Here's How Merck Is Making Their COVID Antiviral Drug Accessible Worldwide

The world's first approved COVID-19 antiviral pill, molnupiravir, was authorized last week for use in the United Kingdom.

Early data shows that the antiviral pill, developed by Merck & Co. and Ridgeback Biotherapeutics LP, can reduce the risk of hospitalization and death by 50%. The U.S. Food and Drug Administration (FDA) is currently in the process of evaluating the safety and effectiveness data submitted by the developers.

In late October, Merck signed a voluntary licensing agreement to increase affordable global access for the drug in low- and middle-income countries. According to the agreement, the developers will not receive royalties for the sales of molnupiravir as long as the World Health Organization (WHO) declares COVID-19 a "Public Health Emergency of International Concern."

Experts say this deal is a game-changer for the pandemic, and many hope that vaccine manufacturers would follow suit.

How Will Merck’s Agreement Help Other Countries?

“Antiviral medicines work by inhibiting the replication of viruses in a variety of ways,” Vincent Hsu, MD, executive director of infection control at AdventHealth, told Verywell. “In the case of molnupiravir, it significantly increases the number of mutations as it tries to replicate, thus reducing the number of effective copies to the point it cannot reproduce effectively.”

If the virus cannot reproduce functional copies of itself, there will be fewer virus particles to infect other cells, which can prevent the disease from spreading.

“Pills can easily be stored at room temperature, and apart from distribution, require little resources to give to patients compared to injections,” Hsu said. “Allowing other drugmakers to produce this antiviral will make it easier and less expensive for the public and less expensive to manufacture and distribute around the world.”

Experts say increased access to molnupiravir can be a significant relief to low- and middle-income countries that have fewer available resources to provide medical care to large numbers of patients. It could potentially reduce COVID-19 transmission in those countries as well.

“Previously approved treatments for COVID-19 are all given to patients in the hospital, and most of these treatments—such as remdesivir and monoclonal antibodies—are given through a needle into a vein,” Albert Shaw, MD, Yale Medicine infectious diseases specialist and professor of medicine at Yale School of Medicine, told Verywell. “Because molnupiravir is available in pill form, it can be given to patients with COVID-19 who are not in the hospital.”

The pill can be distributed more easily to patients in areas with lower vaccination rates. It may also reduce the burden on the healthcare systems of various countries by preventing cases from overwhelming them even further.

“It’s also worth noting that vaccine supplies in developing nations are generally much more limited than they are in developed countries,” Shaw said. “So far, no similar agreement to give a royalty-free license to produce vaccines in developing countries has been reached.”

Antiviral Medicines and Vaccines

Although vaccines are highly effective at preventing COVID-19 disease, it’s necessary to continue developing antiviral medicines for individuals who did get infected. An antiviral pill is a tool for disease management, not prevention.

Molnupirivir is expected to reduce the risk of hospitalization or death when given early in the course of the disease. Patients who would otherwise get severe COVID-19 might only have milder symptoms if treated quickly, Geoffrey Chupp, MD, Yale Medicine pulmonologist and professor of medicine at Yale School of Medicine, told Verywell.

Additionally, low-income countries have received only 0.4% of the world’s vaccines. Even though the vaccines are effective, millions of people remain unvaccinated, so it is crucial to develop effective COVID-19 treatments that are available when needed.

“Vaccines are still not widely available in much of the world, so tools to treat COVID-19 and potentially prevent progression to severe disease requiring hospitalization is especially important in resource-limited nations,” Shaw said. “Another reason is that vaccines are not 100% effective—breakthrough infections will occur. This is a particular problem in patients with pre-existing medical conditions that weaken their response to vaccination.”

There may be immunocompromised individuals who are fully vaccinated but not adequately protected against COVID-19, and it’s essential to have treatment options that could prevent the progression to severe disease should they get infected.

"It is, of course, important to reiterate that treatments for COVID-19, such as antiviral medications and monoclonal antibodies, are not substitutes for vaccination and vaccination really needs to remain the top priority to fighting the pandemic,” Hsu said. “But we need to use every tool in our toolbox.”

The FDA is already reviewing Merck’s application for an EUA, and they will likely reach a decision within weeks, Chupp says. An advisory committee is set to meet on November 30 to discuss the safety and effectiveness data of molnupiravir as a treatment for mild-to-moderate COVID-19.

“Vaccines have been critical to reduce COVID-19 cases, their severity, and the transmissibility of the virus,” Chupp said. “Oral antiviral medications do the same, by working in patients who contract the disease. Combining the effects of natural immunity, vaccination, and oral antiviral medications will end the pandemic faster and reduce the number of people who die from COVID-19.”

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