On Oct. 19, the Bill and Melinda Gates Foundation announced that it would be setting aside 120 million dollars to ensure Merck’s experimental Coronavirus Disease 2019 (COVID-19) drug, molnupiravir, is made available to people in lower-income nations. Merck’s drug is aimed at combating mild to moderate COVID-19 cases.
The funds will support activities necessary to produce generic versions of molnupiravir. The 120 million dollar commitment builds upon the 1.9 billion dollars in funds the foundation has already allocated to COVID-19 tests, vaccines, treatments, product delivery, regulatory work, and so on. In a statement, Melinda Gates, co-chair of the foundation, said that the commitment will ensure that “more people in more countries” have access to the medication.
“To end this pandemic, we need to ensure that everyone, no matter where they live in the world, has access to life-saving health products. The unjust reality, however, is that low-income countries have had to wait for everything from personal protective equipment to vaccines. That is unacceptable,” Melinda said. At present, the gap between a new drug being introduced in high-income markets versus low-income markets can be 12 months or more.
The foundation claims that initial studies by Merck have shown molnupiravir to reduce the risk of serious disease and death due to COVID-19 by 50 percent. It called the drug a “critical breakthrough” that will help save lives and prevent hospitalizations.
Brad Wilken, Deputy Director at Global Health, stated that molnupiravir works by disrupting the life cycle of the SARS-CoV-2 virus, essentially blocking it from replicating.
However, critics have raised concerns about pushing the drug to market without spending enough time to properly study the pill’s side effects.
Molnupiravir incorporates itself into the genetic material of the virus. As the virus replicates, the drug triggers a large number of mutations that effectively kill it. Lab tests have shown that the drug can sometimes integrate into mammalian cells as well, causing mutations in these cells. If this phenomenon were to occur in the cells of individuals taking the drug, a potential consequence would be cancer.
“Given the possibility that the drug could be incorporated into cellular DNA, it will be very important to demonstrate a lack of cancer in animal models and in humans… Even though it looks good in preliminary animal models, it will be important not to rush this into clinical use before being very confident that it does not cause cancer even at very low frequencies,” Nathaniel Landau, a professor in the department of microbiology at the NYU Grossman School of Medicine, said to Barron’s.
Meanwhile, the U.S. Food and Drug Administration (FDA) announced on Oct. 14 that it will soon hold an advisory committee meeting to discuss Merck’s application for their COVID-19 drug to be used in the country under Emergency Use Authorization (EUA).
“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The advisory committee is scheduled to meet on Nov. 30 and will be live-streamed through the agency’s YouTube channel. They will evaluate effectiveness data for molnupiravir in COVID-19 patients.