FDA Commissioner Issues Vaccine Warning 0:43
Washington (CNN) -
US President Donald Trump said Wednesday that the White House could bypass the US Food and Drug Administration (FDA) if the agency publishes more standards. stringent for the authorization of a covid-19 vaccine, qualifying such a measure as "political."
His comments come as the FDA considers new covid-19 vaccine guidelines that would likely push for a clearance beyond Election Day, according to three sources familiar with the situation.
That schedule would frustrate Trump's hopes for a pre-election clearance.
He had repeatedly said that the vaccine could be ready by November 3.
“We are analyzing that and that has to be approved by the White House.
We can approve or not, ”the president said of the new FDA guidelines at a press conference at the White House.
"That sounds like a political measure."
The FDA "respectfully" declined to comment on Trump's claims.
But generally speaking, the agency's guidelines go through the White House Office of Management and Budget review process, an FDA official told CNN on Wednesday.
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: FDA is considering authorization rules that would leave coronavirus vaccine approval for long after Election Day
In the meantime, the president's comments are sure to fuel new unease in a vaccine process that was already being greeted with skepticism by many Americans in polls.
Lack of confidence in the show is a nightmare scenario.
That's what public health experts say, as a vaccine is the best hope of eventually ending the pandemic and restoring normal life.
Early Wednesday, FDA Commissioner Dr. Stephen Hahn pledged to the United States that "the FDA will not authorize or approve a vaccine that we would not be comfortable giving to our families."
“The FDA will not authorize or approve any COVID-19 vaccine before it has met the agency's rigorous expectations for safety and efficacy.
Decisions to authorize or approve any vaccine or therapeutic treatment will be made by the dedicated professional FDA staff, through our review of processes, and science will guide our decisions, ”Hahn specifically promised the Senate Health Committee.
"The FDA will not allow any pressure from anyone to change that," he added.
Dr. Francis Collins, director of the National Institutes of Health, told CNN's Wolf Blitzer in "The Situation Room" that he trusts the FDA to apply the highest standards of safety and efficacy to all coronavirus vaccines.
Although he admitted that he was not sure whether the FDA or the White House had the final say in the approval of the vaccine.
"I am not a lawyer or a constitutional scholar," he said.
Actually, I don't know the answer to that.
Two former FDA commissioners previously told CNN that while they believe it is highly unlikely that Trump will be able to pressure scientists to authorize or approve a COVID-19 vaccine, this is possible.
In the past, the Department of Health and Human Services overruled FDA drug recommendations.
Despite assurances from federal officials, there are fears that the typical pathway for COVID-19 vaccine review and approval will be avoided.
Or at least deviate, due to political pressure.
"My concern is that there could be a gray area where a vaccine appears partially protective and is released without a full formal review process," said Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine.
CNN's Elizabeth Cohen, Kaitlan Collins, John Bonifield, and Jeremy Diamond contributed to this report.
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