Saint-Herblain (France), November 10, 2023 – 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.

2023年11月10日，法国圣赫布兰（Saint Herblain）-特种疫苗公司Valneva SE（纳斯达克股票代码：VALN；Euronext Paris:VLA）今天宣布，美国食品和药物管理局（FDA）已批准Valneva单剂量的IXCHIQ®，减毒活疫苗适用于预防基孔肯雅病毒（CHIKV）引起的18岁及以上人群接触CHIKV风险增加的疾病。

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.

该适应症基于抗CHIKV中和抗体滴度在加速批准下获得批准。对该适应症的持续批准取决于验证性研究中临床益处的验证。该公司将于2023年11月13日星期一CET下午3点或EDT上午9点举行分析师电话和网络广播。

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.

该链接将在公司的投资者页面上提供。请参阅此链接投资者-Valneva。作为美国批准的第一种基孔肯雅疫苗的赞助商，Valneva已收到FDA的优先审核凭证（PRV），该凭证旨在货币化以帮助资助其研发（R＆D）计划。

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.

随着美国的批准，IXCHIQ®成为世界上第一个获得许可的基孔肯雅疫苗，可用于解决这一未满足的医疗需求，第三种疫苗Valneva1已从早期研发到批准。Valneva在2022年3月报告了疫苗的最终关键阶段3数据，显示单次接种28天时血清反应率为98.9%2，最终批次间一致性结果为20223年5月。

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 Ame.

IXCHIQ®诱导的血清反应持续一段时间，接种疫苗后6个月血清反应率为96.3%2。Valneva将继续评估抗体持续至少五年4。该公司关键的第三阶段成果于2023年6月在“柳叶刀”上发表。每年有超过6000万Ame。

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