J Korean Med Sci.  2024 Mar;39(8):e76. 10.3346/jkms.2024.39.e76.

Adverse Events Following COVID-19 Vaccination in Adolescents: Insights From Pharmacovigilance Study of VigiBase

• Kim DH
• Kim JH
• Oh IS
• Choe YJ
• Choe SA
• Shin JY

• KMID: 2553327
• DOI: http://doi.org/10.3346/jkms.2024.39.e76

Abstract

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.

Keyword

COVID-19 Vaccine; Adolescents; Adverse Events; Disproportionality Analysis

Figure

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  Fig. 1 Reporting odds of myocarditis/pericarditis, MIS/KD, anaphylaxis, Guillain-Barré syndrome, and immune thrombocytopenia for COVID-19 vaccines among adolescents (12–17 years) in World Health Organization VigiBase.ROR = reporting odds ratio, CI = confidence interval, COVID-19 = coronavirus disease 2019, MIS = multisystem inflammatory syndrome, KD = Kawasaki disease.aROR estimated using a logistic regression model adjusted for sex.

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  Fig. 2 Time to onset of myocarditis/pericarditis, MIS/KD, anaphylaxis, Guillain-Barré syndrome, and immune thrombocytopenia after coronavirus disease 2019 vaccination among adolescents (12–17 years), recorded in World Health Organization VigiBase.MIS = multisystem inflammatory syndrome, KD = Kawasaki disease.

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  Fig. 3 Distribution of the adverse events, according to system Organ Class and preferred Term, reported together with myocarditis/pericarditis, MIS/KD, anaphylaxis, Guillain-Barré syndrome, and immune thrombocytopenia in World Health Organization VigiBase.MIS = multisystem inflammatory syndrome, KD = Kawasaki disease.

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