The safety of Vaxzevria is continuously monitored and safety updates are regularly provided to the public. This document outlines the outcomes from the assessment of emerging worldwide safety data carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) (see section 1). It also contains high-level information from the reporting of suspected adverse reactions, which PRAC takes into account in its assessments (see section 2).
This safety update follows the update of 14 July 2021.
Main outcomes from PRAC’s latest safety assessment
No further updates to the product information are currently recommended…