更可惡的是范綱皓貼文以及製表，竟稱現在國際間主流COVID19疫苗是過了第二期就獲得緊急授權使用（Emergency Use Authorization，EUA），公然睜眼說瞎話。
美國食品藥物管理局（Food and Drug Administration，FDA）官方網站，對於取得EUA的規定寫得一清二楚，就是要進入臨床測試第三期（phase 3 clinical efficacy trial）、發布為期至少兩個月的期中報告（median follow-up），其中需包含超過3000個接受疫苗者（其他還有打安慰劑的對照組）的資料。
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.
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Posted - 05/30/2021 : 03:34:54
