Bavarian Nordic A/S (BVNKF.PK) Friday said that it received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its Chikungunya Vaccine, VIMKUNYA for people aged 12 years and older.
The positive recommendation is based on results from two Phase 3 studies, in which VIMKUNYA induced neutralizing antibodies in up to 97.8 percent of the vaccinated individuals.
The company plans to submit a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA), with potential approval expected in the UK in the first half of 2025.
The vaccine is also under review with the U.S. Food and Drug Administration (FDA). A decsion from the regulator is expected on February 14, 2025.
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