PMID- 38442719 OWN - NLM STAT- MEDLINE DCOM- 20240307 LR - 20240423 IS - 1598-6357 (Electronic) IS - 1011-8934 (Print) IS - 1011-8934 (Linking) VI - 39 IP - 8 DP - 2024 Mar 4 TI - Adverse Events Following COVID-19 Vaccination in Adolescents: Insights From Pharmacovigilance Study of VigiBase. PG - e76 LID - 10.3346/jkms.2024.39.e76 [doi] LID - e76 AB - 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-Barre 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. CI - (c) 2024 The Korean Academy of Medical Sciences. FAU - Kim, Dong Hyuk AU - Kim DH AUID- ORCID: 0009-0009-5425-2143 AD - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea. FAU - Kim, Ju Hwan AU - Kim JH AUID- ORCID: 0000-0001-7253-6515 AD - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea. AD - School of Pharmacy, Sungkyunkwan University, Suwon, Korea. FAU - Oh, In-Sun AU - Oh IS AUID- ORCID: 0000-0001-9878-4779 AD - School of Pharmacy, Sungkyunkwan University, Suwon, Korea. AD - Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada. AD - Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Canada. FAU - Choe, Young June AU - Choe YJ AUID- ORCID: 0000-0003-2733-0715 AD - Deparment of Pediatrics, Korea University Anam Hospital, Seoul, Korea. FAU - Choe, Seung-Ah AU - Choe SA AUID- ORCID: 0000-0001-6270-5020 AD - Deparment of Preventive Medicine, Korea University College of Medicine, Seoul, Korea. FAU - Shin, Ju-Young AU - Shin JY AUID- ORCID: 0000-0003-1010-7525 AD - Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, Korea. AD - School of Pharmacy, Sungkyunkwan University, Suwon, Korea. AD - Department of Clinical Research Design & Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Korea. shin.jy@skku.edu. LA - eng GR - 21153MFDS607/MFDS/Ministry of Food and Drug Safety/Korea GR - 22183MFDS433/MFDS/Ministry of Food and Drug Safety/Korea GR - MOE/Ministry of Education/Korea GR - NRF/National Research Foundation of Korea/Korea PT - Journal Article DEP - 20240304 PL - Korea (South) TA - J Korean Med Sci JT - Journal of Korean medical science JID - 8703518 RN - 0 (COVID-19 Vaccines) SB - IM CIN - J Korean Med Sci. 2024 Apr 22;39(15):e142. doi: 10.3346/jkms.2024.39.e142. PMID: 38651228 MH - Adolescent MH - Female MH - Humans MH - Male MH - *Anaphylaxis/epidemiology/etiology MH - *COVID-19/prevention & control MH - *COVID-19 Vaccines/adverse effects MH - *Guillain-Barre Syndrome/epidemiology/etiology MH - *Mucocutaneous Lymph Node Syndrome MH - *Myocarditis MH - *Pericarditis MH - Pharmacovigilance MH - *Purpura, Thrombocytopenic, Idiopathic MH - Vaccination/adverse effects PMC - PMC10911943 OTO - NOTNLM OT - Adolescents OT - Adverse Events OT - COVID-19 Vaccine OT - Disproportionality Analysis COIS- The authors declare no competing interests. Dr. Shin received grants from the Ministry of Food and Drug Safety, the National Research Foundation of Korea, and Pharmaceutical Companies, including Pfizer, Celltrion, and SK bioscience. No other relationships or activities have influenced the submitted work. No other relationships or activities have influenced the submitted work. EDAT- 2024/03/06 00:42 MHDA- 2024/03/07 06:43 PMCR- 2024/03/04 CRDT- 2024/03/05 18:43 PHST- 2023/09/24 00:00 [received] PHST- 2024/01/08 00:00 [accepted] PHST- 2024/03/07 06:43 [medline] PHST- 2024/03/06 00:42 [pubmed] PHST- 2024/03/05 18:43 [entrez] PHST- 2024/03/04 00:00 [pmc-release] AID - 39.e76 [pii] AID - 10.3346/jkms.2024.39.e76 [doi] PST - epublish SO - J Korean Med Sci. 2024 Mar 4;39(8):e76. doi: 10.3346/jkms.2024.39.e76.