Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine
Introduction Double-stranded RNA (dsRNA) is a key impurity of mRNA vaccines prepared by in vitro transcription (IVT) and is primarily transcribed by T7 RNA polymerase. It can trigger innate immunity and induce a series of side effects that may influence the safety of mRNA vaccines.Areas covered This...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/14760584.2025.2510335 |
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| author | Xinjun Liu Chaoying Hu Qian He Yu Bai Xuanxuan Zhang Zhihao Fu Xiao Ma Miao Xu Zhenglun Liang Qunying Mao |
| author_facet | Xinjun Liu Chaoying Hu Qian He Yu Bai Xuanxuan Zhang Zhihao Fu Xiao Ma Miao Xu Zhenglun Liang Qunying Mao |
| author_sort | Xinjun Liu |
| collection | DOAJ |
| description | Introduction Double-stranded RNA (dsRNA) is a key impurity of mRNA vaccines prepared by in vitro transcription (IVT) and is primarily transcribed by T7 RNA polymerase. It can trigger innate immunity and induce a series of side effects that may influence the safety of mRNA vaccines.Areas covered This manuscript summarizes dsRNA generation mechanisms and immunity activation and analyzes the current challenges in dsRNA detection and control strategies. Regulatory standards for dsRNA impurities in mRNA vaccines have also been discussed.Expert opinion dsRNA as a critical quality attribute (CQA), the structural heterogeneity of it (including length and structure) and its precise immunomodulatory mechanisms affecting vaccine safety are poorly understood. Regulatory authorities have not released specific standards for dsRNA. Additionally, there is a lack of comparative analysis data on different corporate testing methods. Therefore, to ensure the safety of dsRNA containing mRNA vaccines and improve mRNA-based platforms, it is of great significance to establish standardized detection methods and standards for dsRNA; to design mRNA production with low dsRNA impurities by adopting the quality by design (QbD) approach; and to evaluate the immune stimulation mechanism of dsRNA impurities in mRNA vaccines. |
| format | Article |
| id | doaj-art-bec2a573d96c4faaa11d7de270c959ae |
| institution | OA Journals |
| issn | 1476-0584 1744-8395 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj-art-bec2a573d96c4faaa11d7de270c959ae2025-08-20T01:56:29ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952025-12-0124145746910.1080/14760584.2025.2510335Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccineXinjun Liu0Chaoying Hu1Qian He2Yu Bai3Xuanxuan Zhang4Zhihao Fu5Xiao Ma6Miao Xu7Zhenglun Liang8Qunying Mao9State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaSinovac Life Sciences Co., Ltd., mRNA Vaccine Center, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Research Units of innovative Vaccine Quality Evaluation and Standardization, Chinese Academy of Medical Sciences, National institutes for Food and Drug Control, Beijing, ChinaIntroduction Double-stranded RNA (dsRNA) is a key impurity of mRNA vaccines prepared by in vitro transcription (IVT) and is primarily transcribed by T7 RNA polymerase. It can trigger innate immunity and induce a series of side effects that may influence the safety of mRNA vaccines.Areas covered This manuscript summarizes dsRNA generation mechanisms and immunity activation and analyzes the current challenges in dsRNA detection and control strategies. Regulatory standards for dsRNA impurities in mRNA vaccines have also been discussed.Expert opinion dsRNA as a critical quality attribute (CQA), the structural heterogeneity of it (including length and structure) and its precise immunomodulatory mechanisms affecting vaccine safety are poorly understood. Regulatory authorities have not released specific standards for dsRNA. Additionally, there is a lack of comparative analysis data on different corporate testing methods. Therefore, to ensure the safety of dsRNA containing mRNA vaccines and improve mRNA-based platforms, it is of great significance to establish standardized detection methods and standards for dsRNA; to design mRNA production with low dsRNA impurities by adopting the quality by design (QbD) approach; and to evaluate the immune stimulation mechanism of dsRNA impurities in mRNA vaccines.https://www.tandfonline.com/doi/10.1080/14760584.2025.2510335dsRNAmRNAmechanismsinnate immunityimpurities control |
| spellingShingle | Xinjun Liu Chaoying Hu Qian He Yu Bai Xuanxuan Zhang Zhihao Fu Xiao Ma Miao Xu Zhenglun Liang Qunying Mao Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine Expert Review of Vaccines dsRNA mRNA mechanisms innate immunity impurities control |
| title | Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine |
| title_full | Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine |
| title_fullStr | Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine |
| title_full_unstemmed | Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine |
| title_short | Research progress on immune mechanism and control strategy of dsRNA impurities in mRNA vaccine |
| title_sort | research progress on immune mechanism and control strategy of dsrna impurities in mrna vaccine |
| topic | dsRNA mRNA mechanisms innate immunity impurities control |
| url | https://www.tandfonline.com/doi/10.1080/14760584.2025.2510335 |
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