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FDA clarifies “Anna Conclusion” … Possibility to mention the results of the advisory committee the day before, including at Pfizer
The President of the United States, Donald Trump, announced on the 18th (local time) that a new vaccine against coronavirus infection (Corona 19) developed by the American pharmaceutical company Modena has been approved.
However, the Food and Drug Administration (FDA) stated that the review is still ongoing.
In a morning tweet, President Trump said: “Modern vaccines were approved by an overwhelming majority.
Distribution begins immediately, ”he wrote.
The Vaccines and Biological Drugs Advisory Committee (VRBPAC), an advisory body to the United States Food and Drug Administration (FDA), held a meeting the day before and recommended to the FDA the urgent use of modder or vaccines with a overwhelming approval of 20 people in favor, 0 people against and 1 abstention.
There were already reports that the FDA, which received the advisory committee’s recommendation, would approve it later that day, but there was no official announcement from the FDA until a tweet from President Trump at 7:37 a.m.
Therefore, the tweet was accepted as the FDA’s decision to approve the advisory committee’s recommendations.
Reuters reported that “the FDA advisory committee met to discuss the Modena vaccine on the 17th, and the FDA was expected to decide (approve) as soon as possible on the 18th,” said President Trump’s tweet, which occurred prior to the official FDA announcement.
However, the FDA clarified that it is still reviewing the data and has not yet approved it after questions from the media followed.
It is unclear if President Trump was informed in advance of the FDA approval decision or if he expressed that the approval came with the recommendation of the advisory committee for approval the day before.
However, considering President Trump’s use of the word ‘overwhelmingly’, it is likely that he was referring to the results of the Advisory Committee the day before, that all but one abstained unopposed.
While the spread of Corona 19 in the United States is very serious, President Trump heeded the image that he is going to great lengths to approve, distribute, and inoculate vaccines.
In the process of first approving a Pfizer-Bioentech vaccine last week, it also put heavy pressure on speedy FDA approval.
President Trump tweeted: “Director Han, hand over that damn vaccine” to FDA Director Stephen Han, perhaps due to the decision that the FDA approval announcement was delayed after the FDA advisory committee recommended the Pfizer vaccine approval on day 10.
In addition, it was reported that White House Secretary Mark Meados called Han Director on the 11th and pressured the FDA to resign if the FDA did not approve emergency use on the same day (11).
/ yunhap news
