Valneva SE, a specialized vaccine company, has received marketing approval from Health Canada for its single-dose chikungunya vaccine, Ixchiq, for individuals aged 12 and above. This approval supplements the existing adult marketing authorization in Canada and the adolescent label extension in Europe obtained in April 2025. Health Canada’s approval was based on data showing that the vaccine’s immune response lasted for 24 months in 97% of participants, regardless of age. Dr. Juan Carlos Jaramillo, Valneva’s chief medical officer, emphasized the importance of making the vaccine accessible to all age groups given the significant risk chikungunya poses to those in endemic regions.
Ixchiq is the first approved chikungunya vaccine in an endemic country, having received marketing authorization in adults from the Brazilian Health Regulatory Agency earlier this year. The global prevalence of chikungunya has been increasing, with recent outbreaks in countries like Brazil, India, and China. Valneva’s partnership with The Coalition for Epidemic Preparedness Innovations (CEPI) aims to expand access to Ixchiq in Low- and Middle-Income Countries (LMICs) where the disease is prevalent. Dr. Richard Hatchett, CEO of CEPI, highlighted the importance of accelerating vaccine licensure in regions where chikungunya is endemic, especially as outbreaks continue to rise worldwide.
The Health Canada label extension for Ixchiq was supported by positive phase 3 data in adolescents, demonstrating that a single dose of the vaccine induced a sustained immune response in 99.1% of participants and was well tolerated. A study published in The Lancet Infectious Diseases in January 2025 confirmed the safety and tolerability of the vaccine in adolescents aged 12 to 17, even in those with previous CHIKV infection. Chikungunya, transmitted by infected Aedes mosquitoes, causes symptoms such as fever, joint and muscle pain, headache, and fatigue. With the disease spreading rapidly since 2004, over 110 countries across continents have reported CHIKV cases, leading to a significant medical and economic burden.
Valneva SE specializes in developing prophylactic vaccines for infectious diseases with unmet medical needs, focusing on innovative vaccine solutions to address global health challenges. The company’s expertise spans various vaccine modalities, aiming to provide first-in-class or best-in-class vaccine options. As the World Health Organization (WHO) recognizes chikungunya as a major public health concern, Valneva’s Ixchiq vaccine approval marks a significant milestone in combating this mosquito-borne disease.
Key Takeaways:
– Valneva’s Ixchiq chikungunya vaccine has received marketing authorization from Health Canada for individuals aged 12 and above.
– The vaccine demonstrated a sustained immune response in 97% of participants over 24 months, leading to its approval for broader age groups.
– Valneva’s partnership with CEPI aims to expand access to the Ixchiq vaccine in regions where chikungunya is endemic, addressing the rising global health threat posed by the disease.
Tags: regulatory
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