Type: Japanese encephalitis vaccine (inactivated, adsorbed)
Form: Suspension for injection
Manufacturer: Valneva Austria GmbH
Imported by: Quality & Compliance Services Inc.
Manufactured for: Valneva Canada Inc.
Indications
Active Immunization: For the prevention of Japanese encephalitis (JE) in individuals 2 months of age and older, particularly those at risk of exposure through travel or occupation.
Contraindications
Hypersensitivity: Individuals who are hypersensitive to any component of the vaccine or who have shown hypersensitivity reactions after receiving the first dose of the vaccine.
Acute Severe Febrile Conditions: Vaccination should be postponed in persons with acute severe febrile conditions.
Dosage and Administration
Children (2 months to <3 years): Two 0.25 mL doses, administered intramuscularly 28 days apart.
Children and Adolescents (3 years to <18 years): Two 0.5 mL doses, administered intramuscularly 28 days apart.
Adults (18 years and older): Two 0.5 mL doses, administered intramuscularly 28 days apart.
Booster Dose: Recommended within the second year (12-24 months) after primary immunization, particularly for those at continuous risk.
Administration
Administer intramuscularly in the deltoid muscle; in infants, the anterolateral aspect of the thigh may be used.
Do not administer intravascularly.
For patients with thrombocytopenia or bleeding disorders, subcutaneous administration may be considered, although it may lead to a suboptimal response.
Storage and Stability
Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light.
Warnings and Precautions
Anaphylaxis: Appropriate medical treatment should be available in case of anaphylactic reactions.
Special Populations:
Pregnant Women: Limited data available; use only if clearly needed.
Nursing Women: Use only if the benefit outweighs the risk.
Elderly (≥65 years): Immune response may be lower; booster dose should be considered before further exposure.
Immunosuppressed Individuals: Adequate immune response may be diminished.
Adverse Reactions
Common: Injection site pain, headache, myalgia, fatigue, injection site tenderness, redness, hardening, swelling, and itching.
Immunogenicity: High seroconversion rates with geometric mean titers indicating strong immune responses.
Long-term Protection: Booster doses shown to maintain protective antibody levels; mathematical modeling suggests average duration of protection could be up to 14 years with a second booster recommended 10 years after the first.
