Concern is growing among advocates that Merck’s promising new COVID-19 treatment pill could deepen the inequalities between rich and poor nations that were exposed during the coronavirus vaccine rollout.
The vast majority of COVID-19 vaccines have gone to people in rich nations. Vaccination rates lag below 10 percent in more than 50 poor countries, according to the World Health Organization (WHO), while many wealthy nations boast inoculation rates above 70 percent. And experts worry the distribution of the new drug could follow a similar trend.
Merck’s antiviral pill, molnupiravir, is a treatment for people who are already infected, not a prophylactic. But the drug appears to keep infected people from being hospitalized and dying and could be another important tool for countries to use alongside vaccines.
Clinical trial results showed the drug cut hospitalizations and death rates in half when used early in the course of infection. The drug can be taken at home, and a standard treatment lasts five days.
The company applied for emergency use authorization with the Food and Drug Administration (FDA) less than two weeks after announcing results, and a decision could be made by December.
Unlike vaccine manufacturers, Merck has already taken steps to preemptively address global access concerns by licensing its technology with five generic manufacturers in India. The move is unusual, since it comes before the brand-name drug is even authorized in the U.S.
Under the agreements, Merck will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 low- and middle-income countries at a far lower price than the branded version.
Advocates and experts said the licensing agreements are encouraging, but they’re hoping for more impactful steps.
“Merck has licensed its technology, and so the most important element of equity is in place, and they do deserve congratulations,” said Lawrence Gostin, a global health law professor at Georgetown University.
Gostin noted that vaccine manufacturers have refused to waive intellectual property rights for other countries to license their products.
“That’s something that Pfizer and Moderna have stubbornly refused to do, which has been catastrophic, because lower-income countries [now] have to rely on charitable donations from the rich, which never seem to come on time or in adequate form,” Gostin said.
Without widespread vaccination, people in poor countries remain vulnerable to COVID-19. A cheap pill like Merck’s could go a long way to helping the population, especially as there have been so few COVID-19 treatments developed to date.
Jenny Ottenhoff, director of the ONE Campaign’s global health and education programs, said manufacturing a generic pill at the scale needed to make an impact in low-income countries is much easier than a vaccine. Once the technology is transferred to additional manufacturers, scaling production shouldn’t be difficult, she said.
Merck this year plans to produce 10 million treatment courses of the pill and another 20 million next year. But it’s unclear how much of the generic will be available or when manufacturing will even begin.
Josh Michaud, a global health policy expert at the Kaiser Family Foundation, said he thinks poor countries may be waiting a lot longer for the drug than wealthy countries if there are initial supply constraints.
“It’s not unlike the vaccine story, in that much of the early vaccine supply was snapped up by high-income countries,” Michaud said.
“So, low-income countries didn’t have the resources and didn’t have the wherewithal to make those early commitments upfront, and that put them at a disadvantage when it came to early access. I can imagine a similar thing playing out here at first.”
The U.S has already locked up a large portion of the global supply in pre-purchase agreements. The Biden administration has a deal for 1.7 million courses of the treatment at a cost of $1.2 billion, with an option for 3.5 million more by 2023.
Merck said it is in discussions with the Medicines Patent Pool, a United Nations-backed nonprofit that works to make medical treatment and technologies accessible, to explore the potential for licenses in additional countries.
But even if the manufacturing is licensed, countries will still have to find a way to pay for the drugs.
The U.S. is paying $700 per treatment course, but Merck said that price is not final and is not reflective of the price point for lower income countries. The company said it plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic.
But even if the drugs are sold at a steep discount, low-income countries may still be hard-pressed to afford the cost.
“When we look at how this global pandemic is being addressed, and while we see most of the effects of it largely mitigated or could be mitigated in high-income countries, the resources for vaccines or drugs or oxygen or whatever, are just not there in low- or lower-middle income countries,” Ottenhoff said.
If the drug is available worldwide, it would likely save lives. But the drug needs to be taken within a few days of infection, essentially as soon as symptoms appear, and there isn’t the capacity to test everyone, even in wealthy countries like the U.S.
Additionally, the drug itself won’t help reduce the spread of the virus, which is why advocates said continued vaccine inequity shouldn’t be overlooked.
“It’s kind of a Band Aid after the fact, after you get the wound. And it’ll prevent you from dying, which is good, of course, but it won’t necessarily prevent this virus from continuing to spread and the scale of the pandemic to continue to grow,” Ottenhoff said. “I’m really worried if we don’t tamp down circulation of the virus in lower income countries ... it’s just going to take one variant to undermine everything we’ve done.”