Chikungunya – VLA1553

Chikungunya is a mosquito-borne virus that has spread to more than 100 countries, with the potential to rapidly expand further through infected travelers who carry the virus to their home countries. With no preventive vaccine or specific treatment yet available, chikungunya is considered a major public health threat. VLA1553 is currently the only chikungunya vaccine candidate for which a regulatory review process is underway with the FDA[1] and, if approved, it could become the first chikungunya vaccine available to address this unmet medical need.

• In February 2023, Valneva was granted Priority Review of a BLA by the FDA[2] for approval of VLA1553 in persons aged 18 years and above;[3]. VLA1553 has currently been assigned a Prescription Drug User Fee Act (PDUFA) review goal date for end of August 2023.
• The BLA application follows final pivotal Phase 3 data in March 2022[4], final lot-to-lot consistency results in May 2022[5] and positive twelve-month persistence data in December 2022[6].
• A clinical study of VLA1553 in adolescents in Brazil is ongoing[7], for which Valneva reported enrollment and vaccination completion in February 2023[8]. This trial 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 in Brazil, which would be the first potential approval for use in endemic populations.
• 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.
• Valneva currently plans to make additional regulatory submissions for VLA1553 in the second half of 2023. The sponsor of the first chikungunya vaccine approved in the U.S. is eligible to receive a Priority Review Voucher (PRV)[9].

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

[2] FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review – Valneva

[3] FDA Accepts Valneva’s Chikungunya Vaccine License Application for Priority Review – Valneva

[4] Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate

[5] Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate

[6] Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate – Valneva

[7] Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate – Valneva

[8] Valneva Completes Enrollment for Adolescent Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate – Valneva

[9] Tropical Disease Priority Review Voucher Program | FDA