First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and olderRepresents first BLA for a chikungunya vaccine for adolescents
COPENHAGEN, Denmark, June 17, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the completion of the rolling submission process which was initiated in April 2024 with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older. Pending acceptance from the FDA, the BLA could support a potential approval of the vaccine in the first half of 2025.
The BLA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years of age and older, demonstrating that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong induction of chikungunya neutralizing antibodies against chikungunya 21 days after vaccination, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection. The CHIKV VLP vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature.
Bavarian Nordic also intends to submit a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) by the end of the first half 2024. The MAA has already been granted accelerated assessment, which means the CHIKV VLP vaccine could potentially obtain approval by the European Commission in the first half of 2025.
“The completion of the BLA submission marks a significant milestone in the development of our CHIKV VLP vaccine and represents an important contribution to the development of preventative solutions for individuals 12 years of age and older at risk of chikungunya virus from
