First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and olderRepresents first BLA for a chikungunya vaccine for adolescents COPENHAGEN, Denmark, June 17, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the completion of the rolling submission process which was initiated in April 2024 with the U.S.

CHIKV VLP的首次监管提交已完成，寻求批准针对12岁及以上个体的基孔肯雅病毒感染的候选疫苗。2024年6月17日，丹麦哥本哈根-巴伐利亚北欧a/S（OMX:BAVA）今天宣布完成了2024年4月与美国发起的滚动提交过程。

Food and Drug Administration (FDA) for a Biologics License Application (BLA) for the licensure of its CHIKV VLP vaccine candidate for immunization against chikungunya virus infection in individuals 12 years of age and older. Pending acceptance from the FDA, the BLA could support a potential approval of the vaccine in the first half of 2025.

美国食品和药物管理局（FDA）申请生物制品许可证申请（BLA），以获得其CHIKV VLP候选疫苗的许可证，用于对12岁及以上的个体进行基孔肯雅病毒感染的免疫接种。在FDA接受之前，BLA可能会在2025年上半年支持该疫苗的潜在批准。

The BLA submission includes results from two phase 3 clinical trials in more than 3,600 healthy individuals 12 years of age and older, demonstrating that the CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong induction of chikungunya neutralizing antibodies against chikungunya 21 days after vaccination, with antibody titers equal to or above the threshold agreed with authorities as a marker of seroprotection.

BLA提交的报告包括对3600多名12岁及以上的健康个体进行的两项3期临床试验的结果，表明CHIKV VLP疫苗具有高度免疫原性，如疫苗接种后21天强烈诱导针对基孔肯雅病毒的基孔肯雅中和抗体所证明的，抗体滴度等于或高于当局同意的阈值，作为血清保护的标志。

The CHIKV VLP vaccine was well-tolerated across both studies and vaccine-related adverse events were mainly mild or moderate in nature. Bavarian Nordic also intends to submit a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) by the end of the first half 2024. The MAA has already been granted accelerated assessment, which means the CHIKV VLP vaccine could potentially obtain approval by the European Commission in the first half of 2025.

CHIKV VLP疫苗在两项研究中都具有良好的耐受性，疫苗相关的不良事件主要是轻度或中度的。巴伐利亚北欧公司还打算在2024年上半年末之前向欧洲药品管理局（EMA）提交上市许可申请（MAA）。MAA已经获得加速评估，这意味着CHIKV VLP疫苗可能在2025年上半年获得欧盟委员会的批准。

“The completion of the BLA submission marks a significant milestone in the development of our CHIKV VLP vaccine and r.

“BLA提交的完成标志着我们开发CHIKV VLP疫苗和r的一个重要里程碑。