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President Donald Trump has accused the Food and Drug Administration (FDA) of launching a “political hit job” on him, hours after the White House accepted the regulator’s stricter guidelines for coronavirus vaccine developers.
Trump has consistently said he hopes to have a vaccine ready before election day, but the new FDA guidelines will make it difficult for any COVID-19 vaccine to be approved before the November 3 vote.
He lashed out at the FDA in a tweet on Tuesday evening, tagging commissioner Stephen Hahn.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA
— Donald J. Trump (@realDonaldTrump) October 7, 2020
He did not offer any evidence for his claim the new guidelines were motivated by politics.
The tougher guidelines were cleared by the Office of Management and Budget on Tuesday after a two-week hold-up, during which they were reportedly blocked by senior White House officials, including Mark Meadows, chief of staff.
In the guidelines, the FDA said that before vaccine makers submit an emergency-approval application they should monitor trial participants for a minimum of two months after their final dose in phase-three clinical trials. The agency also expects vaccine developers to document five cases of severe infection in volunteers who took the placebo instead of the vaccine.
Four vaccines have entered the final stage of testing in the US, including one from Pfizer and one from Moderna. Both drug companies expected to enroll 30,000 volunteers when their initial trials kicked off on July 27, but instead only enrolled half this number.
Volunteers usually receive their second dose less than a month after their first, but two months of monitoring make it unlikely that either company will have have enough data before November.
Moderna’s CEO said on September 30 that the firm wouldn’t be able to submit an application for emergency approval until late November at the earliest, as it wouldn’t have enough safety data, per the Financial Times.
Coronavirus has claimed more than 210,000 lives in the US so far, and infected more than 7.5 million people.
Among those that have been infected is Trump himself: He tweeted on October 2 that he and Melania Trump had tested positive for the virus. After being flown to Walter Reed Medical Center, he received two experimental treatments to fight the infection. He has since returned to the White House, where staff are reportedly anxious about catching COVID-19 from him, per multiple reports.
SEE ALSO: If Trump bypassed the FDA on a COVID-19 vaccine it could ‘upend’ the traditional approval structure and erode the public’s trust in the executive agency, expert says
SEE ALSO: Trump reportedly wants to bypass health regulations to approve an experimental coronavirus vaccine before the election
SEE ALSO: Ex-FDA commissioners, including former Trump advisor, warn against White House efforts to ‘tip the scales’ on COVID-19 vaccine
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Source:: Businessinsider – Politics