FDA Approves Bavarian Nordic’s Chikungunya Vaccine

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Denmark-based Bavarian Nordic announced on Feb. 14, 2025 that its recombinant vaccine for chikungunya, marketed as Vimkunya, was approved by FDA for use in individuals aged 12 and older, the first such virus-like particle (VLP), single-dose vaccine for the chikungunya virus in the United States (1).

Vimkunya was previously recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency at CHMP’s January 2025 meeting (2). FDA’s approval carries with it a priority review voucher (PRV) under the Tropical Disease PRV program, which Bavarian Nordic said it intends to monetize when appropriate (1).

“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, in a company press release (1). “As climate change continues to expand the reach of mosquito-borne illnesses [such as] 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.”

As Chaplin indicated, chikungunya is a mosquito-borne disease caused by the virus of the same name (CHIKV) (1). Bavarian Nordic said CHIKV has been identified in more than 110 countries, and over the last five years, evidence of transmission has been confirmed in more than 50 countries. Also, CHIKV may be underreported or misdiagnosed as dengue fever due to a similar symptom profile.

Those symptoms, according to Bavarian Nordic, include fever, rash, fatigue, headache, and joint pain that can be severe or even incapacitating. Although most patients recover, as many as 40% may have chronic symptoms lasting anywhere from months to years (1).

More than 200 deaths from chikungunya were reported worldwide in 2024, out of 620,000 confirmed cases (1).

FDA approved Vimkunya under priority review based on results from two Phase III trials, which between them enrolled 3500 healthy people in the appropriate age range (12 and older). Twenty-one days after the administration of the single-dose vaccination, neutralizing antibodies were induced in up to 97.8% of treated individuals, with a rapid immune response beginning within one week (1). Vaccine-related adverse events were reported to have been mostly mild to moderate in nature.

Bavarian Nordic was noticeably involved in the race to develop an effective vaccine against another virus, in 2022. As reported by Pharmaceutical Technology Europe^TM at the time, as the World Health Organization was receiving reports of mpox cases in countries where that virus was not endemic, Bavarian Nordic was one of four main companies—along with Siga Technologies, Emergent BioSolutions, and Moderna—working on treatments and vaccines (3). Bavarian Nordic’s efforts consisted primarily of signing multiple supply contracts for its existing smallpox vaccine, which was considered one of the main therapeutic options available in efforts to immediately curb the outbreak.

Following the FDA approval of Vimkunya, plus the positive opinion from CHMP, Bavarian Nordic expects to make this vaccine commercially available in the US and in key European markets by the end of the first half of 2025 (1).

References

1. Bavarian Nordic. Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. Press Release. Feb. 14, 2025.
2. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. Press Release. Jan. 31, 2025.
3. Thomas, F. An Unusual Threat. Pharmaceutical Technology Europe 2022, 34 (6).