Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) announced on Wednesday that it has received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for IXCHIQ, the first chikungunya vaccine.
The single-dose vaccine -- produced at Valneva's facility in Livingston, Scotland -- is approved for individuals aged 18 and older.
The MHRA's approval was based on IXCHIQ's final pivotal Phase 3 data, demonstrating that IXCHIQ induced a rapid and strong immune response in over 4,000 participants. Studies indicate the immune response lasts at least three years across age groups.
This marks Valneva's fourth regulatory approval for IXCHIQ, following authorisations in the United States, Europe and Canada. A decision in Brazil is expected in the first quarter of 2025, which would represent the first approval in an endemic region. Valneva is also pursuing label extensions for adolescent use in multiple markets, including the UK.
Chikungunya virus, transmitted by Aedes mosquitoes, causes fever, severe joint pain and other debilitating symptoms. The World Health Organisation recognises it as a major public health concern due to its growing global impact.
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