Practical handling of allergic reactions to COVID-19 vaccines: A position paper from German and Austrian Allergy Societies AeDA, DGAKI, GPA and ÖGAI.

Background: For the preventive treatment of the 2019 coronavirus disease (COVID-19) an unprecedented global research effort studied the safety and efficacy of new vaccine platforms that have not been previously used in humans. Less than one year after the discovery of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral sequence, these vaccines were approved for use in the European Union (EU) as well as in numerous other countries and mass vaccination efforts began. The so far in the EU approved mRNA vaccines BNT162b2 and mRNA-1273 are based on similar lipid-based nanoparticle carrier technologies; however, the lipid components differ. Severe allergic reactions and anaphylaxis after COVID-19 vaccination are very rare adverse events but have drawn attention due to potentially lethal outcomes and have triggered a high degree of uncertainty.
Methods: Current knowledge on anaphylactic reactions to vaccines and specifically the new mRNA COVID-19 vaccines was compiled using a literature search in Medline, PubMed, as well as the national and international study and guideline registries, the Cochrane Library, and the Internet, with special reference to official websites of the World Health Organization (WHO), US Centers for Disease Control and Prevention (CDC), Robert Koch Institute (RKI), and Paul Ehrlich Institute (PEI).
Results: Based on the international literature and previous experience, recommendations for prophylaxis, diagnosis and therapy of these allergic reactions are given by a panel of experts.
Conclusion: Allergy testing is not necessary for the vast majority of allergic patients prior to COVID-19 vaccination with currently licensed vaccines. In case of allergic/anaphylactic reactions after vaccination, allergy workup is recommended, as it is for a small potential risk population prior to the first vaccination. Evaluation and approval of diagnostic tests should be done for this purpose.
Competing Interests: Conflict of interestL. Klimek reports grants and/or personal fees from Allergopharma, MEDA/Mylan, HAL Allergie, ALK Abelló, LETI Pharma, Stallergenes, Quintiles, Sanofi, ASIT Biotech, Lofarma, Allergy Therapeutics, AstraZeneca, GSK, Inmunotek, Cassella med and Novartis, outside of the submitted work; and memberships in the following organizations: AeDA, DGHNO, German Academy for Allergology and Clinical Immunology, ENT-BV, GPA, EAACI. L. Klimek is editor in chief of Allergo Journal International. R. Brehler reports fees and/or research support from ALK, Allergopharma, Bencard, HAL, Leti, Stallergenes, Astra Zeneca, GSK, MedUpdate, Novartis, BiotechTools, Genentech and Circassia, outside of the submitted work. W. Pfützner reports grants and/or personal fees and/or non-financial support from ALK-Abello, Biomay, Cilag-Janssen, Lilly, Novartis and Thermo Fisher outside of the submitted work. T. Zuberbier reports grants and/or personal fees from AstraZeneca, AbbVie, ALK, Almirall, Astellas, Bayer Health Care, Bencard, Berlin Chemie, FAES, HAL, Leti, Meda, Menarini, Merck, MSD, Novartis, Pfizer, Sanofi, Stallergenes, Takeda, Teva, UCB, Henkel, Kryolan and L’Oréal outside of the submitted work; and the following organizational affiliations: Member of the committee: WHO initiative “Allergic Rhinitis and its Effects on Asthma” (ARIA), Board member: German Society for Allergy and Clinical Immunology (DGAKI), Chairman of the Board: Foundation of the European Center for Allergy Research (ECARF), President: Global European Network on Allergy and Asthma (GA2LEN), Member: Committee on Allergy Diagnosis and Molecular Allergology, World Allergy Organization (WAO). K. Hartmann has received research grants outside of the present work from Euroimmun and Thermofisher as well as consulting or lecture fees from Allergopharma, ALK-Abelló, Blueprint, Deciphera, Menarini, Novartis and Takeda. T. Jakob reports grants and/or personal fees and/or non-financial support from Novartis, ALK-Abello, Allergy Therapeutics/Bencard, Allergopharma, and Thermo Fisher outside of the submitted work. T. Jakob is editor in chief of Allergo Journal International. N. Novak reports grants and/or personal fees from Alk Abelló, HAL Allergy, Stallergenes Geer, Leti Pharma, Novartis, Leo Pharma, Abbvie, Sanofi Genzmye, Lofarma and Bencard Allergy Therapeutics, outside of the submitted work. J. Ring reports fees from Mylan and Allergika outside of the submitted work. T. Ankermann received fees outside the submitted work from the following companies and organizations: Abbvie, Allergopharma, Chiesi, Infectopharm, Novartis, UKSH Akademie, RG, Springer Verlag, Wissenschaftliche Verlagsgesellschaft, GPP eV, GPA eV, nappa eV and ÖGKJ eV and is an advisory agent active for Boehringer Ingelheim, Aimmune and Allergopharma. S. Schmidt reports grants and/or personal fees and/or non-financial support from Allergopharma, ALK, Bencard, Gilead, Mundipharma, Novartis, Vertex, HAL, Sanofi, Olympus, Infectopharm, Pari and Pfizer outside of the submitted work. V. Mahler The positions stated in this work represent the personal views of the author as an expert in the field of allergology and must not be understood or cited as the view of the Federal Institute for Vaccines and Biomedical Medicines, the European Medicines Agency or one of its Committees or working groups. There are no conflicts of interest. M. Worm reports fees for consulting and lecture activities from Regeneron Pharmaceuticals, DBV Technologies SA, 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 and Lilly Deutschland GmbH, outside of the submitted work. K.-C. Bergmann, H. Merk, E. Hamelmann, E. Untersmayr, W. Hötzenecker, E. Jensen-Jarolim and K. Brockow declare that they have no competing interests.
(© The Author(s) 2021.)