FDA advisors unanimously vote to approve Moderna’s mRNA after agency drama

FDA顾问小组在经历机构风波后全票通过莫德纳mRNA流感疫苗

Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna’s seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed. 周五，美国食品药品监督管理局（FDA）的独立顾问小组以9票赞成、0票反对的结果，支持批准莫德纳（Moderna）的季节性mRNA流感疫苗。此前，该机构的一名特朗普任命官员曾试图阻止该疫苗进入审查程序。

In an all-day meeting, members of the FDA’s advisory committee—known as VRBPAC for Vaccines and Related Biological Products Advisory Committee—pored over data and presentations on the vaccine, which is dubbed mRNA-1010 and branded as mFlusiva. The presentations included a review from FDA scientists, which was supportive of the vaccine. 在全天的会议中，FDA疫苗及相关生物制品咨询委员会（VRBPAC）的成员们仔细审阅了关于该疫苗（代号mRNA-1010，品牌名为mFlusiva）的数据和演示报告。报告中包括了FDA科学家的评估，他们对该疫苗持支持态度。

Data from a Phase 3 trial including over 40,000 adults age 50 and older found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial, involving data from nearly 3,000 people age 65 years and older, showed the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for this age group. The safety profile of the vaccine was also generally good. 一项涵盖超过4万名50岁及以上成年人的三期临床试验数据显示，该mRNA疫苗预防季节性流感的有效性比标准流感疫苗高出约27%。另一项涉及近3000名65岁及以上人群的小型三期试验显示，该疫苗产生的免疫反应强于目前推荐给该年龄段人群使用的高剂量流感疫苗。此外，该疫苗的安全性总体良好。

“I think that the studies that were presented today were very well conducted,” VRBPAC voting member Flor Munoz-Rivas, a pediatric infectious disease expert at Baylor College of Medicine, said after the vote. “They have very clear results that are very robust in terms of demonstrating that additional efficacy.” “我认为今天展示的研究开展得非常出色，”VRBPAC投票成员、贝勒医学院儿科传染病专家Flor Munoz-Rivas在投票后表示，“研究结果非常清晰，在证明其额外疗效方面非常有说服力。”

She also expressed enthusiasm for the agile mRNA platform for the flu vaccine, which is based on the same platform Moderna used to develop its mRNA COVID-19 vaccines. In addition to the better efficacy, it allows for “rapid development of the vaccines in regular seasonal flu activity” and makes us “better prepared for emerging strains or pandemic strains in the future,” she said. 她还对用于流感疫苗的灵活mRNA平台表示赞赏，该平台与莫德纳开发新冠mRNA疫苗所使用的技术相同。她指出，除了更高的疗效外，该平台还能实现“在常规季节性流感活动中快速开发疫苗”，并使我们“为未来可能出现的新毒株或大流行毒株做好更充分的准备”。

Fellow voting member Hayley Gans, a pediatric infectious disease expert at Stanford University, agreed. “I think that this particular platform adds exciting ways that we can actually move our vaccines to the future,” she said. “The signals that we’re seeing now are not putting people at risk and the benefits are actually large not only for this season, but for really what it can do for our vaccine platform. … This one has the potential to really move us in a modern direction.” 另一位投票成员、斯坦福大学儿科传染病专家Hayley Gans对此表示赞同。“我认为这个特定的平台为我们推动疫苗技术的未来发展增添了令人兴奋的方式，”她说，“我们目前看到的信号并未显示出对人群的风险，其益处不仅体现在本季度，更在于它对我们整个疫苗平台的影响……它有潜力真正引领我们走向现代化。”

FDA drama

FDA内部风波

The outcome today is in stark contrast to a few months ago, when Trump official Vinay Prasad was overseeing vaccines at the FDA. In a shocking decision in February, Prasad rejected Moderna’s filing, refusing to even review the vaccine. Prasad claimed that the large vaccine trial was not “adequate and well-controlled” because it did not compare efficacy to a high-dose vaccine in people 65 and older. Instead, Moderna used the smaller trial to compare immune responses of mRNA-1010 to a high-dose vaccine—which was a plan the FDA had previously agreed would be acceptable. 今天的结果与几个月前形成了鲜明对比，当时特朗普政府官员Vinay Prasad负责FDA的疫苗监管工作。在二月份的一项惊人决定中，Prasad拒绝了莫德纳的申请，甚至拒绝审查该疫苗。Prasad声称，大型疫苗试验“不够充分且缺乏良好对照”，因为它没有在65岁及以上人群中将疗效与高剂量疫苗进行对比。然而，莫德纳此前是利用较小的试验来对比mRNA-1010与高剂量疫苗的免疫反应，而这一方案此前已获得FDA的认可。

Moderna was blindsided by the refusal, which Prasad issued over the objections of FDA scientists and career officials. Amid widespread outcry, the FDA reversed the decision the next week, agreeing to review the vaccine. Around the same time, Prasad was also behind the rejection of a closely watched gene therapy for Huntington’s disease made by UniQure, which was widely criticized and called “truly evil” by a former FDA official. Prasad was pushed out of FDA at the end of April amid a string of decried decisions and controversies. Prasad’s decision on UniQure’s gene therapy was reversed on Wednesday. 莫德纳对这一拒绝决定感到措手不及，因为Prasad是在无视FDA科学家和职业官员反对的情况下做出该决定的。在舆论的强烈抗议下，FDA在次周撤销了该决定，同意审查该疫苗。与此同时，Prasad还曾拒绝了一项备受关注的、由UniQure公司研发的亨廷顿舞蹈症基因疗法，此举遭到广泛批评，甚至被一位前FDA官员称为“极其邪恶”。在经历了一系列备受诟病的决策和争议后，Prasad于4月底被逐出FDA。Prasad此前对UniQure基因疗法的否决决定已于周三被撤销。

Moderna released a statement saying it was pleased with today’s outcome. “We appreciate the thoughtful review by the members of VRBPAC and their recognition of the clinical evidence supporting mRNA-1010,” Moderna CEO Stéphane Bancel said in the statement. “We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention and further demonstrate the versatility of our mRNA platform. We look forward to continuing to work with the FDA as it completes its review.” 莫德纳发表声明称，对今天的结果感到满意。莫德纳首席执行官Stéphane Bancel在声明中表示：“我们感谢VRBPAC成员的深思熟虑，以及他们对支持mRNA-1010临床证据的认可。我们相信mRNA-1010有潜力为季节性流感预防提供一种重要的新选择，并进一步展示我们mRNA平台的通用性。我们期待在FDA完成审查的过程中继续与他们合作。”

Next steps

后续步骤

While unanimous support from the advisors is a positive sign for the vaccine’s fate, the FDA ultimately decides whether to grant approval. The agency has set a deadline for a decision by August 5. Moderna has previously said it is aiming to release the vaccine later this year, pending approval. 虽然顾问小组的全票支持对该疫苗的前景是一个积极信号，但最终决定权仍在FDA手中。FDA已将决策截止日期定为8月5日。莫德纳此前表示，如果获得批准，计划在今年晚些时候发布该疫苗。

A further hurdle will be getting a recommendation from the Centers for Disease Control and Prevention. Newly FDA-approved vaccines would first be reviewed by the CDC’s advisory committee—the Advisory Committee on Immunization Practices (ACIP)—which would vote on recommendations for use that it thinks the CDC should adopt. Having recommendations from ACIP and CDC mean that almost all commercial insurance providers and federal programs would be required by law to cover the vaccine at no cost. 另一个障碍是获得美国疾病控制与预防中心（CDC）的推荐。新获FDA批准的疫苗通常首先由CDC的咨询委员会——免疫实践咨询委员会（ACIP）进行审查，该委员会将投票决定其认为CDC应采纳的使用建议。获得ACIP和CDC的推荐意味着，根据法律规定，几乎所有商业保险提供商和联邦项目都必须免费覆盖该疫苗。

However, ACIP is effectively defunct after a federal judge issued a temporary injunction that blocked almost all of the allies anti-vaccine Health Secretary Robert F. Kennedy Jr. installed on the committee. The judge ruled that Kennedy’s handpicked advisors were appointed improperly. Like Kennedy, many of them hold anti-vaccine views and are also openly hostile to mRNA technology. The US Department of Health and Human Services is now appealing the injunction on an expedited schedule that will stretch at least into July. 然而，在一名联邦法官发布临时禁令，阻止了反疫苗卫生部长小罗伯特·F·肯尼迪（Robert F. Kennedy Jr.）在委员会中安插的几乎所有盟友后，ACIP实际上已陷入瘫痪。法官裁定，肯尼迪亲手挑选的顾问任命程序不当。与肯尼迪一样，他们中的许多人持有反疫苗观点，并公开敌视mRNA技术。美国卫生与公众服务部目前正在以加急程序对该禁令提出上诉，预计诉讼过程至少将持续到7月。