Don’t worry, Trump is under review by the FDA, but tweets “modern or vaccine approval” (2 reports)

FDA clarifies “Conclusion Anna”… Possibility of mentioning the results of the advisory committee the day before, even at Pfizer

U.S. Food and Drug Administration (FDA) Advisory Committee recommends urgent use of Modena Corona 19 vaccine (PG)

[장현경 제작] Photo composition/illustration

(Washington = Yonhap News) Correspondent Ryu Ji-bok = US President Donald Trump announced on the 18th (local time) that a new coronavirus infection (Corona 19) vaccine developed by US pharmaceutical company Modena was approved.

However, the US Food and Drug Administration (FDA) stated that the review is still underway.

In a tweet in the morning, President Trump wrote, “Moder or vaccine has been overwhelmingly approved. Distribution will begin immediately.”

The Vaccine and Biological Drugs Advisory Committee (VRBPAC), an advisory body for the US Food and Drug Administration (FDA), held a meeting the day before and recommended the FDA for urgent use of modder or vaccines with overwhelming approval from 20 people in favor, 0 people against, and 1 abstention.

Reports had already been made that the FDA, which received the advisory committee’s recommendation, would approve it as early as the day, but there was no official announcement from the FDA until a tweet by President Trump was posted at 7:37 am.

Therefore, the tweet was taken as the FDA’s decision to approve the advisory committee’s recommendations.

Reuters reported that “the FDA advisory committee met to discuss Modena vaccine on the 17th, and the FDA was expected to decide (approval) as soon as possible on the 18th,” said President Trump’s tweet, which came before the FDA’s official announcement.

[그래픽]  Comparison of two major vaccines for COVID-19
[그래픽] Comparison of two major vaccines for COVID-19

(Seoul = Yonhap News) Reporter Seong-gu Jang = The Canadian government is planning to bring in the first supply within the year as soon as the health authorities approve the use of a novel coronavirus infection (Corona 19) vaccine developed by the US pharmaceutical company Modena.
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However, the FDA clarified that it is still reviewing the data and has not yet approved it after the media inquiries followed.

It is unclear whether President Trump had informed the FDA’s approval decision in advance, or expressed that approval was given with the advisory committee’s recommendation for approval the day before.

However, considering President Trump’s use of the word’overwhelmingly’, it is possible that he referred to the results of the Advisory Committee the day before, which all but one abstentioned without opposition.

While the spread of Corona 19 in the United States is very serious, President Trump has shown attention to the image that he is making great efforts to approve, distribute, and inoculate vaccines.

In the process of first approving a vaccine from Pfizer-Bioentech last week, he also put strong pressure on the FDA’s rapid approval.

President Trump tweeted, “Director Han, deliver that damn vaccine” to FDA Director Stephen Han, perhaps because of the decision that the FDA’s approval announcement was delayed after the FDA Advisory Committee recommended Pfizer vaccine approval on the 10th.

In addition, reports were reported that White House Secretary Mark Meadows called Han Director on the 11th and pressured the FDA to resign if the FDA did not approve emergency use by the same day (11th).

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