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Summary of Information
Childhood/Adolescent Schedule Workgroup
Hepatitis B Virus Vaccine Birth Dose
December 4, 2025
Overview
•Childhood/Adolescent Schedule Workgroup
•Workgroup Process
•Workgroup Findings
•Proposed Voting Language
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Workgroup Members
ACIP members
Kirk Milhoan, MD, PhD
Martin Kulldorff , PhD
Evelyn Griffin, MDVicky Pebsworth, PhD, RN
Outside Experts
Brian Morse, MD, PhD, Christine Stabell Benn, MD
Ex-officio
Tracy Beth Hoeg, MD, PhD
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Policy Request
Assess the use of a universal birth dose of
Hepatitis B vaccine in children whose mothers are
HBsAg- negative.
(Which necessarily involves more than the birth dose.)
Terms of Reference Document
“Review the efficacy and safety of the
immunization schedule for children and
adolescents, identify efficacy and safety
problems, and address stakeholder concerns. ”
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Motivation and Public Health Importance
•Feedback from stakeholders
•Misalignment with existing recommendations in
most developed countries
•Prolonged time since last comprehensive review as per ACIP’s charter
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Workgroup Process
•September 18 -19, 2025, ACIP Meeting
•Request to CDC for Additional Information to Address
ACIP Questions
16 questions: descriptive safety and data
•Workgroup Meetings
Between 10/17/25 and 11/24/25, the workgroup met 7 times
•Workgroup Process - Presentations, Discussions, and
Straw Polls
12 presentations by CDC staff, workgroup members, and invited ad
hoc experts that covered clinical ethics, non- specific vaccination
effects, aluminum adjuvant exposures, clinical practice challenges and solutions, and the Alaska Hepatitis B vaccine trials.
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Workgroup Findings:
Areas of Full/Nearly Full Agreement (1)
•Hepatitis B virus can be
transmitted vertically and
horizontally to infants, is a
serious disease, and can be prevented by vaccination with the HBV vaccine
•There is uncertainty about
true rates of incidence,
prevalence and horizontal
transmission rates•There is uncertainty about
whether all three
recommended doses are
needed to acquire protection
•There are gaps in evidence
and limitations related to evidence of safety (per
GRADE quality of safety
evidence is poor)
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Workgroup Findings:
Areas of Full/Nearly Full Agreement (2)
•Infants born to mothers who
test positive for HBsAg should
continue to be vaccinated with HBV vaccine and receive hepatitis B immunoglobulin
soon after birth
•Any gaps in screening pregnant
women for HBsAg should be eliminated so that all infants
receive appropriate care •Re- screening of pregnant
mothers upon admission for
delivery should be considered
so that there are no mothers
whose HBsAg is “unknown ”
which should be regarded as a serious quality of care problem, if not a medical error, and a
“never event”
•Infants born to mothers who
test negative for HBsAg have
extremely low risk of horizontal infection during childhood and particularly in first months of life
and therefore, do not need to be
routinely vaccinated with the HBV vaccine at birth
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Workgroup Findings:
Central Themes Related to Hepatitis B Preventive Care
Improving Quality and Appropriateness of Hepatitis B
Preventive Care
•screen all pregnant mothers (no unknowns), appropriately treat
all newborns
Minimizing AEFI in Vulnerable Newborns
•avoid unnecessary early life exposures
Fostering Individual -based Decision -making and Respect for
Parental Autonomy
•permit clinical flexibility and individual risk assessments
Improving Safety Monitoring and Research
•close evidence gaps
Modifying US Policy, Consider other Countries
•return to a targeted and successful strategy more in line with other
developed countries with low endemicity
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Evaluation of Voting Language Categories
•Universal Vaccination Option
•No Recommendation Option
•Individual -based Decision -making Option
(preferred first choice for Workgroup members.)
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Rationale for Preferring an Individual- based
Decision -making Option (1)
•The overwhelming majority of infants born to mothers who test
negative for hepatitis B surface antigen are not at high risk of being infected with the hepatitis B virus, especially in the first few months of life.
•The 1991 recommendation was made in error.
•Vaccine safety risks are not well understood and were never assessed appropriately.
•An individualized, risk -based approach is needed, with
recommendations tailored to risk/benefit profiles and preferences and involve informed consent.
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Rationale for Preferring an Individual- based
Decision -making Option (2)
•It has the potential to allow the parent to choose a point in time
closer to the onset of risky behaviors sometimes encountered in
adolescence, and, for those who prefer to wait, the “catch -up”
schedule could be used by those who delay until age 11.
•It also provides options for avoiding vaccinating in early infancy and
adolescence when there are biological windows of vulnerability.
•Creates an opportunity to use serology testing to determine whether additional doses of vaccine are needed for protection.
•Could end disputes between parents of newborns, hospital staff and others who do not agree about administration of a birth dose,
consent, and cease to be the “gateway to vaccine hesitancy. ”
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Rationale for Preferring an Individual- based
Decision -making Option (3)
•Provides for a return of decision -making to parents in
collaboration with the health care provider who wants to be
able to recommend a flexible schedule and the ability to tailor
care to individual needs, risks and preferences.
•Benefits of using two months for starting HBV vaccine series
•the additional two months of maturation, as it relates to the
blood -brain barrier, liver, and kidney function, is desirable.
•is in line with the policy of other comparable countries
•would permit the use of combination vaccines and limit the number of injections, as well as access to lower -aluminum-
containing products
.
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Rationale for NOT Preferring an Individual-
based Decision -making Option
•Concerns about rare exposures to the hepatitis B virus that could cause an infection and a chronic infection
•Concerns about acceptability to the medical and public health communities and others, media backlash, unfair treatment by medical boards
•The system that’s in place that will be difficult to change
•It will take too much time to counsel patients about risks and benefits, and access to educational materials isn’t obvious
•Concerns about liability, payments, additional paperwork
•The safety concern may be more theoretical than real
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Implementation Considerations
•PEP in births to HBsAg+ mothers:
Strengthen maternal screening programs
Immigrant medical examination screening
•Delaying the timing of the first dose will allow choice of using
different vaccines, monovalent and polyvalent
14Birth dose 2/4/6 month 4 years 8 years 12 years
Target groups HBsAg+ only All or high risk HHs All All All
Vaccine type Monovalent/poly
valent mixPolyvalent Monovalent series Monovalent Monovalent
Implementation Considerations
•Even under the existing universal dose policy not all babies are
vaccinated at birth with no detectable increase in incidence of HBV infections
•Data from the 2016 -2021 Centers for Medicare & Medicaid
Services (CMS) Transformed Medicaid Statistical Information System (T -MSIS)1
Comments:
•T-MSIS Analytic Files are research- optimized collection data submitted as part of state -
level Medicaid submission.
•Includes enrollment data, demographics, and service utilization.2
•Hepatitis B antigen tests identified using Current Procedural Terminology [CPT] codes
1https://www.medicaid.gov/medicaid/data -systems/macbis/transformed -medicaid -
statistical -information- system -t-msis/index.html
2https://www.medicaid.gov/medicaid/data -systems/macbis/transformed -medicaid -
statistical -information- system -t-msis/t -msis -analytic -files
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CMS Medicaid
•Pregnancies:
•At least one ICD -10 diagnosis code ('O80' , 'O81' , 'O82' , 'O83' , 'O84' ,
'Z370' , 'Z372' , 'Z375’) in inpatient or other service files
•Live Born Pregnancies:
•At least one ICD -10 Diagnosis code ('O80' , 'O81' , 'O82' , 'O83' , 'O84' ,
'Z370' , 'Z372' , 'Z375’)
•Death not recorded during first hospitalization
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Table 1: Receipt of HBV Vaccine Among Infants
CMS Medicaid Births, 2016 -2020
T otal B irth% To t a l
Birt h s
T otal B irths 7,284,953 100%
Infants Receiving First HBV Dose by 2 yrs
(0-730 days)6,573,976 90%
Infants R eceiving HB V B irth Dose (0-30 days)5,076,855 70%
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Age of First HBV Vaccination
within first 730 Days
A ge of First HBV V accinationTo t a l
V accinatedTo t a l
V accinated
%
Birth Dose Received During Birth Hospitalization 4,966,112 76%
1 - 30 days 110,743 2%
31 - 180 days 1,289,749 20%
181 - 365 days 145,947 2%
365 - 730 days 61,425 1%
Infants Receiving First Dose by 2 yrs (0 -730 days) 6,573,976 100%
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•Markman, Putting Public Health Ethics Into Practice
•Expected health benefits for the target population
•Potential harms and burdens for all stakeholders
•Impact on autonomy
•Impact on equity
•Expected efficiency
•Ethics of Vaccination
•Preserve Health
•Means -end Proportionality
•Discretion
•Parsimony
-Marckmann G, Schmidt H, Sofaer N, Strech D. Putting public health ethics into practice: a systematic framework. Front Public Hea lth. 2015
Feb 6;3:23. doi: 10.3389/fpubh.2015.00023. PMID: 25705615; PMCID: PMC4319377.Public Health and Vaccination Ethics
ACIP Childhood/Adolescent Immunization Schedule Workgroup
Vote Language, 12/3/25
VOTE 1
•ACIP recommends a birth dose of Hepatitis B virus (HBV) vaccine and
Hepatitis B Immunoglobulin for infants born to women who test HBsAg -
positive. ACIP recommends individual -based decision -making, in
consultation with a health care provider, for parents deciding whether to give the HBV vaccine birth dose to infants born to women who are HBsAg -
negative or whose HBsAg status is unknown. Parents should consult with health care providers and decide when or if their child will begin the HBV vaccine series.
1 Parents and health care providers should consider vaccine
benefits, vaccine risks, and infection risks. For those not receiving the HBV birth dose, it is suggested that the initial dose is administered no earlier than 2 months of age. Y/N
VOTE 2
•When evaluating the need for subsequent HBV vaccine dose in children, parents should consult with health care providers to determine if a post -
vaccination anti -HBs serology testing should be offered prior to subsequent
HBV vaccine dose administration. Serology results should determine whether the established protective anti -HBs titer threshold of ≥10 mIU /mL
has been achieved. The cost of this testing should be covered by insurance. Y/N
1 Parents and health care providers should also consider whether there are risks, for example, such as a household
member is HBsAg -positive or when there is frequent contact with persons who have emigrated from areas where
Hepatitis B is common.
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