FDA Approves Recombinant Chikungunya Vaccine, Vimkunya
The vaccine is the first virus-like particle single-dose vaccine for chikungunya for patients 12 years and older.
The FDA approved chikungunya vaccine, recombinant (Vimkunya), as the first virus-like particle single-dose vaccine against chikungunya for patients 12 years and older. The vaccine was approved under priority review and was based on 2 phase 3 clinical trials.1
The vaccine was approved under priority review and was based on 2 phase 3 clinical trials. | Image Credit: Daniel CHETRONI | stock.adobe.com
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 news release. “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.”1
Chikungunya virus is a mosquito-borne viral disease, with outbreaks previously occurring in Africa, the Americas, Asia, Europe, and islands in the Indian and Pacific Oceans. Additionally, the virus has the potential to spread to other areas via infected travelers, according to the CDC. The most common symptom includes fever and joint pain, but others can include headache, muscle pain, joint swelling, or rash. Currently, there are no treatments for the virus.Most patients recover from illness in approximately 1 week; however, there are long-term effects, such as joint pain.2,3
In a phase 3 trial (NCT05072080), investigators enrolled 3254 patients who received randomized vaccination with either a single intramuscular injection of the vaccine or the placebo. The results showed that the vaccination was highly immunogenic up to 22 days postvaccination, with neutralizing antibodies in 98% of patients who were vaccinated. Vaccination post-2 weeks showed neutralizing antibodies in 97% of patients, and at 6 months, the percentage was 86% of individuals.In another study (NCT05349617), the results showed that after 22 days postvaccination, 87% of adults 65 years and older had neutralizing antibodies.4
In 2023, the FDA approved Ixchiq, which became the first licensed vaccination for the virus for adults 18 years and older who are at risk of exposure.Ixchiq is a live-attenuated vaccine that is administered via a single dose intramuscularly. The vaccine could cause symptoms that might be similar to chikungunya disease. Ixchiq was approved under the accelerated approval pathway and was also granted fast track and breakthrough designations. The FDA also granted it priority review.5
For this vaccine, investigators found that it met all primary and secondary end points, including proportion of participants with seropositive chikungunya virus antibody levels and immune response at 7, 28, and 84 days. A total of 4115 patients were enrolled in the study, and the most commonly reported adverse effects included headache, fatigue, muscle pain, joint pain, fever, nausea, and tenderness at the injection site.5
READ MORE: Infectious Diseases Resource Center
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