Safety of BNT162b2 mRNA COVID-19 Vaccine in children with chronic kidney disease: a national population study of South Korea

Abstract

Abstract Background In South Korea, COVID-19 vaccination has been recommended to children since October 2021, targeting all teenagers aged 12–15 years, with emphasis on high-risk group including chronic kidney disease (CKD) pediatric patients. In this study, we aimed to assess the rate of adverse events following COVID-19 vaccination in children with CKD in South Korea, using national cohort data. Methods We retrieved the Korea Disease Control and Prevention Agency-COVID19-National Health Insurance Service (K-COV-N) cohort data linked to the National Health Insurance System (NHIS) data, to calculate rate of purpura and other hemorrhagic conditions, Guillain-Barré syndrome (GBS), myocarditis and/or pericarditis, and anaphylaxis incidence in children with CKD, after BNT162b2 vaccination. Results Among the 2,078 children with CKD, 69.2% (n = 1,437) had received BNT-162b2 vaccine. Guillain-Barré syndrome and anaphylaxis or anaphylactic shock did not occur during observed period. Purpura and hemorrhagic conditions were more frequent in the unvaccinated group (5/641 vs 1/1,437) while myocarditis/pericarditis was observed only in vaccinated group (0/641 vs 3/1437). The difference in the risk of any of these two events between vaccinated and unvaccinated groups was insignificant. Conclusions In this national cohort study of children with CKD in Korea, we found no evidence of increased risk of adverse events following BNT162b2 vaccination. Our results provide the safety profiles of COVID-19 vaccine for patients with CKD.