The FDA has narrowly backed Merck’s covid pill—but it’s not that effective
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 high-risk covid-19 patients. 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 high-risk, unvaccinated volunteers. Last week, after receiving 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 vote was so tight 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” due to worries 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 people at high risk of severe covid-19 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, due to concerns about the potential side effects.
What’s next: In the coming weeks, the FDA will assess a similar pill from Pfizer which seems to be significantly more effective than Merck’s, reducing the risk of hospitalization or death within the same patient groups by 89%. The hope is that these drugs could provide promising new weapons in our arsenal against covid, especially as they are easily stored and can be taken at home. The US government has already spent billions of dollars to secure large supplies of both new pills.