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MRNA

信使核糖核酸

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A researcher works in the lab at the Moderna Inc. headquarters in Cambridge, Massachusetts, US, on Tuesday, March 26, 2024.

研究人员于2024年3月26日星期二，在美国马萨诸塞州剑桥市莫德纳公司总部的实验室工作。

Adam Glanzman | Bloomberg | Getty Images

亚当·格兰兹曼 | 彭博社 | 盖蒂图片社

The Food and Drug Administration has refused to start a review of

食品药品监督管理局拒绝开始审查

Moderna

莫德纳

's application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration's influence on

公司周二宣布，其试验性流感疫苗的申请，这是特朗普政府影响力的另一个迹象。

tightening vaccine regulations

加强疫苗监管措施

in the U.S.

在美国

The company's stock fell roughly 7% in after-hours trading Tuesday.

周二盘后交易中，该公司股票下跌了大约7%。

Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to 'understand the path forward.'

Moderna 表示，这一举动与其在提交申请并开始对名为 mRNA-1010 的疫苗进行第三阶段试验之前从该机构收到的反馈不一致。这家制药商表示，它已要求与 FDA 会面，以“了解前进的道路”。

Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won't impact its 2026 financial guidance.

Moderna 指出，该机构并未发现疫苗存在任何具体的安全性或有效性问题，而是反对研究设计，尽管之前已经批准了该设计。公司还补充说，这一举措不会影响其 2026 年的财务指导。

Moderna's jab

莫德纳的疫苗

showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.

去年公布了积极的三期数据，达到了所有的试验目标。当时，Moderna表示，单独的流感疫苗对其推进针对流感和新冠的联合疫苗的努力至关重要。

The announcement follows

以下内容紧随公告之后

sweeping changes to U.S. immunization policy

美国免疫政策的重大变革

over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.

在过去的一年里，在卫生与公众服务部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.），一位著名的疫苗怀疑论者的领导下。

Moderna on Tuesday specifically pointed to the FDA's top vaccine regulator, Vinay Prasad, who returned to the agency in August after being ousted. Prasad, who heads the agency's Center for Biologics Evaluation and Research, or CBER, has been vocal about tightening regulations for vaccines and recently linked child deaths to Covid shots. .

Moderna 周二特别提到了 FDA 的顶级疫苗监管官员 Vinay Prasad，他在被解雇后于八月重返该机构。Prasad 负责领导 FDA 的生物制品评估与研究中心 (CBER)，一直主张加强对疫苗的监管，并最近将儿童死亡与新冠疫苗联系起来。

In a letter signed by Prasad on Feb. 3, he said the sole reason why the FDA refused to review the application was because of how the clinical trial on the shot was designed.

普拉萨德在 2 月 3 日签署的一封信中表示，FDA 拒绝审查该申请的唯一原因在于疫苗临床试验的设计方式。

The agency specifically took issue with Moderna's decision to compare its product to a standard, approved flu shot, arguing that it 'does not reflect the best-available standard of care.' As a result, the FDA said the study did not meet its definition of an 'adequate and well-controlled' trial.

该机构特别对莫德纳将其产品与标准的获批流感疫苗进行比较的决定提出了异议，认为其“并未反映最佳的现有护理标准”。因此，FDA表示该研究不符合其对“充分且良好对照”试验的定义。

Moderna disputes that reasoning, noting that FDA rules and guidance do not actually require trials to use the most advanced or highest-dose vaccine as a comparator in clinical studies.

莫德纳对此理由提出异议，指出美国食品药品监督管理局（FDA）的规则和指南实际上并未要求试验使用最先进或最高剂量的疫苗作为临床研究中的对照。

'This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines,' Moderna CEO Stéphane Bancel said in a release. 'It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting.'.

“CBER 的这一决定并未发现我们产品存在任何安全或有效性问题，但这并没有进一步推动我们加强美国在创新药物开发方面领导地位的共同目标，”Moderna 首席执行官斯特凡·班塞尔在一份声明中表示。“在一项事先与 CBER 讨论并达成一致的研究中，使用 FDA 批准的疫苗作为对照品，对流感疫苗提交材料进行全面审查不应存在争议。”

Moderna said it expects the earliest approval for its flu shot to be in late 2026 or late 2027, pending regulatory reviews in the U.S., Europe, Canada and Australia.

Moderna 表示，预计其流感疫苗最早将在 2026 年底或 2027 年底获得批准，具体取决于美国、欧洲、加拿大和澳大利亚的监管审查。

The FDA said it does not comment on regulatory communications to individual sponsors.

FDA表示，它不会对与个别赞助商的监管沟通发表评论。