Pfizer formally applied to FDA for emergency use of vaccine, which was decided at the meeting on December 10

category:Finance
 Pfizer formally applied to FDA for emergency use of vaccine, which was decided at the meeting on December 10


Screenshot of Pfizers official website statement

According to Pfizers current estimate, the company will produce 50 million doses of vaccine worldwide by the end of 2020 and 1.3 billion doses by the end of 2021. Once authorized, the company will be able to prepare and start distributing the vaccine within hours.

According to Reuters, the FDA plans to hold a meeting on December 10 to discuss whether to approve the emergency use authorization application for the new crown vaccine jointly developed by Pfizer and biontech, which will take about three weeks, according to Reuters, citing people familiar with the situation.

Screenshot of Reuters report

The so-called emergency use authorization means that a limited number of Americans can be allowed to vaccinate the vaccine immediately after the FDA Approves the emergency use authorization application for the vaccine, which will be significantly faster than the traditional approval for several months. But FDA officials said the door frame for emergency authorization would be high.

Although we cant predict the time it will take for the review, the FDA will review the application as soon as possible. FDA official Stephen Hahn said in a statement that the agency has been preparing for several months to review the emergency use authorization application for the new crown vaccine and will carry out the review at any time after receiving the application.

According to reports, Pfizer and biontech jointly developed the new crown vaccine called bnt162b2. On November 9, the two companies announced that their joint research and development of the new crown vaccine can prevent 90% of infections; on November 18, they announced the latest clinical trial results, saying that the vaccine effective rate reached 95%, without serious side effects, and it also performed well in protecting the elderly.

According to the news from the New York Times and CNN, Modena plans to apply to the FDA for emergency use authorization later this month after accumulating more safety data. The FDA will review Modenas new coronavirus vaccine as soon as possible after reviewing Pfizer. Since Pfizer and Modenas two new crown vaccines use similar technologies, and the safety and efficacy data obtained from large-scale clinical trials are very similar, the FDA is likely to consider both applications at the same time, the report said. The New York Times quoted federal government officials and pharmaceutical companies as saying that if both vaccines were authorized by the FDA for emergency use, the doses of the vaccines could immunize about 20 million Americans against the new coronavirus by the end of this year, mainly including health care workers and elderly people in nursing homes. Source: observer.com editor in charge: Wang Xiaowu_ NF

Combined with the news from the New York Times and CNN, Modena plans to apply to the FDA for emergency use authorization later this month after accumulating more safety data. The FDA will review the new vaccine as soon as possible after Pfizer is reviewed.

Since Pfizer and Modenas two new crown vaccines use similar technologies, and the safety and efficacy data obtained from large-scale clinical trials are very similar, the FDA is likely to consider both applications at the same time, the report said.

The New York Times quoted federal government officials and pharmaceutical companies as saying that if both vaccines were authorized by the FDA for emergency use, the doses of the vaccines could immunize about 20 million Americans against the new coronavirus by the end of this year, mainly including health care workers and elderly people in nursing homes.