US FDA clears Pfizer Covid-19 vaccine; millions of doses to be shipped right away

The Food and Drug Administration authorised Pfizer’s Covid-19 vaccine for emergency use Friday, according to two people with knowledge of the decision who spoke on condition of anonymity because they were not authorised to discuss it. The action means millions of highly vulnerable people will begin receiving the vaccine within days.

The authorisation is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.

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The FDA’s action followed an extraordinary sequence of events Friday morning in which the White House chief of staff, Mark Meadows, told the FDA commissioner, Dr. Stephen Hahn, to consider looking for his next job if he didn’t get the emergency approval done Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter. 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 3 million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.

Pfizer has a deal with the US government to supply 100 million doses of the vaccine by March. Under that agreement, the shots will be free to the public.

Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals: in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies.

The decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95% effective.