An independent panel of health experts formed by the U.S. government recommended on Tuesday that an oral treatment developed by Merck for COVID-19 be granted emergency use authorization under specific conditions and for individuals at high health risk. The committee voted in favor of granting emergency use authorization for the drug by a majority of 13 members to 10, reflecting recent concerns over a decline in the drug's effectiveness and increasing worries about its potential risks. This committee's opinion is advisory, and the final decision on whether to grant authorization rests with the U.S. Food and Drug Administration (FDA).
Many people are eagerly waiting for the authorization of Merck's antiviral treatment called "molnupiravir," as it consists of pills that can be taken easily at home without the need to go to the hospital during the first five days after symptoms of COVID-19 appear. Committee member David Hardy, who voted in favor of the authorization, stated, "This is the first opportunity that allows for oral treatment" taken by patients outside the hospital for mild to moderate disease symptoms.
However, many experts, including those who voted to allow the use of this treatment, acknowledged that the decision was "difficult." Experts particularly expressed concerns regarding the drug's effectiveness in preventing hospitalization or death, with its effectiveness dropping to only 30% according to data published Friday, which considered the total number of participants in the clinical trials for the drug. The initial effectiveness of the drug, based on data from only a portion of those who participated in the clinical trial, was reported at 50%.
Experts are also worried that this treatment might lead to the emergence of undesirable viral mutations, resulting in new variants due to the technique that Merck used to develop the drug. Committee member Sankar Swaminathan justified his vote against the authorization, stating, "I consider the overall impact (of the treatment) on the total number who received it to be modest at best," expressing concern that the available data did not specifically address "the risks associated with mutagenic effects."
Several experts also indicated that pregnant women should avoid this treatment or, at the very least, prefer other treatments such as monoclonal antibodies when available. During the animal trials, there appeared to be an increased incidence of congenital birth defects in animals that were administered this treatment.
