Impact of Removing the Universal Hepatitis B Birth-Dose Vaccination in the US

Abstract

Importance: In December 2025, the Advisory Committee on Immunization Practices (ACIP) voted to replace the universal hepatitis B birth-dose recommendation with shared clinical decision-making for infants born to mothers who screen negative for hepatitis B surface antigen. Although the proposal would not alter recommendations for infants of unscreened mothers, historical data suggest that removing a universal birth-dose vaccine recommendation may reduce vaccination coverage in this group. Objective: To estimate the impact of replacing universal hepatitis B virus (HBV) birth-dose vaccination with a targeted recommendation on neonatal and subsequent chronic HBV infections in the US. Design, Setting, and Participants: A compartmental model and simulated a US birth cohort (n = 3659289) under the 2 vaccine recommendations: universal birth-dose vaccination and targeted birth-dose vaccination vaccine recommendations, where the birth dose was recommended to infants of screened-positive or unscreened mothers and shared-decision making is recommended for infants of screened-negative mothers. Parameter values were literature derived and uncertainty was incorporated across 5000 iterations. These data were analyzed from September through November 2025. Exposures: Birth-dose vaccine recommendations and birth-dose vaccination coverage among infants of unscreened mothers. Main Outcomes and Measures: Numbers of neonatal and subsequent chronic HBV infections. Results: With the current maternal HBV screening rate of 86%, the universal birth-dose vaccine recommendation resulted in a median of 1292 neonatal infections (95% percentile interval [PI], 670-2228). In comparison, the targeted birth-dose vaccine recommendation was associated with 628 additional neonatal infections (95% PI, 340-1034) when birth-dose vaccination coverage among infants of unscreened mothers was 10% (mirroring historic coverage declines under a targeted recommendation) and 69 additional infections (95% PI, -32 to 190) when coverage was 80% (mirroring levels under a universal recommendation.) To offset the excess infections under the targeted birth-dose vaccine recommendation, more than 100000 additional pregnant individuals would need to be screened if the birth-dose vaccination coverage among infants of unscreened mothers was 80%, and more than 400000 if coverage was 10%. Conclusions and Relevance: Findings from this study indicate that the targeted birth-dose vaccine recommendation will likely increase neonatal infections unless maternal screening rises substantially or vaccination coverage among infants of unscreened mothers exceeds current levels. As historic data show such improvements are unlikely, these findings underscore the continued importance of universal screening and vaccination as complementary safeguards.