Valneva Applies for IXCHIQ® Chikungunya Vaccine Label Extension in EMA and Health Canada

Valneva SE, a specialty vaccine company, has announced the submission of applications to the European Medicines Agency (EMA) and Health Canada to extend the use of its chikungunya vaccine, IXCHIQ®. The proposed extension aims to include adolescents aged 12 to 17 years in Europe and Canada. The application to Health Canada also incorporates data on two-year antibody persistence, a feature that had been part of the initial EMA submission. Valneva plans to submit similar data to the U.S. Food and Drug Administration (FDA) within the year to support potential label extensions in the U.S.

IXCHIQ® is the first and only licensed chikungunya vaccine globally, addressing a significant unmet medical need. It is currently approved for adults aged 18 and older in the U.S., Europe, and Canada. The U.S. rollout is in progress, with sales in Canada and Europe expected to begin in the fourth quarter of 2024.

Valneva is not only focused on increasing sales but also on expanding the vaccine's applicability and access. The company anticipates receiving marketing authorization in Brazil in the latter half of 2024. Additionally, Valneva has expanded its collaboration with The Coalition for Epidemic Preparedness Innovations (CEPI) to broaden access to the vaccine in Low and Middle-Income Countries (LMICs). This partnership includes post-marketing trials and potential label extensions for children, adolescents, and pregnant women. CEPI will provide up to $41.3 million in additional funding over the next five years, supported by the European Union’s Horizon Europe program.

Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, emphasized the importance of making the vaccine available to all age groups due to the significant risks posed by chikungunya. He noted that broader accessibility would help mitigate the burden of the disease, which is spreading to previously unaffected areas. The persistence of the immune response is particularly crucial for endemic regions where access to immunization can be challenging.

The label extension applications to EMA and Health Canada are built on positive six-month adolescent Phase 3 data reported by Valneva in May 2024. The data demonstrated that a single dose of IXCHIQ® induces a robust and sustained immune response in 99.1% of adolescents and is generally well-tolerated. The Lancet Infectious Diseases journal recently published an article confirming the vaccine's tolerability in adolescents aged 12 to 17, regardless of prior CHIKV infection.

In addition to adolescent data, Health Canada's application features antibody persistence data showing that the vaccine’s immune response lasted for 24 months in 97% of participants, with similar durability across younger and older adults. Valneva expects to publish 36-month persistence data later this year.

Chikungunya is a viral disease transmitted by Aedes mosquitoes, causing 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, the virus has spread rapidly, now identified in over 110 countries across Asia, Africa, Europe, and the Americas. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas, significantly impacting the economy. The World Health Organization (WHO) has emphasized chikungunya as a major public health issue due to its growing geographical spread, exacerbated by climate change.

Valneva SE specializes in developing, manufacturing, and commercializing vaccines for infectious diseases with unmet medical needs. The company has a strong track record in advancing vaccines from early research to approval and currently markets three proprietary travel vaccines, including the first and only chikungunya vaccine. Valneva also has a pipeline that includes vaccine candidates for Lyme disease, partnered with Pfizer, and the most clinically advanced Shigella vaccine candidate, as well as candidates for Zika virus and other global health threats.