ARTICLE | Regulation

Dec. 10 FDA panel could be gateway to first emergency authorization of COVID-19 vaccine

BioNTech, Pfizer prepare to roll out mRNA vaccine

November 20, 2020 10:58 PM UTC

A Dec. 10 FDA advisory committee meeting could be the springboard for emergency use authorization for BNT162b2, enabling high-risk patients to receive by mid-December the first doses of the mRNA vaccine candidate against SARS-CoV-2 from BioNTech and Pfizer.

Rolling submissions for the vaccine from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) are under way in multiple other jurisdictions, including Australia, Canada, Europe, Japan and the U.K., and the partners plan to submit applications as soon as possible to other regulatory agencies around the globe...