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.
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
[저자] Fariba Ahmadizar, Nicoletta Luxi, Monika Raethke, Sandor Schmikli, Fabio Riefolo, Putri Widi Saraswati, Camelia Bucsa, Alhadi Osman, Megan Liddiard, Francisco Batel Maques, Giuliana Petrelli, Simona Sonderlichová, Nicolas H. Thurin, Felipe Villalobos, Gianluca Trifirò, Miriam Sturkenboom,
ilmiovaccinoCOVID19 collaborating groupMoretti Ugo Bellitto Chiara Ciccimarra Francesco Gonella Laura Augusta Arzenton Elena Chiamulera Cristiano Lora Riccardo Bellantuono David Sabaini Alberto Firenze Alberto Zodda Donatella Guidotti Fabrizia Zappone Maria Alagna Bernardo Cutroneo Paola Maria Minore Claudia Costantino Claudio Vitale Francesco D’Alessandro G. Morreale Ilaria Marsala Laura Farinella Desirè Bavetta Silvana Fantini Maria Pia Reno Chiara Raschi Emanuel Poluzzi Elisabetta Sapigni Ester Potenza Anna Maria Podetti Debora Nikitina Victoria Ricciardelli Rita Mogheiseh Nazanin Croce Silvia Paltrinieri Barbara Castellani Sofia Sangiorgi Elisa Selleri Margherita Lucchesi Simona Catucci Giuseppe Savini Denis Sacripanti Chiara Faccioli Marco Romio Maria Silvia Rossi Laura Radici Simonetta Negri Giovanna Fares Lidia Ajolfi Chiara Fadda Antonella Chiarello Antonella Pieraccini Fabio Gavioli Barbara Palazzi Simonetta Tuccori Marco Vannacci Alfredo Bonaiuti Roberto Ravaldi Claudia Lombardi Niccolò Crescioli Giada Gori Francesco Tessari Roberto Zandonà Emanuela Zanoni Giovanna Senna Gianenrico Crivellaro Maria Angiola Cancian Mauro Venturini Francesca Ferri Marina Leonardi Luca Orzetti Sabrina Caccin Elisabetta Baldo Paolo Capuano Annalisa Rafaniello Concetta Ferrajolo Carmen Pagliaro Claudia Mercaldo Mariangela di Giorgio Annalisa Tari Michele Manna Sonia Farina Giuseppina Di Mauro Cristina De Carlo Ilenia Senesi Ilenia Pileggi Claudia Palleria Caterina Gallelli Luca De Sarro Giovambattista de Sarro Caterina Verduci Chiara Papadopoli Rosa Trabace Luigia Morgese Mariagrazia Schiavone Stefania Tucci Paolo Bove Maria Lapi Francesco Cricelli Claudio Racagni Giorgio Tonolo Silvia Fava Giusi Giuffrida Sandro Amato Vincenza Gambera Marco Montresor Valentina Mastropasqua Dario
, Ugo Moretti, Chiara Bellitto, Francesco Ciccimarra, Laura Augusta Gonella, Elena Arzenton, Cristiano Chiamulera, Riccardo Lora, David Bellantuono, Alberto Sabaini, Alberto Firenze, Donatella Zodda, Fabrizia Guidotti, Maria Zappone, Bernardo Alagna, Paola Maria Cutroneo, Claudia Minore, Claudio Costantino, Francesco Vitale, G. D’Alessandro, Ilaria Morreale, Laura Marsala, Desirè Farinella, Silvana Bavetta, Maria Pia Fantini, Chiara Reno, Emanuel Raschi, Elisabetta Poluzzi, Ester Sapigni, Anna Maria Potenza, Debora Podetti, Victoria Nikitina, Rita Ricciardelli, Nazanin Mogheiseh, Silvia Croce, Barbara Paltrinieri, Sofia Castellani, Elisa Sangiorgi, Margherita Selleri, Simona Lucchesi, Giuseppe Catucci, Denis Savini, Chiara Sacripanti, Marco Faccioli, Maria Silvia Romio, Laura Rossi, Simonetta Radici, Giovanna Negri, Lidia Fares, Chiara Ajolfi, Antonella Fadda, Antonella Chiarello, Fabio Pieraccini, Barbara Gavioli, Simonetta Palazzi, Marco Tuccori, Alfredo Vannacci, Roberto Bonaiuti, Claudia Ravaldi, Niccolò Lombardi, Giada Crescioli, Francesco Gori, Roberto Tessari, Emanuela Zandonà, Giovanna Zanoni, Gianenrico Senna, Maria Angiola Crivellaro, Mauro Cancian, Francesca Venturini, Marina Ferri, Luca Leonardi, Sabrina Orzetti, Elisabetta Caccin, Paolo Baldo, Annalisa Capuano, Concetta Rafaniello, Carmen Ferrajolo, Claudia Pagliaro, Mariangela Mercaldo, Annalisa di Giorgio, Michele Tari, Sonia Manna, Giuseppina Farina, Cristina Di Mauro, Ilenia De Carlo, Ilenia Senesi, Claudia Pileggi, Caterina Palleria, Luca Gallelli, Giovambattista De Sarro, Caterina de Sarro, Chiara Verduci, Rosa Papadopoli, Luigia Trabace, Mariagrazia Morgese, Stefania Schiavone, Paolo Tucci, Maria Bove, Francesco Lapi, Claudio Cricelli, Giorgio Racagni, Silvia Tonolo, Giusi Fava, Sandro Giuffrida, Vincenza Amato, Marco Gambera, Valentina Montresor, Dario Mastropasqua
[Category] update2024,
[Article Type] Original Research Article
[Source] PMC
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