FDA advisors unanimously vote to approve Moderna's mRNA after agency drama
摘要
美国食品药品监督管理局（FDA）独立顾问委员会以9票赞成、0票反对的结果，支持批准莫德纳（Moderna）季节性mRNA流感疫苗。此前，一名特朗普任命的FDA官员曾试图阻止该疫苗进入审查流程。该疫苗名为mRNA-1010，商品名mFlusiva。一项涉及4万多名50岁以上成年人的3期试验数据显示，该疫苗预防季节性流感的效力比标准流感疫苗高约27%。另一项针对
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.
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.
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.
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