Pfizer and BioNTech apply for full FDA approval of COVID-19 vaccine
The companies also intend to submit an application to expand use to individuals 12 to 15 years of age.
(Photo: Longhua Liao/Getty Images)
Pfizer and BioNTech announced today they have submitted an application to the Food and Drug Administration for full approval of their COVID-19 vaccine.
The companies also said they want to expand the current emergency use authorization for their vaccine to include individuals 12 to 15 years of age.
The request for full approval is being initiated as a rolling submission of a biologics license application.
Pfizer and BioNTech have submitted the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the Phase 3 clinical trial showing the vaccine's efficacy and favorable safety profile up to six months after the second dose.
The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the application.
WHY THIS MATTERS
This is the first request for full approval of a COVID-19 vaccine before the FDA.
The Pfizer, Moderna and Johnson & Johnson vaccines are being used under an emergency use authorization.
Getting shots into the arms of individuals 12-15 years old will help in getting the country to the herd immunity needed to stop the spread of the virus.
Pfizer and BioNTech intend to submit a supplemental application to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.
THE LARGER TREND
The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. for those 16 years of age and older under an emergency use authorization granted by the FDA on December 11, 2020.
Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S.
ON THE RECORD
"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," said Albert Bourla, chairman and CEO, Pfizer. "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," said Dr. Ugur Sahin, CEO and cofounder of BioNTech. "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."
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
