The Advisory Committee on Immunization Practices is tasked with helping the Centers for Disease Control and Prevention develop vaccine recommendations based on the best data and medical science and informed by leading vaccine and infectious disease researchers and doctors.
Or at least, that’s what the committee, known as ACIP, is supposed to do.
The committee met last week for the third time since Health and Human Services Secretary Robert F. Kennedy Jr. fired its previous members and packed the panel with allies, skeptics, and openly anti-vaccine advocates. Past ACIP convenings featured structured and dispassionate discussions of the vaccine schedule. Their recommendations are always consequential, but their meetings were typically jargony and boring.
This meeting was different. A chaotic two-day session punctuated by shouting matches, passive-aggressive insults, and confusion about the agenda did not stop a majority of the panel from removing a 35-year-old recommendation for a routine birth dose of the hepatitis B vaccine. Anti-vaccine advocates gave presentations that public health researchers and major medical associations criticized as distorted, inaccurate, and misleading. The committee is now poised to deliver similar treatment to the entire childhood vaccine schedule.
The meeting made explicit what was already becoming apparent: The iconoclasts are in charge and pursuing a campaign against public health guidance, as such.
The proceedings were at times confused and seemingly rushed. Members had not seen the exact recommendation language beforehand and had to delay voting to allow time for review. Three days before, a new chair was installed, but he couldn’t run the meeting because he was traveling internationally and missed much of the discussion. A member of the committee work group that developed the new recommendations resigned the night before because she had not seen any of the material.
Dr. Kevin Ault, vice president of the National Foundation for Infectious Diseases, served on ACIP when it expanded the adult hepatitis B recommendation to be universal in 2022. He told The Dispatch that adjusting the recommendation took almost a year and that the language changes were circulated to the full committee well in advance. Ault participated in last week’s meeting as a liaison representative of the American College of Obstetricians and Gynecologists. “Obviously this was put together at the last minute,” he said of the votes.
A recommendation rollback.
The new guidance maintains the recommendation for infants born to mothers who have tested positive for hepatitis B or whose status is unknown, but mothers who test negative for hepatitis B should engage in “individual-based decision-making, in consultation with a medical provider, for … deciding when or if to give the HBV vaccine, including the birth dose.” The recommendation also suggests that parents who choose to skip the birth dose should wait until a baby is at least two months old for the first dose of the vaccine. Notably, as vaccine skeptics on the panel emphasized, the latter change does not affirmatively recommend that a dose be given at two months, only that parents wait at least two months.
The change was not based on new findings or data suggesting the vaccine may be less effective or pose safety risks, and in fact the committee discussed a similar change at its September meeting, only to delay a vote because of the very absence of such data. At the September meeting, CDC scientists who specialize in hepatitis B presented a systematic review of the evidence behind the routine recommendation. But this time, several vaccine skeptics delivered the presentations on hepatitis B, including Cynthia Nevison, a climate researcher, and Mark Blaxill, a former businessman and anti-vaccine advocate, who together have published autism research that was later retracted. A third presentation was given by Vicky Pebsworth, a nurse and ACIP member who also serves as a board member of a leading anti-vaccine group. Pebsworth has a son with autism who she believes was harmed as a result of vaccinations as an infant.
Dr. Cody Meissner, a pediatrician and current ACIP member, struggled to describe how distorted and off-base he thought the presentations were, noting, “There were so many statements that I disagree with, it’s hard to be succinct.”
The argument the presenters and the skeptics on the committee tried to advance was that infants born to mothers who test negative are at a low enough risk to not merit a routine recommendation. There was no credible evidence presented proving that the birth dose is unsafe for infants, so to make the case that the risks outweigh the benefits, the skeptics cast doubt on existing safety studies and vaccine surveillance data, and hypothesized about potential adverse effects that could have been missed. Hepatitis B researchers criticized the presentations as inaccurate and misleading—one of the authors of a referenced study told the committee during the meeting that her work had been misconstrued.
It was clear that most members believed there was some elevated level of risk from the vaccine, even if unknown and undocumented, and that justified taking a “more humble” approach and rolling back the routine recommendation in order to “do no harm.” Some members openly encouraged general vaccine skepticism because of what they claimed was insufficient safety data. “I suggest to parents to be very, very suspicious when people tell them that something is safe, especially a vaccine,” said Retsef Levi, a mathematician and MIT business school professor who backed the recommendation.
Other members decried what they saw as a flimsy and speculative basis for decision-making. “For many weeks now I have been advocating in our committee that we have a scientific framework for making our decisions,” Dr. Joseph Hibbeln, a psychiatrist, told his colleagues. “No valid scientific frameworks were proposed.”
Hepatitis B researchers, doctors, medical associations, and the handful of dissenting ACIP members panned the rollback of the recommendation. The universal birth dose guidance and corresponding high uptake among parents—an estimated 75 percent of babies receive a birth dose—has led to a huge decrease in hepatitis B cases contracted by infants and younger children. Significantly, the U.S. tried a similar targeted approach in the 1980s to what the committee adopted last week, recommending a newborn dose for mothers testing positive, but the strategy still resulted in upwards of 16,000 hepatitis B cases annually in infants and adolescents.
Why were cases still so high? Doctors and researchers point to a variety of factors, including imperfect screening and testing of mothers. While universal prenatal testing for pregnant women has long been recommended by ACIP, it’s not universal in practice—an estimated 12 to 16 percent of women do not receive testing. Screening is also often done early in the pregnancy but not always again at the time of delivery, a window during which a mother could unknowingly become infected. And although it’s uncommon, the tests themselves can return false negative results.
There’s also the risk of transmission early in life from interactions in the home or in daycare settings with other kids and adults who do not know that they are hepatitis B-positive—half of adults with hepatitis B don’t know they have the disease and can unknowingly spread it. Hepatitis B is orders of magnitude more contagious than HIV, can live on surfaces for days, and can be transmitted through even non-visible, specks of blood on things like shared nail clippers or tooth brushes. After the universal recommendation in 1991, the documented number of infant and adolescent hepatitis B cases fell by 99 percent, and now the number is less than two dozen annually. Multiple groups, including the Center for Infectious Disease and Research Policy (CIDRAP) at the University of Minnesota, have documented in detail the shortcomings of the narrowed recommendation and the subsequent success of the routine recommendation.
“If you’re the one who wants to change guidelines, the onus is on you to show that you have a suitable substitute for something that’s 99 percent successful,” Ault, the former ACIP member, told The Dispatch.
The added recommendation to wait till two months of age before receiving an initial dose has even less plausible scientific basis. The committee picked two months as a threshold simply because it’s further away from birth but cited no information showing that a delayed first dose is any safer than at birth. To the contrary, CIDRAP’s hepatitis B safety review identified four studies that compared the birth dose to a first dose given at one month, and none of the studies demonstrated any increased risk of adverse events in babies who received the birth dose. “This specific point is the reason we tabled this issue for three months to more fully discuss it,” Hibbeln said of the delay recommendation.“However, we have still not had any information or science presented or discussed with regards to this issue before or after two months of age. This is unconscionable.” Another committee member Raymond Pollak, a surgeon and transplant specialist, agreed: “If we’re here as a science-based committee, there is no data to support a two-month recommendation.”
Blood test hypotheticals.
The committee also adopted an additional recommendation suggesting that blood testing be used to assess antibody levels after an initial vaccine dose to help parents decide if their children should complete the full series of the hepatitis B vaccine. But there are no studies or data showing that an antibody test can be used as an indicator that a child can take an incomplete series of the vaccine and still receive long-lasting protection from the disease. Meissner was astounded at the proposal, describing it as “like never-never land” and “pulled out of the air.” CDC scientists urged the committee that while this is something that could possibly be studied, it should not issue a recommendation based on something entirely untried.
Dr. Robert Malone, the current ACIP vice chair who has served as a paid witness in lawsuits against vaccine manufacturers, and Levi, the management professor, backed the proposal. While the pair had repeatedly argued public health authorities need to be more humble and not take risks based on insufficient data, they seemed satisfied with doing just that when it came to the testing recommendation. Levi said it was “reasonable to hypothesize” that antibody testing would work as an indicator of lasting protection, and Malone said, “As an experimentalist and trialist, I’m really intrigued by the possibilities that this recommendation might open up,” adding later on social media it will help “stop over vaccination.”
Public health vs. individual choice.
While the meeting surfaced little new information about the hepatitis B vaccine, it did make clear that an ACIP remade in Kennedy’s image now has a fundamentally different understanding of its job. Malone signaled this when trying to articulate what he saw as the crux of disagreement over the hepatitis B recommendation. “This topic seems to me to be right at the center of that paradox between managing individual patients and focusing on the rights and interests of that particular patient in front of you,” he said, “and the interests of maximizing the greatest good for the greatest number that drives public health policy. My personal bias is to err on the side of enabling individual decision-making and individual rights over the collective.”
“It means that there are these two fundamental differences of opinion about the rights of individuals versus the rights of society and the goals and objectives of society. And it seems to me that is the essence of what we’re dealing with,” he added. Dr. Kirk Milhoan, the ACIP chair, echoed the sentiment: “Some of us fall more on the side of patient, physician decision-making and the others are looking at it from a public health [perspective].”
The recommendation, said Levi, “rejects the idea that vaccines in general, and this vaccine in particular, should be used to mandate vaccination and coercion to vaccination and condition attendance to educational settings or clinical care settings.” Other members made similar statements, frequently bringing up whether parents received enough information before giving their consent for vaccination. “I don’t see how a universal policy is informed consent,” said Catherine Stein, an ACIP member and tuberculosis researcher.
But multiple medical group liaisons and CDC staff pointed out that the problem with that thinking is that ACIP issues recommendations, not mandates, and nothing the committee decides can take away informed consent or the right of anyone or any parent to refuse a vaccine. “Making a recommended dose at birth does not in any way impede those parents from being able to decline the vaccine at that point or any point or to never vaccinate their child if that is their choice,” Dr. Laura Morris, a liaison representing the American Academy of Family Physicians, said during the meeting “They have that option with the recommendation the way that it currently stands.”
If medical providers are not properly informing patients and parents about benefits and potential risks before obtaining consent for vaccination or not obtaining consent at all—as several committee members argued, citing examples from their own lives and from people they’ve spoken with—then that is a legal and compliance issue with individual hospitals and practices. Ault, the former ACIP member, told The Dispatch that to the extent lack of informed consent is an issue currently, ACIP’s new wording is probably not going to change how providers obtain informed consent on the ground.
Parents always have the ability to refuse vaccination for their child regardless of whether an ACIP recommendation is categorized as routine or shared-clinical decision making. States tie some of their school and daycare vaccination mandates to ACIP recommendations and or the CDC vaccine schedule, but no state mandates a hepatitis B birth dose.
“The committee was not, in that case, balancing public health and individual rights at all,” Dorit Reiss, law professor at the University of California San Francisco whose work focuses on vaccine legal issues, told The Dispatch. She said that the members’ framing of the vote as the individual versus public health “shows, at best, a misunderstanding of the topic of discussion and what they’re doing.” Reiss agreed that while people can experience problems with how their doctors conduct informed consent around the birth dose and other vaccines, changing ACIP’s recommendations wouldn’t address this problem, saying the committee’s “job is not directly related to parental autonomy.”
Trust issues.
Jerome Adams, the surgeon general during the first Trump administration, posted on X that the panel’s recommendation change doesn’t solve the problem it sought to fix: “A patient and provider education campaign would’ve been better, and more widely accepted without further eroding public trust in HHS.”
Adam Langer, a career CDC scientist and specialist in hepatitis B, told the committee that he agreed that mandates are problematic but they have no bearing on the science of ACIP’s recommendations. “We have a lot of challenges with our culture and our traditions in our country with telling people what they must and must not do,” he said. “But that’s not what we’re saying here. We’re saying at a population level this is what the science shows is the best practice.”
Yet, after the meeting, Malone still described votes as a victory for informed consent and against vaccine mandates, writing that the new guidance “enable[s] parents/guardians to decide when or even if their children should receive this product” and it “means that any HepB Vax mandate, anywhere in the USA, is not consistent with the ACIP recommendation.” That logic makes sense if you think of ACIP as the top of the pyramid of a coercive national vaccine system that is leveraged to force mandates onto parents. But such thinking confuses causation for correlation. States use ACIP recommendations and the CDC vaccine schedules to inform mandates because they see the guidance as a reliable authority on vaccines. As the committee has become more defined by vaccine skepticism, state mandates haven’t changed, but more than 20 states have started turning to other medical advisory groups they view now as more credible sources of vaccine guidance than ACIP and the CDC.
A key takeaway from last week seems to be that the committee isn’t so much concerned with making what it sees as the best population-level recommendation for each vaccine on the schedule—in fact, some members appear averse to the very concept of routine recommendations. Instead, the vaccine iconoclasts seem more focused on using the platform of ACIP to protest how medical providers address vaccine skepticism in practice and state-level vaccine mandates, neither of which the committee has control over.
With the president directing the Department of Health and Human Services and the CDC to review the entire childhood vaccine schedule and an ACIP work group already beginning to review other vaccines, it’s likely we’ll see this process repeated again. The latter effort was kicked off Friday during the meeting with a presentation on safety studies from Aaron Siri, a lawyer whose firm has sued vaccine manufacturers.
Republican Sen. Bill Cassidy, the lawmaker whose vote advanced Kennedy’s nomination as HHS secretary, said Siri’s inclusion in the meeting showed that “ACIP is totally discredited.” Cassidy, a liver doctor who has treated patients with hepatitis B, urged the CDC director to not adopt the committee’s new hepatitis B guidance.
“Ending the recommendation for newborns makes it more likely the number of cases will begin to increase again,” he said. “This makes America sicker.”
