White House OKs FDA asking for 2 months monitoring, likely delaying vaccine authorization past Election Day

The White House denied reports it had tried to block the new FDA guidance.

A spokesperson for the White House budget office denied those reports and said the approved guidance was never blocked and went through the normal review process.

Trump lashed out at the news on Twitter Tuesday night, writing, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” He also tagged FDA Commissioner Stephen Hahn in the tweet.

In September, Trump had said that the White House might not approve the new guidance, given what it could mean in terms of timing. “We may or may not approve it,” he told reporters, suggesting the FDA was reacting to questions about White House pressure to act faster, saying it “was a political move more than anything else.”

The guidance was posted on the agency’s website on Tuesday and as part of a packet of background material posted ahead of the vaccine advisory board’s scheduled meeting on COVID vaccine candidates on Oct. 22.

The FDA is laying out criteria for an emergency authorization of a vaccine candidate, not a full approval, and has repeatedly sought to encourage the public it will make decisions based only on the science and data from clinical trials regardless of political pressure.

FDA officials have said they expect an emergency authorization to target specific populations at higher risk for the virus — including health care workers or older populations living in group settings — and that a vaccine would not be widely available outside those groups until into next year.

Experts including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have said it takes about a month and a half for some side effects or problems to present themselves.

“Most of the adverse events that you’re talking

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