- An FDA panel has voted to authorize the antiviral pill made by Merck and Ridgeback Biotherapeutics.
- Data has shown that the pill is modestly effective at reducing risk of hospitalization and death from COVID-19.
- The panel voted that the pill should only be given to people with symptomatic infections and people who have a high risk of developing severe symptoms.
In a narrow vote, a key advisory panel for the Food and Drug Administration (FDA)
The FDA’s Antimicrobial Drugs Advisory Committee voted 13-to-10 to allow the drug, called molnupiravir, to be prescribed to people with symptomatic COVID-19.
The FDA does not need to follow the panel’s recommendation, but it generally does.
The close vote reflected data that showed only modest improvement in people with COVID-19 who took the drug.
The panel recommended the drug should only be given to people who have a high risk of severe disease after they test positive and show symptoms of the coronavirus.
The vote comes days after the new Omicron variant was detected, which has led experts to worry another global viral surge might arrive soon.
David Eastmond, PhD, professor emeritus at the department of molecular, cell, and systems biology at the University of California, Riverside, voted in favor of authorizing the antiviral pill.
“I feel like the potential… benefits outweigh the risks in this case,” he said in the meeting after the vote. “I think the FDA should not approve it for the use in pregnant women except in exceptional circumstances. They should limit the drug to high risk individuals.”
Dr. Sankar Swaminathan, chief of the division of infectious diseases at the University of Utah School of Medicine, voted against authorizing the drug.
“I felt the overall absolute effect in the trial population was modest at best,” he said in the meeting after the vote.
Swaminathan also explained that the potential birth defect risk had not been adequately studied for pregnant people.
If the FDA signs off on the drug, it would be the first oral antiviral treatment for COVID-19 approved in the United States, and could be available to patients within weeks.
Pfizer, Inc. is seeking FDA emergency authorization of its COVID-19 antiviral treatment, called Paxlovid. Preliminary data showed this drug is significantly more effective than Merck’s.
Both pills could be prescribed by a doctor and taken at home, which would provide another way to reduce hospitalizations and deaths caused by the coronavirus.
After a daylong
This would include older adults and those with other
Clinical trial data presented at Tuesday’s meeting showed that the drug reduced the risk of hospitalization or death in high-risk unvaccinated volunteers by
Among people who received the drug, 6.8 percent ended up in the hospital or died, compared to 9.7 percent of those who got an inactive placebo.
Preliminary data released last month by Pfizer showed that its antiviral drug reduced the risk of hospitalization or death in high-risk adults with COVID-19 by about 89 percent. This data has not yet been reviewed by the FDA.
The Pfizer antiviral must be taken with another medication, ritonavir, which interacts with many other medications, vitamins, and nutritional supplements.
Given the modest effectiveness of Merck’s drug, several FDA panel members recommended it be used only in high-risk unvaccinated people, or in people who had a suboptimal response to vaccination, such as older adults and the immunocompromised.
Dr. Mohammad Sobhanie, an infectious disease expert at The Ohio State University Wexner Medical Center, who’s not a member of the FDA panel, said that as COVID-19 cases pick up in the United States, and with the appearance of the Omicron variant, it’s good to have additional medications to treat COVID-19.
“I do think there may be a role for molnupiravir, but that really has to be judged on a case-by-case basis,” he said. “And I think that’s what the [panel’s] vote reflects.”
Merck’s drug is taken twice a day for 5 days — for a total of 40 pills. Treatment would need to be started within 5 days of the onset of symptoms.
This short window could limit the drug’s benefit. People would need to test positive for the coronavirus and obtain a prescription from a physician before picking up the pills at a pharmacy.
Turnaround times for COVID-19 tests still vary throughout the country, with people in certain areas having to wait 5 days or more for test results.
Many Americans also don’t have a regular doctor who can write them prescriptions.
Sobhanie said part of the physician’s job is to help people weigh the risks and benefits of medications such as Merck’s antiviral pill, so “if you don’t have a primary care physician, now is a great time to get one.”
In addition, a recent poll by Morning Consult found that about half of unvaccinated adults — who are at higher risk of developing severe COVID-19 — said they would not take an FDA-authorized antiviral pill if they got sick.
Merck’s drug works by causing errors in the coronavirus’ genome, which prevents the virus from replicating.
Several members of the FDA advisory panel raised concerns that the drug could, in theory, trigger mutations in the genetic material of people’s cells. These kinds of changes to DNA could potentially lead to birth defects, damage to sperm, or a long-term cancer risk.
“The overall risk of mutagenicity in humans is considered low,” Dr. Aimee Hodowanec, a senior medical officer at the FDA said at the meeting, referring to the possibility that the drug could cause mutations in the DNA of people taking it.
This assessment was based on laboratory tests and clinical trial data from Merck showing that the drug is safe, as well as the short-term use of the drug.
Some members of the FDA panel said because of the possibility of birth defects, the drug should not in general be given to pregnant people.
However, others pointed out that the
“I don’t think you can ethically say it’s OK to give this drug in pregnancy, obviously,” Dr. Janet Cragan of the CDC said during the meeting. “But at the same time, I’m not sure you can ethically tell a pregnant woman who has COVID-19 that she can’t have the drug if she’s decided that’s what she needs.”
Several FDA panel members recommended that women undergo pregnancy testing before being prescribed the drug, and that someone who’s pregnant speak with a qualified physician to discuss their individual risks and benefits.
The United Kingdom, which authorized Merck’s pill in early November, recommends against its use in pregnant or breastfeeding women. Women who could become pregnant are also advised to use contraception for 4 days after their last dose of the drug.
Sobhanie said although antivirals can help keep people with COVID-19 out of the hospital, vaccines are also a key tool in the fight against the coronavirus — one that we have more data on the safety and effectiveness.
“We know that vaccines work. We know they protect people from severe illness. We know they protect from hospitalization,” he said. “If you’re not vaccinated, get vaccinated. If you’re eligible for boosters, get boosted.”