Merck calls for access to low-income countries to spark Covid-19 pill

For example, only 5% of Africa’s population is immunized, creating an urgent need for medical science that can keep people out of hospitals. This compares to over 70% vaccination rates in most wealthy countries.

On October 11, Merck applied for US emergency approval for the first pill for COVID-19, as it cut hospitalizations and deaths by 50% in a large clinical trial. The drug, made from Ridgeback Biotherapeutics, may get approval in December.

The US drugmaker has taken the unusual pandemic step of licensing several generics of its antiviral mollupiravir before its branded version can be authorized for marketing.

But international health officials said low- and middle-income countries do not have enough of the drug in sufficient numbers, noting shortages and red tape among global organizations, which could further slow distribution. Is.

Merck plans to roll out 10 million treatment courses of the pill this year, taken twice a day for five days, and another 20 million next year.

In addition, its licensing deals with eight Indian drugmakers will allow cheaper generic versions for 109 low- and middle-income countries, including Africa, a move the international group acknowledges is a positive concession.

But as wealthy nations secure mollupiravir supply deals — the United States has already closed 1.7 million courses, with 3.5 million more options for about $700 per course by January of 2023 Worries increase as to who can be left out.

not moving fast enough

Merck said it has worked out the technology transfer needed to begin manufacturing generics, unlike vaccine makers, who continue to resist calls to waive patents or allow generic versions to boost supply .

But a recent report prepared for the United Nations’ Access to the COVID-19 Equipment Accelerator Program tasked with procuring COVID-19 therapeutics for poor countries cited concerns that UN agencies would Prematures weren’t moving fast enough to secure a substantial amount of potential new treatments. Including Merck’s drug.

The United Nations-backed public health organization Medicines Patent Pool (MPP) has tied up with 24 companies and is ready to make the drug if Merck agrees to extend the license.

“If you are not licensed, you are relying on Merck, and it seems to us that this could mean a potential supply crunch as well as higher pricing,” said Peter Mebarduk of Public Citizen, Who sits on the MPP Governance Board. He suggested that rich countries could be outnumbered poor countries for medicine.

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

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

Merck said it is committed to providing timely access to its drug globally, with pricing plans aligned with the country’s ability to pay. A spokesperson confirmed that it is discussing an extension of the license for generic molnupiravir “to manufacture a sufficient global supply of the quality-assured product to meet orders globally.”

But middle-income countries will have to work harder to negotiate against the richest countries, another MPP official said.

The governments of Australia, South Korea, Thailand, Taiwan, Singapore and Malaysia said they already have deals in place or are negotiating supply contracts with Merck. Merck is considering purchasing the EU pill after applying for authorization in Europe.

According to Paul Shaper, Merck’s executive director of global public policy, the eight generic manufacturers selected by Merck have WHO pre-qualified facilities to allow them to supply to buyers such as the Global Fund. They will set their own pricing and decide how much they plan to manufacture.

“What we are expecting and hoping is that they will compete with each other on pricing,” Schaper said.