Valneva completes BLA submission to FDA for chikungunya vaccine candidate

Valneva "announces that it has completed rolling submission of the Biologics License Application to the U.S. Food and Drug Administration for its single-shot chikungunya vaccine candidate, VLA1553. Valneva is seeking approval of its investigational chikungunya vaccine in persons aged 18 years and above. This BLA application follows final pivotal Phase 3 data reported in March 2022 and final lot-to-lot consistency results reported in May 2022. 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. The Company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after a single-dose vaccination."Reference Link