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MeterPfizer turns 20 in GermanyWe have applied to the US Food and Drug Administration (FDA) for an emergency use permit (EUA) for a new coronavirus vaccine candidate that is being developed jointly with Biontech.
This is the first application for an emergency license to the FDA with the new corona vaccine. If permission is obtained from the FDA, it is very likely that it will be the first time that vaccination has been initiated, limiting it to medical personnel and the elderly.
Earlier this week, the two companies announced that a final analysis of data from clinical trials showed that vaccination was 95% effective in preventing new corona infections. It is effective regardless of age group and race, and the trial involving about 44,000 people has not caused any serious safety concerns so far.
The FDA hopes to spend the next few weeks reviewing the data and, with permission, vaccines could begin in mid-December through the end of the same month. An important part of the process thus far is the meeting of an advisory council made up of experts in external infectious diseases and vaccines. The FDA plans to hold an advisory committee meeting on the 10th of the same month to carefully examine the data from the clinical trials.Announced.
In a video announcing the US application, Pfizer CEO Albert Bula said: “Today we have a very strong data set that we believe will meet or often exceed the high FDA standards. I was able to submit.”
Bula also revealed that the company has already started submitting data for sequential review in Australia, Canada, Europe, Japan, UK, etc., and plans to “immediately send it to other authorities around the world.” did.
Pfizer’s stock price rose 1.4% and Biontech’s US deposit securities (ADRs) closed 9.6% on the US stock market on the 20th.
Original title:
Pfizer Covid vaccine is the first to apply for US emergency approval (3) (抜 粋)