The Bill & Melinda Gates Foundation will provide up to $120 million to help lower-income countries access a new pill to treat COVID-19, the foundation announced Tuesday.
Molnupiravir cuts the risk of hospitalization or death of newly diagnosed patients by about one half, according to initial clinical trial data released by pharma giant Merck early this month. Merck collaborated with Ridgeback Biotherapeutics to develop the pill, which was tested in high-risk patients.
Merck is seeking emergency use authorization for the pill from the U.S. Food and Drug Administration, and regulatory agencies in other countries will also be weighing in. The pill has been widely heralded as the first oral, easy-to-use potential treatment for COVID-19.
The new funding from the Gates Foundation will support the development and manufacture of generic versions of the molnupiravir. The foundation, for instance, has provided $2.4 million in grants to companies to expedite readiness for manufacture, and $1.3 million to develop low-cost manufacturing processes.
“Today’s commitment will ensure that more people in more countries get access to the promising drug molnupiravir,” said Melinda French Gates, co-chair of the foundation, in a statement. She also called on other donors to act, including foundations and governments.
The new effort brings the Gates Foundation’s total funding commitment for pandemic-related measures to $1.9 billion. The foundation has supported the development, manufacturing and delivery of COVID-19 tests, treatments and vaccines.
To end this pandemic, we must ensure that everyone has access to life-saving treatments, no matter where they live.
This commitment will help expand access to the promising drug molnupiravir, but it’s not the end of the story. We need other donors to act.https://t.co/9LdGDp5Dhs
— Melinda French Gates (@melindagates) October 20, 2022
Distribution and access to Molnupiravir are high on government official’s minds.
The U.S. government in June signed a $1.2 billion deal with Merck for 1.7 million doses, which breaks down to $712 for a five-day treatment course. Other countries are also rapidly placing orders for the drug.
By early October, Merck had forged licensing agreements with eight large generic makers. India’s generic manufacturers will sell the pills at a lower price in poorer countries, but many nations with low vaccination rates are not part of such agreements, according to The New York Times.
Efforts to ensure access to molnupiravir are taking place against a backdrop of slow vaccine distribution to low-income countries.
98% of people in low-income countries have not been vaccinated, and the international group charged with the effort, COVAX, had shipped only 330 million out of 2 billion planned doses, reports STAT News. COVAX is led by the World Health Organization and two Gates-funded groups, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations.
In a recent editorial, Bill Gates maintained that manufacturing roadblocks, not intellectual property restrictions, have been the major impediment to vaccination.
“The world learned the hard way with COVID-19 vaccines that unless we are willing to invest at-risk and at-scale as soon as promising technologies emerge – and ideally before – then there will be limited access for some time, even when need and demand are clear,” said a Gates Foundation spokesperson in an email, referring to the risk of investing in a product before regulatory approval. “We are aiming to do our part to ensure resources are not a barrier to equitable access to molnupiravir.”
An FDA panel will meet Nov. 30 to discuss the safety and effectiveness of the new pill, with a decision on emergency use expected soon after.