Outcomes and Implications of ACIP’s Vote on the Hepatitis B Vaccine for Newborns
On Dec. 4 and 5, the Advisory Committee on Immunization Practices (ACIP) held a long-anticipated meeting open_in_new featuring two major topics of discussion: the hepatitis B birth dose and the pediatric vaccine schedule. The committee voted on two questions open_in_new related to the pediatric hepatitis B vaccine schedule, both of which passed.
To briefly summarize the outcome of the meeting, ACIP shifted from recommending a universal birth dose of the hepatitis B vaccine for all newborns to individualized decision-making for newborns born to HBsAg-negative mothers. There was no change to the recommendation for infants born to HBsAg-positive mothers or whose HBsAg status is unknown.
CDC has not yet adopted these changes. In the meantime, many states are taking actions to provide clarity to providers and promote public confidence in the vaccine.
How States Are Taking Action
In response to (and in some cases before) the new ACIP recommendations, several states issued recommendations, guidelines, standing orders, executive directives, and health alerts for providers to provide clarity.
States Recommending or Encouraging the Full Vaccine Series
Some states are issuing their own guidance and recommendations for the hepatitis B vaccine series or encouraging providers to adhere to the series as is it was before the new ACIP recommendations:
- The Northeast Public Health Collaborative released a consensus statement open_in_new before the ACIP meeting recommending the hepatitis B vaccine birth dose and a schedule that aligns with clinical recommendations. Collaborative members also issued statements reaffirming their adherence to established hepatitis B vaccine recommendations, including Connecticut open_in_new, Maine open_in_new, Maryland open_in_new, Massachusetts open_in_new, New Jersey open_in_new, New York open_in_new, Pennsylvania open_in_new, and Rhode Island open_in_new.
- Maryland also released guidance for parents and caregivers open_in_new about its childhood immunization recommendations.
- States in the West Coast Health Alliance issued statements supporting the universal birth dose of the hepatitis B vaccine. These states include California open_in_new, Hawaii open_in_new, Oregon open_in_new, and Washington open_in_new.
- Many individual states also issued statements affirming the recommendation for the continued use of the hepatitis B vaccine birth dose, including Arizona open_in_new, Colorado open_in_new, Illinois open_in_new, Michigan open_in_new, New Mexico open_in_new, and Vermont open_in_new.
States Issuing Standing Orders and Executive Directives
At least two states issued a standing order or executive directive related to the hepatitis B vaccine:
- The Maryland Department of Health issued a standing order open_in_new to ensure hepatitis B vaccine access for infants and children in the state. The standing order authorizes qualified health care providers to administer the hepatitis B vaccine and outlines the policies and procedures for administering the vaccine.
- In New Jersey, the acting health commissioner issued an executive directive open_in_new recommending the hepatitis B vaccine birth dose and full series.
States Issuing Public Health Alerts and Advisories
Well before the recent ACIP meeting, the Maine CDC issued a health advisory to providers open_in_new recommending the hepatitis B vaccine birth dose and full series. Since the ACIP meeting, at least two other states have released provider advisories. Maryland issued a letter to providers open_in_new laying out the state’s hepatitis B vaccine recommendations, and New Hampshire issued a health alert open_in_new with a continued recommendation for the full hepatitis B vaccine series and birth dose. In addition, Vermont sent a guidance letter open_in_new to the providers in the state’s vaccine program.
States Reexamine State Statutes and Agency Rules Linking to ACIP Recommendations
Over the last several months, many states have proposed and enacted legislation open_in_new to move away from sole reliance on ACIP recommendations. More recently, Massachusetts adopted H 4761 open_in_new, authorizing the health commissioner — in consultation with a newly established committee on immunization recommendations — to review and issue alternative standards to ACIP recommendations.
States are also proposing changes to agency rules related to school and childcare immunization requirements. For example, Colorado’s health department has issued a proposed rule open_in_new to modify the state’s standards for school and childcare immunization requirements and to align its rules with recent changes to state statute.
Additional Considerations for States
If CDC adopts the proposed ACIP recommendations, states can consider the following actions.
Hepatitis B Screening
States should continue to work with health care providers to close gaps in hepatitis B screening and follow-up for infants of HBsAg-positive mothers. Data show the most common cause of perinatal infection open_in_new occurs when a mother with hepatitis B gives birth and the infant does not receive follow-up postexposure prophylaxis.
Insurance Coverage
While public and private insurance, including the Vaccines for Children open_in_new program, are still required to cover the hepatitis B vaccine, such as any birth doses given to infants of HBsAg-negative mothers under shared clinical decision-making, states can consider creating additional coverage requirements. Some states have passed policies on insurance coverage, and other states have proposed legislation related to other vaccine coverage.
Implementation of Shared Clinical Decision-Making
While health care providers and parents have the flexibility to determine their approach for infants of HBsAg-negative mothers (i.e., continuing to recommend/give a birth dose), ACIP recommendations that rely on shared clinical decision-making have increased provider questions on how to have and document these conversations.
States can work with medical associations, provider boards, and health care partners to ensure clinicians understand how to apply shared clinical decision-making recommendations. This includes educating staff in birthing hospitals, community clinics, and pediatric practices on how to counsel parents and document informed discussions. Jurisdictions can also develop or adapt educational materials and decision aids that clearly outline benefits, risks, timing, and follow-up options to support both providers and parents.
More information on shared clinical decision-making is available from CDC and Common Health Coalition. States can also encourage providers and birthing institutions to examine workflows, Immunization Information System documentation, and follow-up to ensure scheduling of future doses.
Implications for Vaccine Supply
States can examine vaccine supply through the Vaccines for Children program to understand how the new recommendations impact supply of single antigen hepatitis B vaccines. If a significant percentage of the population receives vaccines on a different timetable, it could impact supply and timing for other vaccinations, given the reliance on combination vaccines for hepatitis B dose two and three, which can include DTaP, polio, and Hib vaccines.
Supplemental Resources
- Common Health Coalition:
- Vaccine Integrity Project – Hepatitis B open_in_new by Centers for Infectious Disease Research and Policy
- Understanding the Benefits of Vaccines: Common Questions open_in_new by HealthyChildren.org
- Childhood Vaccinations (PDF) open_in_new by Your Local Epidemiologist
- Hep B Birth Dose Media Toolkit open_in_new by Hepatitis B Foundation
- Reframing the Conversation About Child and Adolescent Vaccinations open_in_new by Frameworks Institute
- CDC:
- ACIP Shared Clinical Decision-Making Recommendations open_in_new
- ACIP Meeting Materials for Public Posting: Hepatitis B Birth Dose Briefing Document (PDF) open_in_new
- Hepatitis B Birth Dose Vaccination (PDF) open_in_new
December 11, 2025 | Susan Kansagra, Andy Baker-White, Kim Martin, Jessica Baggett
Original Article
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