Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has approved IXCHIQ®, Valneva’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.

The Company will hold an analyst call and a webcast at 3:00pm CET or 9:00am EDT on Monday, November 13, 2023. The link will be available on the Company’s investor page. Please refer to this link Investors - Valneva.

As sponsor of the first chikungunya vaccine approved in the U.S., Valneva has received a Priority Review Voucher (PRV) from the FDA, which it intends to monetize to help finance its research and development (R&D) programs.

With this U.S. approval, IXCHIQ® becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva1 has brought from early R&D to approval. Valneva reported final pivotal Phase 3 data for the vaccine in March 2022 showing a 98.9% seroresponse rate at 28 days with a single vaccination2 and final lot-to-lot consistency results in May 20223. IXCHIQ®-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination2. Valneva will continue to evaluate antibody persistence for at least five years4. The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.

Every year, more than 60 million Americans travel to countries where mosquito-borne diseases are endemic5. Initially addressing the potential needs of U.S. travelers, IXCHIQ® fits seamlessly into Valneva’s global established travel vaccines business, which includes vaccines against Japanese encephalitis and cholera/ETEC6, leveraging Valneva’s existing commercial and industrial infrastructure, which has been augmented with this newest product.