Pfizer, BioNTech begin process of seeking full FDA approval for COVID-19 vaccine
Pfizer and BioNTech have started the process of seeking full FDA approval for their COVID-19 vaccine for use in people aged 16 years or older in the United States.
The companies on Friday announced that they have initiated a rolling submission of a Biologics License Application (BLA) with the FDA for approval of the messenger RNA vaccine.
The BLA is based on nonclinical and clinical data, including phase 3 findings publicized last month that showed the vaccine was more than 91% effective overall up to 6 months after receipt of a second dose — including at least 95% effective against severe disease — and was protective against circulating SARS-CoV-2 variants.
The vaccine has been available to people aged 16 years or older in the United States since December under an emergency authorization (EUA) granted by the FDA. According to Pfizer, the companies have distributed more than 170 million doses in the U.S. since the EUA was granted, with a goal of delivering 300 million doses by the end of July.
“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, DVM, PhD, said in a news 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.”
The companies have also submitted an application to expand the current EUA to adolescents aged 12 to 15 years. They plan to submit a supplemental BLA to support licensure of the vaccine to this age group once the required 6-month data are available.
“The BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” BioNTech Ugur Sahin, MD, said in a statement. “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.”