韩彬 曹萌 成殷

    摘 要 随着生物科学技术和制药工艺的进步，mRNA疫苗在新冠疫情背景下进入了快速发展阶段，其具有研发周期短、生产快速、临床有效性高等优势，但在开发和生产领域存在较多技术难题。药品监管机构如何对mRNA疫苗进行全链条的质量控制也成为一个研究热点。WHO在2021年发布了关于mRNA疫苗的技术指南，本文归纳了该指南的技术要点，结合我国实际情况探讨mRNA疫苗监管关注点，并对未来相关指南体系进行展望。

    关键词 mRNA疫苗 WHO指南 研发 监管

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2023)09-0067-04

    引用本文 韩彬， 曹萌， 成殷. WHO发布mRNA疫苗指南的思考及对我国的启示[J]. 上海医药， 2023， 44(9)： 67-70； 75.

    Thoughts on the WHO release of mRNA vaccine guidelines and enlightenment to China

    HAN Bin， CAO Meng， CHENG Yin

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT With the advancement of bioscience technology and pharmaceutical manufacturing process， the mRNA vaccines have entered a stage of rapid development under the background of COVID-19， which have the advantages of short R&D cycle， rapid production and high clinical effectiveness. However there are various technical difficulties in the field of their development and production. How the drug regulatory agencies can implement the quality control of the entire chain of mRNA vaccines has also become a research hotspot. The WHO released technical guidelines on mRNA vaccines in 2021. This article summarizes the key points of WHO guideline ......