ArticleDrug safety2023
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials.
Article in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 13 citations in OpenAlex.
- Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective.Drug safety · 2025Article
- Serious Adverse Drug Reactions to COVID-19 Vaccines in the Pediatric Population: A Retrospective, Cross-Sectional Study Utilizing the Eudravigilance Database for the European Economic Area.Journal of clinical medicine · 2025Article
- The Long-Term Tolerability of BNT162b2 in Children and Adolescents (the CoVacU18 Study).Deutsches Arzteblatt international · 2025Article
- Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women.Frontiers in drug safety and regulation · 2025Article
- Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance.Frontiers in medicine · 2025Article
- Overview of adult immunization in Italy: Successes, lessons learned and the way forward.Human vaccines & immunotherapeutics · 2024Review
- What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European "Covid Vaccine Monitor" Active Surveillance Study.Drug safety · 2024Article
- Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study.Vaccines · 2024Article
- Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally.Vaccine: X · 2024Article
- Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study.Vaccines · 2024Article
- Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the "ilmiovaccinoCOVID19 collaborating group".Frontiers in drug safety and regulation · 2024Article
- Clinical Syndromes Related to SARS-CoV-2 Infection and Vaccination in Pediatric Age: A Narrative Review.Medicina (Kaunas, Lithuania) · 2023Review
Corrections and comments
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Authors and funding
17 authors at 9 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesThe 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.
methodsIn 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.
resultsThe 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.
conclusionsThe 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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