Valneva SE , a specialty vaccine company, has announced that Health Canada has granted marketing authorization for IXCHIQ® in individuals aged 12 years and older. This decision extends the vaccine’s indication beyond adults and follows the adolescent label expansion already approved in Europe in April 2025.
The label extension was supported by antibody persistence data, which demonstrated that 97% of participants maintained an immune response for 24 months, with equal durability in both younger and older adults.
Dr. Juan Carlos Jaramillo, Chief Medical Officer at Valneva, stated:
“This approval is a key milestone as chikungunya continues to pose a risk globally. Ensuring access to both adults and adolescents is critical, especially as the disease spreads into new regions.”
Earlier this year, Brazil became the first endemic country to approve IXCHIQ® for adults. Chikungunya remains a rising public health threat, with outbreaks recently reported in Brazil, India, and China. To expand global access, Valneva is collaborating with the Coalition for Epidemic Preparedness Innovations (CEPI), supported by the European Union’s Horizon Europe program, to ensure vaccine availability in low- and middle-income countries (LMICs).
Dr. Richard Hatchett, CEO of CEPI, added:
“With rising outbreaks, broader access to vaccines is essential. Health Canada’s approval may help accelerate regulatory decisions in other regions, particularly in endemic areas.”
The approval is based on Phase 3 clinical trial data in adolescents, which showed that a single dose of IXCHIQ® induced a strong immune response in 99.1% of adolescents and was well tolerated. These findings were published in The Lancet Infectious Diseases in January 2025, confirming the vaccine’s safety and immunogenicity in the 12–17 age group.