The Bill & Melinda Gates Foundation says it will spend $ 120 million to expand access to generic versions of Merck’s COVID-19 antiviral pill for low-income countries if the drug is approved by regulators.
The private foundation said in a statement released Wednesday that it has not determined how it will distribute the money, but will use the funds to “support the range of activities needed to develop and manufacture generics” for molnupiravir.
Merck has licensed its technology from generic drug manufacturers in India. Under the agreement, the company said it would provide licenses to manufacturers to supply the drug to India and more than 100 other low- and middle-income countries. It is unclear what part of the generic may be available for use.
The Gates Foundation says its funding is also intended to help develop regulations, delivery methods, and other means to make the pill more affordable if it becomes available.
The FDA has not approved the pills, and its external experts are expected to meet on November 30 to scrutinize the drug. If approved by regulatory authorities, the drug will be the first available pill for the treatment of COVID-19.
Trevor Mandel, president of the foundation’s global health program, believes generic manufacturers will not ramp up production unless they know there will be demand and will likely wait until next year to start production.
“We want them not to wait,” he said. “So this money is for them to be active now.”
Merck and partner Ridgeback Biotherapeutics said early results for the pill showed high-risk patients who received it within five days of COVID-19 symptoms onset had about half the hospitalization and death rates.
Mundel of the Gates Foundation says the research needs to be replicated in other countries so that officials can learn more about the drug. “Otherwise, there will be no deferred demand for healthcare professionals and doctors, which will lead to an immediate perception of how it would be elsewhere,” he said.
Funding comes as many countries struggle to access COVID-19 vaccines.
Lawrence Gostin, professor of global health law at Georgetown University, says more is being done to help manufacturing businesses overseas, but notes that more challenges may lie ahead. “It’s only limited to India,” he said. “So their ability to ramp up production fast enough to supply middle and low income countries is going to be a huge challenge indeed.”
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