FDA to meet on Pfizer's coronavirus vaccine EUA application: What to expect

On Thursday the U.S. Food and Drug Administration (FDA) will meet to discuss Pfizer and BioNTech’s emergency use authorization application for its coronavirus vaccine candidate.

The companies were the first to submit their application for EUA to the FDA, with Moderna following suit shortly after.

The meeting will include members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Pfizer representatives and will begin at approximately 9 a.m., with opening remarks and introductions, according to a draft agenda published by the regulatory agency. Next will be a presentation on emergency use authorization, followed by an update on epidemiology and a question-and-answer session.

Dr. Nancy Messonnier, director for the National Center for Immunization and Respiratory Disease and a senior official on the Centers for Disease Control and Prevention (CDC) task force, will then lead a discussion on vaccine safety and effectiveness monitoring, which will precede a presentation on operational distribution plans. Messonnier played a pivotal role in the CDC’s early coronavirus response press conferences.