White House summons Head of the F.D.A to explain why the Pfitzer vaccine has not received approval

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Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, headed into the White House on Tuesday morning to meet with Mark Meadows, the chief of staff, who summoned Dr. Hahn to explain why regulators have not yet approved the emergency use of the coronavirus vaccine developed by Pfizer, according to people familiar with the situation.
Dr. Hahn prepared for the meeting by pulling data from the past few weeks showing how productive the F.D.A. has been, an administration official said.
One official said Mr. Meadows is concerned that the British government may approve emergency use of a coronavirus vaccine before American regulators act, potentially embarrassing the Trump administration. The meeting was reported earlier by Axios.
On Friday, the British government asked its drug regulator to consider AstraZeneca’s vaccine for emergency approval. The regulator, the Medicines and Healthcare products Regulatory Agency, had previously been conducting a rolling review of the vaccine. It is also reviewing Pfizer’s vaccine.
President Trump and Mr. Meadows have pressured the F.D.A. for months to speed up the development and approval of a vaccine, and allies of Dr. Hahn are worried that he could be fired if he fails to satisfy the White House demands.
Pfizer and its German partner, BioNTech, announced on Nov. 18 that clinical trial results showed its vaccine was 95 percent effective and had no serious side effects. It submitted an application for emergency use authorization to the F.D.A. two days later.
An F.D.A. spokesman said that government experts must now review “thousands of pages of technical information.” Among other matters, he said, they must analyze the effects of the vaccine on various groups of patients and Pfizer’s controls on the manufacturing process.
The agency’s outside advisory panel of experts is scheduled to meet on the Pfizer vaccine on Dec. 10. Unless the reviews uncover unexpected problems, the F.D.A. is expected to approve the Pfizer vaccine within days.
Credit: New York Times
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