尽管试验结果呈阳性,但FDA 拒绝了 Moderna 的 mRNA 流感疫苗申请,理由是其比较方法已过时. The FDA rejected Moderna’s mRNA flu vaccine application, citing outdated comparator, despite positive trial results.

美国林业发展局以使用标准剂量季节性流感疫苗作为参照标准为由,拒绝审查现代公司对MRNA流感疫苗(mRNA-1010)的申请。 该机构说,这种疫苗没有反映最佳的护理标准。 The U.S. FDA has refused to review Moderna’s application for its mRNA flu vaccine, mRNA-1010, citing the use of a standard-dose seasonal flu vaccine as a comparator, which the agency said did not reflect the best-available standard of care. 该决定通过一封拒绝投案信件传达,没有引起安全或效力方面的关切,但与林业发展局先前核准试验设计的反馈相矛盾。 The decision, communicated via a Refusal-to-File letter, did not raise safety or efficacy concerns but contradicts prior FDA feedback that approved the trial design. 现代公司报告其疫苗在晚期试验中比GSK疫苗有效26.6%,表示惊讶,并计划要求召开会议,澄清该机构的理由。 Moderna, which reported its vaccine was 26.6% more effective than a GSK shot in late-stage trials, expressed surprise and plans to request a meeting to clarify the agency’s rationale. 欧盟、加拿大和澳大利亚仍在审查该疫苗,预计到2026年底或2027年初可能会得到批准。 The vaccine remains under review in the EU, Canada, and Australia, with potential approvals expected by late 2026 or early 2027.