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BioNTech says Pfizer plans to file a COVID-19 vaccine application on Friday

Pfizer shares PFE,
-0.35%
After announcing plans with BioNTech BNTX, it won 1.4% in pre-market trading on Friday.
+ 4.96%
Submit an application for an emergency license for an experimental COVID-19 vaccine candidate later in the day. BioNTech’s share price soared 6.9% before the market opened. Both companies’ planned EUA submissions to the Food and Drug Administration will make their vaccine candidates the first in line with US regulators. Earlier this week, they said the efficacy rate of a vaccine called BNT162b2 was 95% in late-stage clinical trials. “The application in the United States represents an important milestone in our journey to bring the COVID-19 vaccine to the world,” Pfizer CEO Dr. Albert Bourla said in a news release. He also said he was looking forward to the upcoming FDA Vaccine and Related Biologics Advisory Board meeting, which would include a group of independent clinical experts convened by the FDA. This is considered the next step in the regulatory process. Those familiar with the matter are asking CNBC for the FDA to “set aside three days in early December for a potential meeting to discuss the COVID-19 vaccine” from these experts. Said. In the traditional FDA approval process, this committee recommends whether treatment should be approved by regulators. The FDA is not obliged to follow the advice of the Commission, but often.So far this year, Pfizer’s share price has fallen 2.5%, BioNTech’s share price has risen 180.2%, and the S & P 500 SPX
+ 0.39%
It has increased by 10.8%.

BioNTech says Pfizer plans to file a COVID-19 vaccine application on Friday

Source link BioNTech says Pfizer plans to file a COVID-19 vaccine application on Friday

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