Pfizer Corona Vaccine Allows Emergency Use by US FDA-Bloomberg



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The US Food and Drug Administration (FDA) announced on its website that it has granted an emergency license (US) for the new coronavirus infection (COVID19) vaccine developed by Pfizer in the US and Biontech in Germany. It will be the first corona vaccine to be put into practical use in the United States, where the number of corona-related hospitalizations and deaths is increasing rapidly.

Vaccination will begin in a few days across the country, and priority will be given to medical personnel, as well as the elderly living in long-term care facilities. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research (CBER), which reviews vaccine applications, said in a statement that the EUA grant decision was “scientifically guided and supported by available safety and security data. effectiveness”. “The known effects and potential of the vaccine clearly outweigh the perceived risks and potential,” he continued.

In a video posted on Twitter, President Trump said it was “one of the greatest scientific achievements in history” and that the vaccine would save the lives of many and end the pandemic. Said.

UK Pfizer Vaccine

Vaccine developed by Pfizer and Biontech

The UK approved the use of the Pfizer and Biontech vaccines earlier than other countries on Day 2 and started vaccination on Day 8. As well as being approved in Canada and elsewhere, it is also under review by the European Union (EU).

New Corona vaccine begins to be administered to UK citizens, leading the West

For several weeks, the FDA has been under pressure from the White House to swiftly grant the U.S. President Meadows urged FDA Secretary Hahn to resign on the 11th if there was no grant on the day. day, according to people familiar with the Washington Post.I report. Secretary Hahn issued a statement calling the report “false.” Meanwhile, a person familiar with the matter told Bloomberg News in a phone conversation that day that Meadows warned Hahn that if emergency use is not approved soon, his continuation of duties could be compromised.

At a meeting on the 10th, the FDA’s advisory board decided in favor of the conclusion that the benefits of receiving the vaccine for people 16 and older outweigh the risks. The result of the vote was 17 in favor, 4 against and 1 withdrawn.

Pfizer Vaccine Endorsed by FDA Advisory Board: Advancement for Practical Use in the United States

Original title:Pfizer vaccine approved in the US, a milestone in the fight against Covid-19 (1) 、Pfizer’s Covid Vaccine Gets FDA Emergency Use Clearance (1) 、Meadows suggested Hahn’s job was in jeopardy over the vaccine approval (抜 粋)

(I will update the second and third paragraphs with comments from the FDA and President Trump.)

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