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Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project

Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety an...

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Autores principales: Polewska, Karolina, Tylicki, Piotr, Biedunkiewicz, Bogdan, Rucińska, Angelika, Szydłowska, Aleksandra, Kubanek, Alicja, Rosenberg, Iwona, Rodak, Sylwia, Ślizień, Waldemar, Renke, Marcin, Dębska-Ślizień, Alicja, Tylicki, Leszek
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8307559/
https://www.ncbi.nlm.nih.gov/pubmed/34357013
http://dx.doi.org/10.3390/medicina57070732
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author Polewska, Karolina
Tylicki, Piotr
Biedunkiewicz, Bogdan
Rucińska, Angelika
Szydłowska, Aleksandra
Kubanek, Alicja
Rosenberg, Iwona
Rodak, Sylwia
Ślizień, Waldemar
Renke, Marcin
Dębska-Ślizień, Alicja
Tylicki, Leszek
author_facet Polewska, Karolina
Tylicki, Piotr
Biedunkiewicz, Bogdan
Rucińska, Angelika
Szydłowska, Aleksandra
Kubanek, Alicja
Rosenberg, Iwona
Rodak, Sylwia
Ślizień, Waldemar
Renke, Marcin
Dębska-Ślizień, Alicja
Tylicki, Leszek
author_sort Polewska, Karolina
collection PubMed
description Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety and tolerances of vaccinations with BNT162b2 performed in chronically dialyzed patients. Materials and Methods: We performed a prospective cohort study including a group of 190 dialyzed patients (65% male) at median age 68.0 (55–74) years. 169 (89.0%) patients were treated with hemodialysis and 21 (11.0%) with peritoneal dialysis. The control group consisted of 160 people (61% male) without chronic kidney disease at median age 63 (range 53–77) years. Both groups were vaccinated with BNT162b2 with a 21-day interval between the first and the second dose. Solicited local and systemic reactogenicity, unsolicited adverse events and antipyretic and pain medication use were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA Center for Biologics Evaluation and Research guidelines. Results: 59.8% (dose 1), 61.4% (dose 2) and 15.9% (dose 1), 29.4% (dose 2) dialyzed patients reported at least one local and one systemic reaction respectively within seven days after the vaccination. Many local and systemic solicited reactions were observed less frequently in dialyzed patients than in the age and sex matched control group and much less frequently than reported in the pivotal study. They were mostly mild to moderate, short-lived, and more frequently reported in younger individuals and women. No related unsolicited adverse events were observed. Conclusions: We have shown here that BNT162b2, an mRNA vaccine from Pfizer-BioNTech against SARS-COV-2 is safe and well-tolerated by dialyzed patients. The results can be useful for the nephrological community to resolve patients’ doubts and reduce their vaccine hesitancy.
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spelling pubmed-83075592021-07-25 Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project Polewska, Karolina Tylicki, Piotr Biedunkiewicz, Bogdan Rucińska, Angelika Szydłowska, Aleksandra Kubanek, Alicja Rosenberg, Iwona Rodak, Sylwia Ślizień, Waldemar Renke, Marcin Dębska-Ślizień, Alicja Tylicki, Leszek Medicina (Kaunas) Article Background and Objectives: The Pfizer-BioNTech (BNT162b2) COVID-19 mRNA vaccine has demonstrated excellent efficacy and safety in phase 3 trials. However, no dialyzed patients were included, and therefore safety data for this patient group is lacking. The aim of the study was to assess the safety and tolerances of vaccinations with BNT162b2 performed in chronically dialyzed patients. Materials and Methods: We performed a prospective cohort study including a group of 190 dialyzed patients (65% male) at median age 68.0 (55–74) years. 169 (89.0%) patients were treated with hemodialysis and 21 (11.0%) with peritoneal dialysis. The control group consisted of 160 people (61% male) without chronic kidney disease at median age 63 (range 53–77) years. Both groups were vaccinated with BNT162b2 with a 21-day interval between the first and the second dose. Solicited local and systemic reactogenicity, unsolicited adverse events and antipyretic and pain medication use were assessed with a standardized questionnaire. The toxicity grading scales were derived from the FDA Center for Biologics Evaluation and Research guidelines. Results: 59.8% (dose 1), 61.4% (dose 2) and 15.9% (dose 1), 29.4% (dose 2) dialyzed patients reported at least one local and one systemic reaction respectively within seven days after the vaccination. Many local and systemic solicited reactions were observed less frequently in dialyzed patients than in the age and sex matched control group and much less frequently than reported in the pivotal study. They were mostly mild to moderate, short-lived, and more frequently reported in younger individuals and women. No related unsolicited adverse events were observed. Conclusions: We have shown here that BNT162b2, an mRNA vaccine from Pfizer-BioNTech against SARS-COV-2 is safe and well-tolerated by dialyzed patients. The results can be useful for the nephrological community to resolve patients’ doubts and reduce their vaccine hesitancy. MDPI 2021-07-19 /pmc/articles/PMC8307559/ /pubmed/34357013 http://dx.doi.org/10.3390/medicina57070732 Text en © 2021 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
Polewska, Karolina
Tylicki, Piotr
Biedunkiewicz, Bogdan
Rucińska, Angelika
Szydłowska, Aleksandra
Kubanek, Alicja
Rosenberg, Iwona
Rodak, Sylwia
Ślizień, Waldemar
Renke, Marcin
Dębska-Ślizień, Alicja
Tylicki, Leszek
Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project
title Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project
title_full Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project
title_fullStr Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project
title_full_unstemmed Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project
title_short Safety and Tolerability of the BNT162b2 mRNA COVID-19 Vaccine in Dialyzed Patients. COViNEPH Project
title_sort safety and tolerability of the bnt162b2 mrna covid-19 vaccine in dialyzed patients. covineph project
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8307559/
https://www.ncbi.nlm.nih.gov/pubmed/34357013
http://dx.doi.org/10.3390/medicina57070732
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