新冠肺炎疫苗緊急使用授權之政策與法規

Policy and Regulation of Emergency Use Authorization of COVID-19 Vaccine

自2019年底疫情爆發至2022年底，新冠肺炎（COVID-19）疫情已造成全球有超過6億人確診，及造成超過6百萬人死亡，對經濟和社會活動帶來巨大影響。全球生技醫藥產業均致力於治療藥品及預防性疫苗開發，期能緩和疫情並減少擴散。疫苗臨床試驗進度、緊急使用授權情形，影響政府對於新冠肺炎所採取防疫決策和作法，尤其是緊急使用授權牽涉面向廣大，科學專業、公衛健康、人道關懷、國家安全等，需通盤思索才能面面俱到。本文將就國際間疫苗緊急使用授權切入，延伸國內作法及管理，最後提出後疫情時代期待與展望。

Since the outbreak of new coronavirus SARS-CoV-2 from the end of 2019 to the end of 2022, it has so far caused more than 600 million confirmed cases and 6 million of deaths worldwide, and made a huge impact to global economic and social activities. The global pharmaceutical industries has committed to develop therapeutic drugs and preventive vaccines, hoped to alleviate the epidemic. The progress of COVID-19 vaccine clinical trials and the emergency use authorization affect the government's decision-making and measures in response to COVID-19. In particular, the authorization of emergency use involves a wide range consideration of scientific professions, public health, humane care, national security, etc. This article will discuss the international and domestic management for emergency use authorization of COVID-19 vaccines, and further bring forward to the expectations and prospects of post- pandemic.