Second Chikungunya Vaccine Candidate May Curtail Global Outbreak

As the global Chikungunya outbreak continues in July 2024, a second vaccine may soon become available.

This is essential news since the World Health Organization recently confirmed the mosquito-borne viral Chikungunya virus was identified in nearly 115 countries in 2024, primarily in the Region of the Americas.

Bavarian Nordic A/S today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) 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 MAA begins the EMA’s centralized review procedure under accelerated assessment.

The accelerated assessment, granted by EMA’s Committee for Medicinal Products for Human Use in February 2024, aims to reduce the timeframe for the CHMP to review an MAA. This could support the European Commission's vaccine approval in the first half of 2025.

Bavarian Nordic also completed the submission of a Biologics License Application for the CHIKV VLP vaccine to the U.S. Food and Drug Administration (FDA) in June 2024, potentially also supporting the approval of the vaccine in the first half of 2025.

CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection.

“The MAA submission and review marks a pivotal milestone for Bavarian Nordic in 2024....,” said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release on July 18, 2024.

In November 2023, the U.S. FDA approved Valneva SE's monovalent, single-dose, live-attenuated IXCHIQ® Chikungunya vaccine. It has been available in the U.S. since the beginning of 2024.