ATLANTA - Federal vaccine advisers selected by Health Secretary Robert F. Kennedy Jr. delayed until Friday a vote to lift a long-standing recommendation for all newborns to get the hepatitis B vaccine in what would be the most sweeping revision to the childhood vaccine schedule under Kennedy.

The advisers heard presentations in the morning - including from two prominent vaccine critics recently hired by the Centers for Disease Control and Prevention - casting doubt on the safety and necessity of a three-dose series of hepatitis B vaccines given to babies, despite widespread agreement by medical and public health experts that the vaccine is safe and effective.

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The 11-member panel was scheduled to vote midafternoon on recommending the vaccine at birth only for infants born to mothers with infections. It would recommend other parents delay the first dose for babies for at least two months and consult with their doctors about if or when to administer it. But some members were frustrated at last-minute changes to the language, and the panel agreed 7-3 to delay a vote so they could have more time to review it.

“We really need to know what we’re voting on,” said panel member Joseph Hibbeln, a psychiatrist.

While babies born to uninfected mothers are unlikely to contract hepatitis B, medical associations urge retaining the universal recommendation to ensure none lack protection from a highly infectious virus that can cause serious lifelong liver disease, cancer and death. Some babies have fallen through the cracks because their mothers were not tested, received false negatives or became infected after testing.

The Advisory Committee on Immunization Practices, a group of advisers outside government, recommends the immunization guidance for the CDC director to provide Americans. The practical consequences of a vote to end the universal hepatitis B birth vaccination recommendation would be limited. Doctors and hospitals can still offer the shots, and major private insurers have pledged to continue coverage for vaccines previously recommended by the panel through the end of 2026. A representative from the Centers for Medicare and Medicaid Services said in the Thursday meeting that the change won’t affect insurance coverage of the vaccines.

Panel member Vicky Pebsworth said in a presentation that the committee is trying to address “stakeholder and parent dissatisfaction” and better align the United States with other countries that don’t recommend a birth dose for every baby. She said a working group formed in September to assess the evidence around hepatitis B vaccine safety overwhelmingly agreed with changing the recommendation.

“Infants born to mothers who test negative have extremely low risk of horizonal infection and therefore do not need to be routinely vaccinated with the hepatitis B vaccine at birth,” Pebsworth, who works for the nation’s largest anti-vaccine organization, told the panelists.

Several members appeared deeply skeptical of the proposed changes, pointing to plummeting infection rates ever since the U.S. adopted the universal recommendation in 1991.

“There is no evidence of harm,” said Cody Meissner, a professor of pediatrics at the Geisel School of Medicine at Dartmouth and one of the most vocal panelists defending current recommendations.

Hibbeln warned that the committee needs a “high burden of proof” to change a recommendation he credited for such an important public health achievement.

Medical experts say the hepatitis B vaccine is so safe - and the consequences of getting the virus are so severe - that narrowing the recommendation would only result in missed shots for some infected babies. Ninety percent of newborns born to mothers with hepatitis B develop chronic infections, one-fourth of whom will die of chronic liver disease, according to the CDC.

Some ACIP members - who include vaccine skeptics selected by Kennedy after he purged the panel in June - have suggested that hepatitis B vaccine guidance should be based on risk, as some Western European countries do.

Critics of broad vaccination recommendations argue they overlook individual risk factors - especially in the case of hepatitis B, which primarily spreads among adults through bodily fluids, such as during sex or sharing needles. Kennedy said in a 2022 interview that the vaccine for the virus “was made for prostitutes and for promiscuous gay men.” But the virus can also spread through contact with caregivers or household members, even with small amounts of blood.

During a portion of the meeting for people to testify about their lived experiences, physician Su Wang said she became infected in her first month of life from her parents, who were unaware they had the virus. “If there had been a universal birth dose at that time I would have been protected,” she said. Some panelists partly blamed immigration for hepatitis B cases in the United States, where infections surged through the 1970s and 1980s before falling dramatically in the 1990s.

Pebsworth said immigrants from China and other Asian countries brought the virus to the U.S. after the Vietnam War. Panelist Evelyn Griffin said undocumented immigrants aren’t being sufficiently tested for hepatitis B. Adults need to solve that problem rather than “asking babies to solve this problem for us,” she said.

Cynthia Nevison, an autism and climate researcher with ties to anti-vaccine groups, delivered a presentation arguing that the risk of hepatitis B to the average American child has been overstated. In a presentation on vaccine safety, anti-vaccine activist Mark Blaxill said there has not been enough research into potential side effects. He said animal models suggest there could be vaccine safety issues.

While Nevison and Blaxill both recently began working for the CDC, the agency’s senior career scientists with expertise in pathogens would typically deliver such presentations.

Safety data presented by career employees at the September meeting, when the vaccine advisers also delayed a vote on the hepatitis B shot, showed administering the vaccine at birth did not increase risk for allergic reaction, deaths, seizures or neurological diseases.

Nevison and Blaxill also cited millions in claims paid out by the federal Vaccine Injury Compensation program to people who claimed injuries by the vaccine.

To cite those claims as evidence is “incorrect,” Meissner said, saying those settlements were part of a court process and do not represent confirmed associations.

Robert Malone, a close Kennedy ally who presided over the Thursday meeting, summarized the discussions as showing a “diversity of opinion regarding the existence of evidence of harm” of the hepatitis B vaccine.

The panel took a brief recess in the noon hour after adding a third vote on affirming that newborn doses should be given to infants of mothers who were untested for the virus. About 12 to 16 percent of pregnant women do not receive prenatal screening for hepatitis B, according to the CDC. Hibbeln complained about the last-minute addition, saying members were being asked to evaluate language they hadn’t been consulted on ahead of time.

Public health advocates who have criticized the new members of the panel, many of whom have histories of criticizing coronavirus or other vaccines, said the confusion over the language reveals incompetence and how they are ill-suited to shape immunization policy.

“For a committee making vaccine decisions for 330 million Americans, this level of dysfunction is unacceptable and, quite frankly, terrifying,” said Jason Goldman, president of the American College of Physicians, who during the meeting accused the committee of presenting cherry-picked data to undermine the hepatitis B vaccine.

The American Academy of Pediatrics says it will continue promoting CDC guidance in place for babies to get the first dose at birth, the second at one or two months and the third between six and 18 months.

The new vaccine advisers selected by Kennedy have altered other child vaccine recommendations, including delaying the use of a combined measles, mumps, rubella and chicken pox vaccine.

On Friday, the panel is planning to broadly scrutinize the childhood immunization schedule, with scheduled presentations from vaccine skeptics examining whether the U.S. recommends too many shots compared with European countries and whether aluminum components in vaccines that scientists have deemed safe are detrimental to health.

Sen. Bill Cassidy (R-Louisiana), a physician who specializes in liver disease and has criticized Kennedy’s approach to vaccination, wrote Thursday morning on X that “ACIP is totally discredited” and is “not protecting children” by allowing Aaron Siri, a top attorney for the anti-vaccine movement, to be one of the presenters Friday.

Siri responded by challenging Cassidy to a public debate on vaccines and complaining that ACIP has in the past heard testimony from vaccine makers but not from people like him. “Under your logic, in deciding upon a new car, one should only listen to car companies and salesmen, but not consumer advocates,” Siri wrote on X.

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Graphics:

https://washingtonpost.com/documents/e4e69fa5-18cd-4402-ac30-b774ce4075a6.pdf

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