FDA approval of Vimkunya (vaccine) for chikungunya for persons aged 12 and older – Bavarian Nordic

Bavarian Nordic A/S announced that the FDA has approved Vimkunya (Chikungunya Vaccine, Recombinant) for injection, the first virus-like particle (VLP) single-dose chikungunya vaccine in the U.S. for persons 12 years of age and older.

The FDA approved Vimkunya under Priority Review, based on results from two phase III clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. 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. 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 nature. 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.