EMA will now initiate its centralized review procedure under accelerated assessment for Bavarian Nordic’s chikungunya vaccine COPENHAGEN, Denmark, July 18, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA), which was submitted in June 2024 for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.

欧洲药品管理局将于2024年7月18日在丹麦哥本哈根启动巴伐利亚北欧基孔肯雅疫苗加速评估下的集中审查程序——巴伐利亚北欧A/s（OMX:BAVA）今天宣布，欧洲药品管理局（EMA）已经验证了上市授权申请（MAA），该申请于2024年6月提交给CHIKV VLP，该公司的候选疫苗用于预防12岁及以上个体感染基孔肯雅病毒引起的疾病。

Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure under accelerated assessment. The accelerated assessment, which was granted by EMA’s Committee for Medicinal Products for Human Use (CHMP) in February 2024, aims to reduce the timeframe for the CHMP to review a MAA, potentially supporting approval of the vaccine by the European Commission in the first half of 2025.

申请的验证确认提交完成，并在加速评估下开始EMA的集中审查程序。该加速评估于2024年2月由欧洲药品管理局人类使用药品委员会（CHMP）批准，旨在缩短CHMP审查MAA的时间框架，可能支持欧盟委员会在2025年上半年批准该疫苗。

“The MAA submission and review marks a pivotal milestone for Bavarian Nordic in 2024, and we look forward to working closely with EMA throughout the evaluation process to make our chikungunya vaccine available to individuals 12 years of age and older at risk of chikungunya virus infection,” said Paul Chaplin, President and CEO of Bavarian Nordic.

巴伐利亚北欧公司总裁兼首席执行官保罗·卓别林说：“MAA的提交和审查标志着巴伐利亚北欧公司在2024年的一个关键里程碑，我们期待在整个评估过程中与EMA密切合作，使我们的基孔肯雅疫苗可供12岁及以上有基孔肯雅病毒感染风险的个人使用。”。

Bavarian Nordic also completed the submission of a Biologics License Application (BLA) for the CHIKV VLP vaccine to the U.S. Food and Drug Administration (FDA) in June 2024, potentially also supporting a US approval of the vaccine in the first half of 2025. About CHIKV VLP vaccineCHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection.

巴伐利亚北欧公司还于2024年6月向美国食品和药物管理局（FDA）提交了CHIKV VLP疫苗的生物制剂许可证申请（BLA），这也可能支持美国在2025年上半年批准该疫苗。关于CHIKV VLP疫苗CHIKV VLP是一种基于佐剂VLP的疫苗候选物，用于主动免疫，以预防由CHIKV感染引起的疾病。

Pending regulatory approval, the single-dose vaccine will be made in a pre-filled syringe, designed to .

在监管部门批准之前，单剂量疫苗将在预先填充的注射器中制造，旨在。

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2024-20-en

2024-20-en