Hepatitis B Vaccine

Sayenna Uduman, Dr. M.I. Sahadulla, Dr. Raja Lakshmi, Dr. Abdul Kareem Uduman
Hepatitis B Vaccine - Introduction
Hepatitis B virus (HBV) infection has been identified as a major public health problem worldwide and in India. A safe and effective vaccine to prevent from Hepatitis B (HepB) diseases is available for nearly 3 decades. The vaccine was first introduced in mid-1980 and became part of the recommended immunization schedule in the United States in early 1990’s. Since then, the incidence of acute HepB has dropped by more than 95 percent in children and adolescents, and by more than 75 percent overall. At the global level, the epidemiology of the HBV is changing rapidly, as vaccination programs become the standard of health care. Of the 2.6 crore (26 million) infants born annually in India, approximately 10 lakh (one million) run a life time risk of developing chronic HBV infections. Nearly 170 World Health Organization (WHO) member countries have adopted a national policy of immunizing all infants at birth. Universal vaccination beginning at birth has been very effective in preventing perinatal transmission and reducing early viral exposures and the development of chronic HepB infection in children and adults.
The world’s first recombinant (r) HepB vaccine produced in single-antigen (HBsAg) formulation by recombinant DNA technology has been in use since 1986. The monovalent vaccines contain 10 to 40 µg of HBsAg protein/mL, and a completed 3-dose vaccination schedule at 0 - 1 and 6 months, results in minimum protective level of anti-HBs of at least 10 mIU/mL in most recipients, which provides long-term protection. Outside the US, other levels of antibody may be used to determine immunity. Although the concentration of rHBsAg protein differs among vaccine products, rates of seroprotection are probably equivalent when given to immunocompetent infants, children, adolescents, or young adults in the doses recommended.
In the United States, two monovalent vaccines being used continually over 3 decades, to prevent HepB infection among infants, children and adults; these vaccines are manufactured using recombinant technology and neither contains blood products. Recently CDC approved 3 other combination (Combo’s) vaccines for use beyond neonatal age groups. (Table-1).

Table -1: CDC & ACIP approved HepB vaccines & doses of both monovalent and combo’s vaccines.
Patients age & clinical backgrounds # Monovalent
Engerix-B Dose,µg (mL); GSK
# Monovalent
Recombivax HB Dose, µg (mL); Merck
Comvax* Dose, µg (mL) .Merck & co
Combo’sPediarix** Dose, µg/mL GSK Combo’sTwinrix @ Dose, µg (mL)f
Infants, children and adolescents < 20 y 10 (0.5) 5 (0.5) 5 µg HBsAg (0.5) 10 µg HBsAg (0.5) Not applicable
Infants of HBsAg-positive mothers (HBIG [0.5 mL] also is recommended) 10 (0.5) 5 (0.5) 5 µg HBsAg (0.5) 10 µg HBsAg (0.5) Not applicable
Adolescents 11–15 y of age Not applicable 10 (1) Not applicable Not applicable Not applicable
Adults 20 y or older 20 (1) 10 (1) Not applicable Not applicable 20 (1)
Adults undergoing dialysis and other immunosuppressed adults 40 (2) 40 (1) Not applicable Not applicable Not applicable
Note: Single-dose (including pediatric) formulations contain no thimerosal as a preservative

#Engerix-B (GSK) has been in use in India over a decade. # Both monovalent vaccines are administered in a 3-dose schedule at 0, 1, and 6 months.

*Comvax: is a combination of HepB (Recombivax, 5 µg) and Haemophilus influenzae type b (PRP-OMP) vaccine is approved for use at 2, 4, and 12 through 15 months of age. This combo vaccine should not be administered at birth, before 6 weeks of age, or after 71 months of age.

**Pediarix: is a combination of diphtheria and tetanus toxoids and acellular pertussis (DTaP), injectable poliovirus (IPV), and HepB (Engerix-B 10 µg) is approved for use at 2, 4, and 6 months of age. This vaccine should not be administered at birth, before 6 weeks of age, or at 7 years of age or older.

@Twinrix: is combination of HepB (Engerix-B, 20 µg) and hepatitis A (Havrix, 720 enzyme-linked immunosorbent assay units [ELU]) vaccine; Licensed for use in people 18 years of age and older in a 3-dose schedule at 0, 1, and 6 months. Alternately, a 4-dose schedule at days 0, 7, and 21 to 30 followed by a booster dose at 12 months may be used.

In India, the HepB vaccines are of public health importance and government has initiated since the year 2002 with further expansion in a phased manner. The available and the marketed monovalent brands are many, over 20 commercial products, with an affordable price ranges & may be equally immunogenic despite recombinant sAg component differences. Interchange of brands is permitted but not routinely recommended. The national policy in India recommends that children receive 3 doses including a birth dose for all new-born's (within 24 h of delivery), for all institutional deliveries. (Table-2)

Table 2: Three doses - childhood Immunization schedules (monovalent HepB vaccine); US-ACIP & India-ACVIP
Recommended schedule Birth dose 2 Mon 4 Mon 6 Mon 9 Mon 12 Mon 15 Mon 18 Mon Comments
*ACIP, CDC (2016 ) 1st 2nd     3rd
    3 doses monovalent schedules : birth – 2 mon and 3rd at 9 through 12 months
@IAP , ACVIP (2014) 1st 2nd at 6 wk. of age   3rd
3rd 3rd 3rd 3rd
3 doses monovalent schedules : birth – 6 wk. -3rd at 6 through 18 months
*ACIP- Advisory Committee on Immunization Practices; @ACVIP - Advisory Committee on Vaccines & Immunization Practices (IAP)

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