Description
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.
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.
