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

廖雯娸(Wern-Chir Liao) ； 黃玫甄(Mei-Chen Huang) ； 林意筑(Yi-Chu Lin) ； 吳明美(Ming-Mei Wu) ； 祁若鳳(Jo-Feng Chi) ； 林建良(Chien-Liang Lin) ； 陳惠芳(Hwei-Fang Cheng) ； 吳秀梅(Shou-Mei Wu)

《台灣醫學》 27卷2期 (2023/03) Pp. 197-205

https://doi.org/10.6320/FJM.202303_27(2).0010

摘要

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。

關鍵字

新冠肺炎 ； 疫苗 ； 緊急使用授權 ； 法規科學 ； 免疫橋接

並列摘要

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.

並列關鍵字

COVID-19 ； vaccines ； emergency use authorization ； regulatory science ； immuno-bridging

參考文獻

U.S. Food and Drug Administration. COVID-19 Vaccines Authorized for Emergency Use or FDA-Approved. https://www.fda.gov/ emergency-preparedness-and-response/ coronavirus-disease-2019-covid-19/covid-19-vaccines./ Accessed November 8, 2022.

Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. Emergency Use Authorization for Vaccines to Prevent COVID-19, Guidance for Industry. Maryland: Center for Biologics Evaluation and Research, 2020.

European Medicines Agency. COVID-19 vaccines: authorized. https://www.ema.europa. eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-authorised#authorised-covid-19-vaccines-section./ Accessed February 1, 2023.

European Medicines Agency. EMA considerations on COVID-19 vaccine approval. Amsterdam: European Medicines Agency, 2020.

United Kingdom National Health Service. Coronavirus (COVID-19) vaccine. https://www. nhs.uk/conditions/coronavirus-covid-19/coronavirus-vaccination/coronavirus-vaccine/ Accessed November 8, 2022.