Based on today's announcement by Valneva SE, adolescents may soon have access to the only approved chikungunya vaccine. This is essential news as the chikungunya virus (CHIKV) has now been identified in over 110 countries in Asia, Africa, Europe, and the Americas.
On September 18, 2024, Valneva submitted label extension applications to the European Medicines Agency (EMA) and Health Canada to potentially expand the use of its approved chikungunya vaccine, IXCHIQ®, to adolescents aged 12 to 17 years in Europe and Canada.
The Canadian label extension application also includes two-year antibody persistence data, a key differentiator for IXCHIQ® that was already included in the initial EMA filing.
Valneva expects to submit data to the U.S. Food and Drug Administration (FDA) in 2024 to support potential label extensions in the U.S.
IXCHIQ is currently approved in the U.S., Europe, and Canada to prevent disease caused by mosquito-spreading CHIKV in individuals 18 and older.
In the U.S., the commercial launch is underway, as IXCHIQ is available at health clinics and pharmacies.
First sales in Canada and Europe are anticipated in the fourth quarter of 2024.
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 in the second half of 2024 and recently expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access to the vaccine in Low Middle-Income Countries, post-marketing trials, and potential label extensions in children, adolescents, and pregnant women.
CEPI previously confirmed it will provide Valneva up to $41.3 million of additional funding over the next five years, with support from the European Union’s Horizon Europe program.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, “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 durability of the immune response is also extremely important, especially for endemic countries where access to immunization can be difficult.”
EMA and Health Canada’s label extension applications are based on positive six-month adolescent Phase 3 data 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 also recently published an article showing that the vaccine was well tolerated in adolescents aged 12 to 17 28 days after a single injection, regardless of previous CHIKV infection.
In addition to the adolescent data, Health Canada’s label extension application included IXCHIQ®‘s antibody persistence data, which showed that 97% of participants sustained the vaccine’s immune response for 24 months and was equally durable in younger and older adults.
Valneva expects to publish 36 months of persistence data later in 2024.
