Valneva Submits Label Extension Application for its Chikungunya Vaccine, IXCHIQ, to the U.S. FDA

Valneva SE, a specialty vaccine company, announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of its chikungunya vaccine IXCHIQ, which is currently approved in adults, to adolescents aged 12 to 17 years. The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ. This FDA application follows the submission of label extension applications to the European Medicines Agency (EMA) and Health Canada two months ago.

These label extension applications are based on positive adolescent Phase 3 data, which the Company reported in May 2024. These data showed that a single-dose vaccination with IXCHIQ induces a high and sustained immune response in 99.1% of adolescents, and that the vaccine was generally well tolerated. The Lancet Infectious Diseases, a world leading infectious diseases journal, also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous CHIKV infection.

In addition to the adolescent data, the U.S. and Canadian label extension applications included IXCHIQ’s long-term antibody persistence data, which showed that the vaccine’s immune response was sustained by 97% of participants after 24 months and was equally durable in younger and older adults. These persistence data were already included in the initial EMA filing. The Company expects to publish 36-month persistence data in the coming weeks.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “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. This broader accessibility would certainly help provide protection and mitigate the burden of this debilitating illness which is currently spreading in areas that were previously unaffected. The long-term durability of the immune response from a single shot is also extremely important, especially for endemic countries where access to immunization can be difficult.”

IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. The vaccine is currently approved in the U.S., Europe, and Canada for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. It was launched in the U.S. at the beginning of March 2024, following adoption of the U.S. Advisory Committee on Immunization Practices (ACIP)’s recommendations by the U.S. Centers for Disease Control and Prevention (CDC), and launches in France and Canada are underway.

In addition to ramping up sales, Valneva is focused on expanding the vaccine’s label and access. The Company expects a marketing authorization in Brazil before the end of the year and expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) earlier this year to support broader access to the vaccine in Low and Middle-Income Countries (LMICs), post-marketing trials and potential label extensions in children, adolescents and pregnant women. CEPI will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s (EU) Horizon Europe program.