KKK 喜歡
4 years ago
COVID-19國產疫苗信任危機走火關鍵──比臨床試驗更需要「解盲」的決策過程 - 報導者 The Re... 報導者的報導通常會有很多方的意見,不會只偏某一方,推薦><
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KKK
4 years ago
另外我也去看了美國FDA的EUA標準原文解釋
Emergency Use Authorization for Vaccines Explained
KKK
4 years ago
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
KKK
4 years ago
(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,
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KKK
4 years ago
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.
KKK
4 years ago
看起來就是美國的EUA,需要第一期+第二期+第三期期中分析報告(不用做完)
KKK
4 years ago
但第三期其中分析報告應該要有一半的疫苗施打者追蹤2個月
KKK
4 years ago
且第三期的報告希望有3000位施打疫苗者
KKK
4 years ago
有不良反應者,需要追蹤一個月
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