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The FDA's Senseless Lack of Urgency in Full Vaccine Licensing

机译：FDA在全疫苗许可中毫无意义地缺乏紧迫性

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As calls for the U.S. Food and Drug Administration to fully approve Covid-19 vaccines grow louder, the agency itself has little to say. This is a mistake. The FDA insists it's "working as quickly as possible" and has suggested that full approval may come for at least one vaccine by the end of summer. The public is left wondering: What's taking so long? This isn't just a minor nuisance. It undermines trust in the vaccines and damages the FDA's most valuable asset, its credibility. The drug regulators have good reason to insist on thoroughly reviewing many months of clinical trial data before fully licensing any medicine. The emergency use authorizations for the vaccines now administered in the U.S. were based on just two months of follow-up data; that was enough to be confident that the vaccines are safe, effective, and fit for use in response to a pressing need, but it required a faster analysis than the FDA requires for its normal approval process. To fully approve the vaccines, the FDA looks at more data and satisfies itself on a range of other issues, including developing detailed guidance on use.
机译：由于美国食品和药物管理局的呼吁全面批准Covid-19疫苗，因此该机构本身几乎没有说。这是个错误。 FDA坚持认为它是“尽快工作”，并建议在夏季结束时至少有一个疫苗可以全额批准。公众留下了想念：这么长时间呢？这不仅仅是一个轻微的滋扰。它破坏了对疫苗的信任，并损害了FDA最宝贵的资产，其可信度。药物监管机构有充分的理由坚持在完全授权任何药物之前彻底审查许多月的临床试验数据。现在在美国现在管理的疫苗的紧急使用授权是基于仅仅两个月的后续数据;这足以确信疫苗是安全，有效的，并且适合用于响应压迫需求，但它需要比FDA更快的分析，以获得其正常批准过程。为了完全批准疫苗，FDA看起来更多数据并满足一系列其他问题，包括开发有关使用的详细指导。

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    《Bloomberg business week》 |2021年第4709期|7-7|共1页
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