Jeewoo Kang, Jaeyu Park, Hyesu Jo, Hyeri Lee, Kyeongmin Lee, Soeun Kim, Jiseung Kang, Jun Hyuk Lee, Nikolaos G Papadopoulos, Lee Smith, Ju-Young Shin, Masoud Rahmati, Seong H Cho, Joong Ki Cho, Sooji Lee, Damiano Pizzol, Seung Geun Yeo, Hayeon Lee, Seon-Pil Jin, Dong Keon Yon
{"title":"2010-2023年全球疫苗相关慢性荨麻疹负担：来自全球药物警戒数据库","authors":"Jeewoo Kang, Jaeyu Park, Hyesu Jo, Hyeri Lee, Kyeongmin Lee, Soeun Kim, Jiseung Kang, Jun Hyuk Lee, Nikolaos G Papadopoulos, Lee Smith, Ju-Young Shin, Masoud Rahmati, Seong H Cho, Joong Ki Cho, Sooji Lee, Damiano Pizzol, Seung Geun Yeo, Hayeon Lee, Seon-Pil Jin, Dong Keon Yon","doi":"10.4168/aair.2024.16.6.613","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>The etiology and pathophysiology of vaccine-associated chronic urticaria (CU) remain unclear, particularly during the coronavirus disease 2019 (COVID-19) pandemic. Thus, this study aimed to comprehensively investigate the global burden and long-term trends of vaccine-associated CU, with a focus on the associated vaccines and the distribution of cases across different age groups and sexes.</p><p><strong>Methods: </strong>Using data from the World Health Organization international pharmacovigilance database (VigiBase), which encompasses reports from 156 countries and territories between 1968 and 2023, we systematically analyzed the global burden and long-term trends in vaccine-associated CU reports (total individual case safety reports = 131,255,418). We estimated the global and regional reports, information component (IC) with IC<sub>0.25</sub> using disproportionality analyses, and reporting odds ratio (ROR) with 95% confidence interval (CI) to investigate the potential associations between 27 vaccines and CU.</p><p><strong>Results: </strong>Among the 3,474 reports of all-cause CU, 1,898 vaccine-associated CU reports were identified between 2010 and 2023. A dramatic surge in vaccine-associated CU reports has been observed since 2020, primarily driven by the COVID-19 mRNA vaccines. The COVID-19 mRNA vaccines were associated with the most CU reports (ROR, 26.52 [95% CI, 24.33-28.90]; IC, 3.18 [IC<sub>0.25</sub>, 3.10]), followed by papillomavirus (ROR, 4.23 [95% CI, 2.55-7.03]; IC, 1.93 [IC<sub>0.25</sub>, 1.06]), influenza (ROR, 3.09 [95% CI, 2.16-4.43]; IC, 1.57 [IC<sub>0.25</sub>, 0.96]), Ad5-vectored COVID-19 (ROR, 2.82 [95% CI, 2.40-3.31]; IC, 1.42 [IC<sub>0.25</sub>, 1.16]), and zoster vaccines (ROR, 2.28 [95% CI, 1.32-3.93]; IC, 1.12 [IC<sub>0.25</sub>, 0.18]). These increased risks were particularly pronounced for males and older adults. No fatal outcomes have been reported in vaccine-associated CU.</p><p><strong>Conclusions: </strong>This study underscores the importance of clinicians considering the potential risk factors associated with vaccine-associated CU, especially in the context of COVID-19-related vaccines. Ongoing pharmacovigilance efforts facilitated by robust reporting systems are required to further validate our findings.</p>","PeriodicalId":7547,"journal":{"name":"Allergy, Asthma & Immunology Research","volume":"16 6","pages":"613-625"},"PeriodicalIF":4.1000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11621480/pdf/","citationCount":"0","resultStr":"{\"title\":\"Global Burden of Vaccine-Associated Chronic Urticaria, 2010-2023: From the Global Pharmacovigilance Database.\",\"authors\":\"Jeewoo Kang, Jaeyu Park, Hyesu Jo, Hyeri Lee, Kyeongmin Lee, Soeun Kim, Jiseung Kang, Jun Hyuk Lee, Nikolaos G Papadopoulos, Lee Smith, Ju-Young Shin, Masoud Rahmati, Seong H Cho, Joong Ki Cho, Sooji Lee, Damiano Pizzol, Seung Geun Yeo, Hayeon Lee, Seon-Pil Jin, Dong Keon Yon\",\"doi\":\"10.4168/aair.2024.16.6.613\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>The etiology and pathophysiology of vaccine-associated chronic urticaria (CU) remain unclear, particularly during the coronavirus disease 2019 (COVID-19) pandemic. Thus, this study aimed to comprehensively investigate the global burden and long-term trends of vaccine-associated CU, with a focus on the associated vaccines and the distribution of cases across different age groups and sexes.</p><p><strong>Methods: </strong>Using data from the World Health Organization international pharmacovigilance database (VigiBase), which encompasses reports from 156 countries and territories between 1968 and 2023, we systematically analyzed the global burden and long-term trends in vaccine-associated CU reports (total individual case safety reports = 131,255,418). We estimated the global and regional reports, information component (IC) with IC<sub>0.25</sub> using disproportionality analyses, and reporting odds ratio (ROR) with 95% confidence interval (CI) to investigate the potential associations between 27 vaccines and CU.</p><p><strong>Results: </strong>Among the 3,474 reports of all-cause CU, 1,898 vaccine-associated CU reports were identified between 2010 and 2023. A dramatic surge in vaccine-associated CU reports has been observed since 2020, primarily driven by the COVID-19 mRNA vaccines. The COVID-19 mRNA vaccines were associated with the most CU reports (ROR, 26.52 [95% CI, 24.33-28.90]; IC, 3.18 [IC<sub>0.25</sub>, 3.10]), followed by papillomavirus (ROR, 4.23 [95% CI, 2.55-7.03]; IC, 1.93 [IC<sub>0.25</sub>, 1.06]), influenza (ROR, 3.09 [95% CI, 2.16-4.43]; IC, 1.57 [IC<sub>0.25</sub>, 0.96]), Ad5-vectored COVID-19 (ROR, 2.82 [95% CI, 2.40-3.31]; IC, 1.42 [IC<sub>0.25</sub>, 1.16]), and zoster vaccines (ROR, 2.28 [95% CI, 1.32-3.93]; IC, 1.12 [IC<sub>0.25</sub>, 0.18]). These increased risks were particularly pronounced for males and older adults. No fatal outcomes have been reported in vaccine-associated CU.</p><p><strong>Conclusions: </strong>This study underscores the importance of clinicians considering the potential risk factors associated with vaccine-associated CU, especially in the context of COVID-19-related vaccines. Ongoing pharmacovigilance efforts facilitated by robust reporting systems are required to further validate our findings.</p>\",\"PeriodicalId\":7547,\"journal\":{\"name\":\"Allergy, Asthma & Immunology Research\",\"volume\":\"16 6\",\"pages\":\"613-625\"},\"PeriodicalIF\":4.1000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11621480/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergy, Asthma & Immunology Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4168/aair.2024.16.6.613\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergy, Asthma & Immunology Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4168/aair.2024.16.6.613","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ALLERGY","Score":null,"Total":0}
Global Burden of Vaccine-Associated Chronic Urticaria, 2010-2023: From the Global Pharmacovigilance Database.
Purpose: The etiology and pathophysiology of vaccine-associated chronic urticaria (CU) remain unclear, particularly during the coronavirus disease 2019 (COVID-19) pandemic. Thus, this study aimed to comprehensively investigate the global burden and long-term trends of vaccine-associated CU, with a focus on the associated vaccines and the distribution of cases across different age groups and sexes.
Methods: Using data from the World Health Organization international pharmacovigilance database (VigiBase), which encompasses reports from 156 countries and territories between 1968 and 2023, we systematically analyzed the global burden and long-term trends in vaccine-associated CU reports (total individual case safety reports = 131,255,418). We estimated the global and regional reports, information component (IC) with IC0.25 using disproportionality analyses, and reporting odds ratio (ROR) with 95% confidence interval (CI) to investigate the potential associations between 27 vaccines and CU.
Results: Among the 3,474 reports of all-cause CU, 1,898 vaccine-associated CU reports were identified between 2010 and 2023. A dramatic surge in vaccine-associated CU reports has been observed since 2020, primarily driven by the COVID-19 mRNA vaccines. The COVID-19 mRNA vaccines were associated with the most CU reports (ROR, 26.52 [95% CI, 24.33-28.90]; IC, 3.18 [IC0.25, 3.10]), followed by papillomavirus (ROR, 4.23 [95% CI, 2.55-7.03]; IC, 1.93 [IC0.25, 1.06]), influenza (ROR, 3.09 [95% CI, 2.16-4.43]; IC, 1.57 [IC0.25, 0.96]), Ad5-vectored COVID-19 (ROR, 2.82 [95% CI, 2.40-3.31]; IC, 1.42 [IC0.25, 1.16]), and zoster vaccines (ROR, 2.28 [95% CI, 1.32-3.93]; IC, 1.12 [IC0.25, 0.18]). These increased risks were particularly pronounced for males and older adults. No fatal outcomes have been reported in vaccine-associated CU.
Conclusions: This study underscores the importance of clinicians considering the potential risk factors associated with vaccine-associated CU, especially in the context of COVID-19-related vaccines. Ongoing pharmacovigilance efforts facilitated by robust reporting systems are required to further validate our findings.
期刊介绍：
The journal features cutting-edge original research, brief communications, and state-of-the-art reviews in the specialties of allergy, asthma, and immunology, including clinical and experimental studies and instructive case reports. Contemporary reviews summarize information on topics for researchers and physicians in the fields of allergy and immunology. As of January 2017, AAIR do not accept case reports. However, if it is a clinically important case, authors can submit it in the form of letter to the Editor. Editorials and letters to the Editor explore controversial issues and encourage further discussion among physicians dealing with allergy, immunology, pediatric respirology, and related medical fields. AAIR also features topics in practice and management and recent advances in equipment and techniques for clinicians concerned with clinical manifestations of allergies and pediatric respiratory diseases.
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