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Key points for nonclinical safety evaluation of mRNA vaccines
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Ming-lan ZHENG, Xiao-fen LI, Zi-wei LI, Meng-ran ZHANG, Hui-fang YIN, Yi FAN*
Chinese Journal of New Drugs | 2026, 35(18) : 1932 - 1938
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Chinese Journal of New Drugs | 2026, 35(18): 1932-1938
Key points for nonclinical safety evaluation of mRNA vaccines
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Ming-lan ZHENG, Xiao-fen LI, Zi-wei LI, Meng-ran ZHANG, Hui-fang YIN, Yi FAN*
Affiliations
  • Yangtze River Delta Center for Drug Evaluation and Inspection of National Medical Products Administration, Shanghai 201210, China
Published: 2026-09-30 doi: 10.20251/j.cnki.1003-3734.2026.18.004
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mRNA therapeutics have emerged as a promising platform in treating a wide range of diseases, including cancers, infections, genetic disorders, and autoimmune diseases. This article reviews the current development status of mRNA vaccines, existing challenges, relevant guidelines for nonclinical evaluation, and key focuses of nonclinical safety evaluation. Nonclinical research should focus on proof of concept, administration routes, species selection, and toxicity characteristics (such as inflammatory responses, hepatosplenic toxicity, and immune responses). This article systematically summarizes the research progress and safety evaluation strategies of mRNA vaccines, providing important references for future studies.

mRNA vaccine  /  non-clinical safety evaluation  /  lipid nanoparticles  /  immunotoxicity  /  inflammatory response  /  liver and spleen toxicity
郑明岚, 李小芬, 李紫薇, 张梦然, 尹慧芳, 范乙. mRNA疫苗非临床安全性评价的关注点. 中国新药杂志, 2026 , 35 (18) : 1932 -1938 . DOI: 10.20251/j.cnki.1003-3734.2026.18.004
Ming-lan ZHENG, Xiao-fen LI, Zi-wei LI, Meng-ran ZHANG, Hui-fang YIN, Yi FAN. Key points for nonclinical safety evaluation of mRNA vaccines[J]. Chinese Journal of New Drugs, 2026 , 35 (18) : 1932 -1938 . DOI: 10.20251/j.cnki.1003-3734.2026.18.004
Year 2026 volume 35 Issue 18
59
6
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doi: 10.20251/j.cnki.1003-3734.2026.18.004
  • Online Date:2026-10-26
  • Published:2026-09-30
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  • Accepted:2025-10-30
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    Yangtze River Delta Center for Drug Evaluation and Inspection of National Medical Products Administration, Shanghai 201210, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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