Pfizer, BioNTech Initiate Application Process for Full FDA Approval of COVID-19 Vaccine

Pfizer and BioNTech have initiated a biologics license application (BLA) with the FDA for full approval of their COVID-19 vaccine in individuals 16 years of age and older. Data to support the application will be submitted over the coming weeks, as well as a request for FDA Priority Review.

The vaccine is currently available in the United States under an emergency use authorization (EUA) granted on December 11, 2020. More than 170 million doses have been delivered since then, according to a press release.

“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, DVM, PhD, chairman and chief executive officer of 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.”

The BLA process requires longer-term follow-up data for acceptance and approval and is the next step in the FDA review. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision will be set once the BLA is complete and formally accepted by the agency. The BLA process was initiated by submitting the nonclinical and clinical data necessary to support licensure of the vaccine for use in patients 16 years of age and older.

These data include the most recent analyses from the phase 3 clinical trial, which observed the vaccine’s efficacy and found a favorable safety profile for up to 6 months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks.

The companies have also submitted an application to expand the current EUA for the vaccine to include individuals 12 to 15 years of age. According to the press release, they intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required 6-month data are available.

“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, 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.”

REFERENCE

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. 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?linkId=118126423. Accessed May 7, 2021.