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Important Safety Information

Indication & Usage

IXIARO is a vaccine indicated for the prevention of disease caused by JE virus, approved for use in individuals 2 months of age and older.

Important Safety Information

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of IXIARO, any other Japanese encephalitis vaccine, or any component of IXIARO, including protamine sulfate ─ a compound known to cause hypersensitivity reactions in some individuals ─ is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO might be considered.

Vaccination with IXIARO may not protect all individuals. Immunocompromised individuals may have a diminished immune response to IXIARO.  Syncope can occur in association with administration of injectable vaccines, including IXIARO. Procedures should be in place to prevent injury from falling and manage syncopal reactions.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, myalgia, and injection site pain and tenderness in adults.

Healthcare practitioners are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit or call 1-800-822-7967.  Healthcare practitioners are also encouraged to report inadvertent use in pregnant women to Valneva at 844-349-4276 (8443-IXIARO), or +1-301-556-4500.

Please see full Prescribing Information.

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