Ribak Yaarit, Rubin Limor, Talmon Aviv, Dranitzki Zvi, Shamriz Oded, Hershkowitz Isca, Tal Yuval, Hershko Alon Y
Allergy and Clinical Immunology Unit, Department of Medicine, Hadassah Medical Organization, Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.
Front Immunol. 2023 Aug 15;14:1172896. doi: 10.3389/fimmu.2023.1172896. eCollection 2023.
The mRNA-based COVID-19 vaccine was introduced to the general public in December 2020. Shortly thereafter, safety concerns were raised due to the reporting of allergic reactions. Allergy-related disorders were suspected to be significant risk factors and the excipient polyethylene glycol was suggested to be a robust allergen.
This is a retrospective study analysis. Subjects with putative risk factors for severe allergic reactions to the Pfizer-BioNTech BNT162b2 vaccine were referred for vaccination under observation at the Unit of Allergy and Clinical Immunology. Data was collected for each subject, including demographic details, medical history and previous reactions to any allergen. When appropriate, skin tests were done prior to vaccination.
A total of 346 subjects received 623 vaccine doses under observation. The study included patients with various allergy-related disorders (n=290) and those with allergy to a previous COVID-19 vaccine dose (n=56). Both groups showed female predominance (78% and 88%, p=NS). Patients without reactions to previous doses reported more drug allergy (80% vs. 39%, p<0.001) and previous anaphylaxis (64% vs. 14%, p<0.001). There was no difference in sensitivity to other allergens, including polyethylene glycol. Under observation, mild allergic reactions were noted in 13 individuals characterized by female gender (100%), a history of anaphylaxis (69%) and drug allergy (62%). In 7 subjects, allergy was treated with antihistamines while others recovered spontaneously.
Our study demonstrates that vaccination under specialist-supervision is a powerful tool for reducing over-diagnosis of systemic reactions and for rapid and reliable collection of vaccine safety data.
基于信使核糖核酸的新冠疫苗于2020年12月向公众推出。此后不久，由于过敏反应的报告，引发了对安全性的担忧。与过敏相关的疾病被怀疑是重大风险因素，辅料聚乙二醇被认为是一种强烈的过敏原。
这是一项回顾性研究分析。对辉瑞-生物科技公司的BNT162b2疫苗有严重过敏反应潜在风险因素的受试者，在过敏与临床免疫科的观察下接受疫苗接种。收集了每个受试者的数据，包括人口统计学细节、病史以及之前对任何过敏原的反应。在适当情况下，接种疫苗前进行皮肤测试。
共有346名受试者在观察下接受了623剂疫苗。该研究包括患有各种与过敏相关疾病的患者（n = 290）和对之前一剂新冠疫苗过敏的患者（n = 56）。两组均以女性为主（分别为78%和88%，p = 无显著性差异）。之前接种疫苗无反应的患者报告有更多药物过敏（80%对39%，p < 0.001）和之前有过敏反应（64%对14%，p < 0.001）。对包括聚乙二醇在内的其他过敏原的敏感性没有差异。在观察过程中，13名个体出现轻度过敏反应，其特征为女性（100%）、有过敏反应病史（69%）和药物过敏（62%）。7名受试者的过敏反应用抗组胺药治疗，其他受试者自行康复。
我们的研究表明，在专家监督下接种疫苗是减少全身反应过度诊断以及快速可靠收集疫苗安全性数据的有力工具。
