Hepatitis Vaccines Available in India
In India, the available hepatitis vaccines include Hepatitis B vaccines (Recombivax HB, Engerix-B) and Hepatitis A vaccines (Havrix), as well as the combination vaccine Twinrix that protects against both Hepatitis A and B. 1
Hepatitis B Vaccines
- Hepatitis B vaccines available in India are recombinant DNA vaccines containing HBsAg produced in yeast, administered intramuscularly 1
- Single-antigen formulations include Recombivax HB and Engerix-B, which are used for vaccination starting from birth 1
- These vaccines provide protection from HBV infection when used for both pre-exposure vaccination and post-exposure prophylaxis 1
- The recommended dosing schedule varies by product and age, with three different 3-dose schedules approved for adolescents and adults: 0,1, and 6 months; 0,1, and 4 months; or 0,2, and 4 months 1
- A 2-dose schedule of Recombivax HB adult formulation (10 μg) is licensed for adolescents aged 11-15 years, with a 4-month minimal interval between doses 1
Hepatitis A Vaccines
- Hepatitis A vaccines available in India are inactivated, whole-cell virus vaccines that contain aluminum hydroxide as an adjuvant 1, 2
- Havrix is available in two formulations: a pediatric/adolescent dose (720 ELU in 0.5 mL) for ages 12 months to 18 years, and an adult formulation (1440 ELU in 1 mL) 1, 3
- These vaccines are administered intramuscularly into the deltoid muscle 2
- None of the hepatitis A vaccines licensed in India contain thimerosal 1, 2
- Within 1 month of receiving the first dose, 97% of children/adolescents and 95% of adults develop protective antibody levels 2
- After completing the recommended two-dose schedule, virtually 100% of individuals are protected against hepatitis A infection 2, 3
Combination Vaccine (Hepatitis A and B)
- Twinrix is a combination vaccine that provides protection against both hepatitis A and B viruses 1
- It contains recombinant HBsAg (20 μg) and inactivated hepatitis A virus (720 ELU) 1, 4
- Twinrix is administered on a 0-, 1-, and 6-month schedule 4, 5
- The vaccine has been shown to be safe and highly immunogenic in Indian children 6
- At month 7 (one month after the final dose), 100% of subjects develop protective antibody levels against both hepatitis A and B 6, 5
- Antibodies to both HAV and HBV surface antigen have been demonstrated to persist for at least 4 years after the first vaccine dose in a 3-dose series 4
Storage Requirements
- All hepatitis vaccines should be stored and shipped at temperatures ranging from 2°C to 8°C (35.6°F to 46.4°F) 2, 4
- The vaccines should not be frozen, and should be discarded if they have been frozen 2, 4
Considerations for Vaccination in India
- Hepatitis A is endemic in India, with changing epidemiology showing increased susceptibility among children 7
- Studies have shown that almost 50% of children aged 1-5 years in India may be susceptible to HAV 7
- While hepatitis vaccines are available in India for those who can afford them, there have been recommendations to include hepatitis A vaccine as a priority in the national immunization schedule 7
- The combination vaccine Twinrix has been shown to be safe and highly immunogenic specifically in Indian children, making it a viable option for protection against both viruses 6