| アブストラクト | 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. |
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| 投稿者 | Ahmadizar, Fariba; Luxi, Nicoletta; Raethke, Monika; Schmikli, Sandor; Riefolo, Fabio; Saraswati, Putri Widi; Bucsa, Camelia; Osman, Alhadi; Liddiard, Megan; Maques, Francisco Batel; Petrelli, Giuliana; Sonderlichova, Simona; Thurin, Nicolas H; Villalobos, Felipe; Trifiro, Gianluca; Sturkenboom, Miriam |
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| 組織名 | Department of Data Science and Biostatistics, Julius Global Health, University;Medical Centre Utrecht, Utrecht, the Netherlands.;Department of Medicine, University of Verona, Verona, Italy.;Netherlands Pharmacovigilance Centre Lareb, 's Hertogenbosch, the Netherlands.;Teamit Institute, Partnerships, Barcelona Health Hub, 08025, Barcelona, Spain.;Pharmacovigilance Research Center, Iuliu Hatieganu University of Medicine and;Pharmacy, Cluj-Napoca, Romania.;Drug Safety Research Unit, Southampton, UK.;Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University;of Coimbra, Coimbra, Portugal.;Department of Diagnostics and Public Health, University of Verona, Verona, Italy.;Faculty of Medicine, SLOVACRIN, Pavol Jozef Safarik University in Kosice, Kosice,;Slovakia.;Bordeaux PharmacoEpi, INSERM CIC-P 1401, Univ. Bordeaux, Bordeaux, France.;Fundacio Institut Universitari per a la recerca a l'Atencio Primaria de Salut;Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.;M.C.J.Sturkenboom@umcutrecht.nl. |
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