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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)

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 individual...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Medizin 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903024/
https://www.ncbi.nlm.nih.gov/pubmed/33643776
http://dx.doi.org/10.1007/s40629-020-00160-4
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author 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
author_facet 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
author_sort Klimek, Ludger
collection PubMed
description 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.
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spelling pubmed-79030242021-02-24 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) 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 Allergo J Int Position Article 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. Springer Medizin 2021-02-24 2021 /pmc/articles/PMC7903024/ /pubmed/33643776 http://dx.doi.org/10.1007/s40629-020-00160-4 Text en © The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Position Article
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
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Position Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903024/
https://www.ncbi.nlm.nih.gov/pubmed/33643776
http://dx.doi.org/10.1007/s40629-020-00160-4
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