Biologics

Covid-19 Vaccine EUA Granted Amid White House Pressure

FDA late Friday (12/11) granted an emergency use authorization (EUA) for Pfizer-BioNTech’s Covid-19 vaccine. The agency action comes after the White House reportedly ordered FDA commissioner Stephen Hahn to grant the EUA or submit his resignation by the end of the day. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” Hahn was quoted in a release as saying.

The White House pressure followed a positive vote 12/10 by the agency’s vaccine advisory committee to recommend the EUA (see earlier story). The resignation threat was preceded by an early morning Trump Twitter tirade, calling FDA a “big, old, slow turtle. ” He further said in the post: “Get the dam (sic) vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!”

Hahn disputed the description of his White House interaction, which was first reported by the Washington Post. He said Pfizer on Friday was informed that FDA will rapidly work toward finalization and issuance of the EUA. The agency also notified CDC and Operation Warp Speed, so they can execute their plans for vaccine distribution, he said.

President Trump has previously railed against FDA and Hahn, calling into question the timing of positive Covid-19 vaccine data announcements that were made shortly after the election last month. In a fit of rage, Trump called Hahn in anger, according to a Washington Post article. The phone call was followed up by a Trump Twitter post saying the vaccine data should have been announced earlier by FDA, “not for political purposes, but for saving lives! The FDA and the democrats didn’t want to have me get a vaccine win, prior to the election, so instead it came out five days later — As I’ve said all along!”

Last week, president Trump had his chief of staff Mark Meadows summon Hahn to the White House to learn why the agency has not approved or authorized the use of Covid-19 vaccines after promising data were recently reported on their efficacy. Despite the appearance of political pressure being directed at FDA, Trump wanted answers as to why FDA’s reviews were taking so long. The president reportedly was angered by the UK authorizing the vaccine before the U.S.

Critics of the White House’s recent stance worry that public confidence in the vaccine could be undermined.

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