A US government-appointed panel of health experts voted Tuesday to endorse Merck’s anticovid pill for high-risk adult patients who are within five days of first experiencing symptoms.
The vote, which took place during a day of discussions broadcast live, was close, with 13 votes in favor and 10 against. The recommendation of this panel is advisory and the final decision rests with the US drug agency FDA.
Merck’s antiviral treatment, molnupiravir, was highly anticipated because it is easy to administer – just take one pill at home within five days of COVID-19 symptoms onset.
“This is the first opportunity that an oral treatment is available” outside the hospital for mild to moderate cases of the disease, remarked David Hardy, a member of the committee that spoke in favor of the emergency authorization.
However, several experts, including those who voted in favor of allowing the treatment, called the decision “difficult.”
They were particularly concerned that its effectiveness has dropped to 30% against hospitalizations and deaths, according to documents released Friday, taking the total number of participants in the clinical trial.
Preliminary results from only a portion of the participants initially suggested 50% effectiveness.
Experts have also raised concerns about the possibility that the treatment could introduce new unwanted mutations of the virus, creating new variants, as a result of the technology Merck uses.
“I think the overall effect (of treatment) on the total trial population is modest at best,” cautioned committee member Sankar Swaminathan, explaining his vote against the recommendation.
“The risk of mutagenic effects … is not firmly established or characterized,” he added.
Many experts have also considered that pregnant women should avoid taking this treatment, or at least favor others such as synthetic antibodies when available.
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