Document text
VFC Resolution Update: Hepatitis B Vaccine
December 4, 2025National Center for Immunization & Respiratory Diseases
•Red font in the presentation is used to indicate changes to the resolution in
comparison to the currently approved version.Note
•The purpose of this resolution is to update the Recommended Vaccination
Schedule and Intervals section to reflect updated ACIP recommendations
about the use of Hepatitis B vaccine. Purpose of the Resolution
• All children and adolescents birth through 18 years of age. Eligible Groups
The tables below list the acceptable vaccination schedules for children and
adolescents, birth through 18 years of age.
Table 1. InfantsRecommended Vaccination Schedule and Intervals (1)
Single antigen vaccine1Single -antigen1and combination
vaccine2,3,4
Birth
weight Maternal
HBsAg status Dose Age Dose Age
≥2000 g Positive 1 B irth (≤12 hrs)11 B irth (≤12 hrs )1
2 1-2 months12 2 months
3 6 months 3 4 months
4 6 months
Unknown 1 B irth (≤12 hrs)1 1 B irth (≤12 hrs)1
2 1-2 months12 2 months
3 6 months 3 4 months
4 6 months
Negative51 2 months 1 2 months
2 3-4 months 2 4 months
3 6 -18 months 3 6 months
The tables below list the acceptable vaccination schedules for children and
adolescents, birth through 18 years of age.
Table 1. InfantsRecommended Vaccination Schedule and Intervals (2)
Single antigen vaccine1Single -antigen1and combination
vaccine2,3,4
Birth
weight Maternal
HBsAg
status Dose Age Dose Age
<2000 g Positive 1 Birth (≤12 hrs)1 1 B irth (≤12 hrs)1
2 1 month1 2 2 months
3 2-3 months 3 4 months
4 6 months 4 6 months
Unknown 1 B irth (≤12 hrs)1 1 B irth (≤12 hrs)1
2 1 month1 2 2 months
3 2-3 months 3 4 months
4 6 months 4 6 months
Negative51 2 months 1 2 months
2 3-4 months 2 4 months
3 6 -18 months 3 6 months
Table Notes:
1. Only a single antigen hepatitis B vaccine (ENGERIX -B or RECOMBIVAX HB) can be given at <6 weeks of age.
2. Pediarix [DTaP -IPV-HepB] is licensed for children 6 weeks through 6 years of age. For adequate immune response, the
last dose of hepatitis B vaccine should be given >24 weeks of age and therefore this combination vaccine should not be
administered as a complete primary series on an accelerated schedule at 4- week intervals for prevention of pertussis.
3. Vaxelis [DTaP -IPV-Hib-HepB ] is licensed for children 6 weeks through 4 years of age. For adequate immune response,
the last dose of hepatitis B vaccine should be given >24 weeks of age and therefore this combination vaccine should
not be administered as a complete primary series on an accelerated schedule at 4- week intervals for prevention of
pertussis.
4. Use of brand names is not meant to preclude the use of other comparable US licensed vaccines.
5. Infants born to HBsAg -negative mothers may receive a dose of hepatitis B vaccine before two months of age under
individual-based decision -making (also referred to as shared clinical decision -making), including consideration of risks
such as a household member who is HBsAg positive or when there is frequent contact with persons who have
emigrated from areas where Hepatitis B is common. Infants vaccinated before two months of age under individual-
based decision -making may receive up to four doses of hepatitis B vaccine (1 dose of single antigen vaccine followed
by 3 doses of combination vaccine). Recommended Vaccination Schedule and Intervals (3)
Table 2. Children and AdolescentsRecommended Vaccination Schedule and Intervals (5)
Age Schedule1,6
Children
(1 through 10 years)0, 1, and 6 months2
0, 2, and 4 months2
0, 1, 2, and 12 months2,4
Adolescents (11 through 18 years)0, 1, and 6 months
2
0, 1, and 4 months2
0, 2, and 4 months2
0, 12, and 24 months2
0 and 4 -6 months3
0, 1, 2, and 12 months2,4
0, 7 days, 21 -30 days, 12 months5
Table Notes:
1.Children and adolescents not vaccinated at birth may be vaccinated according to any of the
schedules indicated, except as noted. Selection of a schedule should consider the need to optimize
compliance with vaccination.
2.Pediatric/adolescent formulation.
3.A two -dose schedule of Recombivax -HB Adult Formulation is (10 micrograms) is licensed for
adolescents aged 11 through 15 years. When scheduled to receive the second dose, adolescents
aged > 15 years should be switched to a three -dose series, with doses 2 and 3 consisting of the
pediatric formulation administered on an appropriate schedule.
4.A four -dose schedule of Engerix B is licensed for all age groups.
5.Twinrix can be administered to persons 18 years of age before travel or any other potential
exposure on an accelerated schedule at 0, 7, and 21 -30 days, followed by a dose at 12 months.
6.Use of brand names is not meant to preclude the use of other comparable US licensed vaccines. Recommended Vaccination Schedule and Intervals (6)
Interrupted schedules and minimum dosing intervals
•When the HepB vaccine schedule is interrupted, the vaccine series does not need to be restarted. If
the series is interrupted after the first dose, the second dose should be administered as soon as
possible, and the second and third doses should be separated by an interval of at least eight weeks.
If only the third dose has been delayed, it should be administered as soon as possible.
•The final dose of vaccine must be administered at least eight weeks after the second dose and should
follow the first dose by at least 16 weeks; the minimum interval between the first and second doses
is four weeks. Inadequate doses of hepatitis B vaccine or doses received after a shorter -than
recommended dosing interval should be re -administered, using the correct dosage or schedule.
•Vaccine doses administered ≤4 days before the minimum interval or age are considered valid. Because of the unique accelerated schedule for Twinrix , the four -day guideline does not apply to the
first three doses of this vaccine when administered on a 0 day, 7 day, 21 -30 day, and 12 month
schedule.
•In infants, administration of the final dose is not recommended before age 24 weeks (164 days). Recommended Vaccination Schedule and Intervals (7)
Revaccination
Revaccination (i.e., booster dose, challenge dose, or revaccination with a complete series) is not
generally recommended for persons with a normal immune status who were vaccinated as infants,
children, or adolescents. Revaccination when anti -HBs is <10 mIU/mL is recommended for the following:
-Infants born to HBsAg -positive mothers . HBsAg -negative infants with anti -HBs <10 mIU/mL
should be re -vaccinated with a single dose of HepB vaccine and receive post vaccination serologic
testing 1 -2 months later. Infants whose anti -HBs remains <10 mIU/mL following single dose
revaccination should receive two additional doses of HepB vaccine, followed by PVST 1 -2 months
after the final dose.
•Based on clinical circumstances or family preference, HBsAg -negative infants with anti -HBs
<10 mIU/mL may instead be revaccinated with a second, complete 3 -dose series, followed
by post vaccination serologic testing (PVST) performed 1 -2 months after the final dose of
vaccine.
-Hemodialysis patients . For hemodialysis patients, the need for booster doses should be assessed
by annual anti -HBs testing. A booster dose should be administered when anti -HBs levels decline to
<10 mIU/mL.Recommended Vaccination Schedule and Intervals (8)
Revaccination
-Other immunocompromised persons . For other immunocompromised persons (e.g., HIV -infected
persons, hematopoietic stem -cell transplant recipients, and persons receiving chemotherapy), the
need for booster doses has not been determined. When anti -HBs levels decline to <10 mIU/mL,
annual anti -HBs testing and booster doses should be considered for persons with an ongoing risk
for exposure.
-Persons with postvaccination serologic testing results that do not demonstrate protection . This
includes children and adolescents through age 18 years who are chronic hemodialysis patients,
HIV-infected, otherwise immunocompromised (e.g., hematopoietic stem -cell transplant recipients
or persons receiving chemotherapy), or sex partners of HBsAg -positive persons. Persons in these
groups found to have anti -HBs concentrations of <10 mIU/mL after the primary vaccine series
should be revaccinated. Recommended Vaccination Schedule and Intervals (9)
Recommended dosage
Refer to package inserts available at: Vaccines Licensed for Use in the United
States | FDA
Contraindications and Precautions
Contraindications can be found in the package inserts available at: Vaccines
Licensed for Use in the United States | FDADosage, Contraindications, Precautions
•[If an ACIP recommendation or notice regarding hepatitis B vaccination
immunization is published within 6 months following this resolution, the
relevant language above (except in the eligible groups sections) will be
replaced with the language in the recommendation and incorporated by
reference to the publication URL.]Statement Regarding Update Based on Published Documents