What is the recommended schedule for hepatitis B (HBV) vaccination according to the Indian guideline?

Indian Hepatitis B Vaccination Schedule

In India, the recommended hepatitis B vaccination schedule includes a birth dose given as early as possible after birth (preferably within 24 hours for all institutional deliveries), followed by three additional doses at 6,10, and 14 weeks of age, administered concurrently with DPT and OPV vaccines. 1

Standard Schedule for Indian Infants

The Indian National Immunization Schedule follows a specific timing pattern that differs from some international recommendations:

• Birth dose: Administered as early as possible after birth, preferably within 24 hours for all institutional deliveries, as this is highly effective in preventing perinatal transmission of hepatitis B 1
• Three subsequent doses: Given at 6,10, and 14 weeks of age, administered at the same time as DPT and OPV vaccines 1, 2

This schedule has been validated in Indian populations, with studies demonstrating 98-99% seroconversion rates and 94-96% seroprotection rates when vaccines are administered at 6,10, and 14 weeks 2

Alternative Birth Dose Schedule

An alternative schedule that has been studied in India includes:

• Birth dose (0 weeks)
• Second dose at 6 weeks
• Third dose at 14 weeks 3

This 0,6, and 14-week schedule demonstrated comparable sero-efficacy to the 6,10, and 14-week schedule, with 100% seroconversion in both groups and >94% seroprotection rates 3

Critical Implementation Considerations

The birth dose is particularly crucial in the Indian context, where an estimated 25 million infants are born annually, with over one million running lifetime risk of developing chronic HBV infection 1. Despite high institutional delivery rates (79%), birth-dose coverage was only 45% in 2015, highlighting a significant implementation gap 4

Key Points for Birth Dose Administration:

• The birth dose should be given regardless of whether subsequent doses follow the 6,10,14-week schedule 1
• For infants born to HBsAg-positive mothers, the birth dose must be given within 12 hours along with HBIG at a separate anatomical site 5
• WHO/SAGE recommendations suggest administering the birth dose up to 7 days after birth should be incorporated into the National Immunization Schedule to improve coverage 4

Special Populations in India

Infants Born to HBsAg-Positive Mothers:

• First dose plus HBIG: Within 12 hours of birth at separate injection sites 5
• Second dose: At 1-2 months of age 5
• Third dose: At 6 months of age 5
• Post-vaccination serologic testing should be performed at 9-15 months of age for HBsAg and anti-HBs 6

Infants Born to Mothers with Unknown HBsAg Status:

• Administer hepatitis B vaccine within 12 hours of birth 5
• Draw maternal blood for HBsAg testing immediately 5
• If mother tests positive, administer HBIG as soon as possible, no later than 7 days of birth 5

Common Pitfalls to Avoid

• Do not delay the birth dose beyond 24 hours for institutional deliveries, as this significantly increases infection risk, particularly for infants born to HBsAg-positive mothers 6, 1
• Do not skip the birth dose even if planning to give subsequent doses at 6,10, and 14 weeks—the birth dose provides critical early protection 1
• Do not restart the series if interrupted—simply continue where you left off, maintaining minimum intervals of 4 weeks between doses 1 and 2, and 8 weeks between doses 2 and 3 6, 7
• Ensure proper spacing: The minimum interval between first and third doses must be at least 16 weeks 6, 7

Vaccine Immunogenicity in Indian Population

Studies conducted in India demonstrate that both locally manufactured vaccines (GeneVac-B) and international vaccines (Engerix-B) are highly immunogenic when administered at 6,10, and 14 weeks, with geometric mean titers of 229 and 167 mIU/mL respectively 2. The vaccines are well-tolerated when co-administered with DPT vaccine, with most adverse events being mild and transient 2