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.
The two vaccine candidates are based on BioNTech's messenger RNA (mRNA) platform, which the biotech believes produces vaccines that are safer and easier to manufacture than classic vaccines using dead or attenuated viruses. BNT162b1 and BNT162b2 are designed to cause the patient's cells to produce two variations of antigen that stimulate the production of antibodies to SARS-CoV-2.
BioNTech and Pfizer expect to launch a phase 2b/3 vaccine trial later this month, enrolling up to 30,000 subjects. If the study succeeds, it could lead to approval of the vaccine, and the companies said they expect to manufacture up to 100 million doses by the end of this year and more than 1.2 billion doses by the end of 2021.