Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2
(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that two of the companies four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).
- (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, BioNTech) today announced that two of the companies four investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2 (the virus that causes COVID-19), received Fast Track designation from the U.S. Food and Drug Administration (FDA).
- The FDAs decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2, said Peter Honig, Senior Vice President, Global Regulatory Affairs, Pfizer.
- 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 zlem Treci, Chief Medical Officer at BioNTech.
- The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.