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Ann mark this message contains personal perspective
｜originally written by Ann
1. 台灣食藥署針對「國產」疫苗的緊急授權條件，確實只要第二期臨床試驗收案人數達3千人、追蹤一個月後，就可以先量產100萬劑，予「高風險族群」施打，但並非針對一般大眾。疫苗正式取得藥證時，仍要求得完成第三期臨床試驗。
2. 而根據美國FDA10月時發布的新冠疫苗緊急授權（EUA）新標準，則要求業者在第三階段臨床實驗參與者施打第二劑疫苗後，至少平均追蹤兩個月，才可申請緊急授權。
2. 而根據美國FDA10月時發布的新冠疫苗緊急授權（EUA）新標準，則要求業者在第三階段臨床實驗參與者施打第二劑疫苗後，至少平均追蹤兩個月，才可申請緊急授權。
Opinion Sources
FDA：Emergency Use Authorization for Vaccines to Prevent COVID-19https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19
美國FDA本周宣布嚴格標準 疫苗恐難在大選前上市
https://udn.com/news/story/120944/4882557
國產新冠疫苗何時上市? 食藥署有條件放寬量產標準
https://news.pts.org.tw/article/498390
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19
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