Aug 2026· Expert Review of Vaccines· Vol 25 1, pp.
2720955
· 0 citations· 31 references
Medicine
TL;DR
These findings provide no evidence of increased short-term stroke risk following BNT162b2 vaccination at the population level.
Abstract
INTRODUCTION
Whether BNT162b2 (Pfizer-BioNTech) vaccination increases stroke risk remains a public health concern. This is the first meta-analysis to synthesize self-controlled case series (SCCS)-derived stroke risk estimates specifically for BNT162b2 vaccination.
Methods
PubMed and Embase were searched from inception through 9 May 2026, following PRISMA 2020 guidelines. Eight eligible SCCS studies were pooled using a random-effects model with restricted maximum likelihood (REML) estimation and the Knapp-Hartung adjustment.
Results
Eight studies across six countries encompassing several million vaccinated individuals were included. The pooled incidence rate ratio (IRR) was 0.967 (95% CI 0.892-1.049; I2 = 69.2%), indicating no statistically significant increase in stroke risk. Subgroup analyses showed no evidence of effect modification across continent, risk-window length, dose category, SCCS variant, or age group.
Conclusions
These findings provide no evidence of increased short-term stroke risk following BNT162b2 vaccination at the population level. The observed heterogeneity appeared to be partly driven by methodological differences rather than true biological variation in vaccine effect.
BACKGROUND
The self-controlled case series (SCCS) design is widely used for short-term vaccine safety assessment but allows only indirect estimation of absolute risk differences. This study evaluated whether absolute measures should be estimated exclusively using cohort designs by comparing excess stroke incidence foll...
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BACKGROUND
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OBJECTIVES
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