A recent federal advisory committee meeting descended into confusion and near pandemonium as members voted 8 to 3 against recommending a combination vaccine for children under four years old. This shot protects against measles, mumps, rubella, and chickenpox (MMRV).
The highly anticipated vote on whether newborns should receive the standard hepatitis B vaccine, which protects against a highly infectious disease that can severely damage the liver, was unexpectedly postponed until Friday.
Approximately half of the panel’s members were only just appointed by Health Secretary Robert F. Kennedy Jr. this week. Their apparent lack of familiarity with established meeting protocols, scientific study design, and even fundamental flaws in suggested data highlighted the rushed and disorganized nature of the committee’s formation.
Many panelists also appeared unfamiliar with the core function of the Vaccines for Children program, which provides free immunizations to nearly half of all American children, including the crucial responsibility of approving which vaccines are covered by the program.
Despite the contentious vote, the decision to revoke the MMRV vaccine recommendation is not expected to have broad consequences. Guidelines for the individual vaccines protecting against these diseases—which are more commonly administered separately—remain unchanged.
In a peculiar turn of events, the committee also voted 8 to 1 to continue covering the MMRV vaccine for children under four within the Vaccines for Children program. It was unclear if all members fully grasped the implications of their vote, with three members explicitly abstaining due to their confusion.
Nevertheless, this vote is likely just the beginning of numerous alterations to the official childhood immunization recommendations.
During an extensive discussion, committee members seemed inclined to limit the hepatitis B vaccine to newborns whose mothers are confirmed to be infected, and to delay vaccination for other infants until they are at least one month old.
However, experts warn that such a change could significantly increase risks for newborns. Many hepatitis B infections in pregnant women are not detected, even with routine testing. Furthermore, infected women might not be identified due to inaccurate test results or issues with reporting and interpretation.
Chari Cohen, president of the Hepatitis B Foundation, explained, "It will be difficult to pinpoint every positive mother and ensure birth doses are available in hospitals for these infants, particularly those who lack prenatal care." She added, "This will likely lead to new chronic hepatitis B infections among some newborns."
A separate vote regarding Covid-19 vaccine recommendations is also scheduled for Friday.
The Advisory Committee on Immunization Practices (ACIP) also established two new work groups, according to its chair, Martin Kulldorff: one to examine vaccine use during pregnancy and another to review existing childhood and adolescent vaccination schedules.
The prospect of significant changes to the childhood vaccine schedule by the new administration has deeply concerned many public health experts. They fear that restricting access to certain vaccines could lead to a resurgence of diseases that were once largely eradicated.
Dr. Sean T. O’Leary, chair of the infectious diseases committee for the American Academy of Pediatrics, stated, "If individuals cannot access vaccines, we will undoubtedly witness the return of diseases that once inflicted severe health problems on children."
He continued, "These diseases are now almost entirely preventable, and as a pediatrician, it is heartbreaking to see a child and family suffer unnecessarily."
An embedded graphic illustrates the recommended childhood vaccination schedule, from birth through 16 years of age. It highlights that the Hepatitis B shot (1st, 2nd, and 3rd doses), the combined Measles, Mumps, Rubella, Varicella (MMRV) vaccine (1st and 2nd doses), and the Covid-19 vaccine are currently under review by the advisory panel.
The MMRV vaccine has been available since 2005, offering a combined alternative to the two separate shots for measles, mumps, rubella (MMR) and varicella (chickenpox).
During Thursday’s meeting, scientists from the Centers for Disease Control and Prevention (CDC) presented data indicating that the combination MMRV vaccine slightly increases the risk of febrile seizures. While such seizures are common with many childhood illnesses, like ear infections, they typically cause no lasting harm.
Historically, the CDC has recommended administering the MMR and chickenpox shots separately to children under four due to the slight risk of seizures associated with the combination vaccine.
Nonetheless, some pediatricians and parents chose the MMRV combination shot to reduce the number of clinic visits and injections. The panel’s recent recommendation aims to remove this option.
Medical organizations have strongly voiced their opposition to the panel’s decision.
Dr. Amy Middleman, who leads pediatrics and adolescent medicine at Case Western Reserve University and serves as a liaison to the committee, noted that Thursday’s MMRV discussion lacked the usual comprehensive presentations on feasibility, acceptability, cost-benefit analysis, and equity concerns.
Dr. Middleman urged, "I implore the committee to adhere to a thorough, evidence-based recommendation process before making decisions that profoundly impact public health."
Adding to the controversy, Susan Monarez, who was removed as CDC director after less than a month, informed lawmakers that Mr. Kennedy had instructed her to approve all panel recommendations "regardless of the scientific evidence."
Historically, the advisory panel’s decisions have guided state vaccine mandates, and insurance companies are mandated to cover all recommended shots. However, the panel’s recent actions appear to have undermined its authority.
Following the committee’s initial meeting in June, several medical organizations ended their decades-long partnership with the panel, opting to issue their own recommendations instead.
Moreover, on Tuesday, most major insurers confirmed they would continue to cover routine immunizations through 2026, irrespective of any panel votes to restrict their use. On Wednesday, Senator Bill Cassidy (R-Louisiana) and chair of the Senate health committee, advised Americans not to trust the panel’s efforts to revise childhood vaccine recommendations.
Tensions among the panelists were evident during the MMRV discussion.
"What we’re saying is, We don’t trust parents to make a decision," remarked Dr. H. Cody Meissner, a pediatrician from the Dartmouth Geisel School of Medicine, widely recognized as one of the most qualified members on vaccine science and practice.
He emphasized that if the panel votes against the combination vaccine, "the shot won’t be an option."
Most current panelists are new appointments. In June, Mr. Kennedy dismissed all 17 previous committee members and subsequently appointed seven new ones, most of whom align with his skeptical views on vaccines. He then announced five more members earlier this week. Traditionally, ACIP members undergo months, even years, of vetting before being invited to join.
During their June meeting, the initial seven panelists declared their intention to meticulously examine all recommended vaccinations for children and adolescents. They also voted to reverse a long-standing recommendation for a specific subset of flu shots containing thimerosal, a preservative falsely linked to autism by many anti-vaccine groups.
The panel was also expected to modify hepatitis B recommendations on Thursday. However, due to a "small discrepancy" in the wording of the vote, the decision was deferred to Friday, according to a spokesman for the Department of Health and Human Services, who, along with Dr. Kulldorff, declined to elaborate further.
The first dose of the hepatitis B vaccine is typically administered to newborns within 24 hours of birth. Public health experts credit this shot with virtually eradicating maternal transmission of the disease in the United States, reducing its incidence from approximately 20,000 cases annually before 1991 to fewer than 20 cases per year now.
Untreated hepatitis B can severely damage the liver, potentially leading to cirrhosis, liver failure, and liver cancer. Ninety percent of babies infected at birth develop chronic hepatitis B, and one in four of these children face severe complications or death from the disease.
Mr. Kennedy and his allies have asserted that hepatitis B is exclusively transmitted through sexual contact or shared needles, and therefore, only infants of infected mothers should be immunized at birth.
However, Dr. Noele P. Nelson, a lead author on the current vaccine guidelines and a former head of the CDC’s hepatitis vaccines work group, explained that a pregnant woman’s hepatitis B status is not always known.
She added that an infection could also be overlooked due to inaccurate test results. "Hepatitis B vaccination at birth for all newborns provides an effective safety net," Dr. Nelson stated, "ensuring that infants born to mothers with unknown or inaccurate infection status are protected." Dr. Nelson resigned from the CDC in July.
Dr. James Campbell, vice chair of the infectious disease committee for the American Academy of Pediatrics, highlighted that hepatitis B, a highly contagious virus, can spread through non-sexual means, such as sharing household items like toothbrushes, razors, or combs.
"In the past, we had risk-based hepatitis B vaccination recommendations, and they did not reduce the overall burden," he said, referring to the practice of vaccinating only at birth when a mother is known to be infected. "That’s why we now have a universal recommendation."
Mr. Kennedy has raised concerns about the safety of the hepatitis B vaccine, incorrectly claiming it was not properly tested. During his confirmation hearing in January, he notably avoided stating that the hepatitis B vaccine does not cause autism, a fact widely accepted by the scientific community.
Conversely, Dr. Claudia A. Hawkins, who treats hepatitis B and C patients at Northwestern University’s Feinberg School of Medicine, affirmed that hepatitis B vaccines are "exceptionally safe, with no reported serious side effects in infants, children, or adults since their introduction."
"There is no reason to delay the hepatitis B vaccine," she concluded.
Correction: An earlier version of this article misstated the date that AHIP, the national trade association representing the health insurance industry, said health plans would continue to cover all immunizations recommended as of Sept. 1. It was Tuesday, Sept. 16, not Wednesday.