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Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

 
• By Brenda Sandburg

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

Molnupiravir
US FDA advisory committee favors FDA authorization of Merck's molnupiravir • Source: Alamy

A slim majority of US Food and Drug Administration advisory committee members concluded that Merck & Co., Inc.’s molnupiravir showed sufficient efficacy in reducing hospitalizations and deaths in those with mild to moderate COVID-19 to outweigh potential risks. But many expressed reluctance in making this call and recommended that the company conduct additional studies, including in the vaccinated and immunocompromised.

At its 30 November meeting, the Antimicrobial Drugs Advisory Committee voted 13-10 that the known and potential benefits of molnupiravir...

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