Version 1
: Received: 5 April 2024 / Approved: 8 April 2024 / Online: 8 April 2024 (08:28:10 CEST)
How to cite:
Romantowski, J.; Nazar, W.; Bojahr, K.; Popiołek, I.; Niedoszytko, M. Analysis of allergy and hypersensitivity reactions to COVID-19 vaccines according to the EudraVigilance database. Preprints2024, 2024040516. https://doi.org/10.20944/preprints202404.0516.v1
Romantowski, J.; Nazar, W.; Bojahr, K.; Popiołek, I.; Niedoszytko, M. Analysis of allergy and hypersensitivity reactions to COVID-19 vaccines according to the EudraVigilance database. Preprints 2024, 2024040516. https://doi.org/10.20944/preprints202404.0516.v1
Romantowski, J.; Nazar, W.; Bojahr, K.; Popiołek, I.; Niedoszytko, M. Analysis of allergy and hypersensitivity reactions to COVID-19 vaccines according to the EudraVigilance database. Preprints2024, 2024040516. https://doi.org/10.20944/preprints202404.0516.v1
APA Style
Romantowski, J., Nazar, W., Bojahr, K., Popiołek, I., & Niedoszytko, M. (2024). Analysis of allergy and hypersensitivity reactions to COVID-19 vaccines according to the EudraVigilance database. Preprints. https://doi.org/10.20944/preprints202404.0516.v1
Chicago/Turabian Style
Romantowski, J., Iwona Popiołek and Marek Niedoszytko. 2024 "Analysis of allergy and hypersensitivity reactions to COVID-19 vaccines according to the EudraVigilance database" Preprints. https://doi.org/10.20944/preprints202404.0516.v1
Abstract
Background: The Coronavirus Disease 2019 (COVID-19) pandemic presented a new challenge in modern medicine. The development of vaccines was followed by massive population vaccinations. A few reports on post-vaccination allergic reactions have made patients and medical personnel uneasy as to anti-COVID-19 vaccines’ allergising potential. Most of the studies in this area to date have been small, and some that were based on global databases skipped most of the allergic diseases and concentrated only on anaphylaxis. We aimed to analyse the incidence of serious allergic reactions based on the EudraVigilance (EV) database, regardless of the reported symptoms and allergy mechanism. Methods: The total number of administrated vaccine doses was extracted on the 5th October 2023 from Vaccine Tracker and included all administrations since vaccinations began in the European Economic Area (EEA). Data on serious allergic reactions to COVID-19 vaccines was extracted from the EudraVigilance database with the same time point. The code names of 147 allergic symptoms or diseases were used. Results: The frequency of serious allergic reactions per 100,000 administered vaccine doses was 1.53 for Comirnaty, 2.16 for Spikevax, 88.6 for Vaxzevria, 2.11 for Janssen, 7.9 for Novavax, 13.3 for VidPrevtyn Beta and 3.1 for Valneva. The most prevalent reported reactions were oedema (0.46) and anaphylaxis (0.40). Only 6% of these reactions were delayed hypersensitivity-oriented. Conclusions: The overall frequency of potential serious allergic reactions to COVID-19 is very rare. Therefore, COVID-19 vaccines seem to be safe for human use. The lowest frequency of allergic reaction was observed for Comirnaty and the highest for Vaxzevria.
Keywords
vaccination; drug allergy; anaphylaxis; rash; side effect; adverse drug reaction; COVID-19
Subject
Medicine and Pharmacology, Immunology and Allergy
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
