The FDA has given the final go-ahead to Pfizer-BioNTech's coronavirus vaccine.
Shots will begin in a few days after the decision, but initial doses will be scare and rationed to health workers and nursing home residents and staff first.
Enough vaccinations for the general population isn't expected until spring, prompting experts to urge the public to continue using face coverings and physically distance through the winter.
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. Trump tweeted 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!!!”
While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!— Donald J. Trump (@realDonaldTrump) December 11, 2020
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 Times reports 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.