Bavarian Nordic Secures Approval for VIMKUNYA™ Chikungunya Vaccine
Saturday, February 15, 2025
Bavarian Nordic has received approval from the United States Food and Drug Administration (FDA) for VIMKUNYA™ (Chikungunya Vaccine, Recombinant).
Chikungunya is a mosquito-borne viral disease that has spread widely across Asia, Africa, and the Americas over the past two decades, often leading to unpredictable outbreaks.
It has been detected in over 110 countries, with active transmission confirmed in more than 50 nations in the past five years. The infection causes symptoms such as fever, rash, fatigue, headache, and severe joint pain, which can be prolonged in 30-40% of cases.
In 2024, approximately 620,000 cases and over 200 deaths were recorded worldwide. Chikungunya is frequently misdiagnosed as dengue fever due to similar symptoms.
VIMKUNYA is designed to prevent chikungunya virus infection in individuals aged 12 and above. Additional clinical studies are planned to further evaluate its efficacy and safety. The vaccine is supplied as a single-dose 0.8 mL injection in a pre-filled syringe.
This marks the first virus-like particle (VLP) chikungunya vaccine in the US, authorised for use in individuals aged 12 years and older.
The approval follows a Priority Review based on data from two Phase 3 clinical trials involving over 3,500 healthy participants. Results showed that 21 days after vaccination, up to 97.8% of recipients had developed neutralising antibodies, with an immune response beginning within one week.
The vaccine was well-tolerated, with most side effects reported as mild or moderate. As a VLP vaccine, VIMKUNYA mimics the chikungunya virus without causing infection or disease.
Alongside the approval, Bavarian Nordic has been granted a Priority Review Voucher (PRV) under the Tropical Disease PRV programme, which the company plans to monetise when suitable. Commercial availability in the US is expected in the first half of 2025.
The vaccine has also received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
A final decision on marketing authorisation from the European Commission is awaited, with launches in key European markets planned for early 2025.
Source: bavarian-nordic.com
