Posted by Michael Wonder on 07 May 2021
Pfizer and BioNTech initiate rolling submission of biologics license application for U.S. FDA approval of their COVID-19 vaccine
7 May 2021 - - Pfizer and BioNTech today announced the initiation of a biologics license application with the U.S. FDA for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review.
The Prescription Drug User Fee Act goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.
