The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Valneva’s single-dose chikungunya vaccine for use in adults.
Ixchiq is now the first vaccine approved in the UK to prevent disease caused by the chikungunya virus (CHIKV) in individuals aged 18 years and older.
CHIKV is a mosquito-borne viral disease that causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash.
Symptoms typically resolve within seven to ten days and most patients make a full recovery. However, in some cases joint pain and arthritis may persist for several months or even years, and cases of eye, neurological and heart complications have also been reported.
The virus has now been identified in over 110 countries in Europe, Asia, Africa and the Americas, and the number of cases in India is rapidly increasing due to the current outbreak in the Indian states of Maharashtra and Telangana.
Valneva’s Ixchiq contains a weakened form of CHIKV to train the body’s immune system to recognise the virus and produce specific antibodies against it.
The MHRA’s decision is supported by late-stage data demonstrating that 99% of individuals who received the vaccine had the required level of antibodies after one month, compared with none of those who received placebo. This immune response was sustained for 24 months by 97% of study participants.
Data has since shown this response can be maintained for at least three years in both younger and older adults, Valneva said.
The company’s chief medical officer, Juan Carlos Jaramillo, said: “With the current outbreak in India, it is critical to ensure UK travellers have access to this vaccine, not only for their protection when travelling to India or other chikungunya endemic countries but also to prevent potential chikungunya transmission when returning to the UK.”
Ixchiq is already approved in the US, Europe and Canada for use in individuals aged 18 years and older.
The latest approval comes less than three weeks after Valneva shared positive results from a late-stage study of the vaccine in adolescents aged 12 to 17 years.
The company said the updated results from the phase 3 VLA1553-321 trial “strengthen” the pivotal data previously reported for Ixchiq in adolescents, which supported label extension applications for the vaccine in this age group.