After weeks of delay, the Food and Drug Administration finally released its Emergency Use Authorization standards for prospective coronavirus vaccines on Tuesday, Oct. 6. The stricter standards were released after American Oversight filed Freedom of Information Act requests seeking these guidelines.
The new guidelines were published in the face of threats from the White House to block their release. Last month, the New York Times reported that the FDA was planning to release a new, tougher standard for emergency authorization of a coronavirus vaccine. But the administration pushed back, with President Donald Trump saying, “We may or may not approve it. That sounds like a political move.”
The Washington Post reported that the FDA provided the White House with additional data justifying the change, but when the guidelines were still not approved, FDA officials circumvented the White House and published the criteria online as part of a briefing package. The White House approved the standards shortly after they were published.
We sent the FDA, the Department of Health and Human Services, and the Office of Management and Budget requests seeking the guidelines on Sept. 30. This week, the FDA emailed us, “In response to your FOIA request, the EUA guidance is posted.”
The guidelines set in place new requirements that make it unlikely that a vaccine will receive authorization by the election — something Trump has wishfully promised as recently as Monday evening, in a video recorded after his return to the White House. The FDA is now advising vaccine developers to monitor trial participants for at least two months following their final dose of a vaccine or placebo. In addition, vaccine developers are urged to wait until at least five severe cases of Covid-19 have been reported among trial participants. Both of these requirements should be met before developers can apply for emergency authorization.
The president still isn’t satisfied: He tweeted that the new authorizations were “just another political hit job” just hours after they were published.
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