Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study

Vaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in childre...

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Main Authors: Martina Capponi, Federica Pulvirenti, Bianca Laura Cinicola, Giulia Brindisi, Maria Giulia Conti, Giovanni Colaiocco, Giovanna de Castro, Cristiana Alessia Guido, Marzia Duse, Fabio Midulla, Anna Maria Zicari, Alberto Spalice
Format: Article
Language:English
Published: MDPI AG 2022-06-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/10/7/1056
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author Martina Capponi
Federica Pulvirenti
Bianca Laura Cinicola
Giulia Brindisi
Maria Giulia Conti
Giovanni Colaiocco
Giovanna de Castro
Cristiana Alessia Guido
Marzia Duse
Fabio Midulla
Anna Maria Zicari
Alberto Spalice
author_facet Martina Capponi
Federica Pulvirenti
Bianca Laura Cinicola
Giulia Brindisi
Maria Giulia Conti
Giovanni Colaiocco
Giovanna de Castro
Cristiana Alessia Guido
Marzia Duse
Fabio Midulla
Anna Maria Zicari
Alberto Spalice
author_sort Martina Capponi
collection DOAJ
description Vaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in children aged 5–11 years. However, no surveys in real-life settings have been carried out in this age range. Here, we conducted a cross-sectional study to evaluate the short-term adverse reactions (ARs) and the rate of protection against infection of the BNT162b2 vaccine in children aged 5–11 years by the compilation of two surveillance questionnaires conceived using Google Forms. Five-hundred and ninety one children were included in the analysis. ARs were reported by 68.9% of the children, being mainly local. The incidence of systemic ARs, especially fever, was higher after the second dose. The incidence of infection after completing the immunization accounted for 13.6% of the children. COVID-19 symptoms reported were mild, with the exception of one case of pneumonia. Only 40% of infected participants needed to take medication to relieve symptoms, mostly paracetamol and NSAIDs, and none reported persistent symptoms. The Pfizer–BioNTech vaccine in children aged 5–11 years is safe and well tolerated. The mild clinical course of COVID-19 in immunized children confirmed the favorable risk–benefit ratio, encouraging parents to immunize their children.
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spelling doaj.art-dd6a46d9dec842f9b90abd255e52468f2023-12-01T22:46:13ZengMDPI AGVaccines2076-393X2022-06-01107105610.3390/vaccines10071056Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World StudyMartina Capponi0Federica Pulvirenti1Bianca Laura Cinicola2Giulia Brindisi3Maria Giulia Conti4Giovanni Colaiocco5Giovanna de Castro6Cristiana Alessia Guido7Marzia Duse8Fabio Midulla9Anna Maria Zicari10Alberto Spalice11Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyReference Centre for Primary Immune Deficiencies, Azienda Ospedaliera Universitaria Policlinico Umberto I, 00161 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Prevention and Public Health, Coordination of Vaccination Activities, Azienda Sanitaria Locale (ASL) Roma 2, 00157 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyDepartment of Maternal Infantile and Urological Sciences, Sapienza University of Rome, 00185 Rome, ItalyVaccination against COVID-19 is the most effective tool to protect both the individual and the community from this potentially life-threatening infectious disease. Data from phase-3 trials showed that two doses of the BNT162b2 vaccine were safe, immunogenic, and effective against COVID-19 in children aged 5–11 years. However, no surveys in real-life settings have been carried out in this age range. Here, we conducted a cross-sectional study to evaluate the short-term adverse reactions (ARs) and the rate of protection against infection of the BNT162b2 vaccine in children aged 5–11 years by the compilation of two surveillance questionnaires conceived using Google Forms. Five-hundred and ninety one children were included in the analysis. ARs were reported by 68.9% of the children, being mainly local. The incidence of systemic ARs, especially fever, was higher after the second dose. The incidence of infection after completing the immunization accounted for 13.6% of the children. COVID-19 symptoms reported were mild, with the exception of one case of pneumonia. Only 40% of infected participants needed to take medication to relieve symptoms, mostly paracetamol and NSAIDs, and none reported persistent symptoms. The Pfizer–BioNTech vaccine in children aged 5–11 years is safe and well tolerated. The mild clinical course of COVID-19 in immunized children confirmed the favorable risk–benefit ratio, encouraging parents to immunize their children.https://www.mdpi.com/2076-393X/10/7/1056COVID-19SARS-CoV-2childrenvaccinesafetyside effects
spellingShingle Martina Capponi
Federica Pulvirenti
Bianca Laura Cinicola
Giulia Brindisi
Maria Giulia Conti
Giovanni Colaiocco
Giovanna de Castro
Cristiana Alessia Guido
Marzia Duse
Fabio Midulla
Anna Maria Zicari
Alberto Spalice
Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study
Vaccines
COVID-19
SARS-CoV-2
children
vaccine
safety
side effects
title Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study
title_full Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study
title_fullStr Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study
title_full_unstemmed Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study
title_short Short-Term Side Effects and SARS-CoV-2 Infection after COVID-19 Pfizer–BioNTech Vaccine in Children Aged 5–11 Years: An Italian Real-World Study
title_sort short term side effects and sars cov 2 infection after covid 19 pfizer biontech vaccine in children aged 5 11 years an italian real world study
topic COVID-19
SARS-CoV-2
children
vaccine
safety
side effects
url https://www.mdpi.com/2076-393X/10/7/1056
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