Potential adverse events in Japanese women who received tozinameran (BNT162b2, Pfizer-BioNTech)

Abstract

AbstractReports of cerebral venous sinus thrombosis and intracranial hemorrhage (ICH) following the administration of coronavirus vaccines have raised concerns regarding their safety. Although no regulatory authority has recognized ICH as an adverse event associated with tozinameran (BNT162b2, Pfizer-BioNTech), fatal and non-fatal cases have been reported. In Japan, 10 fatal cases (five men and women) have been reported to date. Four of the five women died of ICH and the other died of aspiration pneumonia, whereas all five men died of causes other than stroke. This imbalance is incompatible with the mortality data on cardiovascular diseases in the National Statistics, which show no apparent disparity between sexes or between hemorrhagic and ischemic stroke. Cumulatively, our analysis reveals a disproportionately high incidence of death by ICH in Japanese women who received tozinameran, suggesting a potential association of ICH with the vaccine. Although we understand that the benefits of tozinameran still outweigh the risks, we believe that a causal link with the vaccine is not proven but possible and warrants further analysis.