Second Chikungunya Vaccine Coming in 2025

With one approved chikungunya vaccine already available, the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Biologics License Application (BLA) for Bavarian Nordic A/S CHIKV VLP, a vaccine candidate for immunization to prevent disease outbreaks caused by chikungunya virus infection in individuals 12 years of age and older.

The Priority Review designation means the FDA aims to complete its review within six months. The FDA has assigned a target action date for the Prescription Drug User Free Act of February 14, 2025.

CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection.

Paul Chaplin, President and CEO of Bavarian Nordic, said in a press release on August 13, 2024, “The FDA review, along with the ongoing review of our CHIKV VLP vaccine by the European Medicines Agency, represent the first regulatory reviews of a chikungunya vaccine for adolescents, potentially providing a broader usage by populations at risk of this debilitating disease.”

CHIKV VLP is currently also under accelerated assessment review with the EMA, potentially supporting approval of the vaccine by the European Commission in the first half of 2025.

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV). The disease typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain.

While mortality is relatively low, morbidity is high; nearly 50% of individuals with CHIKV disease have debilitating long-term symptoms that can intensify with age.

Over the past few decades, CHIKV has emerged in several previously non-endemic regions in Asia, Africa, southern Europe, and the Region of the Americas, often causing large, unpredictable outbreaks. 

As of August 8, 2024, the Pan American Health Organization (PAHO) reported over 371,167 CHIKV cases in the Americas this year. Between 2013 and 2023, the PAHO reported more than 3.7 million CHIKV cases in the Americas. 

The U.S. CDC reported from 2006 to 2023, 4,590 travel-related CHIKV cases were reported in the U.S., in areas such as Florida.

However, Locally acquired cases have not been reported in U.S. states or territories since 2019.