Regulatory review of the single-dose CHIKV VLP vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older is now underway in both the EU and in the U.S. 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. “The MAA marks our second major submission in just a few weeks as part of our efforts to launch the chikungunya vaccine next year in the U.S. and Europe. Chikungunya, like other mosquito-borne infectious diseases, represents an increasing public health threat due to factors such as climate-change, but also resulting from improved disease surveillance and diagnosis. Our CHIKV VLP vaccine is designed for ease of use in individuals 12 years of age and older at risk of chikungunya virus and represents an important contribution to the development of preventative solutions against this debilitating disease,” said Paul Chaplin, President and CEO of Bavarian Nordic.