FDA in final stages before issuing Pfizer, BioNTech EUA

By The Science Advisory Board staff writers

December 11, 2020 -- The U.S. Food and Drug Administration (FDA) has informed Pfizer and BioNTech that it will work rapidly toward the finalization and issuance of an emergency use authorization (EUA) for the company's COVID-19 vaccine candidate.

The statement was given by Dr. Stephen Hahn, the FDA commissioner and Dr. Peter Marks, PhD, the director of the Center for Biologics Evaluation and Research, following the December 10 meeting of the Vaccines and Related Biologicals Products Advisory Committee (VRBPAC), which produced a positive outcome.

In addition to notifying the sponsors, the FDA also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed so that execution of plans for a timely vaccine distribution can begin.

FDA committee gives nod to move Pfizer, BioNTech COVID-19 vaccine toward EUA
A COVID-19 vaccine candidate from Pfizer-BioNTech, BNT162b2, passed a major milestone today when a U.S. Food and Drug Administration (FDA) advisory committee...
Pfizer, BioNTech to submit EUA request
Pfizer and BioNTech will submit a request on November 20 to the U.S. Food and Drug Administration for emergency use authorization (EUA) of their messenger...
FDA to review Pfizer, BioNTech's vaccine EUA on December 10
The Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration (FDA) has set a date of December 10 to discuss...

Copyright © 2020 scienceboard.net

Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter