28 August 2025
Valneva SE, a specialized vaccine company, received marketing authorization from Health Canada for the single-dose vaccine IXCHIQ for serving prevention of disease related to the chikungunya virus for individuals aged 12 years and older. Additionally, the adult marketing authorization that was already granted in Canada is a complement to the adolescent label extensively received in April 2025 in Europe. In adolescent data, Health Canada’s label extension application consists of IXCHIQs antibody persistence data. The data witness that the vaccine’s immune responsiveness survived for 24 months, with 97% of participants responding to it it was also durable in older and younger adults.
IXCHIQ is the first-ever approved chikungunya vaccine in an endemic country globally this year, when the Brazilian health regulatory agency (ANVISA) gave thumbs up to marketing authorization in adults. Chikungunya is increasingly becoming a crucial public health problem, according to recent studies in India, China, and Brazil. Valneva’s collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) is popularly supported by the European Union’s Horizon Europe programme. It contributed to the vast access to the IXCHIQ, mainly in low and middle-income countries (LMICs).
Health Canada’s label extension was possible due to Valneva’s effective six-month adolescent phase 3 data, reported by the company in May 2024. The data showed that the single-dose vaccination with IXCHIQ has shown a well-survived immune response in 99.1% of adolescents, and the vaccine was also tolerable. The Lancet Infectious Diseases is a globally leading infectious disease journal. The journal published an article in January 2025 highlighting the vaccine's safety and tolerability in adolescents aged between 12 to 17 years counting 28 days after a single injection, despite previous CHIKV records.
MD, chief medical officer of Valneva, Juan Carlos Jaramillo, said, “This approval symbolizes another crucial milestone for our chikungunya vaccine that aims a prominent risk to individuals living in or traveling to endemic regions. Our vaccine is accessible to every important age group. Further, the company is waiting for regulatory decisions from other countries where vast access will support serving protection and reduce the burden of this capable debilitating illness that continues to circulate into previously unaffected areas.”
Chief executive officer of the Coalition for Epidemic Preparedness Innovations (CEPI), Dr. Richard Hatchett, said, “With chikungunya spreading across countries, the extensive access to vaccines became more important. The approval will help to leverage the licensing of IXCHIQ in this age group in many other regions, mainly in areas where this disease is more prevalent.”
28 August 2025
28 August 2025
28 August 2025
28 August 2025