新冠肺炎疫苗研究倫理探討與公眾信任之建立

The ethics of COVID-19 vaccine research and establishment of public trust

陳妤嘉(Yu-Chia Chen)

《應用倫理評論》 71期 (2021/10) Pp. 137-160

摘要

新冠肺炎疫情肆虐，為全球公共衛生及社會構成極大威脅。瞬息萬變之疫情，為疫苗之研發與核准帶來莫大挑戰。本文將探討疫苗研發技術與科學之不確定性及因加速疫苗研發之時程所衍發之倫理議題，並以國產高端新冠肺炎疫苗通過緊急使用授權所引發之爭議作為反思，以歐妮爾對於信任觀點之討論為核心對照國際研究成果與實務經驗，呼籲政府相關部門重視可問責性，廣納專家意見凝聚共識，落實公眾溝通並促進公眾參與，以重建信任。

關鍵字

新冠肺炎 ； 緊急使用授權 ； 可問責性 ； 公眾信任 ； 公眾參與

並列摘要

The spread of the COVID-19 poses a significant threat to global public health and society. The rapidly changing epidemic has brought significant challenges to vaccine research and approval. This article will discuss the uncertainty of vaccine science and manufacturing technology, and the ethical issues arising from acceleration of the schedule of development and approval. This article also reflects the controversy caused by the emergency use authorization of the domestically developed COVID-19 vaccine-Medigen (MVC-COV1901), taking Onora O'Neill's view on trust research as the main point of discussion and compare the results of international research and actual cases. We call on government departments to pay attention to accountability, gathers expert opinions to build consensus, implement public communication, and promote public engagement to rebuild trust.

並列關鍵字

COVID-19 ； Emergency Use Authorization (EUA) ； accountability ； public trust ； public engagement

參考文獻

O’Neill, Onora, 2004, “Accountability, trust and informed consent in medical practice and research,” Clinical medicine (London, England)4(3): 269-276, URL=https://doi.org/10.7861/clinmedicine. 4-3-269 (Retrieved on 5 September, 2021).

Petersen, Michael Bang, Bor, Alexander, Jørgensen, Frederik and Lindholt, Marie Fly, 2021, “Transparent communication about negative features of COVID-19 vaccines decreases acceptance but increases trust,” Proceedings of the National Academy of Sciences 118(29): e2024597118, URL=https://doi.org/10.1073/pnas.2024597118.

Kreps, S. E. and Kriner, D. L., 2020, “Model uncertainty, political contestation, and public trust in science: Evidence from the COVID-19 pandemic,” Science advances 6(43): eabd4563, URL=https://doi.org/10.1126/sciadv.abd4563 (Retrieved on 5 September, 2021).

Dawson, Angus, 2020. “Pandemic vaccine trials: expedite, but don’t rush,” Research Ethics 16(3-4): 1-12, URL=https://doi.org/10.1177/1747016120943730 (Retrieved on 5 September, 2021).

王竣鋒，2021，〈美國 FDA 於 2021 年 2 月更新「預防 COVID-19疫苗之緊急使用授權」指引〉，《當代醫藥法規月刊》第 127期，頁 23-24。