Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate

Valneva SE announces that it has initiated rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the Company’s single-shot chikungunya vaccine candidate in persons aged 18 years and above.

This BLA submission 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 approved in adults.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “This is an extremely important milestone for our VLA1553 program and we are very proud to be the first company worldwide that has begun submission of a BLA for a chikungunya vaccine candidate. Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible.”

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. VLA1553 was also granted PRIority MEdicine (PRIME) designation by the European Medicines Agency (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe in the first half of 2023.