The developing world is fighting for greater access to lifesaving COVID-19 vaccines and therapeutics. If regulatory bodies approve it, a new COVID-19 antiviral pill called molnupiravir could bring relief in the next year because it would be affordable, easy to distribute and easy to administer. Approval is all but guaranteed, however, several NGOs and manufacturers are jumping into high gear to help ensure equitable access to the drug throughout the world.
The Current Situation
No nation, no matter how wealthy, is exempt from the heartache and struggle that COVID-19 brought. According to the World Health Organization (WHO), COVID-19 has led to the deaths of more than five million people worldwide. In addition to the many lives lost, the disease caused by the novel coronavirus, SARS-CoV-2, has also left many survivors with long-lasting negative health effects. Then, there is the economic toll — experts consider the global economic contraction that the pandemic caused to be the most severe since the aftermath of World War II.
Now, nearly a year after the arrival to the market of the first COVID-19 vaccines, the developed world is wondering if the end is near — if the world can get back to a pre-pandemic sense of normal. However, in the developing world, the end does not appear to be near because many developing countries have yet to gain adequate access to vaccines. For instance, in September 2021, WHO Chief Tedros Adhanom Ghebreyesus said that “more than 5.7 billion COVID-19 vaccine doses have been administered globally, but only 2% of them in Africa.” Africa, however, makes up nearly 16% of the global population, making it clear that the push for vaccine equity must continue.
However, the developing world is now finding some hope in a COVID-19 antiviral pill that a partnership between Merck and Ridgeback Biotherapeutics brought to market. Researchers invented the drug, called molnupiravir, at Emory University with research funding from the U.S. government. In the Phase 3 clinical study, the pill proved efficient in reducing risks of hospitalization and death by 50% in at-risk individuals when administered before symptoms increase in severity. Following these promising outcomes, Merck has applied for Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) so that it can bring this promising COVID-19 antiviral pill to the market as soon as possible.
3 Advantages of Molnupiravir for the Developing World
- Affordability. Merck and Ridgeback Biotherapeutics have agreed to license the production of their COVID-19 antiviral pill to several generic drug manufacturers in India. In addition, they have signed a royalty-free licensing agreement with the United Nations-backed Medicines Patent Pool (MPP). The agreement remains valid so long as WHO classifies COVID-19 as a global public health emergency. MPP will sublicense production of the molnupiravir to qualifying generic drug manufacturers in the developing world. In turn, those manufacturers will be free to market the drug to a collection of 105 low- to middle-income countries for around $20 per five-day course of treatment. For reference, in its initial purchase agreement for the drug, the U.S. government agreed to pay about 35 times as much per treatment.
- Ease of Distribution. Depending on the brand, COVID-19 vaccines require either freezing or refrigeration up until the time of administration. The Pfizer-BioNTech mRNA vaccine even requires sub-zero freezing at -80℃ to -60℃, thus requiring specialized sub-zero freezers. These cold storage requirements for vaccines, while not insurmountable, do provide logistics challenges for the delivery of vaccines in rural areas of low-to-middle-income countries (LMICs). On the other hand, molnupiravir is shelf-stable, meaning its attributes allow for safe storage at room temperature. This element will make distribution much easier in LMICs with limited cold storage facilities.
- Ease of Administration. Even in high-income countries, there are many accounts of hospitals stretching themselves dangerously thin on resources because of aggressive surges in infections. The limited clinical capacity of LMICs means that the ideal COVID-19 therapeutic would allow for home-based patient administration instead of clinical administration. Because molnupiravir is an oral medication that is shelf-stable, it would meet this need.
Improving Production Capacity
There is some concern that ongoing COVID-19-induced supply chain disruptions could interfere with the mass global production capacity of molnupiravir should the disruptions result in inadequate supplies of the base ingredients needed for manufacture. For its part, the Bill and Melinda Gates Foundation has pledged $120 million to help ensure equitable distribution of molnupiravir. Part of the initiative is to fund research to look into the most efficient and streamlined manufacturing methods to maximize the production capacity of the drug. These efforts bring hope that production capacity goals will meet their mark. Only time will tell, but for many in the developing world, molnupiravir may bring COVID-19 relief before vaccines do.
– Jeramiah Jordan
Photo: Wikipedia Commons