Pfizer Inc. and BioNTech SE announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration for full approval of their 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 Pfizer-BioNTech vaccine is currently available in the U.S. under an Emergency Use Authorization granted by the FDA on December 11, 2020.
Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process.
The Pfizer/BioNTech vaccine requires two doses to be more than 90 percent effect in stoping the virus.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, CEO of Pfizer. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
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. The companies intend to submit an emergency use designation once the required data six months after the second vaccine dose are available.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.
