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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

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On October 16, 2024, Novavax, Inc., a biotechnology company specializing in protein-based vaccines, announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination (CIC) vaccine and its standalone influenza vaccine candidates. The hold was initiated following a report of a serious adverse event (SAE) of motor neuropathy in a participant from a Phase 2 trial of the CIC vaccine conducted outside the United States. The participant received the vaccine in January 2023, the trial concluded in July 2023, and the SAE was reported in September 2024. Novavax is working with the FDA to resolve the clinical hold and aims to commence the Phase 3 trial as soon as...Show More
On October 16, 2024, Novavax, Inc., a biotechnology company specializing in protein-based vaccines, announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination (CIC) vaccine and its standalone influenza vaccine candidates. The hold was initiated following a report of a serious adverse event (SAE) of motor neuropathy in a participant from a Phase 2 trial of the CIC vaccine conducted outside the United States. The participant received the vaccine in January 2023, the trial concluded in July 2023, and the SAE was reported in September 2024. Novavax is working with the FDA to resolve the clinical hold and aims to commence the Phase 3 trial as soon as possible. The company's previous trials for COVID-19 and influenza vaccines did not show any signs of motor neuropathy. The clinical hold does not affect Novavax's IND for its standalone COVID-19 vaccine. Novavax's Chief Medical Officer, Dr. Robert Walker, emphasized the company's commitment to safety and resolving the FDA's concerns promptly.
2024年10月16日，生物技術公司諾瓦瓦克斯醫藥宣佈，美國食品藥品監督管理局（FDA）對其新型疫苗（IND）申請進行了臨床暫停，包括其新冠肺炎-流感聯合疫苗（CIC）和獨立流感疫苗的申請。此次暫停是在一名CIC疫苗第2階段試驗參與者在美國以外進行的試驗中報告發生嚴重不良事件（SAE）—運動神經病變後啓動的。該參與者於2023年1月接受了疫苗的接種，試驗於2023年7月結束，SAE於2024年9月報告。諾瓦瓦克斯醫藥正在與FDA合作解決臨床暫停，並計劃儘快啓動第3階段試驗。該公司之前進行的新冠肺炎和流感疫苗試驗未顯示出任何運動神經病變的跡象。臨床暫停不會影響諾瓦瓦克斯醫藥獨立新冠肺炎疫苗的申請。諾瓦瓦克斯醫藥首席醫學官羅伯特·沃克博士強調了公司對安全性的承諾，並表示將盡快解決FDA的擔憂。
2024年10月16日，生物技術公司諾瓦瓦克斯醫藥宣佈，美國食品藥品監督管理局（FDA）對其新型疫苗（IND）申請進行了臨床暫停，包括其新冠肺炎-流感聯合疫苗（CIC）和獨立流感疫苗的申請。此次暫停是在一名CIC疫苗第2階段試驗參與者在美國以外進行的試驗中報告發生嚴重不良事件（SAE）—運動神經病變後啓動的。該參與者於2023年1月接受了疫苗的接種，試驗於2023年7月結束，SAE於2024年9月報告。諾瓦瓦克斯醫藥正在與FDA合作解決臨床暫停，並計劃儘快啓動第3階段試驗。該公司之前進行的新冠肺炎和流感疫苗試驗未顯示出任何運動神經病變的跡象。臨床暫停不會影響諾瓦瓦克斯醫藥獨立新冠肺炎疫苗的申請。諾瓦瓦克斯醫藥首席醫學官羅伯特·沃克博士強調了公司對安全性的承諾，並表示將盡快解決FDA的擔憂。
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