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.
Chikungunya is a mosquito-borne viral disease characterized by the sudden onset of fever, rash and severe joint pain, which can persist for months or even years. Historically confined to parts of Africa and Asia, the virus has expanded its reach over the past two decades, now affecting over 110 countries across Asia, Africa and the Americas.3 In 2024 alone, more than 620,000 cases and over 200 deaths were reported globally, underscoring the need for effective preventive measures.4
Innovative vaccine design and clinical evaluation
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
Implications and future outlook
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
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
Editor: Katey Gabrysch, Editorial Director.
Disclosures: This article was created by the touchINFECTIOUS DISEASES team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: Chikungunya Milestone: FDA approves first chikungunya vaccine for teens and adults. touchINFECTIOUS DISEASES. May 8, 2025.
References
- Bavarian Nordic. Bavarian Nordic announces commercial launch of chikungunya vaccine. 2025. Available at: www.bavarian-nordic.com/media/chikungunya/2025-03-18-commercial-launch-of-chikungunya-vaccine.aspx (accessed 6 May 2025)
- Bavarian Nordic. Bavarian Nordic’s chikungunya vaccine receives recommendation from US CDC’s Advisory Committee on Immunization Practices (ACIP). 2025. Available at: www.bavarian-nordic.com/media/media/news.aspx?news=7130 (accessed 6 May 2025)
- World Health Organization. Chikungunya fact sheet. 2025. Available at: www.who.int/news-room/fact-sheets/detail/chikungunya (accessed 6 May 2025)
- European Centre for Disease Prevention and Control. Chikungunya virus disease case notification rate per 100 000 population, January 2024-December 2024. 2025. Available at: www.ecdc.europa.eu/en/publications-data/chikungunya-virus-disease-case-notification-rate-100-000-population-january-2024 (accessed May 2025)
- Epocrates. Recombinant chikungunya vaccine approved. 2025. Available at: www.epocrates.com/online/article/recombinant-chikungunya-vaccine-approved (accessed 6 May 2025)
- ClinicalTrials.gov. A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine). 2024. Available at: www.clinicaltrials.gov/study/NCT05072080 (accessed 08 May 2025)
- ClinicalTrials.gov. Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years. 2024. Available at: www.clinicaltrials.gov/study/NCT05349617 (accessed 08 May 2025)
- Bavarian Nordic. Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. 2025. Available at: www.bavarian-nordic.com/media/media/news.aspx?news=7053. (accessed May 2025)
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