Hepatitis B Vaccination at Birth: Safety, Effectiveness, and Public Health Benefit

Since 1991, the CDC has recommended screening for hepatitis B virus (HBV) infection in pregnancy and universal hepatitis B vaccination of all medically stable infants at birth, serving as a core strategy to prevent perinatal and postnatal infection and eliminate HBV transmission nationwide. On December 5, 2025, the Advisory Committee on Immunization Practices (ACIP) voted (1) among women who screen negative in pregnancy, parents decide, in consultation with providers, when or if to vaccinate their child for hepatitis B, and if not at birth, then aged no earlier than 2 months, and (2) consider collection of infant immune titers to guide decision-making for completing the vaccine series. We conducted a comprehensive review of the evidence on the safety, immunogenicity, efficacy, and effectiveness of the birth dose and a delayed first dose, and of the potential role of serology for clinical decision-making. We analyzed studies of the epidemiology of HBV infection, clinical trials, systematic reviews, vaccine safety from surveillance and clinical studies, and the potential impact of revised guidelines on individual and public health. We synthesized the history of ACIP recommendations and resulting trends in HBV incidence. The review found strong evidence for the safety and effectiveness of the birth dose, and no improvement in safety or effectiveness with a delayed first dose. We found no evidence to support the use of postvaccination serology. Infant vaccination has resulted in a 99% reduction in pediatric HBV infections; we found no evidence to support a change in vaccine recommendations but identified potential health consequences.