White House ignoring, unlikely to approve FDA's new COVID-19 vaccine guidelines

The FDA's new COVID-19 vaccine approval guidelines have been stalled by the White House and are unlikely to gain approval from the president, according to an Oct. 5 report from The New York Times.

The agency sent its guidelines to the Office of Management and Budget for approval around mid-September, and they have stalled in the office of White House Chief of Staff Mark Meadows, according to the newspaper.

Those familiar with the FDA's new set of guidelines, which have yet to be released publicly, told The New York Times it requires drugmakers to include at least five cases of severe COVID-19 in the placebo group to prove the vaccine can prevent more than just mild to moderate cases and stipulates they must continually study the vaccine's safety and efficacy after emergency use authorization is granted.

The guidelines also require trial volunteers who received a vaccine to be observed for about two months after they get their final dose before the FDA issues an authorization. This would make it impossible for an FDA-approved vaccine to emerge before the presidential election.

The FDA plans to enforce its guidelines without White House approval, The New York Times reported. The agency also plans to share its new guidance with an external advisory committee that will meet publicly before any vaccine is granted approval, according to the newspaper.  

The new set of guidelines aims to instill confidence in the public about the vaccine approval process and show  that drugmakers are being held to a high scientific standard. Pew Research Center's most recent survey asking Americans whether they would get a COVID-19 vaccine found that 51 percent of respondents would receive one, down from 72 percent when the survey was conducted in July.

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