Pfizer Submits Application for FDA Approval of COVID-19 Vaccine
May 7, 2021
This morning, Pfizer-BioNTech submitted a Biologics License Application (BLA) to the FDA for approval of their COVID-19 vaccine. Currently, the Pfizer vaccine has been granted an EUA due to the state of the pandemic, which allowed them to provide safety and efficacy data from two months of trials versus the standard six months. “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” (1).
The Pfizer vaccine has been readily available since mid-December 2020. Alongside their Phase 3 clinical trial, data regarding the vaccine’s safety and efficacy has been collected from the 170+ million doses administered in the U.S.
Pfizer is currently the only vaccine manufacturer authorized for people 16+ years of age. The approval would cover the same ages, even though Pfizer is currently applying for an EUA extending use of their vaccine to children 12-15 years of age. They expect to apply for final approval after acquiring six months worth of data after the second dose is administered.