EC Approves Valneva's Chikungunya Vaccine for Adults

The European Commission (EC) has granted marketing authorization to Valneva's single-dose chikungunya vaccine, Ixchiq, for use in individuals aged 18 and older. Chikungunya is a viral disease transmitted by mosquitoes, characterized by symptoms such as fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. The virus has been identified in over 110 countries across Europe, Asia, Africa, and the Americas, with more than 3.7 million cases reported in the Americas alone between 2013 and 2023.

The decision by the EC to authorize Ixchiq follows a recommendation from the European Medicines Agency’s human medicines committee. This recommendation was based on positive results from a late-stage clinical trial, which showed a 98.9% seroresponse rate 28 days after a single dose of the vaccine. The immune response continued for 24 months in 97% of the study participants, demonstrating long-lasting protection and equal efficacy in both younger and older adults, according to Valneva.

In addition to the successful late-stage trial, Valneva recently announced further positive data for Ixchiq in adolescents. These results revealed that a single dose of the vaccine produced a high and sustained immune response in a subset of adolescents who were initially chikungunya-negative. Specifically, the seroresponse rate was 99.1% after 180 days following vaccination, slightly increasing from 98.8% after 29 days. Moreover, the 180-day data confirmed that the vaccine was generally safe and well tolerated among adolescents, regardless of their prior infection status.

Juan Carlos Jaramillo, Valneva's Chief Medical Officer, emphasized that the approval is a significant achievement in making the vaccine available to European citizens. He highlighted the importance of providing a vaccine solution not only for European travelers heading to chikungunya-endemic regions like South America or Africa but also for local European populations affected by invasive mosquitoes.

The approval by the EC comes less than eight months after Ixchiq made history by becoming the first chikungunya vaccine to be licensed globally. This initial licensing was granted by the US Food and Drug Administration (FDA) for use in individuals aged 18 and older who are at increased risk of exposure to the disease.

This regulatory milestone marks a vital step forward in combating chikungunya, a disease that has significantly impacted millions of people worldwide. By offering long-term protection with a single dose, Ixchiq has the potential to greatly reduce the burden of chikungunya, providing a much-needed solution for both travelers and those living in regions where the virus is prevalent.