Valneva's IXCHIQ® Vaccine for Adolescents Achieves Positive CHMP Opinion
If granted, IXCHIQ will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents aged 12 and older.
Positive Steps for Chikungunya Prevention
Recently, Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a leader in specialty vaccines, announced a significant advancement for its chikungunya vaccine, IXCHIQ®. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive recommendation for a label extension, allowing this single-dose vaccine to be administered to individuals aged 12 years and older.
This momentous decision comes after IXCHIQ® received marketing authorization for adults 18 years and older in July 2024. The European Commission (EC) is now set to review this recommendation, and a decision regarding the application across the EU, Norway, Liechtenstein, and Iceland is anticipated within the next two months.
Supporting Data for IXCHIQ®'s Efficacy
The positive opinion from the CHMP is underpinned by the results from a Phase 3 clinical trial that demonstrated a robust immune response. Conducted in Brazil, this study, financed by the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union's (EU) Horizon Program, revealed that a staggering 99.1% of adolescents who received a single dose of IXCHIQ® developed a significant immune response. Furthermore, Valneva confirmed that this response was maintained in 98.3% of those adolescents one year post-vaccination.
Previous studies affirm that IXCHIQ® has shown a strong persistence of immunity, a crucial factor given the virus's capability to spread. An article published in The Lancet Infectious Diseases indicated that adolescents experienced favorable outcomes regarding the vaccine's safety and tolerability.
Impact on Public Health and Future Aspirations
Dr. Juan Carlos Jaramillo, Valneva’s Chief Medical Officer, emphasized the importance of making this vaccine accessible to all demographics, particularly in areas where chikungunya risk is growing. He described the adoption of this vaccine as a critical step toward combating chikungunya, which increasingly affects regions previously untouched by the virus.
This CHMP recommendation follows other critical approvals obtained by Valneva, including marketing authorization in the U.S., Europe, Canada, and the UK for adults. The company is also preparing for marketing approval in Brazil, which would mark the first such approval in a territory where chikungunya is endemic.
Strategic Partnerships for Vaccine Accessibility
Valneva is keen on broadening the availability of IXCHIQ®. Recently, it expanded its partnership with CEPI through a grant of $41.3 million aimed at increasing access to this vaccine in Low- and Middle-Income Countries (LMICs). This funding will facilitate post-marketing studies and research to further extend the vaccine's indications.
In a testament to its commitment, Valneva has entered into an exclusive licensing agreement with the Serum Institute of India, the largest vaccine manufacturer globally, ensuring the vaccination program's affordability and priority supply in Asian markets. This strategy aligns with previous agreements signed in Brazil, aimed at providing an accessible chikungunya vaccine throughout Latin America and selected LMICs.
The Growing Concern of Chikungunya
The chikungunya virus, primarily transmitted by Aedes mosquitoes, causes debilitating symptoms like fever and severe joint pain, which can last for extended periods. The World Health Organization (WHO) cautions that as more regions experience the effects of climate change, the public health threat posed by chikungunya is likely to grow, emphasizing the need for effective vaccination strategies.
About Valneva SE
Valneva SE stands at the forefront of vaccine innovation, committed to developing and delivering exceptional vaccines for infectious diseases. The company continues to progress beyond its chikungunya vaccine to develop solutions for Lyme disease, Zika, and other global health threats. With a strong commercial footprint through its proprietary travel vaccines and partnerships, Valneva is focused on addressing unmet medical needs.
For more information, interested parties can reach out to:
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
Email: laetitia.bachelot-fontaine@valneva.com
Phone: +33 (0)6 4516 7099
Joshua Drumm, Ph.D.
VP Global Investor Relations
Email: joshua.drumm@valneva.com
Phone: +001 917 815 4520
Frequently Asked Questions
What is IXCHIQ®?
IXCHIQ® is Valneva's single-dose vaccine aimed at preventing chikungunya virus infection.
What age groups is IXCHIQ® intended for following the CHMP opinion?
Following the CHMP recommendation, IXCHIQ® will be available for adolescents aged 12 years and older.
What is the expected timeline for the European Commission's decision?
A decision on the label extension application is expected within sixty days of the CHMP's recommendation.
How effective is IXCHIQ® according to the Phase 3 trial?
The Phase 3 trial showed a 99.1% immune response rate among adolescents following vaccination.
How is Valneva addressing global access to the vaccine?
Valneva has secured significant partnerships and funding to ensure broader access, especially in low- and middle-income countries.
