When a ‘Miracle’ Cystic Fibrosis Drug Is Out of Reach

Trikafta’s U.S. list price is over $322,000 a year. That is nearly 60 times the annual salary of a minimum wage earner in Turkey, where the government wanted to import a generic version made in Argentina. Vertex sued and blocked it.Vertex has brought in $17 billion from Trikafta since 2019. An analysis by researchers in Britain found that a year’s supply of the drug could be manufactured for just $5,700.The company says it is working to increase access to the drug globally.

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‘Miracle’ Cystic Fibrosis Drug Kept Out of Reach in Developing Countries

When Seshagiri Buddana learned of a powerful new cystic fibrosis drug that was transforming lives in the United States and Europe, he was filled with hope that it could help his son, Hemanth, who had spent much of his childhood in a hospital bed. But the family couldn’t get the drug because they live in India.The drug’s maker, Vertex Pharmaceuticals, a large biotech company based in Boston, is not making it available in India or virtually anywhere in the developing world. The company is not trying to sell it, or allowing a local company to make it. Vertex is blocking potential generic competitors by seeking patents in numerous countries.Hemanth died in December, a day before his ninth birthday and 18 months after he would have been eligible to get the drug, called Trikafta, had he lived in the United States.Throughout much of Asia, Africa and Latin America, families like Hemanth’s are watching Trikafta transform the lives of tens of thousands of cystic fibrosis patients in wealthy nations but say they are blocked by the company at every turn in their efforts to get the drug themselves.Trikafta, taken as three tablets a day, is the most powerful and widely used of Vertex’s four cystic fibrosis medications. With a list price of over $322,000 annually in the United States, it is expected to cost millions of dollars over the course of a patient’s lifetime. An analysis led by researchers in Britain found that a year’s supply of the drug could be manufactured at an estimated cost of just $5,700.Vertex has reported more than $15 billion in sales for Trikafta since it was first approved in 2019.This week, a group of patients and their families in four countries on four continents initiated legal and regulatory steps to try to force their governments to override intellectual property protections and allow a low-cost generic version of Trikafta to be imported or made locally. Under the process, known as compulsory licensing, generic makers would pay Vertex a royalty.Three of the actions are in India, Ukraine and South Africa — where Vertex has been obstructing efforts to make the drug available, patients and families say. The fourth is in Brazil, where Vertex is trying to win coverage for the drug; the patients and families’ concern there is that the brand-name drug will be too expensive.Trikafta is taken as three tablets a day and has a list price of $322,000 annually in the U.S.Dado Galdieri for The New York TimesRodrigo Rockenbach, 11, lives with cystic fibrosis in Brazil, where his father sued the government to get him Vertex’s drugs, and now helps other patients do the same.Dado Galdieri for The New York TimesRaphaelle Pereira of Brazil blows on a small pump as part of regular physiotherapy for her lungs.Dado Galdieri for The New York TimesCystic fibrosis is a genetic disease that damages the lungs and digestive system. Patients often die in early adulthood, but Trikafta is dramatically extending life expectancy.“Every patient in the world has access to the internet and wants this drug,” Christine Noke, a patient advocate in Turkey, said.More on IndiaAdani Group: Gautam Adani has often said his company’s goals were in lock step with India’s needs. Now, Adani Group’s fortunes are crashing, a collapse whose pain will be felt across the country.Gin Boom: A blossoming of gin distillers in the southern state of Goa is challenging India’s conservative attitude toward alcohol, along with the country’s often stultifying bureaucracy.On the Big Screen: A Mumbai theater has shown the movie “D.D.L.J.” nearly every day since 1995. In many ways, the India of today looks like the India on the screen.India’s Cram City: In Kota, students from across the country pay steep fees to be tutored for elite-college admissions exams — which most of them will fail.In theory, reaching patients in the developing world would bring in more revenue for a drug company. But some manufacturers resist making their drugs available in poorer countries at lower prices because doing so can erode their ability to charge more in high-income countries. Vertex, which has a monopoly on transformative cystic fibrosis drugs, said it was pushing to increase access globally.“Our teams are working every day to expand access to even more patients around the world through a range of routes, including in low-middle-income countries and low-income countries where access barriers are high due to challenging economic conditions and limited health care infrastructure,” Heather Nichols, a spokeswoman for Vertex, said.Ms. Nichols said that Vertex has begun a “product donation program” in low-income countries. She said the company has provided some form of access to at least one of its cystic fibrosis drugs in Brazil, Poland, Bulgaria, Estonia, Greece, Latvia, Slovakia, Slovenia, Romania and Oman. The company declined to specify which lower-resourced countries have access to Trikafta. The genetic defect that causes cystic fibrosis is most common in people of Northern European ancestry, as are the specific mutations needed for Trikafta to work. The number of cystic fibrosis patients in developing countries who are diagnosed and eligible for the drug is unknown but believed to number in the thousands.In India, a recent survey counted just 600 diagnosed cystic fibrosis patients. Counting India’s tens of thousands of patients who have not been diagnosed, some researchers estimate that India’s total cystic fibrosis population is higher than that in Europe. While a minority of Indians with cystic fibrosis are believed to have mutations that make them eligible for Trikafta, the size of India’s population translates into huge numbers of patients who could benefit from Trikafta.Hemanth Buddana, the Indian boy who died, was given therapies and antibiotics for his frequent lung infections, but there was little available in India to help him breathe or gain weight. Stuck in bed at home in Hyderabad, he taught himself to draw and to speak new languages. A genetic test confirmed that he would be eligible for Trikafta, which has a U.S. list price 20 times as much as the annual salary Mr. Buddana earns as an operations manager at Google. He joined other parents in pushing the Indian government to find a way to get Trikafta for their children. But there was no progress.Vihaan’s father, Sai, prepared his nebulizer at their home in Hyderabad, India.Atul Loke for The New York TimesA nearly abandoned oxygen cylinder in Ms. Pereira’s bedroom. She used a legal process to get Brazil’s public health system to supply her with Trikafta.Dado Galdieri for The New York TimesCheri Nel, 38, a South African who lives with cystic fibrosis, has launched a legal battle to make her government facilitate access to an affordable version of Trikafta.Joao Silva/The New York Times“They say it’s a miracle drug, but it’s not a miracle if it is not available to everyone who need it,” said Shwetha Sree, who also lives in Hyderabad. Her 5-year-old son, Vihaan, has cystic fibrosis — and the mutation that would make him eligible for the drug when he turns 6, if he were to live in the U.S. Since the fight over access to H.I.V. treatment in sub-Saharan Africa in the early 2000s, some drug companies have agreed to sell their medicines at a profitable but significantly lower price in developing countries. The companies also sometimes work with a drug importer to sell the products in those regions.There is also compassionate use, through which drug companies supply products to desperate patients in places where they are unauthorized. Vertex said that it has provided its medications free of charge to 6,500 patients worldwide that way. The company declined to say specifically where it has provided the drugs that way and where it is still doing so. A company can also agree to voluntary licenses, allowing generic manufacturers to make and sell a drug in certain countries, typically in exchange for a royalty. The Medicines Patent Pool, a United Nations-backed nonprofit that brokers that process by issuing sublicenses to generic manufacturers, said it has had no contact with Vertex.New drugs typically take longer to reach poorer countries. But frustration with Vertex’s failure to provide them with any form of access brought together cystic fibrosis patients online and led to a coordinated campaign for compulsory licensing.Governments are often reluctant to do compulsory licensing, which capital markets tend to view as an alarming crack in the wall of intellectual property protection. Still, even if governments refuse to issue a compulsory license, the patient actions may pressure Vertex to make Trikafta available in those countries.Cheri Nel, a 38-year-old investment banker in South Africa who has cystic fibrosis and is eligible for Trikafta, said that she had approached Vertex and suggested several ways the company could increase access and still safeguard its profit and intellectual property. She said she got nowhere and is now leading the action in South Africa.“There’s a balance: You want to keep companies incentivized to investigate and do research and development,” she said. “But it does them no financial harm to let us import a generic because they’re not even trying to sell it.”Vertex has not registered Trikafta with South Africa’s drug regulator, but the company said on Monday that it recently signed an agreement with a distributor there.Rodrigo Rockenbach, 11, uses a nebulizer to increase his intake of medication, as his parents look on.Dado Galdieri for The New York TimesRaphaelle Pereira of Brazil is looking forward to the removal of the port-a-cath that was inserted for her frequent infections and hospitalizations before she began treatment with Trikafta.Dado Galdieri for The New York TimesMs. Sree helped Vihaan with his physiotherapy after a session with the nebulizer.Atul Loke for The New York TimesIn many countries, Vertex has also been seeking patents which deter generic manufacturers from selling the drug there, according to patent filings viewed by The New York Times. The company has a running legal battle with Gador, one of several manufacturers in Argentina making lower-cost generic versions of Vertex’s drugs.Argentina does not recognize Vertex’s intellectual property rights because the company has not joined the global treaty on patent protection. Gador’s scientists reverse-engineered the Vertex drugs and began to sell them to Argentine patients. Then patients from foreign countries began to fly to Argentina to buy the drugs, which can cost as little as $18,000 per year using pesos exchanged on the black market. In the late 2010s, Gador tried to strike a deal with the Turkish government to import its low-cost version of another expensive Vertex cystic fibrosis drug, Orkambi. In 2018, Vertex sued Gador in a Turkish court, arguing that the company was infringing on Vertex’s patents. Vertex won, and the government abandoned the Gador deal.In 2021, after Trikafta had become available in parts of Europe, patients in Turkey began suing their government to try to get the drug.Today, more than 100 patients who have successfully sued the Turkish social security system are on Vertex medications, mostly Trikafta now. Dr. Bulent Karadag, the head of pediatric pulmonology at Turkey’s main cystic fibrosis center, said he had 250 more patients who have been confirmed as eligible for Trikafta but have not been able to get it. “Some patients say they can’t even afford the bus ticket to the hospital, let alone hire a lawyer,” he said. The U.S. list price for a year’s supply of Trikafta is nearly 60 times as much as the annual salary of a minimum wage earner in Turkey.Until Vertex’s drugs, patients had few options, mainly palliative treatment to help them breathe a bit better, and if they could get one, a lung transplant. Vertex’s drugs addressed the underlying cause of the illness, preventing patients’ lungs from clogging in sludgy mucus. Trikafta is stunningly effective at helping patients breathe better, keeping them out of the hospital and extending their lives. Patients and doctors say that the drug’s power becomes evident almost immediately.Raphaelle Pereira, 22, had been waiting for years for a lung transplant in the Brazilian city of Curitiba. By 2021, her weight had dropped to 80 pounds, and she no longer had the strength to walk to the bathroom. Family members sold property and scraped together $54,000 to purchase a two-month supply of Trikafta in the U.S.“I took it for a couple of days, and then I just got up and said, ‘I think I’ll have a shower.’ My whole family was in shock,” she said. “A few days before I couldn’t even lift my arm.” With the data on how the medication had changed her condition, Ms. Pereira used a legal process to get Brazil’s public health system to buy a steady supply for her. She’s now working toward a career as a soccer commentator. Belinda Nell with photos of her sisters Lorryn and Jennifer, both of whom died of cystic fibrosis. Joao Silva/The New York TimesThe obstacles to getting Trikafta in the developing world go beyond the availability of the product. Huge numbers of patients remain undiagnosed. Those who do get diagnosed are unlikely to have access to expensive genetic testing to determine whether they have one of the mutations necessary for the drug to work.About 90 percent of patients of Northern European ancestry have the most common mutation needed for the drug to work, compared with far fewer people from the Middle East, Asia and Africa. In India, estimates range from 19 to 44 percent.Vertex is funding an academic project to better understand the genetics of cystic fibrosis patients in poorer countries. Dr. Milan Macek Jr., a geneticist in Prague, is working with doctors in lower-resourced countries to collect and analyze blood samples from willing patients. He has identified hundreds of diagnosed patients in Eastern Europe, the Middle East and Central Asia who have the most common mutation.Belinda Nell, who is working on the action in South Africa, followed the news about Vertex’s drugs closely, as her two sisters grew increasingly frail with cystic fibrosis.In 2014, Ms. Nell and her sister, Lorryn, who also had the disease, nursed a third sibling, Jennifer, as she was dying of it. Ms. Nell promised Lorryn that she would keep her from the same fate and, in early 2022, managed to obtain a couple months’ supply of Trikafta for her. But Lorryn’s lungs were too damaged, and she died last October.“It’s vital that children everywhere get access from a young age so they don’t endure the end stage like I saw with my sisters,” Ms. Nell said.Elif Ince

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Covid Vaccine Makers Kept Prepayments for Canceled Shots for Poor Nations

Separately, Johnson & Johnson is demanding additional payment for unwanted shots, confidential documents show.As global demand for Covid-19 vaccines dries up, the program responsible for vaccinating the world’s poor has been urgently negotiating to try to get out of its deals with pharmaceutical companies for shots it no longer needs.Drug companies have so far declined to refund $1.4 billion in advance payments for now-canceled doses, according to confidential documents obtained by The New York Times.Gavi, the international immunization organization that bought the shots on behalf of the global Covid vaccination program, Covax, has said little publicly about the costs of canceling the orders. But Gavi financial documents show the organization has been trying to stanch the financial damage. If it cannot strike a more favorable agreement with another company, Johnson & Johnson, it could have to pay still more.Gavi is a Geneva-based nongovernmental organization that uses funds from donors including the U.S. government and the Bill and Melinda Gates Foundation to provide childhood immunizations to lower-income nations. Early in the pandemic, it was charged with buying Covid vaccinations for the developing world — armed with one of the largest-ever mobilizations of humanitarian funding — and began negotiations with the vaccine makers.Those negotiations went badly at the outset. The companies initially shut the organization out of the market, prioritizing high-income countries that were able to pay more to lock up the first doses. Gavi eventually reached deals with nine manufacturers.But the shots did not begin to reach developing countries in significant numbers until mid-2022. By the time Gavi had a steady flow of supply, demand had begun to decline: countries with frail health systems struggled to deliver the shots, and the dominance of the milder Omicron variant sapped people’s motivation to be vaccinated. Now, Covax is winding down far short of its goal of vaccinating 70 percent of the population of each country.The vaccine makers have brought in more than $13 billion from the shots that have been distributed through Covax. Under the contracts, the companies are not obligated to return the prepayments Gavi gave them to reserve vaccines that were ultimately canceled.But in light of how many vaccine doses Gavi has had to cancel, some public health experts criticized the companies’ actions.Covid vaccine manufacturers “have a special responsibility” because their products are a societal good and most were developed with public funding, said Thomas Frieden, the chief executive of the global health nonprofit Resolve to Save Lives and a former director of the United States Centers for Disease Control and Prevention.“That’s a lot of money that could do a lot of good,” he said.He added that other large global health programs have budgets roughly equal to the amount the vaccine makers are holding on to. “The entire polio eradication effort costs about $1 billion a year, and that’s a huge infrastructure,” he said.More on the Coronavirus PandemicEnd of an Era: The Biden administration plans to let the coronavirus public health emergency expire in May, a sign that federal officials believe the pandemic has moved into a new, less dire phase.Long Covid: An analysis of workers’ compensation claims in New York found that 71 percent of claimants with long Covid needed continuing medical treatment or were unable to work for six months or more.Annual Boosters: The Food and Drug Administration proposed that most Americans be offered a single dose of a Covid vaccine each fall, much as they are given flu shots.Gavi has reached settlements with Moderna, the Serum Institute of India and several Chinese manufacturers to cancel unneeded doses, surrendering $700 million in prepayments, the documents show.Another drug company, Novavax, is refusing to refund another $700 million in advance payments for shots it never delivered.Gavi and Johnson & Johnson are locked in a bitter dispute over payment for shots that Gavi told the company months ago it would not need, but which the company produced anyway. Johnson & Johnson is now demanding that Gavi pay an additional, undisclosed amount for them. Gavi had an indirect supply relationship with Pfizer; the Biden administration purchased a billion shots from it to donate through Covax. The United States last year revised its deal with the company, converting an order for 400 million doses into future options. The company said it did not charge any fees to change the order.The terms of Gavi’s deals were kept secret because they were with private companies. There has been no public accounting of how much drug companies have earned from canceled vaccines.The documents say that the manufacturers collectively made $13.8 billion in revenue on the vaccines that were distributed through Covax. Almost 1.9 billion doses have now been shipped, to 146 countries. More than half were purchased directly by Gavi and the rest were donated by high-income countries.Coronavirus vaccines being manufactured at the Serum Institute, in Pune, India. The Serum Institute also struck a deal with Gavi that allowed it to keep payments Gavi had already made, plus a credit.Atul Loke for The New York TimesGavi’s settlements with Moderna and Serum took into account that the manufacturers had already incurred costs such as those for raw ingredients, according to the documents.In a deal to cancel more than 200 million doses reached late last year, Gavi agreed to allow Moderna to keep an advance payment it had made. In exchange, Gavi was released from having to make any additional payments for the doses, meaning they were canceled at a cost “substantially lower” than expected, according to the documents. Moderna also issued Gavi a credit for $58 million for future products, which is good until 2030.Gavi also made concessions to exit its deal with the Serum Institute of India. Gavi canceled 145 million doses by allowing the company to keep money Gavi had paid in advance, in order to cover the cost of materials that had already been procured. Serum also gave Gavi a credit note of an undisclosed amount that the organization can use to procure the many routine immunizations it buys from Serum each year.Moderna and Serum declined to comment on the terms.Gavi and Johnson & Johnson are at odds over 150 million Covid vaccine doses that Gavi ordered but has been trying to cancel for months.Gavi had been expecting a significant share of those doses to be distributed by the end of 2021, but Johnson & Johnson had delivered fewer than 4 million doses by then. (Gavi’s contract with the company did not require it to finish deliveries by that deadline.) When the company was finally ready to ramp up its deliveries last year, demand had plummeted.Gavi’s administrators alerted the company by mid-2022 that they would not need those doses and requested that it stop making new shots for Covax, according to the documents.Johnson & Johnson nevertheless continued to make the shots and sought to deliver them by late 2022, according to the documents. Now, as stipulated in the contract, the company wants Gavi to make additional payment and accept the vaccines. Gavi has proposed that the dispute go to mediation, but the company has “until now refused to engage in meaningful negotiations,” the documents say. Some of the disputed vaccines have expiration dates as early as mid-2023. “In a pandemic, I would want to err on the side of buying too many doses, rather than err on the side of not having enough doses,” said Dr. Seth Berkley, Gavi’s chief executive.Markus Schreiber/Associated PressJake Sargent, a spokesman for Johnson & Johnson, said the company had made the ordered doses available to Covax and kept Gavi informed about production details.In negotiations with Novavax, Gavi is seeking a refund for $700 million it spent on advance payments for shots.Gavi had been expecting Novavax deliveries to begin as soon as summer 2021, but the company bungled its vaccine production. As a consequence, Gavi did not proceed with placing the orders for the vaccines it had originally reserved. Novavax said this was a breach of contract and canceled the deal, keeping the $700 million.The dispute is unresolved. The company is hoping to negotiate a new deal to supply its vaccine to Gavi, said a Novavax spokeswoman, Alison Chartan.Some of the vaccine contracts that Gavi entered into were completely fulfilled. In one case, AstraZeneca issued Gavi a refund when final production costs were lower than expected.Had some vaccine manufacturers not been willing to renegotiate their contracts with Gavi, the costs to the organization could have been much higher. Gavi would have been on the hook for $2.3 billion for the doses it wanted to cancel, the documents show, but it saved $1.6 billion by exiting those contracts.A spokesman for Gavi, Olly Cann, said the organization had made no new payments related to canceled doses. He said the surrendered advance payments represented a fraction of what Gavi would have paid for finished doses.Dr. Seth Berkley, Gavi’s chief executive, declined to comment for this article. But in an interview in December about the future of the global Covid vaccination program, he said Gavi was paying less per dose than what it had initially planned for vaccine purchases and substantially less than high-income countries paid for their shots.Donations for Covid shots substantially inflated Gavi’s budget, and the lost prepayments for canceled Covid vaccines do not threaten its regular childhood-vaccination work.A vaccine storage space in Juba, South Sudan. Lynsey Addario for The New York TimesThe contracts that Gavi has been trying to downsize were negotiated in the uncertain early months of the pandemic, in some cases before the vaccines had been shown to work.“In a pandemic, I would want to err on the side of buying too many doses, rather than err on the side of not having enough doses, particularly given the fact that countries felt that there weren’t enough doses at the beginning,” Dr. Berkley said.Wealthy countries, who ordered many more doses than they needed, have tried to offload their own surpluses onto Covax, which has struggled to absorb them.Covax began deliveries to developing countries in 2021, but the early pace was glacial. When the program finally had vaccines, the shots presented challenges that weak health systems were ill-equipped to manage.Frustrated by the erratic supply, some public health agencies did little to create demand for the vaccines, while a tide of misinformation discouraged people from seeking them out. Sub-Saharan Africa remains the world’s least-vaccinated region, but reported Covid death rates in the region have been comparatively low, which has further eroded interest in the shots.“We have so many offers of donations but we don’t take them, because we don’t want to have them expire here,” said Dr. Andrew Mulwa, who oversees the Covid response at Kenya’s health ministry. “We wonder, do we need to continue to spend money administering Covid-19 vaccines when we have other glaring disparities?”Gavi is sitting on a stockpile of vaccines and expects millions more in donations from high-income countries that are seeking to shed their own oversupply. The organization anticipates a maximum demand of 450 million doses this year — half of what Covax shipped in 2022.

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In Africa, a Mix of Shots Drives an Uncertain Covid Vaccination Push

Supplies are more plentiful now but they are unpredictable and often a jumble of brands. Many places can’t meet the W.H.O.’s recommended dosing schedules.KAMAKWIE, Sierra Leone — In the tumbledown concrete room that has been commandeered as this sleepy African trading center’s Covid-19 vaccination headquarters, a battered freezer holds stacks of boxes with dozens of small glass vials.Stuffed among shots for rotavirus and measles are four brands of Covid vaccines. The vaccination team gives Sinopharm, donated from China, to the youngest and healthiest people because they’ve been told it’s the least effective of the vaccines, said Abdulai Conteh, who runs the operation. AstraZeneca, in which they have more faith, is normally just for people with underlying medical conditions. But the town recently received a big shipment that will expire soon, so the health workers are rushing to use it all up. Johnson & Johnson is given mostly to teachers, as a single shot.Rattling around in a salvaged carton tucked in a corner of the freezer are six vials that came in the last delivery — 36 shots of Pfizer, the most popular vaccination in the United States. That is the only Covid vaccine authorized here for people under 18, so in theory the heath workers try to save it for teenagers — but they also have to use up a vial once it’s open, so sometimes Pfizer is for whomever walks in the door.“More will be coming,” Mr. Conteh said. “We are not sure when.”The jumbled contents of the freezer, and the town’s improvised distribution strategy, are reflective of a new phase in the effort to vaccinate the world against Covid. Supply in the lowest-income countries is growing more plentiful, but it is often an unpredictable hodgepodge, arriving on an irregular schedule, making planning difficult. Underfunded health systems still lack the storage, personnel and transportation needed to carry out broad vaccination campaigns. Scientific understanding is continuously evolving about what it takes to achieve full and strong protection against existing and new Covid-19 variants. The United States and many wealthy countries have been pushing booster shots from Pfizer and Moderna, which use new technology seen as the gold-standard, in line with the latest thinking about the best chance for protection.But African countries continue to rely in part on products and dosing schedules that many researchers believe offer lower levels of protection, further clouding the prospect of stopping potential variants. Many are sticking with regimens that are no longer preferred by the World Health Organization, which developing countries look to for guidance on how and when to give Covid vaccines.In Sierra Leone, the Johnson & Johnson vaccine is still being used as a single shot, although the W.H.O. recommended in December that it should be given as two doses when possible.“What we say is, better one dose than zero,” Austin Demby, Sierra Leone’s health minister, said in an interview in the capital, Freetown. “And I would prefer two doses any time. But the logistics of it is just unbelievable. Imagine trying to track these multiple vaccinations, different dates, different times, different expiration dates. It’s a medley of protocols. It’s a nightmare.”Abdulai Conteh, right, the district health superintendent, loaded a cooler of vaccine doses for delivery at Kamakwie’s Covid vaccine headquarters.Finbarr O’Reilly for The New York TimesThe Pfizer vaccine, donated by the United States, is being delivered here as a two-shot regimen, not three, as it is in high-income countries. In January, the W.H.O. recommended booster shots of Pfizer’s vaccine, starting with the highest priority groups such as older people and health care workers.The two doses of the AstraZeneca shot are being delivered at erratic intervals, not the W.H.O.-recommended gap of eight to 12 weeks, because of difficulty tracking recipients, many of whom are subsistence farmers in rural areas.Sinopharm — the first Covid vaccine Sierra Leone received, through a gift from China early last year — has been found to produce a minimal immune response against the Omicron variant, even when given as three doses. Sierra Leone is giving it as two shots, with an often erratic dosing schedule.With Covid vaccination rates averaging about 14 percent across the continent, public health experts expect Africa to experience a fifth wave of the virus in the coming months, potentially from a new variant that could be more lethal. The target in Sierra Leone is to give primary immunizations to 40 percent of the population by June, but Dr. Demby acknowledged that this is hugely ambitious. Currently the figure is just 12 percent, and almost no one has received a booster shot.Here, as in the rest of West Africa, relatively few Covid cases or deaths have been recorded, likely as a result of a combination of poor reporting, limited testing and a younger population. The Omicron wave that hit the continent late last year drove an apparent spike in cases but not a surge in hospitalizations and deaths. As a result, there is less of a sense of urgency around vaccination.Dr. Denby, the health minister, said that after months of shortages, his country now has “a good stock” of Covid vaccines, but most people are preoccupied with the challenges of daily life, and have “no time whatsoever to go and stand in line for a vaccine.”His ministry has found that the best way to get people to accept a shot is to take it right to them, at churches and mosques, football matches or their doorsteps. But that is expensive. And it requires intensive staffing and diverting other resources away from polio vaccination and anti-malaria efforts that many here see as equal or greater priorities.Vaccine deliveries are now coming to Africa faster than many vaccination programs can get them into arms. Some African governments have had to ask manufacturers to pause shipments until they can use up what they have on hand. An African Union official said the bloc has effectively halted ordering more vaccines until countries can use a recent influx of donated doses from China and Covax, the clearinghouse that orders vaccines for poorer countries and delivers doses donated by other countries.About a quarter of the Covid vaccines that African countries have received have been the shots made by Pfizer and Moderna, which use newer messenger RNA technology, and have been regarded as the gold standard among Covid shots. (That figure omits instances in which the W.H.O. did not have data on which brand was delivered.) This year, the vast majority of the donations expected from the United States and Europe will be those two products.But as the mRNA products come into wider use in Africa, a debate has grown over whether those shots are optimal, both for the population being vaccinated and for stopping the emergence of variants and ending the pandemic.Christiana Dora Dumbuya, left, and Abdul K. Bangura, center, at a vaccination pop-up in Kathantha Yimbo. James S. Conteh, right, received a blue card documenting his first dose.Finbarr O’Reilly for The New York TimesThe shots from Pfizer and Moderna have consistently been found to perform better than vaccines using older technology, on different metrics of inducing immunity to the coronavirus. In particular, mRNA appears to offer the strongest short-term protection against Omicron. Some researchers expect this might well prove true with future variants as well.But the shots that use traditional vaccine technologies are easier to store and transport, and a mounting body of evidence shows that several may offer especially long-lasting protection across new variants, while the protection against infection offered by the Pfizer and Moderna has been found to fade faster over time.“Better means a few things,” Dr. Seth Berkley, the chief executive of Gavi, the main nonprofit behind Covax, in an interview from Geneva. “It obviously means high efficacy but it also means ease of use. It means cost effectiveness, it means duration of protection, and it means the ability to protect against different strains.”He added, “It may be that eventually mRNAs are the best vaccines — I don’t want to say that I know they’re not — but boy, do I not have any evidence that suggests now that they are the best vaccines.”For lower-income countries, non-mRNA shots and single-dose regimens still have an important role to play, said Katherine O’Brien, who directs the W.H.O.’s work on vaccines and immunizations. “Any vaccine that you can deliver is better than no vaccine that can be delivered,” she said.When given the option by the United States and Covax to choose which brand of donated vaccine they want, many lower-income countries have opted for products that have been spurned by rich countries. In Sierra Leone, as in other countries, the top preference is often Johnson & Johnson, because its ease of use as a single shot trumps all other factors.Last year, the W.H.O. called the push for boosters in rich countries morally indefensible when poor countries were facing severe supply shortages. But though those countries are still struggling to administer first doses widely, the agency has recently recommended additional shots for certain populations, and last week it endorsed boosters more emphatically than ever before.A booster shot can take different forms. It could be a second shot of any brand for a person who was initially immunized with a single dose of Johnson & Johnson’s vaccine. Or it could be a third shot — of any brand, but usually mRNA when possible — for someone who had already been fully vaccinated with two shots.When the United States donates doses, it encourages countries to both “double down on primary immunization, because the most important thing is that we get people that baseline of protection, but also make boosters available for people that are eligible,” said Hilary Marston, who leads the Biden administration’s vaccine donation program.Mr. Conteh in an office with freezers containing all types of Covid vaccines.Finbarr O’Reilly for The New York TimesBut in most African countries there is far too little of everything — vaccines, and all of the equipment and trained people it takes to administer them — to envision a significant booster campaign now.At the vaccine headquarters in Kamakwie, the health workers are just trying to figure out how to use the supplies they’ve been given as efficiently as possible. The health ministry, for instance, never instructed health workers to give Pfizer to teens and Johnson & Johnson to teachers, Dr. Demby, the health minister, said. Instead, the community came up with that patchwork rubric on its own. Many local officials have been hesitant to try to stimulate demand in the public, he said, not knowing what shots they will get and when.On a recent Tuesday, the vaccination team headed out with a small Styrofoam cooler of their mishmash of vaccines to the village of Kathantha Yimbo, about a 40 minute drive on a rough dirt track. An advance team had gone through with a motorbike and a bullhorn urging all those who had a vaccination card to turn up in the central square.About 40 people wandered in, but the cards of most showed they already had two Sinopharm shots. They were sent away, with no offers of boosters. Some people had one AstraZeneca, but it was delivered last June so the second shot they got that day came about six months later than the recommended eight to 12-week interval.Rugiatu Dumbuya, 35, who was selling fry cakes in the market, came to see what the excitement was about and decided to get her first vaccine, since the shots were right there. She had heard about Covid on a DVD of news reports a friend of hers purchased in town and played in the market recently. “I saw that people die of Covid sometimes, so I will take this even though I am not sure what it will do to me,” she said, just before she was given a Pfizer vaccine from the one vial the team brought.Mr. Conteh gave her a blue card recording her first vaccination and sent her on her way. No one discussed when — or if — she might get a second.Noah Weiland

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Pfizer Will Allow Its Covid Pill to Be Made and Sold Cheaply in Poor Countries

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.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.The pharmaceutical company Merck will allow its pill, called molnupiravir, to be made and sold inexpensively in 105 poorer countries.MerckFor 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?”

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