Europe Issues Positive Opinion for IXCHIQ Chikungunya Vaccine

Valneva SE today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva's IXCHIQ® single-dose vaccine for the prevention of disease caused by the chikungunya virus in adults.

The European Commission will review the CHMP recommendation, and a decision on the marketing authorization application (MAA) of IXCHIQ in the European Union (EU), Norway, Liechtenstein, and Iceland is expected in the third quarter of 2024.

It will become the first chikungunya vaccine available in the EU under the International Reliance Procedure to address this unmet medical need if approved. 

The U.S. Food and Drug Administration approved IXCHIQ in 2023. In February 2024, the U.S. Centers for Disease Control and Prevention (CDC)  vaccine committee voted to recommend using IXCHIQ.

Valneva is also preparing an MAA for submission to the U.K. Medicines and Healthcare products Regulatory Agency.

Two additional MAAs are under review by Health Canada and the Brazilian Health Regulatory Agency, with potential approvals in 2024.

Dr. Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations, commented in a press release on May 31, 2024, "Over one billion people live in areas where Chikungunya is endemic, and recent large outbreaks underline the urgent need for safe and effective vaccines against this debilitating disease."

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus, which is transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans four to seven days after the mosquito bite.

According to the U.S. CDC, chikungunya outbreaks have accelerated in 2024.

For example, the CDC recently issued a Level 2 Travel Health Advisory for the Maldives. Local authorities reported elevated chikungunya activity in multiple areas in the Maldives in May 2024.