The European Commission (EC) has granted marketing authorisation to Valneva’s single-dose chikungunya vaccine Ixchiq for use in individuals aged 18 years and older.
Chikungunya is a mosquito-borne viral disease that causes symptoms including fever, severe joint and muscle pain, headache, nausea, fatigue and rash.
The virus has now been identified in over 110 countries in Europe, Asia, Africa and the Americas, with more than 3.7 million cases reported in the Americas alone between 2013 and 2023.
The EC’s decision on Ixchiq follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by positive results from a late-stage trial, which demonstrated a 98.9% seroresponse rate at 28 days after a single dose of the vaccine.
This immune response was sustained for 24 months by 97% of study participants and was equally durable in younger and older adults, Valneva said.
The company also recently shared further positive data for the vaccine in adolescents. The results showed that a single-dose generated a high and sustained immune response in an immunogenicity subset of adolescents who were chikungunya-negative at baseline, with a seroresponse rate of 99.1% after 180 days following vaccination compared to 98.8% after 29 days.
The day 180 data also confirmed that a single dose of the vaccine was generally safe and well tolerated in adolescents, regardless of previous infection status.
Juan Carlos Jaramillo, Valneva’s chief medical officer, said the approval “marks a crucial milestone toward making this vaccine available to as many European citizens as possible”.
“It is critical to provide a vaccine solution not only to European travellers going to endemic chikungunya areas, such as South America or Africa, but also to the local European populations experiencing invasive mosquito attacks,” he said.
The approval comes less than eight months after Ixchiq became the first chikungunya vaccine to be licensed anywhere in the world after receiving accelerated approval from the US Food and Drug Administration for use in individuals ages 18 years and older who are at an increased risk of exposure to the disease.