Hepatitis A is an acute liver disease caused by the Hepatitis A Virus (HAV). It is usually spread by close personal contact and by eating food or drinking water that contains HAV. The incubation period of acute Hepatitis A is usually 14–28 (up to 50) days. The clinical outcome is strongly correlated with age: while young children usually have asymptomatic infection, older children and adults commonly experience symptomatic disease.

• IAP recommended Hepatitis A Vaccine is used for long-term prevention of HAV infection in people who are one year old or older.

• WHO recommends vaccination against HAV for children aged ≥ 1 year.

Hepatitis A Vaccine should be kept and transported at a temperature +2°C to +8°C in a dark place. Do not use vaccine beyond the expiration date.

BIOVAC A: Pack of 0.5 ml vial of BIOVAC A along with 0.5 ml ampoule of sterile water for injection.

• Parenteral biological products should be inspected visually for extraneous particulate matter and/or discolouration before administration.

• If these conditions exist, the product should not be administered.

• Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.

• Administer the vaccine subcutaneously. The preferred site is over the deltoid muscle. Do not administer over the buttocks.

• After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel. Do not inject intravenously.

Adverse events to Hepatitis A vaccine are usually mild and one would need to rest for a few days post vaccination for spontaneous recovery.

Local

• Pain at the site of injection

• Redness

• Swelling, Hematoma, Induration/Edema

• Pruritus

If treatment is needed, relevant treatment may be given.

Systemic

• Fever (>37.5°C axillary)

• Asthenia/Drowsiness

• Headache, Myalgia/Arthralgia

• Gastrointestinal disorders

• Behavioural changes, skin disorders

• The product is a live attenuated vaccine; the contact of the vaccine with any disinfectant should be avoided during manipulation.

• The product should not be used if it is found to have a crack in the vial, or unclear label, or turbidity after dissolution or the presence of foreign body.

• The vaccine should be given more than 3 months after gamma globulin administration.

• As with any parenteral vaccine, epinephrine should be available for use in case of anaphylaxis or anaphylactoid reaction.

• Prior to injection, with any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient’s history with respect to possible hypersensitivity to the vaccine.

• A separate syringe and needle must be used for each patient to prevent the transmission of infectious agents.

• Use by pregnant women is not recommended.