Health and Human Services Secretary Robert F. Kennedy Jr.’s hand-picked vaccine committee voted Friday to remove the longstanding universal recommendation that all babies receive a hepatitis B vaccine at birth, issuing weaker guidelines for some infants.
The group, called the Advisory Committee on Immunization Practices, or ACIP, recommended that parents make individual decisions in consultation with a health care provider to determine when or whether to give the hepatitis B birth dose to a baby whose mother has tested negative for the virus. For babies who do not receive the birth dose, the committee recommends waiting to receive a first vaccine until they are at least 2 months old.
The acting director of the Centers for Disease Control and Prevention must still approve this new recommendation. The CDC currently recommends that every baby be vaccinated against hepatitis B within 24 hours of birth, regardless of the mother’s testing status.
The move overturns those guidelines, which have been credited with reducing infections in children by 99% since their introduction three decades ago and are widely considered a public health success story. Some committee members and public health experts warn that the change could have broad consequences, such as an increase in infections among children.
The vote only affects the timing of administration of the first dose of the hepatitis B vaccine series. The second would still be given one to two months after birth, with a third dose between 6 and 18 months.
All pregnant women are supposed to be tested for hepatitis B during their pregnancy. In previous meetings, some councilors have questioned the need for babies to receive a shot if their mother’s test is negative.
But test results can produce false negatives, some people become infected later in pregnancy after being tested, and babies can be infected by other members of their household.
The committee’s closely watched two-day meeting in Atlanta comes after Kennedy gutted the committee and appointed 12 new members, including some well-known vaccine critics. The ACIP makes recommendations on who should receive certain shots and which vaccines insurers should cover for free.
Eight members voted yes, while three voted no. Some councilors strongly pushed back against the new directions before the vote.
“This presents great potential for harm, and I hope the committee will accept responsibility when that harm is caused,” said Dr. Joseph Hibbeln, a psychiatrist and voting member.
Dr. Cody Meissner, a voting member and professor of pediatrics at the Dartmouth Geisel School of Medicine, said he hopes pediatricians will continue to administer the birth dose within 24 hours of delivery and before hospital discharge.
“Taking another path is not in the best interest of infants,” he said.
Meissner added that more children will be injured and contract hepatitis B infections. Hepatitis B, which can be passed from mother to baby during childbirth, can lead to liver disease and premature death. Infants are more vulnerable to developing chronic hepatitis B infections, which have no cure.
“We will see hepatitis B come back,” he said. “The vaccine is so effective. It makes no sense, in my opinion, to change the vaccination schedule.”
In a statement Friday, the American Medical Association said the vote was “reckless and undermines decades of public confidence in a proven, life-saving vaccine.” The group added that the decision was not based on scientific evidence and “created confusion among parents about how best to protect their newborns.”
Meanwhile, Retsef Levi, a voting member and professor at the Massachusetts Institute of Technology, falsely claimed in meetings that experts had “never tested” the hepatitis B vaccine “properly.”
Some committee members expressed concerns about vaccination during the so-called neonatal period, which is a critical period of development for the brain and immune system. But decades of evidence show that the hepatitis B vaccine has been given safely to newborns.
Other advisers said there was no evidence to support the two-month delay in giving the birth dose.
“We need to make decisions with the data we have, and we need to use only credible data to make decisions, not speculation or assumptions,” Hibbeln said.
A 2024 CDC study showed that the current vaccination schedule has prevented more than 6 million hepatitis B infections and nearly 1 million hepatitis B-related hospitalizations.
Merck and GSK make hepatitis B vaccines used from birth. None of these measures constitute a significant source of revenue for businesses, so the new recommendations are not expected to have a material impact on their businesses.
Nonetheless, Merck said in a statement Friday that it was “deeply concerned” about the vote, which it said risks “reversing this progress and putting infants at unnecessary risk of chronic infection, liver cancer and even death.” The company added that “there is no evidence supporting the fact that it provides any benefit to children.”
In a statement, GSK said: “We are awaiting additional information and formal adoption of today’s recommendations by the CDC to fully understand the potential impact.”
The panel’s vote will not affect insurance coverage for the shots, including under Medicaid and the Children’s Health Insurance Program, Andrew Johnson, senior policy analyst for the Centers for Medicare and Medicaid, told members at the meeting.