Bavarian Nordic A/S announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of the Company's vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older. The application was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) in February 2024, supporting the potential approval of the vaccine by the European Commission in the first half of 2025. The MAA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years of age and older.

The results showed that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong induction of chikungunya neutralizing antibodies 21 days after vaccination, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection in the majority of individuals. The CHIKV VLP vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature.