由于试验设计和比较器有缺陷,FDA拒绝了Moderna的mRNA流感疫苗,这引发了对监管一致性和对创新的影响的担忧. FDA rejected Moderna’s mRNA flu vaccine due to flawed trial design and comparator, raising concerns over regulatory consistency and impact on innovation.

尽管该公司声称符合监管机构的期望,并在其他国家获得了先前批准,但FDA拒绝了Moderna的mRNA流感疫苗申请,理由是试验设计不足,对比方法不足. The FDA rejected Moderna’s application for its mRNA flu vaccine, citing insufficient trial design and an inadequate comparator, despite the company’s claims of meeting regulatory expectations and prior approvals in other countries. 在Robert F. Kennedy Jr. 被任命为HHS秘书后, 拒绝提交文件,这是罕见的举动,通常保留给不完整的提交材料,引起了对监管一致性和潜在政治影响力的关切。 The refusal to file, a rare move typically reserved for incomplete submissions, has raised concerns about regulatory consistency and potential political influence following Robert F. Kennedy Jr.’s appointment as HHS secretary. 工业领导人警告这一决定可能会阻止对MRNA技术的投资,减缓创新,并威胁美国公共卫生准备,特别是在严重流感季节。 Industry leaders warn the decision may deter investment in mRNA technology, slowing innovation and threatening U.S. public health preparedness, especially amid a severe flu season.