NEW YORK and MAINZ, GERMANY, JULY 16, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the 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, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States (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 has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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.
Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at www.cvdvaccine-us.com.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
Photo Credit –Biontech website