| アブストラクト | Background: mRNA vaccines, first approved in December 2020, have been used globally to prevent infectious diseases, and those for treating cancers are being developed. Safety-related labelling changes of Comirnaty and Spikevax were made in June 2025; however, concerns remain. This study assessed the potential risks associated with mRNA vaccines on the indications previously approved, utilizing Real-World Data (RWD) of Adverse Events Following Immunization (AEFIs) derived from the Vaccine Adverse Event Reporting System (VAERS) and Academic Literature Databases (ALD). Methods: A Disproportionality Analysis (DPA) was performed using the Reporting Odds Ratio (ROR) and the Bayesian Confidence Propagation Neural Network (BCPNN) algorithm on spontaneous case reports from VAERS. Statistical positive signals were cross-validated with literature case reports from ALD to provide more comprehensive medical descriptions and clearer causal assessments, and compared with safety information documented in clinical trials and on vaccine labelling. Time-to-onset, stratified, and immunization schedule analyses were conducted to characterize the safety profiles of mRNA vaccines. Results: In total, 5,040,725 spontaneous case reports and 4,387 literature case reports were analyzed. In both VAERS and ALD, new signals involving blood and lymphatic system disorders (e.g., thrombotic thrombocytopenic purpura) and ear and labyrinth disorders (e.g., deafness) were detected from Comirnaty as Designated Medical Events (DMEs), while blood and lymphatic system disorders (e.g., thrombotic thrombocytopenic purpura) from Spikevax in ALD only. No new signals were detected from other vaccines on the DMEs list. In VAERS, Serious Adverse Events (SAEs) were more common in females, while death risk was higher in males. In ALD, SAEs were more common in males for most mRNA vaccines, except Comirnaty. Medical history emerged as a key risk factor for SAEs, particularly among older adults. Conclusions: Statistically significant safety signals were detected across all mRNA vaccines based on five-year cumulative RWD, indicating the need of intensified monitoring of specific populations, including older adults and individuals with medical histories, alongside further optimization of vaccination strategies. |
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| ジャーナル名 | Vaccines |
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| Pubmed追加日 | 2026/6/25 |
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| 投稿者 | Tulisibaike, Bagejiang; Yang, Tian-Yi; Gu, Wen-Jun; Liu, Huan; Wang, Yuan-Hui; Yang, Jin-Qi; Wang, Tong; Ding, Si-Miao; Cai, Rong-Xue; Wang, Yuan-Jie; Wang, Wei; Pan, Hong-Xing; Shao, Fang; Su, Yu-Wen |
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| 組織名 | National Vaccine Innovation Platform, School of Pharmacy, Nanjing Medical;University, Nanjing 211166, China.;Institute of Pharmacovigilance, Nanjing Medical University, Nanjing 211166,;China.;Department of Surgery, Mount Sinai West Hospital, New York, NY 10019, USA.;Department of Clinical Pharmacology, Sir Run Run Hospital, Nanjing Medical;Jiangsu Provincial Centre for Disease Control and Prevention, Public Health;Research Institute of Jiangsu Province, Nanjing 210009, China.;National Vaccine Innovation Platform, School of Public Health, Nanjing Medical |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42347645/ |
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