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Pfizer and BioNTech announce FDA submission for Emergency Use Authorization

Posted on: Nov 22, 2020

On Friday, Pfizer and BioNTech announced their submission to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for their vaccine candidate. The companies are also submitting applications with several other regulatory agencies around the world. 

The FDA said it has scheduled to meet with Pfizer and BioNTech on December 10. It will be a public meeting, and FDA career scientists and members of the independent advisory board will ask Pfizer questions about its product, then the advisory board will make its recommendation to the FDA. 

The FDA in its press release on Friday stated:

“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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. 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.”

The companies stated they will be prepared to distribute the vaccine candidate within hours of FDA authorization.