Moderna’s mRNA flu shot earns FDA approval after rollercoaster review

莫德纳 mRNA 流感疫苗在经历波折的审查后获得 FDA 批准

Despite significant drama from Trump officials this year, the Food and Drug Administration has for the first time approved a flu vaccine that uses mRNA technology. On Thursday, vaccine maker Moderna announced that its flu shot, mRNA-1010, aka mFLUSIVA, had earned approval for use in all adults ages 50 and up. 尽管今年特朗普政府官员引发了诸多风波，美国食品药品监督管理局（FDA）还是首次批准了一款使用 mRNA 技术的流感疫苗。周四，疫苗制造商莫德纳（Moderna）宣布，其流感疫苗 mRNA-1010（又称 mFLUSIVA）已获批用于 50 岁及以上的所有成年人。

The approval announcement follows a unanimous vote by FDA advisors in June to approve the vaccine. That vote was based on its superior efficacy to existing seasonal flu shots and a good safety record demonstrated in trials that included nearly 44,000 people. After that vote, the FDA set a goal of August 5 for a decision on the vaccine’s fate. 此次批准公告是在 FDA 顾问委员会于 6 月一致投票通过该疫苗后发布的。该投票基于其优于现有季节性流感疫苗的疗效，以及在涵盖近 4.4 万人的临床试验中所展现出的良好安全性记录。投票结束后，FDA 将 8 月 5 日定为决定该疫苗命运的截止日期。

While the unanimous support from FDA advisors boded well for Moderna’s shot, the overall path to approval was treacherous and uncertain, even until the end. For one thing, current Health Secretary Robert F. Kennedy Jr. is a well-established anti-vaccine advocate who has worked diligently in his time in office to thwart vaccinations. One of his first acts as health secretary was canceling a federal campaign to encourage people to get flu shots in the midst of a bad flu season—despite the fact that the Centers for Disease Control and Prevention had already paid for the campaign and the flu season was killing relatively high numbers of children. 尽管 FDA 顾问委员会的一致支持为莫德纳的疫苗带来了好兆头，但其整体获批之路却充满坎坷与不确定性，甚至直到最后一刻。首先，现任卫生部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）是一位知名的反疫苗倡导者，他在任职期间一直致力于阻挠疫苗接种工作。他上任后的首批举措之一，就是在严重的流感季期间取消了一项鼓励民众接种流感疫苗的联邦宣传活动——尽管美国疾病控制与预防中心（CDC）此前已为该活动支付了费用，且当时的流感季正导致大量儿童死亡。

Kennedy is also openly hostile to mRNA vaccines, having called the mRNA COVID-19 vaccine the “deadliest vaccine ever made” and canceling hundreds of millions of dollars’ worth of federal research grants for mRNA technology. In February, Trump appointee Vinay Prasad—a Kennedy ally—refused to even review the vaccine, despite objections from FDA staff and career officials, shocking Moderna and the larger biomedical community. Prasad defended his decision by arguing that the company didn’t compare its mRNA vaccine’s efficacy to the correct existing vaccine. But Moderna firmly and publicly pushed back, noting that FDA officials previously signed off on its trial designs. The FDA reversed Prasad’s rejection the following week, and Prasad was pushed out of the agency at the end of April amid a series of controversial and widely decried moves. 肯尼迪还公开敌视 mRNA 疫苗，曾称 mRNA 新冠疫苗是“有史以来最致命的疫苗”，并取消了价值数亿美元的 mRNA 技术联邦研究拨款。今年 2 月，特朗普任命的官员、肯尼迪的盟友维奈·普拉萨德（Vinay Prasad）甚至拒绝审查该疫苗，尽管遭到了 FDA 工作人员和职业官员的反对，此举震惊了莫德纳及整个生物医学界。普拉萨德为自己的决定辩护称，该公司未将其 mRNA 疫苗的疗效与正确的现有疫苗进行对比。但莫德纳坚定且公开地进行了反驳，指出 FDA 官员此前已批准了其试验设计。FDA 在随后的一周推翻了普拉萨德的拒绝决定，而普拉萨德本人也在 4 月底因一系列充满争议且广受谴责的行为被逐出该机构。

Remaining uncertainty

依然存在的不确定性

At the FDA advisory committee’s June meeting, experts expressed optimism about an mRNA-based flu vaccine. The platform—the same used in the company’s COVID-19 vaccines—is agile, easily allowing tweaks and updates to vaccine design, and it offers swifter vaccine production at scale compared to existing flu vaccines. Traditional flu vaccines are grown in fertilized chicken eggs, a process that requires six to eight months, compared to mRNA vaccines’ one to two months. 在 FDA 顾问委员会 6 月的会议上，专家们对基于 mRNA 的流感疫苗表示乐观。该平台与该公司的新冠疫苗所使用的平台相同，具有灵活性，可以轻松地对疫苗设计进行调整和更新，并且与现有流感疫苗相比，它能实现更快速的规模化生产。传统的流感疫苗是在受精鸡蛋中培养的，这一过程需要 6 到 8 个月，而 mRNA 疫苗仅需 1 到 2 个月。

Moderna CEO Stéphane Bancel celebrated the approval in a statement Thursday, saying it “demonstrates the continued strength and versatility of our mRNA platform.” “Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America’s seniors,” he said. “This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.” 莫德纳首席执行官斯特凡·班塞尔（Stéphane Bancel）在周四的一份声明中对获批表示庆祝，称这“证明了我们 mRNA 平台的持续实力和多功能性”。他表示：“流感仍然是一项重大的公共卫生挑战，mFLUSIVA 为美国老年人提供了一个重要的新选择。此次获批也反映了我们 mRNA 平台通过持续的科学创新，在帮助应对重要公共卫生挑战方面的持续潜力。”

Despite the approval, the vaccine still faces some uncertainty. The CDC advisory panel that makes recommendations for federal vaccine policy is effectively defunct. In March, a federal judge ruled that most of the anti-vaccine allies Kennedy had installed onto the advisory panel were unqualified. The judge thus ordered a temporary injunction reversing their appointments and undoing many of Kennedy’s changes to federal vaccine recommendations. The Trump administration is currently appealing the judge’s ruling. But amid the litigation, the CDC’s panel—the Advisory Committee on Immunization Practices—has not met. 尽管已获批准，该疫苗仍面临一些不确定性。负责制定联邦疫苗政策建议的 CDC 咨询小组实际上已处于停摆状态。今年 3 月，一名联邦法官裁定，肯尼迪安插进该咨询小组的大多数反疫苗盟友均不具备资格。因此，法官下达了临时禁令，撤销了他们的任命，并推翻了肯尼迪对联邦疫苗建议所做的许多更改。特朗普政府目前正在对该法官的裁决提出上诉。但在诉讼期间，CDC 的咨询小组——免疫实践咨询委员会（ACIP）——一直未能召开会议。

Without an ACIP recommendation on mFLUSIVA’s clinical use for the quickly approaching flu season, doctors will face uncertainty about which adults over age 50 should be recommended to use the vaccine. It’s also unclear if mFLUSIVA will be covered by federal vaccine programs or private insurance companies, which are required to cover ACIP-recommended vaccines. Moderna said it expects to have mFLUSIVA available for the 2026–2027 flu season. But The Wall Street Journal reported that Wall Street is not expecting meaningful sales until the 2027–2028 season. 由于缺乏 ACIP 关于 mFLUSIVA 在即将到来的流感季中临床使用的建议，医生们将无法确定应向哪些 50 岁以上的成年人推荐该疫苗。此外，目前尚不清楚 mFLUSIVA 是否会被联邦疫苗计划或私人保险公司覆盖（这些机构通常被要求覆盖 ACIP 推荐的疫苗）。莫德纳表示，预计 mFLUSIVA 将在 2026-2027 流感季上市。但《华尔街日报》报道称，华尔街预计要到 2027-2028 季度该疫苗才会产生显著的销售额。