The vaccine, which is approved for adults currently, may soon be available for use in adolescents aged 12 to 17 years if the extension is granted.
This move follows the company’s previous applications to the European Medicines Agency (EMA) and Health Canada.
The label extension application is supported by positive Phase III data from adolescent trials reported in May this year.
In the US and Canada, the application also includes two-year antibody persistence data, demonstrating that 97% of subjects maintained their immune response after 24 months.
This data were part of the initial EMA filing, and Valneva anticipates releasing 36-month persistence data soon.
Currently, IXCHIQ is the only licensed chikungunya vaccine globally and is approved in the US, Europe, and Canada for individuals aged 18 and above.
The vaccine was introduced in the US in early March 2024 and launches in Canada and France are in progress.
Valneva chief medical officer Juan Carlos Jaramillo 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.
“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 immunisation can be difficult.”
Valneva is also focused on broadening the vaccine’s label and accessibility and anticipates receiving marketing authorisation in Brazil by the end of this year.