Health and Human Services Secretary Robert F. Kennedy Jr.’s handpicked vaccine committee voted Friday to repeal the long-standing universal recommendation that all infants receive hepatitis B vaccination at birth, with weaker guidance for certain infants.
The group, called the Advisory Committee on Immunization Practices (ACIP), recommended that parents, in consultation with their health care providers, make individual decisions about whether or not to give birth doses of hepatitis B to babies whose mothers have tested negative for the virus. The committee recommended that infants who have not received the birth dose wait until they are at least 2 months old to receive their first vaccination.
The acting director of the Centers for Disease Control and Prevention still needs to approve the new recommendations. The CDC currently recommends that all babies be vaccinated against hepatitis B within 24 hours of birth, regardless of the mother’s testing status.
The move reverses the guidance, which is credited with reducing infections among children by 99% since it was first introduced 30 years ago and is widely considered a public health success story. Some committee members and public health experts have warned that the changes could have wide-ranging effects, including an increase in infections among children.
This vote only affects the timing of the first dose of the hepatitis B vaccine series. The second dose is given 1 to 2 months after birth, and the third dose is given between 6 and 18 months of age.
All pregnant women should be tested for hepatitis B during pregnancy. At previous meetings, some advisers questioned the need for infants to be vaccinated if their mothers test negative.
However, test results can give false negatives, some people can become infected later in pregnancy after the test, and the baby can get infected from other members of the family.
The commission’s two-day meeting in Atlanta comes after President Kennedy disbanded the commission and appointed 12 new members, including prominent vaccine critics. ACIP sets out recommendations for who should receive certain vaccinations and which vaccine insurance companies should cover them for free.
Eight members voted in favor and three voted no. Some advisers strongly opposed the new guidelines ahead of the vote.
“This is very likely to cause harm, and I hope the committee accepts responsibility if this harm occurs,” said Dr. Joseph Hibbeln, a psychiatrist and voting member.
Dr. Cody Meisner, a voting member and professor of pediatrics at Dartmouth Geisel School of Medicine, said he hopes pediatricians continue administering the birth dose within 24 hours of delivery and before discharge from the hospital.
“Following other courses is not in the interest of young children,” he said.
Meissner added that more children will be injured and infected with hepatitis B. Hepatitis B can be passed from mother to baby during birth and can lead to liver disease and early death. Infants are susceptible to chronic hepatitis B infection, and there is no cure.
“Hepatitis B will be back in the air,” he said. “The vaccine is very effective. Changing the vaccination schedule makes no sense in my opinion.”
The American Medical Association said in a statement Friday that the vote was “reckless and undermines decades of public trust in proven, lifesaving vaccines.” The group added that the decision was not based on scientific evidence and “leads to confusion for parents about how best to protect their newborns.”
Meanwhile, voting member and Massachusetts Institute of Technology professor Retsev Levi falsely claimed during the meeting that experts had “never properly” tested the hepatitis B vaccine.
Some members expressed concerns about vaccination during the so-called neonatal period, a critical period of brain and immune system development. However, decades of evidence show that hepatitis B vaccines are safely administered to newborns.
Other advisers said there was no evidence to support a two-month delay in giving birth doses.
“We have to make decisions using the data we have, and we have to use only reliable data to make decisions, not guesses or hypotheses,” Hibbeln said.
A 2024 CDC study showed that current vaccination schedules helped prevent more than 6 million hepatitis B infections and nearly 1 million hepatitis B-related hospitalizations.
Merck and GSK produce the hepatitis B vaccine, which is used from birth. Neither measure is a significant revenue driver for the company, so the new recommendations will not have a material impact on the company’s business.
Still, Merck said in a statement Friday that it was “deeply concerned” by the vote, which risks “reversing this progress and putting infants at risk of chronic infections, liver cancer, and even death.” The company added: “There is no evidence that it would delay providing benefits to children.”
“We are awaiting additional information and formal adoption of today’s recommendations by the CDC to fully understand the potential impact,” GSK said in a statement.
Andrew Johnson, chief policy analyst at the Centers for Medicare and Medicaid, told commissioners during the meeting that the commission’s vote does not affect coverage for immunizations, including in Medicaid and the Children’s Health Insurance Program.
