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Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.
Pfizer and BioNTech announced on May 7, 2021 that they have initiated a rolling submission of a biologics license application (BLA) to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.
The companies initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the vaccine, Pfizer said in a company press release. The companies will continue to submit data on a rolling basis over the next few weeks, with a request for priority review from FDA.
Currently, the vaccine is available in the United States under an emergency use authorization granted by FDA on December 11, 2020.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US Government,” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “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.”
“Following the successful delivery of more than 170 million doses to the US population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” added Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “We are pleased to work with US regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”