“Monthly safety reports primarily focus on events that occurred during the reporting intervaland include information not relevant to a BLA submission such as line lists of adverse eventsby country. We are most interested in a cumulative analysis of post-authorization safety datato support your future BLA submission. Please submit an integrated analysis of yourcumulative post-authorization safety data, including U.S. and foreign post-authorizationexperience, in your upcoming BLA submission. Please include a cumulative analysis of theImportant Identified Risks, Important Potential Risks, and areas of Important MissingInformation identified in your Pharmacovigilance Plan, as well as adverse events of specialinterest and vaccine administration errors (whether or not associated with an adverse event).Please also include distribution data and an analysis of the most common adverse events. Inaddition, please submit your updated Pharmacovigilance Plan with your BLA submission.”This document provides an integrated analysis of the cumulative post-authorization safetydata, including U.S. and foreign post-authorization adverse event reports received through 28February 2021.
