Denmark-based vaccines company Bavarian Nordic A/S (CPH:BAVA) announced on Thursday that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for its chikungunya vaccine, CHIKV VLP.
This initiates the EMA's centralised review under accelerated assessment, potentially supporting approval of the vaccine by the European Commission in the first half of 2025.
The company also submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in June 2024, targeting a potential US approval in the same timeframe.
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