An advisory panel for the U.S. Food and Drug Administration (FDA) recommended Merck’s antiviral COVID-19 pill for use in adults who are at a high risk of contracting the virus, although the panel did not all agree on the decision.
As reported by The New York Times:
The drug, known as molnupiravir, has been shown to modestly reduce the risk of hospitalization and death, predominantly from the Delta, Mu and Gamma variants. The expert panel recommended it for Covid patients who are older or have medical conditions that make them vulnerable to severe illness. The pill could be authorized in the United States within days, and available by year’s end.
CNBC noted, “The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir,” adding that it is an 800-milligram pill intended to be “taken every 12 hours for five days after symptom onset.”
“Merck originally said the drug was more than 50% effective in preventing hospitalizations and death, but a more full set of data presented to the FDA on Tuesday noted the drug is just 30% effective,” the outlet added.
Members who did not vote in favor of endorsing the treatment said the aid of the pill was “modest,” and also cited worries about safety due to the experiments. “The treatment works by inserting errors into the virus’s genes. Some scientists say there is a theoretical risk that it could trigger mutations in cells as well, potentially causing reproductive harm or a long-term risk of cancer,” the Times reported.
“I was not convinced that the potential benefit outweighed risk,” Dr. Peter Weina, the director of the Office of Research Protections at the Defense Health Agency, said, per the Times.
Merck and the FDA noted that women who are pregnant should not get the pill. Kids and pregnant women were not included in the treatment’s clinical trials.
CNBC added, “Molnupiravir was found to be lethal to embryos in pregnant rats, also causing birth defects and reducing fetal body weight. It also caused other defects that interfered with bone growth in young pups, along with other abnormalities, the data shows.”
Concern over the drug potentially prompting COVID to mutate in less treatable ways was present.
“Even if the probability is very low, 1 in 10,000 or 100,000, that this drug would induce an escape mutant from which the vaccines we have do not cover, that could be catastrophic for the whole world actually,” Dr. James Hildreth, CEO of Meharry Medical College in Nashville, Tennessee, reportedly said to the panel.
While the advisory panel is not the final say in approval, the FDA typically goes in favor of their recommendations. The U.S. Centers for Disease Control and Prevention would also need to approve the pill.
CNBC also noted:
Robert Heflich, director of the FDA’s genetic and molecular toxicology division, said the risk of molnupiravir altering human genes in a clinical setting is low, given that the drug clearly was not mutagenic during a study in rodents. That study showed no increased mutation frequency in the liver or bone marrow of rodents, according to Merck.
However, the study was conducted as a follow-up to a previous investigation using rodents that was inconclusive about whether molnupiravir is mutagenic. Molnupiravir was found to be mutagenic during in vitro investigations using bacteria and hamster cells.
The data on whether molnupiravir is associated with gene mutation was a source of contention during the public comment portion of the meeting. Some experts and members of the public expressed concern that a single study was the basis for the conclusion about potential human risk. However, FDA experts said they believe the risk of gene mutation is low given molnupiravir’s short five-day treatment period.
The FDA could also move to approve a pill from Pfizer that acts in a similar way, called Paxlovid.
As reported by NPR, “Both molnupiravir and Paxlovid are a series of pills that are taken twice daily for five days. Paxlovid is taken with an additional booster pill of ritonavir, a drug that helps keep the drug active in the body for longer.”
The news come after the new Omicron variant stressed global markets over the weekend, and led to President Biden shutting down travel from several South African countries.