The US Food and Drug Administration said Friday it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Dec. 10.
The companies submitted their application for an EUA earlier Friday. It’s the first application for an FDA regulatory OK for a coronavirus vaccine.
"The FDA recognizes that transparency and dialogue are critical for the public to have confidence in Covid-19 vaccines. I want to assure the American people that the FDA's process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible," FDA Commissioner Dr. Stephen Hahn said in a statement.
"The FDA has been preparing for the review of EUAs for Covid-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted. While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”
The FDA is supposed to post the VRBPAC meeting schedule in the Federal Register at least two weeks ahead of time. The agency has promised to fully consider input from the committee, which is made up of vaccine experts and others with no ties to the companies submitting vaccines for FDA approval or authorization.
“A discussion about the safety and effectiveness of Pfizer and BioNTech's vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of Covid-19,” Hahn said.
The FDA said it will livestream the VRBPAC meeting on the agency's YouTube, Facebook and Twitter channels and from the FDA website.
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November 21, 2020 at 08:12PM
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