Luxi Nicoletta, Ciccimarra Francesco, Bellitto Chiara, Raethke Monika, van Hunsel Florence, Lieber Thomas, Mulder Erik, L'Abbate Luca, Marques Francisco Batel, Furci Fabiana, Farcas Andreea, Giele-Eshuis Janneke, Morton Kathryn, Sonderlichová Simona, Thurin Nicolas H, Villalobos Felipe, Riefolo Fabio, Sturkenboom Miriam C, Trifirò Gianluca
Department of Medicine, University of Verona, 37134 Verona, Italy.
Department of Diagnostics and Public Health, University of Verona, 37134 Verona, Italy.
Vaccines (Basel). 2024 Sep 17;12(9):1059. doi: 10.3390/vaccines12091059.
Conventional vaccines rarely cause severe allergic reactions. However, the rapid development and approval of COVID-19 vaccines left limited initial data on their adverse reactions, particularly in individuals with a history of allergy. The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. From February 2021 to February 2023, a web-based prospective study gathered vaccinee-reported outcomes using electronic questionnaires across eleven European countries. Baseline and up to six follow-up questionnaires captured data on vaccinee demographics, as well as both solicited and unsolicited adverse reactions. Overall, 3476 vaccinees with a history of allergy were matched with 13,872 vaccinees from the general population at the first vaccination cycle and were included in the analysis. A total of 825 vaccinees with a history of allergy who had received a booster dose, matched to 3297 vaccinees from the general population, were included in the analysis. Higher rates of ADRs occurred after the first vaccination cycle compared to after the booster dose (64-91% vs. 56-79%). However, most reported ADRs were solicited and not serious, and no case of anaphylaxis was reported. Women and vaccinees with a history of allergy reported ADRs more frequently than men and the matched controls, respectively. Compared to other COVID-19 vaccines, a higher proportion of vaccinees experiencing at least one ADR following their first vaccination cycle was observed with Comirnaty and Vaxzevria. Statistically significant differences were observed among the study cohorts for median TTO after the second dose, and for median TTR following the first vaccination cycle and booster dose ( < 0.001). Typically, any drug or vaccine use carries a risk of severe allergic reactions, yet the benefits of vaccination generally outweigh these potential risks, as shown with the COVID-19 vaccines.
传统疫苗很少引起严重过敏反应。然而，新冠疫苗的快速研发和获批使得关于其不良反应的初始数据有限，尤其是在有过敏史的个体中。本研究的目的是评估和比较不同剂量和品牌的新冠疫苗在有过敏史与无过敏史受试者中的安全性概况。2021年2月至2023年2月，一项基于网络的前瞻性研究通过电子问卷收集了11个欧洲国家疫苗接种者报告的结果。基线问卷和多达六份随访问卷收集了疫苗接种者的人口统计学数据，以及预期和非预期的不良反应数据。总体而言，3476名有过敏史的疫苗接种者在首次接种周期与13872名普通人群中的疫苗接种者进行匹配，并纳入分析。共有825名接受加强针的有过敏史的疫苗接种者与3297名普通人群中的疫苗接种者进行匹配，并纳入分析。与加强针后相比，首次接种周期后出现不良反应的发生率更高（64 - 91%对56 - 79%）。然而，大多数报告的不良反应是预期的且不严重，并且未报告过敏反应病例。女性和有过敏史的疫苗接种者报告不良反应的频率分别高于男性和匹配的对照组。与其他新冠疫苗相比，接种Comirnaty和Vaxzevria后，在首次接种周期后经历至少一种不良反应的疫苗接种者比例更高。在研究队列中，观察到第二剂后中位失能调整生命年（TTO）以及首次接种周期和加强针后中位恢复时间（TTR）存在统计学显著差异（<0.001）。通常，任何药物或疫苗的使用都有发生严重过敏反应的风险，但正如新冠疫苗所示，接种疫苗的益处通常超过这些潜在风险。
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