On March 18, 2025, Bavarian Nordic A/S announced the US commercial launch of its recently approved Chikungunya Vaccine, Recombinant (Vimkunya) for use in individuals aged 12 years and older, according to an announcement from the vaccine company.¹

Bavarian received approval for the virus-like particle (VLP) vaccine on February 14, 2025, making it the first VLP single-dose, pre-filled syringe for chikungunya among the indicated age group. Prior to this approval, the only FDA approved vaccine for chikungunya prevention, Ixchiq (Valneva), was indicated for individuals aged 18 years and older.^1,2

“The commercial availability of VIMKUNYA™ in the U.S. underscores our commitment to addressing emerging health threats and safeguarding communities nationwide,” said Lee Ann Kimak, vice president, Commercial for North America at Bavarian Nordic, in a statement.¹

“As the first virus-like particle single-dose, pre-filled syringe chikungunya vaccine, Vimkunya provides a crucial new tool to help protect at-risk individuals traveling to regions where the virus is spreading," Kimak added.

Approval of Vimkunya was based on 2 phase 3 clinical trials that enrolled over 3500 healthy individuals aged 12 years and up.

"Primary endpoints were met in the phase 3 trials, with results showing that 21 days after vaccination, Vimkunya induced neutralizing antibodies in up to 97.8% of individuals vaccinated and demonstrated a rapid immune response starting to develop within [1] week," Bavarian Nordic stated.

According to the company, the vaccine was well-tolerated and adverse events were mild or moderate.

Over the last 20 years, the mosquito-borne disease caused by the chikungunya virus has emerged in several regions in Africa, Asia, and the Americas, stated Bavarian Nordic. Since discovery, the virus has been identified in over 110 countries, with data on confirmed transmission in more than 50 countries in the last 5 years.

Presentation of chikungunya typically includes acute symptoms such as fever, rash, fatigue, headache, and severe joint pain.

More on chikungunya

Ixchiq was approved on November 10, 2023, as the world's first approved vaccine for chikungunya, in individuals aged 18 years and older who are at an increased risk of exposure to the virus.²

In January 2025, Valneva reported positive phase 2 data among children aged 1 to 11 years from the VLA1553-221 trial (NCT06106581). According to results, the vaccine was well tolerated in this age group, regardless of a half of full dose, or previous chikungunya infection.³

In the phase 3 trial, "A full dose of the vaccine exhibited a more robust immune response compared to a half dose by providing protective antibody titers already at Day 15 and Day 29 post-vaccination, confirming the excellent immunogenicity previously observed in adults and adolescents," stated Valneva at the time of data announcement.

Click here for more on IXCHIQ.

References:

1. Bavarian Nordic announces commercial launch of chikungunya vaccine in the US. Bavarian Nordic. Press release. March 18, 2025. Accessed March 18, 2025. https://www.bavarian-nordic.com/media/chikungunya/2025-03-18-commercial-launch-of-chikungunya-vaccine.aspx

2. Fitch, J. World’s first chikungunya vaccine FDA approved for individuals 18 years and up. Contemporary Pediatrics. November 10, 2023. Accessed March 18, 2025. https://www.contemporarypediatrics.com/view/world-s-first-chikungunya-vaccine-fda-approved-for-individuals-18-years-and-up

3. Fitch, J. IXCHIQ chikungunya vaccine meets phase 2 endpoint in children. Contemporary Pediatrics. January 23, 2025. Accessed March 18, 2025. https://www.contemporarypediatrics.com/view/ixchiq-chikungunya-vaccine-meets-phase-2-endpoint-in-children