‘NOT CONVINCED’

Merck COVID Pill Narrowly Endorsed by FDA Panel for High-Risk Adults

“The efficacy of this product is not overwhelmingly good,” one expert on the advisory panel said.

An expert advisory panel for the Food and Drug Administration on Tuesday narrowly voted to endorse the authorization of Merck’s COVID-19 oral pill for high-risk adults. The drug, known as molnupiravir, was recommended in a 13-10 vote after data were presented showing its “modest” effect on reducing hospitalization and death. The decision was made despite members of the panel going back and forth on the drug’s effectiveness, safety, and whether it could potentially aid the virus’ mutation capabilities. “I was not convinced that the potential benefit outweighed the risk,” said Dr. Pete Weina, the director of the Office of Research Protections at the Defense Health Agency.

A final study analysis showed that the pill reduced hospitalization and death by 30 percent, despite an interim clinical trial’s findings that molnupiravir cut the risk of both in half. A Merck executive said he didn’t “have a satisfying answer” on the discrepancy. It is also unknown what effect, if any, the pill has on the Omicron variant, although another executive said the company was “feverishly working” to determine that. The FDA panel ultimately recommended the pill be used only to treat older COVID patients or those with other medical conditions. “The efficacy of this product is not overwhelmingly good,” one panel member said. “I think we really have to be careful about saying this is the way to go.”