Trump claims White House can overrule FDA’s attempt to toughen guidelines for coronavirus vaccine

President Donald Trump claimed Wednesday that the White House could override the US Food and Drug Administration if the agency released tougher standards for the authorization of a Covid-19 vaccine, casting such a move as “political.”

His comments come as the FDA considers new Covid-19 vaccine guidelines that would likely push an authorization beyond Election Day, according to three sources familiar with the situation. That timeline would dash Trump’s hopes of a pre-election authorization, having repeatedly said the vaccine could be ready by November 3.

“We’re looking at that and that has to be approved by the White House. We may or may not approve it,” the President said of the new FDA guidelines at a White House news conference. “That sounds like a political move.”

The FDA “respectfully” declined to comment on Trump’s claims. But generally speaking, agency guidelines do go through the White House Office of Management and Budget review process, an FDA official told CNN Wednesday.

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. A lack of trust in the program is a nightmare scenario, public health experts say, since a vaccine is the best hope of eventually ending the pandemic and restoring normal life.

Earlier Wednesday, the commissioner of the FDA, Dr. Stephen Hahn, made a commitment to America that the “FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families.”

“FDA will not authorize or approve any Covid-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes, and science will guide our decisions,” Hahn specifically promised the Senate Health Committee.

“FDA will not permit any pressure from anyone to change that,” he added.

National Institutes of Health Director Dr. Francis Collins told CNN’s Wolf Blitzer on “The Situation Room” that he trusts the FDA to apply the highest safety and efficacy standards to all the coronavirus vaccines, though he conceded that he wasn’t sure if the FDA or White House had the final say on vaccine approval.

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

Two former FDA commissioners previously told CNN that while they think it’s very unlikely that Trump could pressure scientists into authorizing or approving a Covid-19 vaccine, it’s possible. The Department of Health and Human Services has in the past overruled the FDA’s recommendations on medications.

Despite reassurances from federal officials, there are fears that the typical pathway for review and approval of the Covid-19 vaccine will be eschewed, or at least bent, because of political pressure.

“What I’m concerned about is there could be a gray zone where a vaccine looks partially protective and it goes on the market without a full formal review process,” said Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine.