Merck’s Covid-19 drug may soon get to the poor countries

The Bill and Melinda Gates Foundation says that millions of courses of Merck’s promising pill for Covid-19 could begin to reach lower-income countries early in 2022 as the charity kicks in as much as $120m to widen global access to the therapy.

The funds will help spur generic-drugs manufacturers, some of which have indicated they could produce as many as 10-million treatments a month, according to Trevor Mundel, president of the global-health division at the Gates foundation.

While regulatory hurdles and other challenges need to be resolved, those drugmakers could start shipments in the first quarter, he said.

“Could there be twists in that plot, and could there be delays, yes, but that’s what we’ve got to aim for,” Mundel said in an interview. “There’s a lot of capacity out there, but it’s a question of when they actually commit to that.”

The drug’s progress has been accompanied by concern that lower-income countries struggling to get vaccines could be left behind once again when it comes to therapies. The foundation is calling on other donors to devote resources to accelerating the rollout of Merck’s experimental molnupiravir to poorer nations if it’s approved.

OFF SIDELINES

The production potential will not be realised without incentives and guarantees in place, Mundel said. Manufacturers are uncertain of the level of demand for the therapy, who will pay for it and how much production to allocate, he said, “so we want to get them off the sidelines and actually into action”.

Merck is expecting to produce 10-million courses by the end of the year, and substantially more should become available in 2022.

The drugmaker has taken steps to ensure countries around the world can get its medicine, including licensing the medication to generic-drugs firms. Last week, Merck and partner Ridgeback Biotherapeutics sought US emergency use authorisation, and the treatment is set for US Food and Drug Administration committee review in November.

Still, health advocates are calling for further action to broaden the availability of Covid-19 drugs, including increased testing in lowerincome nations to detect cases in the first days of infection, when the drugs could be most effective.

Some wealthy and middleincome nations such as Australia, Singapore, Malaysia and Thailand have already followed the US and secured the drug or started talks to obtain it. Meanwhile, a global initiative to deploy treatments is at risk of running into the same problems the Covax vaccine distribution effort faced, according to an independent report commissioned by the World Health Organization.

The Gates organisation aims to reduce substantially the time it takes for new drugs to arrive in low-income regions after they become available in wealthier markets. That gap, it said, can be at least 12 months. Some of the latest funding includes $2.4m in grants to help speed generic companies’ applications to the WHO for manufacturing prequalification.

The foundation highlighted its move in 2017 to establish a volume guarantee with two generic suppliers to bring HIV therapies to lower-income countries. That work was carried out in coordination with the US President’s Emergency Plan for Aids Relief (Pepfar) and the Global Fund to Fight Aids, Tuberculosis and Malaria.