FDA Approves Bavarian Nordic’s Chikungunya Vaccine Vimkunya

Image Credit: Adobe Stock Images/Arora Chan

The FDA has approved Bavarian Nordic’s Vimkunya, the first virus-like particle (VLP) chikungunya vaccine for patients over 12 years of age. According to the company, approval was based on strong immunogenicity data from two Phase III trials that included over 3,500 participants. Vimkunya was previously granted Priority Review and received a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency.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, CEO, Bavarian Nordic, in a press release. “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.”

In the Phase III trials, the vaccine was found to neutralize antibodies in up to 97.8% of recipients within 21 days and demonstrated a rapid response within one week of treatment, which was the primary endpoint of the study. Additionally, the vaccine was reported to be well tolerated, with most vaccine-related adverse events being mild or moderate. According to Bavarian Nordic, additional studies are required to determine the clinical profile of Vimkunya.

Bavarian Nordic warns against administering Vimkunya in patients who are allergic to the vaccine or any of its ingredients. Additionally, patients with a compromised immune system may have a minimal response to Vimkunya, including those who take medications that affect the immune system.¹

According to the Centers for Disease Control and Prevention (CDC), anywhere from 3% to 28% of people infected with chikungunya virus will remain asymptomatic. The virus mainly occurs in tropical and subtropical regions, affecting up to 75% of the population in areas where the virus is prevalent. In Africa, outbreaks are most common after long periods of drought, while in most regions, it is most common during the tropical rainy season.²

According to the European Center for Disease Prevention and Control, over 5,000 cases of chikungunya were reported in January across three countries in the Americas and one in Europe, with two deaths. In 2024, there was a total of 620,000 cases of chikungunya and 213 deaths. The highest number of cases were reported in Brazil, with a total of 422,615. There were also a high number of cases reported in Paraguay, Argentina, and Bolivia. In Asia, India reported 192,518 cases, with Pakistan coming in a distant second. In Africa, Senegal was the only country to report, with nine cases.³

According to the CDC, an average of 28 people per year between 2006 and 2013 tested positive for chikungunya in the United States. All reported cases were in travelers returning from affected areas in Asia, Africa, or the Indian Ocean. Before 2006, it was rarely found in the United States. In 2024, 199 cases were reported inp travelers who were either returning from other regions or people from those regions visiting the United States.⁴

Vimkunya is expected to be commercially available in the United States in the first half of 2025, with a European launch anticipated following EMA approval.¹

References

1. Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older. GlobeNewswire. February 14, 2025. Accessed February 18, 2025. https://www.globenewswire.com/news-release/2025/02/14/3026914/0/en/Bavarian-Nordic-Receives-U-S-FDA-Approval-of-Chikungunya-Vaccine-for-Persons-Aged-12-and-Older.html

2. Chikungunya CDC Yellow Book 2024. CDC. Accessed February 18, 2025. https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/chikungunya#:~:text=Chikungunya%20virus%20occurs%20in%20tropical,Ae.

3. Chikungunya worldwide overview. ECOC. Accessed February 18, 2025. https://www.ecdc.europa.eu/en/chikungunya-monthly

4. Chikungunya in the United States. CDC. Accessed February 18, 2025. https://www.cdc.gov/chikungunya/data-maps/chikungunya-us.html#:~:text=Chikungunya%20in%20the%20United%20States%20*%20Chikungunya,from%20U.S.%20states%20or%20territories%20since%202019.