vaccines

a-fentanyl-vaccine-is-about-to-get-its-first-major-test

A fentanyl vaccine is about to get its first major test


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.

Photo of WIRED

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

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

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.”

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as-shutdown-ends,-dubious-cdc-panel-gets-back-to-dismantling-vaccine-schedule

As shutdown ends, dubious CDC panel gets back to dismantling vaccine schedule

Nevertheless, Kennedy’s ACIP members planned to push the first dose back a month. A vote was prepared to recommend not giving a birth dose unless there was “individual based decision-making.” While at first the panel seemed poised to vote in favor of the change, the plan collapsed with basic questioning.

Voting ACIP member Joseph Hibbeln, a psychiatrist, noted: “I’m unclear if we’ve been presented with any safety or data comparing before one month to after one month,” he said. They had not.

“And,” Hibbeln continued, “I’m wondering why one month was selected as our time point and if there are data to help to inform us if there’s greater risk of adverse effects before one month or after one month at all.”

There is no data suggesting that such a move would be more or less safe.

The discussion quickly spiraled from there with an eventual vote of 11-1 to table voting on the vaccine recommendation. According to the Federal Register notice, ACIP will try to take up the topic again. They could revive the vote or attack some other aspect of vaccine recommendations.

Pediatricians fight back

Health experts have blasted Kennedy’s lineup and their attacks on childhood vaccines, including the hepatitis B vaccination schedule. The current schedule “remains the best protection against serious health problems like liver disease and cancer,” the American Academy of Pediatrics emphasized to Ars.

With ACIP’s standing tarnished under Kennedy, AAP has put forth its own evidence-based vaccine schedule for pediatricians to trust. They’ve also been a prominent opponent among medical organizations to Kennedy’s efforts. For instance, in a revised federal lawsuit, the AAP along with other medical organizations is seeking to overturn all decisions made by Kennedy’s ACIP and replace the entire panel with actual experts.

Kennedy’s appointees “lack the credentials and experience required of their role,” and all their votes should be declared “null and void,” the organization said.

AAP President Susan Kressly said that pediatricians are already seeing the effects of having an anti-vaccine activist as the US health secretary, namely “fear, decreased vaccine confidence, and barriers for families to access vaccines.”

“The nation’s children are already paying the price in avoidable illnesses and hospitalizations,” Kressly said. “We urge federal leaders to restore the science-based deliberative process that has made the United States a global leader in public health. Urgent action is needed.”

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Inside the marketplace for vaccine medical exemptions


Not everything was quite as it seemed

Frontline Health Advocates provides medical exemption notes—for a fee. What exactly are they selling?

Maybe a client hears about them in the comment section of the Facebook group “Medical Exemption Accepted,” or on the r/unvaccinated forum on Reddit. Maybe it’s through an interview posted on the video-sharing platform Rumble. Or maybe it’s the targeted advertisements on Google: “We do medical exemptions.”

Cassandra Clerkin, a mother in upstate New York, first got in touch with Frontline Health Advocates near the start of the 2024–2025 school year, after hearing they had doctors who would write exemptions from school immunization requirements. One of Clerkin’s children, she said, had suffered seizures after receiving a vaccine. The family didn’t want more shots. But New York has some of the country’s strictest school immunization policies.

Perhaps Frontline could help.

Vaccine mandates have a long history in the United States, but they’ve been subject to fresh public attention—and partisan dispute—since the start of the Covid-19 pandemic. Frontline Health Advocates seemingly emerged from pandemic-era battles with a model that, experts say, appears to be unique: It bills itself as a standalone organization that supplies people across the US with medical exemptions from vaccination requirements—for a fee of $495.

On forms obtained by Undark, Frontline’s listed addresses are a storage facility in Denison, Texas, and a package store in Sedona, Arizona. The group publishes little information online about its leadership or finances, but it has quietly developed a following.

There’s little question that Frontline exemptions sometimes work, and some parents report positive experiences with the organization. But there are real questions about whether its legal strategy would hold up in court—and whether clients are confused about what, precisely, they are receiving.

In upstate New York, Clerkin said she spoke with a representative from Frontline by phone about the process. They made it sound, she said, like getting an exemption “would be pretty seamless.”

Soon after, she recalled, she received a call from a doctor named Andrew Zywiec. A week after the family issued a credit card payment of $495 to a chiropractic firm in California, the medical exemption arrived by email. “The duration of the restriction from receiving VACCINATIONS is PERMANENT,” the document stated, citing a range of health concerns, and warning that civil or criminal penalties could result if the school district ignored the request.

Clerkin submitted the document to the district.

Every state in the country has legal language on the books that seems to require certain immunizations before children can enroll in school—although in some places exemption policies are so lax that shots are effectively optional. The military also has vaccine requirements, as do some civilian workplaces, including many hospitals and nursing homes. Immigration proceedings, too, often require applicants to receive shots.

Some people may register personal objections to vaccination, or they may have medical conditions that could make receiving a shot dangerous. Workarounds exist. Most states, for example, allow parents to apply for religious or personal belief exemptions from school vaccine requirements by stating that they object to vaccination due to deeply held convictions. But those exemptions are sometimes denied, and in four states—California, Connecticut, Maine, and New York—they aren’t an option at all. (The policy in a fifth state, West Virginia, is currently in flux.)

In those states, the only way to attend school without a required shot is to receive a medical waiver. There are real reasons for some people to pursue them: They may be immunocompromised in a way that makes certain vaccines high-risk, or they may have had a bad reaction to a shot in the past. In some cases, families may earnestly believe their child cannot safely receive a vaccine, but have difficulty finding a physician who agrees, or who is willing to attest to that on an exemption.

Interest in medical exemptions tends to grow when laws tighten. In 2015, after a measles outbreak at Disneyland sickened hundreds of people, California lawmakers ended the state’s personal belief exemption. Almost immediately, the medical exemption rate more than doubled, according to a 2019 paper by a team of public health researchers. The law “created a black market for medical exemptions,” one unnamed health officer told the researchers. Parents, the officer added, would go online and “get medical exemptions from physicians who were not their child’s treating physician.”

The state cracked down, prosecuting some health care providers for allegedly providing improper medical exemptions, and tightening the rules for receiving a waiver. New York, which eliminated religious exemptions in 2019, has taken similar steps; the Department of Health maintains a public list of health care providers who have been banned or suspended from using immunization registries in the state, on a webpage titled “School Vaccination Fraud Awareness.”

In New York, advocates say, state policies have made it prohibitively difficult for some families to obtain medical exemptions, regardless of the reason. “My understanding is that up until this year, again, a lot of doctors weren’t willing to write these medical exemptions,” said Chad Davenport, an attorney outside Buffalo, New York, who often represents families seeking medical exemptions. (One of his clients recently won a key ruling in a federal court case against a Long Island school district that had denied medical exemptions from at least six health care providers.)

Enter Frontline Health Advocates. The organization, Davenport said, “kind of stepped in and provided families at least an option, or a potential path.”

Two researchers who have studied vaccination exemptions in the United States said the organization appears to have a unique model: While individual doctors have sometimes gained a reputation for supplying medical exemptions, neither expert had seen a full-fledged national organization offering those services.

“They’re very blatant,” said Dorit Reiss, a professor at UC Law San Francisco who studies vaccine law and policy.

The group’s founder and director is William Lionberger, a chiropractor who has been licensed to practice in California since 1981, and who once maintained a practice north of San Diego. According to public records, he has also served as a police officer in a town near Sedona. (Lionberger declined a request for an on-the-record interview, and the organization did not answer a list of questions from Undark.) Interviewers who have hosted Lionberger on their shows describe him as affiliated with America’s Frontline Doctors, a group that opposed Covid-19 vaccines and other public health measures while promoting unproven treatments like hydroxychloroquine.

Frontline Health Advocates’ webpage was first registered in March 2022, with a name echoing that of America’s Frontline Doctors. By April of that year, the website was inviting visitors to “Get your exemption now.” In a 2023 interview, Lionberger described having a “team of medical experts” who “work with all kinds of situations,” evaluating clients both for “regular vax injuries and regular vax exemptive conditions.”

He added: “People now don’t even want their kids to get anywhere near a regular vaccine.”

The group employs a pair of distinctive legal strategies. One of these is to form itself as something called a Private Ministerial Association. Online, some groups that help set up such private associations describe them as offering special First Amendment protections. A membership application document hosted on Frontline’s website describes the group as “a private, unincorporated ministry that operates as much as possible, outside the jurisdiction of government entities, agencies, officers, agents, contractors, and other representatives, as protected by law.”

Another strategy is to invoke federal disability law. In the 2023 interview, Lionberger boasted that they drew on “the most powerful thing that you can bring against discrimination”—specifically, federal protections. A promotional video posted on the Frontline website makes a similar claim, advertising waivers “supported by the protections under US federal laws.” Undark obtained three near-identical exemptions sent to New York families in 2024. In them, Frontline argues that the client’s need for a medical exemption is protected under the Americans with Disabilities Act, or ADA, which guarantees certain accommodations for people with disabilities and other medical needs.

In Frontline documents from 2024, the organization suggests that this federal protection supersedes state vaccination laws—offering a way around exemption policies across the country.

In New York, Clerkin had received a document combining medical language with legal details. The document bore the signatures of doctor Andrew Zywiec and an administrative law specialist and JD, Christine Pazzula, along with the seal of the United States Department of Justice.

Not everything was quite as it seemed. Frontline has no relationship with the Department of Justice. Pazzula, according to her LinkedIn profile, had received her legal degree from an unaccredited correspondence school in California, and her name does not appear in databases of attorneys admitted to the bar in New York, Texas, or Nevada, where her LinkedIn profile says she is based. (In a brief email to Undark, Pazzula said she no longer works for Frontline.)

Another parent who received a Frontline exemption in 2024 would later testify under oath that she believed Zywiec to be a physician licensed in the state of New York, but state records show that nobody named Zywiec has ever held a medical license in the state.

Multiple online testimonials about Frontline mention Zywiec. A review of public records suggests a turbulent history. Zywiec served in the Army and graduated from medical school in 2019, according to a CV. In 2020, he began a pediatrics residency at The Brooklyn Hospital Center, but the relationship soured: He ultimately sued the hospital, alleging an unsafe work environment, and filed an employment complaint that, among other concerns, said he had been “coerced into taking the so-called Covid-19 vaccine.” In court documents associated with the lawsuit, a hospital official described an employee who was “spotty and difficult.” In 2021, Zywiec’s co-residents had written a letter to their superiors alleging that he had made offensive remarks to colleagues and treated nurses poorly, also writing that he “would delay care to patients because he wanted to participate in procedures unrelated to his patients because they interested him.”

Zywiec maintains an online medical practice, where he describes himself as “an international medical doctor and board-certified indigenous medicine provider” and offers a range of services, including a $150, 30-minute, “Medical Excuse/Note” consultation that yields a “legitimate medical excuse tailored to your situation.” On X, where he has amassed a following in the tens of thousands, Zywiec regularly shares content about the dangers of vaccines.

The promotional video on Frontline’s website describes the exemptions as “signed by state-licensed physicians with full credentials.” Zywiec’s name does not appear in a national database of licensed physicians maintained by the Federation of State Medical Boards. (In a brief email, Zywiec referred interview requests to Frontline. He did not answer a list of questions from Undark, and Frontline did not respond to a question about Zywiec’s license status.)

The exemption that Zywiec had signed for Clerkin was denied. In a letter, the school district explained that New York law requires exemptions to be signed by a physician licensed in the state. Clerkin said that she was aware Zywiec was not licensed in New York, but Frontline seemed confident in their approach, and she thought it might work. That did not pan out, she said. “I feel like they talk this big thing,” Clerkin said. But, she added, “if you know that you can’t help these children, and you’re just preying on these mothers who will do anything for their children, that is evil.”

Some Frontline exemptions do get through, at least in New York. “I can certainly tell you that there have been some people, even this year, who have been able to get their Frontline Health waivers accepted,” Davenport told Undark. But, he said, courts have not tested the argument that an exemption invoking federal law will trump the state’s requirement that the exemption comes from a New York-licensed physician. He does not recommend Frontline to clients. “I basically tell them, although Frontline may technically be correct, it’s not a good legal position for you to be in,” Davenport said. “And so I always advise them to try to get a New York state waiver signed by a New York state doctor and then submit that, because that puts you in the best legal position.”

In a video on its website, Frontline warns potential clients that exemptions may be denied, noting that the group “cannot guarantee that an unknown person you are engaging with is going to abide by federal laws.” But Rita Palma, a health freedom activist on Long Island who has worked with many families seeking medical exemptions, told Undark that she thinks parents are still confused about the limitations of the waivers. “What I’m getting from parents is that Frontline Health Advocates say that federal law overrides state law,” she said. Whether or not that’s true in the case of vaccine exemptions remains unclear.

The $495 fee—extra for expedited service—is a steep price for some families. “They’ve made a nice killing in New York,” Palma said. “I hate to put it like that, but they’ve definitely gotten a lot of parents to pay them to get exemptions.”

It’s difficult to know how many waivers Frontline has sold. In online forums, people describe successes with schools. “I got lifetime medical exemptions for my children,” one parent wrote in a Facebook group in April, noting that she was not affiliated with Frontline. The group is “replete with lawyers to respond to any pushback from schools,” she added.

One mother in Connecticut told Undark that she had contacted Frontline in 2024, when her son needed a flu shot to stay in daycare. “I was looking around for a way to get an exemption,” she said. (The mother spoke on condition of anonymity, citing a professional need for privacy.) After a phone call with a licensed pediatrician in Texas, she received an exemption. The daycare, she said, accepted it. “It was a pretty smooth experience, overall,” she said.

“I was aware that it was a gamble,” the mother said; Frontline had told her the exemption might not be accepted. “But then they kind of were like, well, you know, technically, if they don’t accept it, it’s illegal because it’s protected by ADA and all that kind of thing,” she said.

The group has attracted attention from some public health officials. In Los Angeles County, a public health department website is topped by a large red banner warning that Frontline exemptions don’t work in California. In October 2024, in Connecticut, minutes from a meeting of the state’s School Nurse Advisory Council described Frontline as providing what the council believed to be “fraudulent” exemptions to families. A spokesperson for Connecticut Public Health, Brittany Schaefer, told Undark in late September that Frontline is the subject of “an active investigation.”

Undark asked three legal experts to review a copy of an exemption issued to a family in New York in September 2024 and obtained via court records. “It seems to be a fill-in-the-blank type of form,” said Barbara Hoffman, an expert in disability law at Rutgers Law School. The waiver, Hoffman believes, overstates the penalties generally levied for ADA infractions. School districts, employers, or others who received this form, she speculated, might feel like “it’s not worth the effort to reject this.”

“This looks like an official document,” she added, highlighting the seal of the Department of Justice and references to potential civil penalties. “It’s designed to intimidate somebody who doesn’t really know better, or just doesn’t want to risk any potential litigation.”

Could invoking the ADA really override state-level vaccine requirements? Reiss, the UC Law San Francisco expert, was skeptical, noting that state law has generally held in similar cases. “My expectation,” she wrote in an email, “is that that won’t hold.”

This article was originally published on Undark. Read the original article.

http://arstechnica.com/

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Childhood vaccines safe for a little longer as CDC cancels advisory meeting

An October meeting of a key federal vaccine advisory committee has been canceled without explanation, sparing the evidence-based childhood vaccination schedule from more erosion—at least for now.

The Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention was planning to meet on October 22 and 23, which would have been the committee’s fourth meeting this year. But the meeting schedule was updated in the past week to remove those dates and replace them with “2025 meeting, TBD.”

Ars Technica contacted the Department of Health and Human Services to ask why the meeting was canceled. HHS press secretary Emily Hilliard offered no explanation, only saying that the “official meeting dates and agenda items will be posted on the website once finalized.”

ACIP is tasked with publicly reviewing and evaluating the wealth of safety and efficacy data on vaccines and then offering evidence-based recommendations for their use. Once the committee’s recommendations are adopted by the CDC, they set national vaccination standards for children and establish which shots federal programs and private insurance companies are required to fully cover.

In the past, the committee has been stacked with highly esteemed, thoroughly vetted medical experts, who diligently conducted their somewhat esoteric work on immunization policy with little fanfare. That changed when ardent anti-vaccine activist Robert F. Kennedy Jr. became health secretary. In June, Kennedy abruptly and unilaterally fired all 17 ACIP members, falsely accusing them of being riddled with conflicts of interest. He then installed his own hand-selected members. With the exception of one advisor—pediatrician and veteran ACIP member Cody Meissner—the members are poorly qualified, have gone through little vetting, and embrace the same anti-vaccine and dangerous fringe ideas as Kennedy.

Corrupted committee

So far this year, Kennedy’s advisors have met twice, producing chaotic meetings during which members revealed a clear lack of understanding of the data at hand and the process of setting vaccine recommendations, all while setting policy decisions long sought by anti-vaccine activists. The first meeting, in June, included seven members selected by Kennedy. In that meeting, the committee rescinded the recommendation for flu vaccines containing a preservative called thimerosal based on false claims from anti-vaccine groups that it causes autism. The panel also ominously said it would re-evaluate the entire childhood vaccination schedule, putting life-saving shots at risk.

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Despite RFK Jr.’s shenanigans, COVID shot access will be a lot like last year

In an interview with Ars Technica in August, Brigid Groves, vice president of professional affairs for the American Pharmacists Association (APhA), signaled that efforts to limit access to COVID-19 vaccines is concerning to APhA, which is the leading organization representing pharmacists.

“We are concerned about that because the data and evidence point to the fact that this vaccine is safe and effective for [young, otherwise healthy] patients,” Groves said. “So, to suddenly arbitrarily limit that is very concerning to us.”

And, with the CDC’s permissive recommendations, pharmacies are not limiting them. Representatives for both CVS and Walgreens told The Washington Post that they would not require patients under 65 to prove they have an underlying condition to get a COVID-19 vaccine. CVS won’t ask you to self-attest to having a condition, and Walgreens also said that it won’t require any proof.

“In simplest terms, if a patient wants to get the vaccine, they’ll get it,” Amy Thibault, a CVS spokesperson, told the Post.

With the shared decision-making, there may be extra forms about risks and benefits that might take an extra few minutes, but it should otherwise be just like past years.

On Tuesday, this reporter was able to easily book same-day appointments for an updated COVID-19 vaccine at local CVS and Walgreens pharmacies in North Carolina, without attesting to any medical conditions.

Children

Shots for younger children could be trickier: While adults and older children can visit their pharmacy and get vaccinated relatively easily, younger children (particularly those under age 5) may have a harder time. Pharmacists typically do not vaccinate those younger children—which has always been the case—and parents will have to visit the pediatrician.

Pediatricians, like pharmacists, are likely to be supportive of broad access to the shots. The American Academy of Pediatrics has said that all children should have access. The AAP also specifically encourages children under age 2 and children with underlying conditions to get vaccinated, because those children are at higher risk of severe disease.

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RFK Jr. drags feet on COVID-19 vaccine recommendations, delaying shots for kids

Previously, the FDA narrowed the shots’ labels to include only people age 65 and older, and those 6 months and older at higher risk. But the ACIP recommended that all people age 6 months and older could get the shot based on shared decision-making with a health care provider. Although the shared decision-making adds a new requirement for getting the vaccine, that decision-making does not require a prescription and can be done not only with doctors, but also with nurses and pharmacists. Most people in the US get their seasonal COVID-19 vaccines at their local pharmacy.

Ars Technica reached out to the HHS on Thursday about whether there was a determination on the COVID-19 vaccine recommendations and, if not, when that is expected to happen and why there is a delay. The HHS responded, confirming that no determination had been made yet, but did not answer any of the other questions and did not provide a comment for the record.

In past years, ACIP recommendations and CDC sign-offs have happened earlier in the year to provide adequate time for a rollout. In 2024, ACIP voted on COVID-19 vaccinations in June, for instance, and then-CDC Director Mandy Cohen signed off that day. Now that we’re into October, it remains unclear when or even if the CDC will sign off on the recommendation and then, if the recommendation is adopted by the CDC, how much longer after that it would take for states to roll out the vaccines to children in the VFC program.

“Children who depend on this program, including children with chronic conditions, are still waiting unprotected. The delay in adopting COVID-19 vaccine recommendations puts their health at risk, reduces access and choice for families, and puts a strain on providers who want to deliver the best care for their youngest patients,” Susan Kansagra, the chief medical officer of the Association of State and Territorial Health Officials, said in a statement to Stat.

For now, children and adults with private insurance have access to the shots without the final sign-off, and health insurance companies have said that they will continue to maintain coverage for the vaccines without the final federal approval.

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The current war on science, and who’s behind it


A vaccine developer and a climate scientist walk into a bar write a book.

Fighting against the anti-science misinformation can feel like fighting a climate-driven wildfire. Credit: Anadolu

We’re about a quarter of the way through the 21st century.

Summers across the global north are now defined by flash floods, droughts, heat waves, uncontainable wildfires, and intensifying named storms, exactly as predicted by Exxon scientists back in the 1970s. The United States secretary of health and human services advocates against using the most effective tool we have to fight the infectious diseases that have ravaged humanity for millennia. People are eagerly lapping up the misinformation spewed and disseminated by AI chatbots, which are only just getting started.

It is against this backdrop that a climate scientist and a vaccine developer teamed up to write Science Under Siege. It is about as grim as you’d expect.

Michael Mann is a climate scientist at the University of Pennsylvania who, in 1998, developed the notorious hockey stick graph, which demonstrated that global surface temperatures were roughly flat until around the year 1900, when they started rising precipitously (and have not stopped). Peter Hotez is a microbiologist and pediatrician at Baylor College of Medicine whose group developed a low-cost, patent-free COVID-19 vaccine using public funds (i.e., not from a pharmaceutical company) and distributed it to almost a hundred million people in India and Indonesia.

Unlikely crusaders

Neither of them anticipated becoming crusaders for their respective fields—and neither probably anticipated that their respective fields would ever actually need crusaders. But they each have taken on the challenge, and they’ve been rewarded for their trouble with condemnation and harassment from Congress and death threats from the public they are trying to serve. In this book, they hope to take what they’ve learned as scientists and science communicators in our current world and parlay that into a call to arms.

Mann and Hotez have more in common than being pilloried all over the internet. Although they trained in disparate disciplines, their fields are now converging (as if they weren’t each threatening enough on their own). Climate change is altering the habitats, migrations, and reproductive patterns of pathogen-bearing wildlife like bats, mosquitoes, and other insects. It is causing the migration of humans as well. Our increasing proximity to these species in both space and time can increase the opportunities for us to catch diseases from them.

Yet Mann and Hotez insist that a third scourge is even more dangerous than these two combined. In their words:

It is currently impossible for global leaders to take the urgent actions necessary to respond to the climate crisis and pandemic threats because they are thwarted by a common enemy—antiscience—that is politically and ideologically motivated opposition to any science that threatens powerful special interests and their political agendas. Unless we find a way to overcome antiscience, humankind will face its gravest threat yet—the collapse of civilization as we know it.

And they point to an obvious culprit: “There is, unquestionably, a coordinated, concerted attack on science by today’s Republican Party.”

They’ve helpfully characterized “the five principal forces of antiscience “ into alliterative groups: (1) plutocrats and their political action committees, (2) petrostates and their politicians and polluters, (3) fake and venal professionals—physicians and professors, (4) propagandists, especially those with podcasts, and (5) the press. The general tactic is that (1) and (2) hire (3) to generate deceitful and inflammatory talking points, which are then disseminated by all-too-willing members of (4) and (5).

There is obviously a lot of overlap among these categories; Elon Musk, Vladimir Putin, Rupert Murdoch, and Donald Trump can all jump between a number of these bins. As such, the ideas and arguments presented in the book are somewhat redundant, as are the words used. Far too many things are deemed “ironic” (i.e., the same people who deny and dismiss the notion of human-caused climate change claimed that Democrats generated hurricanes Helene and Milton to target red states in October 2024) or “risible” (see Robert F. Kennedy Jr.’s claim that Dr. Peter Hotez sought to make it a felony to criticize Anthony Fauci).

A long history

Antiscience propaganda has been used by authoritarians for over a century. Stalin imprisoned physicists and attacked geneticists while famously enacting the nonsensical agricultural ideas of Trofim Lysenko, who thought genes were a “bourgeois invention.” This led to the starvation of millions of people in the Soviet Union and China.

Why go after science? The scientific method is the best means we have of discovering how our Universe works, and it has been used to reveal otherwise unimaginable facets of reality. Scientists are generally thought of as authorities possessing high levels of knowledge, integrity, and impartiality. Discrediting science and scientists is thus an essential first step for authoritarian regimes to then discredit any other types of learning and truth and destabilize their societies.

The authors trace the antiscience messaging on COVID, which followed precisely the same arc as that on climate change except condensed into a matter of months instead of decades. The trajectory started by maintaining that the threat was not real. When that was no longer tenable, it quickly morphed into “OK, this is happening, and it may actually get pretty bad for some subset of people, but we should definitely not take collective action to address it because that would be bad for the economy.”

It finally culminated in preying upon people’s understandable fears in these very scary times by claiming that this is all the fault of scientists who are trying to take away your freedom, be that bodily autonomy and the ability to hang out with your loved ones (COVID) or your plastic straws, hamburgers, and SUVs (climate change).

This mis- and disinformation has prevented us from dealing with either catastrophe by misleading people about the seriousness, or even existence, of the threats and/or harping on their hopeless nature, sapping us of the will to do anything to counter them. These tactics also sow division among people, practically ensuring that we won’t band together to take the kind of collective action essential to addressing enormous, complex problems. It is all quite effective. Mann and Hotez conclude that “the future of humankind and the health of our planet now depend on surmounting the dark forces of antiscience.”

Why, you might wonder, would the plutocrats, polluters, and politicians of the Republican Party be so intent on undermining science and scientists, lying to the public, fearmongering, and stoking hatred among their constituents? The same reason as always: to hold onto their money and power. The means to that end is thwarting regulations. Yes, it’s nefarious, but also so disappointingly… banal.

The authors are definitely preaching exclusively to the converted. They are understandably angry at what has been done to them and somewhat mocking of those who don’t see things their way. They end by trying to galvanize their followers into taking action to reverse the current course.

They advise that the best—really, the only—thing we can do now to effect change is to vote and hope for favorable legislation. “Only political change, including massive turnout to support politicians who favor people over plutocrats, can ultimately solve this larger systemic problem,” they write. But since our president and vice president don’t even believe in or acknowledge “systemic problems,” the future is not looking too bright.

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Anti-vaccine allies cheer as Trump claims shots have “too much liquid”


Why babies don’t pop like water balloons when they get vaccines—and other info for Trump.

President Donald Trump, flanked by senior health officials, speaks during a news conference on September 22, 2025 inside the Roosevelt Room at The White House in Washington. Credit: Getty | Tom Brenner

When the bar is set at suggesting that people inject bleach into their veins, it’s hard to reach a new low. But in a deranged press event on autism Monday evening, President Trump seemed to go for it—sharing “rumors” and his “strong feelings” not just on Tylenol but also his bonkers views on childhood vaccines.

Trump was there with his health secretary, anti-vaccine activist Robert F. Kennedy Jr., to link autism to the use of Tylenol (acetaminophen) during pregnancy. While medical experts condemn the claim as unproven and dangerous (which it is), Kennedy’s anti-vaccine followers decried it as a distraction from their favored false and dangerous explanation—that vaccines cause autism (they don’t).

Pinning the blame on Tylenol instead of vaccines enraged Kennedy’s own anti-vaccine organization, Children’s Health Defense. In the run-up to the event Monday evening, CHD retweeted an all-caps defense of Tylenol, and CHD President Mary Holland called the announcement a “sideshow” in an interview with Steve Bannon.

But fear not. The rift was short-lived, as their big feelings were soothed mere minutes into Monday’s event. After smearing Tylenol, the president’s unscripted remarks quickly veered into an incoherent rant linking vaccines to autism as well.

At one point in his comments, he rattled off a list of anti-vaccine activists’ most vilified vaccine components (mercury and aluminum). But his attack largely ignored the content of vaccines and instead surprisingly focused on volume. Overall, his comments were incoherent, but again and again, he seemed to swirl back to this bizarre concern.

Wut?

If you piece together Trump’s sentence- and thought-fragments, his comments created a horrifying picture of what he thinks childhood vaccinations look like:

They pump so much stuff into those beautiful little babies. It’s a disgrace. I don’t see it. I think it is very bad. They’re pumping. It looks like they’re pumping into a horse. You have a little child, little fragile child, and you get a vat of 80 different vaccines, I guess, 80 different blends and they pump it in.

It seemed that Trump’s personal solution to this imagined problem is to space out and delay vaccines so they are not given at one time:

Break it up because it’s too much liquid. Too many different things are going into that baby at too big a number. The size of this thing, when you look at it, it’s like 80 different vaccines and beyond vaccines and 80. Then you give that to a little kid.

From Trump’s loony descriptions, you might be imagining an evil cartoon doctor wielding a bazooka-sized syringe and cackling maniacally while injecting a baby with a vat’s worth of 80 different vaccines until it inflates like a water balloon ready to burst.

But this cuckoo take is not how childhood vaccinations go in routine well-baby doctor’s visits. First, most vaccines have a volume of 0.5 milliliters, which is about a tenth of a teaspoon. And babies and children do not get 80 different vaccines ever, let alone at one time. In fact, no recommendations would see anyone get 80 different types of vaccines cumulatively.

By age 18, it’s recommended that people get vaccinated against 17 diseases, including seasonal flu and COVID-19. And some vaccines are combination shots, knocking out three or four diseases with one injection, such as the measles, mumps, rubella (MMR) vaccine or the Diphtheria, tetanus, & acellular pertussis (DTaP) vaccine. And again, even those combination shots are 0.5 mL total.

Modern vaccines

Trump’s claim of 80 vaccines doesn’t even stand up when you count vaccine doses rather than different vaccines. Some childhood vaccines require multiple doses—MMR is given in two doses, and DTaP is a five-dose series, for example. According to current recommendations, by age 18, kids should have 36 vaccine doses against childhood diseases. If you add in a flu shot every year, that’s 54 doses. If you add in a COVID-19 vaccine every year, that’s 72.

While 72 might seem like a big number, again, that’s spread out over 18 years and includes seasonal shots. And medical experts point to another key fact—the vaccines that children get today are much more streamlined and efficient than vaccines of yore. A helpful myth-busting info sheet from experts with Yale’s School of Public Health points out that in the mid-1980s, children under age 2 were vaccinated against seven diseases, but those old-school vaccines included more than 3,000 germ components that can spur immune responses (aka antigens). Today, children under age 2 get vaccinated against 15 diseases, but today’s more sophisticated vaccine designs include just 180 antigens, making the protection more targeted and reducing the risk of errant immune responses.

In all, the facts should dash any worries of nefarious doctors inflating children with vast volumes of noxious concoctions. But for those who may hew closely to the cautionary principle, Trump’s “space the shots out” plan may still seem reasonable. It’s not.

At most, children might get five or six vaccines at one time. But again, the number of antigens in those shots is far lower than those in vaccines children received decades ago. And the number of antigens in those vaccines is just a fraction of the number kids are exposed to every day just from their environments. If you’ve ever watched a kindergartener touch every surface and object in a classroom and then shove their fingers in their nose and mouth, you understand the point.

Vaccinations don’t overwhelm children’s immune systems. And there’s no evidence that spacing them out avoids any of the very small risks they pose.

Data against dogma

After Trump shared his personal feelings about vaccines, the American Academy of Pediatrics rushed to release a statement, first refuting any link between vaccines and autism and then warning against spacing out vaccine doses.

“Pediatricians know firsthand that children’s immune systems perform better after vaccination against serious, contagious diseases like polio, measles, whooping cough, and hepatitis B,” the AAP said. “Spacing out or delaying vaccines means children will not have immunity against these diseases at times when they are most at risk.”

Such messages make no impact on the impervious dogma of anti-vaccine activists, of course. While medical experts and organizations like AAP scrambled to combat the misinformation and assure pregnant people and parents that Tylenol was still safe and vaccines don’t cause autism, anti-vaccine activists cheered Trump’s comments.

“We knew today was going to be about acetaminophen,” CHD President Mary Holland said, speaking on Bannon’s podcast again after the event. “We didn’t know if he’d touch on vaccines—and he was all over it. It was an amazing, amazing speech.

“I’m happy to say he basically gave parents permission not to vaccinate their kids—and definitely not to take Tylenol.”

In a new pop-up message on Tylenol’s website, the maker of the common pain reliever and fever reducer pushed back on Trump’s feelings.

Tylenol is one of the most studied medications in history–and is safe when used as directed by expecting mothers, infants, and children.

The facts remain unchanged: over a decade of rigorous research, endorsed by leading medical professionals, confirm there is no credible evidence linking acetaminophen to autism.

The same is true for vaccines.

Photo of Beth Mole

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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Bonkers CDC vaccine meeting ends with vote to keep COVID shot access

At one point, Hillary Blackburn, a pharmacist and daughter-in-law of Sen. Marsha Blackburn (R-Tenn.), noted that her mother developed lung cancer two years after getting a COVID-19 vaccine, suggesting, without any evidence, that there could be a link. Evelyn Griffin, an obstetrician and gynecologist in Louisiana who reportedly lost her job for refusing to get a COVID-19 vaccine, meanwhile, did her own research and tried to suggest that the mRNA in mRNA vaccines could be turned into DNA inside human cells and integrate into our genetic material. She made this assertion to a scientist at Pfizer (a maker of an mRNA COVID-19 vaccine), asking him to respond.

With admirable composure, the Pfizer scientist explained that it was not biologically plausible: “RNA cannot reverse transcribe to DNA and transport from the cytoplasm to the nucleus and then integrate. That requires a set of molecules and enzymes that don’t exist in humans and are largely reserved for retroviruses.”

At the very start of the meeting, liaisons from mainstream medical organizations pressed that the ACIP committee needs to ditch such anecdotal nonsense and unvetted data, and return to the high-quality framework for evidence-based decision-making that ACIP has used in the past, which involves comprehensive, methodical evaluations.

Retsef Levi, who works on operations management and has publicly said that COVID-19 vaccines should be removed from the market, responded by falsely claiming that there are no high-quality clinical trials to show vaccine safety, so calls to return to methodological rigor for policy making are hypocritical. “With all due respect, I just encourage all of us to be a little bit more humble,” Levi, who was the head of the ACIP’s COVID-19 working group, said.

During his response, a hot mic picked up someone saying, “You’re an idiot.” It’s unclear who the speaker was—or how many other people they were speaking for.

This post was updated to include the adoption of the recommendation by the CDC.

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RFK Jr.’s CDC may limit COVID shots to 75 and up, claim they killed kids

While some experts and health care providers had hoped that next week’s ACIP meeting would add clarity to the situation and allow healthy adults and children better access to the shots, the Post’s reporting suggests that’s unlikely. According to their sources, Kennedy’s ACIP is considering recommending the vaccines to those 75 and older, while instructing those 74 and younger to speak with their doctor about getting a shot. Another reported option is to not recommend the vaccine to people under the age of 75 at all, unless they have a preexisting condition.

Backlash

Such additional restrictions would likely intensify the backlash against Kennedy’s anti-vaccine agenda. Already, medical organizations have taken the unprecedented action to release their own evidence-based guidances that maintain COVID-19 vaccine recommendations for healthy children, particularly those under age 2, pregnant people, and healthy adults. Many medical and health organizations, as well as lawmakers, and over 1,000 current and former HHS employees have also called for Kennedy to resign.

Criticism of Kennedy’s actions has spread across party lines. Sen. Bill Cassidy (R-La.), a vaccine-supporting physician who cast a critical vote for Kennedy’s confirmation, had accused Kennedy of denying people vaccines and called for next week’s ACIP meeting to be postponed.

“Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting,” Cassidy said. “These decisions directly impact children’s health, and the meeting should not occur until significant oversight has been conducted. If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership.”

Meanwhile, in a clear rebuff of Kennedy’s cancellation of mRNA vaccine funding, the Republican-led House Committee on Appropriations this week passed a 2026 spending bill that was specifically amended to inject the words “including of mRNA vaccines” into a sentence about pandemic preparedness funding. The bill now reads: “$1,100,000,000, to remain available through September 30, 2027, shall be for expenses necessary to support advanced research and development, including of mRNA vaccines, pursuant to section 319L of the PHS Act and other administrative expenses of the Biomedical Advanced Research and Development Authority.”

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