Overview of IXCHIQ® Approval

In a major public health advancement, Valneva SE has received approval from the European Commission (EC) for its groundbreaking chikungunya vaccine, IXCHIQ®, which is now authorized for use in adolescents aged 12 and above across the European Union (EU), Norway, Liechtenstein, and Iceland. This marks a significant extension from the adult-only authorization Valneva secured in July 2024.

Significance of IXCHIQ®

IXCHIQ® represents a historic milestone as the first-ever licensed vaccine aimed at preventing the chikungunya virus (CHIKV), a mosquito-borne disease that has rapidly become a global concern. With outbreaks occurring in various regions, including India, Brazil, and La Réunion, the timely introduction of this vaccine for adolescents is a critical step forward in combatting the illness that affects millions worldwide.

Expert Commentary

Dr. Juan Carlos Jaramillo, Valneva's Chief Medical Officer, emphasized the importance of making IXCHIQ® available to younger populations, stating, “This adolescent approval marks a crucial milestone toward introducing a more robust preventative solution against chikungunya in the EU. Broader accessibility will help mitigate the burden of this debilitating illness, particularly in areas where chikungunya has started to emerge.”

Clinical Trial Evidence

Evidence supporting the efficacy and safety of IXCHIQ® in adolescents comes from a Phase 3 clinical trial conducted in Brazil, funded in part by the Coalition for Epidemic Preparedness Innovations (CEPI) and the EU’s Horizon Program. The trial demonstrated that a single dose of IXCHIQ® generated a strong immune response in 99.1% of adolescents participants, and this response remained at an impressive 98.3% one year after vaccination. Safety profiles were also reassuring, with the vaccine being well tolerated among participants.

Global Supply Commitment

As Valneva continues to expand its reach, the company announced its commitment to supply 40,000 doses of IXCHIQ® to La Réunion, addressing urgent local needs amidst ongoing outbreaks. Dr. Richard Hatchett, CEO of CEPI, remarked on the global implications of the vaccine, highlighting the rising incidence of chikungunya and the urgent need for effective interventions to protect vulnerable populations.

Access in Low- and Middle-Income Countries

Furthermore, Valneva is actively working on increasing vaccine accessibility in low- and middle-income countries, having signed a significant licensing agreement with the Serum Institute of India. This collaboration aims to provide the chikungunya vaccine at an affordable price for public health markets, further broadening its global impact.

Chikungunya Virus Overview

Chikungunya virus, transmitted by infected Aedes mosquitoes, leads to symptoms like high fever, debilitating joint pain, and fatigue. Since its recent resurgence in 2004, the virus has spread to over 110 countries, with millions of reported cases, particularly impacting the Americas. As climate change continues to shift mosquito habitats, the spread of chikungunya poses an increasing public health threat, making the availability of IXCHIQ® even more crucial.

Conclusion

For adolescents and their families, the authorization of IXCHIQ® is more than just a public health development—it represents hope for effective prevention of a virus that can significantly impair quality of life. As Valneva moves ahead with its expansion efforts, this innovative vaccine could play a pivotal role in controlling future outbreaks.