VLA1553: Presenting Single-Shot Chikungunya Vaccine Candidate at Leading Scientific Conferences
October 10, 2022
Valneva initiated rolling submission with the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for licensure of its single-shot chikungunya vaccine candidate in individuals aged 18 years and above in August 2022.
This BLA submission follows final pivotal Phase 3 data reported in March 2022[1] and final lot-to-lot consistency results reported in May 2022[2]. A clinical study of VLA1553 in adolescents is ongoing in Brazil[3], which may support future regulatory submissions in this group if VLA1553 is approved in adults.
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.
Saint-Herblain (France), October 10, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA),
a specialty vaccine company, announces today it will present on its single-shot chikungunya vaccine candidate at several leading scientific conferences during the fourth quarter of 2022.
At the World Vaccine Congress Europe in Barcelona, Valneva will present
“One step closer to a chikungunya vaccine: update on Valneva’s live-attenuated vaccine candidate,”
on October 13, 2022 at 2:45pm CEST. The Company will also have a display in the
exhibit area at booth #46 for the duration of the Congress, from October 11 through 14, 2022.
On October 27, 2022 at 10:30am ICT, Valneva will present
“Progress of Clinical Development of a Live-Attenuated Single Shot Chikungunya Vaccine Candidate” as part of the
Vaccines for Tropical Diseases symposium at the 20th International Congress for Tropical Medicine and Malaria (ICTMM2020) in Bangkok.
Valneva will also present on the Phase 3 clinical development of its single-shot chikungunya
vaccine candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 2022 Annual Meeting,
taking place October 30 through November 3, 2022 in Seattle.
The Company will present an abstract on November 1, 2022 at 10:15am PST during an in-person scientific session.
At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) European Congress taking
place November 6 through 9, 2022 in Vienna and online, two posters will be presented:
“Burden of Illness and Paucity of Treatment of the Mosquito-Borne Chikungunya Virus (CHIKV)” and
“The Economic Burden of the Globally Spreading Chikungunya Virus: A Systematic and Targeted Review.”
Finally, the Company will present at the Joint International Tropical Medicine Meeting (JITMM) 2022 in
Bangkok from December 7 through 9, 2022.
Presentations will be made by Valneva’s senior scientific leadership, including Juan Carlos Jaramillo, MD,
Chief Medical Officer of Valneva; Katrin Dubischar, VP Program Director – Chikungunya Vaccine; and Susanne Eder-Lingelbach, VP Clinical Development, among others.
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