Merck Molnupiravir Advisory Committee To Consider Pregnancy Risk, Viral Mutations
US FDA seems poised to authorize the oral COVID treatment, but panel discussion will likely highlight the limitations of the antiviral.
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Authorized for mild-to-moderate COVID-19 in patients 12 and older at high risk for severe disease, Paxlovid (nirmatrelvir/ritonavir) jumped ahead of Merck & Co./Ridgeback’s molnupiravir in the EUA queue for oral antivirals, with the latter possibly hung up by efficacy and safety concerns.
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.
While news of a potentially highly transmissible new variant is causing alarm, Pfizer/BioNTech and Moderna are already pursuing a multi-pronged response to B.1.1.529.