Pfizer-BioNTech COVID-19 Vaccine Approval Expected in 2022

Germany-based BioNTech SE and New York-based Pfizer Inc. announced the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine (Comirnaty) to prevent COVID-19 in individuals 16 years of age and older.

The Prescription Drug User Fee Act goal date for a decision by the U.S. FDA is in January 2022.

Pfizer and BioNTech completed the rolling submission of the BLA in May 2021. The application includes clinical data from the pivotal Phase 3 clinical trial of the vaccine, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose.

On May 10, 2021, the FDA expanded the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to include individuals 12 through 15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.

The Pfizer-BioNTech COVID-19 vaccine, based on BioNTech proprietary mRNA technology, was developed by BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the European Union and the holder of EUA or equivalent in the USA (jointly with Pfizer), Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.

The Pfizer-BioNTech COVID-19 vaccine (Comirnaty) has not been Approved or licensed by the U.S. FDA. Still, it has been Authorized for emergency use by FDA under a EUA to prevent COVID-19 caused by the SARS-CoV-2 betacoronavirus for use in individuals 12 years of age and older.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

About BioNTech - Biopharmaceutical New Technologies is a next-generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

About Pfizer - Breakthroughs That Change Patients’ Lives. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.