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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

諾瓦瓦克斯醫藥 | 8-K：Novavax COVID-19流感組合和獨立流感三期試驗最新情況
美股SEC公告 ·  2024/10/16 20:02

Moomoo AI 已提取核心訊息

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.
美國食品藥品管理局已對諾瓦瓦克斯醫藥針對其COVID-19-流感組合（CIC）和獨立流感疫苗候選者的臨牀研究新藥申請實施了控制項。這一措施是因一名在美國以外的單個CIC二期試驗參與者報告了嚴重的不良事件——運動性神經病，該參與者於2023年1月接種了疫苗，並於2024年9月報告了該控制項。該控制項可能會影響二期免疫原性試驗的啓動時間和兩種疫苗候選者的數據收集。諾瓦瓦克斯醫藥的首席醫療官強調，儘管尚未確定因果關係，但公司正與FDA緊密合作以解決這一問題。FDA將在30天內提供正式的臨牀控制項信函。值得注意的是，諾瓦瓦克斯醫藥之前進行的COVID-19和流感試驗未顯示運動性神經病的信號。該公司的當前COVID-19疫苗IND未受到此控制項的影響。研究人員已被告知這一進展，公司旨在迅速回應FDA的信息請求。
美國食品藥品管理局已對諾瓦瓦克斯醫藥針對其COVID-19-流感組合（CIC）和獨立流感疫苗候選者的臨牀研究新藥申請實施了控制項。這一措施是因一名在美國以外的單個CIC二期試驗參與者報告了嚴重的不良事件——運動性神經病，該參與者於2023年1月接種了疫苗，並於2024年9月報告了該控制項。該控制項可能會影響二期免疫原性試驗的啓動時間和兩種疫苗候選者的數據收集。諾瓦瓦克斯醫藥的首席醫療官強調，儘管尚未確定因果關係，但公司正與FDA緊密合作以解決這一問題。FDA將在30天內提供正式的臨牀控制項信函。值得注意的是，諾瓦瓦克斯醫藥之前進行的COVID-19和流感試驗未顯示運動性神經病的信號。該公司的當前COVID-19疫苗IND未受到此控制項的影響。研究人員已被告知這一進展，公司旨在迅速回應FDA的信息請求。
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