health – Page 4

A fentanyl vaccine is about to get its first major test

fentanyl, health, opioids, Science, syndication, vaccines / Mike M. / December 4, 2025

Vaccine trial in the Netherlands hopes to protect against fentanyl-related overdose and death.

Just a tiny amount of fentanyl, the equivalent of a few grains of sand, is enough to stop a person’s breathing. The synthetic opioid is tasteless, odorless, and invisible when mixed with other substances, and drug users are often unaware of its presence.

It’s why biotech entrepreneur Collin Gage is aiming to protect people against the drug’s lethal effects. In 2023, he became the cofounder and CEO of ARMR Sciences to develop a vaccine against fentanyl. Now, the company is launching a trial to test its vaccine in people for the first time. The goal: prevent deaths from overdose.

“It became very apparent to me that as I assessed the treatment landscape, everything that exists is reactionary,” Gage says. “I thought, why are we not preventing this?”

Fifty times more potent than heroin and 100 times more potent than morphine, fentanyl was first approved by the Food and Drug Administration in 1968 as an intravenous pain reliever and anesthetic. Its potential for abuse was recognized even then, and clinicians could get it only in combination with the sedative droperidol in a ratio of 50:1 droperidol to fentanyl.

Cheap to make and incredibly addictive, fentanyl is now found in street drugs and counterfeit pills, because it boosts their potency and cuts costs. The drug is the biggest driver of overdose deaths in the United States and the leading cause of death for Americans aged 18 to 45.

Naloxone, known by the brand name Narcan, can rapidly reverse overdoses caused by fentanyl and other opioids. Widespread distribution of the medication contributed to a 24 percent decline in US drug overdose deaths in 2024. It works by attaching to opioid receptors throughout the body and displacing the opioid molecules that are attached there.

But a vaccine like the one ARMR Sciences is developing would be given before a person even encounters the drug. Gage likens it to a bulletproof vest or a suit of armor—hence the company’s name. (It was previously registered as Ovax but switched names in January.) “This is something that could completely change the paradigm of how we deal with overdose, because it doesn’t require someone to be carrying the treatment on them,” Gage says.

Opioid vaccines were initially proposed in the 1970s, but after early attempts at heroin vaccines failed, much of the research was abandoned. The modern opioid epidemic has led to a resurgence of interest, with backing from the US government.

ARMR’s experimental vaccine is designed to neutralize fentanyl in the bloodstream before it reaches the brain. Keeping fentanyl out of the brain would prevent the respiratory failure that comes with overdose, which causes death, as well as the euphoric high people get while taking fentanyl.

The basic idea behind ARMR’s shot is the same as any other vaccine. It trains the body’s immune system to make antibodies that recognize a foreign invader. But since fentanyl is much smaller than the pathogens our current vaccines target, it doesn’t trigger a natural antibody response on its own. To stimulate antibody production, ARMR has paired a fentanyl-like molecule with a “carrier” protein—a deactivated diphtheria toxin that’s already used in several approved medical products.

If a vaccinated person encounters fentanyl, antibodies in the blood would then bind to the drug and prevent it from traveling to the brain. Normally, fentanyl molecules can pass through the blood-brain barrier with ease, in part because of their small size. But fentanyl molecules with antibodies attached would be too big to get through. The result? No high and no overdose. The antibody-bound fentanyl molecules would eventually be passed in the urine.

The vaccine is based on work from the University of Houston, with collaborators at Tulane University designing an adjuvant derived from E.coli bacteria to boost the immune response to the vaccine. In rats, the shot blocked 92 to 98 percent of fentanyl from entering the brain and prevented the behavioral effects of the drug. The effects lasted for at least 20 weeks in the rats, which Gage thinks could translate to a year of protection in people.

“The big breakthrough in the past five or six years is the advancement of the adjuvant technology that we’re able to utilize now, which causes an extremely robust immune system response,” he says.

ARMR’s Phase 1/2 trial, which is slated to begin in early 2026, will enroll around 40 healthy adults at the Centre for Human Drug Research in the Netherlands. The first part of the trial will evaluate the vaccine’s safety and determine the best dosage. Volunteers will receive a series of two shots in varying doses, and researchers will measure their blood antibody levels. In the second part of the trial, a small group of participants will receive a medical dose of fentanyl so that investigators can study how well the vaccine blocks its effects. Gage says ARMR chose the Dutch site because of its experience conducting studies on naloxone and nalmefene, another medication that reverses opioid overdose.

The company is testing an injectable vaccine in this study but is also looking into an oral formulation, akin to a Listerine strip, for future trials.

Marco Pravetoni, founder and chief scientific officer of CounterX Therapeutics, has been studying opioid vaccines in his lab at the University of Washington but thinks a shorter-acting monoclonal antibody therapy is more commercially viable right now given the Trump administration’s hostility toward vaccines. The injectable antibody his company is developing is meant to provide monthlong protection against overdose. He says the product is intended for high-risk patients, such as those who are in addiction recovery programs. The Seattle-based company is poised to begin an initial human trial in early 2026.

“We think a month of protection is pretty good in terms of providing a safety net,” Pravetoni says. It would be comparable to Vivitrol, a prescription injectable on the market that’s used to prevent relapse in adults with alcohol or opioid dependence, which lasts for about a month.

One big question facing the development of a fentanyl vaccine or antibody treatment is whether a large enough dose of the drug could skirt by antibodies, making its way to the brain. Sharon Levy, an addiction medicine specialist at Boston Children’s Hospital who has worked on fentanyl vaccines and is one of ARMR’s scientific advisers, says it’s possible. “There’s only going to be so many antibodies,” she says.

In addiction treatment, Levy says there’s always a risk of patients trying to override the effects of a prescribed opioid-blocking medication by taking a high dose of an opioid—which is highly dangerous—but she says this is rare.

Levy and her colleagues have been conducting surveys on the acceptability of a fentanyl vaccine. She thinks a major target group would be teenagers and young adults who may be accidentally exposed to fentanyl when taking street drugs. Individuals with an opioid use disorder who are in active treatment would also be good candidates for vaccination.

“Overall, our experience has been that people would be interested in this,” she says.

Mike Selick, director of capacity building and community mobilization for the National Harm Reduction Coalition, worries that a fentanyl vaccine could block the effects of other opioids, leaving vaccinated individuals with few options for pain medications if they ever needed them.

In animal studies, the University of Houston team found no cross-reactivity with other common opioid-based common pain and addiction treatment medications, such as buprenorphine, methadone, morphine, or oxycodone. But there’s a downside to a lack of cross-reactivity. It means that people could still overdose on other types of opioids—and get high from them.

Gage knows that a fentanyl vaccine isn’t a perfect solution. Even if it works, it won’t end the opioid epidemic or cure opioid addiction. It won’t stop people from seeking out drugs entirely. But it could be another tool for helping to prevent overdose deaths.

“What we’re trying to do is put some innovation and new newfound technology behind this problem,” he says “because I think we’re in desperate need of it.”

This story originally appeared on WIRED.com.

Wired.com is your essential daily guide to what’s next, delivering the most original and complete take you’ll find anywhere on innovation’s impact on technology, science, business and culture.

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12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid

CDC, clinical trials, COVID-19, fda, health, Science, vaccines, vinay prasad / Mike M. / December 4, 2025

On Friday, Vinay Prasad—the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator—emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.

On Wednesday evening, a dozen former FDA commissioners, who collectively oversaw the agency for more than 35 years, responded to the memo with a scathing rebuke. Uniting to publish their response in the New England Journal of Medicine, the former commissioners said they were “deeply concerned” by Prasad’s memo, which they framed as a “threat” to the FDA’s work and a danger to Americans’ health.

In his memo, Prasad called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19. Those updates currently involve studies that measure well-characterized immune responses (called immunobridging studies). Prasad dismissed this approach as insufficient and, instead, plans to require expensive randomized trials, which can take months to years for each vaccine update.

FDA staff who disagree with the plans can “submit your resignation letters,” Prasad wrote. And airing concerns or criticisms is seen as “unethical” and “illegal.”

Together, the former commissioners called Prasad’s memo the “latest in a series of troubling changes at the FDA,” and the planned policy updates “not … coherent.” Prasad’s arguments against immunobridging, they add, “misrepresent both the science and the regulatory record, especially in the case of vaccines that target well-understood pathogens through an established mechanism of action.”

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Meet CDC’s new lead vaccine advisor who thinks shots cause heart disease

ACIP, anti-vaccine, CDC, fda, health, Kirk Milhoan, myocarditis, robert f kennedy jr, vinay prasad / Kelly Newman / December 2, 2025

Milhoan has a history of touting unproven COVID cures while disparaging vaccines.

Kirk Milhoan, James Pagano, and Robert Malone are seen during a meeting of the CDC’s Advisory Committee on Immunization Practices on September 18, 2025 in Chamblee, Georgia. Credit: Getty | Elijah Nouvelage

When the federal vaccine committee hand-picked by anti-vaccine Health Secretary Robert F. Kennedy Jr. meets again this week, it will have yet another new chairperson to lead its ongoing work of dismantling the evidence-based vaccine recommendations set by the Centers for Disease Control and Prevention.

On Monday, the Department of Health and Human Services announced that the chairperson who has been in place since June—when Kennedy fired all 17 expert advisors on the committee and replaced them with questionably qualified allies—is moving to a senior role in the department. Biostatistician Martin Kulldorff will now be the chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS said. As such, he’s stepping down from the vaccine committee, the Advisory Committee on Immunization Practices (ACIP).

Kulldorff gained prominence amid the COVID-19 pandemic, criticizing public health responses to the crisis, particularly lockdowns and COVID-19 vaccines. He was a co-author of the Great Barrington Declaration that advocated for letting the deadly virus spread unchecked through the population, which was called unethical by health experts.

As ACIP chair, Kulldorff frequently made false and misleading statements about vaccine safety and efficacy that were in line with Kennedy’s views and statements. While Kulldorff presided over the committee, it made a series of decisions that were sharply denounced by scientific and medical groups as being based on ideology rather than evidence. Those include voting for the removal of the vaccine preservative thimerosal from some flu vaccines, despite well-established data indicating it is safe, with no evidence of harms. The committee also added restrictions to a combination measles, mumps, rubella, and varicella (chickenpox) MMRV vaccine and made an unprecedented effort to prevent Americans from getting COVID-19 vaccines, though the moves were largely ineffective.

In his new role, Kulldorff will be working with ASPE to provide analyses on health policy options, coordinate research efforts, and provide policy advice.

“It’s an honor to join the team of distinguished scientists that Secretary Kennedy has assembled,” Kulldorff said in a press release announcing his new role. “I look forward to contributing to the science-based public health policies that will Make America Healthy Again.”

The new chair, Kirk Milhoan

With Kulldorff moving on, ACIP will now be chaired by Kirk Milhoan, a pediatric oncologist with a track record for spreading COVID-19 misinformation and anti-vaccine views. In August 2021, the Hawaii Medical Board filed a complaint against Milhoan after he appeared on a panel promoting ineffective COVID-19 treatments, downplaying the severity of the disease, and spreading misinformation about COVID-19 vaccines, according to the Maui News. The complaint was dropped in April 2022 after state regulators said they had insufficient evidence to prove a violation of statutes regarding the practice of medicine.

While Milhoan claimed at the time that he is “pro-vaccine,” his statement, affiliations, and prescribing practices suggest otherwise. Milhoan is a member of the Independent Medical Alliance (formerly the Front Line COVID-19 Critical Care Alliance), a group of dubious health care providers set up amid the pandemic to promote the use of the anti-malaria drug hydroxychloroquine and the de-worming drug ivermectin to treat COVID-19. Both drugs have shown to be ineffective and potentially harmful when used to treat or prevent COVID-19. The IMA also emphasizes vaccine injuries while pushing vitamins and other unproven treatments.

In 2024, Milhoan appeared on a panel set up by Rep. Marjorie Taylor Greene (R-Ga.) to discuss alleged injuries from COVID-19 vaccines alongside other prominent anti-vaccine and COVID-19 misinformation voices. In his opening statement, Milhoan suggested that COVID-19 vaccines were causing severe cardiovascular disease and death in people aged 15 to 44—an unsubstantiated claim he frequently echoes. In his bio for the IMA, he touts that he offers treatment for “vaccine-related cardiovascular toxicity due to the spike protein.”

CDC data has found that boys and young men, aged 12 to 24, have a heightened risk of myocarditis (inflammation of the heart) after COVID-19 vaccination. However, the cases are rare, relatively mild, and almost always resolve, according to CDC data. In a COVID-19 safety data presentation in June, CDC staff scientists reported that its vast vaccine safety monitoring systems indicated that in males 12–24, there are 27 myocarditis cases per million doses of COVID-19 vaccine administered (roughly one case in 37,000 doses). In cases identified during 2021, 83 percent recovered within three months, with more than 90 percent recovering within the year. The monitoring data found no instances of cardiac transplant or death from COVID-19 vaccination.

While anti-vaccine activists have seized on this minor risk from vaccination, health experts note that the risk of myocarditis and other inflammatory conditions from a COVID-19 infection is significantly greater than the risk from vaccination. Exact estimates vary, but one CDC study in 2021 found that people with COVID-19 infections had a 16-fold higher risk of myocarditis than people without the infection. Specifically, the study estimated that there were 150 myocarditis cases among 100,000 COVID-19-infected patients versus just nine myocarditis cases among 100,000 people without COVID-19 infections and who were also unvaccinated. Similar to what’s seen with vaccination, the study found that young males were most at risk of myocarditis.

Kennedy’s allies attack on COVID-19 shots

Kennedy and his allies, like Milhoan, have consistently inflated the risk of myocarditis from COVID-19 vaccination, with some claiming without evidence that they have caused sudden cardiac arrest and deaths in young males, though studies have found no such link. In 2022, Milhoan and fellow ACIP member and conspiracy theorist Robert Malone were featured in a viral social media post suggesting that 50 percent of college athletes in the Big Ten athletic conference had myocarditis linked to COVID-19 vaccines, which could lead to deaths if they played. But the two were referencing a JAMA Cardiology study that examined subclinical myocarditis in Big Ten athletes after COVID-19 infection—not vaccination. In fact, researchers confirmed for an AFP fact check that none of the athletes in the study were vaccinated. And the rate of subclinical myocarditis in the group was 2.3 percent, not 50 percent.

Milhoan’s misinformation about the cardiovascular harms from COVID-19 vaccines seems particularly pertinent to the direction of Kennedy’s anti-vaccine allies. On Friday, Vinay Prasad, the Food and Drug Administration’s top vaccine regulator, sent a memo to staff claiming without evidence that COVID-19 vaccines have killed 10 children. The memo provides little information about the extraordinary claim, but it hints that the deaths were linked to myocarditis and found among reports submitted between 2021 and 2024 to the CDC’s Vaccine Adverse Event Reporting System (VAERS).

VAERS is a system by which anyone, including members of the public, can report anything they think could be linked to vaccines. The reports are considered a type of early warning system, but the vast majority of the reports submitted are not actually related to vaccines. Further, CDC scientists have thoroughly evaluated VAERS reports and ruled out deaths attributed to COVID-19 vaccines. Prasad’s memo—which experts have speculated was designed to be leaked to produce alarming headlines about child deaths—claimed that before Trump administration officials with anti-vaccine views began sifting through the data, these deaths were “ignored” by FDA and CDC scientists. Prasad also claimed that there could be many more deaths that have gone unreported, despite the fact that healthcare providers have been legally required to report any deaths that occurred after COVID-19 vaccination, regardless of cause.

This week’s ACIP meeting

In this week’s scheduled ACIP meeting on Thursday and Friday, COVID-19 vaccines don’t appear on the draft agenda. Instead, ACIP is expected to vote to remove a recommendation for a birth dose of the hepatitis B vaccine. That dose protects newborns from contracting the highly infectious virus from their mothers during birth or from other family or acquaintances shortly after birth. About half of the people infected with hepatitis B are not aware of their infections, and testing of mothers before birth is imperfect. That can leave newborns particularly vulnerable, as infections that start at or shortly after birth almost always develop into chronic infections that can lead to liver disease, liver transplant, and cancer. In a previous ACIP meeting, CDC staff scientists presented data showing that there are no significant harms of birth doses and there is no evidence that delaying the immunization offers any benefit.

The committee is also taking on the childhood vaccine schedule as a whole, though the agenda on this topic is not yet clear. In his memo, Prasad attacked the common practice of providing multiple vaccinations at once, hinting that it could be a way in which the committee will try to dismantle current childhood vaccination recommendations. On Tuesday, The Washington Post reported that the committee will examine whether the childhood vaccine schedule as a whole is causing allergies and autoimmune diseases, something Kennedy and his anti-vaccine organization have long floated despite evidence refuting a link.

Under clear attack are aluminum salt adjuvants, which are used in many vaccines to help spur protective immune responses. Aluminum salts have been used safely in vaccines for more than 70 years. The FDA notes that the most common source of aluminum exposure is from food and water, not vaccines.

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

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Achieving lasting remission for HIV

health, HIV, remission, Science, syndication / Shannon Garcia / November 29, 2025

Promising trials using engineered antibodies suggest that “functional cures” may be in reach.

A digital illustration of an HIV-infected T cell. Once infected, the immune cell is hijacked by the virus to produce and release many new viral particles before dying. As more T-cells are destroyed, the immune system is progressively weakened. Credit: Kateryna Kon/Science Photo Library via Getty Images

Around the world, some 40 million people are living with HIV. And though progress in treatment means the infection isn’t the death sentence it once was, researchers have never been able to bring about a cure. Instead, HIV-positive people must take a cocktail of antiretroviral drugs for the rest of their lives.

But in 2025, researchers reported a breakthrough that suggests that a “functional” cure for HIV—a way to keep HIV under control long-term without constant treatment—may indeed be possible. In two independent trials using infusions of engineered antibodies, some participants remained healthy without taking antiretrovirals, long after the interventions ended.

In one of the trials—the FRESH trial, led by virologist Thumbi Ndung’u of the University of KwaZulu-Natal and the Africa Health Research Institute in South Africa—four of 20 participants maintained undetectable levels of HIV for a median of 1.5 years without taking antiretrovirals. In the other, the RIO trial set in the United Kingdom and Denmark and led by Sarah Fidler, a clinical doctor and HIV research expert at Imperial College London, six of 34 HIV-positive participants have maintained viral control for at least two years.

These landmark proof-of-concept trials show that the immune system can be harnessed to fight HIV. Researchers are now looking to conduct larger, more representative trials to see whether antibodies can be optimized to work for more people.

“I do think that this kind of treatment has the opportunity to really shift the dial,” Fidler says, “because they are long-acting drugs”—with effects that can persist even after they’re no longer in the body. “So far, we haven’t seen anything that works like that.”

People with HIV can live long, healthy lives if they take antiretrovirals. But their lifespans are still generally shorter than those of people without the virus. And for many, daily pills or even the newer, bimonthly injections present significant financial, practical, and social challenges, including stigma. “Probably for the last about 15 or 20 years, there’s been this real push to go, ‘How can we do better?’” says Fidler.

The dream, she says, is “what people call curing HIV, or a remission in HIV.” But that has presented a huge challenge because HIV is a master of disguise. The virus evolves so quickly after infection that the body can’t produce new antibodies quickly enough to recognize and neutralize it.

And some HIV hides out in cells in an inactive state, invisible to the immune system. These evasion tactics have outwitted a long succession of cure attempts. Aside from a handful of exceptional stem-cell transplants, interventions have consistently fallen short of a complete cure—one that fully clears HIV from the body.

A functional cure would be the next best thing. And that’s where a rare phenomenon offers hope: Some individuals with long-term HIV do eventually produce antibodies that can neutralize the virus, though too late to fully shake it. These potent antibodies target critical, rarely changing parts of HIV proteins in the outer viral membrane; these proteins are used by the virus to infect cells. The antibodies, able to recognize a broad range of virus strains, are termed broadly neutralizing.

Scientists are now racing to find the most potent broadly neutralizing antibodies and engineer them into a functional cure. FRESH and RIO are arguably the most promising attempts yet.

In the FRESH trial, scientists chose two antibodies that, combined, were likely to be effective against HIV strains known as HIV-1 clade C, which is dominant in sub-Saharan Africa. The trial enrolled young women from a high-prevalence community as part of a broader social empowerment program. The program had started the women on HIV treatment within three days of their infection several years earlier.

The RIO trial, meanwhile, chose two well-studied antibodies shown to be broadly effective. Its participants were predominantly white men around age 40 who also had gone on antiretroviral drugs soon after infection. Most had HIV-1 clade B, which is more prevalent in Europe.

By pairing antibodies, the researchers aimed to decrease the likelihood that HIV would develop resistance—a common challenge in antibody treatments—since the virus would need multiple mutations to evade both.

Participants in both trials were given an injection of the antibodies, which were modified to last around six months in the body. Then their treatment with antiviral medications was paused. The hope was that the antibodies would work with the immune system to kill active HIV particles, keeping the virus in check. If the effect didn’t last, HIV levels would rise after the antibodies had been broken down, and the participants would resume antiretroviral treatment.

Excitingly, however, findings in both trials suggested that, in some people, the interventions prompted an ongoing, independent immune response, which researchers likened to the effect of a vaccine.

In the RIO trial, 22 of the 34 people receiving broadly neutralizing antibodies had not experienced a viral rebound by 20 weeks. At this point, they were given another antibody shot. Beyond 96 weeks—long after the antibodies had disappeared — six still had viral levels low enough to remain off antiviral medications.

An additional 34 participants included in the study as controls received only a saline infusion and mostly had to resume treatment in four to six weeks; all but three were back on treatment within 20 weeks.

A similar pattern was observed in FRESH (although, because it was mostly a safety study, this trial did not include control participants). Six of the 20 participants retained viral suppression for 48 weeks after the antibody infusion, and of those, four remained off treatment for more than a year. Two and a half years after the intervention, one remains off antiretroviral medication. Two others also maintained viral control but eventually chose to go back on treatment for personal and logistical reasons.

It’s unknown when the virus might rebound, so the researchers are cautious about calling participants in remission functionally cured. However, the antibodies clearly seem to coax the immune system to fight the virus. Attached to infected cells, they signal to immune cells to come in and kill.

And importantly, researchers believe that this immune response to the antibodies may also stimulate immune cells called CD8+ T cells, which then hunt down HIV-infected cells. This could create an “immune memory” that helps the body control HIV even after the antibodies are gone.

The response resembles the immune control seen in a tiny group (fewer than 1 percent) of individuals with HIV, known as elite controllers. These individuals suppress HIV without the help of antiretrovirals, confining it mostly to small reservoirs. That the trials helped some participants do something similar is exciting, says Joel Blankson, an infectious diseases expert at Johns Hopkins Medicine, who coauthored an article about natural HIV controllers in the 2024 Annual Review of Immunology. “It might teach us how to be able to do this much more effectively, and we might be able to get a higher percentage of people in remission.”

One thing scientists do know is that the likelihood of achieving sustained control is higher if people start antiretroviral treatment soon after infection, when their immune systems are still intact and their viral reservoirs are small.

But post-treatment control can occur even in people who started taking antiretrovirals a long time after they were initially infected: a group known as chronically infected patients. “It just happens less often,” Blankson says. “So it’s possible the strategies that are involved in these studies will also apply to patients who are chronically infected.”

A particularly promising finding of the RIO trial was that the antibodies also affected dormant HIV hiding out in some cells. These reservoirs are how the virus rebounds when people stop treatment, and antibodies aren’t thought to touch them. Researchers speculate that the T cells boosted by the antibodies can recognize and kill latently infected cells that display even trace amounts of HIV on their surface.

The FRESH intervention, meanwhile, targeted the stubborn HIV reservoirs more directly through incorporating another drug, called vesatolimod. It’s designed to stimulate immune cells to respond to the HIV threat, and hopefully to “shock” dormant HIV particles out of hiding. Once that happens, the immune system, with the help of the antibodies, can recognize and kill them.

The results of FRESH are exciting, Ndung’u says, “because it might indicate that this regimen worked, to an extent. Because this was a small study, it’s difficult to, obviously, make very hard conclusions.” His team is still investigating the data.

Once he secures funding, Ndung’u aims to run a larger South Africa-based trial including chronically infected individuals. Fidler’s team, meanwhile, is recruiting for a third arm of RIO to try to determine whether pausing antiretroviral treatment for longer before administering the antibodies prompts a stronger immune response.

A related UK-based trial, called AbVax, will add a T-cell-stimulating drug to the mix to see whether it enhances the long-lasting, vaccine-like effect of the antibodies. “It could be that combining different approaches enhances different bits of the immune system, and that’s the way forward,” says Fidler, who is a co-principal investigator on that study.

For now, Fidler and Ndung’u will continue to track the virally suppressed participants — who, for the first time since they received their HIV diagnoses, are living free from the demands of daily treatment.

This story originally appeared at Knowable Magazine.

Knowable Magazine explores the real-world significance of scholarly work through a journalistic lens.

Achieving lasting remission for HIV Read More »

Four-inch worm hatches in woman’s forehead, wriggles to her eyelid

CDC, eye, health, Infectious disease, New England Journal of Medicine, parasite, worm / Mike M. / November 27, 2025

Creeping

For anyone enjoying—or at least trying to enjoy—Thanksgiving in America, you can be thankful that these worms are not present in the US; they are exclusive to the “Old World,” that is Europe, Africa, and Asia, according to the Centers for Disease Control and Prevention. They’re often found in the Mediterranean region, but reports in recent years have noted that they seem to be expanding into new areas of Europe—particularly eastward and northward. In a report earlier this year of cases in Estonia, researchers noted that it is also emerging in Lithuania, Latvia, and Finland.

Researchers attribute the worm’s creep to climate change and globalization. But in another report this year of a case in Austria (thought to be acquired while the patient was vacationing in Greece), researchers also raised the speculation that the worms may be adapting to use humans as a true host. Researchers in Serbia suggested this in a 2023 case report, in which an infection led to microfilariae in the patient’s blood. The researchers speculated that such cases, considered rare, could be increasing.

For now, people in America have less to worry about. D. repens has not been found in the US, but it does have some relatives here that occasionally show up in humans, including D. immitis, the cause of dog heartworm, and D. tenuis. The latter can cause similar cases to D. repens, with worms wandering under the skin, particularly around the eye. So far, this worm has mainly been found in raccoons in Florida.

For those who do find a worm noodling through their skin, the outlook is generally good. Treatment includes surgical removal of the worm, which largely takes care of the problem, as well as anti-parasitic or antibiotic drugs to be sure to stamp out the infection or any co-infections. In the woman’s case, her symptoms disappeared after doctors pulled the worm from her eyelid.

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RFK Jr.’s new CDC deputy director prefers “natural immunity” over vaccines

anti-vaccine, CDC, health, public health, ralph abraham, Robert F Kenned Jr., vaccine / Kelly Newman / November 26, 2025

Under ardent anti-vaccine Health Secretary Robert F. Kennedy Jr., the Centers for Disease Control and Prevention has named Louisiana Surgeon General Ralph Abraham as its new principal deputy director—a choice that was immediately called “dangerous” and “irresponsible,” yet not as bad as it could have been, by experts.

Physician Jeremy Faust revealed the appointment in his newsletter Inside Medicine yesterday, which was subsequently confirmed by journalists. Faust noted that a CDC source told him, “I heard way worse names floated,” and although Abraham’s views are “probably pretty terrible,” he at least has had relevant experience running a public health system, unlike other current leaders of the agency.

But Abraham hasn’t exactly been running a health system the way most public health experts would recommend. Under Abraham’s leadership, the Louisiana health department waited months to inform residents about a deadly whooping cough (pertussis) outbreak. He also has a clear record of anti-vaccine views. Earlier this year, he told a Louisiana news outlet he doesn’t recommend COVID-19 vaccines because “I prefer natural immunity.” In February, he ordered the health department to stop promoting mass vaccinations, including flu shots, and barred staff from running seasonal vaccine campaigns.

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There may not be a safe off-ramp for some taking GLP-1 drugs, study suggests

GLP-1, health, obesity, Tirzepatide, weight loss / Mike M. / November 26, 2025

Of the 308 who benefited from tirzepatide, 254 (82 percent) regained at least 25 percent of the weight they had lost on the drug by week 88. Further, 177 (57 percent) regained at least 50 percent, and 74 (24 percent) regained at least 75 percent. Generally, the more weight people regained, the more their cardiovascular and metabolic health improvements reversed.

Data gaps and potential off-ramps

On the other hand, there were 54 participants of the 308 (17.5 percent) who didn’t regain a significant amount of weight (less than 25 percent.) This group saw some of their health metrics worsen on withdrawal of the drug, but not all—blood pressure increased a bit, but cholesterol didn’t go up significantly overall. About a dozen participants (4 percent of the 308) continued to lose weight after stopping the drug.

The researchers couldn’t figure out why these 54 participants fared so well; there were “no apparent differences” in demographic or clinical characteristics, they reported. It’s clear the topic requires further study.

But, overall, the study offers a gloomy outlook for patients hoping to avoid needing to take anti-obesity drugs for the foreseeable future.

Oczypok and Anderson highlight that the study involved an abrupt withdrawal from the drug. In contrast, many patients may be interested in slowly weaning off the drugs, stepping down dosage levels over time. So far, data on this strategy and the protocols to pull it off have little data behind them. It also might not be an option for patients who abruptly lose access to or insurance coverage for the drugs. Other strategies for weaning off the drugs could involve ramping up physical activity or calorie restriction in anticipation of dropping the drugs, the experts note.

In addition to more data on potential GLP-1 off-ramps, the pair calls for more data on the effects of weight fluctuations from people going on and off the treatment. At least one study has found that the regained weight after intentional weight loss may end up being proportionally higher in fat mass, which could be harmful.

For now, Oczypok and Anderson say doctors should be cautious about talking with patients about these drugs and what the future could hold. “These results add to the body of evidence that clinicians and patients should approach starting [anti-obesity medications] as long-term therapies, just as they would medications for other chronic diseases.”

There may not be a safe off-ramp for some taking GLP-1 drugs, study suggests Read More »

Why you don’t want to get tuberculosis on your penis

case report, health, mycobacterium, penis, Tuberculosis / DJ Henderson / November 22, 2025

Miliary tuberculosis (MTB) is a severe form of tuberculosis in which the instigating bacteria— Mycobacterium tuberculosis or potentially a relative that infects cows and deer, Mycobacterium bovis—spread widely through the body and create small lesions. The name “miliary” dates back to 1700, when a physician noted that the specks resembled millet seeds.

While Mycobacterium can spread through the air and are often found in the lungs, the bacteria can strike anywhere in the body. Still, penile tuberculosis is exceedingly rare. In fact, it’s uncommon to have tuberculosis erupt anywhere in the urinary and genital tracts. Among the infections that spring up in the region, penile infections account for less than 1 percent.

But, given the man’s lungs and his immunosuppressed status, the unusual presentation became their leading guess—and tests soon confirmed it. Mycobacterium were identified in the man’s respiratory tract, and penile tissue tested also showed the bacteria, though the testing couldn’t identify what species of Mycobacterium.

Treatment for tuberculosis requires a regimen of several antibiotics and takes months. In the man’s case, they customized his treatment with a 12-month, four-drug regimen that wouldn’t interfere with his transplant.

Still, the penile lesion got worse before it got better. He developed a large necrotic ulceration on the side of his penis, and his foreskin began to “break down.” Surgeons had to mechanically cut out the dead tissue. After 10 months, his infection appeared to have cleared, and his penile lesion had improved.

Unexplained exposure

It remains unclear how the man got the infection. He told doctors he wasn’t aware of coming in contact with any tuberculosis patients and wasn’t in settings where the bacteria normally spread, such as prisons. It’s possible that the bacteria had been lurking in his transplanted kidney.

Why you don’t want to get tuberculosis on your penis Read More »

Infant botulism outbreak doubles; ByHeart confirms bacteria in formula

botulism, ByHeart, Formula, health, outbreak / DJ Henderson / November 21, 2025

ByHeart announced on Thursday that its own testing identified the bacterium that causes botulism in its baby formula, which is linked to an ongoing infant botulism outbreak that has doubled since last week.

As of November 19, there have been 31 cases across 15 states—up from 15 cases in 12 states reported last week. All 31 cases so far have been hospitalized. No deaths have been reported.

The outbreak was announced on November 8, and ByHeart was, at first, unusually aggressive in deflecting blame for linked illnesses.

The link between infant botulism cases and ByHeart was first spotted by the California Department of Public Health (CDPH). The department is the world’s sole source of the infant botulism treatment BabyBIG, and, as such, is contacted when any infant botulism cases arise. CDPH started to notice a pattern of ByHeart exposure among the cases. While ByHeart products account for just 1 percent of infant formula sales, babies fed ByHeart formula accounted for 40 percent of infant botulism cases with dry formula exposure between August 1 and November 10. Soon, preliminary testing by the department identified the bacterium that causes botulism—Clostridium botulinum—in an opened can of ByHeart from one of the sick babies.

Changing tune

However, ByHeart didn’t buy it. In a video posted to social media the day the outbreak was announced, one of ByHeart’s co-founders, Mia Funt, said: “I want to make something really clear: There is no reason to believe that infant formula can cause infant botulism.” Funt claimed that “multiple regulatory bodies” have concluded that formula can’t cause infant botulism, and the US Food and Drug Administration has never found a “direct connection” between formula and infant botulism. She added that no “toxins” have been found in the formula.

Infant botulism outbreak doubles; ByHeart confirms bacteria in formula Read More »

RFK Jr.’s loathesome edits: CDC website now falsely links vaccines and autism

aluminum, anti-vaccine, autism, CDC, health, MMR, vaccines / 9u50fv / November 20, 2025

With ardent anti-vaccine activist Robert F. Kennedy Jr. as the country’s top health official, a federal webpage that previously laid out the ample evidence refuting the misinformation that vaccines cause autism was abruptly replaced Wednesday with an anti-vaccine screed that promotes the false link.

It’s a move that is sure to be celebrated by Kennedy’s fringe anti-vaccine followers, but will only sow more distrust, fear, and confusion among the public, further erode the country’s crumbling vaccination rates, and ultimately lead to more disease, suffering, and deaths from vaccine-preventable infections, particularly among children and the most vulnerable.

On the Centers for Disease Control and Prevention’s website titled “Autism and Vaccines,” the previous top “key point” accurately reported that: “Studies have shown that there is no link between receiving vaccines and developing autism spectrum disorder (ASD).”

But, under Kennedy, the top “key point” is now the erroneous statement: “The claim ‘vaccines do not cause autism’ is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism.”

The Department of Health and Human Services, which oversees the CDC, did not respond to questions from Ars Technica about the change, including why it appears to be dismissing the substantial number of high-quality studies providing evidence that there is no association between lifesaving immunizations and the neurodevelopmental disorder. It also did not address questions of whether CDC scientists were included in the rewrite.

An emailed response attributed to HHS spokesperson Andrew Nixon said, “We are updating the CDC’s website to reflect gold standard, evidence-based science.”

RFK Jr.’s loathesome edits: CDC website now falsely links vaccines and autism Read More »

CDC data confirms US is 2 months away from losing measles elimination status

arizona, CDC, health, Infectious disease, measles, outbreak, texas, Utah, vaccination / 9u50fv / November 19, 2025

Unsurprising

This 9171 subtype “continues, unfortunately uninterrupted, across multiple jurisdictions,” David Sugerman, who leads the CDC measles response, said on the call.

According to the Times, local health officials are pessimistic that they’ll be able to stamp out the virus’s spread, saying that vaccination efforts have had “limited” impact. As Ars reported previously, vaccination rates are dangerously low in two measles hotspots: northwestern Mohave County, Arizona, and the southwest health district of Utah. Vaccination rates among kindergartners in the 2024–2025 school year were 78.4 percent and 80.7 percent, respectively. That’s well below the 95 percent target needed to keep the virus from spreading onward in the communities.

In addition, public health officials in Arizona and Utah have reported barriers to responding to the outbreak. Around a quarter of cases don’t know how they were exposed, suggesting cases and exposures are being missed. In late October, health officials in Salt Lake County, Utah, said that a person likely infected with measles refused to cooperate with their investigation, leaving them unable to confirm the probable case.

David Kimberlin, who sits on a panel of experts that analyzes measles data for the United States’ elimination status review, told the Times, “It would not surprise me in the least if there’s continued spread across these next several months.”

To date, the CDC has tallied 1,723 measles cases across 42 states. Most (87 percent) of those cases were linked to outbreaks, of which there have been 45 this year. For context, there were 16 outbreaks and a total of 285 measles cases in the US last year. This year’s measles cases mark a 33-year high.

CDC data confirms US is 2 months away from losing measles elimination status Read More »

Trump admin axed 383 active clinical trials, dumping over 74K participants

clinical trials, grants, health, JAMA, NIH / Kelly Newman / November 18, 2025

“A betrayal”

Jena and colleagues examined the greater context, comparing the number of canceled trials in each treatment category to the total number of all funded trials in those categories. For instance, while cancer trials made up 30 percent of the 383 canceled trials, the 118 canceled cancer trials accounted for only 2.7 percent of the total 4,424 cancer trials funded in the study period. The canceled infectious disease trials, on the other hand, accounted for over 14 percent of all infectious disease trials funded (675). The categories most disproportionately affected were infectious diseases, respiratory diseases, and cardiovascular diseases.

The researchers also looked at the purpose of the canceled trials—for instance, for treatment of a disease, prevention, supportive care, or diagnostics. Of the 383, 140 were for treatments and 123 were for prevention.

The authors note that they weren’t able to determine the stated reasons for the cancellations (if any) or compare this year’s trial cancellations to trends from previous years, which could offer more context to the cuts. There simply isn’t the same comprehensive data on clinical trial cancellations for past years, the authors said, noting “termination of federal grant funding was rare prior to 2025.”

In the accompanying editor’s note, Teva Brender and Cary Gross blasted the revealed cancellations. To cancel trials already underway is to “squander participants’ and investigators’ valuable time, effort, and resources,” they write, since there have already been “substantive sunk costs.” It also “stifles scientific discovery and innovation.”

But “there is a more direct and sobering impact of premature and scientifically unjustifiable trial terminations: the violation of foundational ethical principles of human participant research,” they write. “First and foremost, it is betrayal of the fundamental principles of informed consent for research.” And “participants who have been exposed to an intervention in the context of a trial may be harmed by its premature withdrawal or inadequate follow-up and monitoring for adverse effects.”

Over 74,000 trial participants entrusted researchers with “their health and hope,” but even if the trial funding is restored—as it may be for some—it would “at best mitigate the harms.”

Trump admin axed 383 active clinical trials, dumping over 74K participants Read More »