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Valneva: positive opinion from the CHMP in chikungunya

( - Valneva announced Friday evening the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending a marketing authorization (MA) for its chikungunya vaccine in people aged 18 and over.

This opinion is based on phase 3 data, published in The Lancet, which showed a seroresponse rate of 98.9% at 28 days with a single vaccination. This robust immune response was maintained for 24 months by 97% of participants.

The European Commission will now examine the CHMP's recommendation for Ixchiq, with a decision on the marketing authorization application in the European Union, Norway, Liechtenstein and Iceland expected in the third quarter of 2024.

If approved, Ixchiq will become the first chikungunya vaccine available in Europe to address this unmet medical need. Valneva is also preparing a marketing authorization application for submission to the UK MHRA.

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