ACIP to Revisit Newborn Hepatitis B Guidance After Panel Shakeup — Experts Warn Delays Could Raise Infections

Health and Human Services Secretary Robert F. Kennedy Jr.’s reconfigured vaccine advisory committee will meet this week to vote on proposed changes to the timing of the hepatitis B vaccine for newborns and to revisit broader childhood immunization guidance.

The Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention is scheduled to convene Thursday and Friday to reconsider a recommendation first discussed in September: delaying the routine hepatitis B dose typically given within 24 hours of birth to about one month of age for infants whose mothers test negative for the virus, while allowing earlier administration based on “individual-based decision-making.”

Supporters say periodic review of vaccine guidance is appropriate when new evidence emerges. Critics — including clinicians, public-health advocates and some lawmakers — argue the current proposal is poorly worded and could reduce early coverage, threaten insurance reimbursement for vaccines, and ultimately lead to preventable infections.

“Right now, we have a situation where none of that has happened.” — Chari Cohen, president of the Hepatitis B Foundation, on the need for a systematic, transparent review.

ACIP postponed a vote on the change in September after concerns about the potential consequences. Member Cody Meissner warned the proposed language could, in his view, “increase the risk of harm based on no evidence of benefit, because there will be fewer children who will get the full hepatitis B vaccine series.”

Sen. Bill Cassidy (R-La.), a hepatologist and chair of the Senate Health, Education, Labor and Pensions Committee, has also criticized the idea. On CBS’s Face The Nation he said the move reflects a misunderstanding of hepatitis B epidemiology and an overconfidence born of past success in reducing cases.

The debate has been intensified by recent personnel changes at HHS: Martin Kulldorff — a prominent vaccine critic who served as ACIP chair during the September meeting — was appointed to a role within the department this week. Kulldorff has argued that reducing vaccine mandates could restore public trust, though there is currently no federal mandate for the hepatitis B vaccine and parents already retain the choice to vaccinate newborns under existing policies.

Independent reviews and modeling have bolstered concerns about delaying the birth dose. An independent evidence review by the Center for Infectious Disease Research and Policy and the Vaccine Integrity Project found the hepatitis B vaccine to be consistently safe regardless of timing and identified no benefits to delaying the first dose in terms of efficacy, effectiveness, or long-term protection.

Modeling from HepVu, the Hepatitis B Foundation and the National Viral Hepatitis Roundtable estimated that a two-month delay in the initial dose could result in 238 additional infections among children and about $21.6 million in added health-care costs. Eric Hall, an assistant professor at Oregon Health & Science University and co-author of that modeling, warned that even short delays are likely to cause more infections, greater long-term complications and higher costs.

Public-health advocates emphasize that infants can acquire hepatitis B from infected mothers and that tiny amounts of blood can transmit the virus. Chari Cohen noted that roughly 70 percent of people living with hepatitis B in the U.S. are undiagnosed and that about 16 percent of pregnant women are unaware of their hepatitis B status despite ACIP’s September recommendation for universal prenatal testing.

Acquiring hepatitis B in early childhood carries serious long-term risks. Experts estimate a substantially increased lifetime risk of liver disease and cancer for those who contract the virus as infants or young children. Given those stakes, ACIP members will weigh the evidence, practical implications and public confidence as they decide whether to revise longstanding guidance credited with dramatically reducing hepatitis B in the United States.