Romantowski Jan, Nazar Wojciech, Bojahr Kinga, Popiołek Iwona, Niedoszytko Marek
Department of Allergology, Medical University of Gdansk, 80-210 Gdansk, Poland.
Faculty of Medicine, Medical University of Gdańsk, 80-210 Gdańsk, Poland.
Life (Basel). 2024 May 31;14(6):715. doi: 10.3390/life14060715.
The coronavirus disease 2019 (COVID-19) pandemic presented a new challenge in modern medicine: the development of vaccines was followed by massive population vaccinations. A few reports on post-vaccination allergic reactions have made patients and medical personnel uneasy as to COVID-19 vaccines' allergic potential. Most of the studies in this area to date have been small, and some that were based on global databases skipped most of the allergic diseases and concentrated only on anaphylaxis. We aimed to analyze the incidence of serious allergic reactions based on the EudraVigilance (EV) database, regardless of the reported symptoms and allergy mechanism.
The total number of administrated vaccine doses was extracted on 5 October 2023 from Vaccine Tracker and included all administrations since vaccinations began in the European Economic Area (EEA). Data on serious allergic reactions to COVID-19 vaccines were extracted from the EudraVigilance database with the same time point. The code names of 147 allergic symptoms or diseases were used.
The frequency of serious allergic reactions per 100,000 administered vaccine doses was 1.53 for Comirnaty, 2.16 for Spikevax, 88.6 for Vaxzevria, 2.11 for Janssen, 7.9 for Novavax, 13.3 for VidPrevtyn Beta, and 3.1 for Valneva. The most prevalent reported reactions were edema (0.46) and anaphylaxis (0.40). Only 6% of these reactions were delayed hypersensitivity-oriented.
The overall frequency of potential serious allergic reactions to COVID-19 is very rare. Therefore, COVID-19 vaccines seem to be safe for human use. The lowest frequency of allergic reaction was observed for Comirnaty and the highest for Vaxzevria.
2019年冠状病毒病（COVID-19）大流行给现代医学带来了新挑战：疫苗研发之后是大规模人群接种。一些关于接种后过敏反应的报告让患者和医务人员对COVID-19疫苗的过敏可能性感到不安。迄今为止，该领域的大多数研究规模较小，一些基于全球数据库的研究跳过了大多数过敏性疾病，仅专注于过敏反应。我们旨在基于欧洲药品不良反应数据库（EudraVigilance，EV）分析严重过敏反应的发生率，而不考虑报告的症状和过敏机制。
2023年10月5日从疫苗追踪器中提取了接种疫苗的总剂量，其中包括自欧洲经济区（EEA）开始接种以来的所有接种情况。与上述时间点相同，从欧洲药品不良反应数据库中提取了关于COVID-19疫苗严重过敏反应的数据。使用了147种过敏症状或疾病的代码名称。
每10万剂接种疫苗中，Comirnaty的严重过敏反应发生率为1.53，Spikevax为2.16，Vaxzevria为88.6，杨森疫苗为2.11，诺瓦瓦克斯疫苗为7.9，VidPrevtyn Beta为13.3，瓦尔内瓦疫苗为3.1。报告的最常见反应是水肿（0.46）和过敏反应（0.40）。这些反应中只有6%是迟发型超敏反应。
COVID-19潜在严重过敏反应的总体发生率非常低。因此，COVID-19疫苗似乎对人类使用是安全的。Comirnaty的过敏反应发生率最低，Vaxzevria最高。
