Merck COVID-19 pill sparks calls for access for low-income countries, Health News, ET HealthWorld

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By Francesco Guarascio and Michael Erman

Merck & Co’s promising antiviral pill rollout plan to treat COVID-19 risks repeating inequalities in vaccine distribution, potentially leaving countries most in need at the back of the pack, according to international health groups.

For example, only around 5% of the African population is immune, creating an urgent need for therapies that could prevent people from going to hospitals. This compares to an inoculation rate of over 70% in most wealthy countries.

On October 11, Merck requested emergency US clearance of the first pill for COVID-19 after cutting hospitalizations and deaths by 50% in a large clinical trial. The drug, made with Ridgeback Biotherapeutics, could get clearance as early as December.

The US drugmaker took the unusual pandemic step of clearing several generics of its antiviral molnupiravir even before its branded version was released for sale.

But international health officials have said that even that was not enough for the drug to reach large numbers of people in low- and middle-income countries, while noting gaps and red tape among global organizations that could slow down. more distribution.

Merck plans to produce 10 million pill treatments this year, which are taken twice a day for five days, and 20 million more next year.

In addition, its licensing agreements with eight Indian drugmakers will allow cheaper generic versions for 109 low- and middle-income countries, including Africa, a move international groups recognize as a positive concession.

But as rich countries strike deals for molnupiravir – the United States has already blocked 1.7 million courses with an option for 3.5 million more by January 2023 at around $ 700 per course – concerns are growing about who might be left behind.

DO NOT MOVE QUICKLY ENOUGH

Merck said it has worked on the technology transfer needed to start manufacturing generics, unlike vaccine makers who continue to resist calls to waive patents or allow generic versions to increase supplies.

But a recent report prepared for the United Nations COVID-19 Tool Access Tool Accelerator Program to Purchase COVID-19 Therapies for Poor Countries raised concerns that UN agencies were not acting quickly enough to get adequate volumes of potential new treatments ahead of time, including the drug from Merck.

Medicines Patent Pool (MPP), a United Nations-backed public health organization, has 24 companies registered and willing to manufacture the drug if Merck agrees to extend the licenses.

“If you’re not in the license, you’re relying on Merck, and it looks to us like that could mean a potential supply shortage as well as price overstatement,” said Peter Maybarduk of Public Citizen, who sits at Public Citizen. MPP governance board. . He suggested that this could lead rich countries to outbid poor countries for the drug.

It is not known how many generic pills will be available or when. Authorized Indian manufacturers, including Aurobindo Pharma, Cipla Ltd, Dr. Reddy’s Labs, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals and Torrent Pharmaceuticals, declined to provide details of production plans.

In addition, manufacturing for low-income countries in many countries also requires approval from the World Health Organization (WHO), a regulatory process that typically takes months.

Merck said it is committed to providing rapid access to its drug worldwide with tiered pricing plans aligned with a country’s ability to pay. A spokesperson confirmed that he was in talks to extend the licenses for generic molnupiravir “in order to build a sufficient global supply of quality-assured products to meet orders around the world.”

But middle-income countries will find it difficult to negotiate against richer nations, another MPP official said.

The governments of Australia, South Korea, Thailand, Taiwan, Singapore and Malaysia have said they have already made deals or are in the process of negotiating supply contracts with Merck. The EU plans to buy the pill after Merck’s application for authorization in Europe.

The eight generics manufacturers chosen by Merck all have WHO prequalified facilities to enable them to supply buyers like the Global Fund, according to Paul Schaper, executive director of global public policy at Merck. They will set their prices and decide how much they plan to manufacture.

“What we anticipate and hope is that they will compete on price,” Schaper said.


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