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WASHINGTON (NYTIMES, AFP) – The U.S. Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday (Dec. 11), according to two people with knowledge of the decision who spoke on condition anonymity because they were not authorized to discuss it.
The action means that millions of highly vulnerable people will begin receiving the vaccine within days.
The authorization is a historic turning point in a pandemic that has claimed more than 290,000 lives in the United States.
With the decision, the US becomes the sixth country, in addition to Great Britain, Bahrain, Canada, Saudi Arabia and Mexico, to approve the vaccine. Other authorizations, including from the European Union, are expected in a few weeks.
President Donald Trump said the United States would begin administering the vaccine “in less than 24 hours.”
“Through our partnership with FedEx and UPS, we have already started shipping the vaccine to every state and zip code in the country,” he said, adding that governors would decide who would get the vaccines first in their states.
“We want our seniors, healthcare workers and first responders to be first in line,” Trump said. “This will quickly and dramatically reduce deaths and hospitalizations.”
The FDA action followed an extraordinary sequence of events Friday morning in which White House Chief of Staff Mark Meadows told FDA Commissioner Stephen Hahn to consider seeking his next job if it was not getting emergency approval on Friday, according to a senior administration official who spoke on condition of anonymity because he was not authorized to discuss the matter.
Then Dr. Hahn ordered the agency’s vaccine regulators to do so at the end of the day.
The authorization triggered a complicated coordinating effort by Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to obtain the first week’s batch of approximately three million doses for the healthcare workers and nursing home residents as soon as possible, all while keeping the vaccine at ultra-cold temperatures.
Pfizer has an agreement with the United States government to supply 100 million doses of the vaccine by March. Under that agreement, the shots will be free to the public. All states, along with six major cities, have submitted to the federal government a list of locations, mostly hospitals, where the Pfizer vaccine will initially be shipped.
In populous Florida, the first beneficiaries will be five hospitals: in Jacksonville, Miami, Orlando, Tampa and Hollywood.
In small, rural Vermont, only the University of Vermont Medical Center and a state warehouse will receive supplies.
The decision is a victory for Pfizer and its German partner BioNTech, which began work on the vaccine 11 months ago. Vaccines often take years to develop. The companies’ late-stage clinical trial, involving nearly 44,000 people, was found to be 95% effective.
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