Baldo Aline, Leunda Amaya, Willemarck Nicolas, Pauwels Katia
Sciensano, Service Biosafety and Biotechnology, Rue Juliette Wytsmanstraat 14, B-1050 Brussels, Belgium.
Vaccines (Basel). 2021 May 3;9(5):453. doi: 10.3390/vaccines9050453.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of the coronavirus disease 2019 (COVID-19) pandemic. Over the past months, considerable efforts have been put into developing effective and safe drugs and vaccines against SARS-CoV-2. Various platforms are being used for the development of COVID-19 vaccine candidates: recombinant viral vectors, protein-based vaccines, nucleic acid-based vaccines, and inactivated/attenuated virus. Recombinant viral vector vaccine candidates represent a significant part of those vaccine candidates in clinical development, with two already authorised for use in the European Union and one currently under rolling review by the European Medicines Agency (EMA). Since recombinant viral vector vaccine candidates are considered as genetically modified organisms (GMOs), their regulatory oversight includes besides an assessment of their quality, safety and efficacy, also an environmental risk assessment (ERA). The present article highlights the main characteristics of recombinant viral vector vaccine (candidates) against SARS-CoV-2 in the pipeline and discusses their features from an environmental risk point of view.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是2019冠状病毒病（COVID-19）大流行的病原体。在过去几个月里，人们为研发针对SARS-CoV-2的有效且安全的药物和疫苗付出了巨大努力。多种平台正被用于开发COVID-19候选疫苗：重组病毒载体疫苗、基于蛋白质的疫苗、基于核酸的疫苗以及灭活/减毒病毒疫苗。重组病毒载体候选疫苗是临床开发中众多候选疫苗的重要组成部分，其中两种已在欧盟获批使用，一种目前正在接受欧洲药品管理局（EMA）的滚动审查。由于重组病毒载体候选疫苗被视为转基因生物（GMOs），对它们的监管除了评估其质量、安全性和有效性外，还包括环境风险评估（ERA）。本文重点介绍了正在研发的针对SARS-CoV-2的重组病毒载体疫苗（候选疫苗）的主要特征，并从环境风险角度探讨了它们的特点。
