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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowFederal regulators authorized a second pill to treat covid-19 Thursday, adding another at-home treatment option to help keep high-risk people out of the hospital.
Doctors have clamored for easy-to-use medications throughout the pandemic, but the new drug, molnupiravir, has had an uneasy reception because of its modest efficacy and potential safety risks. Some experts say another tool will be helpful as the omicron variant, which is resistant to other key treatments, surges. But others say they would be hesitant to use the drug.
Molnupiravir, developed by Merck and Ridgeback Biotherapeutics, cut the risk of hospitalization and death in high-risk patients by 30%. In contrast, Pfizer’s antiviral drug, authorized a day earlier, reduced hospitalizations and death by nearly 90%.
Molnupiravir is authorized for people 18 and older who are at high risk of covid-19 but is not recommended for use during pregnancy. Men and women of childbearing potential are recommended to use birth control, with men recommended to use birth control for three months after the last dose. The drug carries additional safety risks because it works by introducing mutations to the virus – and some experts fear it will fuel the rise of new variants or could cause mutations in people who take it.
“While 30% is definitely less than 88% [for Pfizer], this is still better than 0%,” said David Boulware, an infectious-diseases physician at the University of Minnesota Medical School. “Due to safety concerns, pregnant women as well as men or women who are trying to conceive should not receive molnupiravir.”
Other experts questioned the modest benefit and worried that it could lead to the emergence of future variants.
“Someone taking that drug is cheating themselves out of the opportunity to take a better, more effective drug,” said Michael Z. Lin, a biochemist at Stanford Medicine who has been working on a different type of antiviral drug. “Approval of Merck’s drug would be the worst decision in FDA history. . . . It’s almost certainly going to create viral variants that escape.”
Molnupiravir has been authorized in the United Kingdom, but France canceled its order for the drug this week.
But molnupiravir may be the most plentiful option as cases soar, driven by the omicron variant. In a coronavirus task force briefing Wednesday, Jeffrey Zients, the White House coronavirus response coordinator, said that by the end of January, the government expects to ship 3 million treatment courses to the states. Pfizer’s production is expected to ramp up more slowly.
The federal government will allocate doses to states, which will then decide how the pills should be distributed and prioritized, said Tom Kraus, vice president of government relations at the American Society of Health-System Pharmacists.
Kraus noted that consumer and physician preference played a role in vaccines, and he expected that patients would have a preference for one drug. But, as with the initial vaccine rollout, demand will likely outstrip supply, causing shortages and a lack of choices.
“At the end of the day, omicron is racing across the country. It seems like the federal government needs to be doing everything they can do to rapidly bring supply online,” Kraus said. “The existence of these drugs is unequivocally a reason to be positive. It is absolutely another substantial arrow in the quiver, to fight this pandemic.”
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