RFK Jr.’s Vaccine Panel Questions Use of Routine Childhood Shots

(Bloomberg) -- Robert F. Kennedy Jr.’s hand-selected vaccine advisers questioned the safety of shots administered to millions of children as they prepare for a pivotal vote Thursday that could change how immunizations are given in the US.

Members of a key Centers for Disease Control and Prevention panel debated whether children under 4 should be able to get Merck & Co.’s combination vaccine that protects against measles and three other viruses in one shot, citing rare cases of seizures. The group, called the Advisory Committee on Immunization Practices, will vote on whether to instead recommend young children get separate vaccines to protect against the infections.

The advisers, who wield sweeping influence over vaccination in the US, will also consider changing recommendations for hepatitis B and Covid vaccines during their two-day meeting. The hepatitis B vote, which could delay the first dose from birth to at least one month for most babies, is viewed as key test of Kennedy’s efforts as secretary of Health and Human Services to alter the current vaccine schedule.

“I think families are very concerned,” said committee member Kirk Milhoan, a pediatric cardiologist. “There is an increased hesitancy” around vaccinations, and the panel members are going to give parents the best understanding of the risks and benefits that they can, he said.

The meeting is being closely watched as an indicator of how significantly Kennedy plans to upend the established rhythm of childhood vaccination in the US, which is widely credited with controlling scores of diseases that led to permanent disability and death. The agency is increasingly being driven by political priorities under Kennedy, a shift cemented in a new mission statement focused on hot-button issues like immigration, diversity and inclusion, crime and parenting.

Kennedy dismissed all 17 sitting members of the panel when he took the nation’s top health spot, and replaced them with hand-picked alternatives. The new members includes some who have echoed debunked theories about the safety of immunizations and others who served as paid expert witnesses for plaintiffs suing Merck.

Combination Shots

The panelists said they weren’t sure doctors fully understand why some children have seizures after getting the combination measles, mumps, rubella and chickenpox vaccine, a well-established risk that hasn’t been linked to long-term complications.

“I’m not sure we have a good mechanistic answer for what is going on here,” said panelist Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology, adding that he’s very concerned about the issue.

The discussion Thursday morning focused on the safety of Merck’s ProQuad, a widely used combination vaccine that covers all four viruses. Panelists debated whether ProQuad should be used for the first of two doses, pointing to evidence of increased fever-related seizures when it’s given to children under 4.

In 2010, that same evidence led the CDC to recommend kids get separate vaccines for MMR and varicella, the virus that causes chickenpox, for the first dose that’s typically administered at 12 months of age. They said ProQuad should be used for the second dose, which is given years later.

In comments submitted to the panel ahead of the meeting, Merck pointed out there’s no evidence of increased seizure risk when ProQuad is used as a second dose and cited studies concluding that combination vaccines improved health outcomes and reduced the number of missed or delayed shots.

Most children recover quickly from the seizures and experience no lasting effects, according to the CDC. The seizures are rare, affecting about one in every 2,300 kids who gets the combination vaccine.

Childhood Schedule

The panel has also promised to re-examine the US pediatric vaccine schedule, following Kennedy’s repeated claims that children receive too many shots. It also create a new working group to study vaccines during pregnancy. 

Its recommendations dictate which vaccines are available nationwide and must be covered by insurers at no cost to the patient. About half of American children rely on a federal free-vaccine program that is required to adhere to the panel’s advice, giving it power to effectively deny access to certain shots.

The proposed votes on Thursday are “a step in the wrong direction,” said Susan Kressly, president of the American Academy of Pediatrics. 

“The meeting happening today and tomorrow is not a legitimate process,” according to Kressly, who said her organization was excluded from working groups preparing for the hearing. “It was not informed by the right experts,” she said in an interview. “We will not lend our credibility to a process that doesn’t serve the best interest of children.”

She noted that public health officials are pushing back, and several states have started issuing their own vaccine recommendations.

A health insurance company trade group, AHIP, pledged its members would cover vaccines recommended as of Sept. 1 with no cost sharing through the end of 2026. Coverage decisions “are grounded in each plan’s ongoing, rigorous review of scientific and clinical evidence, and continual evaluation of multiple sources of data,” the group said in a statement on its website.

The ACIP meeting comes amid turmoil at the CDC, following Kennedy’s decision to fire the agency’s director after less than one month on the job, leading to the resignations of other key personnel.

Martin Kulldorff, who now chairs the ACIP committee, said the former CDC director never contacted him with questions or concerns about the panel, which he argued is “pro-vaccine.” Kulldorff, a Harvard-trained epidemiologist who earned expert witness fees from plaintiffs suing over Merck’s Gardasil vaccine, invited former CDC directors to debate the issues with him.

“If they are unwilling to engage in an open and honest debate with the chair of a committee that they are so severely criticizing, then I advise that you should not trust them,” he said.

Hepatitis B

Hepatitis B is a highly transmissible viral infection that can attack the liver. The CDC currently recommends that the first dose of the hepatitis B vaccine be given within 24 hours of birth to protect newborns who may have been exposed to the virus during labor and delivery. The American Academy of Pediatrics says this is critical to reduce chronic hepatitis B later in life.

Some critics claim the immunizations sold in the US by Merck and GSK Plc unnecessarily add to the number of shots given to babies because the virus is typically spread through infected blood or body fluids, often linked to sex or sharing needles. They argue only those born to mothers who test positive for the liver-damaging virus need the vaccine right after birth.

But many women aren’t aware that they are infected, and not everyone is tested before giving birth. The panel will also vote on recommending testing for all pregnant women.

While a potential delay in giving the hepatitis B vaccine isn’t as drastic a change as had been rumored, it could still undermine vaccine confidence, said Paul Offit, who heads the vaccine education center at Children’s Hospital of Philadelphia and has clashed with Kennedy on vaccines.

“I don’t understand the reasoning behind it. Why delay it? What is the advantage?” Offit said. “It just sends this message that in some way it was less safe” when given at birth, when there is no evidence for this, he said, potentially discouraging its use. 

The prospect of ending the birth dose could splinter Kennedy’s support among Republicans. Senator Bill Cassidy, chair of the Senate health committee, ended a hearing Wednesday with an impassioned plea for keeping the vaccine schedule as it is.

“Before 1991, as many as 20,000 babies were infected with hepatitis B in the United States of America,” said Cassidy, a trained liver doctor. “And that changed when the hepatitis B vaccine was approved for newborns.”

Infections among children, adolescents and young adults plunged 99% in the US after universal infant vaccination for the condition was introduced in 1990, according to a CDC study.

--With assistance from Robert Langreth and John Tozzi.

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