儿童和青少年接种 mRNA COVID-19 疫苗后的过敏反应发生率：EudraVigilance 报告数据的分析。
Anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents: Analysis of data reported to EudraVigilance.
机构信息
Directorate of Research, Studies and Documentation, National Public Health Organization, Athens, Greece.
Laboratory of Pharmaceutical Technology, Department of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece.
出版信息
Vaccine. 2023 Mar 31;41(14):2382-2386. doi: 10.1016/j.vaccine.2023.02.067. Epub 2023 Feb 27.
AIM
The present study aimed to estimate the anaphylaxis rates following mRNA COVID-19 vaccination in children and adolescents in Europe.
METHODS
We retrieved data on 371 anaphylaxis cases following mRNA COVID-19 vaccination in children ≤ 17 years old notified to EudraVigilance as of October 8, 2022. Overall, 27,120,512 doses of BNT162b2 vaccine and 1,400,300 doses of mRNA-1273 vaccine have been delivered to children during the study period.
RESULTS
The overall mean anaphylaxis rate was 12.81 [95% confidence interval (CI): 11.49-14.12] per 10 mRNA vaccine doses [12.14 (95% CI: 6.37-17.91) per 10 doses for mRNA-1273 and 12.84 (95% CI: 11.49-14.19) per 10 doses for BNT162b2]. Children 12-17 years old accounted for 317 anaphylaxis cases, followed by 48 cases in children 3-11 years old, and 6 cases in children 0-2 years old. Children 10-17 years old had a mean anaphylaxis rate of 13.52 (95% CI: 12.03-15.00) cases per 10 mRNA vaccine doses and children 5-9 years old had a mean anaphylaxis rate of 9.51 (95% CI: 6.82-12.20) cases per 10 mRNA vaccine doses. There were two fatalities, both in the 12-17 years age group. The fatal anaphylaxis rate was 0.07 cases per 10 mRNA vaccine doses.
CONCLUSIONS
Anaphylaxis is a rare adverse event after receiving an mRNA COVID-19 vaccine in children. Continuous surveillance of serious adverse events is needed to guide vaccination policies as we move towards SARS-CoV-2 endemicity. Larger real-world studies on COVID-19 vaccination in children, using clinical case confirmation, are imperative.
目的
本研究旨在估计欧洲儿童和青少年接种 mRNA COVID-19 疫苗后的过敏反应发生率。
方法
截至 2022 年 10 月 8 日，我们从 EudraVigilance 中检索了 371 例 17 岁以下儿童接种 mRNA COVID-19 疫苗后发生的过敏反应病例数据。在此期间，共向儿童接种了 2712.0512 剂 BNT162b2 疫苗和 14 万 3000 剂 mRNA-1273 疫苗。
结果
总体而言，mRNA 疫苗每 10 剂的过敏反应发生率为 12.81 [95%置信区间（CI）：11.49-14.12] [mRNA-1273 每 10 剂 12.14（95%CI：6.37-17.91），BNT162b2 每 10 剂 12.84（95%CI：11.49-14.19）]。12-17 岁儿童占 317 例过敏反应病例，其次是 3-11 岁儿童 48 例，0-2 岁儿童 6 例。10-17 岁儿童每 10 剂 mRNA 疫苗的过敏反应发生率为 13.52（95%CI：12.03-15.00），5-9 岁儿童每 10 剂 mRNA 疫苗的过敏反应发生率为 9.51（95%CI：6.82-12.20）。有 2 例死亡，均发生在 12-17 岁年龄组。致命过敏反应发生率为每 10 剂 mRNA 疫苗 0.07 例。
结论
在儿童中接种 mRNA COVID-19 疫苗后，过敏反应是一种罕见的不良事件。随着我们向 SARS-CoV-2 流行转变，需要持续监测严重不良事件，以指导疫苗接种政策。在儿童中使用临床病例确认进行更大规模的真实世界 COVID-19 疫苗接种研究至关重要。
Zotero 插件