RFK Jr.’s panel weakens forecast
Health and Human Services Secretary Robert F. Kennedy Jr.’s hand-picked immunization committee voted Friday to eliminate the longstanding, general recommendation that all babies receive a hepatitis B vaccine at birth and to issue weaker guidelines for certain infants.
The group, called the Advisory Committee on Immunization Practices (ACIP), recommended that parents make an individual decision, in consultation with a health care provider, to determine when and whether to give the hepatitis B birth dose to a baby whose mother tested negative for the virus. For babies who do not receive the birth dose, the committee recommended waiting until they are at least two months old to receive their first vaccination.
The acting director of the Centers for Disease Control and Prevention has yet to 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 repeals that policy, which has been credited with a 99% decline in infections among children since it was introduced three decades ago and is widely considered a public health success story. Some committee members and health experts warn that the change could have far-reaching consequences, such as a rise in infections among children.
The vote only affects the timing of the first dose of the hepatitis B vaccine series. The second dose would be given one to two months after birth and the third dose 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 babies to receive a shot if their mother’s test came back negative.
However, 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 panel’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. ACIP provides recommendations about who should receive certain vaccinations and which vaccinations insurers must cover for free.
Eight members voted yes, three voted no. Some advisers strongly opposed the new guidelines ahead of the vote.
“This has great potential for harm and I hope that the committee will take responsibility if this harm occurs,” said Dr. Joseph Hibbeln, psychiatrist and voting member.
Dr. Cody Meissner, a voting member and professor of pediatrics at Dartmouth Geisel School of Medicine, said he hopes pediatricians continue to administer the birth dose within the first 24 hours after delivery and before discharge from the hospital.
“Any other approach is not in the interests of young children,” he said.
Meissner added that more children will be injured and contract hepatitis B infections. Hepatitis B, which can be passed from mother to child during birth, can cause liver disease and early death. Infants are more susceptible to developing chronic hepatitis B infections, for which there is no cure.
“We will see hepatitis B come back,” he said. “The vaccine is so effective. In my opinion, it makes no sense to change the vaccination schedule.”
In a statement Friday, the American Medical Association said the vote was “reckless and undermines decades of public trust in a proven, life-saving vaccine.” The group added that the decision was not based on science and was “creating 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” “adequately” tested the hepatitis B vaccine.
Some committee members expressed concerns about vaccination during the so-called neonatal period, which is a critical window of development for the brain and immune system. But decades of evidence show that the hepatitis B vaccine has been administered safely to newborns.
Other consultants said there was no evidence to support the two-month delay in birth doses.
“We have to make decisions with the data we have and we must only use the credible data to make the decisions and not speculation and not hypotheses,” Hibbeln said.
A 2024 CDC study showed that the current vaccination schedule helped prevent more than 6 million hepatitis B infections and nearly 1 million hepatitis B-related hospitalizations.
Merck and GSK make the hepatitis B vaccines, which are used from birth. None of the vaccinations represent a significant revenue driver for the companies, so the new recommendations are unlikely to have a significant impact on their business.
Still, Merck said in a statement Friday that it was “deeply troubled” by the vote, which it said risked “undoing this progress and putting infants at unnecessary risk of chronic infections, liver cancer and even death.” The company added that “there is no evidence that the delay provides any benefit to children.”
In a statement, GSK said: “We await additional information and official adoption of today’s recommendations by the CDC to fully understand the potential impact.”
The panel’s vote will not affect coverage for the vaccinations, including under Medicaid and the Children’s Health Insurance Program, Andrew Johnson, senior policy analyst for the Centers for Medicare and Medicaid, told members during the meeting.
