Valneva’s Chikungunya Vaccine IXCHIQ® Gains CHMP Support For Adolescent Use
CHMP backs broader approval of Valneva’s IXCHIQ® vaccine for adolescents, boosting chikungunya protection efforts.
Breaking News
Mar 01, 2025
Simantini Singh Deo
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Valneva SE, a specialty vaccine company, has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has positively adopted an opinion of extending the label for IXCHIQ®. This single-dose vaccine for chikungunya prevention, initially approved in Europe for adults 18 and older in July 2024, may now be authorised for use in individuals aged 12 and above. The European Commission (EC) will review this recommendation from CHMP, with a final decision expected within 60 days for the European Union, Norway, Liechtenstein, and Iceland.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said, “Given the substantial risk that chikungunya presents to individuals residing in or travelling to endemic regions, ensuring the vaccine is available to all age groups is imperative. Therefore, this positive CHMP opinion marks a crucial milestone toward introducing a more robust preventative solution against chikungunya in the EU. Broader accessibility will help provide protection and mitigate the burden of this debilitating illness, which is continuing to spread in previously unaffected areas.”
The CHMP’s endorsement is based on promising adolescent Phase 3 trial data from a Brazil-based study funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and the EU’s Horizon Program. The results demonstrated that IXCHIQ® produced a strong immune response in 99.1% of adolescents, with 98.3% maintaining immunity a year later. The vaccine was well tolerated, reaffirming its efficacy and safety profile in younger populations. These results were also published in The Lancet Infectious Diseases, further supporting its use among adolescents.
Dr Richard Hatchett, Chief Executive Officer of CEPI, commented, “Cases of Chikungunya are increasing around the world, making populations of all ages vulnerable to the disease’s long-term debilitating effects, such as prolonged joint plan and inflammation. The CHMP’s recommendation for using IXCHIQ in adolescents in the European Union is an important stepping stone that could help accelerate the vaccine's approval in this age group in other regions, including areas where the disease is endemic.”
Following regulatory approvals for adults in the U.S., Europe, Canada, and the UK, Valneva anticipates Brazilian approval in early 2025, marking the first in an endemic region. The company has also submitted label extension applications to U.S. and Canadian health authorities and plans to do the same in the UK. Valneva strengthened its CEPI partnership by expanding access with a $41.3 million grant to support broader distribution in low- and middle-income countries (LMICs). The company also signed a licensing agreement with the Serum Institute of India for Asian markets, complementing its 2021 agreement with Instituto Butantan in Brazil for affordable vaccine distribution in Latin America.
