The news: A US Food and Drug Administration panel has voted by 13 to 10 to recommend that the government authorize Merck’s antiviral pill for patients with early covid-19 who are at high risk for severe infection. The drug, called molnupiravir, has been shown to reduce the risk of hospitalization and death, although by less than previously thought. Initial results in October found it cut the risk of hospitalization or death by 50% when given to 755 unvaccinated volunteers who were mildly to moderately ill with covid-19 and had at least one risk factor for severe illness. Last week, with updated data from 1,433 patients, that figure was cut to 30%. “The efficacy of this product is not overwhelmingly good,” said panel member David Hardy.
Lacking consensus: The closeness of the vote was due to concerns over the change in the drug’s efficacy data, but also over its safety. James Hildreth, CEO of Meharry Medical College and one of the panel members, said he voted no because he worried that the use of molnupiravir could, theoretically, lead to new covid-19 variants. Other panelists, though, argued that the overall risk was small enough to vote it through.
Who can take it: If it’s authorized, the drug will be prescribed to high-risk people who have begun experiencing symptoms to take twice a day at home for five days. Tens of millions of Americans who are older or have underlying medical conditions would qualify, and they’d need to begin taking it within five days of symptoms appearing. The committee recommended tight restrictions on molnupiravir’s use in pregnant women, given concerns about the potential side effects.
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