Patient or population:
Setting:
Intervention:
Comparison:
Summary of findings: | ||||||
mRNA-1273 compared to Placebo for vaccination against COVID-19 |
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Patient or population:
Setting:
Intervention:
Comparison:
|
||||||
Outcomes |
Anticipated absolute effects* (95% CI) |
Relative effect |
№ of participants
|
Certainty of the evidence |
Comments |
|
---|---|---|---|---|---|---|
Risk with Placebo |
Risk with mRNA-1273 |
|||||
Incidence of participants with positive test for SARS-CoV-2 infection - not reported
|
-
|
-
|
-
|
-
|
-
|
outcome not yet measured or reported
|
Incidence of symptomatic COVID-19 confirmed with positive test for SARS-CoV-2
b,c
|
1,315 per 100,000
|
79 per 100,000
(39 to 145) |
Rate Ratio 0.06
(0.03 to 0.11) |
28207
(1 RCT) d |
⨁⨁⨁◯
MODERATE e,f,g |
Vaccine efficacy 94.1% (95%CI 89.3% to 96.8%)
h
|
Incidence of hospitalization or death due to confirmed COVID- 19 - not reported
|
-
|
-
|
-
|
-
|
-
|
outcome not yet measured or reported
|
Severe or critical disease due to COVID-19
b,c
|
213 per 100,000
|
4 per 100,000
(0 to 58) |
RR 0.02
(0.00 to 0.27) |
28207
(1 RCT) d |
⨁⨁◯◯
LOW f,g,i |
Vaccine efficacy: 100% (95%CI NE to 100%)
j
|
All-cause mortality
k,l
|
46 per 100,000
|
40 per 100,000
(13 to 118) |
RR 0.86
(0.29 to 2.55) |
30351
(1 RCT) d |
⨁◯◯◯
VERY LOW f,g,m |
|
Incidence of any adverse events
l,n
|
21,608 per 100,000
|
23984 per 100,000
(22,904 to 24,849) |
RR 1.11
(1.06 to 1.15) |
30351
(1 RCT) d |
⨁⨁⨁◯
MODERATE g |
|
Incidence of serious adverse events (SAEs)
l
|
1,009 per 100,000
|
968 per 100,000
(777 to 1,211) |
RR 0.96
(0.77 to 1.20) |
30351
(1 RCT) d |
⨁⨁⨁◯
MODERATE g |
|
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio |
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GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |