Hepatitis B

Healthcare workers, travelers to endemic areas, newborns, people with multiple sexual partners.

Pregnancy: Safe and recommended when indicated.

Hepatitis B vaccine is a recombinant (non-infectious) vaccine and is safe during all trimesters of pregnancy.

• WHO and CDC recommend vaccination for pregnant women at risk of HBV infection.

• Neonatal hepatitis B prevention: if the mother is HBsAg-positive, the neonate must receive HBIG + first vaccine dose within 12 hours of birth.

• No teratogenic or fetotoxic effects observed in extensive post-marketing surveillance.

• Standard 3-dose schedule can be initiated or continued during pregnancy.

Breastfeeding: Safe — no restrictions.

Hepatitis B vaccine is a recombinant, non-infectious vaccine and is completely safe during breastfeeding. No vaccine components are excreted in breast milk in clinically significant amounts. No modification to breastfeeding or vaccination schedule is required.

Pediatric use:

• Birth dose recommended by WHO within 24 hours of birth (universal).

• Pediatric dose: 5–10 µg depending on formulation (half the adult dose).

• Schedule: birth, 1, 6 months (or as part of hexavalent combination vaccines).

• Preterm infants (<2000 g): may have reduced response to birth dose — repeat 3-dose series starting at 1 month of chronological age.

• Anti-HBs testing 1–2 months after series completion recommended for infants born to HBsAg-positive mothers.

• Seroprotection rate (anti-HBs ≥10 mIU/mL): >95% in healthy infants after complete series.

Geriatric use:

• Immune response decreases with age: seroprotection rates are 75–90% in adults >40 years and may be lower in ≥60 years.

• Higher dose (40 µg) or additional doses may be required for elderly non-responders.

• Check anti-HBs 1–2 months after series completion to verify seroprotection (≥10 mIU/mL).

• Heplisav-B (adjuvanted, 2-dose schedule) achieves higher seroprotection rates in older adults compared to standard formulations.

• No dose adjustment for standard formulations in the absence of other risk factors (renal insufficiency, immunosuppression).