Tag: FR0011472943

Saint Herblain (France), August 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ^®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. This announcement adds to the adult marketing authorization already received in Canada¹ and complements the adolescent label extension received in Europe in April 2025².

Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ^® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ^®. IXCHIQ^® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.

VALNEVA

VALNEVA

Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva’s single-dose chikungunya vaccine IXCHIQ^® by EMA’s safety committee (PRAC).

Saint Herblain (France), le 11 juillet 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), Valneva SE (Nasdaq : VALN ; Euronext Paris : VLA), société spécialisée dans les vaccins, a annoncé aujourd'hui que l’agence européenne des médicaments (EMA) allait lever sa restriction temporaire sur la vaccination des personnes âgées de 65 et plus avec le vaccin à dose unique contre le chikungunya IXCHIQ^® de Valneva suite à l’achèvement d’une revue complète du vaccin par le comité pour l’évaluation des risques en matière de pharmacovigilance de l’EMA (PRAC).

Saint-Herblain (France), June 5, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial evaluating the safety and immunogenicity of two different dose levels of its single-shot chikungunya vaccine, IXCHIQ^®, in 304 children. Partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the European Union, the trial is intended to support a pivotal Phase 3 study in children, which the Company expects to initiate in the first quarter of 2026, with the objective of extending the product label to this age group.