Vimkunya FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 17, 2025.
FDA Approved: Yes (First approved February 14, 2025)
Brand name: Vimkunya
Generic name: chikungunya vaccine, recombinant
Dosage form: Injection
Company: Bavarian Nordic A/S
Treatment for: Chikungunya Disease Prevention
Vimkunya (chikungunya vaccine, recombinant) is a vaccine used for the prevention of disease caused by chikungunya virus.
- Vimkunya is indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.
This indication is approved under accelerated approval based on anti-chikungunya virus neutralizing antibody levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years.
- Vimkunya is a VLP vaccine, which means that it uses virus-like particles designed to mimic the chikungunya virus without the ability to infect cells, replicate or cause disease.
- The FDA approved Vimkunya under Priority Review, based on the results from two phase 3 clinical trials. The trials met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals and demonstrated a rapid immune response starting to develop within one week.
- Vimkunya is administered as a single dose via intramuscular injection.
- Warnings and precautions associated with Vimkunya include potential anaphylactic reactions, diminished immune response in immunocompromised individuals, and syncope (fainting).
- Commonly reported solicited adverse reactions (>10%) in individuals 12 through 64 years of age include injection site pain (23.7%), fatigue (19.9%), headache (18.0%), and myalgia (17.6%).
Commonly reported solicited adverse reactions (>5%) in individuals 65 years of age and older include injection site pain (5.4%), myalgia (6.3%), and fatigue (6.3%).
Development timeline for Vimkunya
Further information
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