Pfizer and BioNTech Seek FDA Approval for COVID-19 Vaccine

Pfizer and BioNTech have initiated the process of seeking full FDA approval for their COVID-19 vaccine to prevent infection in individuals 16 years of age and older.

The Biologics License Application (BLA) will be supported by data submitted on a rolling basis in the coming weeks, with a request for priority review, Pfizer said. The Prescription Drug User Fee Act goal date will be set once the BLA is complete and formally accepted.

Additionally, Pfizer and BioNTech have submitted an application to expand the current emergency use authorization (EUA) for the vaccine to include individuals aged 12 to 15 years of age. This expanded authorization could come in the next several days, according to federal officials. Pfizer and BioNTech recently announced positive results from their phase 3 trial of BNT162b2 in adolescents. The results showed that the vaccine demonstrated 100% efficacy and robust antibody responses, as well as adequate tolerability.

Pfizer and BioNTech have delivered more than 170 million doses of the vaccine since it was granted EUA by the FDA in December 2020.

“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,” said Ugur Sahin, MD, CEO and co-founder of BioNTech. “We are pleased to work with US regulators to seek approval for our COVID-19 vaccine based on our pivotal phase 3 trial and follow-up data.”

References

1. Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for US FDA Approval of Their COVID-19 Vaccine. News Release. Pfizer; May 7, 2021. Accessed May 7, 2021. https://investors.pfizer.com/investor-news/press-release-details/2021/Pfizer-and-BioNTech-Initiate-Rolling-Submission-of-Biologics-License-Application-for-U.S.-FDA-Approval-of-Their-COVID-19-Vaccine/default.aspx
2. Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents. News Release. Pfizer; May 7, 2021. Accessed May 7, 2021.