Many middle-income countries are left out of the deal, widening a gulf in access to critical medicines.The drugmaker Gilead Sciences on Wednesday announced a plan to allow six generic pharmaceutical companies in Asia and North Africa to make and sell at a lower price its groundbreaking drug lenacapavir, a twice-yearly injection that provides near-total protection from infection with H.I.V.Those companies will be permitted to sell the drug in 120 countries, including all the countries with the highest rates of H.I.V., which are in sub-Saharan Africa. Gilead will not charge the generic drugmakers for the licenses.Gilead says the deal, made just weeks after clinical trial results showed how well the drug works, will provide rapid and broad access to a medication that has the potential to end the decades-long H.I.V. pandemic.But the deal leaves out most middle- and high-income countries — including Brazil, Colombia, Mexico, China and Russia — that together account for about 20 percent of new H.I.V. infections. Gilead will sell its version of the drug in those countries at higher prices. The omission reflects a widening gulf in health care access that is increasingly isolating the people in the middle.Gilead charges $42,250 per patient per year for lenacapavir in the United States, where it is approved as a treatment for H.I.V. The company has said nothing about what lenacapavir will cost when used to prevent H.I.V. infections, a process called pre-exposure prophylaxis, or PrEP.The generics makers — four companies in India, one in Pakistan and one in Egypt — are expected to sell it for much less. Researchers at Liverpool University found the drug could profitably be produced for as little as $40 per patient per year, if it were being purchased in large volumes.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The decision is a crucial step in getting shots to the Democratic Republic of Congo, the center of the outbreak.The World Health Organization has given its authorization to a first vaccine to protect against mpox, a decision announced in such haste on Friday that it caught even the head of the company that makes the vaccine by surprise.The vaccine, made by the Danish company Bavarian Nordic, has been approved by the regulatory authorities in Europe as well as the United States and other high-income countries since a global mpox outbreak in 2022. But low- and middle-income countries rely on the W.H.O., through a process called prequalification, to determine which drugs, vaccines and health technologies are safe and efficient uses of limited health funding, and the organization had declined to act until now.The W.H.O. had come under increasing criticism for declaring a global public health emergency for mpox last month without giving a vaccine that prequalification stamp of approval, or a more provisional form of approval called emergency use authorization. Bavarian Nordic first submitted its safety and effectiveness data on the vaccine, called Jynneos, to the W.H.O. in 2023. The W.H.O. had defended its slow pace of review, saying that it needed to subject the vaccine to careful study because it, and two others that have been used to protect against mpox, were originally designed as smallpox immunizations, and because delivering it in low-resource settings such as Central Africa would involve factors different from those relating to its use in high-income countries.But on Friday morning, the W.H.O. suddenly said it was authorizing the shot.“This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future,” Dr. Tedros Adhanom Ghebreyesus, the W.H.O. director general, said in a statement.Paul Chaplin, Bavarian Nordic’s chief executive, said he was among the many who had been caught off guard.“We’ve got there eventually — I don’t know quite how,” he said. “But it’s good news. It’s going to make the regulatory pathway much easier.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Fatalities spiked 71 percent last year, far outpacing the 13 percent rise in cases, the World Health Organization said.The cholera outbreaks spreading across the globe are becoming more deadly. Deaths from the diarrheal disease soared last year, far outpacing the increase in cases, according to a new analysis by the World Health Organization.Cholera is easy to prevent and costs just pennies to treat, but huge outbreaks have swamped even well-prepared health systems in countries that had not confronted the disease in years. The number of cholera deaths reported globally last year increased by 71 percent from deaths in 2022, while the number of reported cases rose 13 percent. Much of the increase was driven by conflict and climate change, the W.H.O. report said.“For death rates to be rising so much faster even than cases are increasing, this is totally unacceptable,” said Philippe Barboza, who leads the cholera team in the health emergencies program of the W.H.O. “It reflects the world’s lack of interest in a disease that has plagued humans for thousands of years, afflicting the poorest people who cannot find clean water to drink,” he said.More than 4,000 people were officially reported to have died from cholera in 2023, but the true number is probably far higher, Dr. Barboza said. The W.H.O.’s efforts to model the actual number of cholera deaths, using data gathered from testing programs, found that the total death count for 2023 could be more than 100,000.Cholera can cause death by dehydration in as little as a single day, as the body tries to expel virulent bacteria in streams of vomit and watery diarrhea.“How can we accept that in 2024 that people are dying because they don’t have access to a simple bag of oral rehydration salts that cost 50 cents?” Dr. Barboza said. “It’s not because they don’t have an I.C.U. — it’s just IV fluid and antibiotics that they need.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The country at the center of a global health emergency is struggling even to diagnose cases and provide basic care.Health officials in the Democratic Republic of Congo, the epicenter of a shape-shifting mpox outbreak, say they lack even the most basic tools necessary to contain and treat the virus.The country has limited capacity to diagnose cases of mpox, even as transmission and the presentation of the disease are changing. That is complicating efforts to trace contacts and establish the true scale and spread of the outbreak.There is no effective antiviral treatment for mpox in Congo. The country is also short on the medications necessary to treat people with painful mpox lesions. Its fragile public health system is struggling to provide those infected with basic care, which has been shown to improve survival rates even in the absence of antiviral drugs.And the country is still waiting for vaccines to begin a campaign to protect health workers and close contacts of those infected and to try to check spread of the virus.“We thought when there was an emergency declaration from the World Health Organization in 2022 that then we would get help with surveillance and really understanding this disease,” said Dr. Jean-Jacques Muyembe-Tamfum, the director of the National Institute of Biomedical Research in Kinshasa.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

Drugmakers have supplies ready to ship that are necessary to stop a potential pandemic. But W.H.O. regulations have slowed access.There are no vaccines for mpox available in the Democratic Republic of Congo, the epicenter of a global health emergency declared last week, even though the country first asked for the shots two years ago and the manufacturers say they have supplies.“The most important thing we need right now are the vaccines,” said Dr. Samuel-Roger Kamba, health minister of Congo.So where are the shots? They are trapped in a byzantine drug regulatory process at the World Health Organization.Three years after the last worldwide mpox outbreak, the W.H.O. still has neither officially approved the vaccines — although the United States and Europe have — nor has it issued an emergency use license that would speed access.One of these two approvals is necessary for UNICEF and Gavi, the organization that helps facilitate immunizations in developing nations, to buy and distribute mpox vaccines in low-income countries like Congo.While high-income nations rely on their own drug regulators, such as the Food and Drug Administration in the United States, many low- and middle-income countries depend on the W.H.O. to judge what vaccines and treatments are safe and effective, a process called prequalification.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The first vaccine for malaria received major regulatory approval in 2015.It didn’t become part of vaccination programs in Africa until 2024.What if it had come faster?What if the shots had arrived9 years ago?143,000.That’s how many children’s deaths could have been averted.July 5, 2024Nurses in countries from Sierra Leone to Cameroon are packing a new vaccine into the coolers they tote to villages for immunization clinics: a shot to protect against malaria, one of the deadliest diseases for children.Babies and toddlers in eight countries in the region recently started to get the vaccine as part of their routine childhood shots. Seven other African countries are eagerly awaiting its arrival.This is a milestone in global health.But it’s also a cautionary tale about a system that is ill equipped to deliver critical tools to the people who need them most.It took decades and at least a billion dollars to reach this point. Even now, only a fraction of the children whose lives are at risk will get the vaccine this year, or next year, or the year after.It’s been clear for some time what went wrong, but almost none of those issues have been fixed. That means that the next desperately needed vaccine stands every chance of running into those same problems.Take, for example, a new vaccine for tuberculosis that started clinical trials a few months ago. If it works as well as hoped, it could save at least a million lives a year. We’ll know by 2028 if it stops tuberculosis infections. But if it follows the same trajectory, it will be at least 2038 before it’s shipped to clinics.“Children are receiving the vaccine, and for that, I am the happiest man in the world. But on the other hand, I cannot avoid being dismayed at this inexcusably long delay.”— Dr. Joe Cohen, co-inventor of the first malaria vaccineThe U.S. Army started work on a malaria vaccine back in the 1980s, hoping to protect soldiers deployed to the tropics. It teamed up with the drug company GlaxoSmithKline, and together they produced promising prototypes. But the military lost interest after a few years, and that left GSK with a problem.The people who desperately needed a malaria vaccine were in villages in sub-Saharan Africa. They would not be able to pay for a product that would cost millions of dollars to develop.GSK needed an altruistically minded partner. It found one in the nonprofit global health agency PATH, and by the late 1990s they had a vaccine to test. The Bill & Melinda Gates Foundation put up more than $200 million to test it.The clinical trials were complex, because this was a whole new type of vaccine — the first ever against a parasite — delivered to children in places with limited health systems. The process took more than a decade.Finally, in 2014, results showed this vaccine cut severe malaria cases by about a third.This was a successful result, but not as much protection as scientists had hoped to see. Still, GSK and PATH planned a production facility to make millions of doses. Gavi, the organization that procures vaccines for low- and middle-income countries, with funds from donors, would buy them.Then the Gates Foundation pulled its support.There was a shake-up in the malaria division, and the leadership reoriented toward a new goal: eliminating the disease.The new malaria team said the vaccine didn’t work well enough to justify pouring millions more dollars into it. It would be better, they said, to wait for a more effective shot in the future, and in the meantime to fund other strategies, such as genetically modifying mosquitoes.“If you go from very enthusiastic to very unenthusiastic and you’re the Gates Foundation, people pay attention.”— Dr. Robert Newman, former director, Global Malaria Program, W.H.O.The decision was driven by researchers who were looking at data. They didn’t factor in that the idea of a vaccine, even one with limited efficacy, would be so important to African parents — and African governments, which would come to see this as a classic example of a paternalistic donor ignoring their priorities. More than 300,000 children died of malaria that year.The foundation’s announcement shoved the vaccine into limbo — in ways the foundation today says it did not anticipate.“In hindsight, we could have communicated more often and more clearly about our decisions and listened more clearly to what the impact of those might have been on other institutions and their decisions.”— Dr. Chris Elias, president of global development at the Bill & Melinda Gates Foundation

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An injection given just twice a year could herald a breakthrough in protecting the population that has the highest infection rates.Researchers and activists in the trenches of the long fight against H.I.V. got a rare piece of exciting news this week: Results from a large clinical trial in Africa showed that a twice-yearly injection of a new antiviral drug gave young women total protection from the virus.“I got cold shivers,” said Dr. Linda-Gail Bekker, an investigator in the trial of the drug, lenacaprivir, describing the startling sight of a line of zeros in the data column for new infections. “After all our years of sadness, particularly over vaccines, this truly is surreal.”Yvette Raphael, the leader of a group called Advocacy for Prevention of H.I.V. and AIDS in South Africa, said it was “the best news ever.”The randomized controlled trial, called Purpose 1, was conducted in Uganda and South Africa. It tested whether the every-six-months injection of lenacaprivir, made by Gilead Sciences, would provide better protection against H.I.V. infection than two other drugs in wide use in high-income countries, both daily pills.The results were so convincing that the trial was halted early at the recommendation of the independent data review committee, which said all participants should be offered the injection because it clearly provided superior protection against the virus.None of the 2,134 women in the arm of the trial who received lenacapavir contracted H.I.V. By comparison, 16 of the 1,068 women (or 1.5 percent) who took Truvada, a daily pill that has been available for more than a decade, and 39 of 2,136 women (1.8 percent) who received a newer daily pill called Descovy were infected.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The shortage highlights a widening gulf in the standard of care for people with diabetes, most of whom live in low-income countries.South Africa’s public health care system has run out of the human insulin pens that it provides to people with diabetes, as the pharmaceutical industry shifts production priorities to blockbuster weight-loss drugs that use a similar device for delivery.Novo Nordisk, the company that has supplied South Africa with human insulin in pens for a decade, opted not to renew its contract, which expired last month. No other company has bid on the contract — to supply 14 million pens for the next three years, at about $2 per pen.“Current manufacturing capacity limitations mean that patients in some countries, including South Africa, may have limited access to our human insulins in pens,” said Ambre James-Brown, a spokeswoman for Novo Nordisk. The company did not reply to questions about which other countries are affected.Novo Nordisk’s drugs Ozempic and Wegovy, which are widely prescribed in the U.S. for weight loss, are sold in single-use pens produced by many of the same contracted manufacturers who make the multidose insulin pens. A month’s supply of Ozempic in the United States costs about $1,000, far more than insulin.Novo Nordisk dominates the global market for insulin in pens and has supplied South Africa since 2014. Eli Lilly, the other major producer, has indicated in recent months that it is struggling to keep up with the significant demand for its weight-loss drug Zepbound.“This is because of the global demand for Ozempic and these drugs,” said Khadija Jamaloodien, the director of sector-wide procurement for South Africa’s health service. “They’re shifting the focus on the more profitable line.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

The company has told countries that it can supply only 18.8 million of the 29.6 million doses it was contracted to deliver this year.Nearly 1.5 million teenage girls in some of the world’s poorest countries will miss the chance to be protected from cervical cancer because the drugmaker Merck has said it will not be able to deliver millions of promised doses of the HPV vaccine this year.Merck has notified Gavi, the international organization that helps low- and middle-income countries deliver lifesaving immunizations, and UNICEF, which procures the vaccines, that it will deliver only 18.8 million of the 29.6 million doses it was contracted to deliver in 2024, Gavi said.That means that more than 10 million girls will not receive their expected HPV shots this year — and 1.5 million of them most likely will never get them because they will be too old to qualify for the vaccine in subsequent years.Patrick Ryan, a spokesman for Merck, said the company “experienced a manufacturing disruption” that required it to hold and reinspect many doses by hand. He declined to give further details about the cause of the delay.“We are acting with urgency and rigor to deploy additional personnel and resources to resolve this matter as soon as possible,” he said.Mr. Ryan said that Merck would deliver the delayed doses in 2025. He also said the company would ship 30 million doses of the vaccine to Gavi-supported countries this year. However about a third of these are doses that were supposed to have been sent in 2023, leaving Gavi with the 10.7 million dose shortfall.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

A public research institute in Brazil has proved a new shot protects against the disease, but can’t make it fast enough to stop the huge outbreak sweeping Latin America.The outbreak of dengue fever that has unfolded in Latin America over the past three months is staggering in its scale — a million cases in Brazil in a matter of weeks, a huge spike in Argentina, a state of emergency declared in Peru, and now another, in Puerto Rico.It forewarns of a changing landscape for the disease. The mosquitoes that spread dengue thrive in densely populated cities with weak infrastructure, and in warmer and wetter environments — the type of habitat that is expanding quickly with climate change.More than 3.5 million cases of dengue have been confirmed by governments in Latin America in the first three months of 2024, compared with 4.5 million in all of 2023. There have been more than 1,000 deaths so far this year. The Pan-American Health Organization is warning that this may be the worst year for dengue ever recorded.The rapidly shifting disease landscape needs new solutions, and researchers in Brazil delivered the lone shred of good news in this story with the recent announcement that a clinical trial of a new dengue vaccine, delivered in a single shot, had provided strong protection against the disease.A health worker leaves a home after fumigating it for mosquitoes to help mitigate the spread of dengue in Peru.Martin Mejia/Associated PressThere are two existing vaccines for dengue, but one is an expensive two-shot regimen, while the other can only be given to people who have already had a dengue infection.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.