Mary Wilson
Well-known member
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.
https://investors.biontech.de/news-...priority-review-biologics-license-application
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.
https://investors.biontech.de/news-...priority-review-biologics-license-application