Single-dose Chikungunya Vaccine Candidate Seeks Europe's Authorization

Bavarian Nordic A/S today 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 and older.

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

The MAA application was granted accelerated assessment by the Committee for Medicinal Products for Human Use in February 2024, supporting the potential approval of the vaccine by the European Commission in the first half of 2025.

In the past 20 years, the chikungunya virus has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Americas, often causing large, unpredictable outbreaks.

The ECDC says Chikungunya is not endemic in mainland Europe, and most cases are travelers infected outside of the mainland European Union/European Economic Area.

“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, in a press release on June 26, 2024.

The MAA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years 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.