Hepatitis B Vaccine is used for active immunization against infections caused by all known subtypes of the Hepatitis B virus. Since Hepatitis D (delta virus) cannot occur without Hepatitis B infection, vaccination against Hepatitis B also helps prevent Hepatitis D.

Immunization is recommended for people of all age groups, particularly those who are at increased risk of exposure to the Hepatitis B virus, such as:

A newborn whose mother is infected at birth. Children, adolescents, and adults may become infected through:

• Contact with blood or body fluids entering the body through cuts, wounds, or bites
• Contact with contaminated objects such as toothbrushes, razors, or medical devices used for diabetes
• Unprotected sexual contact with an infected person
• Sharing needles during drug use
• Accidental needle-stick injuries
• Household contact with infected individuals
• Residents and staff of institutions for the developmentally disabled
• Patients undergoing kidney dialysis
• Travelers to regions where Hepatitis B is common
• People living with HIV infection
• Individuals with hemophilia, thalassemia, sickle cell anemia, or cirrhosis

Military personnel at increased risk
Morticians and embalmers
Prisoners
Users of injectable illicit drugs
Other at-risk groups such as police, firefighters, first aid providers, and anyone whose occupation or lifestyle increases exposure risk.

Hepatitis B Vaccine is a non-infectious recombinant DNA vaccine. It is a sterile suspension containing purified hepatitis B surface antigen (HBsAg), produced by culturing genetically engineered yeast cells (Saccharomyces cerevisiae) that carry the gene responsible for HBsAg production. The HBsAg protein expressed in these yeast cells is purified through multiple physicochemical processes and formulated as a suspension adsorbed onto aluminium hydroxide. No materials of human origin are used in the manufacturing of this vaccine.

Each 0.5 ml dose contains more than 10 mcg of hepatitis B surface antigen adsorbed on aluminium hydroxide gel equivalent to 0.25 mg aluminium.

Each 1 ml dose contains more than 20 mcg of hepatitis B surface antigen adsorbed on aluminium hydroxide gel equivalent to 0.5 mg aluminium.

Neonates, infants and children upto 19 years of age: The recommended dose of Hepatitis B vaccine (rDNA) is ≥10 mcg of antigen protein in 0.5 ml.

Adults 19 years of age and older: The recommended dose of Hepatitis B vaccine (rDNA) is ≥20 mcg of antigen in 1 ml.

Primary immunization schedule for all ages:
The usual immunization schedule consists of 3 doses of vaccine-
• First dose: at elected date
• Second dose: 1 month after first dose
• Third dose: 6 months after first dose

or accelerated schedule consists of 4 doses of vaccine-
• First dose: at elected date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 12 months after first dose

Accelerated schedule confer protection more quickly and is expected to provide better patient compliance.

Neonate born to hepatitis B surface antigen-positive mother, 4 doses of 10 micrograms:
• First dose: at birth with Hepatitis B immunoglobulin injection (separate site)
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 12 months after first dose

Travellers departing within 1 month, adult over 18 years,
• First dose: at elected date
• Second dose: 7 days after first dose
• Third dose: 21 days after first dose
• Fourth dose: 12 months after first dose

Renal insufficiency (including haemodialysis patients), adult and child over 16 years 4 doses of 40 micrograms:
• First dose: at the appropriate date
• Second dose: 1 month after first dose
• Third dose: 2 months after first dose
• Fourth dose: 6 months after first dose

Immunization schedule and booster doses may need to be adjusted in those with low antibody concentration.

Booster vaccinations: For persons with normal immune status who have been vaccinated, booster doses of Hepatitis B vaccine has not been established. However, booster doses are recommended for hemodialysis patients or other immunocompromised persons.

Method of administration: Hepatitis B Vaccine is for intramuscular injection only. Do not inject intravenously. Hepatitis B Vaccine should be given intramuscularly in the deltoid muscle of adult and children or in the anterolateral aspect of thigh in children under 1 year.

Preparation for administration: The vaccine should be shaken well before use to obtain a homogenous turbid white suspension. Do not shake vigorously. The vaccine should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered. The vaccine should be used as supplied; no dilution is necessary.

Co-administration: Hepatitis B vaccine can be given at the same time with other vaccines as Diphtheria, Tetanus, Pertussis (DTP), Polio (OPV), Measles, Mumps and Rubella (MMR), Haemophilus influenzae B, Hepatitis A and BCG vaccines at separate sites and with separate syringes. It should not be mixed with other vaccines or medicinal products in the same syringe.

Hypersensitivity to any ingredient of the vaccine, including yeast, is a contraindication. This vaccine should not be given to individuals who have previously shown hypersensitivity reactions to any Hepatitis B containing vaccine.

Hepatitis B vaccine is generally well tolerated. Most individuals may experience mild to moderate reactions after vaccination, which are usually short-lasting. These commonly include local reactions at the injection site such as redness, swelling, and tenderness. Less frequently, systemic reactions such as malaise, headache, diarrhea, vomiting, muscle pain, and fever may occur. In very rare cases, allergic reactions such as itching, rash, or urticaria may be observed.

The effects of Hepatitis B vaccine on fetal development and reproductive capacity have not been fully studied. It should therefore be used during pregnancy only when there is a significant risk of infection. There is limited data regarding its use during breastfeeding, and adequate animal studies are not available. It should be administered to nursing mothers only if clearly necessary.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the reach and sight of children. Store at a temperature between +2°C and +8°C. Transportation should also be maintained within +2°C to +8°C. Protect from light. Do not freeze.