FDA expected to approve vaccine Friday evening, following public and private threats

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Posted at 3:22 PM, Dec 11, 2020

It appears the FDA is planning to grant the Pfizer COVID-19 vaccine emergency use authorization Friday evening, and according to multiple reports, the agency’s commissioner may have had his job threatened during discussions with the White House.

Authorization had been expected Saturday morning, after an advisory panel recommended approval of the vaccine Thursday evening. According to reports, the agency was working to move it up to Friday evening.

Friday morning, President Donald Trump lashed out at the Food and Drug Administration and its commissioner, Dr. Stephen Hahn, for not moving faster. Trumptweeted the FDA “is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn@SteveFDA. Stop playing games and start saving lives!!!”

Later in the morning, the president’s chief of staff, Mark Meadows, reportedly called Dr. Hahn to discuss the timeline for approval. According to the New York Times, Washington Post, and Associated Press, Dr. Hahn was told he may be out of a job if he didn’t get the vaccine approved by Friday night.

Pfizer and the FDA are now reportedly rushing to complete needed paperwork for the emergency use authorization. These include a vaccine fact sheet, information for physicians and other required documents.

Dr. Hahn denies the description of the conversation he had with the White House.

"This is an untrue representation of the phone call with the Chief of Staff. The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech's (emergency use authorization) request," Hahn said in a statement Friday afternoon. "FDA is committed to issuing this authorization quickly, as we noted in our statement this morning."

A statement issued Friday morning by the FDA said they would “rapidly work toward finalization and issuance of an emergency use authorization” following the approval from their advisory committee.

Whether the Pfizer vaccine is approved for emergency use Friday evening or Saturday morning, the New York Timesreports that will not necessarily change the speed of shipping out the first doses.

On Thursday, the U.S. recorded a second day in a row of 3,000 deaths from COVID-19.