Panel Recommends Delay in Hepatitis B Vaccination for Babies

A U.S. vaccine advisory panel has voted to suggest postponing the hepatitis B vaccination for most infants, reversing a long-standing policy established over 30 years ago that significantly reduced cases of the virus.

On Friday, the Advisory Committee on Immunization Practices (ACIP) decided in an 8-3 vote after lengthy discussions that parents should consult their doctors about whether to vaccinate their newborns at birth. For those opting to proceed, the new guideline recommends starting the vaccination series at a minimum age of two months.

This advice specifically targets mothers who have tested negative for hepatitis B during pregnancy. Until now, the guideline, which has been effective since 1991, mandated all infants receive a hepatitis B shot shortly after birth.

For this recommendation to be officially adopted into the CDC’s vaccination schedule, it must be approved by Jim O’Neill, the acting director of the CDC, or Health Secretary Robert F. Kennedy Jr.

The decision faced immediate criticism from Senator Bill Cassidy (R-La.), a physician who played a key role in Kennedy’s Senate confirmation. Cassidy voiced his disapproval, urging federal health officials to dismiss the recommendation.

As Cassidy stated on social media, “As a liver doctor who has treated patients with hepatitis B for decades, this change to the vaccine schedule is a mistake. This makes America sicker.”

If implemented, this new recommendation could further divide vaccine guidelines in the U.S. The American Academy of Pediatrics has stated it will maintain its position on administering the birth dose. Similarly, New York State’s Department of Health announced it would continue advising practitioners to provide the initial dose at birth.

This change won’t affect the vaccination guidance for infants born to mothers who have tested positive for hepatitis B or whose infection status is unknown. Those infants will still need to receive a vaccine dose within 12 hours of birth, alongside hepatitis B immune globulin.

The move to eliminate the universal birth dose reflects Kennedy’s broader shift in vaccine policy, which some critics argue undermines public confidence in vaccinations. Before assuming the role of health secretary, Kennedy was known for founding a group opposing vaccines and has since pushed to change vaccination policies rapidly.

This vote won’t alter insurance coverage for hepatitis B vaccinations, including provisions under Medicaid and the Children’s Health Insurance Program. The CDC confirmed that coverage through the Vaccines for Children program would also remain unchanged.

The reconsideration of the hepatitis B birth dose wasn’t prompted by any new safety concerns; instead, panelists cited rising parental apprehensions, the differing practices in most European countries, and the length of time since the last review by ACIP as motivating factors.

Some ACIP members questioned the necessity of the vaccine for all infants, suggesting that the risk is relatively low and that hepatitis B is primarily associated with certain high-risk populations.

While testing for hepatitis B is standard for all pregnant individuals, not every test is accurate, and some may become infected after testing. This has left gaps in protection for newborns, posing potential risks.

After implementing the birth dose policy in 1991, the incidence of infants testing positive for hepatitis B dramatically dropped from the thousands to just single or low double digits.

Experts like James Campbell from the American Academy of Pediatrics warned that the new policy could endanger children’s health. He recounted a tragic case of a girl he treated—a victim of chronic hepatitis B—who died due to complications linked to the virus after missing the birth vaccination.

Others on the committee expressed concern that delaying vaccinations might lead to significant health issues, citing an online study predicting over 1,400 additional infants could become chronically infected due to the proposed delay.

Many liaison members, representing various organizations interested in vaccination policy, expressed opposition to the change. The atmosphere of the ACIP meeting felt different from prior sessions, with some stating that experts with pro-vaccine stances were absent while those linked to anti-vaccine communities had more influence during the presentations.

Despite being invited, prominent advocates for vaccines declined to participate. They suggested that engaging in what they see as an illegitimate process could lend it undue credibility.

Throughout the discussions, committee members acknowledged gaps in data supporting their recommendations, particularly regarding the acceptance of delaying the initial dose. Some proposed that more research is necessary to evaluate the effectiveness of fewer than three doses of the vaccine.

As the committee reviews recommendations, an ongoing working group—comprised of individuals with affiliations to vaccine-critical groups—is expected to examine possible updates to the entire childhood vaccination schedule.