Valneva recently announced the approval of IXCHIQ by the US Food and Drug Administration (FDA), marking the approval of the world’s first chikungunya vaccine. IXCHIQ is a single-dose, live-attenuated vaccine for use in adults 18 years of age and older, for the prevention of disease caused by the chikungunya virus (CHIKV). IXCHIQ has the potential to mitigate a major public health threat, and prevent millions of cases of chikungunya worldwide, says GlobalData, a leading data and analytics company.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “In spite of the significant disease burden, there are currently no treatment options for chikungunya, and prevention has previously relied upon the avoidance of mosquito bites. The approval of IXCHIQ therefore addresses an important unmet need and has the potential to benefit millions of lives.”

Valneva’s pivotal Phase III data demonstrated positive seroresponse rates 28 days post-vaccination and six months post-vaccination, exhibiting the vaccine’s ability to sustain antibody responses over time*. Valneva has also partnered with Instituto Butantan to continue clinical testing of the vaccine and make it accessible to those most affected by chikungunya in low- and middle-income countries (LMICs)**.

Kurdach continues: “IXCHIQ’s approval in the US will enhance Valneva’s travel vaccines business unit and add to a portfolio of vaccines against diseases such as Japanese encephalitis and cholera/enterotoxigenic E. coli (ETEC). However, over time, IXCHIQ will be the most advantageous for individuals in LMICs, as it only requires one dose for maximum effectiveness. This ensures protection from CHIKV, while eliminating possible access constraints.”

The US Advisory Committee on Immunization Practices (ACIP) will meet at the end of February 2024, where they will vote on the recommended use of IXCHIQ.

According to GlobalData, there are also four other vaccines currently in late-stage development (PII-III) for chikungunya. One product of interest is Bavarian Nordic’s CHIKV VLP, a subunit vaccine in Phase III clinical testing which has reported positive safety and immunogenicity data***. CHIKV VLP has received Breakthrough Therapy designation and Fast Track designation from the FDA, as well as PRIME (PRIority MEdicines) designation from European Medicines Agency (EMA).

Kurdach concludes: “Mosquitoes are the world’s deadliest animals. The approval of IXCHIQ is a major milestone in the prevention of chikungunya, especially as climate change and current travel patterns are exacerbating the spread of mosquito-borne diseases, thereby increasing the demand for effective prophylactic options.”

*Valneva’s pivotal Phase III data show that following a single vaccination, IXCHIQ demonstrated a 98.9% seroresponse rate 28 days post-vaccination. Furthermore, IXCHIQ demonstrated a 96.3% seroresponse rate six months post-vaccination. Valneva plans to continue monitoring antibody persistence for at least five years.

**Clinical trial NCT04650399 is ongoing in Brazil. This would be the first potential approval for use in an endemic region.

***The Phase III development program for CHIKV VLP consists of two studies, NCT05072080 and NCT05349617. The company plans to submit regulatory filings in 2024.