If the December 2025 recommendation1 of the ACIP to replace universal hepatitis B (HepB) birth-dose vaccination with targeted vaccination based on "shared-decision" and positive or unknown maternal status is implemented, substantially more maternal screening or vaccinating infants of unscreened mothers will be necessary to mitigate the increase in infections, according to projections of a compartmental modeling study.2
"Avoiding an increase in neonatal infections under the targeted recommendation would require historically unattained levels of maternal HBsAg screening or birth-dose coverage among infants of unscreened mothers," warn study lead author Margaret Lind, PhD, School of Public Health, Boston University, Boston, MA, and colleagues, in a recent issue of JAMA Pediatrics.
"Although the recommendation change does not alter recommendations for infants of unscreened mothers, historic data suggest that maintaining high coverage in this group without a universal recommendation is unlikely," they add.
What the Data Shows
That conclusion from historical data is supported by a study3 concurrently published in JAMA Network Open that compares rates of HepB series completion in infants who did or did not receive the first dose at birth.Joshua Williams, MD, Denver Health and Hospital Authority, Denver, CO, and colleagues found that 97.6% of the infants who received a birth dose completed the series, in contrast to 55.3% in 2023 of those who did not receive it.
The modeling study was also accompanied by another predictive study4 in JAMA Pediatrics, which projects the economic impact, not only from the increase in neonatal infections, but from subsequent progression to chronic infections and the sequelae of cirrhosis and hepatocellular carcinoma. Eric Hall, PhD, MPH, School of Public Health, Oregon Health & Science University, Portland, OR, and colleagues estimate that even with perfect adherence to the series, a delay of HepB vaccination of just 2 months in a simulated population of over 3 million infants would result in an additional $16.4 million in costs for infants born during 1 year.
What You Need to Know
Modeling suggests that replacing universal HepB birth-dose vaccination with a targeted approach could lead to hundreds of additional neonatal infections unless maternal screening and vaccination rates reach levels that have not historically been achieved.
A concurrent study found that 97.6% of infants who received a HepB birth dose completed the vaccine series, compared with just 55.3% of infants who did not receive the birth dose, highlighting the importance of early vaccination for long-term protection.
Researchers projected that even a 2-month delay in infant HepB vaccination could result in millions of dollars in additional health care costs due to increased infections and subsequent complications such as chronic hepatitis B, cirrhosis, and hepatocellular carcinoma, while decades of safety data continue to support the vaccine's favorable safety profile.
As to concern about the safety of HebB vaccine as a rationale for withdrawing the universal birth-dose recommendation, Hall and colleagues cite studies that evidence possible short-term (less than 1 week) increased reactogenicity (eg, fever, local injection site reaction) but without an increase of serious or lasting adverse reactions. "Similarly, post-licensure safety data have revealed no new or unexpected safety concerns over decades of review," they relate.
Modeling
In the compartmental model and simulation of a US birth cohort of over 3 million births (n= 3,659,289), applying the current maternal HBV screening rate of 86% and universal birth-dose vaccination, there were 1,292 (95% PI, 670-2228) neonatal infections.With the targeted vaccination, and 10% coverage of infants among unscreened mothers (also derived from historical data with a targeted recommendation) Lind and colleagues project an additional 628 (340-1034) neonatal infections.In a scenario where coverage is increased to 80%, comparable to the level with universal birth-dose recommendation, there are still 69 additional infections.
To offset the excess infections projected with targeted vaccination, the investigators determined that more than 100,000 additional maternal screenings will be necessary with 80% birth-dose vaccination coverage among infants of unscreened mothers, and more than 400,000 if coverage is 10%.
"As historic data show such improvements are unlikely, these findings underscore the continued importance of universal screening and vaccination as complementary safeguards," Lind and colleagues advise.
References
1. US Centers for Disease Control and Prevention. ACIP recommends individual-based decision-making for hepatitis B vaccine for infants born to women who test negative for the virus. 2025, December 5. CDC news release. https://www.cdc.gov/media/releases/2025/2025-acip-recommends-individual-based-decision-making-for-hepatitis-b-vaccine-for-infants-born-to-women.html. Accessed April 29, 2026.
2. Lind ML, Hitchings MDT, Singh RP, et al. Impact of removing the universal hepatitis B birth-dose vaccination in the US. JAMA Pediatr. 2026, published online April 27, 2026. doi:10.1001/jamapediatrics.2026.1226.
3. Williams JTB, Cruz H, Stein A, et al. Hepatitis B vaccine series completion by 18 months in infants without a birth dose. JAMA Netw Open. 2026;9(4):e269962. doi:10.1001/jamanetworkopen.2026.9962.
4. Hall EW, Gounder P, Bradley P, et al. Economic impact of delaying the infant hepatitis B vaccination schedule. JAMA Pediatr. 2026, published online April 27, 2026. doi:10.1001/jamapediatric.2026.1221.
