WASHINGTON — Federal vaccine advisers, through a freewheeling, and at times combative two-day meeting, recommended a major change to childhood vaccinations that runs counter to the medical consensus — and began setting the stage for a larger rethink in the future.
The new recommendations and many of the arguments about U.S.vaccination strategies overlook vast bodies of data that show shots are safe and effective, infectious disease and public health experts said, while embracing unsubstantiated notions that immunizations could pose hidden dangers. The committee’s new approach could harm American children, medical groups said.
“This is a significant departure from the historic role ACIP has played in shaping vaccine policy in the United States,” a joint statement from dozens of groups representing doctors and public health interests said. “Previously, we could expect science to drive decisions, experts to debate evidence, and consensus to lead to shared, clear recommendations. That is not the case with the current committee, and this change puts Americans’ health at risk.”
CDC panel recommends delaying birth dose of hepatitis B vaccine
On Friday, the Advisory Committee on Immunization Practices voted to pull back a decades-old recommendation that every baby receive a hepatitis B vaccine at birth. Troubling to medical experts, the group made the move despite a lack of any new data showing that the shots are unsafe or don’t work.
In fact, hepatitis B vaccines have been proven safe in more than a dozen randomized controlled trials, according to the Evidence Collective, a group of health subject matter experts. Four of those studies directly compared the birth dose to a delayed first dose, as recommended by the committee, and found no increased risk of any short- or long-term adverse event for the birth dose.
Now, ACIP is looking to scrutinize more childhood vaccines — though it hasn’t said which ones. ACIP has formed a working group to review the childhood vaccine schedule, including alleged risks of multiple shots being given at once. (Experts have long found the current schedule is safe.) The committee is scheduled to meet again in February.
Several members of the committee, even before finishing the vote on hepatitis B, suggested their consideration of that shot could offer a roadmap for thinking about other vaccines on the schedule.
Those members, including Retsef Levi and committee vice chair Robert Malone, hinged their arguments on a contention that the risk of giving a hepatitis B vaccine to a newborn could outweigh the benefits, because of their young age and underdeveloped brains.
“As a parent, we encourage you, in consultation with your physician, to think very carefully: Do you want to expose your baby to an intervention that could have some harms when the risk [of hepatitis B] is so low?” Levi said.
ACIP begins discussing the childhood vaccine schedule
Malone went further. He said that there may be unknown risks to giving multiple shots at the same time in early childhood.
“My point of view is that this topic has merit,” Malone said. “It’s the whole reason why we now have a childhood vaccine schedule working group.”
Tracy Beth Høeg, a top Food and Drug Administration official who liaises with ACIP, questioned whether babies born to mothers who test negative for hepatitis B should be vaccinated against the virus at all.
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Once the group finished its business on hepatitis B vaccination, it moved on to discussions about the childhood vaccine schedule broadly.
The first person to present was Aaron Siri, a vaccine critic and attorney who represents people who make vaccine injury claims. Siri, who has become a leading voice in the anti-vaccine movement, offered a sweeping presentation in which he worked to undermine confidence in the current childhood vaccine schedule.
Levi called for the group to explore the “underlying biological mechanisms that take place when we vaccinate children with one vaccine, with multiple vaccines, and how timing, genetics impact this.”
The argument that multiple vaccines given in a relatively small time frame could present new risks, which has been repeated by anti-vaccine activists for years, could have implications for the series of shots that protect kids against a host of dangerous illnesses, from polio to diphtheria.
Even President Trump, speaking from the White House in September, urged parents to hold off on giving their children some vaccines until they’re older. And following a similar logic, he called for the combination measles, mumps, and rubella vaccination to be separated.
It is not surprising that ACIP members are heavily scrutinizing proven shots. Earlier this year, health secretary Robert F. Kennedy Jr. remade ACIP, firing all existing members and adding new members, many of whom have criticized mainstream vaccine guidance. Kennedy’s HHS has also hired a number of individuals who’ve long questioned vaccines into roles across the department, including at the Centers for Disease Control and Prevention.
Still, two ACIP members, Cody Meissner and Joseph Hibbeln, tried to walk the panel back from extrapolating that potential, unknown risks of vaccines given to children outweigh their benefits. During a discussion on aluminum in vaccines, Meissner, a pediatrician, urged the committee not to get distracted by rehashing settled debates, including whether vaccines cause autism, which has been thoroughly debunked. Aluminum, which is used to boost the effects of vaccines, has been heavily studied as well.
“To have ACIP and the CDC spend more time on the aluminum issue, I don’t think it’s going to be very productive,” he said.
Infectious disease experts were alarmed by the committee’s focus on the larger childhood schedule — especially after the committee was willing to change its recommendations on hepatitis B vaccines without evidence, they said.
“No one should follow any recommendations from ACIP,” Peter Hotez, an infectious diseases expert and vaccine developer at Baylor College of Medicine in Houston, said in an interview Thursday. Hotez was invited to present before the committee but declined, saying he believed it was a mistake to legitimize the process by participating.
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The committee voted on Friday to recommend delaying the first dose of hepatitis B vaccine from birth for children whose mothers tested negative for the virus. The group also voted to recommend babies who get the shot may get blood tests to see if they need boosters — despite a lack of understanding of whether a single dose would actually provide sustained protection.
The committee’s vote to recommend delaying the vaccine is unlikely to change doctors’ and hospitals’ practice of recommending it at birth, three doctors told STAT. But they expect the meetings to further erode trust in the shots — and should the committee move forward in examining other vaccines as it did hepatitis B, that erosion is likely to grow, they said.
Hibbeln appeared disturbed by the votes that transpired — and what they could mean for future recommendations.
“This has great potential to cause harm,” Hibbeln said Friday, as he voted against a change to the hepatitis B recommendations. “I simply hope the committee will accept its responsibility when the harm is caused.”
“Roger that,” Malone responded, before moving on to the next item on the agenda.
Aluminum in vaccines is under the microscope
Study finds no evidence aluminum salts in vaccines are tied to higher risk of asthma, other childhood diseases
The committee took particular interest in vaccines that contain aluminum-based adjuvants, with members of the group saying they should investigate the ingredient — used in many vaccines — for association with a number of adverse events.
That’s likely to be key to the committee’s future work: Kirk Milhoan, the committee’s chair, said the group should be “asking significant questions” about a possible link between aluminum and adverse events, despite mainstream researchers finding aluminum is safe and plays an important role in vaccinations globally.
Government pressure to remove aluminum could reduce access to several shots that have long been core to the childhood vaccine schedule. Ordering aluminum removed from vaccines could be among the most impactful actions yet from the administration, experts and employees of vaccine manufacturers previously told STAT — though the impact depends on how aggressively officials move on the issue.
The aluminum adjuvants targeted by the committee are used in many vaccines to boost their effectiveness, essentially allowing less antigen to produce a greater immune response (and more protection against disease).
Vaccine experts and manufacturers have been alarmed that Kennedy and even the president himself have said they want to review or remove aluminum from vaccines. Changing the formulations, they said, would likely take a decade and more than $1 billion for each new vaccine — and is needless, given the current evidence.
The adjuvants are well studied, vaccine safety experts said, and nearly everyone ingests more aluminum in their food and water than the small amounts that are in the shots. An evidence review published in the journal Pediatrics also noted that the aluminum in vaccines is generally removed from the body via the kidneys.
Despite some health care providers believing the new recommendations won’t change how most doctors practice medicine, the ACIP meetings are part of a larger messaging campaign that will erode public trust in vaccines.
“That damage has already been happening,” Sean O’Leary, a doctor who chairs the American Academy of Pediatric’s Committee on Infectious Diseases, told reporters Tuesday, ahead of the ACIP meeting. “I think it’s only going to happen more.”