Scientists' recommendations are not binding but often guide agency decisions.
A panel of US government experts recommended an experimental drug from the pharmaceutical company Merck against COVID-19 that could become the first pill authorized by the United States to treat the coronavirus.
The Food and Drug Administration (FDA) asked its outside experts whether it should authorize the pill, weighing new information that it is less effective than initially reported and may cause congenital disabilities. The panel's recommendations they are not binding, but they often guide FDA decisions.
Tuesday's meeting came as infections in the United States are on the rise again, and health authorities around the world are struggling to assess the threat posed by the new omicron variant of the coronavirus.
If licensed, the Merck pill would be the first to be taken at home. The drug, molnupiravir , is already approved for emergency use in the UK.
Given the ongoing threat of the pandemic, the FDA is expected to approve the emergency use of the Merck pill.
On Friday, Merck said the final results of the study showed that molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, compared to a 50% reduction that it first announced in October based on incomplete results.
A key question is whether the use of the drug should be restricted in pregnant women or women of childbearing age.
In their safety review, FDA staff said animal studies suggested that Merck's drug could cause congenital disabilities when given in high doses. As a result, regulators said they are considering a complete ban on the use of molnupiravir during pregnancy and other preventive measures, including recommending contraception for some patients taking the drug.
Merck's drug uses a novel approach to combat COVID-19: It inserts minor errors into the coronavirus genetic code to prevent the virus from reproducing. However, that genetic effect has raised concerns that the drug could cause mutations in human fetuses or even stimulate more virulent strains of the virus.
Another critical question is whether the drug should be offered to patients who have been vaccinated or who have previously had COVID-19. Merck did not study the drug in vaccinated people. Still, data from a handful of patients with previous infections suggested it had little benefit. The drug works best when given within five days of the first symptoms of COVID-19.