Cargando…

Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data

This study aimed at producing an updated assessment of the incidence of anaphylaxis associated with COVID-19 vaccines based on pharmacovigilance data. Anaphylactic reaction and anaphylactic shock data post-COVID-19-vaccination reported from week 52, 2020 to week 1 or week 2, 2023 were collected from...

Descripción completa

Detalles Bibliográficos
Autores principales: Boufidou, Fotini, Hatziantoniou, Sophia, Theodoridou, Kalliopi, Maltezou, Helena C., Vasileiou, Konstantinos, Anastassopoulou, Cleo, Medić, Snežana, Tsakris, Athanasios
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10051410/
https://www.ncbi.nlm.nih.gov/pubmed/36992197
http://dx.doi.org/10.3390/vaccines11030613
_version_ 1785014879425396736
author Boufidou, Fotini
Hatziantoniou, Sophia
Theodoridou, Kalliopi
Maltezou, Helena C.
Vasileiou, Konstantinos
Anastassopoulou, Cleo
Medić, Snežana
Tsakris, Athanasios
author_facet Boufidou, Fotini
Hatziantoniou, Sophia
Theodoridou, Kalliopi
Maltezou, Helena C.
Vasileiou, Konstantinos
Anastassopoulou, Cleo
Medić, Snežana
Tsakris, Athanasios
author_sort Boufidou, Fotini
collection PubMed
description This study aimed at producing an updated assessment of the incidence of anaphylaxis associated with COVID-19 vaccines based on pharmacovigilance data. Anaphylactic reaction and anaphylactic shock data post-COVID-19-vaccination reported from week 52, 2020 to week 1 or week 2, 2023 were collected from the VAERS and EudraVigilance databases, respectively, and analyzed comparatively. Incidence rates were calculated using the corresponding administered vaccine doses as denominators for all licensed vaccines and both platform types (mRNA or vectored). The latest data from the present analysis showed lower anaphylaxis incidence associated with COVID-19 vaccination compared to previous estimates from week 52, 2020 to week 39, 2021 (anaphylactic reaction: 8.96 (95% CI 8.80–9.11)/million doses overall (EEA: 14.19 (95% CI 13.92–14.47)/million/US: 3.17 (95% CI 3.03–3.31)/million); anaphylactic shock: 1.46 (95% CI 1.39–1.52)/million doses overall (EEA: 2.47 (95% CI 2.36–2.58)/million/US: 0.33 (95% CI 0.29–0.38)/million)). Incidence rates varied by vaccine and were higher as captured in EudraVigilance compared to the VAERS and for vectored compared to mRNA vaccines. Most reported cases had a favorable outcome. The extremely rare fatalities (overall rates across continents 0.04 (95% CI 0.03–0.06)/million doses for anaphylactic reaction and 0.02 (95% CI 0.01–0.03)/million vaccine doses for anaphylactic shock) were also associated with vector-rather than mRNA-based vaccines. The diminished incidence of anaphylaxis post-vaccination with COVID-19 vaccines offers assurance about their safety, as does the continuous potential adverse events monitoring through specialized pharmacovigilance databases.
format Online
Article
Text
id pubmed-10051410
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-100514102023-03-30 Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data Boufidou, Fotini Hatziantoniou, Sophia Theodoridou, Kalliopi Maltezou, Helena C. Vasileiou, Konstantinos Anastassopoulou, Cleo Medić, Snežana Tsakris, Athanasios Vaccines (Basel) Article This study aimed at producing an updated assessment of the incidence of anaphylaxis associated with COVID-19 vaccines based on pharmacovigilance data. Anaphylactic reaction and anaphylactic shock data post-COVID-19-vaccination reported from week 52, 2020 to week 1 or week 2, 2023 were collected from the VAERS and EudraVigilance databases, respectively, and analyzed comparatively. Incidence rates were calculated using the corresponding administered vaccine doses as denominators for all licensed vaccines and both platform types (mRNA or vectored). The latest data from the present analysis showed lower anaphylaxis incidence associated with COVID-19 vaccination compared to previous estimates from week 52, 2020 to week 39, 2021 (anaphylactic reaction: 8.96 (95% CI 8.80–9.11)/million doses overall (EEA: 14.19 (95% CI 13.92–14.47)/million/US: 3.17 (95% CI 3.03–3.31)/million); anaphylactic shock: 1.46 (95% CI 1.39–1.52)/million doses overall (EEA: 2.47 (95% CI 2.36–2.58)/million/US: 0.33 (95% CI 0.29–0.38)/million)). Incidence rates varied by vaccine and were higher as captured in EudraVigilance compared to the VAERS and for vectored compared to mRNA vaccines. Most reported cases had a favorable outcome. The extremely rare fatalities (overall rates across continents 0.04 (95% CI 0.03–0.06)/million doses for anaphylactic reaction and 0.02 (95% CI 0.01–0.03)/million vaccine doses for anaphylactic shock) were also associated with vector-rather than mRNA-based vaccines. The diminished incidence of anaphylaxis post-vaccination with COVID-19 vaccines offers assurance about their safety, as does the continuous potential adverse events monitoring through specialized pharmacovigilance databases. MDPI 2023-03-08 /pmc/articles/PMC10051410/ /pubmed/36992197 http://dx.doi.org/10.3390/vaccines11030613 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Boufidou, Fotini
Hatziantoniou, Sophia
Theodoridou, Kalliopi
Maltezou, Helena C.
Vasileiou, Konstantinos
Anastassopoulou, Cleo
Medić, Snežana
Tsakris, Athanasios
Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
title Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
title_full Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
title_fullStr Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
title_full_unstemmed Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
title_short Anaphylactic Reactions to COVID-19 Vaccines: An Updated Assessment Based on Pharmacovigilance Data
title_sort anaphylactic reactions to covid-19 vaccines: an updated assessment based on pharmacovigilance data
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10051410/
https://www.ncbi.nlm.nih.gov/pubmed/36992197
http://dx.doi.org/10.3390/vaccines11030613
work_keys_str_mv AT boufidoufotini anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT hatziantoniousophia anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT theodoridoukalliopi anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT maltezouhelenac anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT vasileioukonstantinos anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT anastassopouloucleo anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT medicsnezana anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata
AT tsakrisathanasios anaphylacticreactionstocovid19vaccinesanupdatedassessmentbasedonpharmacovigilancedata