MHRA grants Valneva marketing authorization for chikungunya vaccine

Valneva (VALN) announced that the Medicines and Healthcare products Regulatory Agency or MHRA has granted marketing authorization in the United Kingdom for the world’s first and only chikungunya vaccine, IXCHIQ . The single-dose vaccine is indicated for active immunization for the prevention of disease caused by chikungunya virus or CHIKV in individuals 18 years of age and older. The UK approval marks the fourth regulatory approval Valneva has received for its single-shot chikungunya vaccine. Valneva expects to receive marketing approval in Brazil in the first quarter of 2025, which would represent the first approval in an endemic country. Valneva submitted label extension applications to the U.S. Food and Drug Administration FDA , the European Medicines Agency EMA and Health Canada to potentially extend the use of IXCHIQ to adolescents aged 12 to 17 years. The Company now also plans to submit a label extension application to MHRA. Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This latest approval is a further recognition of IXCHIQ s strong product profile and the medical need for a chikungunya vaccine. Travelers from the UK consistently rank among India’s largest tourist groups given cultural ties and shared history. With the current outbreak in India, it is critical to ensure UK travelers have access to this vaccine…”