The European Medicines Agency’s human medicines committee has recommended Valneva’s single-dose chikungunya vaccine for use in individuals aged 18 years and older.
If approved by the European Commission, Ixchiq will become the first vaccine available in the EU against the chikungunya virus.
Chikungunya is a mosquito-borne viral disease that often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.
Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash.
The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was 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, chief medical officer of Valneva, said: “This positive CHMP opinion marks a crucial milestone toward introducing a preventative solution against chikungunya in the EU.”
Jaramillo continued: “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.”
The positive opinion comes just over six 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.