The Bill & Melinda Gates Foundation has announced a commitment of up to $120 million to accelerate access to the investigational antiviral drug molnupiravir for lower-income countries as part of its COVID-19 response effort. The funding will be allocated based on consultations with partners, and will support the range of activities required to develop and manufacture generic versions of the drug, which is being developed by Merck & Co in collaboration with Ridgeback Biotherapeutics.
This commitment builds on the foundation’s ongoing efforts, including $1.9 billion in funding, since the start of the pandemic to increase access to COVID-19 vaccines, treatments, and tests by supporting R&D, regulatory work, at-risk manufacturing, and product delivery.
“To end this pandemic, we need to ensure that everyone, no matter where they live in the world, has access to live-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,” said Melinda French Gates, co-chair of the Gates Foundation. “Today’s commitment will ensure that more people in more countries get access to the promising drug molnupiravir, but it’s not the end of the story—we need other donors, including foundations and governments, to act.”
Initial data reported by Merck suggest that molnupiravir, a broad-spectrum antiviral, can cut the risk of serious disease and death due to COVID-19 by half. Molnupiravir would be the first oral outpatient drug authorized for use in treating COVID-19 patients with mild and moderate disease—a critical breakthrough to prevent hospitalizations and save lives in combination with increased vaccination coverage and existing treatments for severely and critically ill patients. The decision on whether to authorize the drug for use sits with regulatory agencies, including the World Health Organization (WHO) and national governments.
“Africa CDC and the Africa Union have been tracking the exciting developments on the antiviral, molnupiravir,” said John Nkengasong, director of the Africa Centers for Disease Control and Prevention. “In order to make sure that Africa is not left behind, we have been working with the Bill & Melinda Gates Foundation colleagues on various mechanisms they can facilitate, once all of the regulatory processes are completed and the drug is officially made available to the world.”
This commitment leverages the resources of the foundation’s Strategic Investment Fund, which uses a suite of financial tools—including loans and volume guarantees—to address market failures and incentivize private enterprises to develop affordable and accessible health products. The foundation’s previous work to lower costs and increase access to life-saving drugs includes dolutegravir, an HIV drug. In 2017, the foundation established a volume guarantee with two generic suppliers that has brought therapies containing the drug to more than 18 million people in lower-income countries, in coordination with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
Strive Masiyiwa, African Union special envoy on COVID-19 response, said, “We applaud the foundation for its commitment and look forward to continuing our collaboration to ensure this potentially lifesaving treatment, upon regulatory approval, is accessible to as many Africans as possible. This would be a step forward in balancing the inequities seen to date in availability of innovations during the pandemic”
The foundation has already provided expertise and funding to help strengthen generics manufacturers, including $1.3 million to Medicines for All Institute (M4ALL) and the University of Manchester to develop low-cost manufacturing processes that dramatically reduce the cost of raw materials and increase product yields. Several generics manufacturers are investigating these improvements already as they plan to scale up production following regulatory authorization. The foundation has also provided $2.4 million in grants to expedite generic company readiness to apply for WHO prequalification and start manufacturing when prequalification is granted.
“Merck has taken important steps to make this drug available as a COVID-19 therapy, including negotiating licenses with generics manufacturers to increase supply. We are pleased to work alongside these efforts to ensure affordability and availability in lower-income countries,” said Bill Gates, co-chair of the Gates Foundation. “Making life-saving drugs like these available to everyone who needs them is what is necessary to end the acute phase of the pandemic, and open pathways to recovery.”
The goal is to significantly reduce the time it takes for a new drug to reach low-income countries after it becomes available in high-income markets. The standard gap in rolling out global health products can be 12 months or more.
“We have a unique set of resources and expertise that we dedicate to ensuring that everyone, everywhere has access to life-saving health interventions,” said Mark Suzman, chief executive officer of the Gates Foundation. “This is what the foundation does best. We will work with companies, procurement agencies, and donors to make molnupiravir available to low-income countries. Our funding is part of what’s needed to ensure equitable supply. We call on other donors and partners to help mobilize the multiples of additional resources required.”
Since the start of the pandemic, the foundation has worked closely with a range of partners on R&D and delivery of COVID-19 tools. These partners include philanthropic and government donors that are part of the COVID-19 Therapeutics Accelerator and global organizations in the Access to COVID-19 Tools Accelerator (ACT-A) partnership, including Unitaid, UNICEF, WHO, the Global Fund, Wellcome, and the Africa Medical Supplies Platform. The foundation will continue to work with multilateral organizations, nongovernmental organizations, governments, and other partners to ensure that clinical, regulatory, and delivery pathways are ready once molnupiravir and its generic versions become available.