Thiel Natalie, Selwyn Casey, Murphy Georgina, Simpson Shmona, Chakrabarti Ajoy C
University of Washington, School of Public Health, Seattle, WA, USA.
Bill & Melinda Gates Foundation, Seattle, WA, USA.
NPJ Vaccines. 2021 Apr 22;6(1):63. doi: 10.1038/s41541-021-00325-4.
A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic.
一种新的口服脊髓灰质炎疫苗nOPV2已成为首个寻求世界卫生组织紧急使用清单的疫苗。作为加速开发计划和提交过程的一部分，我们吸取了许多经验教训，这些经验教训分为以下几个部分：监管、临床开发、化学制造与控制以及部署后监测。我们努力将这些研究结果应用于新冠病毒疫苗候选产品。其中还包括了在多个功能领域加速新冠病毒疫苗开发的具体概念。这项工作的目标有两个：（1）帮助疫苗开发者熟悉紧急使用清单流程；（2）为在新冠疫情期间更快地开展开发工作和准备推出产品提供一般性指导。
