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我來終結這個話題啦

https://reurl.cc/YO1K4O

這是美國FDA針對COVID-19疫苗, 緊急使用授權(EUA)的取得標準說明
是在2020年11月20日發布

What safety and effectiveness data are required to be submitted
to FDA for an EUA request for a vaccine intended to prevent COVID-19?

COVID-19 vaccines are undergoing a rigorous development process
that includes tens of thousands of study participants to generate
the needed non-clinical, clinical, and manufacturing data. FDA
will undertake a comprehensive evaluation of this information
submitted by a vaccine manufacturer.

For an EUA to be issued for a vaccine, for which there is adequate
manufacturing information to ensure quality and consistency, FDA
must determine that the known and potential benefits outweigh the
known and potential risks of the vaccine. An EUA request for a
COVID-19 vaccine can be submitted to FDA based on a final analysis
of a phase 3 clinical efficacy trial or an interim analysis of
such trial, i.e., an analysis performed before the planned end of
the trial once the data have met the pre-specified success criteria
for the study’s primary efficacy endpoint.

>From a safety perspective, FDA expects an EUA submission will include
all safety data accumulated from phase 1 and 2 studies conducted with
the vaccine, with an expectation that phase 3 data will include a
median follow-up of at least 2-months (meaning that at least half of
vaccine recipients in phase 3 clinical trials have at least 2 months
of follow-up) after completion of the full vaccination regimen. In
 addition, FDA expects that an EUA request will include a phase 3
 safety database of well over 3,000 vaccine recipients, representing
a high proportion of participants enrolled in the phase 3 study, who
have been followed for serious adverse events and adverse events of
special interest for at least one month after completion of the full
 vaccination regimen.

Part of FDA’s evaluation of an EUA request for a COVID-19 vaccine
includes evaluation of the chemistry, manufacturing, and controls
information for the vaccine. Sufficient data should be submitted to
ensure the quality and consistency of the vaccine product. FDA will
use all available tools and information, including records reviews,
site visits, and previous compliance history, to assess compliance
with current good manufacturing practices.


簡單說, FDA只有在疫苗已知及潛在益處大於疫苗已知及潛在風險的情況下才會
授與疫苗EUA, 而授予的標準:

在有效性方面, 必須在三期療效分析的期中或最終報告, 達到預先設定的主要療
效的成功指標

安全性的部分, 必須完成一二期的所有安全性數據, 以及三期最少兩個月的追蹤

所以絕對不是做完二期就可以拿到緊急授權
最低標準也得在三期有效性分析期中解盲達到成功指標
並在三期作完最少兩個月的安全性追蹤

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                          願歲月靜好，現世安穩

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