Valneva Announces Positive Three-Year Data for Chikungunya Vaccine IXCHIQ®

Valneva SE, a specialty vaccine company, has unveiled promising three-year antibody persistence results following a single dose of its chikungunya vaccine, IXCHIQ®. This latest data aligns with previous findings from the past years, showcasing sustained antibody levels for an extended period. The study, which observed 278 healthy adults, revealed that 96% of participants maintained neutralizing antibody titers above the seroresponse threshold three years post-vaccination, confirming the vaccine's efficacy.

The research indicated no significant differences in antibody persistence between different age groups, with older adults (ages 65 and above) showing comparable results to younger adults (ages 18 to 64). The study, designated VLA1553-303, received financial backing from the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union's Horizon Europe program. It also involved monitoring long-term safety, but no new safety evaluations were conducted after the two-year mark as per the clinical trial protocol. Notably, no safety issues were reported throughout the two-year follow-up period.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, expressed satisfaction with the findings, emphasizing the significance of a single-dose vaccine that elicits a lasting immune response. He highlighted the importance of long-term protection against mosquito-borne diseases, especially in regions where vaccine accessibility is limited.

IXCHIQ® is the first and only licensed chikungunya vaccine available globally, approved for individuals aged 18 and above in the U.S., Europe, and Canada. Valneva has submitted applications to extend the vaccine's usage to adolescents aged 12 to 17 to health authorities, including the U.S. FDA, the European Medicines Agency (EMA), and Health Canada. These applications also include the vaccine's two-year antibody persistence data.

The chikungunya vaccine was introduced in the U.S. in March 2024, following recommendations from the U.S. Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC). Launches in France and Canada are currently underway. Valneva is also aiming for a marketing authorization in Brazil and has expanded its partnership with CEPI to enhance vaccine access in low- and middle-income countries. This partnership includes additional funding of up to $41.3 million over the next five years, supported by the EU's Horizon Europe program.

Chikungunya virus (CHIKV) is transmitted through the bites of infected Aedes mosquitoes, causing symptoms such as fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. The joint pain can be debilitating and last for weeks to years. Since its re-emergence in 2004, chikungunya has spread to over 110 countries across Asia, Africa, Europe, and the Americas, with significant outbreaks reported. The economic burden of the disease is substantial, and the spread of mosquito vectors, exacerbated by climate change, is expected to worsen the situation. The World Health Organization (WHO) has recognized chikungunya as a major public health issue.

Valneva is dedicated to developing, manufacturing, and commercializing vaccines for infectious diseases with unmet medical needs. The company's approach is highly specialized, focusing on providing first-in-class, best-in-class, or unique vaccine solutions. Valneva has a track record of advancing multiple vaccines from early research and development to market approval. The company's commercial portfolio includes three proprietary travel vaccines, including the chikungunya vaccine IXCHIQ®.

Revenue from Valneva's commercial business supports the ongoing development of its vaccine pipeline. This pipeline includes a Lyme disease vaccine candidate in collaboration with Pfizer, a Shigella vaccine candidate in advanced clinical development, as well as vaccine candidates targeting the Zika virus and other global health threats.