ENGERIX-B

What it is

ENGERIX-B is a hepatitis B surface antigen recombinant (yeast) vaccine suspension for injection. The paediatric dose contains 10 micrograms of hepatitis B surface antigen in a 0.5 mL dose, while the adult formulation contains 20 micrograms in a 1 mL dose. The antigen is produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology and is adsorbed on aluminium hydroxide hydrate. ENGERIX-B is highly purified and meets the WHO requirements for recombinant hepatitis B vaccines.

Approved indications

— Active immunisation against hepatitis B virus infection

Dosing overview

The vaccine can be administered from birth onwards. For adults and adolescents older than 19 years, a dose of 20 µg of antigen protein in 1 mL is recommended in a 0, 1, 6 month schedule. In adolescents from 10 to 19 years of age, a 10 µg dose is recommended in the 0, 1, 6 month schedule, provided immunisation will ensure compliance to the full vaccination course. The 20 µg vaccine can also be used in participants from 11 to 15 years of age in a 0 and 6 month schedule in situations with relatively low risk of hepatitis B infection during the vaccination course and when compliance with the complete vaccination course can be anticipated. For neonates, infants and children below 10 years of age, a dose of 10 µg of antigen protein in 0.5 mL suspension is recommended in a 0, 1, 6 months schedule. Chronic adult haemodialysis patients or patients with impaired renal function 16 years of age and above require four doses of 40 µg. The 40 µg dose may be administered as 2 × 20 µg in one injection site or in each arm.

Key safety warnings

As with all injectable vaccines, appropriate medical treatment such as adrenaline and supervision should always be readily available in case of anaphylactic reactions following vaccine administration. The vaccine should never be administered intravenously. ENGERIX-B should not be administered in the gluteal region or intradermally or subcutaneously since these routes of administration may not result in an optimum immune response. The immune response to hepatitis B vaccines is related to factors including route of administration, age over 40 years, male gender, obesity, and smoking habits. Individuals in these groups may respond less optimally to hepatitis B vaccines, and administration of additional vaccine doses may be considered. In dialysis patients, HIV infected patients and participants who have impairment of the immune system, adequate antibody concentrations may not be obtained after the recommended primary vaccination course. When administering the primary immunisation series to very premature infants born at or before 28 weeks of gestation, the potential risk of apnoea and the need for respiratory monitoring for 48–72 hours should be considered. However, as the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Contraindications

ENGERIX-B should not be administered to participants with known hypersensitivity to any component of the vaccine, or to participants having shown signs of hypersensitivity after previous ENGERIX-B administration. ENGERIX-B should not be administered to participants with severe febrile infections. However, the presence of minor infections without fever does not contraindicate vaccination. HIV infection is not considered a contraindication to hepatitis B vaccination.

PBS listing

In July 2018, ENGERIX-B was recommended for temporary listing as a designated vaccine under Section 9B of the National Health Act 1953 for hepatitis B virus infection in adolescents and adults due to shortage of the NIP listed adult formulation of H-B-Vax II. The listing was cost neutral and ENGERIX-B was sufficiently interchangeable with H-B-VAX II.

Regulatory history

ENGERIX-B 20 microgram/1 mL injection syringe (ARTG 123713) was first listed on 24 July 2006, while ENGERIX-B PAEDIATRIC DOSE 10 microgram/0.5 mL injection syringe (ARTG 123712) was also first listed on 24 July 2006. In July 2018, the Pharmaceutical Benefits Advisory Committee recommended ENGERIX-B as a new temporary listing for hepatitis B virus infection in adolescents and adults as a designated vaccine under Section 9B of the National Health Act 1953, due to shortage of the NIP listed adult formulation.