DURBAN, South Africa — Pfizer announced a deal on Tuesday to allow its promising Covid-19 treatment to be made and sold inexpensively in 95 poorer nations that are home to more than half of the world’s population.
Merck negotiated a similar arrangement last month. The deals could vastly increase global production of two simple antiviral medications that could alter course of pandemic by preventing severe coronavirus-related illness.
“The fact that we now have two manufacturer-anywhere licenses for these two drugs is a big change, and it draws a big contrast with the restrictive licensing so far for vaccines,” said James Love, who leads Knowledge Ecology International, a nonprofit that researches access to medical products.
The agreement will allow manufacturers to obtain a sublicense. They will receive Pfizer’s formula for the drug, and be able to sell it for use in 95 developing countries, mostly in Africa and Asia, once regulators authorize the drug in those places. Merck reached a similar agreement with the organization for its Covid antiviral drug, molnupiravir. It will be made and sold cheaply to 105 poorer nations.
However, there are serious concerns that this step will not be sufficient to ensure adequate supply of the drug in countries that still lack Covid vaccines.
The Pfizer deal excludes some poorer countries, much like the Merck deal. Brazil, which has one of the world’s worst pandemic death tolls, as well as Cuba, Iraq, Libya and Jamaica, will have to buy pills directly from Pfizer, most likely at higher prices compared with what the generics manufacturers will charge, and those countries risk getting shut out of supplies. China and Russia — middle-income countries that are home to a combined 1.5 billion people — are excluded from both deals, as is Brazil.
Still, Pfizer’s approach on its drug is markedly different from the way it has handled its Covid vaccine. Pfizer has shipped more than 2 billion vaccine doses worldwide, but only 167 million to the developing world, which is home to approximately four billion people. It has not given any manufacturers a license to manufacture its Covid vaccine. However, it is on track for $36 billion in revenue this fiscal year.
The Pfizer pill, which will soon be sold in wealthy nations under the brand Paxlovid was found to be highly effective in preventing severe diseases when administered to high-risk, unvaccinated volunteers shortly after they began to show Covid symptoms.
In areas where many people have not had the opportunity to get vaccinated, the pill is critical. Because it can be taken at-home, it will be easier for people to get it than intravenously.
“This is going to be really important for low- and-middle income countries, because it’s easy to take, just a short course of five days, and potentially relatively cheap to produce,” said Charles Gore, executive director of the Medicines Patent Pool.
But Felipe Carvalho, the coordinator of Doctors Without Borders’ access-to-medicines campaign in Brazil, lamented his country’s exclusion from the deal. “It is outrageous that a high-burden country like Brazil is once again left behind on access to treatment,” he said. Although Brazil is a country with an upper-middle income, he said that three-quarters of Brazilians depend on the public healthcare system and few can afford expensive treatment.
The impact of the Merck and Pfizer pills will not be as impressive as they promise. Patients must have access to affordable, easy-to-use Covid testing. The treatment must be administered within a few days of the onset of symptoms. This is a challenge for wealthy countries, and more so for countries with less reliable access to healthcare providers.
Pfizer’s own production of its treatment will be limited at first. The company says it can produce enough of the pills by the end of this year for 180,000 people — equivalent to about a one-week supply for everyone infected in Florida at the height of that state’s Delta wave. The company plans to increase manufacturing and produce at least 50,000,000 treatment courses by 2022. This includes 21 million in the first half. Pfizer said that it would charge poorer countries less than richer countries for the drug.
Pfizer’s treatment may have several advantages over Merck’s drug: It appears to be more effective, according to trial data, and the way it stops the coronavirus from replicating seems to be safer, especially for use in pregnant women and women who may become pregnant. These factors are likely to increase demand for Pfizer’s pill around the world.
Australia and Britain have already locked up some of Pfizer’s supply of its pill. No supply deal has been announced in the United States, where Pfizer will soon apply for emergency authorization.
Pfizer has yet not to enter into a direct deal with any generics drugmakers like Merck. This could have been a step to ensure a greater supply, but Merck licensed its treatment to Indian generic drug makers while it was still testing the drug.
Mr. Gore said that more than 20 companies had contacted the patents pool to express interest in a license to make Pfizer’s drug and that production could start in the first quarter of next year. He said that access to the medication will depend on how quickly the World Health Organization and regulatory bodies approve the drug.
Aspen Pharmacare’s chief executive Stephen Saad stated that his company would apply for a sublicense for the generic version of the drug. He hopes to sell the drug for around $10 per course in Africa. He said that he couldn’t predict when the company would be able produce the drug as Aspen doesn’t know the exact process or the availability of raw materials.
Pfizer’s treatment is meant to be taken at home as a five-day regimen of 30 pills. Ten pills contain a low amount of an H.I.V. drug known as ritonavir, meant to slow the breakdown of Pfizer’s pill so that it remains active in the body longer.
Generics manufacturers around the world produce ritonavir, but success of the Covid treatment will depend on that drug’s availability. Kit Longley, spokesperson for Pfizer said that they didn’t anticipate any supply issues with ritonavir.
Merck and Pfizer drugs will soon be available as generics so doctors can use them together to treat patients. This will help keep more people from going to hospitals that are struggling. Mr. Gore mentioned his experience with H.I.V. Hepatitis C, and H.I.V., for which antivirals have been more effective when taken together.
Advocates for equity in health said that the Pfizer deal did little to address the crisis created by the large disparity between vaccine access. “Is this the best we can do in a pandemic?” said Fatima Hassan, the director of a South African organization called the Health Justice Initiative. “Who makes these decisions? What’s the rationale for Brazil being excluded? There’s nothing we can do with the M.P.P. or Pfizer to get them included: It’s take it or leave it. So you take whatever scraps come your way, because how can you say no?”
Source: NY Times