FDA Approves Accelerated Vaccination Schedule for Ixiaro

The Food and Drug Administration (FDA) has approved an alternate primary immunization schedule for Ixiaro (Japanese encephalitis vaccine, inactivated, adsorbed; Valneva), a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). Ixiaro acts by inducing antibodies that neutralize live JEV.

The accelerated schedule now allows for adult travelers (18-65 years old) to get 2 doses of Ixiaro 7 days apart. Previously, the prescribing information stated that adults should receive the 2 doses 28 days apart; both schedules are still FDA-approved. “Many people make their travel plans at the last minute, so being able to receive Ixiaro’s 2 shots within 7 days makes it easier for travelers, ultimately enhancing the value proposition of our product,” said Franck Grimaud, Valneva’s Chief Business Officer.

Ixiaro is supplied in 0.5mL single-dose syringes and is administered intramuscularly. The vaccine is indicated for use in individuals >2 months old; for children 2 months to <3 years, a 0.25mL dose should be prepared.  In addition, the new immunization schedule is only approved for adults 18-65 years; children and adolescents and adults >65 years should still receive 2 doses 28 days apart.

For more information visit Valneva.com.