Pfizer and BioNTech Will Ask the FDA to Authorize Their Coronavirus Vaccine Today

Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) will pass an important milestone in the development of a COVID-19 vaccine today when they submit a request to the Food and Drug Administration for Emergency Use Authorization (EUA) of their vaccine candidate. In a press release this morning, the companies said that they will be ready to start distributing the vaccine within hours after receiving authorization, and it could be ready for use by high-risk populations in the U.S. by the middle to the end of December.

The submission means that the vaccine has met endpoints for safety and efficacy in clinical trials. The results from the phase 3 trials demonstrated a 95% efficacy rate, measured seven days after the second dose, and no serious safety concerns reported in 38,000 trial participants who have been followed for a median of two months after the second dose. The efficacy rate was based on 170 confirmed cases of COVID-19 in the trial participants, who were randomly given the vaccine or a placebo.

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