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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.
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.
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
The drug could be an important complement to vaccines
“Despite the effectiveness of vaccines, we still need drugs to treat COVID. Even people who have been double vaccinated stand a small chance of getting COVID and ending up moderately or even severely ill.” — Filipa Henderson Sousa and Peter Barlow, Conversation
Some people will never get vaccinated. Antiviral pills could save their lives.
“It’s doubtful that there are many among the unvaccinated who could be persuaded to get a jab no matter what. As such, rather than worrying about what could possibly come to pass, it’s best to cheer the news from Merck and hope for success.” — Editorial, MassLive
It’s possible antiviral pills could help prevent infections in the first place
“While most of the focus has been on using these drugs as a treatment, their true potential lies in pandemic control, because administering prophylactically can prevent people who have been exposed to the virus from becoming ill or passing on an infection. … If one person tests positive for COVID-19, everyone around him could take a pill to help stave off infection.” — William A. Haseltine, MarketWatch
The pills could finally provide overburdened hospitals some relief
“If taking a pill means that infected patients are half as likely to require a hospital bed, that can help relieve the stress on our health care system and save countless lives.” — Leana S. Wen, Washington Post
Developing nations stand to benefit the most
“The relative ease, speed and economy of pill production could result — with sufficient investment and trial success — in enough timely doses for the entire world. The biggest benefit of expansive supply would come in low-income nations otherwise left behind.” — Max Nisen, Bloomberg
Vaccines are still the only way out of the pandemic
“Treatments do help people get better — but it’s important to remember that vaccination remains the most effective tactic for controlling the pandemic.” — Umair Irfan, Vox
The pills are cheaper than other treatments, but may still be too costly for many
“Offering someone a $700 treatment when they don’t yet feel that ill is going to mean that a lot of people are not going to take it.” — Dzintars Gotham, drug price researcher, to Intercept
Any delay in approval means people will die unnecessarily
“Molnupiravir pills are ready to go. ... These pills are sitting on a shelf as Americans are dying in hospitals.” — Marty Makary, Wall Street Journal
Testing limitations mean many people won’t get the pills in time
“Antiviral agents work best when given at first symptoms of disease. Symptoms of early COVID-19 resemble those of countless other viral respiratory infections, such as flu and common colds: sniffles, cough, an upset stomach, a little fever. Nothing specific. A rapid cheap diagnostic test could clarify the decision, but adds time, cost and a different set of uncertainties regarding test accuracy.” — Kent Sepkowitz, CNN
Lack of access and low awareness could limit how many people can take advantage of the pills
“Molnupiravir is going to be used by humans, not gods. Which means it’s going to be subject to some very human limitations. For the pill to work, people will need to realize they’re sick and confirm that with a test; they will need to seek care from a health care provider and successfully nab a prescription; they will need to access the drug and have the means to obtain it. Then they will need to take the drug successfully.” — Katherine J. Wu, Atlantic
Rich countries may hoard the drugs in the same way they did the vaccines
“Countries that have struggled to vaccinate their populations could end up in the back of the line for brand-new therapies.” — James Paton, Bloomberg
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Photo illustration: Yahoo News; photos: Merck & Co Inc/Handout via Reuters