Pfizer will allow its COVID pill to be made and sold cheaply in poor countries
DURBAN, South Africa — Pfizer announced a deal Tuesday to allow its promising COVID19 treatment to be made and sold inexpensively in 95 poorer nations 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 vastly expand global production of two simple antiviral pills that could alter the course of the pandemic by preventing severe illness from the coronavirus.
“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.
Also Tuesday, Pfizer asked U.S. regulators to authorize the experimental pill in the United States, setting the stage for a likely launch this winter of a the treatment that can be taken at home.
Pfizer’s pill has been shown to significantly cut the rate of hospitalizations and deaths among people with coronavirus infections. The Food and Drug Administration is already reviewing a competing pill from Merck, and several smaller drugmakers are also expected to seek authorization for their own antiviral pills in the coming months.
Under the drugmaking agreement, Pfizer will grant a royalty-free license for the pill to the Medicines Patent Pool, a nonprofit backed by the United
Nations, in a deal that will allow manufacturers to take out 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. The organization reached a similar deal with Merck for its COVID antiviral pill, molnupiravir, to be made and sold inexpensively in 105 poorer countries.
Nevertheless, there are serious concerns about whether this step will do enough to ensure sufficient supply of the drug for countries that continue to lack COVID vaccines.
Like the Merck deal, the Pfizer agreement excludes a number of poorer 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, 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. The company has shipped more than 2 billion vaccine doses globally but sent only about 167 million of those to the developing countries that are home to about 4 billion people. It has not provided any manufacturers a license to make its COVID vaccine, for which it is on track to bring in $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 strongly effective in preventing severe disease when given to high-risk unvaccinated study volunteers soon after they started showing COVID symptoms.
The pill is urgently needed in places where few people have yet had the opportunity to be vaccinated. And because it is a pill that can be taken at home, it will be much easier to distribute 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 take, just a short course of five days, and potentially relatively cheap to produce,” said Charles Gore, executive director of the Medicines Patent Pool.
When both the 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. Gore cited experiences with other viruses, including HIV and hepatitis C, for which antivirals have proved more effective taken in combination.
Advocates for health equity said that the Pfizer deal did far too little to address the crisis that has been created by the huge disparity in vaccine access.
“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’s the rationale for Brazil being excluded? There’s nothing we can do with the MPP 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?”