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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

诺瓦瓦克斯医药 | 8-K：美国食品药品管理局取消对Novavax的COVID-19流感组合和独立流感3期试验的临床搁置
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，生物技术公司诺瓦瓦克斯医药宣布，美国食品药品监督管理局（FDA）已解除其新药申请（IND）的临床中止，涉及其COVID-19-流感联合疫苗和独立流感疫苗候选产品。FDA的批准使诺瓦瓦克斯获准继续进行计划中的第3期临床试验。临床中止最初于2024年10月16日实施，此前有报告称2023年完成的第2期试验中出现一名参与者出现严重不良事件。诺瓦瓦克斯向FDA提供了额外信息，导致不良事件的重新分类，证实该事件与疫苗无关。诺瓦瓦克斯正在积极准备恢复试验活动。公司首席医学官Robert Walker博士对FDA的合作表示感谢，并确认公司打算尽快启动第3期试验。
2024年11月11日，生物技术公司诺瓦瓦克斯医药宣布，美国食品药品监督管理局（FDA）已解除其新药申请（IND）的临床中止，涉及其COVID-19-流感联合疫苗和独立流感疫苗候选产品。FDA的批准使诺瓦瓦克斯获准继续进行计划中的第3期临床试验。临床中止最初于2024年10月16日实施，此前有报告称2023年完成的第2期试验中出现一名参与者出现严重不良事件。诺瓦瓦克斯向FDA提供了额外信息，导致不良事件的重新分类，证实该事件与疫苗无关。诺瓦瓦克斯正在积极准备恢复试验活动。公司首席医学官Robert Walker博士对FDA的合作表示感谢，并确认公司打算尽快启动第3期试验。
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