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Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis
Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgent...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227366/ https://www.ncbi.nlm.nih.gov/pubmed/35746500 http://dx.doi.org/10.3390/vaccines10060892 |
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author | Nuzzo, Amedeo Manacorda, Simona Sammarco, Enrico Sbrana, Andrea Bazzurri, Serena Paolieri, Federico Manfredi, Fiorella Mercinelli, Chiara Ferrari, Marco Massaro, Giulia Bonato, Adele Salfi, Alessia Galli, Luca Morganti, Riccardo Antonuzzo, Andrea Cremolini, Chiara Masi, Gianluca |
author_facet | Nuzzo, Amedeo Manacorda, Simona Sammarco, Enrico Sbrana, Andrea Bazzurri, Serena Paolieri, Federico Manfredi, Fiorella Mercinelli, Chiara Ferrari, Marco Massaro, Giulia Bonato, Adele Salfi, Alessia Galli, Luca Morganti, Riccardo Antonuzzo, Andrea Cremolini, Chiara Masi, Gianluca |
author_sort | Nuzzo, Amedeo |
collection | PubMed |
description | Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors. |
format | Online Article Text |
id | pubmed-9227366 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-92273662022-06-25 Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis Nuzzo, Amedeo Manacorda, Simona Sammarco, Enrico Sbrana, Andrea Bazzurri, Serena Paolieri, Federico Manfredi, Fiorella Mercinelli, Chiara Ferrari, Marco Massaro, Giulia Bonato, Adele Salfi, Alessia Galli, Luca Morganti, Riccardo Antonuzzo, Andrea Cremolini, Chiara Masi, Gianluca Vaccines (Basel) Article Background: Severe acute respiratory syndrome coronavirus 2 disease (COVID-19) has caused a worldwide challenging and threatening pandemic. Multinational, placebo-controlled, observer-blinded trials were conducted since the beginning of pandemic because safe and effective vaccines were needed urgently. In most trials of COVID-19 vaccines patients affected by malignancies or on treatment with immunosuppressive drugs were excluded. Patients and methods: A retrospective monocentric study was conducted at Medical Oncological Unit of Santa Chiara Hospital (Pisa, Italy) in this subset of population to investigate safety and tolerability of COVID-19 vaccines; 377 patients with solid tumor on treatment were enrolled. Vaccine-related adverse events were recorded using a face-to-face questionnaire including a toxicity grading scale. Most of the patients (94%) received mRNA vaccine as indicated by Italian health ministry guidelines. Mean age was 66 years (range 27–87), 62% of the patients were older than 65 years and 68% had at least one additional comorbidity. The majority (86%) of patients were in a metastatic setting and 29% received immunotherapy-based treatment. For statistical analysis, multivariate binary logistic regression models were performed and linear regression models were applied. Results: Adverse events were mild and transient and ended in a few days without any sequelae. No severe or uncommon adverse events were recorded. In multivariate analysis, we found that the female sex was associated with a greater risk of more severe and longer lasting adverse events, and a higher risk of adverse events was found for patients treated with immunotherapy. Conclusions: Our results demonstrate that COVID-19 vaccines were safe and well-tolerated in this population of patients being treated for solid tumors. MDPI 2022-06-02 /pmc/articles/PMC9227366/ /pubmed/35746500 http://dx.doi.org/10.3390/vaccines10060892 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 Nuzzo, Amedeo Manacorda, Simona Sammarco, Enrico Sbrana, Andrea Bazzurri, Serena Paolieri, Federico Manfredi, Fiorella Mercinelli, Chiara Ferrari, Marco Massaro, Giulia Bonato, Adele Salfi, Alessia Galli, Luca Morganti, Riccardo Antonuzzo, Andrea Cremolini, Chiara Masi, Gianluca Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis |
title | Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis |
title_full | Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis |
title_fullStr | Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis |
title_full_unstemmed | Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis |
title_short | Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis |
title_sort | safety and tolerability of covid-19 vaccines in patients with cancer: a single center retrospective analysis |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9227366/ https://www.ncbi.nlm.nih.gov/pubmed/35746500 http://dx.doi.org/10.3390/vaccines10060892 |
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