BioNTech, Pfizer say they plan to submit COVID-19 vaccine application on Friday

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Shares of Pfizer Inc. gained 1.4% in premarket trading on Friday after it announced plans with BioNTech to submit an application later in the day for an emergency use authorization for their experimental COVID-19 vaccine candidate. BioNTech’s stock jumped 6.9% before the market opened. The companies’ planned EUA submission to the Food and Drug Administration would make their vaccine candidate the first in line with U.S. regulators. Earlier this week they said the vaccine, called BNT162b2, had an efficacy rate of 95% in a late-stage clinical trial. “Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world,” Pfizer CEO Dr. Albert Bourla said in a news release. He also said he looks forward to an upcoming FDA Vaccines and Related Biological Products Advisory Committee meeting, which will include a group of independent clinical experts convened by the FDA. It is considered the next step in the regulatory process. People familiar with the matter told CNBC that the FDA has asked those experts “to set aside three days in early December for potential meetings to discuss COVID-19 vaccines.” In the traditional FDA approval process, this committee makes a recommendation to regulators whether or not they should approve a therapy. The FDA is not bound to follow the committee’s advice but often does. So far this year, Pfizer’s stock is down 2.5%, shares of BioNTech have gained 180.2%, and the S&P 500 is up 10.8%.
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