CHMP Supports Ixchiq Label Extension

Valneva SE , a specialty vaccine company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for Ixchiq Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus, to individuals 12 years of age and older. Ixchiq received marketing authorization in Europe for individuals 18 years and older in July 2024.

The European Commission (EC) will now review the CHMP recommendation, and a decision on the label extension application of Ixchiq in the European Union (EU), Norway, Liechtenstein and Iceland is expected within sixty days.

The positive CHMP opinion is supported by positive six-month adolescent Phase III data which Valneva reported in May 2024. These data, collected through a study in Brazil funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union’s (EU) Horizon Program, showed that a single-dose vaccination with Ixchiq induces a high immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. Valneva recently announced that this immune response was sustained in 98.3% of adolescents one-year after single vaccination. These results reaffirm the strong and persistent immune response with only one dose already seen in adults^[ The Lancet Infectious Diseases, a world leading infectious diseases journal, also published an article  showing that the vaccine was generally safe and well tolerated in adolescents 12 to 17 years of age 28 days after a single injection, regardless of previous CHIKV infection.( previously cited)

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said, “Given the substantial risk that chikungunya presents to individuals residing in or traveling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups. Therefore, this positive CHMP opinion marks a crucial milestone toward introducing a more robust preventative solution against chikungunya in the EU. Broader accessibility will help provide protection and mitigate the burden of this debilitating illness, which is continuing to spread in areas that were previously unaffected.”