Trump claims White House may overtake FDA guidelines for coronavirus vaccine

09/24/2020 Health, Science


His comments come as the FDA considers new Covid-19 vaccine guidelines, which will likely push the authority ahead of election day, according to sources familiar with the three situations. That timeline would dampen hopes of Trump’s pre-election authority, repeatedly saying the vaccine could be ready by November 3rd.

“We’re looking at the FDA’s new guidelines and they have to be approved by the White House,” the president told a White House news conference. Whether we can allow it or not. “It sounds like a political move.”

The FDA declined to comment “respectfully” on Trump’s claim. But generally speaking, the agency’s guidelines go through the White House Office Fee Management f management and budget review process, an FDA official told CNN on Wednesday.

Meanwhile, the president’s remarks confirm a new unease in the vaccine process that was already welcomed with skepticism by many Americans in the polls. Lack of confidence in the program is a nightmare, public health experts say, adding that a vaccine is the best hope to finally end the epidemic and restore normal life.

Earlier Wednesday, the FDA’s commissioner, Dr. Step. Stephen Hehn made a commitment to the United States that “the FDA will not approve or approve any vaccines that we would not consider convenient to give to our families.”

“The FDA will not authorize or approve any Covid-19 vaccine before it meets the agency’s strict safety and efficacy expectations. Any such vaccine or remedial approval or approval decision will be made by the FDA’s dedicated career staff, through our thorough review of procedures and science.” Will guide our decisions, ‘Hayne made a special promise to the Senate Health Committee.

He added that the FDA would not allow anyone to pressure him to change.

Dr. Director of the National Institute of Health. Francis Collins told CNN’s Wolf Blitzer on “The Situation Room” that he trusted the FDA to apply the highest safety and efficacy standards to all coronavirus vaccines, although he acknowledged that he was not convinced by the FDA. Or the White House’s final say on vaccine approval.

“I am not a lawyer or a constitutional scholar,” he said. “I don’t really know the answer.”

Two former FDA commissioners previously told CNN that it was possible that Trump might force scientists to authorize or approve the Covid-19 vaccine. The Department of Health and Human Services has in the past overturned FDA recommendations regarding drugs.

Despite assurances from federal officials, there are fears that the typical route for review and approval of the Covid-19 vaccine will be closed due to political pressure, or at least crooked.

“What I am concerned about is that there may be a gray zone where the vaccine seems to be partially protective and it goes on the market without a full formal formal review process,” said Dr. Said Peter Hotz.

CNN’s Elizabeth Cohen, Caitlan Collins, John Bonifield and Jeremy Diamond contributed to the report.

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