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According to people familiar with the matter, White House Chief of Staff Mark Meadows said that if the US Food and Drug Administration (FDA) does not approve Pfizer’s new crown vaccine as soon as possible , Director Stephen Hahn may not be guaranteed.The call between Meadows and Hahn on Friday was to pressure the FDA to quickly approve the vaccine.
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According to a media report, Meadows told Hahn that if the Pfizer vaccine cannot be licensed for emergency use on Friday, Hahn should resign. Hahn denied the content of the report.
Hahn said, “The report on the call with Meadows is not true. The FDA is encouraged to continue to efficiently process” the Pfizer-BioNTech vaccine emergency use authorization request. The FDA is committed to issuing this authorization as soon as possible, as we mentioned in our statement this morning. “
The FDA advisory panel voted 17-4 with 1 abstention on Thursday, agreeing to approve the vaccine’s authorization, believing that the vaccine has more advantages than disadvantages for people 16 and older.
Trump and his administration have exerted tremendous political pressure on the vaccine, and Canada and the United Kingdom have approved the vaccine. Trump said Friday that the FDA was still a big, old, slow turtle, and demanded that Hahn “immediately approve this damn vaccine.”
The Pfizer vaccine is expected to immediately obtain an emergency use permit, followed by an unprecedented mass vaccination in the United States. Official FDA approval will promote national distribution of vaccines, initially providing 2.9 million doses of vaccines to states.
US Secretary of Health and Human Services Alex Azar said in an interview Friday that Americans can begin getting vaccinated next Monday.
Checking for side effects
Senior US health officials said that in preparing to approve the emergency use of the Pfizer vaccine, the FDA is reviewing recent reports of allergic reactions caused by the new corona vaccine.
Before approving a product for public use, the last thing the FDA needs to do is make sure the instructions for doctors and patients on the drug’s label include the latest information about who should use it and how.
In recent days, there have been reports that vaccinators in the UK have had a severe allergic reaction to the vaccine. The British National Health Service (NHS) stated that people with a history of severe allergies should not receive the vaccine. Marion Gruber, director of the Office of Vaccine Research and Review, told the agency’s advisory board on Thursday that the FDA is seeking more information on vaccine allergies from British authorities.
As of Friday, the new corona virus has killed more than 292,000 Americans and more than 15.6 million confirmed cases. After the Thanksgiving holiday, the surge in new cases put enormous pressure on hospitals across the country.
Pfizer declined to comment.