Pfizer and BioNTech announced that they have initiated the process of applying for full U.S. FDA approval of their mRNA COVID-19 vaccine for people 16 and older.
The Pfizer-BioNTech COVID-19 vaccine was granted Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020 and will now be the first coronavirus vaccine to seek a Biologics License Application (BLA) from the agency.
The data to support the BLA will be submitted to the FDA on a rolling basis over the coming weeks, with a request for Priority Review.
According to their press release, the drugmakers initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine. This includes the most recent analyses from the pivotal phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The Companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.
A full approval would allow the Pfizer vaccine to stay on the market after the emergency is declared to be over. The PDUFA goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.
Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age.
Read the press release
