The company announced a deal that could help significantly expand access to the Covid-19 treatment, but the agreement excludes a number of countries hit hard by the pandemic.
By Stephanie Nolen and Rebecca Robbins
Nov. 16, 2021, 6:45 a.m. ET
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.
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.
Under the 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 two billion vaccine doses globally but sent only about 167 million of those to the developing countries that are home to about four 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.
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. While his is an upper-middle-income country, he said, three-quarters of Brazilians rely on the public health system and few can afford expensive treatments.
For all their promise, the impact of the pills from Pfizer and Merck will depend on patients having access to affordable and easy-to-use Covid testing. The treatments must be given within a few days after symptoms start to be 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 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 expects to ramp up manufacturing, producing at least 50 million treatment courses in 2022, including 21 million or more in the first half of the year. Pfizer has said it will charge poorer countries less for the drug than wealthier ones.
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. In the United States, where Pfizer is expected to soon apply for emergency authorization, no supply deal has yet been announced.
Unlike Merck, which also licensed its treatment to Indian generic drug manufacturers while it was still testing its drug, Pfizer has yet to make a deal directly with any generics drugmakers, a step that might have helped ensure larger supply.
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. But access will also depend on how quickly regulatory bodies and the World Health Organization move to authorize the medication, he said.
Stephen Saad, the chief executive of Aspen Pharmacare, a South African drugmaker, said his firm would probably apply for a sublicense to make a generic version of the drug and aim to sell it for about $10 a course across Africa. However, he said he could not predict how soon the company would be able to produce the drug because as yet Aspen knows nothing about what will be involved in making it or what supply of raw ingredients is available.
Pfizer’s treatment is meant to be taken at home as a five-day regimen of 30 pills. Ten of the pills are a low dose 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. A spokesman for Pfizer, Kit Longley, said the company did not foresee any supply concerns with ritonavir.
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. Mr. Gore cited experiences with other viruses, including H.I.V. and hepatitis C, for which antivirals have proven 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, 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?”
Stephanie Nolen covers global health. She has reported on public health, economic development and humanitarian crises from more than 80 countries around the world
Rebecca Robbins joined The Times in 2020 as a business reporter focused on covering Covid-19 vaccines. She has been reporting on health and medicine since 2015.
https://www.nytimes.com/2021/11/16/heal ... fizer.html
Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries
Re: Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries
BUT, a problem in the US alone , let alone poor countries:
By Lev Facher Nov. 23, 2021, STAT News
Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool that could, perhaps, finally help life return to normal. But basic gaps in the U.S. health system could mean that two new treatments from Pfizer and Merck won’t make much of a difference after all.
The companies’ treatments, which haven’t yet received emergency authorization, could make a Covid diagnosis dramatically less threatening. But in practice, before receiving the pills, patients may need to jump through a series of hoops that often prevent Americans from accessing care: Recognizing their symptoms, taking a test, getting a prescription from a clinician, and filling the prescription at a pharmacy.
“Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment.”
The skepticism surrounding the antivirals highlights the country’s continued lack of basic pandemic-response infrastructure, even 22 months after the country’s first recorded case of Covid-19. And it highlights, too, that despite profoundly successful partnerships between the U.S. government and major pharmaceutical companies, the country’s health system often fails to deliver lifesaving vaccines and medicines to those at highest risk.
To make matters worse, access to the antiviral drugs could potentially break down across typical lines of income and race, echoing the country’s initial struggle to vaccinate many of society’s most medically vulnerable, as well as historically marginalized communities.
“Many of the people who will be at highest risk, people with chronic illnesses, people who may not have been vaccinated, individuals who largely don’t have health care, people who may not have a primary care doctor — these are the people who are most likely to benefit from antivirals, but may be those who are least likely to receive them,” said Adam Gaffney, a Harvard Medical School professor and progressive health policy advocate.
Indeed, clinical trials for both the Pfizer and Merck antivirals focused on unvaccinated people with at least one risk factor for developing severe Covid-19. Trial data, as disclosed by the drug companies, shows them to be remarkably effective: No patient in either study died after being treated with a course of antivirals.
But it might be difficult to get the drugs outside a clinical trial setting. Depending on the particular patient, it could involve four individual steps: recognizing symptoms, receiving a positive Covid-19 test result, being prescribed an antiviral by a doctor, and picking up the pills at a nearby pharmacy.
Each step could prove difficult, Gaffney said, beginning with the challenge of recognizing symptoms during winter, when early signs of Covid-19 might be easily written off as a cold, flu, or allergies. Even if patients do quickly suspect they have Covid, diagnostic tests are still sometimes hard to come by. Many of the patients who test positive won’t have primary care physicians. And perhaps worst: The antivirals are ideally taken just three days after symptom onset, meaning the four-step process can’t face any setbacks.
Of all the challenges patients will face when seeking the antiviral treatments, the lack of access to efficient testing is by far the largest.
“I have worries about how impactful [the antivirals] will be, given the fragmentation in our health care system and lack of access to care — and lack of access to testing,” Gaffney said. “Clearly our testing infrastructure is not where it needs to be, particularly for disadvantaged people.”
That puts the U.S. at odds with other high-income countries, like the United Kingdom, where the government is shipping rapid Covid-19 tests for free to anybody who asks.
And even for people who do have access to testing, some PCR diagnostics need to be shipped to a lab that won’t return a result for 24 hours, at least.
“Antivirals like these need ‘companion’ diagnostics,” said Amesh Adalja, a doctor and infectious diseases researcher at the Johns Hopkins School of Public Health. “The tests we have today and throughout the pandemic have not been companions, but more like Cabbage Patch dolls that you have to work hard, stand in lines, and drive all over town to find.”
The Biden administration has already sought to scale up testing availability, announcing a recent $650 million investment in scaling up the manufacturing of rapid tests.
For some populations, though, testing won’t be as much of an obstacle.
Gounder suggested that some immunocompromised people, for instance, should be prescribed the antivirals preemptively, if they’re exposed to Covid but haven’t tested positive — eliminating a potentially burdensome step.
Nursing homes and long-term care facilities, too, might be uniquely equipped to execute the entire four-step process from start to finish: recognizing symptoms, administering a test, prescribing the drugs, and administering them.
Ideally, though, people who live outside congregate settings would be able to access the same level of service at retail pharmacies. Other fixes, Gounder suggested, could include issuing a “standing order” for the drugs — essentially, allowing an entire city or state’s population to receive the drugs without a prescription.
“It has to be one-stop shopping,” Gounder said. “There can’t be multiple steps to all of it. There might be a few different such pathways: One might be that you walk into your local drugstore, which I think for a lot of people is the most likely.”
The Biden administration has already moved to make that a reality, anticipating that the Food and Drug Administration will likely authorize the drugs for emergency use. In a little-noticed regulatory move, the Department of Health and Human Services announced on Sept. 14 that pharmacists can prescribe, dispense, and administer Covid-19 therapeutics.
An FDA advisory committee will meet on Nov. 30 to discuss the antiviral developed by Merck and Ridgeback Therapeutics, which could trigger an emergency authorization soon afterward. Pfizer formally requested an emergency authorization for its drug last week, but the agency hasn’t yet scheduled a hearing date.
Even though regulators haven’t authorized or approved either drug, the White House has aggressively sought to guarantee its future supply.
This month, the White House announced it had acquired 10 million treatment courses of Pfizer’s antiviral, for $5.3 billion. Earlier this year, the administration announced it had paid $1.2 billion for 1.7 million five-day courses of the drug developed by Merck and Ridgeback Therapeutics. Both deals are contingent on FDA authorization.
“This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with Covid-19,” health secretary Xavier Becerra said last week in a statement announcing the Pfizer acquisition.
The administration’s move does solve one early concern about broad access to antivirals: Since the federal government has purchased them in advance, they’ll largely be free to patients, similar to Covid-19 vaccines.
Still, experts cautioned that while the antivirals, at best, are a valuable tool in the country’s Covid-fighting arsenal, they’re no cure-all.
“It’s unlikely,” Gaffney said, “that these drugs are going to be the silver bullet that ends this pandemic.”
By Lev Facher Nov. 23, 2021, STAT News
Antiviral drugs for treating Covid-19 have been hailed as a pandemic “game-changer” — a tool that could, perhaps, finally help life return to normal. But basic gaps in the U.S. health system could mean that two new treatments from Pfizer and Merck won’t make much of a difference after all.
The companies’ treatments, which haven’t yet received emergency authorization, could make a Covid diagnosis dramatically less threatening. But in practice, before receiving the pills, patients may need to jump through a series of hoops that often prevent Americans from accessing care: Recognizing their symptoms, taking a test, getting a prescription from a clinician, and filling the prescription at a pharmacy.
“Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment.”
The skepticism surrounding the antivirals highlights the country’s continued lack of basic pandemic-response infrastructure, even 22 months after the country’s first recorded case of Covid-19. And it highlights, too, that despite profoundly successful partnerships between the U.S. government and major pharmaceutical companies, the country’s health system often fails to deliver lifesaving vaccines and medicines to those at highest risk.
To make matters worse, access to the antiviral drugs could potentially break down across typical lines of income and race, echoing the country’s initial struggle to vaccinate many of society’s most medically vulnerable, as well as historically marginalized communities.
“Many of the people who will be at highest risk, people with chronic illnesses, people who may not have been vaccinated, individuals who largely don’t have health care, people who may not have a primary care doctor — these are the people who are most likely to benefit from antivirals, but may be those who are least likely to receive them,” said Adam Gaffney, a Harvard Medical School professor and progressive health policy advocate.
Indeed, clinical trials for both the Pfizer and Merck antivirals focused on unvaccinated people with at least one risk factor for developing severe Covid-19. Trial data, as disclosed by the drug companies, shows them to be remarkably effective: No patient in either study died after being treated with a course of antivirals.
But it might be difficult to get the drugs outside a clinical trial setting. Depending on the particular patient, it could involve four individual steps: recognizing symptoms, receiving a positive Covid-19 test result, being prescribed an antiviral by a doctor, and picking up the pills at a nearby pharmacy.
Each step could prove difficult, Gaffney said, beginning with the challenge of recognizing symptoms during winter, when early signs of Covid-19 might be easily written off as a cold, flu, or allergies. Even if patients do quickly suspect they have Covid, diagnostic tests are still sometimes hard to come by. Many of the patients who test positive won’t have primary care physicians. And perhaps worst: The antivirals are ideally taken just three days after symptom onset, meaning the four-step process can’t face any setbacks.
Of all the challenges patients will face when seeking the antiviral treatments, the lack of access to efficient testing is by far the largest.
“I have worries about how impactful [the antivirals] will be, given the fragmentation in our health care system and lack of access to care — and lack of access to testing,” Gaffney said. “Clearly our testing infrastructure is not where it needs to be, particularly for disadvantaged people.”
That puts the U.S. at odds with other high-income countries, like the United Kingdom, where the government is shipping rapid Covid-19 tests for free to anybody who asks.
And even for people who do have access to testing, some PCR diagnostics need to be shipped to a lab that won’t return a result for 24 hours, at least.
“Antivirals like these need ‘companion’ diagnostics,” said Amesh Adalja, a doctor and infectious diseases researcher at the Johns Hopkins School of Public Health. “The tests we have today and throughout the pandemic have not been companions, but more like Cabbage Patch dolls that you have to work hard, stand in lines, and drive all over town to find.”
The Biden administration has already sought to scale up testing availability, announcing a recent $650 million investment in scaling up the manufacturing of rapid tests.
For some populations, though, testing won’t be as much of an obstacle.
Gounder suggested that some immunocompromised people, for instance, should be prescribed the antivirals preemptively, if they’re exposed to Covid but haven’t tested positive — eliminating a potentially burdensome step.
Nursing homes and long-term care facilities, too, might be uniquely equipped to execute the entire four-step process from start to finish: recognizing symptoms, administering a test, prescribing the drugs, and administering them.
Ideally, though, people who live outside congregate settings would be able to access the same level of service at retail pharmacies. Other fixes, Gounder suggested, could include issuing a “standing order” for the drugs — essentially, allowing an entire city or state’s population to receive the drugs without a prescription.
“It has to be one-stop shopping,” Gounder said. “There can’t be multiple steps to all of it. There might be a few different such pathways: One might be that you walk into your local drugstore, which I think for a lot of people is the most likely.”
The Biden administration has already moved to make that a reality, anticipating that the Food and Drug Administration will likely authorize the drugs for emergency use. In a little-noticed regulatory move, the Department of Health and Human Services announced on Sept. 14 that pharmacists can prescribe, dispense, and administer Covid-19 therapeutics.
An FDA advisory committee will meet on Nov. 30 to discuss the antiviral developed by Merck and Ridgeback Therapeutics, which could trigger an emergency authorization soon afterward. Pfizer formally requested an emergency authorization for its drug last week, but the agency hasn’t yet scheduled a hearing date.
Even though regulators haven’t authorized or approved either drug, the White House has aggressively sought to guarantee its future supply.
This month, the White House announced it had acquired 10 million treatment courses of Pfizer’s antiviral, for $5.3 billion. Earlier this year, the administration announced it had paid $1.2 billion for 1.7 million five-day courses of the drug developed by Merck and Ridgeback Therapeutics. Both deals are contingent on FDA authorization.
“This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with Covid-19,” health secretary Xavier Becerra said last week in a statement announcing the Pfizer acquisition.
The administration’s move does solve one early concern about broad access to antivirals: Since the federal government has purchased them in advance, they’ll largely be free to patients, similar to Covid-19 vaccines.
Still, experts cautioned that while the antivirals, at best, are a valuable tool in the country’s Covid-fighting arsenal, they’re no cure-all.
“It’s unlikely,” Gaffney said, “that these drugs are going to be the silver bullet that ends this pandemic.”
Re: Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries
This is quite a problem, accurately described, especially if you need to be tested before getting a prescription.“Our routine medical systems are not really set up for this,” said Céline Gounder, a physician and NYU professor who served on President Biden’s Covid advisory board in the months before his inauguration. “These are medications that need to be started within three days of developing symptoms. It can take you longer than three days to get an appointment.”
The best-case scenario would be for everyone to have a course of this medication in their cabinets along with several rapid tests, so that we could self-administer.
Good luck with that!
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