UPDATE 4-Kennedy advisers weigh dropping hepatitis B vaccine recommendation for most US children

Vaccine advisers to Robert F. Kennedy Jr. on Thursday weighed in on whether to scrap a broad recommendation for the hepatitis B vaccine for children, with a vote planned for later in the day, in what would be the most significant shift in U.S. vaccination policy yet under the health secretary. The U.S. vaccine panel has proposed that only infants born to mothers who test positive for hepatitis B would be recommended to get the vaccine. For all other newborns, the decision when or if to vaccinate should be left to parents, in consultation with their healthcare provider, it said.

Parents should consider testing their children for protective antibodies before moving on to any further shots, the panel suggested. Since 1991, the U.S. has had a universal hepatitis B vaccine recommendation including administering a dose just after birth, cutting infection rates by 95%, studies show. The first dose is followed by two more, at 1 to 2 months and 6 to 18 months.

The committee of advisers to the U.S. Centers for Disease Control and Prevention originally raised the issue in September at its first meeting after being entirely reconstituted by Kennedy. He fired the previous 17 independent experts in June and many of the new members are aligned with the health secretary's anti-vaccine views. During the meeting, climate scientist and CDC consultant Cynthia Nevison said in her presentation that the risk of hepatitis B transmission to healthy children has been overstated. Businessman and CDC staffer Mark Blaxill - who has been a leader of anti-vaccine group SafeMinds - presented a review of the vaccine's safety, concluding that there is limited evidence of its safety.

The World Health Organization recommends all babies receive the hepatitis B vaccine as soon as possible after birth, followed by two or three doses of the shot at least four weeks apart. "The way I look at a neonatal birth dose is that it is a safety net," committee member Cody Meissner said, adding that the evidence for lifelong immunity to hepatitis B after completing the series is very strong.

EXPERTS QUESTION RISK EMPHASIS Several infectious disease experts raised concerns that the panel was emphasizing the potential risk of the vaccine, while some CDC employees challenged the lack of evidence for the move and the questionable quality of studies presented.

Some asked why the committee was raising the issue on a vaccine with a long track record of safety and effectiveness in preventing hepatitis B infections in infants, which can lead to serious liver disease. Vaccine makers Sanofi, Merck and GSK , whose shares were down slightly on Thursday, defended their products as safe.

"At present, there is no credible evidence indicating a safety risk with today's immunizations," said Sanofi North American vaccine executive Ayman Chit of hepatitis B vaccines. All three doses of the vaccine are needed to build long-lasting immunity and protection after antibody levels decline, said Demetre Daskalakis, former director at the CDC's National Center for Immunization and Respiratory Diseases.

The universal hepatitis B birth dose recommendation was implemented in 1991 after targeted risk-based vaccination strategies failed to prevent perinatal and early childhood hepatitis B transmission. At the time, nearly 20,000 babies and children were infected annually in the U.S., and most infections went undiagnosed until later in life, frequently when liver cancer or significant liver damage had already developed. "Ending universal hepatitis B vaccination will rob families of a chance to shield babies from cancer," said former committee member Noel Brewer.

LONG-RANGING CONSEQUENCES This change would be the most consequential yet under Kennedy, who founded the anti-vaccine Children's Health Defense and had been part of lawsuits against drugmakers before taking office in January.

His other controversial policy changes include dropping broad recommendations for Americans to get COVID-19 shots, recommending a split of the measles-mumps-rubella shot from varicella for those under age 4, adding new requirements for vaccine trials and cutting funds for mRNA-based vaccines. The CDC's Advisory Committee on Immunization Practices advises the agency on what recommendations to adopt. The recommendations affect health insurance coverage in the United States and play a key role in assisting physicians in choosing appropriate vaccines for patients.

Recommendations for shared clinical decision making, as the committee proposed, can typically be covered by health insurers, but such policies tend to reduce vaccination compared with a recommendation for the inoculations, experts have said. Kennedy's revamped vaccine advisory panel has broken long-standing norms aimed at ensuring scientific rigor and consensus, allowing non-scientists to present on key issues.

Blaxill, a businessman and parent of an autistic daughter who has been tapped as an adviser to the CDC, presented on the hepatitis B shots. He has previously argued that "overvaccination" causes autism, contrary to established science. U.S. Senator Bill Cassidy of Louisiana, a Republican and a physician who chairs the Senate's Health, Education, Labor & Pensions Committee, said in a post on X that the committee is "totally discredited. They are not protecting children."

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)