2026年2月10日 / 美国东部时间晚上11:28 / CBS/美联社
该公司周二宣布，美国食品药品监督管理局（FDA）拒绝考虑其使用诺贝尔奖得主mRNA技术研发的新型流感疫苗申请。
这一消息是FDA在卫生与公众服务部部长小罗伯特·F·肯尼迪领导下对疫苗加强审查的最新迹象，尤其是对那些使用mRNA技术的疫苗——肯尼迪在成为美国最高卫生官员前后均对该技术提出过批评。
Moderna表示，它收到了FDA的”拒绝提交”函，该函反对其开展的一项4万人临床试验的方法。该试验将其新型疫苗与目前使用的一种标准流感疫苗进行比较，结果显示新型疫苗在50岁及以上成年人中效果略好于标准疫苗。
FDA疫苗部门主管Vinay Prasad博士在信中表示，该机构认为申请未包含”充分且控制良好的试验”，因为它没有将新疫苗与”研究时美国可用的最佳护理标准”进行比较。Moderna在网上公布了Prasad的信件，指出这封信提到了2024年拜登政府时期FDA官员给Moderna的一些建议，但Moderna未予采纳。
据Moderna称，当时的反馈认为使用该公司选择的标准剂量流感疫苗是可接受的，但建议65岁及以上人群最好使用另一个专门推荐给老年人的品牌。不过Moderna表示，FDA确实同意按原计划进行研究。
该公司还表示，已向FDA提供了另一项试验的额外数据，该试验将新型疫苗与获批的老年人大剂量疫苗进行了比较。
FDA”未发现我们产品存在任何安全或有效性问题”，并且”没有推进我们共同的目标——增强美国在创新药物研发方面的领导地位”，Moderna首席执行官斯特凡·班塞尔在一份声明中表示。
CBS新闻已联系FDA请求置评。
FDA拒绝提交申请的情况极为罕见，尤其是对新疫苗——这通常需要企业和FDA工作人员进行数月或数年的讨论。
Moderna已要求与FDA举行紧急会议，并指出已在欧洲、加拿大和澳大利亚申请该疫苗的批准。
过去一年中，在肯尼迪领导下工作的FDA官员撤销了新冠疫苗接种建议，对两种主要的mRNA技术新冠疫苗增加了额外警告，并将对政府做法持批评态度的人士从FDA顾问委员会中移除。
肯尼迪去年宣布，其部门将取消超过5亿美元用于mRNA流感和冠状病毒疫苗研发的合同和资金。
肯尼迪称卫生与公众服务部认为”mRNA技术对这些呼吸道病毒的风险大于益处”。疫苗专家谴责这一决定，特朗普第一任期内的卫生部长杰罗姆·亚当斯在社交媒体上写道：”坦率地说，这一举措将导致生命损失。”
数十年来，FDA一直允许疫苗制造商通过证明能引发患者免疫反应，快速更新年度流感疫苗以针对最新毒株。这比进行长期研究追踪患者是否感染流感及预后情况要高效得多。
去年，Prasad在一份内部备忘录中写道，这种简化方法将不再被允许——这促使十多位前FDA专员撰写社论谴责这些言论。
华盛顿州民主党参议员帕蒂·默里谴责FDA对Moderna的决定，称肯尼迪团队”无科学依据地阻止更新流感疫苗”。
“美国疫苗政策已被阴谋论者劫持——然而大多数共和党人却乐于袖手旁观，”默里在X平台上写道。
Moderna says FDA refuses its application for new mRNA flu vaccine
February 10, 2026 / 11:28 PM EST / CBS/AP
The Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.
The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health and Human Services Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.
Moderna says it received what is called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.
The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn’t consider the application to contain an “adequate and well-controlled trial” because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.” Prasad’s letter — which Moderna published online — pointed to some advice that FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow.
According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen — but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study. Still, Moderna said, the FDA did agree to let the study proceed as originally planned.
The company said it also had shared with the FDA additional data from a separate trial comparing the new vaccine against a licensed high-dose shot used for seniors.
The FDA “did not identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stephane Bancel said in a statement.
CBS News has reached out to the FDA for comment.
It’s rare for FDA to refuse to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.
Moderna has requested an urgent meeting with the FDA, and noted that it has applied for the vaccine’s approval in Europe, Canada and Australia.
In the last year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.
Kennedy announced last year that his department would cancel more than $500 million in contracts and funding for the development of vaccines using mRNA, zeroing in on research into coronavirus and flu vaccines.
Kennedy said the Department of Health and Human Services had determined that “mRNA technology poses more risk than benefits for these respiratory viruses.” Vaccine experts condemned the decision, with Jerome Adams, who served as surgeon general in President Trump’s first term, writing on social media, “quite frankly this move is going to cost lives.”
The FDA for decades has allowed vaccine makers to quickly update their annual flu shots to target the latest strains by showing that they trigger an immune response in patients. That’s a far more efficient approach than running long-term studies tracking whether patients get the flu and how they fare.
In an internal memo last year, Prasad wrote that the streamlined method would no longer be permitted – leading more than a dozen former FDA commissioners to pen an editorial condemning the statements.
Democratic Sen. Patty Murray of Washington condemned the FDA’s decision on Moderna, saying Kennedy’s team was “blocking an updated flu vaccine for no reason grounded in science.”
“American vaccine policy has been hijacked by a conspiracy theorist—yet most Republicans are happy to just sit on their hands,” Murray wrote on X.
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