Speaking on the approval, Paul Chaplin, President and CEO of Bavarian Nordic stated: “The approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide. As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travellers and vulnerable populations. We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.”8
The US Food and Drug Administration (FDA) has approved the first virus-like particle (VLP) chikungunya vaccine PXVX0317 (VIMKUNYA™), for individuals aged 12 years and older, with Bavarian Nordic recently announcing its commercial launch.1,2 This approval addresses a critical unmet need for effective prevention of chikungunya virus infections in endemic regions. Prior to this, the only FDA approved vaccine for chikungunya prevention was indicated for travellers aged 18 and older.
VIMKUNYA™ employs a recombinant VLP approach, utilizing non-infectious particles that mimic the chikungunya virus to elicit an immune response without causing disease. This design offers a favourable safety profile, which is particularly important for immunocompromised individuals.2,5
The FDA’s approval was based on data from two pivotal phase 3 trials involving individuals aged 12 years and older, with positive safety and immunogenicity results in adolescents, adults (NCT05072080)6, and older adults (NCT05349617).7 The studies demonstrated that, by 21 days post-vaccination, up to 97.8% of individuals had developed neutralizing antibodies, with a rapid immune response initiated within 1 week. The single-dose vaccine was well tolerated, with adverse events primarily mild to moderate.2,5
The approval of VIMKUNYA™ marks a pivotal step in combating the spread of chikungunya, providing a tool for prevention in both endemic regions and among travellers. The vaccine is planned for commercial launch in the USA in the first half of 2025, with anticipated approvals and launches in key European markets expected shortly thereafter.1,2
(Originally published around May of this year.)
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