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Novavax | 8-K: Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

Novavax | 8-K: Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

诺瓦瓦克斯医药 | 8-K：Novavax COVID-19流感组合和独立流感三期试验最新情况
美股SEC公告 ·  2024/10/16 20:02

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The FDA has placed a clinical hold on Novavax's Investigational New Drug application for its COVID-19-Influenza Combination (CIC) and standalone influenza vaccine candidates. This action follows a serious adverse event report of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S., who received the vaccine in January 2023 and reported the condition in September 2024.The clinical hold may impact the timing of the Phase 3 immunogenicity trial initiation and data collection for both vaccine candidates. Novavax's Chief Medical Officer emphasized that while causality hasn't been established, the company is working closely with the FDA to resolve the matter. The FDA will provide an official clinical hold letter within 30 days.Notably, previous COVID-19 and influenza trials by Novavax have shown no signals for motor neuropathy. The company's current COVID-19 vaccine IND remains unaffected by this clinical hold. Investigators have been informed of this development, and the company aims to address FDA's information requests expeditiously.
The FDA has placed a clinical hold on Novavax's Investigational New Drug application for its COVID-19-Influenza Combination (CIC) and standalone influenza vaccine candidates. This action follows a serious adverse event report of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S., who received the vaccine in January 2023 and reported the condition in September 2024.The clinical hold may impact the timing of the Phase 3 immunogenicity trial initiation and data collection for both vaccine candidates. Novavax's Chief Medical Officer emphasized that while causality hasn't been established, the company is working closely with the FDA to resolve the matter. The FDA will provide an official clinical hold letter within 30 days.Notably, previous COVID-19 and influenza trials by Novavax have shown no signals for motor neuropathy. The company's current COVID-19 vaccine IND remains unaffected by this clinical hold. Investigators have been informed of this development, and the company aims to address FDA's information requests expeditiously.
美国食品药品管理局已对诺瓦瓦克斯医药针对其COVID-19-流感组合（CIC）和独立流感疫苗候选者的临床研究新药申请实施了控件。这一措施是因一名在美国以外的单个CIC二期试验参与者报告了严重的不良事件——运动性神经病，该参与者于2023年1月接种了疫苗，并于2024年9月报告了该控件。该控件可能会影响二期免疫原性试验的启动时间和两种疫苗候选者的数据收集。诺瓦瓦克斯医药的首席医疗官强调，尽管尚未确定因果关系，但公司正与FDA紧密合作以解决这一问题。FDA将在30天内提供正式的临床控件信函。值得注意的是，诺瓦瓦克斯医药之前进行的COVID-19和流感试验未显示运动性神经病的信号。该公司的当前COVID-19疫苗IND未受到此控件的影响。研究人员已被告知这一进展，公司旨在迅速回应FDA的信息请求。
美国食品药品管理局已对诺瓦瓦克斯医药针对其COVID-19-流感组合（CIC）和独立流感疫苗候选者的临床研究新药申请实施了控件。这一措施是因一名在美国以外的单个CIC二期试验参与者报告了严重的不良事件——运动性神经病，该参与者于2023年1月接种了疫苗，并于2024年9月报告了该控件。该控件可能会影响二期免疫原性试验的启动时间和两种疫苗候选者的数据收集。诺瓦瓦克斯医药的首席医疗官强调，尽管尚未确定因果关系，但公司正与FDA紧密合作以解决这一问题。FDA将在30天内提供正式的临床控件信函。值得注意的是，诺瓦瓦克斯医药之前进行的COVID-19和流感试验未显示运动性神经病的信号。该公司的当前COVID-19疫苗IND未受到此控件的影响。研究人员已被告知这一进展，公司旨在迅速回应FDA的信息请求。
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