Officials with Bavarian Nordic A/S have announced that the FDA has approved their recombinant chikungunya vaccine (Vimkunya) for injection, the first virus-like particle single-dose chikungunya vaccine in the United States for persons aged ≥12 years.1
The approval was based on results from 2 phase 3 clinical trials that enrolled more than 3500 healthy individuals. Three weeks after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals and demonstrated a rapid immune response that started to develop within 1 week.
“The approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide,” Paul Chaplin, President and CEO of Bavarian Nordic, said in a press release about the vaccine approval. “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 travelers 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.”
Concurrent with the approval, the FDA awarded Bavarian Nordic a Priority Review Voucher (PRV) under the Tropical Disease PRV program, which the company intends to monetize when appropriate.
Bavarian Nordic provided commercial availability of Vimkunya in the United States as of March 18, 2025.
Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past 5 years. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30% to 40% of those affected may develop chronic symptoms that can last for months or even years. In 2024, 620,000 cases of chikungunya and more than 200 deaths were reported worldwide. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile.
Reference
Bavarian Nordic. Bavarian Nordic receives U.S. FDA approval of chikungunya vaccine for persons aged 12 and older [press release]. February 14, 2025. Accessed February 17, 2025. www.bavariannordic.com/media/media/news.aspx?news=7053