Pfizer Inc. and BioNTech have initiated an application to the US Food and Drug Administration (FDA) requesting a approval of their COVID-19 vaccine for people from ages 16 and older.
The companies made the announcement on Friday, becoming the first in the U.S to initiate Biologics License Application (BLA) for FDA’s full approval.
Pfizer and BioNTech initiated the BLA with the submission of the nonclinical and clinical data which includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed.
The companies are expected to submit data that will support the BLA to the FDA in coming weeks, with a request for Priority Review.
“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,” Albert Bourla, Chairman and Chief Executive Officer of Pfizer, 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.”
“Following the successful delivery of more than 170 million doses to the U.S. 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,” M.D., CEO and Co-founder of BioNTech, Ugur Sahin, , said.
“We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”
Pfizer/BioNTech has also applied for the expansion of its current Emergency Use Authorization (EUA) to include children ages 12 to 15.