Encephalitis Vaccine

• Encephalitis virus vaccine

Encephalitis Vaccine is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Encephalitis Vaccine should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.

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Hypersensitivity to the active substance or to any of the excipients or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite, host cell protein. Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose. Administration must be postponed in persons with acute severe febrile conditions.

The mechanism of action of Japanese encephalitis (JE) vaccines is not well understood. Studies in animals have shown that the vaccine triggers the immune system to produce antibodies against Japanese encephalitis virus that are most often protective. Challenge studies were performed in mice that were treated with human Encephalitis Vaccine antisera. These studies showed that almost all mice that had a Plaque Reduction Neutralization Test titre of at least 1:10 were protected from a lethal Japanese encephalitis virus challenge.

Very common: headache, muscle pain, injection site pain, injection site tenderness, tiredness.Common: Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching).Uncommon: vomiting, skin rash, changes in the lymph-nodes, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), diarrhoea, belly pain, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results (hepatic enzymes increased).

Pregnancy: There are limited amount of data from the use of Encephalitis Vaccine in pregnant women. In animal studies findings of unclear clinical relevance have been identified. As a precautionary measure, the use of Encephalitis Vaccine during pregnancy should be avoided.Breast-feeding: It is unknown whether Encephalitis Vaccine is excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Encephalitis Vaccine is negligible. However, in the absence of data and as a precautionary measure the use of Encephalitis Vaccine during lactation should be avoided.Fertility: A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.

Children below 2 months of age: The safety and efficacy of Encephalitis Vaccine in children younger than 2 months has not been established. No data are available.