Valneva: submitted a vaccine application to the FDA

(CercleFinance.com) - Valneva has announced that it has submitted an indication extension request for its IXCHIQ® chikungunya vaccine to the U.
S. Food and Drug Administration (FDA), with the aim of potentially extending the use of its vaccine to adolescents aged 12 to 17.

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

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

These applications for extension of indication 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 lasting immune response in 99.1% of adolescents, and that the vaccine is generally well tolerated.

Juan Carlos Jaramillo, M.D., Valneva's Medical Director, commented, 'Given the significant threat posed by chikungunya to people living or traveling in endemic areas, it is crucial to make the vaccine accessible to all age groups. By doing so, we will be able to boost protection and reduce the impact of this debilitating disease, which is currently developing in areas previously unaffected by the disease. The sustainability of the immune response is also extremely important, particularly for endemic countries where access to vaccination can be difficult. '

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