This population-based study of over 4 million vaccinated persons in New Zealand aged 5 years or older identified a statistically significant association between BNT162b2 and myo/pericarditis in the 21 days following both doses of the vaccine. We found no other statistically significant associations between BNT162b2 and any of the other outcomes of interest for all ages combined.

Given the concern from the public, health care professionals and regulators around the safety profile of BNT162b2, this study provides important vaccine safety information not only for building public confidence, as the vaccination was not associated with most of the AESIs investigated, but also for evidence-based health policy decisions.

The associations produced by this study are considered statistical signals that indicate the need for additional analytic investigation and validation.