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Pfizer submitted an application for authorization of emergency use of new crown vaccine to FDA

via:CnBeta     time:2020/11/21 8:00:38     readed:514

Pfizer, the pharmaceutical company, said Friday it had applied to the Food and Drug Administration (FDA) for emergency use authorization for its new coronavirus vaccine (EUA).CEO Albert Bourla Pfizer said applications for emergency use authorization for the new crown vaccine are now being processed by the U.S. Food and Drug Administration. The company is expected to produce 50 million potential new crown vaccines worldwide by 2020 and 1.3 billion by 2021.

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Bourla said ," applying for emergency use authorization is an important milestone in the process of providing the world with a new crown vaccine, and now we have a more comprehensive understanding of the efficacy and safety of the vaccine, which gives us confidence in it ."

U.S. Food and Drug Administration (FDA) staff and external consultants need to investigate the trial data and may take at least three weeks to make a decision.

The vaccine, developed jointly by the two companies, showed 95% effectiveness without any major safety problems problems, and is likely to be the first vaccine to be approved, but must evaluated first. The two companies said in a statement that they were expected to be approved no later than late December.

A key step in the process is an advisory committee meeting of external FDA consultants and all infectious disease and vaccine experts. According to a person familiar with the matter, the meeting is scheduled for December 8-10. The FDA will sort out the test data in just a few weeks between receiving an emergency use authorization application and the meeting.

The FDA commissioner said Stephen Hahn earlier this week that the agency would issue review documents for vaccines authorized for emergency use to "increase public confidence in the agency's rigorous review of scientific data and proper use of authorized products ."

Pfizer and federal and state officials are ready to help distribute the vaccine within days of the FDA's approval of the emergency authorization. The vaccine needs special freezers for transportation and storage.

For the meetings of the FDA Advisory Committee, two critical moments deserve attention. First, two days before the conference call, FDA usually publish staff reports on clinical trial data. This helps to understand whether the agency tends to approve emergency use authorizations. At the end of the meeting, a non-binding vote will be held on whether the FDA should be approved for public use.

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