周三，生物技术公司 Moderna, Inc. 盘前股价大跌近10%。消息面上，美国食品药品监督管理局（FDA）已通知Moderna，拒绝启动对其研究性季节性流感疫苗mRNA-1010生物制品许可申请的审查。FDA在发出的不予立卷通知中指出，拒绝审查的唯一原因是该公司在三期临床试验中选择已获批的标准剂量季节性流感疫苗作为对照，认为其缺乏一项“充分且严格对照”的研究，且对照组未能体现“现有最佳医疗标准”。
Moderna公司对此回应称，FDA的这一决定并未指出其产品存在任何具体的安全性有效性问题，并认为该决定与监管机构此前在试验方案沟通阶段的书面反馈意见不一致。公司已要求与FDA会面以明确后续方向。目前，该疫苗的上市申请已在欧盟、加拿大和澳大利亚获得受理，预计最早可能在2026年末至2027年初获批。
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