mRNA疫苗的研究进展及监管概述

Research Progress and Regulatory Overview of mRNA Vaccine

目的:梳理信使核糖核酸(mRNA)疫苗的开发、应用现状及产业化挑战,为国内此类产品的开发提供参考。方法:针对mRNA疫苗的设计、特点、生产及应用现状的相关研究进行整理、分析,介绍国内外对mRNA疫苗的监管采取的相关举措,并对这一突破性平台技术未来产业化应用将面临的关键问题进行总结分析。结果与结论:mRNA技术凭借其通用、快速、灵活的特点应用于不同领域的疫苗/药物开发,尤其是mRNA疫苗在抗击新型冠状病毒肺炎疫情上取得了迅速且显著的成效,开启了核酸药物发展的新时代。为了保障mRNA疫苗的安全、有效、可及,部分国家及地区制定了配套的相关法规,并设立了特别审评部门加强对mRNA疫苗的上市监管。由于产品特性、生产工艺的原因,mRNA疫苗产业化在疫苗可及性、生产管理、质量控制、共线生产导致的系统污染风险、知识产权风险以及新病毒变体的开发等多方面均存在挑战。

Objective: To review and summarize the development, application status and industrialization challenges of mRNA vaccines so as to provide references for the development of such products in China.Methods: The relevant studies on the design, characteristics, production and application status of mRNA vaccine were sorted and analyzed, the relevant measures taken for the supervision of mRNA vaccine at home and abroad were introduced, and the key problems faced by the future industrial application of this breakthrough platform technology were summarized and analyzed. Results and Conclusion: mRNA technology has been applied in different fields of vaccine and drug development with its versatile, fast and flexible characteristics. Especially mRNA vaccine has achieved rapid and remarkable results in fighting against New Coronavirus pneumonia,which unfolds a new era for the development of nucleic acid drugs. In order to ensure the safety, effectiveness and accessibility of mRNA vaccine, some countries and regions formulated supporting relevant laws and regulations, and set up special review departments to strengthen the supervision of mRNA vaccine approval.Due to the product characteristics and production process, the industrialization of mRNA vaccine has challenges in many aspects, such as vaccine accessibility, production management, quality control, system pollution risk caused by multiproduct use of facilities, intellectual property risk and the development of new virus variants.