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IXIARO
Proper Name
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Indication
For the prevention of disease caused by Japanese encephalitis virus in persons 2 months of age and older.
Description

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. IXIARO is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are pooled, clarified and concentrated.

Key Regulatory Milestones

03/30/2009 - Approval of IXIARO by the U.S.

10/14/2010 - inclusion of the long-term immunogenicity data in the PI and the use of a booster dose in persons 17 years of age and older was approved under the efficacy supplement STN 125280/19

05/17/2013 - extension of the approved indication for primary series vaccination to include infants, children, and adolescents two months to less than 17 years of age was approved under the efficacy supplement STN 125280/125

04/13/2018 - booster dose for children and adolescents 14 months to less than 17 years of age and inclusion of longer-term pediatric immunogenicity data in the PI were approved under efficacy supplement STN 125280/235

Pre-submission Regulatory Activities:

  • 01/26/2010 - Joint FDA/EMA Scientific Advice Meeting.
  • 08/04/2015 - Type C meeting was held 
  • 04/12/2016 - Valneva submitted an initial pediatric study plan (iPSP) for review. The agreed iPSP was accepted by FDA on May 9, 2016.

10/04/2018 -  PDUFA Goal Date

10/04/2018 - FDA approval date

Advisory Committee

CBER did not present these data to an Advisory Committee because the review of information submitted in this submission did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

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