Outside advisers to the U.S. Food and Drug Administration (FDA) on Tuesday narrowly voted to recommend the agency grant emergency use authorization (EUA) for a drug from Merck and Ridgeback Biotherapeutics to treat COVID-19, called molnupiravir. Members of the FDA’s Antimicrobial Drugs Advisory Committee voted 13 for and 10 against the EUA for molnupiravir, agreeing with the idea that the drug’s benefits outweigh its potential risks, including potential birth defects if used during pregnancy. While the FDA does not have to follow the advisers’ recommendation, it usually does. It will now consider the committee’s recommendation. The drug is intended for use at home by adults with mild to moderate COVID-19 who are at high risk of developing severe disease. The drug is taken orally in pill form, twice a day for five days, within five days of symptoms onset. Concerns of Triggering New Variants Molnupiravir works by causing errors in the SARS-CoV-2 coronavirus’s genetic code …
FDA Advisers Vote to Recommend Merck COVID-19 Pill for Emergency Use Authorization
November 30, 2021
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