尽管试验结果呈阳性,但FDA 拒绝了 Moderna 的 mRNA 流感疫苗申请,理由是使用过时的比较剂. The FDA rejected Moderna’s mRNA flu vaccine application, citing an outdated comparator, despite positive trial results.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作出,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, delivered via a Refusal-to-File letter, did not raise safety or efficacy concerns but contradicts prior FDA feedback that approved the trial design. 现代化疫苗在晚期试验中报告了比GSK疫苗更高的有效性,表示惊,并计划要求召开会议,澄清FDA的理由. Moderna, which reported positive results in late-stage trials showing greater effectiveness than a GSK vaccine, expressed surprise and plans to request a meeting to clarify the FDA’s rationale. 欧盟、加拿大和澳大利亚仍在审查疫苗,预计可能于2026年底或2027年初得到批准。 The vaccine remains under review in the EU, Canada, and Australia, with potential approvals expected in late 2026 or early 2027.