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
• Publication Date: 2023-04-27T15:02:23Z
• Authors: Fariba Ahmadizar; Nicoletta Luxi; Monika Raethke; Sandor Schmikli; Fabio Riefolo; Putri Widi Saraswati; Camelia Bucsa; Alhadi Osman; Megan Liddiard; Francisco Batel M...; Giuliana Petrelli; Simona Sonderlichová; Nicolas H. Thurin; Felipe Villalobos; Gianluca Trifirò; Miriam Sturkenboom; ; Ugo Moretti; Chiara Bellitto; Francesco Ciccimarra; Laura Augusta Gon...; 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 Cri...; 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...; 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
• Keywords: Postmarketing surveillance

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 COVID-19 through Covid-19 Vaccine Monitor (CVM) EudraVigilance surveillance systems published pivotal clinical trials.In a prospective cohort vaccinees aged between 5 17 years, measured frequency commonly reported (local/systemic solicited) serious adverse drug events (ADRs) following first second doses Europe using data from CVM until April 2022. results previous trials were also analysed.The study enrolled 658 first-dose (children 5-11 years; n = 250 adolescents 12-17 408). Local/systemic solicited ADRs common, whereas uncommon. Among Comirnaty dose recipients, 28.8% 17.1% children 54.2% 52.2% experienced at least one ADR, respectively; injection-site pain (29.2% 20.7%), fatigue (16.1% 12.8%), headache (22.1% 19.3%) most frequent local systemic ADRs. Results consistent but slightly lower than trials. Reporting rates Eudravigilance by factor 1000.The showed high frequencies reactions after vaccination Injection-site pain, fatigue, for trials, higher spontaneously data.