Francesco Guarascio, Michael Erman

(Reuters) – The plan to roll out Merck & Co’s promising antiviral pill to treat COVID-19 risks repeating the inequities of vaccine distribution, potentially leaving the nations with the greatest need once again at the back of the line, international health groups say.

For example, only about 5% of Africa’s population is immunized, creating an urgent need for therapeutics that could keep people out of hospitals. This is compared to the 70% rate of vaccination in many wealthy countries.

Merck applied on October 11 for U.S. emergency approval of COVID-19’s first pill. This was after the drug reduced hospitalizations by half and death rates by half in large clinical trials. Ridgeback Biotherapeutics may soon approve this medicine.

U.S. drugmaker granted several generics for its antiviral molnupiravir prior to its brand being approved for marketing.

However, international health officials have stated that this does not allow the medicine to be distributed in sufficient numbers in low- or middle-income countries.

Merck expects to manufacture 10 million pill treatment kits this year. This is a tablet that’s taken two times a day, for five days. There will also be 20 million more next year.

It also has licensing agreements with eight Indian pharmaceutical companies that will permit cheaper generics for 109 countries, which is something international organizations acknowledge as a concession.

However, as rich nations lock up Molnupiravir supply contracts, the United States has already secured 1.7 Million Courses with an Option for 3.5 Million More by January 20, 2023. The cost of each course is approximately $700. There are growing concerns over who could be affected.

NOT MOVING ENOUGH QUICKLY

Merck claimed it worked with technology transfer to begin generic manufacturing. That contrasts to the vaccine makers, who refuse to grant generic versions of their products or to waive patents.

However, a report by the United Nations Access to COVID-19 tools Accelerator program that purchases COVID-19 therapies for developing countries raised concern about U.N. agencies’ inability to move quickly enough to acquire sufficient volumes of possible new treatment options ahead of time.

Medicines Patent Pool (NASDAQ 🙂 (MPP), an UN-backed public organization for health, currently has 24 companies that have signed up to the pool and are ready to manufacture the drug if Merck expands the licenses.

“If you’re not in the license, you’re relying on Merck, and it looks to us that that could mean a potential supply shortfall as well as overpricing,” said Peter Maybarduk of Public Citizen, who sits on the MPP governance board. That could mean that wealthy countries might outbid poorer nations to purchase the medication.

The availability and timing of generic medications is unknown. The 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.

Additionally, approval by the World Health Organization is required for manufacturing in low-income countries. This regulatory process can often take several months.

Merck said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country’s ability to pay. Merck confirmed that it was in talks about the expansion of generic Molnupiravir licenses “to create sufficient global supply quality-assured product for worldwide orders.”

Another MPP official stated that middle income countries would find it difficult to bargain with the wealthiest nations.

Australia, South Korea and Thailand, as well as Singapore, Singapore, Singapore, Taiwan, Singapore, Malaysia, said that they had already negotiated supply agreements with Merck. After Merck has applied for European authorization, the EU may purchase the pill.

Paul Schaper is Merck’s executive Director of Global Public Policy. He stated that all eight generic manufacturing companies chosen by Merck are WHO qualified facilities. This allows them to supply Global Fund customers like the Global Fund. They will decide their manufacturing costs and set the pricing.

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