FDA 批准可以紧急使用COVID vaccine 到底有没有抄近路？离full approval到底还差什么数据？

来源: 于 2020-12-27 20:25:08 [博客] [旧帖] [给我悄悄话] 本文已被阅读：次

FDA 的网站没有给出具体的答案。 但从vaccine development的图上看似乎现在covid vaccine 都经历过了。 

Illustration of the Vaccine Approval Process. Includes R&D, Pre-Clinical, Phase 1, Phase2, Phase 3, BLA Submitted to FDA, and Phase 4

我发现的一点是在pre-clinical上，可以在紧急情况下省略掉toxicology studies。 但这是离full approval的唯一差别吗？

 

  • When evaluating the need for pre-clinical studies for a vaccine, FDA considers all data relevant to that vaccine and closely related vaccines, as well as the design of the specific clinical study for the vaccine in question. If FDA’s evaluation of these data support initiating human studies of a candidate vaccine intended to prevent an infectious disease without first completing additional toxicology studies, then FDA would consider allowing such human studies to proceed.

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101