Chikungunya Vaccine for Adolescents Approval Pending

With over 100 countries reporting chikungunya virus outbreaks this year, more international travelers may soon have access to an essential vaccine.

Valneva SE  today announced that it has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to potentially extend the use of the only chikungunya vaccine (IXCHIQ®) currently approved in adults and adolescents aged 12 to 17 years.

The application also includes adding the two-year antibody persistence data to the product label, a key differentiator for IXCHIQ®.

This FDA application follows the submission of label extension applications to the European Medicines Agency and Health Canada two months ago. Both Canada and the EMA have already approved IXCHIQ.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release on November 26, 2024, “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.”

As of November 22, 2024, the Pan American Health Organization reported over 412,089 chikungunya cases and 204 related deaths in the Americas this year. 

In the U.S., travel-related chikungunya cases have increased by about 16% in 2024.

The Lancet Infectious Diseases recently published an article showing that IXCHIQ was well tolerated in adolescents 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.

IXCHIQ® was launched in the U.S. at the beginning of March 2024, with launches in France and Canada underway.

In the U.S., IXCHIQ is available at travel clinics and pharmacies.

Valneva expects a marketing authorization in Brazil before the end of 2024 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, post-marketing trials and potential label extensions in children, adolescents and pregnant women.

CEPI will provide Valneva with up to $41.3 million of additional funding over the next five years, with support from the European Union’s Horizon Europe program.

Chikungunya is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes, which causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain is often debilitating and can persist for weeks to years.

A study published by MDPI on October 19, 2024, determined the incidence of post-chikungunya chronic rheumatism and its impact on quality of life and chronic fatigue in adults reached seven years.