A US Food and Drug Administration panel voted 13 to 10 to recommend that the government authorize the pill for patients with early covid-19 who are at high risk for severe infections. molnupiravir has been shown to reduce the risk of hospitalization and death by less than previously thought. 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. The figure was reduced to 30% last week with updated data from 1,433 patients. Panel member David Hardy said that the product's efficacy was not good.
The vote was close due to concerns over the drug's efficacy data and also over its safety. James Hildreth, the CEO of Meharry Medical College, voted no because he was worried that the use of molnupiravir could lead to new covid-19 variant. The risk was small enough to vote it through, argued other panelists.
If it is approved, 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 would need to begin taking it within five days of symptoms appearing. Concerns about the potential side effects of molnupiravir should lead to tight restrictions on its use in pregnant women.
In the coming weeks, the FDA will assess a pill from Pfizer that seems to be significantly more effective than the one from Merck, reducing the risk of hospitalization or death within the same patient groups by 89%. The hope is that these drugs will provide new weapons in our arsenal against covid, because they are easy to take at home. The US government has spent billions of dollars to get large supplies of both new pills.
