After ACIP Debate, CDC Modifies Longstanding Hepatitis B Birth Dose Recommendation

The CDC on December 16, 2025, formally adopted a policy of shared clinical decision-making for hepatitis B vaccination at birth for infants born to women who test negative for hepatitis B surface antigen (HBsAg), marking a significant departure from decades of universal birth-dose guidance.¹

Under the revised recommendation, parents and clinicians may now decide when, or whether, to initiate hepatitis B vaccination in this population, with the first dose suggested no earlier than 2 months of age if the birth dose is deferred.¹

The change, approved the same day by CDC Acting Director and US Department of Health and Human Services Deputy Secretary Jim O’Neill, follows a contentious vote earlier this month by the CDC’s Advisory Committee on Immunization Practices (ACIP).² The revised approach does not alter existing recommendations for infants born to mothers who test positive for hepatitis B or whose infection status is unknown; those infants should continue to receive hepatitis B vaccine and hepatitis B immune globulin at birth.¹

CDC Decision: Scope and Rationale

CDC officials characterized the move as a recalibration rather than a reversal of hepatitis B prevention strategy. On the CDC immunization schedule, the approach is designated as shared clinical decision-making, meaning clinicians and parents are encouraged to weigh vaccine benefits, potential risks, and the infant’s likelihood of exposure before deciding when to initiate vaccination.¹

According to the CDC, relevant considerations include household exposure risks, contact with individuals from regions with high hepatitis B prevalence, and the likelihood of missed vaccination opportunities later in infancy.¹ Coverage under public and private insurance programs will remain unchanged under the new policy, including Vaccines for Children, Medicaid, CHIP, Medicare, and Marketplace plans.¹

O’Neill emphasized informed consent in announcing the decision, stating that the recommendation reflects ACIP’s review of the available evidence and restores parental discretion for newborns perceived to be at low risk of infection.¹ No new safety concerns related to the birth dose were presented during the December ACIP meeting, and hepatitis B vaccination has long been considered safe and effective in newborns.^2,3

Longstanding Universal Guidance Upended

Universal administration of hepatitis B vaccine within 12–24 hours of birth has been a cornerstone of US immunization policy since the early 1990s. The strategy is credited with a dramatic reduction in pediatric hepatitis B infections.^2,3 Between 1991 and 2019, reported hepatitis B infections among US children and adolescents declined by approximately 99%, preventing thousands of cases of cirrhosis, hepatocellular carcinoma, and hepatitis B–related deaths.^2,3

Public health organizations and infectious disease societies have cited these outcomes in opposing the policy change. In a December 2025 statement, the American Public Health Association and allied experts urged the CDC to retain universal newborn vaccination, warning that delays could increase preventable infections and downstream complications.³

Modeling Raises Concerns About Delayed Shots

Concerns about unintended consequences were reinforced by a recent modeling analysis cited during policy deliberations.⁴ That analysis estimated that delaying the hepatitis B birth dose until 2 months of age among infants born to HBsAg-negative mothers could result in at least 1,400 additional pediatric hepatitis B infections annually, along with approximately 300 excess cases of liver cancer, 480 preventable deaths, and more than $222 million in additional health care costs for each year the revised policy remains in effect.⁴

Even under more conservative assumptions, annual delays in birth-dose administration were projected to lead to dozens of preventable deaths and liver cancer cases.⁴ CDC officials acknowledged these data but emphasized that the recommendation applies only to infants considered at low risk and preserves flexibility for clinicians to recommend vaccination at birth when appropriate.¹

ACIP Debate and Vote

The CDC’s action follows ACIP’s December 5 vote (8–3) to replace universal birth-dose language with individual-based decision-making for infants born to HBsAg-negative mothers.² The vote came after months of debate and a postponed attempt to revise the policy at ACIP’s September meeting.^5-8

Meeting transcripts and contemporaneous reporting describe sharp disagreement among committee members. Some argued the revised language allows parental choice without eliminating access to vaccination, while others warned that weakening universal recommendations risks missed doses, undetected maternal infection, and erosion of public health gains.^6-8

ACIP also narrowly approved a secondary recommendation encouraging clinician-parent discussions about hepatitis B antibody testing to determine whether additional doses are needed later in infancy or childhood.^5-8 CDC officials said this aspect of the recommendation remains under review, citing uncertainty about real-world implementation and supporting evidence.¹

Implications for Clinical Practice

Once incorporated into CDC schedules and guidance documents, the revised recommendation will place greater responsibility on clinicians to assess hepatitis B risk, counsel families, and ensure follow-up vaccination when birth doses are deferred. Hepatitis B infection acquired in infancy remains strongly associated with chronic infection and long-term complications, including cirrhosis and liver cancer.⁹

As CDC guidance evolves, clinicians will need to balance parental preferences with population-level prevention goals, an approach that supporters describe as individualized care and critics view as a potential weakening of a highly effective public health intervention.

References

1. Centers for Disease Control and Prevention. CDC adopts individual-based decision-making for hepatitis B immunization for infants born to women who test negative for hepatitis B virus. News release. December 16, 2025. Accessed December 17, 2025. https://www.cdc.gov/media/releases/2025/2025-hepatitis-b-immunization.html

2. Halsey G. ACIP votes to modify decades-long hepatitis B birth dose recommendation. Patient Care. December 5, 2025. Accessed December 17, 2025. https://www.patientcareonline.com/view/acip-votes-to-modify-decades-long-hepatitis-b-birth-dose-recommendation

3. APHA joins GW and dozens of public health and policy experts urging the CDC to maintain universal newborn hepatitis B vaccination. News release. American Public Health Association. December 2, 2025. Accessed December 17, 2025. https://www.apha.org/news-and-media/news-releases/apha-news-releases/public-health-and-policy-experts-urge-the-cdc-to-maintain-universal-newborn-hepatitis-b-vaccination

4. New analysis shows delaying the hepatitis B birth dose may lead to thousands of preventable infections and hundreds of millions in avoidable healthcare costs. HepVu. December 1, 2025. Accessed December 15, 2025. https://hepvu.org/news-updates/new-analysis-shows-delaying-the-hepatitis-b-birth-dose-may-lead-to-thousands-of-preventable-infections-and-hundreds-of-millions-in-avoidable-healthcare-costs/

5. ACIP recommends individual-based decision-making for hepatitis B vaccine for infants born to women who test negative for the virus. News release. US Department of Health and Human Services. December 5, 2025. Accessed December 16, 2025. https://www.hhs.gov/press-room/acip-recommends-individual-based-decision-making-hepatitis-b-vaccine-birth-dose-infants-born-women-test-negative-virus.html

6. Choi J. CDC panel passes recommendation to change hepatitis B vaccine guidance. The Hill. December 5, 2025. Accessed December 5, 2025.

7. Benadjaoud Y, Kekatos M. CDC vaccine advisory committee votes to remove universal recommendation for hepatitis B shot at birth. ABC News. December 5, 2025. Accessed December 5, 2025. https://abcnews.go.com/Health/cdc-vaccine-advisory-committee-votes-remove-universal-recommendation/story

8. Huang P, Stein R, Wroth C. CDC advisers vote to overturn decades-long policy on hepatitis B vaccine for infants. Shots Health News. NPR. December 5, 2025. Accessed December 5, 2025. https://www.whcp.org/2025-12-05/cdc-advisers-vote-to-overturn-decades-long-policy-on-hepatitis-b-vaccine-for-infants

9. World Health Organization. Hepatitis B. Updated July 23, 2025. Accessed December 5, 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b