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Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis

With the mass vaccination program for COVID-19 mRNA vaccines, there has been sufficient real-world study (RWS) on the topic to summarize their safety in the total population and in immunocompromised (IC) patients who were excluded from phase 3 clinical trials. We conducted a systematic review and me...

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Autores principales: Xu, Wanqian, Ren, Weigang, Wu, Tongxin, Wang, Qin, Luo, Mi, Yi, Yongxiang, Li, Junwei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10301865/
https://www.ncbi.nlm.nih.gov/pubmed/37376508
http://dx.doi.org/10.3390/vaccines11061118
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author Xu, Wanqian
Ren, Weigang
Wu, Tongxin
Wang, Qin
Luo, Mi
Yi, Yongxiang
Li, Junwei
author_facet Xu, Wanqian
Ren, Weigang
Wu, Tongxin
Wang, Qin
Luo, Mi
Yi, Yongxiang
Li, Junwei
author_sort Xu, Wanqian
collection PubMed
description With the mass vaccination program for COVID-19 mRNA vaccines, there has been sufficient real-world study (RWS) on the topic to summarize their safety in the total population and in immunocompromised (IC) patients who were excluded from phase 3 clinical trials. We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 mRNA vaccines, with a total of 5,132,799 subjects from 122 articles. In the case of the total population vaccinated with first, second, and third doses, the pooled incidence of any adverse events (AEs) was 62.20%, 70.39%, and 58.60%; that of any local AEs was 52.03%, 47.99%, and 65.00%; that of any systemic AEs was 29.07%, 47.86%, and 32.71%. Among the immunocompromised patients, the pooled odds ratio of any AEs, any local AEs, and systemic AEs were slightly lower than or similar to those of the healthy controls at 0.60 (95% CI: 0.33–1.11), 0.19 (95% CI: 0.10–0.37), and 0.36 (95% CI: 0.25–0.54), with pooled incidences of 51.95%, 38.82%, and 31.00%, respectively. The spectrum of AEs associated with the vaccines was broad, but most AEs were transient, self-limiting, and mild to moderate. Moreover, younger adults, women, and people with prior SARS-CoV-2 infection were more likely to experience AEs.
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spelling pubmed-103018652023-06-29 Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis Xu, Wanqian Ren, Weigang Wu, Tongxin Wang, Qin Luo, Mi Yi, Yongxiang Li, Junwei Vaccines (Basel) Systematic Review With the mass vaccination program for COVID-19 mRNA vaccines, there has been sufficient real-world study (RWS) on the topic to summarize their safety in the total population and in immunocompromised (IC) patients who were excluded from phase 3 clinical trials. We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 mRNA vaccines, with a total of 5,132,799 subjects from 122 articles. In the case of the total population vaccinated with first, second, and third doses, the pooled incidence of any adverse events (AEs) was 62.20%, 70.39%, and 58.60%; that of any local AEs was 52.03%, 47.99%, and 65.00%; that of any systemic AEs was 29.07%, 47.86%, and 32.71%. Among the immunocompromised patients, the pooled odds ratio of any AEs, any local AEs, and systemic AEs were slightly lower than or similar to those of the healthy controls at 0.60 (95% CI: 0.33–1.11), 0.19 (95% CI: 0.10–0.37), and 0.36 (95% CI: 0.25–0.54), with pooled incidences of 51.95%, 38.82%, and 31.00%, respectively. The spectrum of AEs associated with the vaccines was broad, but most AEs were transient, self-limiting, and mild to moderate. Moreover, younger adults, women, and people with prior SARS-CoV-2 infection were more likely to experience AEs. MDPI 2023-06-19 /pmc/articles/PMC10301865/ /pubmed/37376508 http://dx.doi.org/10.3390/vaccines11061118 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 Systematic Review
Xu, Wanqian
Ren, Weigang
Wu, Tongxin
Wang, Qin
Luo, Mi
Yi, Yongxiang
Li, Junwei
Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis
title Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis
title_full Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis
title_fullStr Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis
title_full_unstemmed Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis
title_short Real-World Safety of COVID-19 mRNA Vaccines: A Systematic Review and Meta-Analysis
title_sort real-world safety of covid-19 mrna vaccines: a systematic review and meta-analysis
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10301865/
https://www.ncbi.nlm.nih.gov/pubmed/37376508
http://dx.doi.org/10.3390/vaccines11061118
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