imprecision
Any adverse eventf
Heterologous vaccination scheme vs homologous vaccination scheme
no estimate extracted3 studies · 3 participantsVery low
Downgraded: risk of bias, imprecision, inconsistency
Serious adverse eventsk
Heterologous vaccination scheme vs homologous vaccination scheme
no estimate extracted1 study · 229 participantsVery low
Downgraded: risk of bias, imprecision
Local reactogenicity eventsb
Heterologous vaccination scheme vs homologous vaccination scheme
RR 11.76 [1.59, 87.14]1 study · 101 participantsLow
Downgraded: risk of bias, imprecision

Booster compared to placebo/no booster for vaccination against COVID‐19a

8 questions
OutcomeEffectEvidenceStatus / GRADE
Confirmed SARS‐CoV‐2 infection
Booster vs placebo/no booster
no estimate extractedNRNo studies
Confirmed symptomatic COVID‐19
Booster vs placebo/no booster
no estimate extractedNRNo studies
Severe or critical COVID‐19
Booster vs placebo/no booster
no estimate extractedNRNo studies
All‐cause mortalityb
Booster vs placebo/no booster
RR 1.27 [0.52, 3.05]1 study · 28254 participantsVery low
Downgraded: risk of bias, imprecision
Systemic reactogenicity eventsf
Booster vs placebo/no booster
RR 1.8 [0.71, 4.56]1 study · 119 participantsLow
Downgraded: imprecision
Any adverse event
Booster vs placebo/no booster
no estimate extractedNRNo studies
Serious adverse events
Booster vs placebo/no booster
no estimate extractedNRNo studies
Local reactogenicity eventsf
Booster vs placebo/no booster
RR 6.46 [3.18, 13.13]1 study · 119 participantsModerate
Downgraded: imprecision