Indications and Usage
VIMKUNYA is a vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.
The indication is approved under accelerated approval based on anti-chikungunya virus neutralizing antibody levels. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.
Important Safety Information
Contraindications
Do not administer VIMKUNYA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Warnings and Precautions
- Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions.
- Immunocompromised individuals, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VIMKUNYA.
- Syncope (fainting) may occur in association with administration of injectable vaccines including VIMKUNYA. Procedures should be in place to avoid injury from fainting.
Adverse Reactions
In clinical studies, the most common solicited adverse reactions (>10%) in individuals 12 through 64 years of age were pain at the injection site (23.7%), fatigue (19.9%), headache (18%), and myalgia (17.6%). The most commonly reported solicited adverse reactions (>5%) in individuals 65 years of age and older were injection site pain (5.4%), myalgia (6.3%), and fatigue (6.3%).
Use in Specific Populations
There are no clinical studies of VIMKUNYA in pregnant individuals.
To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic Inc. at
1-833-365-9596 or drug.safety@bavarian-nordic.com or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please see full Prescribing Information here.
References
- Preventing chikungunya. Centers for Disease Control and Prevention. Updated May 15, 2024. Accessed November 14, 2024. https://www.cdc.gov/chikungunya/prevention/
- VIMKUNYA Prescribing Information. Bavarian Nordic; 2025.
- Factors to assess when considering use of chikungunya vaccine. Centers for Disease Control and Prevention. Updated August 27, 2024. Accessed November 14, 2024. https://www.cdc.gov/chikungunya/media/pdfs/2024/05/chikungunya-vaccine-risk-factors-508.pdf
- Richardson JS, Anderson DM, Mendy J, et al. Chikungunya virus VLP vaccine: phase 3 trial in adolescents and adults. Posted October 15, 2024. doi:10.1101/2024.10.11.24315179
- Tindale LC, Richardson JS, Anderson DM, et al. Chikungunya virus VLP vaccine: phase 3 trial in adults ≥65 years of age. Posted October 11, 2024. doi:10.1101/2024.10.10.24315205