The U.S. Food and Drug Administration on Friday authorized a COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the first COVID-19 vaccine to be approved in the U.S.
The emergency use authorization allows BNT162b2, the Pfizer-BioNTech COVID-19 vaccine, to be distributed in the U.S for people over the age of 16. It was found to be 95 percent effective at preventing symptomatic COVID-19 in clinical trials.
“Today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release.
An emergency use authorization means that the FDA has given the drug a special authorization to be used during an emergency period. Pfizer would have to file a separate application for its vaccine to be fully approved by the FDA. Meanwhile, researchers will continue to monitor the vaccine’s effectiveness in the real world.
FDA’s decision to issue an emergency use authorization for the vaccine comes after it faced pressure from the White House to authorize the vaccine. Chief of Staff Mark Meadows told Stephen Hahn, the commissioner of the FDA, to resign if the vaccine was not cleared by Friday, according to the Washington Post. The agency had originally planned to complete the authorization by Saturday.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said Hahn said in a statement. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.
On Thursday, FDA’s vaccine advisory committee had recommended the emergency use of the COVID-19 vaccine. The vaccine has already received a temporary authorization for emergency use in the U.K., Canada, and Bahrain.
Mexico’s health agency Cofepris has also approved Pfizer’s vaccine for emergency use, Deputy Health Minister Hugo Lopez-Gatell said at a press conference on Friday.
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