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The U.S. Food and Drug Administration said on Friday that it has scheduled a meeting of its external advisory committee to discuss Pfizer and BioNTech’s application for emergency use authorization for a coronavirus vaccine.
The Advisory Committee on Vaccines and Related Biological Products (VRBPAC) will meet on 10 December.
The companies submitted their application for an EUA on Friday earlier. It’s the first question for an FDA regulatory OK for a coronavirus vaccine.
“The FDA recognizes that transparency and dialogue are critical for the public to trust Covid-19 vaccines. I want to assure the American people that the FDA process and data evaluation for a potential Covid-19 vaccine will be open and transparent on as much as possible, “FDA Commissioner Dr. Stephen Hahn said in a statement.
“The FDA has been preparing for the EUA review for Covid-19 vaccines for several months and is ready to do so as soon as an EUA application is made. While we cannot predict how long the FDA review will take, the FDA will review the request as quickly as possible, while continuing to do so comprehensively and scientifically so that we can help make available a vaccine that the American people deserve as soon as possible.
The FDA is expected to publish the VRBPAC meeting schedule in the federal registry at least two weeks ahead of time. The agency has promised to fully consider the contribution of the committee, which is composed of vaccine experts and others with no ties to the companies that submit vaccines for FDA approval or clearance.
“A discussion on the safety and efficacy of the Pfizer and BioNTech vaccine with this committee, made up of external scientific and public health experts from across the country, will help ensure clear public understanding of the scientific data and information that the FDA will consider in order to make a decision on whether to authorize a vaccine for emergency use for the prevention of Covid-19, “said Hahn.
The FDA said it will stream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels and from the FDA’s website.
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