EMA will now initiate its centralized review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine
COPENHAGEN, Denmark, July 18, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA), which was submitted in June 2024 for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure under accelerated assessment.
The accelerated assessment, which was granted by EMA’s Committee for Medicinal Products for Human Use (CHMP) in February 2024, aims to reduce the timeframe for the CHMP to review a MAA, potentially supporting approval of the vaccine by the European Commission in the first half of 2025.
“The MAA submission and review marks a pivotal milestone for Bavarian Nordic in 2024, and we look forward to working closely with EMA throughout the evaluation process to make our chikungunya vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection,” said Paul Chaplin, President and CEO of Bavarian Nordic.
Bavarian Nordic also completed the submission of a Biologics License Application (BLA) for the CHIKV VLP vaccine to the U.S. Food and Drug Administration (FDA) in June 2024, potentially also supporting a US approval of the vaccine in the first half of 2025.
About CHIKV VLP vaccine
CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection. Pending regulatory approval, the single-dose vaccine will be made in a pre-filled syringe, designed to ease administration by saving vaccinators’ time and reducing the risk of administrative errors.
The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation
