As part of its COVID-19 response effort, the Bill and Melinda Gates Foundation announced today a pledge of up to $120 million to speed access to the investigational antiviral medication molnupiravir for lower-income nations. The money will be distributed after conversations with partners and will go toward a variety of initiatives needed to develop and produce generic versions of the medication, which Merck & Co is working on alongside Ridgeback Biotherapeutics.
This contribution adds on the foundation’s current efforts to increase access to COVID-19 vaccines, treatments, and testing by supporting R&D, regulatory work, at-risk manufacturing, and product delivery since the pandemic began, including $1.9 billion in funding.
“To put an end to the epidemic, we must ensure that everyone has access to life-saving health supplies, regardless of where they live on the planet. Low-income countries, on the other hand, have had to wait for everything from personal protective equipment to immunizations. That’s not acceptable “Melinda French Gates, co-chair of the Gates Foundation, expressed her gratitude. “Today’s commitment will ensure that more people in more countries have access to the promising medicine molnupiravir, but it’s not the end of the story—other contributors, such as foundations and governments, must also step up.”
Merck’s preliminary findings suggest that the broad-spectrum antiviral molnupiravir can reduce the risk of serious sickness and mortality caused by COVID-19 by half. Molnupiravir would be the first oral outpatient drug approved for treating COVID-19 patients with mild to moderate disease, marking a significant step forward in preventing hospitalizations and saving lives when used in conjunction with increased vaccination coverage and current treatments for severely and critically ill patients. Regulatory organizations, notably the World Health Organization (WHO) and national governments, make the decision on whether or not to approve the medicine for usage.”
“The remarkable findings on the antiviral, molnupiravir, have being tracked by the Africa CDC and the Africa Union,” said John Nkengasong, director of the Africa Centers for Disease Control and Prevention. “To ensure that Africa is not left behind, we’ve been working with Bill and Melinda Gates Foundation colleagues on various strategies that they can support after all of the regulatory processes are done and the medication is formally made available to the world,” says the statement.
This investment taps into the foundation’s Strategic Investment Fund, which employs a variety of financial tools, including as loans and volume guarantees, to overcome market failures and encourage private companies to develop inexpensive and accessible health goods.
Dolutegravir, an HIV medicine, was one of the foundation’s prior efforts to reduce costs and boost access to life-saving drugs. In collaboration with the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the foundation established a volume guarantee with two generic suppliers in 2017, bringing therapies containing the drug to more than 18 million people in low-income countries.
According to Strive Masiyiwa, the African Union’s special envoy for COVID-19 response, “We applaud the foundation’s commitment and look forward to continuing our collaboration to ensure that, once regulatory approval is granted, this potentially life-saving treatment is available to as many Africans as possible. This would be a significant step toward redressing the disparities in the availability of innovations during the epidemic that have been observed thus far.”
The foundation has already offered expertise and financing to support generics producers, including $1.3 million to Medicines for All Institute (M4ALL) and the University of Manchester to create low-cost manufacturing procedures that lower raw material costs and boost product yields. Several generics producers are already looking at these enhancements as they prepare to ramp up manufacturing following regulatory approval. In addition, the foundation has awarded $2.4 million in grants to help generic companies be ready to apply for WHO prequalification and begin manufacturing as soon as prequalification is granted.
“Merck has taken significant steps to make this medicine available as a COVID-19 treatment, including securing licensing with generic manufacturers to boost supply. We are delighted to join these efforts to guarantee that lower-income countries have access to affordable housing “Bill Gates, co-chair of the Gates Foundation, stated this. “Ending the acute phase of the epidemic and opening pathways to recovery requires making life-saving medications like these available to everyone who needs them.”
The idea is to cut the time it takes for a new drug to reach low-income countries once it has been approved in high-income markets. The average time it takes to roll out global health products is 12 months or more.
The Gates Foundation’s chief executive officer, Mark Suzman, said, “We have a unique collection of resources and experience that we dedicate to ensuring that everyone, everywhere has access to life-saving health interventions.” “This is exactly what the foundation excels at. Molnupiravir will be made available to low-income countries through collaboration with corporations, procurement agencies, and funders. Our funding is a necessary component of ensuring an equitable supply. Other donors and partners are urged to assist in mobilizing the multiples of additional resources required.”
Since the beginning of the epidemic, the foundation has collaborated closely with a variety of partners on COVID-19 tool R&D and delivery. Unitaid, UNICEF, WHO, the Global Fund, Wellcome, and the Africa Medical Supplies Platform are among the philanthropic and government donors who are part of the COVID-19 Therapeutics Accelerator, as well as global organizations in the therapeutics pillar of the access to COVID-19 Tools Accelerator (ACT-A) partnership.
When molnupiravir and its generic counterparts become available, the foundation will continue to work with multilateral organizations, nongovernmental organizations, governments, and other partners to ensure that clinical, regulatory, and delivery channels are ready.