Fauci, Hahn Push Back Against White House Review of Vaccine EUA Guidance

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that White House interference with the FDA’s policies for authorizing a COVID-19 vaccine would be “troublesome.”

Both he and FDA Commissioner Stephen Hahn publicly made comments yesterday, sharply criticizing President Trump’s threat to reject an upcoming agency guidance that is expected to strengthen required thresholds for a COVID-19 vaccine Emergency Use Authorization (EUA).

The guidance, which was expected to be released this week, would make it very unlikely that an EUA could be issued before the Nov. 3 presidential election.

In a televised interview, Fauci explained that normally the FDA independently comes up with the particulars of agency guidances. Any Trump administration meddling not based in science could lead to problems, Fauci warned.

“The issue is that the scientists and the FDA have put this forth as what they’re proposing for the criteria for EUAs. Under normal circumstances, that decision is theirs, the secretary [of HHS] approves it and that’s it,” Fauci said. “Something that comes from without, that is not a scientific consideration would be troublesome, I have to tell you.”

The president said Wednesday night that the White House is reviewing the FDA’s proposed guidance and is debating whether or not to approve it. The guidance, which many see as the agency’s effort to persuade a skeptical American public that the FDA will not succumb to political pressure from Trump, are “a political move more than anything else,” the president charged (DID, Sept. 24).

In a talk radio interview Thursday, Hahn once more offered the public assurances that politics will not shape the FDA’s decisions on COVID vaccines or treatments.

“Our experts, who know about vaccines, will make [the] determination, and it'll be only based upon the science and the data, not politics. That's my pledge,” said Hahn. — James Miessler