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The first easy-to-use Covid-19 treatment may be available in the United States by the end of this year, but it’s unlikely to reach developing countries where hundreds of millions of people don’t have access to vaccines, at least until last year. Mid 2022, according to public health officials.
The Bill and Melinda Gates Foundation announced Wednesday that it will seek to accelerate the timeline for bringing the antiviral drug molnupiravir to low-income countries. The drug’s developer has pledged an initial investment of up to $120 million for eight generic drug manufacturers that have signed licensing deals with Merck to start producing the drug now, a type of insurance policy gamble to be approved by regulators.
Molnupiravir was developed at record pace by Merck and Ridgeback Biotherapy, which has filed an application with the Food and Drug Administration. for emergency use. Merck is already producing the drug in anticipation of that approval coming in December.
The US government has a pre-purchase agreement for 1.7 billion cycles of the drug, a simple pill that, in a major clinical trial, halves the risk of hospitalization and death from coronavirus among high-risk people who take it in the early days of infection. . Other wealthy countries are in a rush to negotiate their own deals – the UK on Wednesday announced a deal to buy 480,000 courses pending approval.
In addition to licensing eight Indian manufacturing companies to produce generic versions of molnupiravir, Merck is in talks with the Pharmaceutical Patent Pool, a United Nations-sponsored non-profit organization. raise hopes that simple treatment may be widely available in countries where large numbers of unvaccinated people will continue to die from Covid infections.
But drug manufacturing experts say there are critical challenges in raw material sourcing, regulatory approval and financial investment, which will mean the drug will be in Omaha long before it’s in Zimbabwe.
The drug approval and authorization process usually takes about a year; Unitaid, the Geneva-based global healthcare organization, and the foundation have been working for months to make this process as fast as possible, since conversations with Merck showed that early data on the drug’s efficacy were strong.
Mark Suzman, CEO of the Gates Foundation, said in an interview that moving inequalities in vaccine access to access therapeutics would be an “ugly outcome.”
“We can use the resources that multilateral organizations cannot put forth at this stage, as they are limited to awaiting regulatory approval, to encourage these manufacturers to start production now, so we have a ready stock to distribute and when we get Approval,” he said.
Generic versions of molnupiravir will be evaluated by the World Health Organization and prequalified, the global organization’s stamp of approval, allowing countries to accelerate uptake.
However, this process will take months, said Prashant Yadav, a supply chain expert from the Center for Global Development. There are only a few suppliers of the drug’s ingredients (called the active pharmaceutical ingredient or API) and their manufacturers will need to be persuaded to increase their production at risk.
He said the Gates Foundation’s efforts can make a meaningful difference. “By investing in volume guarantee, the foundation creates a more assured supply of high quality APIs for those who want to make finished formulations for pharmaceuticals,” he said.
Mr. Suzman said the foundation also funds research on how to make the drug manufacturing process cheaper and faster.
Dr. Yadav said it would be unlikely for individual companies to make such expenditures on their own, and this would help drive down drug prices.
If a country like Zimbabwe approves and orders the drug, the timeline for getting it to patients will depend on how much is produced globally. “It could even take months for the product to ship,” he said. “To be pragmatic, I think we’re talking about six months ago, not to mention someone picking it up, let’s say, before it goes into warehouses in a country.”
Multilateral donors and national governments should consider a stockpile of molnupiravir as a way to ensure a continuous flow of the drug’s ingredients, he said. Therapeutic markets can be uncertain: If case numbers fall, manufacturers may reduce their production, and if there were an increase in infections, the drug would not be available.
Mr. Suzman said that in addition to the deals Merck is negotiating with Indian companies, the foundation hopes to encourage pharmaceutical manufacturers in other parts of the world to obtain licenses, knowing that the Gates commitment will bear their risk. “Ideally, you wouldn’t want a single manufacturer in a single country to do this because we’ve seen some of these risks,” he said.
The Gates Foundation has played a similar role in trying to accelerate access to the Covid vaccine, and has struck a $300 million deal with the Serum Institute of India facilitating accelerated production of AstraZeneca and Novavax vaccines. However, India banned the export of vaccines for months during the second waves of Covid.
Financial and vaccine donations to Covax, the global organization aimed at supplying low-income countries, have been slow and erratic.
“The world has learned the hard way with Covid vaccines that if we are not willing to invest at risk and at scale as soon as promising technologies emerge – and ideally sooner – then there will be fair and limited access for too long even when needed. Herve, spokesperson for Unitaid. “The demand is extremely clear,” Verhoosel said.
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