FDA Approves Vimkunya for prevention of Chikungunya

The US Food and Drug Administration (FDA)  has  granted accelerated approval to Vimkunya, a recombinant chikungunya vaccine, for individuals aged 12 and older. The decision was based on a phase 3 clinical trial (NCT05072080), which evaluated the safety and immune response of a single intramuscular dose of Vimkunya in 2,559 participants, compared to 424 receiving a placebo.

The FDA approved VIMKUNYA under Priority Review, based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies 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. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature1. 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 approval of our chikungunya vaccine is a testament to our unwavering commitment to addressing unmet medical needs and protecting communities worldwide,” said Paul Chaplin, President and CEO of Bavarian Nordic. “As climate change continues to expand the reach of mosquito-borne illnesses like chikungunya, this milestone underscores the importance of cutting-edge solutions to safeguard travelers and vulnerable populations. We are proud to provide the first vaccine specifically approved for the prevention of chikungunya virus in individuals aged 12 and over, offering a critical tool to combat this emerging and growing health challenge.”

Concurrent with the approval, the FDA awarded Bavarian Nordic a Priority Review Voucher (PRV) under the Tropical Disease PRV program, which the Company intends to monetize when appropriate.

Bavarian Nordic aims to provide commercial availability of VIMKUNYA in the U.S. in the first half 2025.

The vaccine recently received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and will also be launched in key European markets in the first half of 2025, pending adoption of a final decision on the marketing authorization by the European Commission.

About chikungunya

Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years2. 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 years3. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide4. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile5.

About VIMKUNYA™ (Chikungunya Vaccine, Recombinant)

VIMKUNYA is a vaccine for prevention of disease caused by chikungunya virus in people 12 years of age and older.

Additional clinical studies are required to confirm the clinical profile of VIMKUNYA, and confirmatory efficacy studies are also planned as part of the post-marketing commitments and requirements as agreed with the FDA.

VIMKUNYA is supplied as a single-dose 1-mL glass pre-filled syringe with 0.8 mL dose volume.