CHMP endorses Valneva's chikungunya vaccine for adults

The European Medicines Agency’s (EMA) human medicines committee has given a positive recommendation for Valneva's single-dose chikungunya vaccine, named Ixchiq, intended for people aged 18 and above. If the European Commission endorses this recommendation, Ixchiq will become the first vaccine available in the European Union (EU) to protect against the chikungunya virus.

Chikungunya is a viral disease transmitted by mosquitoes, known for causing sudden outbreaks with high infection rates, often affecting a significant portion of the population in regions where the virus is present. The infection typically manifests symptoms in up to 97% of individuals within three to seven days after being bitten by an infected mosquito. Common symptoms include fever, joint and muscle pain, headache, nausea, and rash.

The Committee for Medicinal Products for Human Use (CHMP) supported its recommendation with positive results from a late-stage clinical trial. This trial demonstrated a 98.9% seroresponse rate 28 days after a single dose of the vaccine. Impressively, this immune response remained strong for 24 months in 97% of the trial participants, with similar durability observed across both younger and older adults.

Valneva has also released more encouraging data regarding the vaccine's efficacy in adolescents. The findings revealed that a single dose elicited a robust and long-lasting immune response in an immunogenicity subset of adolescents who were initially chikungunya-negative. The seroresponse rate was 99.1% after 180 days post-vaccination compared to 98.8% after 29 days. Furthermore, the 180-day data confirmed that the vaccine was generally safe and well-tolerated among adolescents, irrespective of their prior infection status.

Juan Carlos Jaramillo, the chief medical officer of Valneva, expressed that the positive CHMP opinion is a significant step towards providing a preventive solution against chikungunya in the EU. He emphasized that it is vital to offer a vaccine not only to European travelers visiting endemic chikungunya regions like South America or Africa but also to local European populations now facing invasive mosquito species.

This favorable recommendation follows just over six months after Ixchiq became the first chikungunya vaccine to receive a license globally. The United States Food and Drug Administration (FDA) granted it accelerated approval for use in individuals aged 18 and older who are at increased risk of exposure to the virus.

In summary, Valneva’s single-dose chikungunya vaccine has achieved a critical milestone with the EMA’s recommendation, potentially positioning it as the first available vaccine in the EU against the chikungunya virus. This development is especially important given the high infection rates and severe symptoms associated with the disease, and it holds promise for both European travelers and local populations at risk.