The corporation announced a deal that could greatly extend access to the Covid-19 medication, although it excludes several nations that have been heavily struck by the pandemic.
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Pfizer announced a contract on Tuesday that will allow its promising Covid-19 medication to be manufactured and supplied at a cheap cost in 95 impoverished countries that account for more than half of the world’s population.
The pact follows a similar agreement reached by Merck last month, and the partnerships together have the potential to substantially increase global manufacturing of two basic antiviral medicines that could change the trajectory of the pandemic by preventing severe sickness caused by the coronavirus.
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“The fact that we now have two manufacturer-anywhere licences for these two medications is a huge move, and it contrasts sharply with the restrictive licencing for vaccines so far,” said James Love, executive director of Knowledge Ecology International, an organisation that studies medical product availability.
Pfizer will transfer a royalty-free license for the pill to the Medicines Patent Pool, a nonprofit supported by the United Nations, under the terms of the arrangement, which will allow manufacturers to take out a license.
They will receive Pfizer’s medicine formula and will be able to sell it in 95 poor nations, primarily in Africa and Asia, once regulators in those countries approve the drug. A similar agreement was signed with Merck for its Covid antiviral tablet, molnupiravir, to be manufactured and supplied at a low cost in 105 developing nations.
Nonetheless, there are considerable questions about whether this measure will be adequate to secure a sufficient supply of the medicine for nations that still lack Covid vaccines.
The Pfizer accord, like the Merck arrangement, excludes several impoverished countries that have been heavily hit by the virus.
Brazil, which has one of the highest pandemic death rates in the world, as well as Cuba, Iraq, Libya, and Jamaica, will have to buy pills directly from Pfizer, most likely at a greater price than what generics makers will charge, and those countries risk being cut off from supply.
Both treaties exclude China and Russia, two middle-income countries with a combined population of 1.5 billion people. Brazil is also excluded.
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Nonetheless, Pfizer’s approach to its drug is radically different from its approach to the Covid vaccination. The business has distributed over two billion vaccine doses internationally, but only roughly 167 million of those have gone to poor countries, which are home to approximately four billion people.
It has not granted any manufacturers a licence to manufacture its Covid vaccine, which is expected to generate $36 billion in revenue this year.
The Pfizer pill, which will be offered in wealthy nations under the brand name Paxlovid, was proven to be highly effective in preventing severe disease when given to high-risk unvaccinated research volunteers soon after they began showing Covid symptoms in a pivotal clinical experiment.
The medication is desperately required in areas where few people have had the opportunity to be immunized. And because it is a pill that can be taken at home, it will be considerably easier to distribute than intravenous therapies.
“This will be particularly essential for low- and middle-income nations since it’s easy to take, only a five-day course, and possibly quite cheap to create,” said Charles Gore, executive director of the Medicines Patent Pool.
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However, Felipe Carvalho, the coordinator of Doctors Without Borders’ access-to-medicines campaign in Brazil, expressed disappointment that his country was left out of the agreement. “It is inexcusable that a high-burden country like Brazil is once again left behind in terms of access to treatment,” he said.
Even though his country is upper-middle-income, he claims that three-quarters of Brazilians rely on the public health system, and few can afford pricey procedures.
Merck would allow its pill, molnupiravir, to be manufactured and supplied at a reduced cost in 105 developing nations.
Despite their promise, the impact of Pfizer and Merck’s tablets will be dependent on patients’ access to affordable and simple Covid testing.
To be most successful, the medications must be administered within a few days of the onset of symptoms, which experts believe will be tough in wealthy countries and even more difficult in countries where people have less reliable access to health care specialists.
Pfizer’s medication may have the following advantages over Merck’s drug: According to trial results, it looks to be more effective, and the method by which it prevents coronavirus replication appears to be safer, particularly for use in pregnant women and women who may become pregnant.
These reasons are anticipated to raise global demand for Pfizer’s pill.
Pfizer’s medication may have the following advantages over Merck’s drug: According to trial results, it looks to be more effective, and the method by which it prevents coronavirus replication appears to be safer, particularly for use in pregnant women and women who may become pregnant.
These reasons are anticipated to raise global demand for Pfizer’s pill.
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Australia and the United Kingdom have already secured a portion of Pfizer’s tablet supply. No supply contract has yet been announced in the United States, where Pfizer is anticipated to file for emergency authorization soon.
Mr. Gore stated that over 20 companies have contacted the patent pool to indicate interest in a licence to manufacture Pfizer’s medication, and that production may begin in the first quarter of next year.
However, availability will also be determined by how swiftly regulatory organizations and the World Health Organization approve the medicine, he said.
Pfizer’s therapy is designed to be taken at home in the form of a five-day regimen of 30 pills. Ten of the pills include a modest dose of the HIV medicine ritonavir, which is intended to slow the breakdown of Pfizer’s pill so that it remains active in the body for a longer period of time.
Ritonavir is manufactured by generics manufacturers all over the world, however the efficacy of the Covid treatment is dependent on the drug’s availability. Kit Longley, a spokeswoman for Pfizer, stated that the company does not anticipate any supply issues with ritonavir.
When both the Merck and Pfizer medications become generic, clinicians will be able to use them together as a treatment, potentially keeping even more people out of strained hospitals.
Mr. Gore referenced previous experiences with other viruses, such as H.I.V. and hepatitis C, in which antivirals were more successful when used in combination.
