Pan Yuanyi, Han Yun, Zhou Chuan, Zhao Lili, Zheng Jie, Ye Xianwei, He Yongqun
Department of Radiology, People's Hospital of Guizhou Province, Guiyang, Guizhou Province, China.
Unit for Laboratory Animal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.
Nat Commun. 2025 Jul 15;16(1):6514. doi: 10.1038/s41467-025-61613-4.
The safety of XBB.1.5-containing COVID-19 mRNA vaccines warrants investigation. We assessed the relative risk of 15 adverse events following the XBB.1.5 vaccination using a self-controlled case series study design with data from the National COVID Cohort Collaborative (N3C) from September 11, 2023, to June 1, 2024 in the USA. Based on a baseline population of 244,494 patients, adverse events included Guillain-Barré syndrome, seizure, non-hemorrhagic stroke and transient ischemic attack, hemorrhagic stroke, narcolepsy or cataplexy, anaphylaxis, acute myocardial infarction, myo/pericarditis, coagulopathy, multisystem inflammatory syndrome, Bell's palsy, transverse myelitis, appendicitis, pulmonary embolism, and encephalitis. We found an association between vaccination and anaphylaxis (IRR [95% CI]: day 0-17.35 [9.32-30.03], day 1-9.35 [5.12-15.95], day 2-6.20 [3.40-10.57], <20 patients in each risk period). No other outcomes showed significantly increased risk following vaccination. Our results contribute to the safety profile evaluation for XBB.1.5-containing COVID-19 mRNA vaccines utilizing N3C big data.
含XBB.1.5的新冠mRNA疫苗的安全性值得研究。我们采用自控病例系列研究设计，利用美国国家新冠队列协作组（N3C）2023年9月11日至2024年6月1日的数据，评估了接种XBB.1.5疫苗后15种不良事件的相对风险。以244,494名患者为基线人群，不良事件包括格林-巴利综合征、癫痫发作、非出血性卒中和短暂性脑缺血发作、出血性卒中、发作性睡病或猝倒、过敏反应、急性心肌梗死、心肌/心包炎、凝血病、多系统炎症综合征、贝尔麻痹、横贯性脊髓炎、阑尾炎、肺栓塞和脑炎。我们发现接种疫苗与过敏反应之间存在关联（IRR [95% CI]：第0天-17.35 [9.32-30.03]，第1天-9.35 [5.12-15.95]，第2天-6.20 [3.40-10.57]，每个风险期患者数<20）。没有其他结果显示接种疫苗后风险显著增加。我们的结果有助于利用N3C大数据对含XBB.1.5的新冠mRNA疫苗进行安全性评估。
