Hepatitis A, Inactivated, Whole Virus

What it is and how it works

The vaccine contains formaldehyde-inactivated hepatitis A virus grown in cell culture and adsorbed onto an aluminium adjuvant. It induces neutralising anti-HAV antibodies, with protective levels in most recipients within 2–4 weeks of the first dose; a booster dose produces long-lasting immunity.

Indications

Active immunisation against hepatitis A in individuals at risk, including travellers to areas of high or intermediate endemicity, people with chronic liver disease, men who have sex with men, people who inject drugs, those at occupational risk, and for outbreak control and post-exposure prophylaxis.

Dosage and administration (summary)

Adults: a single intramuscular dose (adult formulation) into the deltoid, followed by a booster dose 6–12 months later (timing according to the product); paediatric formulations are used in children according to the national schedule.

Contraindications

Hypersensitivity to any component of the vaccine (including traces such as neomycin or formaldehyde) or a severe reaction to a previous dose; postpone in acute severe febrile illness.

Warnings and precautions

Facilities for treating anaphylaxis must be available. Immunosuppressed patients and those on haemodialysis may have a reduced antibody response; the vaccine should be given subcutaneously only where intramuscular injection is unsuitable (e.g. bleeding disorders), and it does not protect against other hepatitis viruses.

Pregnancy

Data are limited, but as an inactivated vaccine it may be used in pregnancy when there is a clear risk of infection.

Storage and supply

Store refrigerated at 2–8 °C; do not freeze; protect from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.