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

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 and Miriam Sturkenboom ()
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Fariba Ahmadizar: University Medical Centre Utrecht
Nicoletta Luxi: University of Verona
Monika Raethke: Netherlands Pharmacovigilance Centre Lareb
Sandor Schmikli: University Medical Centre Utrecht
Fabio Riefolo: Partnerships, Barcelona Health Hub
Putri Widi Saraswati: University Medical Centre Utrecht
Camelia Bucsa: Iuliu Hatieganu University of Medicine and Pharmacy
Alhadi Osman: University Medical Centre Utrecht
Megan Liddiard: Drug Safety Research Unit
Francisco Batel Maques: University of Coimbra
Giuliana Petrelli: University of Verona
Simona Sonderlichová: Pavol Jozef Šafárik University in Košice
Nicolas H. Thurin: Univ. Bordeaux
Felipe Villalobos: Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
Gianluca Trifirò: University of Verona
Miriam Sturkenboom: University Medical Centre Utrecht

Drug Safety, 2023, vol. 46, issue 6, No 6, 575-585

Abstract: 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.

Date: 2023
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DOI: 10.1007/s40264-023-01304-5

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