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国内外mRNA疫苗临床研发进展和审评考虑

邓霞 鲁爽

中国临床药理学杂志2025,Vol.41Issue(22):3290-3295,6.
中国临床药理学杂志2025,Vol.41Issue(22):3290-3295,6.DOI:10.13699/j.cnki.1001-6821.2025.22.021

国内外mRNA疫苗临床研发进展和审评考虑

Progress in clinical research and review considerations of mRNA vaccines in China and abroad

邓霞 1鲁爽1

作者信息

  • 1. 国家药品监督管理局药品审评中心,北京,100076
  • 折叠

摘要

Abstract

As a representative of the new generation of nucleic acid vaccine technology,messenger ribonucleic acid(mRNA)vaccines have demonstrated advantages such as rapid manufacture,high efficacy,and good safety since Coronavirus Disease 2019(COVID-19),becoming an important direction in global vaccine research and development.Many mRNA vaccines have been approved or in clinical trials.This article systematically reviews and summarizes the current research and development of mRNA vaccines,discussing the current state of mRNA vaccine development and evaluation strategies in China,with the aim of providing scientific basis for the development of mRNA vaccines.

关键词

mRNA疫苗/临床试验/审评考虑

Key words

mRNA vaccines/clinical trial/review considerations

分类

医药卫生

引用本文复制引用

邓霞,鲁爽..国内外mRNA疫苗临床研发进展和审评考虑[J].中国临床药理学杂志,2025,41(22):3290-3295,6.

基金项目

药品监管科学全国重点实验室基金资助项目(2024SKLDRS0229) (2024SKLDRS0229)

中国临床药理学杂志

OA北大核心

1001-6821

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