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News: A U.S. Food and Drug Administration panel voted 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 less than previously thought. Preliminary results in October found it reduced the risk of hospitalization or death by 50% when given to 755 high-risk, unvaccinated volunteers. Last week, this figure was reduced to 30% after receiving updated data from 1,433 patients. “The effectiveness of this product is not overwhelmingly good,” said panel member David Hardy.
Lack of consensus: Voting was very tight due to concerns about changes in the drug’s efficacy data, as well as concerns about its safety. James Hildreth, CEO and panel member of Meharry Medical College, said Voted “no” due to concerns that the use of molnupiravir could theoretically lead to new COVID-19 variants. Another panelists, however, argued that the overall risk was small enough to be voted on.
Who can get: If allowed, the drug would be prescribed to people at high risk of severe covid-19 to take it at home twice a day for five days. Tens of millions of Americans older or with underlying medical conditions will qualify and must start taking it within five days of symptoms appearing. The committee recommended strict restrictions on the use of molnupiravir in pregnant women due to concerns about potential adverse effects.
What’s next: In the coming weeks, the FDA will evaluate a similar Pfizer pill that appears to be significantly more effective than Merck and reduces the risk of hospitalization or death in the same patient groups by 89%. The hope is that these drugs can provide promising new weapons against covid in our arsenal, especially because they are easily stored and can be taken at home. The US government has already spent billions of dollars securing large stocks of both new pills.
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