Klimek Ludger, Novak Natalija, Hamelmann Eckard, Werfel Thomas, Wagenmann Martin, Taube Christian, Bauer Andrea, Merk Hans, Rabe Uta, Jung Kirsten, Schlenter Wolfgang, Ring Johannes, Chaker Adam, Wehrmann Wolfgang, Becker Sven, Mülleneisen Norbert, Nemat Katja, Czech Wolfgang, Wrede Holger, Brehler Randolf, Fuchs Thomas, Jakob Thilo, Ankermann Tobias, Schmidt Sebastian M, Gerstlauer Michael, Vogelberg Christian, Zuberbier Thomas, Hartmann Karin, Worm Margitta
Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany.
Clinic and Polyclinic for Dermatology and Allergology, University Hospital Bonn, Bonn, Germany.
Allergo J Int. 2021;30(2):51-55. doi: 10.1007/s40629-020-00160-4. Epub 2021 Feb 24.
Two employees of the National Health Service (NHS) in England developed severe allergic reactions following administration of BNT162b2 vaccine against COVID-19 (coronavirus disease 2019). The British SmPC for the BNT162b2 vaccine already includes reference to a contraindication for use in individuals who have had an allergic reaction to the vaccine or any of its components. As a precautionary measure, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued interim guidance to the NHS not to vaccinate in principle in "patients with severe allergies". Allergic reactions to vaccines are very rare, but vaccine components are known to cause allergic reactions. BNT162b2 is a vaccine based on an mRNA embedded in lipid nanoparticles and blended with other substances to enable its transport into the cells. In the pivotal phase III clinical trial, the BNT162b2 vaccine was generally well tolerated, but this large clinical trial, used to support vaccine approval by the MHRA and US Food and Drug Administration, excluded individuals with a "history of a severe adverse reaction related to the vaccine and/or a severe allergic reaction (e.g., anaphylaxis) to a component of the study medication". Vaccines are recognized as one of the most effective public health interventions. This repeated administration of a foreign protein (antigen) necessitates a careful allergological history before each application and diagnostic clarification and a risk-benefit assessment before each injection. Severe allergic reactions to vaccines are rare but can be life-threatening, and it is prudent to raise awareness of this hazard among vaccination teams and to take adequate precautions while more experience is gained with this new vaccine.
英国国家医疗服务体系（NHS）的两名员工在接种针对2019冠状病毒病（COVID-19）的BNT162b2疫苗后出现了严重过敏反应。BNT162b2疫苗的英国产品特性概要（SmPC）中已经提及对该疫苗或其任何成分有过敏反应的个体禁用。作为一项预防措施，药品和医疗产品监管局（MHRA）已向NHS发布临时指南，原则上不在“严重过敏患者”中接种疫苗。疫苗过敏反应非常罕见，但已知疫苗成分会引起过敏反应。BNT162b2是一种基于嵌入脂质纳米颗粒中的信使核糖核酸（mRNA）并与其他物质混合以使其能够转运到细胞内的疫苗。在关键的III期临床试验中，BNT162b2疫苗总体耐受性良好，但这项用于支持MHRA和美国食品药品监督管理局批准该疫苗的大型临床试验排除了有“与疫苗相关的严重不良反应史和/或对研究药物的一种成分有严重过敏反应（如过敏反应）”的个体。疫苗被认为是最有效的公共卫生干预措施之一。这种对外源蛋白（抗原）的重复接种需要在每次接种前仔细询问过敏史、进行诊断明确，并在每次注射前进行风险效益评估。疫苗严重过敏反应虽罕见但可能危及生命，在接种团队中提高对这种风险的认识并在对这种新疫苗积累更多经验的同时采取充分的预防措施是审慎之举。
