Valneva SE, a specialized vaccine producer, has put forward a submission to the US Food and Drug Administration (FDA) to widen the application of its chikungunya vaccine, IXCHIQ. Currently approved for adults, Valneva aims to include the 12 to 17-year-old demographic. The proposal also seeks to incorporate two-year data on antibody persistence, a distinguishing factor for IXCHIQ, into the product’s label. This move comes after previous applications for label extensions were made to both the European Medicines Agency (EMA) and Health Canada two months back.
The request draws support from promising Phase 3 data with adolescents, presented by the company in May 2024. The findings demonstrated that a single dose of IXCHIQ triggers a strong and long-lasting immune reaction in 99.1% of the young subjects, and it was generally well-received. An article published in The Lancet Infectious Diseases, an authoritative journal on infectious diseases, confirmed the vaccine’s tolerability in youngsters aged 12 to 17, irrespective of past CHIKV exposure.
Besides results from adolescents, the US and Canadian submissions also included IXCHIQ’s extended antibody persistence data, illustrating that 97% of subjects maintained an immune response after 24 months, consistent across various age groups. This data had already been part of the initial submission to the EMA. Valneva anticipates releasing 36-month persistence findings in the upcoming weeks.
Valneva’s chief medical officer, Juan Carlos Jaramillo, M.D., remarked on the necessity of expansive vaccine availability, “Considering the significant threat chikungunya poses to residents or travelers within endemic regions, broadening vaccine access across all ages is crucial. Such accessibility can help in shielding individuals and reducing the impact of this challenging disease, now appearing in previously unaffected areas. The vaccine’s long-lasting single-dose immune response is especially vital in regions where accessing immunization is challenging.”
IXCHIQ stands as the first and sole approved chikungunya vaccine aiming to fulfill an urgent medical requirement. Authorized in the US, Europe, and Canada, it prevents chikungunya virus infection in those aged 18 and above. It was launched in the US in early March 2024, following the endorsement by the US Centers for Disease Control and Prevention (CDC) of the Advisory Committee on Immunization Practices (ACIP)’s guidelines, with ongoing launches in France and Canada.
Valneva is not only focusing on sales growth but also on extending the vaccine’s label and accessibility. The company anticipates obtaining marketing approval in Brazil later this year and has broadened its collaboration with The Coalition for Epidemic Preparedness Innovations (CEPI) to enhance vaccine access in Low and Middle-Income Countries (LMICs) through post-marketing trials and possible label expansions for children, adolescents, and pregnant women. Under this collaboration, the EU’s Horizon Europe programme is backing CEPI to allocate up to $41.3 million in additional funding to Valneva over the next five years.
Chikungunya virus (CHIKV) is a viral infection borne by mosquitoes, primarily the Aedes species, leading to fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. Joint pain, often debilitating, can continue for weeks to years.
The disease gained rapid traction in 2004, causing widespread outbreaks globally. Since its resurgence, CHIKV has been detected in over 110 nations across Asia, Africa, Europe, and the Americas. Between 2013 and 2023, over 3.7 million cases emerged in the Americas alone, posing significant economic repercussions. Climate change may exacerbate this issue, as mosquito vectors expand their reach. Consequently, the World Health Organization (WHO) recognizes chikungunya as a pressing public health challenge.
Valneva SE is an innovative vaccine firm dedicated to developing, producing, and commercializing preventative vaccines for infectious diseases, fulfilling critical unmet needs.