| アブストラクト | Background: During the global fight against the COVID-19 pandemic, vaccinations have been widely recognized as the most effective and generally safe method for preventing the spread of COVID-19. However, it has been reported that children may experience post-vaccination serious adverse drug reactions (SADRs). Thus, we aimed to analyze the risk of SADRs to COVID-19 vaccines in the pediatric population. Methods: In this retrospective, cross-sectional study, 5422 cases of SADRs (n = 5018 for Pfizer BioNTech, Comirnaty and n = 494 for Moderna, Spikevax) were analyzed after 37,344,343 doses of COVID-19 vaccines were administered. This study covered the European Economic Area. The analysis period for both vaccinations and SADRs spanned from 7 December 2020 to 5 October 2023. The analysis encompassed 207 types of SADRs grouped into 12 categories. All estimated real-world reporting rates were reported as normalized per million ADR reports and adjusted using real-world trial-based scaling (APMR). Results: The total estimated real-world reporting rates of SADRs were 5792 APMR for Comirnaty and 5671 for Spikevax. The most commonly reported clinical categories of suspected SADRs for both vaccines were neuropsychiatric, cardiovascular and gastroenterological disorders. The most often reported SADRs encompassed headaches, myocarditis, episodes of syncope, dizziness and dyspnea. Conclusions: According to the data from this study, several SADRs were reported in children following COVID-19 vaccination. The estimated real-world reporting rates of SADRs related to COVID-19 vaccines seem to be rare among children. Additionally, the data suggest that Comirnaty (Pfizer-BioNTech) may have a similar risk profile compared to Spikevax (Moderna). |
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| ジャーナル名 | Journal of clinical medicine |
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| Pubmed追加日 | 2025/9/27 |
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| 投稿者 | Nazar, Grzegorz; Olszlegier, Julia; Kaminska, Aleksandra; Plata-Nazar, Katarzyna; Nazar, Wojciech |
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| 組織名 | Faculty of Medicine, Medical University of Gdansk, Marii Sklodowskiej-Curie 3a,;80-210 Gdansk, Poland.;Department of Pediatrics, Gastroenterology, Allergology and Nutrition, Medical;University of Gdansk, Nowe Ogrody 1-6, 80-803 Gdansk, Poland.;Laboratory of Experimental and Translational Allergology, Department of;Allergology, Medical University of Gdansk, Mariana Smoluchowskiego 17, 80-214;Gdansk, Poland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41010746/ |
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