Ixiaro regulatory update

Valneva said the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) expanded its recommendation for Ixiaro Japanese Encephalitis (JE) vaccine to include use in pediatric individuals ages >=2 months. ACIP recommended the vaccine in 2009, when it was only approved for use in patients >=17 years. FDA approved the pediatric indication in May (see BioCentury, Feb. 18 & May 27). The product is marketed as Ixiaro in Canada, Europe, Hong Kong, Israel, Singapore and the U.S., where it has Orphan Drug status, and as Jespect in Australia and New Zealand. ...