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)

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Ludger Klimek - , Center for Rhinology and Allergology Wiesbaden (Author)
  • Natalija Novak - , University of Bonn (Author)
  • Eckard Hamelmann - , University Hospital Bielefeld (Author)
  • Thomas Werfel - , Hannover Medical School (MHH) (Author)
  • Martin Wagenmann - , Heinrich Heine University Düsseldorf (Author)
  • Christian Taube - , University of Duisburg-Essen (Author)
  • Andrea Bauer - , Department of Dermatology, Department of Dermatology, TUD Dresden University of Technology (Author)
  • Hans Merk - , RWTH Aachen University (Author)
  • Uta Rabe - , Johanniter-Hospital Treuenbrietzen (Author)
  • Kirsten Jung - , Immunology and Allergology (Author)
  • Wolfgang Schlenter - , Medical Association of German Allergologists (Author)
  • Johannes Ring - , Skin and Laser Center at the Opera (Author)
  • Adam Chaker - , Technical University of Munich (Author)
  • Wolfgang Wehrmann - , Wehrmann Dermatological Group Practice (Author)
  • Sven Becker - , University of Tübingen (Author)
  • Norbert Mülleneisen - , Asthma and Allergy Centre Leverkusen (Author)
  • Katja Nemat - , Pediatric Center Dresden-Friedrichstadt (Kid) (Author)
  • Wolfgang Czech - , Schwarzwald-Baar Hospital Villingen-Schwenningen (Author)
  • Holger Wrede - , ENT and Allergy Center Herford (Author)
  • Randolf Brehler - , University of Münster (Author)
  • Thomas Fuchs - , University of Göttingen (Author)
  • Thilo Jakob - , Justus Liebig University Giessen (Author)
  • Tobias Ankermann - , Kiel University (Author)
  • Sebastian M. Schmidt - , University of Greifswald (Author)
  • Michael Gerstlauer - , University Hospital Augsburg (Author)
  • Christian Vogelberg - , Department of Paediatrics, TUD Dresden University of Technology (Author)
  • Thomas Zuberbier - , Charité – Universitätsmedizin Berlin (Author)
  • Karin Hartmann - , University of Basel (Author)
  • Margitta Worm - , Charité – Universitätsmedizin Berlin (Author)

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.

Details

Original languageEnglish
Pages (from-to)51-55
Number of pages5
JournalAllergo Journal International
Volume30
Issue number2
Publication statusPublished - Mar 2021
Peer-reviewedYes

External IDs

ORCID /0000-0002-4411-3088/work/146644373

Keywords

Sustainable Development Goals

ASJC Scopus subject areas

Keywords

  • Anaphylaxis, BNT162b2, mRNA, Severe allergic reactions, Vaccines