Valneva submitted an application for a vaccine to the FDA – 11/26/2024 at 6:13 p.m.

(CercleFinance.com) – Valneva announced that it has submitted an extension of indication request for its chikungunya vaccine IXCHIQ® to the US health agency Food and Drug Administration (FDA) aiming to potentially expand the use of its vaccine to adolescents aged 12 to 17.

This submission also includes a request to add data on the persistence of antibodies for up to two years, a key differentiator of the IXCHIQ® vaccine, in the summary of product characteristics.

This submission to the FDA follows requests for extension of indication submitted to the European Medicines Agency (EMA) and Health Canada two months ago.

These indication extension requests are based on the positive Phase 3 data obtained in adolescents, which the Company announced in May 2024.

These data showed that vaccination with a single dose of IXCHIQ® induces a high and sustained immune response in 99.1% of adolescents and that the vaccine is generally well tolerated.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, said, ‘Given the significant threat chikungunya poses to people living or traveling in endemic areas, it is crucial to make the vaccine accessible to all age groups. age. In doing so, we will be able to strengthen protection and reduce the impact of this debilitating disease which is currently growing in areas previously unaffected by the disease. The durability of the immune response is also extremely important, particularly for endemic countries where access to vaccination may be difficult. ‘