Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adult
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3.4. Harm-benefit considerations
In the Moderna trial,
the excess risk of serious AESIs was 15.1 per 10,000 participant
One in 662
(over placebo baselines)
In the Pfizer trial,
the excess risk of serious AESIs 10.1 per 10,000
One in 990
(over placebo baselines)
Combined, mRNA vaccines,
risk of serious adverse events of special interest
12.5 per 10,000 vaccinated
One in 800
(over placebo baselines)
1,250 serious events for each million vaccine recipients
Appendix 1: estimation of number needed to vaccinate to prevent a COVID-19 hospitalisation,
for primary vaccination,
booster vaccination (3rd dose),
autumn 2022 booster and,
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