Bavarian Nordic Receives CHMP’s Positive Opinion for Vimkunya to Prevent Chikungunya
Shots:
- The CHMP has recommended Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.), with the EC’s decision & launch expected in H1’25 for the EU, Iceland, Liechtenstein, & Norway
- Opinion was based on 2 P-III studies showing a rapid immune response in 1wk. with ~97.8% of participants (n=3,500) developing neutralizing antibodies by day 21
- Following the positive CHMP opinion, the company will submit an MAA to the UK MHRA under the IRP, with potential UK approval in H1’25. Vaccine is also under priority review by the US FDA (PDUFA: Feb 14, 2025)
Ref: GlobeNewswire | Image: Bavarian Nordic
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