The approval is based on positive phase 3 clinical trial results, offering an effective option for travelers and others at risk of chikungunya, the mosquito-borne illness.
Bavarian Nordic received approval from the US Food and Drug Administration (FDA) for its Vimkunya chikungunya vaccine for individuals aged 12 and older. The vaccine, the first virus-like particle (VLP) single-dose vaccine for chikungunya, was approved based on phase 3 clinical trial results showing up to 97.8% of participants developed neutralizing antibodies within 21 days. The vaccine is expected to be available in the US in the first half of 2025, and the FDA awarded a Tropical Disease Priority Review Voucher to the company.1
Vimkunya aims to address chikungunya, a mosquito-borne disease affecting travel destinations. The vaccine will also be launched in European markets in 2025, pending final approval. In clinical trials, Vimkunya was well tolerated, with mild or moderate side effects. The vaccine approval supports the need for solutions to address the rising impact of mosquito-borne diseases.1
The approval follows positive results in two Phase 3 trials involving over 3,600 individuals aged 12 and older.2 In the first trial (NCT05072080), which enrolled 3,254 participants aged 12 to 64, 98% showed strong neutralizing antibody responses up to 22 days post-vaccination. A similar response was seen in a second trial (NCT05349617) involving participants aged 65 and older, with 87% producing neutralizing antibodies. Both trials met their primary endpoints, demonstrating high levels of seroprotection against chikungunya, and the vaccine was well-tolerated with mostly mild to moderate adverse events.3
Bavarian Nordic's Vimkunya vaccine received FDA approval for those 12 and older after phase 3 trials showed up to 97.8% neutralizing antibody development.
The vaccine will be available in the US by mid-2025 and in Europe after final approval.
Vimkunya showed strong seroprotection in two Phase 3 trials, helping address the rise of mosquito-borne diseases.
Chikungunya, caused by CHIKV, often presents with symptoms of fever and joint pain that typically resolve within a week. Although, some individuals experience debilitating joint pain that can last for months. The new vaccine is an adjuvanted virus-like particle (VLP)-based vaccine, administered as a single intramuscular (IM) dose. Chikungunya has spread globally, causing acute symptoms and long-term joint pain in some cases.4
After the promising trial results, the chikungunya vaccine initially received FDA Breakthrough Therapy and Fast Track designations. The approval comes as the second chikungunya vaccine to reach the US market, following Valneva’s live chikungunya vaccine, Ixchiq, which received Accelerated Approval in November 2023. Unlike Ixchiq, which is indicated for adults, Bavarian Nordic’s vaccine is designed for younger and older adults, making it a key option for broader population protection.2
The CDC currently recommends chikungunya vaccination for travelers at higher risk of CHIKV exposure or those at increased risk of severe disease. The approval of Bavarian Nordic’s vaccine provides an additional tool in global efforts to combat the disease, which remains a public health concern in several regions.
