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Hepatitis B Virus Vaccine
Birth Dose
Vicky Pebsworth, PhD, RN
Advisory Committee on Immunization Practice
Childhood/Adolescent Schedule Workgroup
December 4, 2025
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Presentation Overview
•Introduction and Policy Context
•Burden of Disease
•Efficacy
•Safety
•Conclusions
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Introduction to Policy Context
Policy Request
•Assess the current recommended schedule, including the use
of a universal birth dose of Hepatitis B Virus (HBV) vaccine in children whose mothers test negative for HBsAg at delivery
•Why Are We Here Today?
Feedback from stakeholders
Misalignment of existing recommendations in most developed
countries
Prolonged time since last comprehensive review as per ACIP’s charter
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•Rising transmission of acute hepatitis from 1960s to the mid -1980s due
to blood -borne exposures in high- risk groups
•Introduction of plasma -based vaccine in 1981, high -risk groups targeted
•Concerns over vaccine safety, technology changes, reduced liability
•Evolution of ACIP birth recommendations during the 1980s
•Dissatisfaction with targeting strategy, ambitious new strategy proposed
•Leap to universal birth dose made in 1991How Did We Get to Where We Are Now?
Rapid Rise of Reported Acute U.S. Cases of Hepatitis B
- 5,000 10,000 15,000 20,000 25,000 30,000
1965 1970 1975 1980 1985 1990Source: CDC National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention, Viral Hepatitis Division, Epidemiology and Survei llance Branch
•New Vaccine Licensed in 1981
•Safety Concerns Related to Donor Source Material in Plasma -Derived
Vaccine
•Availability of New Recombinant Technology Platform and Hepatitis B
Antigen- based Product Manufactured in Yeast
•Approval of the National Childhood Vaccine Injury Act in 1986
•Policymaker Support Factors That Affected Policy Shifts
“If vaccinations were given universally at birth to infants in
populations that have a high rate of perinatal HBV transmission,and with childhood immunizations to infants in other parts ofthe world, a worldwide cohort of persons with protection fromthis long -term infection would be established. ”
“In the United States, selective immunization of groups at risk ofinfection has not been effective in lowering the overall incidence
of disease. ”Worldwide Elimination of Hepatitis B Transmissions:
We Have the Way, We Need the Will
Evolution of ACIP Recommendations:
Infant Target Groups, Treatments/Vaccines
ACIP
meetingTarget group Infant treatment Vaccine type Recommendation change logic
6/25/1982 Infants born to
HBsAg+ mothersFirst infant PEP
•HBIG at birth
•Vaccine at 3 monthsHeptavax licensed
11/16/81 Recommended for high- risk groupsNew vaccine licensed.
Numerous risk groups targeted
Infant treatment timing unclear
6/1/1984 Infants born to HBsAg+ mothersRefined infant PEP•HBIG within 12 hours of birth
•Vaccine with 7 daysHeptavax 1983 Lancet study tested 3 different dosing schedules w/HBIG & vaccine. Schedule B
was the rec’n
6/7/1985 Infants born to
HBsAg+ mothersConcurrent PEP dosing•HBIG and vaccine <12 hoursHeptavax 1984 Lancet study finds no interference with
HBIG and vaccine.
1985 JAMA study doses concurrently
6/19/1987 Infants born to
HBsAg+ mothersConcurrent PEP dosing•HBIG and vaccine <12 hoursRecombivax -HB licensed
and recommended
Heptavax New vaccine licensed
Concerns over plasma vaccine citedConcurrent dosing schedule kept
11/22/1991 Universal infant vaccinationVaccination before hospital discharge, no later than 2 months, added to childhood scheduleRecombivax -HB
Engerix -BConcerns w/failure of targeted policy
Safety in infant/child trials cited
12/23/2005 Universal infant
vaccinationVaccination within 12- 24 hrs of birth Recombivax -HB
Engerix -BProvide a “safety net” for medical errors
Eliminate “flexible”/”inconsistent” practices
Motivations to Ask The Question?
What Are We Trying to Accomplish Today?
•Address Stakeholder/Parent Dissatisfaction
•Report on the required periodic review conducted by the Workgroup
•Consider policies that:
•are better aligned with other countries similar to ours
•Are based on evidence and target the needs of high -risk persons and
populations
•Explicitly consider the principles of public health and vaccination ethics
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The Importance of Stakeholders
•Terms of Reference – IOM Stakeholder
Concerns
2002 - Multiple Immunizations and Immune Dysfunction
2013 - The Childhood Immunization Schedule and Safety: Stakeholder
Concerns, Scientific Evidence, and Future Studies
•Stakeholder Surveys
Oregon Survey of Hepatitis B Vaccine Refusal in Newborns, 2014
KFF/Washington Post Survey of Parents, 2025
Stakeholder Feedback
Oregon Survey
2014
•5% Refused HBV birth dose
•8% wanted to wait
•6% were undecided.
Why?
•78.1% baby was too young
•70.4 % vaccine safety concerns
•43.8% baby was at low risk of
infectionKFF/Washington Post Survey
2025
•13% skipped/delayed HBV
•16% skipped/delayed vaccines
---67% side effects concerns
---53% vaccine safety doubts
---51% vaccines not necessary
---42% not wanting multiple shots
---35% safety testing lacking
---26% CDC recommends too
many vaccines
---41% want to space out shots
---58% little/no confidence in
federal agencies
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U.S. Birth Dose Policy is an Outlier Among
Low -prevalence Nations
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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
Policy Context Summary (1)
•Causes of hepatitis B increases in 1970s-80s diminished
with targeted measures
•Universal birth dose set out to eliminate worldwide transmission
•Other countries with similar incidence and prevalence of Hepatitis B use a selective vaccination practice, and not a universal birth dose
•Some parent stakeholder groups would like greater flexibility and the ability to decide what is best for their child.
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Policy Context Summary (2)
•Stakeholder dissatisfaction has been documented for 25 years, is
of societal significance, and creates challenges for immunization policymaking.
•The belief that universal vaccination can eradicate Hepatitis B was endorsed by leaders and shaped public policy.
•In response, between 1983 and 1991, ACIP recommendations shifted from an approach that only targeted high- risk infants to
one that targets all infants.
•The context included the emergence of advanced vaccine technologies and fewer liability concerns.
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