Severe allergic reactions after COVID-19 vaccination with the Pfizer/BioNTech vaccine in Great Britain and USA: Position statement of the German Allergy Societies: Medical Association of German Allergologists (AeDA), German Society for Allergology and Clinical Immunology (DGAKI) and Society for Pediatric Allergology and Environmental Medicine (GPA).
Severe allergic reactions after COVID-19 vaccination with the Pfizer/BioNTech vaccine in Great Britain and USA: Position statement of the German Allergy Societies: Medical Association of German Allergologists (AeDA), German Society for Allergology and Clinical Immunology (DGAKI) and Society for Pediatric Allergology and Environmental Medicine (GPA).
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DOI：
10.1007/s40629-020-00160-4
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发表时间：
2021
影响因子：
--
通讯作者：
Worm M
中科院分区：
文献类型：
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作者：
Klimek L;Novak N;Hamelmann E;Werfel T;Wagenmann M;Taube C;Bauer A;Merk H;Rabe U;Jung K;Schlenter W;Ring J;Chaker A;Wehrmann W;Becker S;Mülleneisen N;Nemat K;Czech W;Wrede H;Brehler R;Fuchs T;Jakob T;Ankermann T;Schmidt SM;Gerstlauer M;Vogelberg C;Zuberbier T;Hartmann K;Worm M
英国国家卫生服务体系（NHS）的两名雇员在接种针对COVID-19（2019冠状病毒病）的BNT 162 b2疫苗后出现严重过敏反应。BNT 162 b2疫苗的英国SmPC已经包括了对疫苗或其任何组分发生过敏反应的个体的禁忌症。作为预防措施，药品和保健产品管理局（MHRA）已向NHS发布临时指导，原则上不要在“严重过敏患者”中接种疫苗。对疫苗的过敏反应非常罕见，但已知疫苗成分会引起过敏反应。BNT 162 b2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能够转运到细胞中。在关键的III期临床试验中，BNT 162 b2疫苗通常耐受良好，但用于支持MHRA和美国食品和药物管理局批准疫苗的这项大型临床试验排除了具有“与疫苗相关的严重不良反应和/或严重过敏反应（例如，过敏性反应）对研究药物的一种组分的影响”。疫苗被认为是最有效的公共卫生干预措施之一。这种外源蛋白（抗原）的重复给药需要在每次应用前仔细了解过敏史，并在每次注射前进行诊断澄清和风险-获益评估。对疫苗的严重过敏反应是罕见的，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，并在获得更多新疫苗经验的同时采取适当的预防措施。
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.