Department of Oncology and Hemato-Oncology, Univeristy of Milan, Milan, Italy.
Department of Medical Biotechnology and Translational Medicine, University of Milan, Milan, Italy.
Bioethics. 2023 Jun;37(5):498-507. doi: 10.1111/bioe.13151. Epub 2023 Mar 11.
The rapid spread of SARS-CoV-2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID-19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the "fast-tracking" of COVID-19 vaccine R&D and approval. Second, drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID-19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll-out of this key pandemic-containment technology worldwide.
SARS-CoV-2 在全球范围内的迅速传播，促使生物技术领域的活动十分活跃，不到 1 年的时间内，就有多种 COVID-19 疫苗研发成功并获得监管批准，与此同时，人们也对这一过程中的伦理问题进行了持续的审查。本文旨在实现两个目标。首先，从临床试验设计到监管程序，本文重构并全面概述了 COVID-19 疫苗研发和批准的“快速通道”所涉及的不同步骤。其次，本文通过对已发表文献的回顾，确定、概述并分析了与这一过程相关的最具伦理挑战性的方面，包括疫苗安全性问题、研究设计问题、研究参与者的招募问题以及获得有效知情同意的挑战。通过仔细审查 COVID-19 疫苗研发和监管流程，本文最终旨在全面概述全球推广这一关键大流行病防控技术所涉及的监管和伦理问题。
