Klimek Ludger, Bergmann Karl-Christian, Brehler Randolf, Pfützner Wolfgang, Zuberbier Torsten, Hartmann Karin, Jakob Thilo, Novak Natalija, Ring Johannes, Merk Hans, Hamelmann Eckard, Ankermann Tobias, Schmidt Sebastian, Untersmayr Eva, Hötzenecker Wolfram, Jensen-Jarolim Erika, Brockow Knut, Mahler Vera, Worm Margitta
Center for Rhinology and Allergology, Wiesbaden, Germany.
Clinic for Dermatology, Venereology and Allergy, Charité-University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany.
Allergo J Int. 2021;30(3):79-95. doi: 10.1007/s40629-021-00165-7. Epub 2021 Apr 19.
For the preventive treatment of the 2019 coronavirus disease (COVID-19) an unprecedented global research effort studied the safety and efficacy of new vaccine platforms that have not been previously used in humans. Less than one year after the discovery of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral sequence, these vaccines were approved for use in the European Union (EU) as well as in numerous other countries and mass vaccination efforts began. The so far in the EU approved mRNA vaccines BNT162b2 and mRNA-1273 are based on similar lipid-based nanoparticle carrier technologies; however, the lipid components differ. Severe allergic reactions and anaphylaxis after COVID-19 vaccination are very rare adverse events but have drawn attention due to potentially lethal outcomes and have triggered a high degree of uncertainty.
Current knowledge on anaphylactic reactions to vaccines and specifically the new mRNA COVID-19 vaccines was compiled using a literature search in Medline, PubMed, as well as the national and international study and guideline registries, the Cochrane Library, and the Internet, with special reference to official websites of the World Health Organization (WHO), US Centers for Disease Control and Prevention (CDC), Robert Koch Institute (RKI), and Paul Ehrlich Institute (PEI).
Based on the international literature and previous experience, recommendations for prophylaxis, diagnosis and therapy of these allergic reactions are given by a panel of experts.
Allergy testing is not necessary for the vast majority of allergic patients prior to COVID-19 vaccination with currently licensed vaccines. In case of allergic/anaphylactic reactions after vaccination, allergy workup is recommended, as it is for a small potential risk population prior to the first vaccination. Evaluation and approval of diagnostic tests should be done for this purpose.
为预防2019冠状病毒病(COVID-19),全球开展了前所未有的研究工作,以研究此前未在人体使用过的新型疫苗平台的安全性和有效性。在发现严重急性呼吸综合征冠状病毒2(SARS-CoV-2)病毒序列不到一年后,这些疫苗在欧盟(EU)以及许多其他国家获得批准使用,大规模疫苗接种工作随即展开。目前在欧盟获批的mRNA疫苗BNT162b2和mRNA-1273基于类似的脂质纳米颗粒载体技术;然而,脂质成分有所不同。COVID-19疫苗接种后的严重过敏反应和过敏症是非常罕见的不良事件,但因其潜在的致命后果而受到关注,并引发了高度的不确定性。
通过检索Medline、PubMed以及国家和国际研究与指南登记处、Cochrane图书馆和互联网,特别参考世界卫生组织(WHO)、美国疾病控制与预防中心(CDC)、罗伯特·科赫研究所(RKI)和保罗·埃利希研究所(PEI)的官方网站,汇编了关于疫苗过敏反应,特别是新型mRNA COVID-19疫苗过敏反应的现有知识。
一组专家根据国际文献和以往经验,给出了这些过敏反应的预防、诊断和治疗建议。
对于绝大多数过敏患者,在使用目前已获许可的疫苗进行COVID-19疫苗接种前无需进行过敏测试。如接种后发生过敏/过敏反应,建议进行过敏检查,就像对一小部分首次接种前的潜在风险人群所做的那样。为此应进行诊断测试的评估和审批。