The Washington Post has been diagnosed with a case of fake news by the head of the Food and Drug Administration.
The Post, citing “people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened,” reported Friday that White House Chief of Staff Mark Meadows gave FDA Commissioner Stephen Hahn an ultimatum on Friday.
The Post claimed Meadows told Hahn that the FDA could either act Friday to give an emergency-use authorization that would allow the drug company Pfizer to start distributing its COVID-19 vaccine or Hahn could resign.
“This is an untrue representation of the phone call with the Chief of Staff,” Hahn said in a statement.
“The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”
Later Friday, the FDA did indeed issue an emergency-use authorization that allows Pfizer’s COVID-19 vaccine to be distributed to Americans.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” Hahn said in a statement.
“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 added.
“The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” he said.
Citing unnamed sources, Fox News reported that Meadows told Hahn to have “all hands on deck” to speed up an authorization, and that The Post’s claim was “not entirely true.”
President Donald Trump’s desire to get the vaccine through the authorization process quickly was reflected in his Friday tweet calling for speedy action.
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
The Pfizer-BioNTech vaccine has shown it was 95 percent effective in trials with no major side effects.
Canada and the United Kingdom authorized the vaccine the Pfizer vaccine before the U.S. However, British authorities have recommended that people with a history of severe allergic reactions not take the vaccine.
The FDA and Pfizer have been discussing the issue, according to Health and Human Services Secretary Alex Azar.
“In the next couple of days, probably, as we work to negotiate with Pfizer the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine,” Azar told CNN on Friday.
“And so we could be seeing people getting vaccinated Monday, Tuesday of next week.
Moncef Slaoui, who’s leading the White House vaccine effort, said no time will be lost getting the vaccine out to Americans.
“The first vaccine shipment will happen on the day after the vaccine is approved,” Slaoui told CBS News this week, according to The Hill.
“That’s how we planned it. If the vaccine is approved on the 10th or the 11th, the minute it’s approved, the shipments will start.”
Pfizer’s vaccine is not the only one making its way to the American people.
According to Fox News, a Dec. 17 FDA meeting is scheduled to consider a request from drug maker Moderna that its vaccine receive fast-track status.
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