FDA advisory committee to discuss emergency authorization for Pfizer's COVID-19 vaccine - Business Insider

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FDA advisory committee to discuss emergency authorization for Pfizer's COVID-19 vaccine

A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.An FDA advisory committee will meet next month to discuss an emergency use authorization for Pfizer's COVID-19 vaccine."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," FDA Commissioner Stephen M. Hahn said.

to the FDA for emergency authorization for the vaccine. If obtained, as many as 20 million Americans could be immunized by the end of the year, per US officials. The meeting, on Dec. 10, will not decide whether or not Pfizer gets that approval. But the FDA's vaccine advisory committee will discuss the matter and provide recommendations to the agency, which will make the final call.

"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," FDA Commissioner Stephen M. Hahn said. Some experts have argued against an emergency authorization of any vaccine. In October, the Emergency Care Research Institute warned that releasing a vaccine without six months of follow-up data on clinical trial participants could pose ""Complete clinical trial information and careful consideration of the limitations of available data are essential to ensuring the safety and effectiveness of a COVID-19 vaccine," ECRI President Marcus Schabacker said.

 

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