Valneva is seeking label extensions in Europe and Canada for the world’s only licensed chikungunya vaccine, Ixchiq, to be used in adolescents, with further plans to file for US approval.
The applications, sent to the European Medicines Agency (EMA) and Health Canada, would allow the vaccine’s use in those aged 12 to 17 years if approved, as per an 18 September press release.
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Valneva plans to file for approval in the same age range with the US Food and Drug Administration (FDA) by the end of this year.
Ixchiq is the only chikungunya vaccine approved for adults in the US, Europe, and Canada.
Chikungunya is a mosquito-borne viral disease that causes severe joint pain, sometimes lasting long after the initial infection. Between August 2023 and July 2024, 21 countries reported 450,000 chikungunya cases, and more than two million cases have been reported since 2005. The burden of the virus is expected to increase with climate change as mosquitoes spread to more countries.
Valneva went ahead with the adolescent label extension submissions based on positive six-month Phase III data (NCT04650399). Valneva reported that a single dose of Ixchiq induced “a high and sustained immune response in 99.1% of adolescents” with good tolerance. Further data published in The Lancet Infectious Diseases demonstrated that the vaccine was well tolerated in the age group 28 days after a single injection, regardless of any previous infection.
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By GlobalDataValneva also included antibody persistence data, which showed a sustained response over 24 months by 97% of participants, being equally durable in younger and older individuals. The French vaccine maker expects to publish 36 month-persistence data later this year.
Ixchiq was approved in the US in November 2023, with marketing authorisation in Europe and Canada coming in June this year. Valneva said that while the US launch is underway, sales in Canada and Europe are anticipated in the fourth quarter of 2024.
Brazil could soon be added to the list of approved territories for Ixchiq as Valneva expects marketing authorisation in the country to come anytime from now until the end of the year.
The company has also expanded its partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access to the vaccine in Low Middle-Income Countries (LMICs), including future use in children, adolescents, and pregnant women. Valneva is line for $41.3m of additional funding over the next five years.
Valneva’s chief medical officer Juan Carlos Jaramillo: “Given the substantial risk that chikungunya presents to individuals residing in or travelling to endemic regions, it’s imperative to ensure the vaccine is available to all age groups.”
The label extension applications come amid the mpox virus taking a hold on healthcare systems in Africa. Bavarian Nordic has sought adolescent extensions for its Jynneos vaccine to help combat the spread of the virus. Valneva did not immediately respond to a question asked by Pharmaceutical Technology whether its label update applications were catalysed by the mpox outbreak. Similar to chikungunya, there is only one FDA-approved vaccine available for mpox.
