The generic versions of molnupiravir will be evaluated by the World Health Organization and receive prequalification, the global body’s stamp of approval, which would allow countries to fast track purchases.
Still, that process will take months, said Prashant Yadav, a supply chain expert with the Center for Global Development. There are only a few suppliers of the drug’s components (called the active pharmaceutical ingredient, or A.P.I.), and its manufacturers will have to be persuaded to ramp up their at-risk production, as well.
The Gates Foundation’s efforts could make a meaningful difference, he said. “The foundation investing in a volume guarantee creates a more guaranteed supply of high quality A.P.I. for whosoever wants to make the finished formulation for the drug,” he said.
The foundation has also been funding research into how the drug production process can be done more cheaply, and more quickly, Mr. Suzman said.
Dr. Yadav said that individual companies would be unlikely to make such expenditures on their own, and that it would help to drive down the price of the medication.
If a country such as Zimbabwe were to approve the drug and order it, the timeline to get it to patients would depend on how much was being made globally. “It could be months before the product is even shipped out,” he said. “To be pragmatic I think we are talking about six months before, I’m not even talking about somebody taking it, but even let’s say, before it’s in warehouses in a country.”
Multilateral donors and national governments should consider a molnupiravir stockpile as a way to ensure continued flow of the drug’s ingredients, he said. Markets for therapeutics can be uncertain: If case counts fall, manufacturers may cut back their production, and the drug would not be available if there were a surge in infections.