About VLA1553 – Valneva’s chikungunya vaccine candidate
According to Valneva, manufacturer of Ixiaro Japanese encephalitis vaccine, VLA1553 is currently the most clinically advanced chikungunya vaccine candidate worldwide. VLA1553 is meant to provide long-term protection following vaccination with a single dose.
Valneva submitted a request for FDA approval of its investigational chikungunya vaccine (VLA1553) for adults in December of 2022. If the FDA accepts the filing, the FDA will determine priority review eligibility along with the action due date upon which it will complete its evaluation.
Additionally, a clinical study of VLA1553 in adolescents is ongoing in Brazil, which may support future regulatory submissions in this group if VLA1553 is initially approved in adults. In December 2022, Valneva also reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination.
Valneva’s chikungunya program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. Valneva currently plans to make additional regulatory submissions for VLA1553 in the second half of 2023.
About chikungunya virus
Chikungunya virus, pronounced "chicken-goon-yuh," is a mosquito-borne virus. Symptoms usually appear within a week of infection, and include sudden onset fever and joint pain. Muscle pain, headache, fatigue, and rash also may occur. Treatment is aimed at helping people feel more comfortable as there is no known cure, other than giving the body time and nourishment to fight off the virus. Most people feel better within a week or so, after the virus runs its course. Chikungunya is found worldwide, particularly in Africa, Asia, and India.
Source
Valneva press release: https://valneva.com/research-development/chikungunya/#:~:text=VLA1553%20%E2%80%93%20Valneva's%20single%2Dshot%20chikungunya,vaccination%20with%20a%20single%20dose.
Comentarios