FDA Approves Bavarian Nordic's Chikungunya Vaccine for Ages 12+

Bavarian Nordic A/S recently announced a significant medical breakthrough with the U.S. FDA's approval of VIMKUNYA™, a novel chikungunya vaccine. This marks the first chikungunya vaccine in the U.S. approved for individuals aged 12 and above, representing a critical advancement in the fight against this mosquito-borne virus. The vaccine, a virus-like particle (VLP) formulation, promises to be a key tool in preventing chikungunya, especially among younger travelers.

VIMKUNYA underwent Priority Review by the FDA, a testament to its potential impact on public health. The approval was based on two phase 3 clinical trials, which involved over 3,500 healthy participants aged 12 and older. These studies met their primary endpoints, showing that 21 days post-vaccination, up to 97.8% of participants developed neutralizing antibodies. Additionally, the vaccine prompted a swift immune response within a week of administration. It was noted for being well-tolerated, with adverse effects being predominantly mild or moderate.

Paul Chaplin, President and CEO of Bavarian Nordic, emphasized the importance of this milestone in the context of global climate change, which is increasing the prevalence of mosquito-borne illnesses like chikungunya. Chaplin highlighted the company's dedication to addressing unmet medical needs and safeguarding vulnerable groups, noting that VIMKUNYA represents the first vaccine specifically approved for chikungunya prevention in those 12 and older. This development is pivotal in tackling the rising health challenge posed by the virus.

In conjunction with the vaccine's approval, Bavarian Nordic received a Tropical Disease Priority Review Voucher from the FDA, which the company plans to capitalize on strategically. The vaccine is expected to be commercially available in the U.S. by the first half of 2025. Additionally, following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, the vaccine is set to launch in key European markets in the same period, pending final marketing authorization from the European Commission.

Chikungunya, caused by the chikungunya virus (CHIKV), is a disease transmitted by mosquitoes. Over the past two decades, it has spread across Asia, Africa, and the Americas, leading to unpredictable outbreaks in popular travel destinations. Since its initial identification, CHIKV has been detected in over 110 countries, with active transmission reported in more than 50 countries in recent years. Symptoms of chikungunya include fever, rash, fatigue, headache, and severe joint pain. While most patients recover, 30-40% may experience chronic symptoms lasting months or years. In 2024, global reports indicated 620,000 cases and over 200 deaths attributed to chikungunya.

VIMKUNYA, supplied as a single-dose pre-filled syringe, provides a preventive measure against the chikungunya virus for those 12 years and older. Ongoing clinical studies are required to further elucidate its clinical profile, and confirmatory efficacy studies are planned as part of post-marketing commitments in coordination with the FDA.

Bavarian Nordic is recognized for its innovative approach to vaccine development and its mission to improve global health. The company is a leading supplier of mpox and smallpox vaccines, supporting public health preparedness worldwide, and boasts an extensive travel vaccine portfolio. Through innovations like VIMKUNYA, Bavarian Nordic continues to make significant strides in combating infectious diseases.