Merck and Ridgeback Therapeutics Inc.’s experimental oral antiviral treatment is being heralded as a pill with major upside potential in the fight against the COVID-19 pandemic.
On Monday, Merck said it filed an application with the Food and Drug Administration seeking emergency use approval of the drug. Given the stakes in the ongoing fight against the virus, Merck has said it is trying to move as quickly as possible to make the treatment available in the U.S. and elsewhere.
But even as experts inside and outside the FDA start combing through data on the drug, molnupiravir, which was shown to halve the risk of death or hospitalization in 775 “at-risk” adults, some say there’s a potential downside worth acknowledging about the drug.
Merck and Ridgeback Therapeutics announced the results on Oct. 1.
The widespread availability of a pill that may prevent the worst outcomes of a COVID-19 infection could make some vaccine holdouts stick to their position of refusing the shot, they say.
“It certainly is likely that some people will take, if you will, refuge that should they become infected, a pill might be available that could help them avert serious disease,” Dr. William Schaffner, a professor at Vanderbilt University Medical Center’s Infectious Diseases Division, said earlier this month, on the day Merck unveiled its results.
“We are seeing this happen already with monoclonal antibody treatments,” he said. The treatments, administered intravenously and subcutaneously, in some instances, are meant for people with mild to moderate COVID-19 cases who are at high risk for severe disease. The fact that those treatments exist may have given some people who are vaccine hesitant the idea that they don’t necessarily need the vaccine, he said.
90% excited, 10% concerned
All told, the prospect of having molnupiravir in the anti-pandemic arsenal leaves Schaffner “90% excited” but “10% concerned” due to the people who might rely on the drug instead of the vaccine. “It’s not a magic pill,” he said.
The pill could be a way to both help patients and relieve health care providers through an easy-to-distribute, easy-to-administer pill. “All that’s wonderful, but it doesn’t take the place of the vaccine,” he said.
An investor note from RBC Capital Markets the same day Merck released the initial results earlier this month called the molnupiravir data “impressive” and said the drug “could help alter the course of the pandemic.”
Yet it echoed Schaffner’s concern on one point.
Though the option of having an effective oral drug could decrease the use of “more dubious therapies” among at-risk and unvaccinated people, “we acknowledge that availability of these therapies could dissuade vaccination and booster shots,” the note said.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, Merck’s CEO and president, said Monday in a statement.
Davis also credited colleagues “in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19 — medicines and vaccines are both essential to our collective efforts.
Merck MRK did not respond to a MarketWatch request for comment.
News of the molnupiravir results come as vaccination mandates take a bigger role in American lives and workplaces, turning up the pressure on people who haven’t received their shots yet.
The Biden administration is working on rules requiring private sector employers with at least 100 employees to either have their staff vaccinated or face regular testing. Meanwhile, hospitals, long-term care providers and even high-profile employers like United Airlines
are getting ready to fire hold-out workers.
The same day of the Merck/Ridgeback Therapeutics announcement, California announced the country’s first statewide vaccination mandate for public and private school children.
Just over 20% of America’s adult population still has not received one dose of the vaccine, according to the U.S. Centers for Disease Control and Prevention. As of Saturday, 78.2% of the country’s adult population had received at least one shot.
There “absolutely” will be people who opt for antiviral pills instead of the vaccine, according to Dr. Gregory Poland, a professor of medicine and infectious diseases at the Mayo Clinic.
“Americans, in general, will take about any magic pill, but not a vaccine” that’s been studied to a much more intensive degree, he said in an interview earlier this month.
The dynamic already plays out every year during flu season when people who don’t have their flu shot look for something like Tamiflu to help them, said Poland, who is also the director of the Mayo Clinic’s Vaccine Research Group.
But even assuming the FDA authorizes molnupiravir, that will take time — and workplace mandates and other pressures might further shrink the share of unvaccinated individuals in that period, he said.
It might also be too expensive for people to buy the drug instead of going for the vaccine, which is free, he added. America has ordered 1.7 million treatment courses of the drug already, priced at about $705 for every five-day treatment course, although that price isn’t necessarily the out-of-pocket cost that patients would pay.
On Monday, the drugmaker said it “expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022.
Like Schaffner, Poland sees the announcement as good news. “I think the more tools in the tool kit, the better,” he said. Still, he added, “anybody who thinks this is the answer to coronavirus is sadly mistaken. This virus has more to teach us than we have possibly begun to scratch the surface of,” he said.
Merck shares were up more than 3% since the start of the year. In that same time, the Dow Jones Industrial Average
was up approximately 13.5%, and the S&P 500
was up nearly 17%.
This story was updated on Oct. 11.