DOI QR코드

DOI QR Code

Short-term safety profile of COVID-19 vaccination in children and adolescents with underlying medical conditions: a prospective cohort study

  • Naye Choi (Department of Pediatrics, Seoul National University Children's Hospital) ;
  • Seung-Ah Choe (Department of Preventive Medicine, Korea University College of Medicine) ;
  • Yo Han Ahn (Department of Pediatrics, Seoul National University Children's Hospital) ;
  • Young June Choe (Department of Pediatrics, Korea University College of Medicine) ;
  • Ju-Young Shin (Department of Biohealth Regulatory Science, School of Pharmacy, Sungkyunkwan University) ;
  • Nam-Kyong Choi (Department of Health Convergence, College of Science and Industry Convergence, Ewha Womans University) ;
  • Seong Heon Kim (Department of Pediatrics, Seoul National University Children's Hospital) ;
  • Hee Gyung Kang (Department of Pediatrics, Seoul National University Children's Hospital)
  • Received : 2023.02.20
  • Accepted : 2023.04.20
  • Published : 2023.06.30

Abstract

Purpose: This article was to collect data on the safety of coronavirus disease 2019 (COVID-19) vaccines in children with underlying medical conditions. Methods: We constructed a prospective cohort of children and adolescents aged 5 to 19 years who had received at least one dose of COVID-19 vaccine. Patients diagnosed with and treated for chronic kidney disease, autoimmune disease, or other chronic conditions at the Seoul National University Children's Hospital were recruited from June to December 2022. A mobile survey questionnaire was sent to their guardians. The presence of adverse events on the day (day 0), 3 weeks (day 21), and 6 months (day 180) after the 1st dose of COVID-19 vaccine was recorded by the guardians. Results: A total of 73 children participated. The median age was 14 years, and 64.4% of the patients were male. On the day of immunization, 65.8% of the patients reported at least one adverse event. Pain at the injection site, fatigue, headache, arthralgia, and myalgia were the most common symptoms. The prevalence of adverse events decreased over time (65.8% on day 0, 27.4% between days 0 and 21, and 24.6% between days 21 and 180). Severe acute respiratory syndrome coronavirus 2 infection after the 1st dose occurred in 17 patients (23.3%) and one of the patients (5.88%) was hospitalized due to infection. Conclusions: Adverse events after COVID-19 vaccination were generally mild in children and adolescents with underlying medical conditions. Our findings provide evidence for the safety of COVID-19 vaccination in the vulnerable pediatric population.

Keywords

Acknowledgement

This research was supported by a grant (22183MFDS433) from the Ministry of Food and Drug Safety in 2022-2025.

References

  1. World Health Organization (WHO). Interim statement on COVID-19 vaccination for children [Internet]. WHO; 2022 [cited 2022 Dec 10]. Available form: https://www.who.int/news/item/11-08-2022-interim-statement-on-covid-19-vaccination-for-children 
  2. World Health Organization (WHO). COVID-19 disease in children and adolescents [Internet]. WHO; 2021 [cited 2022 Dec 10]. Available form: https://www.who.int/publications/i/item/WHO-2019-nCoV-Sci_Brief-Children_and_adolescents-2021.1 
  3. American Academy of Pediatrics (AAP). Children and COVID-19: state-level data report [Internet]. APP; 2022 [cited 2022 Dec 10]. Available form: https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report 
  4. Tsabouri S, Makis A, Kosmeri C, Siomou E. Risk factors for severity in children with coronavirus disease 2019: a comprehensive literature review. Pediatr Clin North Am 2021;68:321-38.  https://doi.org/10.1016/j.pcl.2020.07.014
  5. Frenck RW Jr, Klein NP, Kitchin N, Gurtman A, Absalon J, Lockhart S, et al. Safety, immunogenicity, and efficacy of the BNT162b2 COVID-19 vaccine in adolescents. N Engl J Med 2021;385:239-50.  https://doi.org/10.1056/NEJMoa2107456
  6. Arslanoglu Aydin E, Baglan E, Bagrul I, Tuncez S, Ozdel S, Bulbul M. Safety of COVID-19 vaccines and disease flares after vaccines in children with rheumatic disease. Postgrad Med 2022;134:616-21.  https://doi.org/10.1080/00325481.2022.2074700
  7. Kompaniyets L, Agathis NT, Nelson JM, Preston LE, Ko JY, Belay B, et al. Underlying medical conditions associated with severe COVID-19 illness among children. JAMA Netw Open 2021;4:e2111182. 
  8. Kidney Disease: Improving Global Outcomes (KDIGO). Chapter 2: definition, identification, and prediction of CKD progression. Kidney Int Suppl (2011) 2013;3:63-72.  https://doi.org/10.1038/kisup.2012.65
  9. World Health Organization (WHO). Protocol template to be used as template for observational study protocols: cohort event monitoring (CEM) for safety signal detection after vaccination with COVID-19 vaccines [Internet]. WHO; 2021. [cited 2022 Dec 10]. Available form: https://www.who.int/publications/i/item/9789240027398 
  10. Watanabe Y, Yamaguchi Y. Drug allergy and autoimmune diseases. Allergol Int 2022;71:179-84.  https://doi.org/10.1016/j.alit.2022.02.001
  11. Yeo JG, Chia WN, Teh KL, Book YX, Hoh SF, Gao X, et al. Robust neutralizing antibody response to SARS-CoV-2 mRNA vaccination in adolescents and young adults with childhood-onset rheumatic diseases. Rheumatology (Oxford) 2022;61:4472-81.  https://doi.org/10.1093/rheumatology/keac105
  12. Smith C, Odd D, Harwood R, Ward J, Linney M, Clark M, et al. Deaths in children and young people in England after SARS-CoV-2 infection during the first pandemic year. Nat Med 2022;28:185-92.  https://doi.org/10.1038/s41591-021-01578-1
  13. Harwood R, Yan H, Talawila Da Camara N, Smith C, Ward J, Tudur-Smith C, et al. Which children and young people are at higher risk of severe disease and death after hospitalisation with SARS-CoV-2 infection in children and young people: a systematic review and individual patient meta-analysis. EClinicalMedicine 2022;44:101287. 
  14. Ward JL, Harwood R, Smith C, Kenny S, Clark M, Davis PJ, et al. Risk factors for PICU admission and death among children and young people hospitalized with COVID-19 and PIMS-TS in England during the first pandemic year. Nat Med 2022;28:193-200.  https://doi.org/10.1038/s41591-021-01627-9
  15. Bouwmans P, Messchendorp AL, Sanders JS, Hilbrands L, Reinders ME, Vart P, et al. Long-term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease, on dialysis or after kidney transplantation: a national prospective observational cohort study. BMC Nephrol 2022;23:55. 
  16. Shen Q, Wang M, Che R, Li Q, Zhou J, Wang F, et al. Consensus recommendations for the care of children receiving chronic dialysis in association with the COVID-19 epidemic. Pediatr Nephrol 2020;35:1351-7.  https://doi.org/10.1007/s00467-020-04555-x
  17. Ikizler TA. COVID-19 and dialysis units: what do we know now and what should we do? Am J Kidney Dis 2020;76:1-3.  https://doi.org/10.1053/j.ajkd.2020.03.008
  18. Harambat J, van Stralen KJ, Kim JJ, Tizard EJ. Epidemiology of chronic kidney disease in children. Pediatr Nephrol 2012;27:363-73.  https://doi.org/10.1007/s00467-011-1939-1
  19. Howard LM, Garguilo K, Gillon J, LeBlanc K, Seegmiller AC, Schmitz JE, et al. The first 1000 symptomatic pediatric SARS-CoV-2 infections in an integrated health care system: a prospective cohort study. BMC Pediatr 2021;21:403. 
  20. Centers for Disease Control and Prevention (CDC). Laboratory-confirmed COVID-19-associated hospitalizations. CDC; 2022 [cited 2022 Dec 10]. Available form: https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html 
  21. Wang CS, Doma R, Westbrook AL, Johnson J, Anderson EJ, Greenbaum LA, et al. Vaccine attitudes and COVID-19 vaccine intention among parents of children with kidney disease or primary hypertension. Am J Kidney Dis 2023;81:25-35. https://doi.org/10.1053/j.ajkd.2022.04.011