Valneva recently announced the approval of IXCHIQ by the FDA, marking the world’s first approved 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.

Chikungunya is a mosquito-borne disease, characterised by fever, severe joint pain, headache, nausea, fatigue, and rash, that has been identified in over 110 countries across Asia, Africa, Europe, and the Americas. Despite the significant disease burden, there are currently no treatment options for chikungunya, and prevention has previously relied upon the avoidance of mosquito bites. While mortality rates associated with chikungunya are low, symptoms can be chronic and last for years. The approval of IXCHIQ therefore addresses an important unmet need and has the potential to benefit millions of lives.

IXCHIQ was the recipient of a breakthrough therapy designation and fast track designation from the FDA, as well as PRIME (PRIority MEdicines) designation from the EMA. The vaccine was approved using the FDA’s accelerated approval pathway, based upon pivotal Phase III data reported in 2022. Following a single vaccination, IXCHIQ demonstrated a 98.9% seroresponse rate 28 days post-vaccination. Further, IXCHIQ demonstrated a 96.3% seroresponse rate six months post-vaccination, exhibiting the vaccine’s ability to sustain antibody responses over time. In order to comply with the conditions of IXCHIQ’s approval, the FDA is requiring additional confirmatory clinical testing to verify the clinical benefit of the vaccine. Valneva plans to continue monitoring antibody persistence for at least five years. 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 Escherichia coli (ETEC).

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). A Phase III clinical trial involving adolescents 12–17 years of age is ongoing in Brazil (NCT04650399), which is being funded, in part, by the Coalition for Epidemic Preparedness Innovations (CEPI). This would be the first potential approval for use in an endemic region. 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.

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. Similar to IXCHIQ, CHIKV VLP was the recipient of a breakthrough therapy designation and fast track designation from the FDA, as well as PRIME designation from the EMA. The Phase III development program for CHIKV VLP consists of two studies, NCT05072080 and NCT05349617, both of which have reported positive safety and immunogenicity data. The company plans to submit regulatory filings in 2024. The other chikungunya vaccines in clinical development include Bharat Biotech’s BBV-87 (Phase III), Defender Pharmaceuticals’s TSIGSD-218 (Phase II), and Merck’s V-184 (Phase II).

As climate change and current travel patterns exacerbate the spread of mosquito-borne diseases, there is an increased demand for effective prophylactic options. The approval of IXCHIQ is a major milestone in the prevention of chikungunya. 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. 

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By GlobalData