Latest news with #PeterChin-Hong
Yahoo
20-05-2025
- Health
- Yahoo
2-in-1 COVID-flu vaccine looks promising, but approval could be delayed
When you buy through links on our articles, Future and its syndication partners may earn a commission. Two might be better than one: A new vaccine that targets the viruses behind seasonal flu and COVID-19 triggers a stronger immune response than flu and COVID shots given separately, trial data suggest. The combination shot, dubbed mRNA-1083, is made by the pharmaceutical company Moderna. The promising results of the Phase 3 clinical trial of the vaccine were published May 7 in the journal JAMA. This late-stage trial included two groups of adults ages 50 and older who were given either the new vaccine or a combination of previously approved flu and COVID-19 vaccines. The trial runners looked at the quantity of antibodies, or protective immune proteins, made in response to each vaccine regimen. Antibody levels correlate with how well a shot should protect against a disease and how long that protection might last. They do not provide direct data on how well a shot drives down infection rates in real life — but ethically, such real-world data is difficult to gather when effective vaccines against an illness already exist. While the U.S. Food and Drug Administration (FDA) has not yet given mRNA-1083 a final stamp of approval, experts told Live Science that the trial results are largely positive. However, political factors could hinder the shot's approval, some say. The U.S. Centers for Disease Control and Prevention (CDC) already recommends that people get both their annual flu and updated COVID-19 vaccines at the same time. But at the moment, that requires two separate shots to be given at the same appointment. The combination vaccine would be "a one-stop shop," said Dr. Peter Chin-Hong, an infectious-disease doctor at the University of California, San Francisco (UCSF) who was not involved in the Moderna trial. "A lot of times, people are not excited about needles. I mean, who likes getting a shot?" he told Live Science. With the decline in vaccination rates in the United States, a combination vaccine offers more convenience and helps people get on top of their immunization, he said. The idea of combining multiple immunizations into one shot is not new. "It is a very commonly used strategy, especially in children," said Dr. Monica Gandhi, an infectious-disease doctor at UCSF who was not involved in the study. An example of this is the measles, mumps and rubella (MMR) vaccine, which is a combination of three vaccines in one shot. The new mRNA-1083 vaccine is based on the same messenger RNA (mRNA) technology that Moderna used in its FDA-approved vaccine against SARS-CoV-2, the virus behind COVID-19. mRNA is a genetic molecule that relays instructions for cells to build different proteins. The new COVID-flu shot combines the company's updated SARS-CoV-2 vaccine, called mRNA-1283, and its newly developed flu vaccine, mRNA-1010. As of yet, there is no FDA-approved flu shot that contains mRNA, so this could be the first. The culprits behind seasonal flu are influenza A and B viruses, which can be further classified into subtypes and lineages. Current flu vaccines in the U.S. guard against two subtypes of influenza A viruses, called H1N1 and H3N2, and one influenza B virus lineage, known as the Victoria lineage. (Until very recently, the shots also guarded against a second lineage, called "Yamagata," but it's likely extinct.) The flu component of the new vaccine contains genetic instructions for human cells to make glycoproteins — molecules of protein and carbohydrate — found in these four flavors of influenza A and B viruses. These glycoproteins, known as hemagglutinins (HA), are located on the surface of flu viruses and enable the viruses to latch onto host cells and initiate infection. Once made, these proteins are shown to the immune system so it can recognize the viruses and fight them off. Likewise, the COVID component of the new vaccine contains the genetic instructions to make the proteins displayed by SARS-CoV-2, called spike proteins. "mRNA vaccine is the vaccine of the future, particularly when you want to respond to rapidly changing diseases or new variants," Chin-Hong said. Whereas the molecules in mRNA vaccines can be manufactured very quickly as a virus evolves, conventional flu vaccines take months to make. Chin-Hong described mRNA vaccine production as "cutting and pasting a code"; the mRNA that encodes the virus protein can be conveniently incorporated into the platform. Moderna has already completed Phase 3 clinical trials for the individual flu and COVID components of its new combo vaccine. On its own, the flu shot triggered higher immune responses than two conventional flu vaccines — Fluarix and the high-dose Fluzone — against A(H1N1) and A(H3N2) strains. It triggered comparable immune responses against influenza B viruses, based on the trial results. Moderna also showed that its new COVID vaccine induced greater immune responses than Spikevax — the FDA-approved shot — against XBB.1.5, a version of the omicron variant that's been circulating recently. Both vaccines were tested on adults ages 18 and older. The purpose of Moderna's latest Phase 3 clinical trial was to measure the robustness of the immune response the mRNA-1083 vaccine triggers in people. The trial runners measured this by looking at the number of antibodies vaccinated people produced against both the flu and the SARS-CoV-2 viruses. Real-world data, which would indicate whether the vaccine effectively lowers rates of hospitalization or emergency visits from the infections, is not yet available. Consistent with these earlier studies on individual vaccines, the mRNA-1083 combination shot triggered a strong immune response against all four influenza viruses and XBB.1.5. In the trial, the company recruited two groups of participants: one consisting of adults ages 50 to 64, and another including people 65 and older. Each cohort consisted of about 4,000 adults. The 50-to-64-year-olds received either the new combo shot or a combination of Fluarix and Spikevax. The 65-and-older cohort received either mRNA-1083 or a combination of high-dose Fluzone and Spikevax. (Fluzone, a high-dose flu shot, is approved for adults ages 65 and older and some younger people with weakened immune systems.) The researchers sampled the trial participants' blood at Day 1 and Day 29 of the experiment to measure the levels of antibodies. They found that the mRNA-1083 vaccine triggered a more robust immune response — as reflected in higher levels of antibodies — than the other vaccine combinations against the SARS-CoV-2 variant. It also triggered a stronger antibody response against all four influenza strains compared with Fluarix, and three influenza subtypes — H1N1, H3N2 and Victoria — compared with Fluzone. While the individual components of the new vaccine have been tested in individuals ages 18 to 49, the latest clinical trial for mRNA-1083 did not include this population. "It was done in people who are at the highest risk of getting in trouble medically [from both the flu and COVID-19]," said Dr. Robert Schooley, an infectious-disease specialist at the University of California, San Diego. "But it doesn't mean that if you're under 50, you don't want to get a booster shot." Everyone 6 months and older is recommended to get an updated COVID-19 shot when new ones become available, typically on an annual basis. In a recent statement, Moderna announced that the company is deprioritizing further research on mRNA-1083 testing in adults ages 18 to 49. In the same announcement, the company cited an effort to reduce its operational expenses as a factor in the decision. It is unclear if or when the company might resume testing in this age group. Based on the clinical trial results, the likelihood of mild side effects — such as fever, fatigue and chills — was higher with the combination vaccine than with the currently available vaccines given separately. "These are expected. The side effect is actually your immune system waking up, and likely shows that you'll get a very durable response," Chin-Hong said. He also added that serious side effects are very uncommon for both the already-approved COVID and flu shots and in the trials of the new combo vaccine. There were no serious side effects related to the new vaccine, the trial runners reported. Moderna initially applied for FDA approval back in 2024, using the preliminary results from the same Phase 3 trial. At the time, the FDA asked for more data to show efficacy against the flu. With more data in hand, the company is now "targeting approval" for the vaccine in 2026, according to a recent statement. However, when it comes to mRNA vaccines, both scientific and political factors are at play, Chin-Hong said. "The science is unmistakable: it [mRNA] is very nimble; it is durable; it is effective in general," he said. But he pointed out that mRNA vaccine technology itself has been the target of political criticism in the U.S. that traces back to the COVID-19 pandemic, when the vaccines' development was expedited and safety concerns were raised. Even though mRNA vaccines have proved to be very safe and effective, this history may pose a barrier to FDA approval of the new combination vaccine, Chin-Hong said. In addition, the existence of already-approved separate vaccines for flu and COVID-19 may lessen the urgency in getting the mRNA-1083 approved, he added. Research funding through the National Institutes of Health (NIH) has been widely cut or frozen, and research on vaccine hesitancy and the boosting of vaccination rates was specifically affected. Experts told NPR that they're concerned mRNA research will soon face similar cuts. NIH officials were cautioned to keep the term "mRNA" out of grant applications, KFF reported. There are also uncertainties about whether mRNA-1083 will be subject to the new framework on vaccine approval. On May 1, a Department of Health and Human Services spokesperson told The Washington Post that "all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure." A placebo is an inert or inactive substance, such as a saline shot, that new vaccines would have to be compared against during a clinical trial. Many trials of brand-new vaccines already include placebos. But when there are already existing and effective vaccines for a given disease, comparing a new shot against a placebo isn't necessarily helpful or ethical. Scientists want to understand how much better the new shot works compared with the previous one. "I don't think it's ethical to give someone a shot that is a placebo, that can in no way help them, when you know there's an existing technology that can," said Dr. Paul Offit, a virologist, immunologist and director of the Vaccine Education Center at Children's Hospital of Philadelphia. RELATED STORIES —2-in-1 shot for flu and COVID shows promise in advanced trial —The US is having its most active flu season in 15 years —Is it COVID or the flu? At-home tests can look for both viruses at once Because mRNA-1083 is a modified version of an already-approved vaccine, "I'm not sure whether that counts as new," Offit said. He thinks a placebo-controlled trial would not be appropriate in this case. Although the new combo shot still awaits approval, Gandhi said the current clinical trial results were "already convincing." The Phase 3 clinical trial demonstrated that the vaccine is safe and triggers a robust immune response, she added. "I don't see any red flags at this point," Schooley said. "I'd be confident to take the vaccine myself."


Business Mayor
20-05-2025
- Health
- Business Mayor
2-in-1 COVID-flu vaccine looks promising in trial — but experts say approval may be delayed
Two might be better than one: A new vaccine that targets the viruses behind seasonal flu and COVID-19 triggers a stronger immune response than flu and COVID shots given separately, trial data suggest. The combination shot, dubbed mRNA-1083, is made by the pharmaceutical company Moderna. The promising results of the Phase 3 clinical trial of the vaccine were published May 7 in the journal JAMA . This late-stage trial included two groups of adults ages 50 and older who were given either the new vaccine or a combination of previously approved flu and COVID-19 vaccines. The trial runners looked at the quantity of antibodies , or protective immune proteins, made in response to each vaccine regimen. Antibody levels correlate with how well a shot should protect against a disease and how long that protection might last. They do not provide direct data on how well a shot drives down infection rates in real life — but ethically, such real-world data is difficult to gather when effective vaccines against an illness already exist . You may like While the U.S. Food and Drug Administration (FDA) has not yet given mRNA-1083 a final stamp of approval, experts told Live Science that the trial results are largely positive. However, political factors could hinder the shot's approval, some say. Why do we need a combination vaccine? The U.S. Centers for Disease Control and Prevention (CDC) already recommends that people get both their annual flu and updated COVID-19 vaccines at the same time. But at the moment, that requires two separate shots to be given at the same appointment. The combination vaccine would be 'a one-stop shop,' said Dr. Peter Chin-Hong , an infectious-disease doctor at the University of California, San Francisco (UCSF) who was not involved in the Moderna trial. 'A lot of times, people are not excited about needles. I mean, who likes getting a shot?' he told Live Science. With the decline in vaccination rates in the United States, a combination vaccine offers more convenience and helps people get on top of their immunization, he said. The idea of combining multiple immunizations into one shot is not new. Get the world's most fascinating discoveries delivered straight to your inbox. 'It is a very commonly used strategy, especially in children,' said Dr. Monica Gandhi , an infectious-disease doctor at UCSF who was not involved in the study. An example of this is the measles, mumps and rubella (MMR) vaccine , which is a combination of three vaccines in one shot. What is in mRNA-1083? The new mRNA-1083 vaccine is based on the same messenger RNA (mRNA) technology that Moderna used in its FDA-approved vaccine against SARS-CoV-2, the virus behind COVID-19. mRNA is a genetic molecule that relays instructions for cells to build different proteins. The new COVID-flu shot combines the company's updated SARS-CoV-2 vaccine , called mRNA-1283, and its newly developed flu vaccine, mRNA-1010. As of yet, there is no FDA-approved flu shot that contains mRNA, so this could be the first. The culprits behind seasonal flu are influenza A and B viruses, which can be further classified into subtypes and lineages. Current flu vaccines in the U.S. guard against two subtypes of influenza A viruses, called H1N1 and H3N2, and one influenza B virus lineage, known as the Victoria lineage. (Until very recently, the shots also guarded against a second lineage, called 'Yamagata,' but it's likely extinct .) The flu component of the new vaccine contains genetic instructions for human cells to make glycoproteins — molecules of protein and carbohydrate — found in these four flavors of influenza A and B viruses. These glycoproteins, known as hemagglutinins (HA), are located on the surface of flu viruses and enable the viruses to latch onto host cells and initiate infection. Once made, these proteins are shown to the immune system so it can recognize the viruses and fight them off. Likewise, the COVID component of the new vaccine contains the genetic instructions to make the proteins displayed by SARS-CoV-2, called spike proteins. Current flu shots in the U.S. guard against three broad types of flu virus. (Image credit: KATERYNA KON/SCIENCE PHOTO LIBRARY via Getty Images) 'mRNA vaccine is the vaccine of the future, particularly when you want to respond to rapidly changing diseases or new variants,' Chin-Hong said. Whereas the molecules in mRNA vaccines can be manufactured very quickly as a virus evolves, conventional flu vaccines take months to make. Chin-Hong described mRNA vaccine production as 'cutting and pasting a code'; the mRNA that encodes the virus protein can be conveniently incorporated into the platform. Moderna has already completed Phase 3 clinical trials for the individual flu and COVID components of its new combo vaccine. On its own, the flu shot triggered higher immune responses than two conventional flu vaccines — Fluarix and the high-dose Fluzone — against A(H1N1) and A(H3N2) strains. It triggered comparable immune responses against influenza B viruses, based on the trial results. Moderna also showed that its new COVID vaccine induced greater immune responses than Spikevax — the FDA-approved shot — against XBB.1.5 , a version of the omicron variant that's been circulating recently. Both vaccines were tested on adults ages 18 and older. How did the combination vaccine perform? The purpose of Moderna's latest Phase 3 clinical trial was to measure the robustness of the immune response the mRNA-1083 vaccine triggers in people. The trial runners measured this by looking at the number of antibodies vaccinated people produced against both the flu and the SARS-CoV-2 viruses. Real-world data , which would indicate whether the vaccine effectively lowers rates of hospitalization or emergency visits from the infections, is not yet available. Consistent with these earlier studies on individual vaccines, the mRNA-1083 combination shot triggered a strong immune response against all four influenza viruses and XBB.1.5. In the trial, the company recruited two groups of participants: one consisting of adults ages 50 to 64, and another including people 65 and older. Each cohort consisted of about 4,000 adults. The 50-to-64-year-olds received either the new combo shot or a combination of Fluarix and Spikevax. The 65-and-older cohort received either mRNA-1083 or a combination of high-dose Fluzone and Spikevax. (Fluzone, a high-dose flu shot, is approved for adults ages 65 and older and some younger people with weakened immune systems.) The researchers sampled the trial participants' blood at Day 1 and Day 29 of the experiment to measure the levels of antibodies. They found that the mRNA-1083 vaccine triggered a more robust immune response — as reflected in higher levels of antibodies — than the other vaccine combinations against the SARS-CoV-2 variant. It also triggered a stronger antibody response against all four influenza strains compared with Fluarix, and three influenza subtypes — H1N1, H3N2 and Victoria — compared with Fluzone. Will the combo vaccine be tested in younger adults? While the individual components of the new vaccine have been tested in individuals ages 18 to 49, the latest clinical trial for mRNA-1083 did not include this population. 'It was done in people who are at the highest risk of getting in trouble medically [from both the flu and COVID-19],' said Dr. Robert Schooley , an infectious-disease specialist at the University of California, San Diego. 'But it doesn't mean that if you're under 50, you don't want to get a booster shot.' Everyone 6 months and older is recommended to get an updated COVID-19 shot when new ones become available, typically on an annual basis. In a recent statement , Moderna announced that the company is deprioritizing further research on mRNA-1083 testing in adults ages 18 to 49. In the same announcement, the company cited an effort to reduce its operational expenses as a factor in the decision. It is unclear if or when the company might resume testing in this age group. It's unclear whether the new vaccine may face barriers to approval, despite strong trial data. (Image credit: – Yuri A via Shutterstock) Does the combo shot have more side effects? Based on the clinical trial results, the likelihood of mild side effects — such as fever, fatigue and chills — was higher with the combination vaccine than with the currently available vaccines given separately. 'These are expected. The side effect is actually your immune system waking up, and likely shows that you'll get a very durable response,' Chin-Hong said. He also added that serious side effects are very uncommon for both the already-approved COVID and flu shots and in the trials of the new combo vaccine. There were no serious side effects related to the new vaccine, the trial runners reported. When could the vaccine be approved? Moderna initially applied for FDA approval back in 2024, using the preliminary results from the same Phase 3 trial . At the time, the FDA asked for more data to show efficacy against the flu. With more data in hand, the company is now 'targeting approval' for the vaccine in 2026, according to a recent statement . However, when it comes to mRNA vaccines, both scientific and political factors are at play, Chin-Hong said. 'The science is unmistakable: it [mRNA] is very nimble; it is durable; it is effective in general,' he said. But he pointed out that mRNA vaccine technology itself has been the target of political criticism in the U.S. that traces back to the COVID-19 pandemic, when the vaccines' development was expedited and safety concerns were raised. Even though mRNA vaccines have proved to be very safe and effective, this history may pose a barrier to FDA approval of the new combination vaccine, Chin-Hong said. In addition, the existence of already-approved separate vaccines for flu and COVID-19 may lessen the urgency in getting the mRNA-1083 approved, he added. Research funding through the National Institutes of Health (NIH) has been widely cut or frozen, and research on vaccine hesitancy and the boosting of vaccination rates was specifically affected. Experts told NPR that they're concerned mRNA research will soon face similar cuts. NIH officials were cautioned to keep the term 'mRNA' out of grant applications, KFF reported . There are also uncertainties about whether mRNA-1083 will be subject to the new framework on vaccine approval . On May 1, a Department of Health and Human Services spokesperson told The Washington Post that 'all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.' A placebo is an inert or inactive substance, such as a saline shot, that new vaccines would have to be compared against during a clinical trial. Many trials of brand-new vaccines already include placebos. But when there are already existing and effective vaccines for a given disease, comparing a new shot against a placebo isn't necessarily helpful or ethical. Scientists want to understand how much better the new shot works compared with the previous one. 'I don't think it's ethical to give someone a shot that is a placebo, that can in no way help them, when you know there's an existing technology that can,' said Dr. Paul Offit , a virologist, immunologist and director of the Vaccine Education Center at Children's Hospital of Philadelphia. Because mRNA-1083 is a modified version of an already-approved vaccine, 'I'm not sure whether that counts as new,' Offit said. He thinks a placebo-controlled trial would not be appropriate in this case. Although the new combo shot still awaits approval, Gandhi said the current clinical trial results were 'already convincing.' The Phase 3 clinical trial demonstrated that the vaccine is safe and triggers a robust immune response, she added. 'I don't see any red flags at this point,' Schooley said. 'I'd be confident to take the vaccine myself.'


USA Today
21-04-2025
- Health
- USA Today
What is Tdap? Here's what you need to know to stay protected against whooping cough
What is Tdap? Here's what you need to know to stay protected against whooping cough Show Caption Hide Caption Measles outbreaks on the horizon if US cuts funding, WHO director says WHO Director says the progress measles vaccines have made to save millions of lives is now in jeopardy if U.S. pulls funding. With the risk of whooping cough infections rising, it's a good time to make sure you're up to date on your Tdap booster, experts say. Whooping cough (pertussis) is a highly infectious respiratory illness that causes rapid, uncontrollable coughing fits. Whooping cough is particularly dangerous to young infants—approximately one in three babies under the age of 1will be hospitalized if they develop the illness, according to the U.S. Centers for Disease Control & Prevention. Whooping cough is preventable, and getting vaccinated is the best way to protect yourself. The DTaP and Tdap vaccines are very effective at preventing whooping cough, but you'll need to stay on top of vaccinations to make sure you and your loved ones are protected. Here's what experts need you to know. What is DTaP, Tdap vaccine? DTaP and Tdap are combination vaccines that protect against tetanus, diphtheria and whooping cough. DTaP is given to infants and young children, whereas Tdap is administered to anyone above the age of 7, says Dr. Peter Chin-Hong, a professor of medicine and infectious disease specialist at UCSF Health. DTaP is formulated with full strength doses of the diphtheria, tetanus and whooping cough vaccines. Tdap contains one full strength dose of the tetanus vaccine, and lesser doses of the diphtheria and whooping cough vaccines, per Healthline. Today's whooping cough vaccines contain an acellular pertussis component, which is derived from inactive parts of the bacterium that causes whooping cough, Bordetella pertussis, per CDC. '(The Tdap and DTaP) vaccines are often described as a 'seat belt.' So, (they) should prevent injury for most people,' says Dr. Matthew Harris, a pediatric emergency medicine physician and medical director of clinical preparedness at Northwell Health. Both vaccines are very effective at preventing whooping cough, but in the case you develop the illness, symptoms are typically milder. When should children receive DTaP shots? The people who suffer the most from whooping cough aren't the adults—it's the kids, says Chin-Hong. Whooping cough is highly infectious, and in young children, symptoms can be life-threatening. Severe complications include pneumonia and apnea, says Harris. For this reason, the DTaP vaccination series is encouraged in early childhood. The CDC recommends children under the age of 7 receive a series five DTaP shots at the following ages: 2 months 4 months 6 months 15 to 18 months 4 to 6 years In case you missed: What to know about whooping cough How long is Tdap good for? The CDC recommends adolescents receive a single shot of Tdap at 11 to 12 years old. If you weren't vaccinated with DTaP as a child, you'll receive Tdap as your first dose. Unlike the MMR vaccine, in which you're considered to have lifelong 97% immunity against measles after receiving two doses, one dose of Tdap does not provide lifelong protection against tetanus, diphtheria and pertussis. Of the three diseases, immunity wanes fastest for pertussis, says Chin-Hong. Because protection from Tdap wanes over time, the CDC says adults should receive a booster dose of Tdap or Td (which only protects against tetanus, not diphtheria or pertussis) every 10 years. If you get a deep wound or burn, you might need an additional dose of DTaP, Tdap or Td to protect against tetanus infection, according to Nemours Children's Health. Not all wounds will require a tetanus booster; a physician will take into account how severe the wound is, your age and the last time you were vaccinated, says Harris. Elsewhere in vaccines: What experts need you to know about the MMR vaccine Do I need a Tdap shot to be around a baby? Yes, the CDC suggests anyone in close proximity to infants or young children receive a Tdap booster, regardless of your last dose. Infants under two months of age are particularly vulnerable to severe symptoms of whooping cough (as they aren't yet able to receive the DTaP vaccine), says Chin-Hong. If you're pregnant, the American College of Obstetrics and Gynecology recommends receiving a Tdap shot during your third trimester of pregnancy (between 27 to 36 weeks). It's estimated that this helps prevent 78% of pertussis cases in babies under two months of age, according to a CDC evaluation. As the Tdap takes full effect, protective antibodies are transmitted to the fetus. When the baby is born, these antibodies may offer some degree of protection against whooping cough.


Japan Times
02-04-2025
- Health
- Japan Times
Once-rare fungal diseases are killing millions in an unprepared world
When most people think of dangerous infections, they picture bacteria or viruses. But for infectious disease specialists like Peter Chin-Hong, one of the most insidious threats lurking in hospitals and clinics today is fungal. Chin-Hong's case list is long: a healthy 29-year-old marathon runner from California's Central Valley whose heart lining was invaded by Coccidioides, a soil-dwelling fungus; a lung transplant recipient coughing up mold nodules — fungal growths scattered throughout his lungs — after stopping antifungal medication; and a 45-year-old woman with poorly controlled diabetes, infected by a black fungus that destroyed part of her face and spread to her brain. Despite multiple surgeries and treatment, she died in the hospital. "These aren't rare anymore,' said Chin-Hong, associate dean and professor of medicine at the University of California, San Francisco. "We're seeing them every day.' Once considered obscure or opportunistic, invasive fungal infections are now surfacing with alarming frequency — and in patients and places doctors never used to worry about. Climate change is expanding the geographic reach of fungi. Medical advances like organ transplants, chemotherapy, and intensive care are saving lives, but they also leave more patients immunocompromised. Even common conditions like diabetes raise the risk of severe fungal disease. An estimated 6.5 million people develop invasive fungal infections each year, with about 2.5 million deaths directly caused by them — roughly twice the global toll of tuberculosis. Many of those deaths are in people with advanced HIV, and experts warn the problem may worsen as funding for global HIV/AIDS programs is pulled back. A surge in AIDS-related illness, they say, could turbocharge the fungal crisis, especially in low-resource settings where diagnostic tools and antifungal treatments are already limited. Adding to the danger is the rise of drug-resistant infections — strains that no longer respond to the limited arsenal of antifungal medications. Candida auris, a newly emerging yeast first seen in 2009, has already triggered deadly outbreaks in hospitals and long-term care facilities. Experts warn that broader resistance could soon outpace the slow development of new drugs. Fungal crisis The World Health Organization warned Tuesday of critical global gaps in the ability to diagnose and treat fungal infections. That includes the dangerously thin pipeline of medicines, with just four new antifungals approved globally over the past decade. Of the nine currently in clinical development, only three have reached the final stage of patient studies. "We can expect few new approvals in the next 10 years,' said Valeria Gigante, who leads the antimicrobial resistance division at WHO in Geneva. More than half of the antifungal candidates in development lack true innovation, limiting their ability to counter emerging resistance, Gigante added. "We always need new ways to kill dangerous fungi,' she said. "Only three of the nine candidates even target the most critical pathogens.' Fungal threats have remained dangerously overlooked, said Justin Beardsley, an infectious diseases doctor and University of Sydney researcher who contributed to both WHO reports. "Fungus is not on anybody's radar,' he said. "It's unobserved and out of control — which means we're not developing mitigations.' He also pointed to growing concern over agricultural antifungal use. "A lot of the new drugs being developed don't have a novel mechanism of action,' Beardsley said. And in many cases, new compounds are introduced faster in agriculture to protect crops from diseases like powdery mildew. "That is just really disheartening for human drug developers — and a little bit worrying for public health, that our new-hope drugs are already going to be getting exposed to a biosimilar agent in the environment and we're going to get resistance.' Another shortcoming is around diagnostics, with the WHO cautioning that even when tests exist to identify deadly fungi, they're often unavailable in low— and middle-income countries. Most rely on well-equipped laboratories and trained personnel. The development of systems to detect invasive fungal infections and determine drug susceptibility is also lagging behind what exists for bacteria, Gigante said. Unseen foe Fungal infections behave differently from bacteria and viruses. They rarely spread person to person. Instead, most come from the environment — moldy soil, decaying plants, airborne spores. Some spores can even travel high into the atmosphere and drift across continents, making them especially hard to track or control. That makes it nearly impossible to fully protect vulnerable patients. UCSF's Chin-Hong said doctors often prescribe preventive antifungal medication to people at high risk, such as those who've had lung or blood stem cell transplants. But the drugs don't cover every type of mold. Mucormycosis — a rare but aggressive infection — is notoriously difficult to treat. "Mucormycosis is probably the scariest one we have,' Chin-Hong said. "If it gets into the lungs, the death rate can be as high as 87%.' The fungus can also invade the sinuses and spread to the brain, with a mortality rate around 50%. It causes tissue to die — cutting off blood flow so antifungal drugs can't reach the infection site. "You have to surgically remove the infected area,' he said. "A lot of times people have their eye taken out because it goes up through the sinus cavity, and there's no good treatment for that.' Resection — surgically removing infected tissue — is sometimes possible in the sinuses or skin. But in the lungs, it's often far more difficult. "The reason lung mortality is so high is because you can't just cut out big chunks of lung,' Chin-Hong said. And even when drugs work, they're often less effective in the very patients who need them most — those with weakened immune systems. "We have agents now,' Chin-Hong said, "but we're running out of them.'


Bloomberg
01-04-2025
- Health
- Bloomberg
Once-Rare Fungal Diseases Are Killing Millions in an Unprepared World
When most people think of dangerous infections, they picture bacteria or viruses. But for infectious disease specialists like Peter Chin-Hong, one of the most insidious threats lurking in hospitals and clinics today is fungal. Chin-Hong's case list is long: a healthy 29-year-old marathon runner from California's Central Valley whose heart lining was invaded by Coccidioides, a soil-dwelling fungus; a lung transplant recipient coughing up mold nodules — fungal growths scattered throughout his lungs — after stopping antifungal medication; and a 45-year-old woman with poorly controlled diabetes, infected by a black fungus that destroyed part of her face and spread to her brain. Despite multiple surgeries and treatment, she died in the hospital.