Valneva Seeks FDA Approval to Extend IXCHIQ Chikungunya Vaccine to Adolescents
核心洞察
Valneva (搜索) has submitted a label extension application to the FDA for its IXCHIQ vaccine, seeking approval for use in adolescents aged 12-17 years.
The application includes data demonstrating 99.1% of adolescents showed a high and sustained immune response after a single dose.
Data included in the application shows 97% of participants maintained immune response after 24 months, highlighting the vaccine's durability.
Valneva (搜索) SE has submitted a label extension application to the U.S. Food and Drug Administration (FDA) to broaden the use of its chikungunya (搜索) vaccine, IXCHIQ, to include adolescents aged 12 to 17 years. The application also seeks to include two-year antibody persistence data on the product label, a distinguishing feature of IXCHIQ. This submission follows similar applications made to the European Medicines Agency (EMA) and Health Canada.
The application is supported by positive Phase 3 data in adolescents, which Valneva (搜索) reported in May 2024. The data indicated that a single dose of IXCHIQ induced a robust and sustained immune response in 99.1% of adolescents, with the vaccine being generally well-tolerated. These findings were also published in The Lancet Infectious Diseases. The study showed the vaccine was well-tolerated in adolescents aged 12 to 17 years 28 days after a single injection, regardless of previous CHIKV infection.
In addition to the adolescent trial data, the application includes data on long-term antibody persistence, demonstrating that 97% of participants maintained an immune response 24 months after vaccination. This durable response was consistent across both younger and older adults. Valneva (搜索) anticipates releasing 36-month persistence data soon.
Addressing a Critical Need
"Given the substantial risk that chikungunya (搜索) presents to individuals residing in or traveling to endemic regions, it's imperative to ensure the vaccine is available to all age groups," said Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva (搜索). He emphasized that broader accessibility would help protect against this debilitating illness, which is spreading to previously unaffected areas. Jaramillo also noted the importance of long-term immune response from a single shot, especially in endemic countries where immunization access can be challenging.
IXCHIQ: The First Chikungunya Vaccine
IXCHIQ is the first and only licensed chikungunya (搜索) vaccine globally. It is currently approved for use in adults aged 18 and older in the U.S., Europe, and Canada. The vaccine was launched in the U.S. in early 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 also underway.
Expanding Access and Indications
Valneva (搜索) is actively working to expand the vaccine’s label and accessibility. The company anticipates marketing authorization in Brazil by the end of the year. Furthermore, Valneva has expanded its partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to support broader access to the vaccine in low- and middle-income countries (LMICs), as well as post-marketing trials and potential label extensions for children, adolescents, and pregnant women. CEPI will provide Valneva up to $41.3 million in additional funding over the next five years, with support from the European Union’s Horizon Europe program.
About Chikungunya
Chikungunya (搜索) is a mosquito-borne viral disease transmitted by infected Aedes mosquitoes. Symptoms include fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain can be debilitating and may persist for weeks to years. Since its re-emergence in 2004, the virus has spread to over 110 countries in Asia, Africa, Europe, and the Americas. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas, with significant economic impact. The World Health Organization (WHO) has identified chikungunya as a major public health concern, particularly as climate change facilitates the spread of mosquito vectors.