American Academy of Pediatrics Hepatitis B Vaccination Recommendations
Universal Birth Dose Recommendation
All medically stable infants weighing >2,000 g should receive the first dose of hepatitis B vaccine within 24 hours of birth, regardless of maternal HBsAg status. 1 This represents a critical shift from the earlier "before hospital discharge" recommendation to emphasize the importance of early protection against perinatal transmission. 1
- Only single-antigen hepatitis B vaccine should be used for the birth dose. 1
- The birth dose should be administered before hospital discharge as standard care in all delivery hospitals. 1
- This timing achieves up to 90% effectiveness in preventing perinatal infection when given within the first 24 hours. 2
Complete Vaccination Series
All infants should receive a complete 3-dose hepatitis B vaccine series as part of the routine childhood immunization schedule. 1
Standard Schedule for Infants Born to HBsAg-Negative Mothers:
- Dose 1: Within 24 hours of birth (before hospital discharge) 1
- Dose 2: At 1-2 months of age (typically at the 2-month well visit) 1, 3
- Dose 3: At 6-18 months of age 1
- The final dose must not be administered before 24 weeks (164 days) of age. 1
Four-Dose Series Permissible:
- Administration of 4 doses is acceptable when combination vaccines are used after the birth dose. 1
Special Populations Requiring Modified Approach
Infants Born to HBsAg-Positive Mothers:
These infants require both hepatitis B vaccine AND hepatitis B immune globulin (HBIG) within 12 hours of birth. 1
- Administer single-antigen hepatitis B vaccine and HBIG (0.5 mL) at different injection sites within 12 hours. 1
- Complete the series at 1-2 months and 6 months of age. 1
- Critical: Postvaccination testing for anti-HBs and HBsAg must be performed at 9-18 months of age. 1
- Breastfeeding may begin immediately after birth despite maternal HBsAg-positive status. 1
Preterm Infants (<2,000 g) Born to HBsAg-Negative Mothers:
Delay the first vaccine dose until 1 month after birth or hospital discharge. 1
- The rationale is potentially reduced immunogenicity in very low birth weight infants. 1
- Document maternal HBsAg-negative status clearly in the infant's medical record. 1
Preterm Infants (<2,000 g) Born to HBsAg-Positive or Unknown Status Mothers:
Administer both vaccine and HBIG within 12 hours of birth, but do not count the birth dose toward the series. 1
- These infants require 4 total doses (birth dose plus 3 additional doses starting at 1 month). 1, 3
- This accounts for reduced vaccine response in preterm infants while ensuring immediate protection. 1
Infants Born to Mothers with Unknown HBsAg Status:
Administer hepatitis B vaccine (without HBIG) within 12 hours of birth while maternal testing is pending. 1
- Draw maternal blood for HBsAg testing immediately upon admission for delivery. 1
- If mother tests HBsAg-positive, administer HBIG to infant as soon as possible but no later than 7 days of age. 1
- If mother tests HBsAg-negative, complete series per standard schedule. 1
- For preterm infants <2,000 g with unknown maternal status, give both vaccine and HBIG within 12 hours. 1
Catch-Up Vaccination for Older Children
All children and adolescents aged <19 years who were not previously vaccinated should be vaccinated with an age-appropriate dose and schedule. 1
- Children aged 11-12 years should have immunization records reviewed and complete the series if not previously vaccinated. 1
- High priority populations: Children born in or with parents from Asia, Pacific Islands, Africa, or other high-endemic regions should have records reviewed and series completed. 1
- States are encouraged to require hepatitis B vaccination for middle school entry. 1
Implementation Standards for Delivery Hospitals
All delivery hospitals must implement standing orders for hepatitis B vaccination as routine medical care. 1
- Hospitals should enroll in the Vaccines for Children (VFC) program to obtain free vaccine for eligible newborns. 1
- Document maternal HBsAg test results, infant vaccine administration, and HBIG administration (if given) in the infant's medical record. 1
- Establish policies ensuring all pregnant women are tested for HBsAg during each pregnancy. 1
Common Pitfalls to Avoid
Never Delay Birth Dose for Low-Risk Infants:
- The birth dose may only be delayed on a case-by-case basis in rare circumstances for infants >2,000 g born to documented HBsAg-negative mothers. 1
- Never delay if the mother has high-risk behaviors (multiple sex partners, STD treatment, injection drug use) or if poor follow-up compliance is expected. 1
- If delayed, the first dose must be given no later than 2 months of age. 1
Do Not Confuse Maternal Status Categories:
- The thimerosal controversy in 1999 led to significant decreases in birth-dose coverage for infants born to mothers with unknown HBsAg status (from 53% to 7%), demonstrating how recommendation changes for low-risk infants can inadvertently harm high-risk infants. 4
- Always verify maternal HBsAg status rather than assuming negative status. 1
Preterm Infant Dosing Errors:
- For preterm infants <2,000 g born to HBsAg-positive mothers, the birth dose does NOT count toward the series—they need 4 total doses. 1, 3
- Failing to administer the additional doses compromises protection in this vulnerable population. 1
Timing of Final Dose:
- The final dose must not be given before 24 weeks (164 days) of age to ensure adequate long-term immunity. 1, 5
Expected Immunogenicity
- Approximately 95-100% of healthy infants and children achieve protective antibody levels (≥10 mIU/mL) after completing the 3-dose series. 6, 7
- Vaccine-induced immunity persists for at least 10-30 years in immunocompetent individuals. 6, 5
- Routine post-vaccination serologic testing is NOT recommended for healthy children, even those who are household contacts of HBsAg-positive individuals. 6