ARTICLE
20 February 2025

UK's MHRA Grants Marketing Authorization For Chikungunya Vaccine

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Goodwin Procter LLP

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On February 5, 2025 Valneva SE ("Valneva") announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization...
United Kingdom Food, Drugs, Healthcare, Life Sciences

On February 5, 2025 Valneva SE ("Valneva") announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva's chikungunya vaccine, IXCHIQ. IXCHIQ is a single-dose, live-attenuated vaccine indicated for active immunization against the chikungunya virus, and represents the first (and currently only) chikungunya vaccine. According to Valneva, "[t]he approval is based on IXCHIQ®'s final pivotal Phase 3 data, published in The Lancet, which included more than 4,000 participants and demonstrated that a single dose of the live-attenuated IXCHIQ® vaccine induces a rapid and strong immune response. Data has since shown this response can be maintained for at least three years in both younger and older adults."

The MHRA's approval of Valneva's chikungunya vaccine marks the fourth market approval received by IXCHIQ, which is also approved in the United States, Europe, and Canada. IXCHIQ is currently approved for adults 18 years of age and older. However, Valneva has submitted label extensions to the FDA, the European Medicines Agency, and Health Canada seeking extension to adolescents aged 12 to 17 years.

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