FDA to Meet to Consider Pfizer-BioNTech Emergency Coronavirus Vaccine Authorization
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From the Right
FDA to meet on Pfizer's coronavirus vaccine EUA application: What to expectOn Thursday the U.S. Food and Drug Administration (FDA) will meet to discuss Pfizer and BioNTech’s emergency use authorization application for its coronavirus vaccine candidate.
The companies were the first to submit their application for EUA to the FDA, with Moderna following suit shortly after.
The meeting will include members of the FDA’s Center for Biologics Evaluation and Research advisory committee, outside vaccine experts and Pfizer representatives and will begin at approximately 9 a.m., with opening remarks and introductions, according to a draft agenda published by the regulatory agency. Next...
From the Left
Key committee meets Thursday to consider FDA authorization for Pfizer/BioNTech Covid-19 vaccineThere's not much suspense going into Thursday's meeting of the US Food and Drug Administration's vaccine advisers, who will discuss emergency use authorization for Pfizer and BioNTech's coronavirus vaccine. The EUA is widely expected and has been telegraphed with unusual frankness from the top of the FDA on down. "Our team has done their initial analysis, and we do feel that preliminarily that the success criteria have been met," FDA Commissioner Dr. Stephen Hahn told CNN Tuesday. But the FDA has promised to listen to the advice of its Vaccines...
From the Center
Head of FDA Advisory Panel Predicts Approval for Pfizer’s Covid-19 VaccineThe leader of the advisory panel charged with evaluating the first Covid-19 vaccination to come before the U.S. Food and Drug Administration says the shot is very likely to obtain emergency-use authorization.
“I would predict the likelihood of approval is high,” said Arnold Monto, a University of Michigan health researcher who chairs the advisory committee. “We’re not at the borderline on efficacy,” he added, referring to data from the vaccine’s makers— Pfizer Inc. and Germany’s BioNTech SE—showing the shot is 95% effective at protecting against Covid-19, significantly higher than the...
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