Chikungunya Vaccine Receives FDA Approval for Individuals 12 Years and Older

Chikungunya vaccine (VimKunya; Bavarian Nordic A/S) was granted FDA approval for patients aged 12 and older to prevent against chikungunya virus (CHIKV) during travel. The decision was based on data from two phase 3 clinical trials which met their primary end points.

Vial of vaccine for chikungunya virus | Image Credit: © kitsawet - stock.adobe.com

Chikungunya is caused by CHIKV, an illness spread by mosquitoes that has proliferated throughout Asia, Africa, and the Americas during the last 20 years, including several well-known tourist destinations. This spread frequently results in massive, erratic epidemics. Over 110 nations have detected CHIKV since its discovery, and during the last 5 years, more than 50 countries have confirmed evidence of transmission.¹

Acute symptoms of chikungunya usually include fever, rash, headache, exhaustion, and frequently excruciating, incapacitating joint pain. Although the majority of patients recover, 30% to 40% may experience long-term symptoms that persist for months or even years. More than 200 chikungunya deaths and 620,000 cases were reported globally in 2024.¹

Chikungunya vaccine is a recombinant vaccination designed to protect individuals aged 12 and up from chikungunya virus-related illnesses. It is a virus-like particle (VLP) vaccine that is designed to mimic the virus without the ability to infect cells, replicate, or cause disease. Chikungunya vaccine comes in a single-dose glass syringe that is pre-filled with 0.8 mL of dose volume.¹

The approval of chikungunya vaccine is based on positive data from two phase 3 trials. In one of the phase 3 trials (NCT05072080), researchers recruited 3254 individuals who were randomized to receive a single intramuscular injection of the vaccine or placebo. Neutralizing antibodies were found in 98% of vaccinated patients, indicating that the immunization was highly immunogenic at up to 22 days after vaccination. Neutralizing antibodies were detected in 97% of patients after 2 weeks of vaccination and 86% of people at 6 months. In the second phase 3 trial (NCT05349617), 87% of persons aged 65 and over exhibited neutralizing antibodies 22 days after immunization.^1-4

“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,” said Paul Chaplin, president and CEO of Bavarian Nordic, in a press release. “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.”⁴

The FDA approval of the chikungunya vaccine marks a significant advancement in global public health, providing a critical preventive tool against a virus that has spread across multiple continents. As chikungunya outbreaks continue to emerge unpredictably, particularly in regions frequented by travelers, this vaccine offers a critical layer of protection.

REFERENCES

1. Bavarian Nordic receives U.S. FDA Approval of chikungunya vaccine for persons aged 12 and older. Globe Newswire. February 14, 2025. Accessed February 17, 2025. https://www.globenewswire.com/news-release/2025/02/14/3026914/0/en/Bavarian-Nordic-Receives-U-S-FDA-Approval-of-Chikungunya-Vaccine-for-Persons-Aged-12-and-Older.html

2. FDA approves recombinant chikungunya vaccine, Vimkunya. Drug Topics. February 17, 2025. Accessed February 17, 2025. https://www.drugtopics.com/view/fda-approves-recombinant-chikungunya-vaccine-vimkunya

3. A phase 3 trial of the VLP-based chikungunya vaccine PXVX0317 (CHIKV VLP vaccine). Updated August 30, 2024. Accessed February 17, 2025. https://www.clinicaltrials.gov/study/NCT05072080

4. Safety and immunogenicity of CHIKV VLP vaccine PXVX0317 in adults ≥65 years. Updated December 13, 2024. Accessed February 17, 2025. https://clinicaltrials.gov/study/NCT05349617?term=NCT05349617&rank=1