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A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System

Background: The COVID-19 pandemic is being battled via the largest vaccination campaign in history, with more than eight billion doses administered thus far. Therefore, discussions about potentially adverse reactions, and broader safety concerns, are critical. The U.S. Vaccination Adverse Event Repo...

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Autores principales: Gallo, Kathleen, Goede, Andrean, Mura, Cameron, Abel, Renata, Moahamed, Barbara, Preissner, Saskia, Nahles, Susanne, Heiland, Max, Bourne, Philip E., Preissner, Robert, Mallach, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8950485/
https://www.ncbi.nlm.nih.gov/pubmed/35335040
http://dx.doi.org/10.3390/vaccines10030408
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author Gallo, Kathleen
Goede, Andrean
Mura, Cameron
Abel, Renata
Moahamed, Barbara
Preissner, Saskia
Nahles, Susanne
Heiland, Max
Bourne, Philip E.
Preissner, Robert
Mallach, Michael
author_facet Gallo, Kathleen
Goede, Andrean
Mura, Cameron
Abel, Renata
Moahamed, Barbara
Preissner, Saskia
Nahles, Susanne
Heiland, Max
Bourne, Philip E.
Preissner, Robert
Mallach, Michael
author_sort Gallo, Kathleen
collection PubMed
description Background: The COVID-19 pandemic is being battled via the largest vaccination campaign in history, with more than eight billion doses administered thus far. Therefore, discussions about potentially adverse reactions, and broader safety concerns, are critical. The U.S. Vaccination Adverse Event Reporting System (VAERS) has recorded vaccination side effects for over 30 years. About 580,000 events have been filed for COVID-19 thus far, primarily for the Johnson & Johnson (New Jersey, USA), Pfizer/BioNTech (Mainz, Germany), and Moderna (Cambridge, USA) vaccines. Methods: Using available databases, we evaluated these three vaccines in terms of the occurrence of four generally-noticed adverse reactions—namely, cerebral venous sinus thrombosis, Guillain–Barré syndrome (a severe paralytic neuropathy), myocarditis, and pericarditis. Our statistical analysis also included a calculation of odds ratios (ORs) based on total vaccination numbers, accounting for incidence rates in the general population. Results: ORs for a number of adverse events and patient groups were (largely) increased, most notably for the occurrence of cerebral venous sinus thrombosis after vaccination with the Johnson & Johnson vaccine. The overall population OR of 10 increases to 12.5 when limited to women, and further yet (to 14.4) among women below age 50 yrs. In addition, elevated risks were found (i) for Guillain–Barré syndrome (OR of 11.6) and (ii) for myocarditis/pericarditis (ORs of 5.3/4.1, respectively) among young men (<25 yrs) vaccinated with the Pfizer/BioNTech vaccine. Conclusions: Any conclusions from such a retrospective, real-world data analysis must be drawn cautiously, and should be confirmed by prospective double-blinded clinical trials. In addition, we emphasize that the adverse events reported here are not specific side effects of COVID vaccines, and the significant, well-established benefits of COVID-19 vaccination outweigh the potential complications surveyed here.
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spelling pubmed-89504852022-03-26 A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System Gallo, Kathleen Goede, Andrean Mura, Cameron Abel, Renata Moahamed, Barbara Preissner, Saskia Nahles, Susanne Heiland, Max Bourne, Philip E. Preissner, Robert Mallach, Michael Vaccines (Basel) Article Background: The COVID-19 pandemic is being battled via the largest vaccination campaign in history, with more than eight billion doses administered thus far. Therefore, discussions about potentially adverse reactions, and broader safety concerns, are critical. The U.S. Vaccination Adverse Event Reporting System (VAERS) has recorded vaccination side effects for over 30 years. About 580,000 events have been filed for COVID-19 thus far, primarily for the Johnson & Johnson (New Jersey, USA), Pfizer/BioNTech (Mainz, Germany), and Moderna (Cambridge, USA) vaccines. Methods: Using available databases, we evaluated these three vaccines in terms of the occurrence of four generally-noticed adverse reactions—namely, cerebral venous sinus thrombosis, Guillain–Barré syndrome (a severe paralytic neuropathy), myocarditis, and pericarditis. Our statistical analysis also included a calculation of odds ratios (ORs) based on total vaccination numbers, accounting for incidence rates in the general population. Results: ORs for a number of adverse events and patient groups were (largely) increased, most notably for the occurrence of cerebral venous sinus thrombosis after vaccination with the Johnson & Johnson vaccine. The overall population OR of 10 increases to 12.5 when limited to women, and further yet (to 14.4) among women below age 50 yrs. In addition, elevated risks were found (i) for Guillain–Barré syndrome (OR of 11.6) and (ii) for myocarditis/pericarditis (ORs of 5.3/4.1, respectively) among young men (<25 yrs) vaccinated with the Pfizer/BioNTech vaccine. Conclusions: Any conclusions from such a retrospective, real-world data analysis must be drawn cautiously, and should be confirmed by prospective double-blinded clinical trials. In addition, we emphasize that the adverse events reported here are not specific side effects of COVID vaccines, and the significant, well-established benefits of COVID-19 vaccination outweigh the potential complications surveyed here. MDPI 2022-03-08 /pmc/articles/PMC8950485/ /pubmed/35335040 http://dx.doi.org/10.3390/vaccines10030408 Text en © 2022 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
Gallo, Kathleen
Goede, Andrean
Mura, Cameron
Abel, Renata
Moahamed, Barbara
Preissner, Saskia
Nahles, Susanne
Heiland, Max
Bourne, Philip E.
Preissner, Robert
Mallach, Michael
A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System
title A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System
title_full A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System
title_fullStr A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System
title_full_unstemmed A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System
title_short A Comparative Analysis of COVID-19 Vaccines Based on over 580,000 Cases from the Vaccination Adverse Event Reporting System
title_sort comparative analysis of covid-19 vaccines based on over 580,000 cases from the vaccination adverse event reporting system
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8950485/
https://www.ncbi.nlm.nih.gov/pubmed/35335040
http://dx.doi.org/10.3390/vaccines10030408
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