School of Medicine, Shanghai University, Shanghai, 200444, China.
School of Medicine, Shanghai University, Shanghai, 200444, China; Suzhou Innovation Center of Shanghai University, Suzhou, 215000, Jiangsu, China.
Biologicals. 2024 Nov;88:101799. doi: 10.1016/j.biologicals.2024.101799. Epub 2024 Nov 5.
In recent years, innovative research and development of mRNA vaccines have made remarkable achievements, especially in the context of pandemic infectious diseases such as the COVID-19 virus, and the need for rapid vaccine development has further fueled the rapid growth of this field. Nevertheless, there are still gaps in our understanding of the working mechanism of mRNA vaccines and their long-term safety, efficacy, and quality control. This article summarizes the development background and production process of mRNA vaccines, outlines existing reference guidelines, quality control projects, and testing methods at home and abroad, and also summarizes the difficulties and future prospects in research and development and quality control. It provides a reference for developing guidelines for mRNA vaccine production, quality control, and preclinical and clinical evaluation.
近年来，mRNA 疫苗的创新性研发取得了显著成果，特别是在 COVID-19 病毒等大流行传染病的背景下，对快速开发疫苗的需求进一步推动了该领域的快速发展。然而，我们对 mRNA 疫苗的工作机制及其长期安全性、有效性和质量控制的理解仍存在差距。本文总结了 mRNA 疫苗的发展背景和生产工艺，概述了国内外现有的参考指南、质量控制项目和检测方法，总结了研发和质量控制中面临的困难和未来前景。为制定 mRNA 疫苗生产、质量控制和临床前及临床评价的指南提供了参考。
