Valneva's chikungunya vaccine approved by EC

Valneva has achieved a significant milestone by securing marketing authorization from the European Commission (EC) for IXCHIQ, a single-dose vaccine intended to prevent chikungunya. IXCHIQ stands out as the world’s first vaccine targeting the chikungunya virus and is recommended for individuals aged 18 and above.

This authorization follows a unanimous endorsement by EU member states and a positive evaluation from the European Medicines Agency (EMA). The approval is based on compelling data from a Phase III clinical trial, which revealed a 98.9% seroresponse rate just 28 days after a single dose of the vaccine. Remarkably, this immune response remained robust at 97% even after 24 months, with consistent results across different age groups.

In addition, Valneva reported more positive findings in June 2024, showing strong immune responses in adolescents six months following a single vaccination. These outcomes are intended to support a potential extension of the vaccine's label to include adolescents aged 12 to 17 years.

The EC’s recent decision marks the third authorization for IXCHIQ, following earlier approvals by the US Food and Drug Administration (FDA) in November 2023 and Health Canada in June 2024. Valneva plans to begin delivering vaccine doses in Europe by the fourth quarter of 2024.

The company has also submitted a marketing authorization application to the UK Medicines and Healthcare products Regulatory Agency through the International Recognition Procedure. Additionally, an application is under review by the Brazilian Health Regulatory Agency, with potential approval expected within 2024.

To bolster the vaccine’s accessibility in low and middle-income countries, Valneva has partnered with the Coalition for Epidemic Preparedness Innovations (CEPI) and the Instituto Butantan in Brazil. This collaboration originates from an agreement made in July 2019, which includes funding support of up to $24.6 million, facilitated by the European Union’s Horizon 2020 programme.

Juan Carlos Jaramillo, the chief medical officer of Valneva, emphasized the importance of the EC approval, calling it a pivotal step towards making the vaccine available to a broad European audience. He highlighted the necessity of providing a vaccination solution not only for European travelers heading to chikungunya-endemic areas like South America and Africa but also for local European populations who are increasingly experiencing invasive mosquito attacks.