NEW YORK (1010 WINS) – Pfizer and BioNTech on Friday announced they began the process of seeking full FDA approval of their COVID-19 vaccine in the United States.
The two-dose vaccine is currently being given under an emergency use authorization from the FDA that was granted in December.
The companies said they have initiated the Biologics License Application with the FDA for full approval of the vaccine for people 16 years and older. It’s the next step in a longer-term FDA review process.
Data to support the BLA will be submitted to the FDA on a rolling basis over the coming weeks, the companies said.
So far, the companies have delivered more than 170 million doses of their vaccine across the U.S.
“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,” Pfizer CEO Albert Bourla said in a statement. “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.”