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)

Ludger Klimek¹, Natalija Novak², Eckard Hamelmann³, Thomas Werfel⁴, Martin Wagenmann⁵, Christian Taube⁶, Andrea Bauer⁷, Hans Merk⁸, Uta Rabe⁹, Kirsten Jung¹⁰, Wolfgang Schlenter¹¹, Johannes Ring¹², Adam Chaker^{13

14}, Wolfgang Wehrmann¹⁵, Sven Becker¹⁶, Norbert Mülleneisen¹⁷, Katja Nemat¹⁸, Wolfgang Czech¹⁹, Holger Wrede²⁰, Randolf Brehler²¹, Thomas Fuchs²², Thilo Jakob²³, Tobias Ankermann²⁴, Sebastian M Schmidt²⁵, Michael Gerstlauer²⁶, Christian Vogelberg²⁷, Thomas Zuberbier²⁸, Karin Hartmann²⁹, Margitta Worm³⁰

Affiliations

¹ Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany.
² Clinic and Polyclinic for Dermatology and Allergology, University Hospital Bonn, Bonn, Germany.
³ Pediatric and Adolescent Medicine, Children's Center Bethel, University Hospital OWL of Bielefeld University, Bielefeld, Germany.
⁴ Department of Dermatology, Allergology and Venereology, Hannover Medical School, Hannover, Germany.
⁵ Department of Ear, Nose and Throat Medicine, University Hospital Düsseldorf, Düsseldorf, Germany.
⁶ Clinic for Pneumology, University Medicine Essen-Ruhrlandklinik, West German Lung Center, Essen, Germany.
⁷ Clinic and Polyclinic for Dermatology, University Allergy Center, University Clinic Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
⁸ Department of Dermatology and Allergology, RWTH Aachen, Aachen, Germany.
⁹ Clinic for Allergology, Johanniter Hospital in Fläming Treuenbrietzen GmbH, Treuenbrietzen, Germany.
¹⁰ Practice for Dermatology, Immunology and Allergology, Erfurt, Germany.
¹¹ Medical Association of German Allergologists, Dreieich, Germany.
¹² Skin and Laser Center at the Opera, Munich, Germany.
¹³ Ear, Nose and Throat Clinic, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁴ Center for Allergy and Environment (ZAUM), Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁵ Dermatological Group Practice Wehrmann, Münster, Germany.
¹⁶ Ear, Nose and Throat Clinic, University of Tübingen, Tübingen, Germany.
¹⁷ Asthma and Allergy Center Leverkusen, Leverkusen, Germany.
¹⁸ Practice for Pediatric Pneumology/Allergology at the Children's Center Dresden (Kid), Dresden, Germany.
¹⁹ Practice and Clinic for Allergology/Dermatology Schwarzwald-Baar Clinic, Villingen-Schwenningen, Germany.
²⁰ Ear, Nose and Throat Specialist, Herford, Germany.
²¹ Department of Skin Diseases, Outpatient Clinic for Allergology, Occupational Dermatology and Environmental Medicine, Münster University Hospital, Münster, Germany.
²² Department of Dermatology, Venereology and Allergology, University Medical Center, Georg-August University, Göttingen, Germany.
²³ Department of Dermatology and Allergology, University Hospital Gießen, UKGM Justus Liebig University Gießen, Gießen, Germany.
²⁴ Clinic for Pediatric and Adolescent Medicine, Pneumology, Allergology, Neonatology, Intensive Care Medicine, Infectiology, Schleswig-Holstein University Medical Center, Kiel, Germany.
²⁵ Center for Pediatric and Adolescent Medicine, Clinic and Polyclinic for Pediatric and Adolescent Medicine, University Medicine Greifswald, Greifswald, Germany.
²⁶ Pediatric Pneumology/Pediatric Allergology, 2nd Clinic for Children and Adolescents, University Hospital Augsburg, Augsburg, Germany.
²⁷ Department of Pediatric Pneumology/Allergology, Clinic and Polyclinic for Pediatric and Adolescent Medicine, Carl Gustav Carus University Hospital, Dresden, Germany.
²⁸ Clinic for Dermatology, Venereology and Allergology, Charité-University Medicine Berlin, Berlin, Germany.
²⁹ Clinic for Dermatology and Allergology, University Hospital Basel, Basel, Switzerland.
³⁰ Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.

PMID: 33643776
PMCID: PMC7903024
DOI: 10.1007/s40629-020-00160-4

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)

Ludger Klimek et al. Allergo J Int. 2021.

. 2021;30(2):51-55.

doi: 10.1007/s40629-020-00160-4. Epub 2021 Feb 24.

Authors

Affiliations

¹ Center for Rhinology and Allergology Wiesbaden, Wiesbaden, Germany.
² Clinic and Polyclinic for Dermatology and Allergology, University Hospital Bonn, Bonn, Germany.
³ Pediatric and Adolescent Medicine, Children's Center Bethel, University Hospital OWL of Bielefeld University, Bielefeld, Germany.
⁴ Department of Dermatology, Allergology and Venereology, Hannover Medical School, Hannover, Germany.
⁵ Department of Ear, Nose and Throat Medicine, University Hospital Düsseldorf, Düsseldorf, Germany.
⁶ Clinic for Pneumology, University Medicine Essen-Ruhrlandklinik, West German Lung Center, Essen, Germany.
⁷ Clinic and Polyclinic for Dermatology, University Allergy Center, University Clinic Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
⁸ Department of Dermatology and Allergology, RWTH Aachen, Aachen, Germany.
⁹ Clinic for Allergology, Johanniter Hospital in Fläming Treuenbrietzen GmbH, Treuenbrietzen, Germany.
¹⁰ Practice for Dermatology, Immunology and Allergology, Erfurt, Germany.
¹¹ Medical Association of German Allergologists, Dreieich, Germany.
¹² Skin and Laser Center at the Opera, Munich, Germany.
¹³ Ear, Nose and Throat Clinic, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁴ Center for Allergy and Environment (ZAUM), Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.
¹⁵ Dermatological Group Practice Wehrmann, Münster, Germany.
¹⁶ Ear, Nose and Throat Clinic, University of Tübingen, Tübingen, Germany.
¹⁷ Asthma and Allergy Center Leverkusen, Leverkusen, Germany.
¹⁸ Practice for Pediatric Pneumology/Allergology at the Children's Center Dresden (Kid), Dresden, Germany.
¹⁹ Practice and Clinic for Allergology/Dermatology Schwarzwald-Baar Clinic, Villingen-Schwenningen, Germany.
²⁰ Ear, Nose and Throat Specialist, Herford, Germany.
²¹ Department of Skin Diseases, Outpatient Clinic for Allergology, Occupational Dermatology and Environmental Medicine, Münster University Hospital, Münster, Germany.
²² Department of Dermatology, Venereology and Allergology, University Medical Center, Georg-August University, Göttingen, Germany.
²³ Department of Dermatology and Allergology, University Hospital Gießen, UKGM Justus Liebig University Gießen, Gießen, Germany.
²⁴ Clinic for Pediatric and Adolescent Medicine, Pneumology, Allergology, Neonatology, Intensive Care Medicine, Infectiology, Schleswig-Holstein University Medical Center, Kiel, Germany.
²⁵ Center for Pediatric and Adolescent Medicine, Clinic and Polyclinic for Pediatric and Adolescent Medicine, University Medicine Greifswald, Greifswald, Germany.
²⁶ Pediatric Pneumology/Pediatric Allergology, 2nd Clinic for Children and Adolescents, University Hospital Augsburg, Augsburg, Germany.
²⁷ Department of Pediatric Pneumology/Allergology, Clinic and Polyclinic for Pediatric and Adolescent Medicine, Carl Gustav Carus University Hospital, Dresden, Germany.
²⁸ Clinic for Dermatology, Venereology and Allergology, Charité-University Medicine Berlin, Berlin, Germany.
²⁹ Clinic for Dermatology and Allergology, University Hospital Basel, Basel, Switzerland.
³⁰ Allergologie und Immunologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité - Universitätsmedizin Berlin, Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany.

PMID: 33643776
PMCID: PMC7903024
DOI: 10.1007/s40629-020-00160-4

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.

Keywords: Anaphylaxis; BNT162b2; Severe allergic reactions; Vaccines; mRNA.

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Conflict of interest statement

Conflict of interestL. Klimek reports grants and personal fees from Allergopharma, grants and personal fees from MEDA/Mylan, personal fees from HAL Allergie, personal fees from ALK Abelló, grants and personal fees from LETI Pharma, grants and personal fees from Stallergenes, grants from Quintiles, grants and personal fees from Sanofi, grants from ASIT biotech, grants from Lofarma, personal fees from Allergy Therapeut., grants from AstraZeneca, grants and personal fees from GSK, grants from Inmunotek, personal fees from Cassella med, personal fees from Novartis, outside the submitted work; and Membership: AeDA, DGHNO, Deutsche Akademie für Allergologie und klinische Immunologie, HNO-BV, GPA, EAACI. K. Hartmann has received research funding from Euroimmun and Thermofisher and consultancy or lecture fees from Allergopharma, ALK-Abelló, Blueprint, Deciphera, Menarini, Novartis and Takeda. J. Ring reports personal fees from Mylan, personal fees from Allergika, outside the submitted work. A. Chaker reports grants and other from Allergopharma, grants and other from ALK Abello, grants and other from Bencard/Allergen Therapeutics, grants and other from ASIT Biotech, other from Lofarma, grants and other from GSK, grants and other from Novartis, grants and other from LETI, grants and other from Roche, grants and other from Zeller, other from Sanofi Genzyme, grants from European Institute of Technology, grants and other from AstraZeneca, grants and other from Immunotek, outside the submitted work; in addition, Dr. Chaker has a patent A ratio of immune cells as prognostic indicator of therapeutic success in allergen-specific immunotherapy: 17 177 681.8 licensed to none. M. Wagenmann has received fees for advice, lectures or research support from the following companies in the past 3 years: ALK-Abelló, Allergopharma, AstraZeneca, Bencard Allergie, Genzyme, GSK, HAL Allergie, Infectopharm, LETI Pharma, MEDA Pharma, Novartis, Regeneron, Sanofi Aventis, Stallergenes, Teva—all outside of the present work. T. Ankermann has received fees and accommodation and travel expenses for lectures and publications from the following companies and institutions: Abbvie, Aimmune, Allergopharma, Chiesi, Infectopharm, Novartis, UKSH Academy, RG, Springer publishing house, Scientific publishing company, GPP e. V, GPA e. V., nappa e. V., ÖGKJ e. V. Dr. Ankermann has received fees for advisory boards from Boehringer Ingelheim, Aimmune, and fees for safety board from Allergopharma, all outside of the present work. C. Vogelberg has received lecture fees or consultant fees or travel and accommodation costs from: ALK, Allergopharma, Aimmune, DBV, LETI, Novartis, Stallergenes, HAL, Bencard, Sanofi, Aimmune, GPA e. V., APPA e. V. all outside of the present work. T. Werfel reports grants and/or fees from AbbVie, ALK Abello, Almirall, Astellas, Bencard, Galderma, Janssen/JNJ, Leo Pharma, Leti, Lilly, Novartis, Pfizer, Regeneron/Sanofi, Stallergen, all outside of the present work. A. Bauer reports grants and personal fees from Novartis, Leo Pharma, Sanofi/Regeneron, Shire/Takeda, Genentech, outside the submitted work. T. Zuberbier reports personal fees and/or fees for talk from Bayer Health Care, FAES, Novartis, Henkel, AstraZeneca, AbbVie, ALK, Almirall, Astellas, Bencard, Berlin Chemie, HAL, Leti, Meda, Menarini, Merck, MSD, Pfizer, Sanofi, Stallergenes, Takeda, Teva, UCB, Kryolan, L’Oréal outside the submitted work. T. Jakob reports grants, personal fees and non-financial support from Novartis, grants, personal fees and non-financial support from ALK-Abello, personal fees and non-financial support from Allergy Therapeutics/Bencard, personal fees from Allergopharma, personal fees from Thermo Fisher, outside the submitted work. M. Worm reports honorarium for advisory boards and lecture activities from Regeneron Pharmaceuticals, DBV Technologies S.A, Stallergenes GmbH, HAL Allergie GmbH, Bencard Allergie GmbH, Allergopharma GmbH & Co. KG, ALK-Abelló Arzneimittel GmbH, Mylan Germany GmbH, Leo Pharma GmbH, Sanofi-Aventis Deutschland GmbH, Aimmune Therapeutics UK Limited, Actelion Pharmaceuticals Deutschland GmbH, Novartis AG, Biotest AG, AbbVie Deutschland GmbH & Co. KG, Lilly Deutschland GmbH, outside the submitted work. N. Novak, E. Hamelmann, C. Taube, H. Merk, U. Rabe, K. Jung, W. Schlenter, W. Wehrmann, S. Becker, N. Mülleneisen, K. Nemat, W. Czech, H. Wrede, R. Brehler, T. Fuchs, S. M. Schmidt and M. Gerstlauer declare that they have no competing interests.

Comment in

Hausstauballergie: Adhärenz zur subkutanen Immuntherapie ist höher.
Bublak R. Bublak R. MMW Fortschr Med. 2021 Jul;163(13):11. doi: 10.1007/s15006-021-0166-3. MMW Fortschr Med. 2021. PMID: 34240352 German. No abstract available.

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