Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

doi:10.1007/s40264-023-01304-5

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

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Abstract

BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.

METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.

RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.

CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Original language	English
Pages (from-to)	575-585
Number of pages	11
Journal	Drug Safety
Volume	46
Issue number	6
Early online date	27 Apr 2023
DOIs	https://doi.org/10.1007/s40264-023-01304-5
Publication status	Published - Jun 2023

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@article{bca543bd8981455db16e6e519619ec54,

title = "Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials",

abstract = "BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.",

author = "Fariba Ahmadizar and Nicoletta Luxi and Monika Raethke and Sandor Schmikli and Fabio Riefolo and Saraswati, {Putri Widi} and Camelia Bucsa and Alhadi Osman and Megan Liddiard and Maques, {Francisco Batel} and Giuliana Petrelli and Simona Sonderlichov{\'a} and Thurin, {Nicolas H} and Felipe Villalobos and Gianluca Trifir{\`o} and Miriam Sturkenboom",

note = "Funding Information: The research leading to these results was conducted as part of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network, a public academic partnership coordinated by Utrecht University, The Netherlands, in collaboration with the VAC4EU network. The project has received partial support from the European Medicines Agency (EMA) under the Framework service contract nr EMA/2018/23/PE. The content of this paper expresses the opinion of the authors. It may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. The French part of this research, named EVANESCO, was identified as a “national research priority” (priorit{\'e} nationale de recherche) by the Comit{\'e} ad-hoc de pilotage national des essais th{\'e}rapeutiques et autres recherches sur le COVID-19 (CAPNET), and received a complementary funding from the Minist{\`e}re de la Sant{\'e} et des Solidarit{\'e}s and the Minist{\`e}re de l{\textquoteright}Enseignement sup{\'e}rieur, de la Recherche et de l{\textquoteright}Innovation. Funding Information: The authors thank Jasper Schmitz, Loes Ruijs, Leontine van Balveren and Agnes Kant from Pharmacovigilance Centre Lareb, the Netherlands; Estelle Guiard, St{\'e}phanie Lamarque, Emmanuelle Bignon, Pauline Bosco-Levy, Patrick Blin, and C{\'e}cile Droz-Perroteau who contributed to the French part of this research (EVANESCO), as well as Caroline Dureau-Pournin and all the French vaccination centres, hospitals, and pharmacies that supported this study by promoting the recruitment of vaccinees; the Romanian authors would like to thank the Romanian National and Regional Vaccination Centres and the Department of Public Health of Cluj County for supporting this study and the recruitment of vaccinees; the Primary Care Centres from the Catalan Institute of Health for their support and the recruitment of vaccines: Amposta, Tortosa, Barber{\`a} del Vall{\'e}s, Matar{\'o}, Pineda de Mar and Salou; the Slovak authors would like to thank the Children´s Faculty Hospital Ko{\v s}ice for their enormous commitment, support of this study and the recruitment of vaccinees. Funding Information: The authors thank Jasper Schmitz, Loes Ruijs, Leontine van Balveren and Agnes Kant from Pharmacovigilance Centre Lareb, the Netherlands; Estelle Guiard, St{\'e}phanie Lamarque, Emmanuelle Bignon, Pauline Bosco-Levy, Patrick Blin, and C{\'e}cile Droz-Perroteau who contributed to the French part of this research (EVANESCO), as well as Caroline Dureau-Pournin and all the French vaccination centres, hospitals, and pharmacies that supported this study by promoting the recruitment of vaccinees; the Romanian authors would like to thank the Romanian National and Regional Vaccination Centres and the Department of Public Health of Cluj County for supporting this study and the recruitment of vaccinees; the Primary Care Centres from the Catalan Institute of Health for their support and the recruitment of vaccines: Amposta, Tortosa, Barber{\`a} del Vall{\'e}s, Matar{\'o}, Pineda de Mar and Salou; the Slovak authors would like to thank the Children´s Faculty Hospital Ko{\v s}ice for their enormous commitment, support of this study and the recruitment of vaccinees. ilmiovaccinoCOVID19 collaborating group: Ugo Moretti, Chiara Bellitto, Francesco Ciccimarra, Giuliana Petrelli, Laura Augusta Gonella, Elena Arzenton, Cristiano Chiamulera—University of Verona, Department of Diagnostics and Public Health—Section of Pharmacology, Verona, Italy; Riccardo Lora, David Bellantuono, Alberto Sabaini—MedBrains; Alberto Firenze, Donatella Zodda, Fabrizia Guidotti, Maria Zappone, Bernardo Alagna—Struttura Commissariale per l{\textquoteright}Emergenza COVID della citt{\`a} metropolitana di Messina/Messina Local Health Unit, Messina, Italy; Paola Maria Cutroneo, Claudia Minore—Sicilian Regional Pharmacovigilance Centre, University Hospital of Messina, Messina, Italy; Claudio Costantino, Francesco Vitale—University of Palermo, Palermo, Italy—Department of Health Promotion, Mother and Child Care, Internal Medicine and MedicalSpecialties {"}G. D{\textquoteright}Alessandro{"}, Hygiene section; Ilaria Morreale—Sicilian Regional Center of Pharmacovigilance, Azienda Ospedaliera Universitaria Policlinico P. Giaccone, Internal Medicine, Pharmacovigilance and Clinical Pharmacology Unit; Laura Marsala, Desir{\`e} Farinella, Silvana Bavetta—Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) “Civico”, Palermo, Italy; Maria Pia Fantini, Chiara Reno—Alma Mater Studiorum-University of Bologna, Italy—Dept. of Medical and Surgical Sciences: Emanuel Raschi, Elisabetta Poluzzi; Department of Biomedical and Neuromotor Sciences; Ester Sapigni, Anna Maria Potenza, Debora Podetti, Victoria Nikitina, Rita Ricciardelli, Nazanin Mogheiseh, Silvia Croce, Barbara Paltrinieri - Emilia-Romagna Pharmacovigilance Regional Centre, Bologna—Italy; Sofia Castellani, Elisa Sangiorgi, Margherita Selleri, Simona Lucchesi, Giuseppe Catucci—Ferrara Local Health Unit, Ferrara, Italy; Denis Savini, Chiara Sacripanti, Marco Faccioli, Maria Silvia Romio, Laura Rossi—Bologna Local Health Unit, Bologna, Italy; Simonetta Radici—Piacenza Local Health Unit, Piacenza, Italy; Giovanna Negri—Parma Local Health Unit, Parma, Italy; Lidia Fares—Reggio Emilia Local Health Unit, Reggio Emilia, Italy; Chiara Ajolfi—Modena Local Health Unit, Modena, Italy; Antonella Fadda, Antonella Chiarello—Imola Local Health Unit, Imola, Italy; Fabio Pieraccini, Barbara Gavioli, Simonetta Palazzi—Romagna Local Health Unit, Romagna, Italy; Marco Tuccori—Tuscany Region, Italy—Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Unit of Adverse Drug Reactions Monitoring, Pisa, Italy; Alfredo Vannacci, Roberto Bonaiuti, Claudia Ravaldi, Niccol{\`o} Lombardi, Giada Crescioli—PeaRL-Perinatal Research Laboratory, NEUROFARBA Department, University of Florence and CiaoLapo Foundation for Perinatal Health; Florence, Italy; Francesco Gori—Firenze Local Health Unit, Florence, Italy; Roberto Tessari—IRCCS Ospedale Sacro Cuore Don Calabria—Hospital Pharmacy, Negrar di Valpolicella, Italy; Emanuela Zandon{\`a}—University Hospital of Verona, Italy—Medical Coordination Unit; Giovanna Zanoni, Gianenrico Senna—University Hospital of Verona, Unit of Immunology, Italy; Maria Angiola Crivellaro—University Hospital of Padua, Padova, Italy—Occupational Health Unit and Allergology Unit, Department of Cardiac Thoracic Vascular and Public Health Sciences University of Padova; Mauro Cancian—University Hospital of Padua, Departmental Allergy Unit, Padua, Italy; Francesca Venturini—University Hospital of Padua, Pharmacy Department, Padua, Italy; Marina Ferri, Luca Leonardi—Trento Local Health Unit, Trento, Italy; Sabrina Orzetti, Elisabetta Caccin, Paolo Baldo—Centro di Riferimento Oncologico (CRO) di Aviano, IRCCS—Pharmacy Unit, National Cancer Institute, Aviano, Italy; Annalisa Capuano, Concetta Rafaniello, Carmen Ferrajolo—Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy; Claudia Pagliaro, Mariangela Mercaldo, Annalisa di Giorgio, Michele Tari, Sonia Manna, Giuseppina Farina, Cristina Di Mauro—Caserta Local Health Unit, Caserta, Italy; Ilenia De Carlo, Ilenia Senesi—Abruzzo Region, Pharmacovigilance Regional Centre, Italy; Claudia Pileggi, Caterina Palleria, Luca Gallelli, Giovambattista De Sarro, Caterina de Sarro, Chiara Verduci, Rosa Papadopoli—Department of Health Sciences, University of Catanzaro {"}Magna Gr{\ae}cia{"}/Regional Centre for Pharmacovigilance of Calabria, Catanzaro, Italy; Luigia Trabace, Mariagrazia Morgese, Stefania Schiavone, Paolo Tucci, Maria Bove—University of Foggia, Foggia, Italy; Francesco Lapi, Claudio Cricelli—Italian Society of General Practitioners; Giorgio Racagni—Italian Society of Pharmacology; Silvia Tonolo—Association of Patients with Rheumatic diseases; Giusi Fava, Sandro Giuffrida, Vincenza Amato—Reggio Calabria Local Health Unit, Reggio Calabria, Italy; Marco Gambera, Valentina Montresor—Ospedale Pederzoli—Hospital Pharmacy, Peschiera del Garda, Italy; Dario Mastropasqua—Croce Verde Verona, Verona, Italy. Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = jun,

doi = "10.1007/s40264-023-01304-5",

language = "English",

volume = "46",

pages = "575--585",

journal = "Drug Safety",

issn = "0114-5916",

publisher = "Adis International Ltd",

number = "6",

}

TY - JOUR

T1 - Safety of COVID-19 Vaccines Among the Paediatric Population

T2 - Analysis of the European Surveillance Systems and Pivotal Clinical Trials

AU - Ahmadizar, Fariba

AU - Luxi, Nicoletta

AU - Raethke, Monika

AU - Schmikli, Sandor

AU - Riefolo, Fabio

AU - Saraswati, Putri Widi

AU - Bucsa, Camelia

AU - Osman, Alhadi

AU - Liddiard, Megan

AU - Maques, Francisco Batel

AU - Petrelli, Giuliana

AU - Sonderlichová, Simona

AU - Thurin, Nicolas H

AU - Villalobos, Felipe

AU - Trifirò, Gianluca

AU - Sturkenboom, Miriam

N1 - Funding Information: The research leading to these results was conducted as part of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network, a public academic partnership coordinated by Utrecht University, The Netherlands, in collaboration with the VAC4EU network. The project has received partial support from the European Medicines Agency (EMA) under the Framework service contract nr EMA/2018/23/PE. The content of this paper expresses the opinion of the authors. It may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. The French part of this research, named EVANESCO, was identified as a “national research priority” (priorité nationale de recherche) by the Comité ad-hoc de pilotage national des essais thérapeutiques et autres recherches sur le COVID-19 (CAPNET), and received a complementary funding from the Ministère de la Santé et des Solidarités and the Ministère de l’Enseignement supérieur, de la Recherche et de l’Innovation. Funding Information: The authors thank Jasper Schmitz, Loes Ruijs, Leontine van Balveren and Agnes Kant from Pharmacovigilance Centre Lareb, the Netherlands; Estelle Guiard, Stéphanie Lamarque, Emmanuelle Bignon, Pauline Bosco-Levy, Patrick Blin, and Cécile Droz-Perroteau who contributed to the French part of this research (EVANESCO), as well as Caroline Dureau-Pournin and all the French vaccination centres, hospitals, and pharmacies that supported this study by promoting the recruitment of vaccinees; the Romanian authors would like to thank the Romanian National and Regional Vaccination Centres and the Department of Public Health of Cluj County for supporting this study and the recruitment of vaccinees; the Primary Care Centres from the Catalan Institute of Health for their support and the recruitment of vaccines: Amposta, Tortosa, Barberà del Vallés, Mataró, Pineda de Mar and Salou; the Slovak authors would like to thank the Children´s Faculty Hospital Košice for their enormous commitment, support of this study and the recruitment of vaccinees. Funding Information: The authors thank Jasper Schmitz, Loes Ruijs, Leontine van Balveren and Agnes Kant from Pharmacovigilance Centre Lareb, the Netherlands; Estelle Guiard, Stéphanie Lamarque, Emmanuelle Bignon, Pauline Bosco-Levy, Patrick Blin, and Cécile Droz-Perroteau who contributed to the French part of this research (EVANESCO), as well as Caroline Dureau-Pournin and all the French vaccination centres, hospitals, and pharmacies that supported this study by promoting the recruitment of vaccinees; the Romanian authors would like to thank the Romanian National and Regional Vaccination Centres and the Department of Public Health of Cluj County for supporting this study and the recruitment of vaccinees; the Primary Care Centres from the Catalan Institute of Health for their support and the recruitment of vaccines: Amposta, Tortosa, Barberà del Vallés, Mataró, Pineda de Mar and Salou; the Slovak authors would like to thank the Children´s Faculty Hospital Košice for their enormous commitment, support of this study and the recruitment of vaccinees. ilmiovaccinoCOVID19 collaborating group: Ugo Moretti, Chiara Bellitto, Francesco Ciccimarra, Giuliana Petrelli, Laura Augusta Gonella, Elena Arzenton, Cristiano Chiamulera—University of Verona, Department of Diagnostics and Public Health—Section of Pharmacology, Verona, Italy; Riccardo Lora, David Bellantuono, Alberto Sabaini—MedBrains; Alberto Firenze, Donatella Zodda, Fabrizia Guidotti, Maria Zappone, Bernardo Alagna—Struttura Commissariale per l’Emergenza COVID della città metropolitana di Messina/Messina Local Health Unit, Messina, Italy; Paola Maria Cutroneo, Claudia Minore—Sicilian Regional Pharmacovigilance Centre, University Hospital of Messina, Messina, Italy; Claudio Costantino, Francesco Vitale—University of Palermo, Palermo, Italy—Department of Health Promotion, Mother and Child Care, Internal Medicine and MedicalSpecialties "G. D’Alessandro", Hygiene section; Ilaria Morreale—Sicilian Regional Center of Pharmacovigilance, Azienda Ospedaliera Universitaria Policlinico P. Giaccone, Internal Medicine, Pharmacovigilance and Clinical Pharmacology Unit; Laura Marsala, Desirè Farinella, Silvana Bavetta—Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) “Civico”, Palermo, Italy; Maria Pia Fantini, Chiara Reno—Alma Mater Studiorum-University of Bologna, Italy—Dept. of Medical and Surgical Sciences: Emanuel Raschi, Elisabetta Poluzzi; Department of Biomedical and Neuromotor Sciences; Ester Sapigni, Anna Maria Potenza, Debora Podetti, Victoria Nikitina, Rita Ricciardelli, Nazanin Mogheiseh, Silvia Croce, Barbara Paltrinieri - Emilia-Romagna Pharmacovigilance Regional Centre, Bologna—Italy; Sofia Castellani, Elisa Sangiorgi, Margherita Selleri, Simona Lucchesi, Giuseppe Catucci—Ferrara Local Health Unit, Ferrara, Italy; Denis Savini, Chiara Sacripanti, Marco Faccioli, Maria Silvia Romio, Laura Rossi—Bologna Local Health Unit, Bologna, Italy; Simonetta Radici—Piacenza Local Health Unit, Piacenza, Italy; Giovanna Negri—Parma Local Health Unit, Parma, Italy; Lidia Fares—Reggio Emilia Local Health Unit, Reggio Emilia, Italy; Chiara Ajolfi—Modena Local Health Unit, Modena, Italy; Antonella Fadda, Antonella Chiarello—Imola Local Health Unit, Imola, Italy; Fabio Pieraccini, Barbara Gavioli, Simonetta Palazzi—Romagna Local Health Unit, Romagna, Italy; Marco Tuccori—Tuscany Region, Italy—Unit of Adverse Drug Reactions Monitoring, University Hospital of Pisa, Unit of Adverse Drug Reactions Monitoring, Pisa, Italy; Alfredo Vannacci, Roberto Bonaiuti, Claudia Ravaldi, Niccolò Lombardi, Giada Crescioli—PeaRL-Perinatal Research Laboratory, NEUROFARBA Department, University of Florence and CiaoLapo Foundation for Perinatal Health; Florence, Italy; Francesco Gori—Firenze Local Health Unit, Florence, Italy; Roberto Tessari—IRCCS Ospedale Sacro Cuore Don Calabria—Hospital Pharmacy, Negrar di Valpolicella, Italy; Emanuela Zandonà—University Hospital of Verona, Italy—Medical Coordination Unit; Giovanna Zanoni, Gianenrico Senna—University Hospital of Verona, Unit of Immunology, Italy; Maria Angiola Crivellaro—University Hospital of Padua, Padova, Italy—Occupational Health Unit and Allergology Unit, Department of Cardiac Thoracic Vascular and Public Health Sciences University of Padova; Mauro Cancian—University Hospital of Padua, Departmental Allergy Unit, Padua, Italy; Francesca Venturini—University Hospital of Padua, Pharmacy Department, Padua, Italy; Marina Ferri, Luca Leonardi—Trento Local Health Unit, Trento, Italy; Sabrina Orzetti, Elisabetta Caccin, Paolo Baldo—Centro di Riferimento Oncologico (CRO) di Aviano, IRCCS—Pharmacy Unit, National Cancer Institute, Aviano, Italy; Annalisa Capuano, Concetta Rafaniello, Carmen Ferrajolo—Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy; Claudia Pagliaro, Mariangela Mercaldo, Annalisa di Giorgio, Michele Tari, Sonia Manna, Giuseppina Farina, Cristina Di Mauro—Caserta Local Health Unit, Caserta, Italy; Ilenia De Carlo, Ilenia Senesi—Abruzzo Region, Pharmacovigilance Regional Centre, Italy; Claudia Pileggi, Caterina Palleria, Luca Gallelli, Giovambattista De Sarro, Caterina de Sarro, Chiara Verduci, Rosa Papadopoli—Department of Health Sciences, University of Catanzaro "Magna Græcia"/Regional Centre for Pharmacovigilance of Calabria, Catanzaro, Italy; Luigia Trabace, Mariagrazia Morgese, Stefania Schiavone, Paolo Tucci, Maria Bove—University of Foggia, Foggia, Italy; Francesco Lapi, Claudio Cricelli—Italian Society of General Practitioners; Giorgio Racagni—Italian Society of Pharmacology; Silvia Tonolo—Association of Patients with Rheumatic diseases; Giusi Fava, Sandro Giuffrida, Vincenza Amato—Reggio Calabria Local Health Unit, Reggio Calabria, Italy; Marco Gambera, Valentina Montresor—Ospedale Pederzoli—Hospital Pharmacy, Peschiera del Garda, Italy; Dario Mastropasqua—Croce Verde Verona, Verona, Italy. Publisher Copyright: © 2023, The Author(s).

PY - 2023/6

Y1 - 2023/6

N2 - BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

AB - BACKGROUND AND OBJECTIVES: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.METHODS: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.RESULTS: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.CONCLUSIONS: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

UR - http://www.scopus.com/inward/record.url?scp=85153860147&partnerID=8YFLogxK

U2 - 10.1007/s40264-023-01304-5

DO - 10.1007/s40264-023-01304-5

M3 - Article

C2 - 37103643

SN - 0114-5916

VL - 46

SP - 575

EP - 585

JO - Drug Safety

JF - Drug Safety

IS - 6

ER -

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

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