WaPo: FDA To Set Higher Bar For COVID Vaccine, Likely Delaying Approval Past Election

September 22, 2020 5:03 p.m.
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The Food and Drug Administration is set to issue higher standards before approving a COVID-19 vaccine, the Washington Post reported on Tuesday, a move that could push any vaccine being deployed until after the November election.

A COVID-19 vaccine would almost certainly be approved through emergency use authorization, officials have said, a tool that allows the government to approve treatments before full, multi-year testing regimens are complete.

Citing two anonymous sources, the Post reported that the FDA intends to ask vaccine manufacturers who are seeking an emergency authorization to “follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.”

The two vaccine trials that are the furthest along, Moderna and Pfizer, both require two shots, one month apart. The first people to receive the second round of shots did so in the final week of August, suggesting that the new regulation would prevent a request for authorization from being issued until late October.

The new regulation reportedly also requires there to be cases at least five severe cases of COVID-19 in the trial’s placebo population, as well as some COVID-19 cases in older people, before approval.

The new criteria could prolong the FDA’s timeline for issuing an emergency approval for a vaccine. President Trump has said that a vaccine would be approved before Election Day, while administration officials have reportedly referred to a pre-election vaccine as a “holy grail” for President Trump’s re-election hopes.

It’s not clear how new or tough the criteria are, compared to those that the FDA was previously using for the COVID-19 vaccine. Though Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development, has said that any COVID-19 vaccine must be at least 50 percent effective in order to be approved, the FDA has so far not released the detailed criteria that it is using to establish vaccine safety and efficacy.

Joe Biden has called on the Trump administration to make that criteria publicly available.

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