FDA approves Fast Track for BioNTech, Pfizer vaccines

Monday, 13. July 2020 13:10

Two out of four COVID-19 vaccine candidates developed by BioNTech SE and Pfizer Inc. were approved for a Fast Track designation from the United States Food and Drug Administration (FDA), the companies said on Monday.

Vaccines BNT162b1 and BNT162b2 are undergoing a clinical trial in Germany and the United States and were given the green light by the FDA based on the preliminary data, which showed promising results.

"We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward," said BioNTech's Chief Medical Officer Ozlem Tureci.

Related Links: BioNTech SEPfizer Inc.
Author:
Breaking the News / BU