Pfizer and BioNTech apply for full FDA approval of COVID-19 vaccine

(Image: Longhua Liao/Getty Pictures)

Pfizer and BioNTech announced nowadays they have submitted an application to the Food stuff and Drug Administration for whole approval of their COVID-19 vaccine.

The firms also explained they want to increase the latest emergency use authorization for their vaccine to contain individuals 12 to 15 decades of age. 

The request for whole approval is staying initiated as a rolling submission of a biologics license application.

Pfizer and BioNTech have submitted the nonclinical and medical facts required to guidance licensure of the COVID-19 vaccine for use in individuals 16 decades of age and older. This consists of the most latest analyses from the Section three medical trial demonstrating the vaccine’s efficacy and favorable safety profile up to six months right after the second dose. 

The firms will submit the expected manufacturing and facility facts for licensure in the coming months to finish the application.

WHY THIS Issues

This is the initial request for whole approval of a COVID-19 vaccine prior to the Fda.

The Pfizer, Moderna and Johnson & Johnson vaccines are staying used beneath an emergency use authorization.

Having photographs into the arms of individuals 12-15 decades aged will assistance in receiving the country to the herd immunity required to quit the spread of the virus. 

Pfizer and BioNTech intend to submit a supplemental application to guidance licensure of the vaccine in this age team as soon as the expected facts six months right after the second vaccine dose are readily available.

THE Bigger Development

The Pfizer-BioNTech COVID-19 Vaccine is presently readily available in the U.S. for all those 16 decades of age and older beneath an emergency use authorization granted by the Fda on December eleven, 2020. 

Since then, the firms have sent a lot more than a hundred and seventy million doses of the vaccine across the U.S. 

ON THE Report

“We are proud of the great development we’ve manufactured considering the fact that December in offering vaccines to thousands and thousands of Individuals, in collaboration with the U.S. Federal government,” explained Albert Bourla, chairman and CEO, Pfizer. “We search ahead to performing with the Fda to finish this rolling submission and guidance their review, with the target of securing whole regulatory approval of the vaccine in the coming months.”

“Next the effective shipping and delivery of a lot more than a hundred and seventy million doses to the U.S. inhabitants in just a handful of months, the BLA submission is an vital cornerstone of obtaining extended-time period herd immunity and containing COVID-19 in the upcoming,” explained Dr. Ugur Sahin, CEO and cofounder of BioNTech. “We are happy to get the job done with U.S. regulators to find approval of our COVID-19 vaccine based on our pivotal Section three trial and follow-up facts.”

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