FDA Rolling submission of VLA 1553 vaccine begins for chikungunya fever

This BLA submission follows final pivotal Phase III data reported in March 20221 and final lot-to-lot consistency results reported in May 20222. A clinical study of VLA 1553 in adolescents is ongoing in Brazil, which may support future regulatory submissions in this group if VLA 1553 is approved in adults.

Valneva is currently targeting the end of 2022 for completion of the BLA submission. Once all portions of the application have been submitted and if the filing is accepted, the FDA will determine priority review eligibility and the action date which the FDA will target to complete its evaluation. This rolling BLA submission is part of the accelerated approval pathway agreed upon with the FDA in 2020. The program received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively. VLA 1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA 1553 in Europe in the first half of 2023.