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Headline Roundup December 9th, 2020

FDA to Meet to Consider Pfizer-BioNTech Emergency Coronavirus Vaccine Authorization

Summary from the AllSides News Team

The Food and Drug Administration (FDA) will meet Thursday to discuss emergency use authorization (EUA) for Pfizer and BioNTech's COVID-19 coronavirus vaccine. A vote could come after the advisory committee, the FDA and vaccine experts hear the companies' presentations and participate in a Q&A session. Some FDA officials and advisory committee members predicted the vaccines would receive approval since trial results show the vaccine to be 95% effective, which meets the FDA's required 50 percent. If approved, distribution is expected to start within 24 hours of authorization. This comes after the U.K. authorized the vaccine last week, and after Canada authorized the vaccine Tuesday. The committee is expected to meet once again on Dec. 17 to discuss Moderna's EUA application. Coverage from across the political spectrum tended to speculate about the likelihood of the vaccine receiving approval, as well as providing detailed description of how the vaccine was developed. Editor's Note: A earlier version of this story misspelled BioNTech. We regret the error.

Featured Coverage of this Story

FDA to meet on Pfizer's coronavirus vaccine EUA application: What to expect
FDA to meet on Pfizer's coronavirus vaccine EUA application: What to expect

Fox News Digital

News

On 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...

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Key committee meets Thursday to consider FDA authorization for Pfizer/BioNTech Covid-19 vaccine
News

There'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...

Open on CNN Digital
Head of FDA Advisory Panel Predicts Approval for Pfizer’s Covid-19 Vaccine
News

The 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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