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Novavax | 8-K: U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

Novavax | 8-K: U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

諾瓦瓦克斯醫藥 | 8-K：美國食品藥品管理局取消對Novavax的COVID-19流感組合和獨立流感3期試驗的臨床擱置
美股SEC公告 ·  11/13 00:24

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On November 11, 2024, Novavax, Inc., a biotechnology company specializing in the development of vaccines, announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination vaccine and its stand-alone influenza vaccine candidates. This clearance by the FDA allows Novavax to proceed with the planned Phase 3 clinical trial. The clinical hold, which was initially put in place on October 16, 2024, followed a report of a serious adverse event in a participant from a Phase 2 trial completed in 2023. Novavax provided additional information to the FDA, which led to the reclassification of the adverse event and the conclusion that it was not related to the vaccine. Novavax is now preparing to resume trial activities promptly. The company's Chief Medical Officer, Dr. Robert Walker, expressed gratitude towards the FDA for their cooperation and confirmed the company's intention to initiate the Phase 3 trial as soon as possible.
On November 11, 2024, Novavax, Inc., a biotechnology company specializing in the development of vaccines, announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination vaccine and its stand-alone influenza vaccine candidates. This clearance by the FDA allows Novavax to proceed with the planned Phase 3 clinical trial. The clinical hold, which was initially put in place on October 16, 2024, followed a report of a serious adverse event in a participant from a Phase 2 trial completed in 2023. Novavax provided additional information to the FDA, which led to the reclassification of the adverse event and the conclusion that it was not related to the vaccine. Novavax is now preparing to resume trial activities promptly. The company's Chief Medical Officer, Dr. Robert Walker, expressed gratitude towards the FDA for their cooperation and confirmed the company's intention to initiate the Phase 3 trial as soon as possible.
2024年11月11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）已解除其新藥申請（IND）的臨床中止，涉及其COVID-19-流感聯合疫苗和獨立流感疫苗候選產品。FDA的批准使諾瓦瓦克斯獲准繼續進行計劃中的第3期臨床試驗。臨床中止最初於2024年10月16日實施，此前有報告稱2023年完成的第2期試驗中出現一名參與者出現嚴重不良事件。諾瓦瓦克斯向FDA提供了額外信息，導致不良事件的重新分類，證實該事件與疫苗無關。諾瓦瓦克斯正在積極準備恢復試驗活動。公司首席醫學官Robert Walker博士對FDA的合作表示感謝，並確認公司打算儘快啓動第3期試驗。
2024年11月11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）已解除其新藥申請（IND）的臨床中止，涉及其COVID-19-流感聯合疫苗和獨立流感疫苗候選產品。FDA的批准使諾瓦瓦克斯獲准繼續進行計劃中的第3期臨床試驗。臨床中止最初於2024年10月16日實施，此前有報告稱2023年完成的第2期試驗中出現一名參與者出現嚴重不良事件。諾瓦瓦克斯向FDA提供了額外信息，導致不良事件的重新分類，證實該事件與疫苗無關。諾瓦瓦克斯正在積極準備恢復試驗活動。公司首席醫學官Robert Walker博士對FDA的合作表示感謝，並確認公司打算儘快啓動第3期試驗。
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