The New York Times reports three sources say the US Food and Drug Administration has approved but not yet formally announced emergency use of Pfizer’s vaccine for Covid-19. This comes after interference from the White House may cause some skepticism about the decision.

The action followed an extraordinary sequence of events on Friday morning when the White House chief of staff, Mark Meadows, told the F.D.A. commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. Dr. Hahn then ordered vaccine regulators at the agency to do it by the end of the day.

The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.

On Thursday, a panel of outside experts voted to approve the use of the vaccine, something that usually, but not always, leads the FDA to approve a medication. The US joins Canada, Britain, Mexico, Saudi Arabia, and Bahrain in beginning vaccinations.

Nearly 3 million doses are expected to go out over the next week. Pfizer has a contract to supply 100 million doses to the US government.  The vaccinations, which will require two shots three weeks apart, will be free to the public.

A similar vaccine, developed by Moderna, is also under review by the F.D.A. and could soon be cleared for emergency use. On Friday, the federal government announced it had ordered another 100 million doses from Moderna, adding to a deal this summer for an initial supply of 100 million doses. Other vaccines, including ones developed by Johnson & Johnson and AstraZeneca, are in late-stage trials and could be authorized in the next few months

  • December 12, 2020