German biotechnology BioNTech SE (NASDAQ: BNTX) and his partner Pfizer (NYSE: PFE) announced that the United States Food and Drug Administration (FDA) has granted the Fast Track designation to two of the four vaccines that 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 vaccine candidates.
The agency’s decision was based on initial data from a phase 1/2 study of one of the two vaccine candidates, BNT162b1, which the companies published 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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The two candidate vaccines are based on BioNTech’s messenger RNA (mRNA) platform, which biotechnology says produces safer and easier to manufacture vaccines than conventional vaccines that use killed 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 against SARS-CoV-2.
BioNTech and Pfizer hope to launch a phase 2b / 3 vaccine trial later this month, which will enroll up to 30,000 subjects. If the study is successful, it could lead to vaccine approval, and the companies said they hope 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.
