Pfizer will allow its Kovid pill to be manufactured and sold cheaply in poor countries

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Pfizer will allow its Kovid pill to be manufactured and sold cheaply in poor countries

Durban, South Africa – Pfizer on Tuesday announced a deal to allow it to manufacture and sell its promising COVID-19 treatment cheaply in 95 poor countries that are home to more than half of the world’s population.

The agreement follows a similar arrangement negotiated by Merck last month, and together the deals have the potential to expand global production of two simple antiviral pills that could change the course of the pandemic by preventing serious illness from the coronavirus.

“The fact that we now have two manufacturer-anywhere licenses for these two drugs is a big change, and it’s a big contrast with the hitherto restrictive licenses for vaccines,” said James Love, a Leads the non-profit organization Knowledge Ecology International. Researches access to medical products.

Under the agreement, Pfizer will provide a royalty-free license for the pill to Medicines Patent Pool, a nonprofit backed by the United Nations, which will allow manufacturers to extract a sublicense. They will receive Pfizer’s formula for the drug, and will be able to sell it for use in 95 developing countries, mostly in Africa and Asia, once regulators authorize the drug in those places. The organization struck a similar deal with Merck for its COVID antiviral pill, molnupirvir, which will be manufactured and sold cheaply in 105 poor countries.

Still, there are serious concerns about whether the move will be enough to ensure an adequate supply of the drug to countries that still lack COVID vaccines.

Like the Merck deal, the Pfizer deal does not cover the many poor countries that have been hit hard by the virus. Brazil, which has one of the world’s worst pandemic death tolls, as well as Cuba, Iraq, Libya and Jamaica, must buy pills directly from Pfizer, most likely the generic manufacturers who will charge, and those countries’ Compared to higher prices. risk of supply shutdown China and Russia – middle-income countries that are home to 1.5 billion people combined – are both out of deals, as is Brazil.

Still, Pfizer’s outlook on its medicine differs from the way it has handled its COVID vaccine. The company has shipped more than two billion vaccine doses globally, but only 167 million of them to developing countries where about four billion people live. It has not granted any manufacturer a license to make its own COVID vaccine, for which it is on track to generate $36 billion in revenue this year.

In a major clinical trial, Pfizer’s pill, which will be sold in wealthy countries under the brand name Paxlovid, was found to be significantly more effective in preventing serious disease when high-risk, illiterate study volunteers were given COVID-19 symptoms immediately after they started showing symptoms. given after.

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The pill is urgently needed in places where few people have yet had the opportunity to be vaccinated. And because it’s a pill that can be taken at home, it will be much easier to deliver than treatments typically given intravenously.

“It’s going to be really important for low- and middle-income countries, because it’s easy to take, has a short course of only five days, and has potential for production,” said Charles Gore, executive director of the Medicines Patent Pool. relatively cheap.” ,

But Felipe Carvalho, coordinator of Doctors Without Borders’ access-to-medicine campaign in Brazil, lamented his country’s exclusion from the deal. “It is disgraceful that a heavily burdened country like Brazil is once again left behind in terms of treatment,” he said. While he is an upper-middle-income country, he said, three-quarters of Brazil’s people rely on the public health system and some can afford expensive treatment.

For all their promise, the effectiveness of Pfizer and Merck’s pills will depend on patients having access to affordable and easy-to-use COVID testing. Treatment must be given within a few days after symptoms are most effective, which experts predict will be challenging in wealthy countries and even more difficult in countries where people have less reliable access to health care providers.

Pfizer’s own production of its treatment will be limited at first. The company says it can produce enough pills for 180,000 people by the end of this year — the equivalent of about a week’s supply for everyone infected in Florida at the height of that state’s delta wave. The company expects to ramp up manufacturing, including 21 million or more in the first half of the year, producing at least 50 million treatment courses in 2022. Pfizer has said it will charge poorer countries less for the drug than richer countries.

Pfizer’s treatment may have several advantages over Merck’s drug: according to trial data, it appears to be more effective, and the way it stops the coronavirus from replication seems to be safe, especially for pregnant women and those who are pregnant. For use in women. These factors are expected to drive demand for Pfizer’s pill worldwide.

Australia and Britain have already stopped supplying some of Pfizer’s pills. In the United States, where Pfizer is expected to apply for emergency authorization soon, no supply deals have yet been announced.

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Unlike Merck, which licensed its treatments to Indian generic drug makers while it was still testing its drug, Pfizer has not yet struck a direct deal with any generic drug maker, a move that May have helped ensure a large supply.

Mr Gore said more than 20 companies had approached the patent pool to express interest in licensing Pfizer’s drug and that production could begin in the first quarter of next year. But access will also depend on how quickly regulatory bodies and the World Health Organization move to authorize the drug, he said.

Stephen Saad, chief executive officer of South African drugmaker Aspen Pharmacare, said his firm will probably apply for a sub-license to produce a generic version of the drug and aim to sell it across Africa for around $10 a course. . However, he said he cannot predict how soon the company will be able to produce the drug because Aspen doesn’t yet know what will go into making it or what raw materials are available.

Pfizer’s treatment is to be taken at home as a five-day regimen of 30 tablets. Ten tablets are a low dose of an HIV medicine called ritonavir, which is meant to slow the breakdown of Pfizer’s pill so that it remains active in the body for a longer period of time.

Generic manufacturers worldwide produce ritonavir, but the success of the treatment of COVID will depend on the availability of that drug. Kit Longley, a spokesman for Pfizer, said the company had no supply concerns with ritonavir.

When both Merck and Pfizer drugs are available as generics, it will be possible for doctors to use the two together as a treatment that could keep even more people out of struggling hospitals. Mr Gore cited experiences with other viruses, including HIV and hepatitis C, for which antivirals have been shown to be more effective in combination.

Health equity advocates said the Pfizer deal has done little to address the crisis that has arisen from huge disparities in vaccine access. “Is this the best we can do in a pandemic?” Fatima Hassan, director of a South African organization called the Health Justice Initiative. “Who makes these decisions? What’s the reason Brazil is kicked out? There’s nothing we can do with MPP or Pfizer to get them involved: take it or leave it. So whatever scrap comes your way , you take that, because how can you say no?”

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