Valneva SE announced the submission of a marketing application with the European Medicines Agency (EMA) for approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553. Valneva was also granted accelerated assessment1 for the application by EMA’s Committee for Medicinal Products for Human Use (CHMP) based on the vaccine candidate’s “major interest for public health and therapeutic innovation”.
VLA1553 is currently the first and only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. A Biologic License Application (BLA) is currently under priority review by the U.S. Food and Drug Administration (FDA)2 with a Prescription Drug User Fee Act (PDUFA) action date planned for the end of November 20233. Additionally, a marketing application is under review by Health Canada4.
If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “We welcome EMA’s accelerated assessment and will work closely with them to bring this vaccine to market. Chikungunya virus, or CHIKV, is a serious and debilitating mosquito-borne viral infection that poses a significant unmet need and the risk of chikungunya spreading in Europe is relatively high due to the possibility of infected travelers5. No vaccine or specific treatments are currently available for this debilitating disease. We will continue to work diligently to bring VLA1553 to different territories as soon as possible.”
The regulatory submissions with the EMA, FDA and Health Canada follow final pivotal Phase 3 data in March 20226 (Lancet article), final lot-to-lot consistency results in May 20227, twelve-month persistence data in December 20228 and positive initial Phase 3 safety data in adolescents9.
VLA1553 was granted PRIority MEdicine (PRIME) designation by EMA in 2020 and received FDA Fast Track and Breakthrough Therapy designations in 2018 and 2021, respectively.
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