The plan to treat COVID by Merck Co's promising antiviral pill risks repeating the inequities of vaccine distribution, potentially leaving the nations with the greatest need at the back of the line.
At the moment, about 5% of African population is immunized, by local doctors creating an urgent need for therapeutics that can keep people out of hospitals. That compares to a rate of inoculation of more than 70% in most developing nations.
Merck applied for emergency clearance of the first pill for COVID - 19 in U.S. on Oct 11 after it cut hospitalizations and deaths by 50% in a large clinical trial. The medicine, made with Ridgeback Biotherapeutics, could gain authorization as soon as December.
The U.S. drugmaker took the unusual pandemic step of licensing several generics of its antiviral molnupiravir before its branded version was even licensed for marketing.
But international health officials said even that is not enough for medicine to reach many in low- and middle-income countries in large enough numbers, while noting shortcomings and red tape among global organizations that could further slow the distribution of the medicine.
Merck plans to produce 10 million treatment courses of the pill, which is taken twice a day for five days, and another 20 million later this year.
In addition, its licensing deals with eight foreign drugmakers will allow cheap generic versions for 109 low and middle-income countries including in Africa, a move which international groups acknowledge is a positive concession.
They are concerned that as wealthy nations secure molnupiravir supply deals - the United States has already locked up 1.7 million courses with an option for 3.5 million more by January 2023 at about $700 per course - concerns grow over who might be left out.
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Merck said it has worked on the technology transfer needed to start generic manufacturing, in contrast to vaccine makers who continue to resist calls to waive patents or allow generic versions to boost supplies.
However a recent report prepared for the United Nations' Access to COVID-19 Tools Accelerator program tasked with buying COVID 19 therapeutics for poor countries cited concerns that U.N. agencies were not moving quickly enough to secure adequate volumes of potential new treatments including Merck's drug.
Medicines Patent Pool MPP a United Nations-backed public health organization has 24 companies willing to make the drug if Merck agrees to expand the licenses.
If you're not in the licence, you rely on Merck and it looks to us that that would mean a potential supply shortfall as well as overpricing, said Peter Maybarduk of Public Citizen, who sits on the MPP governance board. He suggested that could lead to poor nations outbidding rich nations for medicine.
How many generic pills are available and when? The licensed Indian manufacturers, including Aurobindo Pharma ARBN.NS Cipla Ltd CIPL.NS Dr. Reddy's Labs REDY.NS Emcure Pharmaceuticals, Heterolabs, Sun Pharmaceuticals, and Torrent Pharmaceuticals TORP.NS declined to provide details of production plans.
In many countries, manufacturing requires WHO approval from the World Health Organization in low-income countries, a regulatory process that usually takes months to complete.
It said it is committed to ensuring timely access to its drug globally with plans for tiered pricing aligned with a countries ability to pay. A spokesperson confirmed it is in discussions about expanding licenses for generic molnupiravir to build sufficient global supply of quality-assured product to meet orders globally. But middle-income countries will be harder to negotiate against richest nations, another MPP official said.
The governments of Australia, South Korea, Thailand, Singapore and Malaysia said they already had deals or were negotiating supply contracts with Merck. The EU is considering buying the pill after Merck applies for authorization in Europe.
The eight generic manufacturers selected by Merck have pre-qualified facilities to allow them to supply clients like the Global Fund, according to Paul Schaper, Merck's executive director of global public policy. They will set their pricing and decide how much they plan to manufacture.
What we are expecting and hoping for is that they would compete with each other on pricing, Schaper said.