Pfizer and BioNTech Get "Fast Track" Designation for 2 COVID-19 Vaccines
German biotech BioNTech SE (NASDAQ: BNTX) and its partner Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to two of four vaccines the companies are developing for SARS-CoV-2, the virus that causes COVID-19. The Fast Track designation means that BioNTech and Pfizer are eligible for more frequent meetings and written communication with the FDA to support an expedited review process for the vaccine candidates.
The decision by the agency was based on early data from a phase 1/2 study of one of the two vaccine candidates, BNT162b1, that the companies released on July 1. The data showed that patients in the trial developed neutralizing antibodies to the virus at levels 1.8 to 2.8 times the number of antibodies measured in patients who had recovered from COVID19.
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Source Fool.com
