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논문 기본 정보

자료유형
학술저널
저자정보
Kim Dong Hyuk (Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.) Kim Ju Hwan (Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.School of Pharmacy, Sungkyunkwan University, Suwon, Korea.) Oh In-Sun (School of Pharmacy, Sungkyunkwan University, Suwon, Korea.Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada.Centre for Clinical Epidemio) Choe Young June (Deparment of Pediatrics, Korea University Anam Hospital, Seoul, Korea.) Choe Seung-Ah (Deparment of Preventive Medicine, Korea University College of Medicine, Seoul, Korea.) Shin Ju-Young (Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea.School of Pharmacy, Sungkyunkwan University, Suwon, Korea.Department of Clinical Research Design)
저널정보
대한의학회 Journal of Korean Medical Science Journal of Korean Medical Science Vol.39 No.8
발행연도
2024.3
수록면
1 - 13 (13page)
DOI
10.3346/jkms.2024.39.e76

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초록· 키워드

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Background: During coronavirus disease 2019 (COVID-19) pandemic, several COVID-19 vaccines were licensed with fast-track procedures. Although these vaccines have demonstrated high immunogenicity, there has been concerns on the serious adverse events (AEs) following COVID-19 vaccination among adolescents. We aimed to analyze comparative safety of COVID-19 vaccination in adolescents. Methods: In this pharmacovigilance study, we performed a disproportionality analysis using VigiBase, the World Health Organization’s global individual case safety report (ICSR) database. To compare serious AEs reported following COVID-19 vaccines vs. all other vaccines in adolescents aged 12–17 years, ICSRs following any vaccines on adolescents aged 12–17 years were included, defining cases as reports with the AEs of interest, with all other AEs as non-cases. The AEs of interest were myocarditis/pericarditis, multisystem inflammatory syndrome/Kawasaki disease (MIS/KD), anaphylaxis, Guillain-Barré syndrome (GBS), and immune thrombocytopenia (ITP). We conducted a disproportionality analysis to estimate reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE of interest, adjusted for sex by using logistic regression. Results: Of 99,735 AE reports after vaccination in adolescents, 80,018 reports were from COVID-19 vaccinated adolescents (52.9% females; 56.3% America). The AEs of interest were predominantly reported as serious AE (76.1%) with mRNA vaccines (99.4%). Generally, higher reporting odds for the AEs were identified following COVID-19 vaccination in adolescents; myocarditis/pericarditis (2,829 reports for the COVID-19 vaccine vs. 35 for all other vaccines, adjusted ROR [aROR], 19.61; 95% CI, 14.05–27.39), and MIS/KD (104 vs. 6, aROR, 4.33; 95% CI, 1.89–9.88). The reporting odds for anaphylaxis (515 vs. 165, aROR, 0.86; 95% CI, 0.72– 1.02), GBS (94 vs. 40, aROR, 0.64; 95% CI, 0.44–0.92) and ITP (52 vs. 12, aROR, 1.12; 95% CI, 0.59–2.09) were not significantly higher following COVID-19 vaccination. Conclusion: In this study, there were disproportionate reporting of immune-related AEs following COVID-19 vaccination. While awaiting definitive evidence, there is a need to closely monitor for any signs of immune-related AEs following COVID-19 vaccination among adolescents.

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