Valneva Files for Chikungunya Vaccine Authorization with Health Canada

Saint-Herblain (France), May 30, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces the filing of a regulatory application with Health Canada for marketing approval of the Company’s single-shot chikungunya vaccine candidate, VLA1553, in persons aged 18 years and above. If accepted, Health Canada will provide additional information on the potential approval timeline.

This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023. A Biologic License Application (BLA) is currently under priority review¹ by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023.

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need. It would also represent the third vaccine Valneva has brought from early R&D to approval.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented, “Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers. This threat continues to grow as shown by the recent epidemiological alert of the Pan American Health Organization (PAHO)². No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to bring VLA1553 to different territories as soon as possible.”

The regulatory submissions with Health Canada and the FDA follow final pivotal Phase 3 data in March 2022³, final lot-to-lot consistency results in May 2022⁴ and positive twelve-month persistence data in December 2022⁵. A clinical study of VLA1553 in adolescents is ongoing in Brazil⁶, for which Valneva reported enrollment and vaccination completion in February 2023⁷. This trial, conducted by Valneva’s partner Instituto Butantan and funded by the Coalition for Epidemic Preparedness Innovations (CEPI), may support future regulatory submissions in this age group, if VLA1553 is initially approved in adults, as well as licensure of the vaccine in Europe and Brazil, which would be the first potential approval for use in an endemic population. First results are expected mid-2023.