Pharmaceutical giant Merck announced Monday that it had submitted an application to the Food and Drug Administration for its new antiviral COVID-19 pill, which many experts believe could become a potent tool in the ongoing battle against the coronavirus.
The pill, known as Molnupiravir, has the potential to reduce COVID hospitalizations and deaths by half if given to patients in the early stages of infection, according to Merck’s clinical data. If approved by the FDA, Molnupiravir would be the first effective COVID treatment to be made available in pill form.
Over the course of the pandemic, scientists have developed formidable methods for preventing COVID cases and deaths — each with benefits and shortcomings. The vaccines are extremely effective at stopping severe infections, but not everyone is willing or able to get them. Treatments like monoclonal antibodies can keep mild cases from getting worse, but they are expensive, are limited in supply and can only be administered intravenously by a medical professional.
Molnupiravir, on the other hand, is relatively cheap, can be manufactured quickly and can be taken by patients without a visit to a hospital or doctor’s office. The U.S. government has already invested $1.2 billion in purchasing 1.7 million doses of the new drug, and other countries have also raced to lock up supplies in anticipation that the drug will soon be approved.
Why there’s debate
The impending availability of molnupiravir represents a “great hope for the future,” one physician and COVID researcher told Yahoo News. Optimistic experts say a readily available, easy-to-administer pill could be a critical element to keep hospitals from becoming overwhelmed and ultimately end the pandemic in the U.S. for good. Others say oral antiviral drugs could have a substantial impact in poor countries that have struggled to get vaccines and may not have the infrastructure or money for other COVID treatments.
For all its promise, molnupiravir should not be viewed as a silver bullet for solving the pandemic, public health officials say. Stopping infections in the first place through vaccinations, they say, will always be more effective than any treatment that comes after someone gets sick. There are also concerns that the U.S. doesn’t have the testing capacity to identify COVID-positive people early in the course of their infections, since the pill only works before symptoms become severe.
Others worry that antiviral treatments could become entangled in many of the same factors that have limited the effectiveness of existing COVID prevention methods, including lack of access, hoarding, misinformation, inequality and politicization.
What’s next
There’s no set timetable for the FDA review of molnupiravir, but experts say approval could come within the next few weeks. The drug has been tested only on unvaccinated adults. It’s unclear whether it will be approved for any other groups. Two other antiviral pills — one from Pfizer, the other from Atea Pharmaceuticals-Roche — are currently in trials and could also be submitted for approval within the next few months.
Perspectives
Promise
Antiviral pills are a key element of any plan to end the pandemic for good
“The path out of the pandemic is clear. Vaccinate a very high percentage of the population, by whatever means necessary including mandates, and combine this with a rapid test for COVID-19 in every home, as well as easy access to the emerging antiviral treatments, beginning with molnupiravir.” — Dr. Marc Siegel, USA Today
The pills could be a lifeline for the immunocompromised
“Molnupiravir also could save vaccinated lives: For those whose vaccine was ineffective, especially due to immune system weakness, molnupiravir’s very different mode of operation could be a lifeline.” — Andy Larsen, Salt Lake Tribune.
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