Valneva’s chikungunya vaccine Ixchiq approved in Europe

Valneva has announced that the European Commission has approved its live-attenuated vaccine, Ixchiq, for preventing chikungunya virus infection in adults aged 18 and older. This approval marks the third regulatory clearance for the vaccine, following U.S. and Canadian approvals last year.

Juan Carlos Jaramillo, Valneva's chief medical officer, highlighted the significance of this approval in light of climate change, which has facilitated the spread of the Aedes mosquito to new areas in Europe. Jaramillo emphasized the importance of offering a vaccine not only to European travelers visiting chikungunya-endemic regions but also to the local European populations. The vaccine is expected to be available in European markets by the fourth quarter.

The European Medicines Agency's (EMA) advisory panel had given a favorable opinion on the vaccine last month, paving the way for the Commission's approval. This decision is supported by the results from the Phase III VLA1553-301 study, which involved over 4000 adults in the United States. The trial demonstrated a 98.9% seroresponse rate 28 days after a single dose of Ixchiq, with nearly 97% of participants maintaining their response for 24 months, consistently across different age groups. Additionally, pivotal data from a study in adolescents showed promising results six months after a single dose, which could support expanding the vaccine's use to ages 12 to 17.

Ixchiq’s accelerated approval by the U.S. Food and Drug Administration (FDA) was initially expected in August of last year but was delayed to November as the agency needed more time to finalize the vaccine's Phase IV program. The FDA also mandated including a warning about the potential risk of severe chikungunya-like adverse reactions on the vaccine's label.

Valneva plans to use the clinical data to support ongoing regulatory review in Brazil, aiming for the first potential approval for use in an endemic population. The company has partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) and Brazil's Instituto Butantan to enhance vaccine access in low- and middle-income countries.

In addition to Valneva, Danish biotech company Bavarian Nordic is also pursuing the chikungunya vaccine market. Bavarian Nordic recently submitted marketing applications to both the FDA and EMA for its own virus-like particle-based vaccine candidate.