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.

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• An FDA advisory committee will meet next month to discuss an emergency use authorization (EUA) for Pfizer's COVID-19 vaccine.
• Earlier this week, Pfizer said clinical trials had shown its vaccine to be 95% effective.
• "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.
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The US Food and Drug Administration will be hosting a meeting in just under three weeks to consider an emergency use authorization for Pfizer's COVID-19 vaccine, the agency announced Friday.

Earlier this week, the pharmaceutical giant revealed that its experimental vaccine is 95% effective at preventing transmission of the coronavirus, citing a clinical trial involving more than 43,000 people. Only mild side effects, such as fatigue and headache, were reported.

The company along with Germany's BioNTech said in a Friday announcement on Twitter that it submitted a request 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 "significant safety risks."

"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. "The risks and consequences of a rushed vaccine could be very severe if the review is anything shy of thorough."

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