FDA advisory committee to discuss emergency authorization for Pfizer's COVID-19 vaccine
FDAadvisory 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.
"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."Have a news tip? Email this reporter: firstname.lastname@example.org
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