Pfizer will allow low-cost manufacture and sale of its Covid pill in poor countries

DURBAN, South Africa – Pfizer on Tuesday announced an agreement allowing its promising treatment against Covid-19 be manufactured and so...


DURBAN, South Africa – Pfizer on Tuesday announced an agreement allowing its promising treatment against Covid-19 be manufactured and sold cheaply in 95 of the poorest countries, which are home to more than half of the world’s population.

The deal follows a similar deal negotiated by Merck last month, and together the deals have the potential to dramatically increase global production by just two antiviral pills that could alter the course of the pandemic by preventing serious illnesses caused by the coronavirus.

“The fact that we now have two manufacturer’s licenses everywhere for these two drugs is a big change, and this contrasts sharply with the restrictive licenses so far for the vaccines,” said James Love, who heads Knowledge Ecology International, a non-profit organization that seeks access to medical products.

Under the deal, Pfizer will grant a royalty-free license for the pill to the Medicines Patent Pool, a United Nations-backed non-profit organization, in an agreement that will allow manufacturers to sub-license. . They will receive Pfizer’s formula for the drug and can sell it for use in 95 developing countries, primarily Africa and Asia, once regulators clear the drug in those locations. The organization made a similar deal with Merck for its Covid antiviral pill, molnupiravir, which will be manufactured and sold cheaply in 105 poorer countries.

Nonetheless, there are serious concerns about whether this step will do enough to ensure a sufficient supply of the drug for countries that continue to run out of Covid vaccines.

Like the Merck deal, the Pfizer deal excludes a number of the poorest countries that have been hit hard by the virus. Brazil, which has one of the worst pandemic death rates in the world, along with Cuba, Iraq, Libya and Jamaica, will have to buy pills directly from Pfizer, most likely at higher prices. compared to what generic manufacturers will charge, and those countries risk being cut off from supplies. China and Russia – middle-income countries that are home to a total of 1.5 billion people – are excluded from the two agreements, as is Brazil.

Still, Pfizer’s approach to its drug is markedly different from the way it handled its Covid vaccine. The company has shipped more than two billion doses of the vaccine worldwide, but only sent about 167 million to developing countries, which are home to around four billion people. It has not provided any manufacturer with a license to make its Covid vaccine, for which it is on track to generate $ 36 billion in revenue this year.

In a key clinical trial, the Pfizer pill, which will be sold in wealthy countries under the brand name Paxlovid, was found to be highly effective in the prevention of serious illness when given to high-risk unvaccinated study volunteers soon after they start showing symptoms of Covid.

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 dispense than treatments that are typically given intravenously.

“This is going to be really important for low- and middle-income countries because it’s easy to follow, a short five-day course and potentially relatively inexpensive to produce,” said Charles Gore, executive director of the Medicines Patent Pool. .

But Felipe Carvalho, the coordinator of Médecins Sans Frontières’ campaign for access to medicines in Brazil, deplored the exclusion of his country from the agreement. “It is scandalous that a high burden country like Brazil is once again left behind when it comes to access to treatment,” he said. Despite being an upper-middle-income country, he said, three-quarters of Brazilians depend on the public health system and few can afford expensive treatments.

Despite all their promises, the impact of Pfizer and Merck’s pills will depend on patient access to affordable and easy-to-use Covid tests. Treatments should be given a few days after symptoms start to work best, which experts say will be difficult in wealthy countries and even more difficult in countries where people have less reliable access to health care providers. health.

Pfizer’s own production of its treatment will initially be limited. The company says it can produce enough pills by the end of this year for 180,000 people, which equates to about a week’s supply for all those infected. in Florida at the height of the Delta wave in that state. The company plans to ramp up manufacturing, producing at least 50 million treatments in 2022, including 21 million or more in the first half of the year. Pfizer said it would charge poorer countries less than richer countries.

Pfizer’s treatment may have several advantages over the Merck drug: it appears to be more effective, according to trial data, and the way it prevents the coronavirus from replicating appears to be safer, especially for use in women. pregnant and women at risk of becoming pregnant. These factors are likely to increase the demand for Pfizer pills around the world.

Australia and Britain have already blocked part of Pfizer’s supply of the pill. In the United States, where Pfizer is expected to seek emergency clearance soon, no supply agreement has yet been announced.

Unlike Merck, which also cleared its treatment to Indian generic drug makers while it was still testing its drug, Pfizer has yet to strike a deal directly with the generic drug makers, a move that could have helped to ensure a larger supply.

Mr Gore said more than 20 companies have contacted the patent pool to express interest in a license to make the drug from Pfizer and production could begin in the first quarter of next year. But access will also depend on how quickly regulators and the World Health Organization approve the drug, he said.

Stephen Saad, chief executive of Aspen Pharmacare, a South African drug maker, said his company would likely apply for a sublicence to make a generic version of the drug and aim to sell it for around $ 10 a course across the country. ‘Africa. However, he said he couldn’t predict how soon the company would be able to produce the drug because, as of now, Aspen has no idea what will be involved in its manufacturing or sourcing. in raw ingredients available.

Pfizer treatment is intended to be taken at home as a 30 tablet regimen over five days. Ten of the pills are a low dose of an anti-HIV medicine known as ritonavir, which is intended to slow down the breakdown of Pfizer’s pill so that it stays active in the body for longer.

Generic manufacturers around the world produce ritonavir, but the success of Covid treatment will depend on the availability of this drug. A spokesperson for Pfizer, Kit Longley, said the company does not anticipate any problems with the supply of ritonavir.

When the Merck and Pfizer drugs become available as generics, it will be possible for doctors to use the two together as a treatment that could prevent even more people from accessing struggling hospitals. Mr Gore cited experiences with other viruses, including HIV and hepatitis C, where antivirals have been shown to be more effective when taken in combination.

Health equity advocates said the Pfizer deal had done far too little to address the crisis created by the huge disparity in access to vaccines. “Is this the best we can do in a pandemic? Said Fatima Hassan, director of a South African organization called the Health Justice Initiative. “Who makes these decisions? What is the reason for excluding Brazil? There is nothing we can do with the MPP or Pfizer to include them: take it or leave it. So you take all the leftovers that come to you, because how can you say no? “

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Newsrust - US Top News: Pfizer will allow low-cost manufacture and sale of its Covid pill in poor countries
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