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Abstract：
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.
摘要：
英国国家卫生局（NHS）的两名员工在服用针对COVID-19（2019年冠状病毒病）的BNT162b2疫苗后出现了严重的过敏反应。BNT162b2疫苗的英国SmPC已经包括对对疫苗或其任何成分有过敏反应的个体使用的禁忌症。作为预防措施,药品和保健产品监管局（MHRA）已向NHS发布了临时指南，原则上不对“严重过敏患者”接种疫苗。对疫苗的过敏反应非常罕见，但是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mRNA的疫苗，并与其他物质混合以使其转运到细胞中。在关键的III期临床试验中，BNT162b2疫苗通常耐受性良好，但是这项大型临床试验，用于支持MHRA和美国食品和药物管理局批准的疫苗，排除具有与疫苗相关的严重不良反应和/或严重过敏反应史的个体(例如，过敏反应)对研究药物的一部分。“疫苗被认为是最有效的公共卫生干预措施之一。外源蛋白（抗原）的重复给药需要在每次应用之前进行仔细的变态反应史，并在每次注射之前进行诊断澄清和风险收益评估。对疫苗的严重过敏反应很少见，但可能危及生命，谨慎的做法是提高疫苗接种团队对这种危害的认识，并采取适当的预防措施，同时获得更多的新疫苗经验。
