White House approves new COVID-19 vaccine standards after FDA publishes them anyway

The White House on Tuesday, in an apparent reversal, approved stringent new Food and Drug Administration guidelines for emergency use approval of a COVID-19 vaccine. The Trump administration was widely reported to have rejected the new guidelines Monday night, citing purported opposition from drugmakers and questioning whether the new standards were necessary. But President Trump had openly criticized the guidelines, which, now in force, will make it difficult but not impossible for a vaccine to get approval before Election Day.

The White House cleared the new standards shortly after the FDA unilaterally published them as part of its briefing materials for an upcoming meeting of its outside vaccine advisory committee, The Washington Post reports. Pfizer also endorsed the guidelines earlier on Tuesday, becoming the last U.S.-backed drugmaker with a late-stage vaccine to publicly signal support. The new standards aren't notably different from other vaccine approval standards, and the FDA created them in part to raise public confidence in COVID-19 vaccines amid politicization from the White House.

"The bottom line is, FDA is going to stick to the objective criteria that they outlined in the guidance, the [advisory committee] is going to support those principles, and the sponsors are going to adhere to them," former FDA Commissioner Scott Gottlieb said Tuesday at a symposium on vaccines and scientific integrity. "There are few moments I can think of where so much political dust was created by political officials for so little actual practical effect — and perhaps negative effect."

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Trump still tweeted his disapproval Tuesday night, tagging FDA Commissioner Stephen Hahn: "New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!"