Clinical Concerns Over the ACIP Infant Hepatitis B Vaccine Decision, With Chari Cohen, DrPH, MPH

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has voted 8 to 3 to overturn the universal recommendation to start hepatitis B immunization at birth.

With the decision, individual-based decision-making is recommended for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For infants not receiving the birth dose, ACIP suggests in its recommendation that the initial dose be administered no earlier than 2 months of age.

The votes were preceded by December 4, 2025, presentations to ACIP on the hepatitis B disease burden, vaccine safety, and comparative nation immunization policies as well as briefings from representatives of the vaccine manufacturers.

In response to these presentations, the Hepatitis B Foundation released a statement expressing disappointment and concern about discussions during the meeting, a lack of transparency, and a “specific agenda” held by Committee members.

In an interview with HCPLive, Chari Cohen, DrPH, MPH, president of the Hepatitis B Foundation, elaborated on some of the points made in the statement, citing a shortened public comment period, confusion regarding what date the meeting was being held, and presentations from external sources rather than the CDC.

“Throughout the day, we saw this trend where when strong scientific data were brought up, somehow it was either ignored or dismissed, and that was very concerning,” Cohen added.

She went on to describe the importance of the universal birth dose of the hepatitis B vaccine and the role it plays in protecting against mother-to-child transmission and protecting infants from accidental exposure during infancy or early childhood.

While Cohen acknowledged the importance of shared decision-making and the role it already plays in healthcare, she pointed out that risk-based implementation has not worked in the context of hepatitis B vaccination in the past. From 1982 to 1991, risk-based hepatitis B vaccination strategies were largely ineffective, with the eventual transition to universal childhood vaccination helping to curb rates of infection.

“I think that pediatricians are going to need to know how to talk to parents about this, how to accurately and clearly state the information on safety to parents and help them make a decision based on science, which isn't always easy to do,” Cohen said. “I don't envy pediatricians. It's going to be really hard to translate some of this information, especially when it's really hard to justify the decision that was made.”

Editors’ Note: Cohen reports relevant disclosures with Gilead Sciences, GlaxoSmithKline, Vir Biotechnology, Dynavax Technologies, and Roche.

References

1. Brooks A. CDC Changes Infant Hepatitis B Vaccine Recommendation. HCPLive. December 5, 2025. Accessed December 5, 2025. https://www.hcplive.com/view/cdc-changes-infant-hepatitis-b-vaccine-recommendation

2. CDC. Achievements in Public Health: Hepatitis B Vaccination --- United States, 1982--2002. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5125a3.htm