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

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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. COVID-19 vaccination safety children chronic kidney disease CKD Introduction Children with underlying medical conditions are at risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its complications. The coronavirus disease-19 (COVID-19) vaccine therefore is particularly important for these children to prevent from severe illness or hospitalization. While the first COVID-19 mRNA vaccines were initially authorized for emergency use in adult population in December 2020, they were not available for children and adolescents under the age of 16 at the time due to the lack of safety data in this age group [ 1 ]. In South Korea, mass vaccination of BNT162b vaccine targeting adolescents aged 12–15 years started since November 2021. Despite of evidence indicating the protective effectiveness of COVID-19 vaccine in children, the parent’s willingness to vaccinate their children was low [ 2 ]. Parents of children with chronic kidney disease (CKD) may show more hesitancy to vaccinate their children [ 3 ]. Given the low COVID-19 vaccination coverage among children and the need for additional vaccination [ 4 ], reassurance of the vaccine safety in children and adolescents with CKD is important. In this study, we aimed to assess the incidence of severe adverse events among children with CKD, using a national population data of South Korea. Methods Data source and cohort construction We used the Korea Disease Control and Prevention Agency-COVID19-National Health Insurance Service (K-COV-N) cohort data established by linking the National Health Insurance System (NHIS) data to the information of COVID-19 infection and vaccination of the Korea Disease Control and Prevention Agency, as described in a previous study [ 5 ]. The NHIS database contains information on socio-demographics, including age, premium percentiles (proxy for income percentile), residential district, and clinical information on diagnoses, prescribed medications, procedures, and treatments covered by the NHIS for every visit to health institutions. Because the NHIS covers almost all the Korean population as a universal health insurance system, this database captures all the health care service use. We constructed a cohort of children aged 12 − 15 years who were diagnosed with CKD (n = 2,127). We identified pediatric CKD patients using operational definition based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and prior treatment codes [ 6 – 8 ]: primary or first secondary diagnosis of chronic kidney disease or end stage kidney disease (ICD-10 codes E102, 'E112', 'E142', 'N08', 'N19', 'N18'), dependence on dialysis (Z992), transplant (Z940), D638 (anemia of renal failure), and either 1) undergoing regular dialysis (hemodialysis and/or peritoneal dialysis) treatment code or prescription code for longer than one month or 2) who had undergone kidney transplantation (R3280). We excluded those with SARS-CoV-2 infection between August 1 and December 31 in 2021 (n = 25) from the analysis due to the possible association between the serious adverse event and the infection. Furthe excluding death from other than COVID-19 infection (n = 24), the final study population was 2,078 adolescents. Definition of adverse events Following the a priori knowledge, four adverse events: purpura and other hemorrhagic conditions, Guillain-Barré syndrome, myocarditis and/or pericarditis, and anaphylaxis, were analyzed. We identified these conditions based on hospital admission with the corresponding ICD-10 codes (Table 1 ). Adverse events that occurred between 0 and 60 days after BNT162b2 vaccination, within the observation period (between November 1 and December 31 in 2021), were counted as adverse events. Table 1 International Classification of Diseases 10th Revision (ICD-10) codes used for identifying the four severe adverse events of special interest. Adverse events ICD-10 codes Purpura and other hemorrhagic conditions D690, D691, D692, D693, D694, D695, D696, D698, D699 Guillain-Barré syndrome G610 Myocarditis/pericarditis I51.4, I30, I31.9, I32.8, I40, I41.8, I51.8 Anaphylaxis or anaphylactic shock T78.2, T88.6 Statistical analysis In the final study population, we compared the baseline characteristics between vaccinated and unvaccinated CKD children in the pooled data. We matched vaccinated CKD children to unvaccinated control CKD children (who were not vaccinated or infected in the relevant exposure period). Matching was done based on the demographic and clinical risk factors including age, sex, medical aid, Seoul capital area residence, and pediatric comorbidity index (PCI). We calculated the PCI based on the methodology developed and validated in a prior study [ 9 ]. Using the Cox proportional hazard model, we estimated the safety of COVID-19 immunization by calculating hazard ratio (HR) of four adverse events in the vaccinated group with that of matched unvaccinated group. The protocol of this study was approved by the institutional review board of Korea University College of Medicine (KUIRB-2023-0030-01). This study was carried out in accordance with the REporting of studies Conducted using Observational Routinely-collected Data (RECORD) guidelines. Result Between January 1, 2021, and October 31, 2021, a total of 2,078 pediatric CKD patients were identified. Among those, 69.2% (n = 1,437) had received BNT-162b2 vaccine between November 1 and December 31 in 2021 (Table 2 ). Mean age was 15 and 14 years in the vaccinated and unvaccinated patients. Twenty percent of pediatric CKD patients lived in Seoul capital area and 5–7% were medical aid beneficiaries. The PCI was higher in unvaccinated group (4.2 vs 4.0). After matching in accordance to the PCI, a total of 641 unvaccinated patients were matched to 1,282 vaccinees and the baseline characteristics were comparable between the two groups (Table 2 ). Table 2 Demographic and clinical characteristics of 2,078 children with chronic kidney disease Variable Before matching After matching Vaccinated N (%) Unvaccinated N (%) Vaccinated N (%) Unvaccinated N (%) Frequency 1437 641 1282 641 Age (years), mean (SD) 15.2 (1.6) 14.2 (1.7) 15.0 (1.6) 14.2 (1.7) Male 739 (51.4) 361 (56.3) 694 (54.1) 361 (56.3) Seoul capital area 300 (20.9) 137 (21.4) 260 (20.3) 137 (21.4) Medical aid beneficiaries 108 (7.5) 32 (5.0) 76 (5.9) 32 (5.0) Comorbidities Any malignancy 43 (3.0) 58 (9.0) 43 (3.4) 58 (9.0) Depression 77 (5.4) 22 (3.4) 76 (5.9) 22 (3.4) Diabetes 469 (32.6) 124 (19.3) 436 (34.0) 124 (19.3) Epilepsy 31 (2.2) 31 (4.8) 29 (2.3) 31 (4.8) Drug abuse 2 (0.1) 0 (0.0) 2 (0.2) 0 (0.0) Psychotic disorders 28 (1.9) 10 (1.6) 28 (2.2) 10 (1.6) Anemia 155 (10.8) 93 (14.5) 140 (10.9) 93 (14.5) Cardiovascular conditions 325 (22.6) 232 (36.2) 304 (23.7) 232 (36.2) Chromosomal anomalies 5 (0.3) 5 (0.8) 5 (0.4) 5 (0.8) Congenital malformations 107 (7.4) 93 (14.5) 96 (7.5) 93 (14.5) Menstrual disorders 57 (4.0) 20 (3.1) 50 (3.9) 20 (3.1) Weight loss 5 (0.3) 7 (1.1) 5 (0.4) 7 (1.1) Anxiety 52 (3.6) 22 (3.4) 48 (3.7) 22 (3.4) Asthma 51 (3.5) 25 (3.9) 47 (3.7) 25 (3.9) Conduct disorder 6 (0.4) 1 (0.2) 5 (0.4) 1 (0.2) Developmental delays 15 (1.0) 14 (2.2) 12 (0.9) 14 (2.2) Eating disorders 3 (0.2) 2 (0.3) 3 (0.2) 2 (0.3) GI conditions 944 (65.7) 393 (61.3) 846 (66.0) 393 (61.3) Joint disorders 23 (1.6) 22 (3.4) 22 (1.7) 22 (3.4) Nausea and vomiting 167 (11.6) 78 (12.2) 152 (11.9) 78 (12.2) Pain conditions 480 (33.4) 199 (31.0) 428 (33.4) 199 (31.0) Sleep disorder 14 (1.0) 8 (1.2) 13 (1.0) 8 (1.2) Pediatric comorbidity index, mean (SD) 4.0 (3.1) 4.2 (3.1) 4.1 (3.1) 4.2 (3.1) CKD, chronic kidney disease; SD, standard deviation; GI, gastrointestinal. Among the four adverse events of special interest, Guillain-Barré syndrome and anaphylaxis or anaphylactic shock did not occur in the study population, therefore were excluded from analysis. Purpura and hemorrhagic conditions were more frequent in the unvaccinated group compared to vaccinated group (5/641 vs 1/1,437) while three cases of myocarditis/pericarditis were observed in vaccinated group (0/641 vs 3/1437) (Table 3 ). The HR in vaccinated group in reference to unvaccinated group for purpura and hemorrhagic conditions was 0.19 (95% CI, 0.02–1.67, P = 0.135). Myocarditis and/or pericarditis occurred only in vaccinated adolescents with an odds ratio of infinity. Any of the two adverse events was 0.71 (95% CI, 0.18–2.70, P = 0.610). Table 3 Adverse events of special interest after vaccination among children with chronic kidney disease who received BNT162b2 mRNA COVID-19 Vaccine and unvaccinated matched control in South Korea from November 1 in 2021 to December 31 in 2021 Adverse event Vaccination status N Event Person-year HR (95% CI) P Before matching Purpura and hemorrhagic conditions Unvaccinated 641 5 104 1.00 (Reference) Vaccinated 1437 1 178 0.16 (0.02–1.40) 0.098 Myocarditis or pericarditis Unvaccinated 641 0 105 1.00 (Reference) Vaccinated 1437 3 177 High (0-Inf) 0.999 Any of the two Unvaccinated 641 5 104 1.00 (Reference) Vaccinated 1437 4 177 0.60 (0.16–2.27) 0.448 After matching Purpura and hemorrhagic conditions Unvaccinated 641 5 104 1.00 (Reference) Vaccinated 1282 1 150 0.19 (0.02–1.67) 0.135 Myocarditis or pericarditis Unvaccinated 641 0 105 1.00 (Reference) Vaccinated 1282 3 150 High (0-Inf) 0.999 Any of the two Unvaccinated 641 5 104 1.00 (Reference) Vaccinated 1282 4 150 0.71 (0.18–2.70) 0.610 HR, hazard ratio; CI, confidence interval. Discussion In this study, we found no increased risk of purpura and hemorrhagic disease, myocarditis/pericarditis in children with CKD who received BNT162b2 vaccine. The COVID-19 vaccine is the most important measure to prevent severe SARS-CoV-2 infection in children with risk factors [ 10 ]. A previous study showed that the children with CKD presenting with moderate-to-severe COVID-19 are at risk of severe complications, including severe acute kidney injury and mortality [ 11 ]. However, limited data on vaccine safety in children with CKD were available. Similar results were found in previous studies in Asia [ 12 ], in U.S. [ 13 ], and in European countries [ 14 ]. Children with CKD were reported to have a higher risk of serious COVID-19 compared to otherwise healthy persons [ 11 ]. In our data, among 1282 vaccinated children with CKD, 3 had a record of myocarditis and/or pericarditis during the observation period. However, when we compared the risk of occurrence of 2 myocarditis/pericarditis in 641 CKD patients without vaccination history, no increased risk was observed, suggesting that vaccination did not increase the risk of heart complication in children with CKD. In the real-world setting, misinformation about the safety of COVID-19 vaccines can lead to vaccine hesitancy, causing low vaccination rates and increasing the risk of infection especially for children with underlying disease [ 2 ]. Because of this, there had been vaccine hesitance among parents of children with CKD. In a previous study, 64% of parents of children with CKD revealed that they were worried of COVID-19 vaccine's safety [ 3 ]. In sum, 30% of our children with CKD were not vaccinated likely due to various concerns about vaccines. As a previous survey showed a significant association between self-reported sufficiency and credibility of vaccine-related information [ 15 ], the findings of this study may aid in parental decision-making regarding COVID-19 vaccination for their children with CKD. Despite evidence from clinical trials that focused on healthy adults, a real-world safety data is needed for children with underlying diseases. Although the children with CKD are at higher risk of complications if infected SARS-CoV-2, there is a public health gap to address this low vaccine coverage, likely due to vaccine hesitancy. Based on our result, vaccination is a safe intervention to prevent COVID-19 in children with CKD; hence the benefits of vaccination in this population must be emphasized. To the best of our knowledge, this is the largest safety data of BNT162b2 in children with CKD. This finding can contribute to pediatrician's and parent's understanding of the safety profile of BNT162b2 vaccine for children with CKD. This study has number of limitations. First, our dataset does not have detailed clinical data, and we were unable to further stratify the analysis by the disease severity. Second, although the data we used covers all healthcare utilization records in Korea, we were unable to include data for prescriptions not reimbursed by the national health insurance. Third, our results of the risk period of 0–60 days might indicate a healthy vaccinee effect. Despite these limitations, the population-representativeness of data and important public health implications is a main strength of this study. In this national cohort study among 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 and highlight the importance of vaccination to prevent potential severe outcomes if infected. Declarations Acknowledgment This study used the KDCA and NHIS databases for policy and academic research (KDCA-NHIS-2022-1-587). The conclusions of this study are not related to this institution. This research was supported by a grant (22183MFDS433) from the Ministry of Food and Drug Safety in 2022-2025 References FDA (2020) FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. FDA news release. U.S. Food & Drug Administration Cho HK, Lee H, Choe YJ, Kim S, Seo S, Moon J, Choi EH, Kwon GY, Shin JY, Choi SY, Jeong MJ, You M (2022) Parental concerns on COVID-19 vaccine safety and hesitancy in Korea: Implications for vaccine communication. Epidemiol health :e2023004 Wang CS, Doma R, Westbrook AL, Johnson J, Anderson EJ, Greenbaum LA, Rana SA, George RP, Garro R, Khanna-Farber A, Escoffery C, Bednarczyk RA (2023) Vaccine Attitudes and COVID-19 Vaccine Intention Among Parents of Children With Kidney Disease or Primary Hypertension. Am J kidney diseases: official J Natl Kidney Foundation 81:25–35e21 Babel N, Hugo C, Westhoff TH (2022) Vaccination in patients with kidney failure: lessons from COVID-19. Nat Rev Nephrol 18:708–723 Oh J, Lee W, Kim CJ, Kim YJ, Park H, Lee JH, Park MH, Lee S, Ha E, Lee KA (2023) COVID-19, maternal, and neonatal outcomes: National Mother-Child Cohort (NMCC) of K-COV-N cohort in South Korea. PLoS ONE 18:e0284779 Sood MM, Murphy MSQ, Hawken S, Wong CA, Potter BK, Burns KD, Tsampalieros A, Atkinson KM, Chakraborty P, Wilson K (2018) Association Between Newborn Metabolic Profiles and Pediatric Kidney Disease. Kidney Int Rep 3:691–700 Bjornstad EC, Marshall SW, Mottl AK, Gibson K, Golightly YM, Charles A, Gower EW (2020) Racial and health insurance disparities in pediatric acute kidney injury in the USA. Pediatr Nephrol 35:1085–1096 Friberg L, Gasparini A, Carrero JJ (2017) A scheme based on ICD-10 diagnoses and drug prescriptions to stage chronic kidney disease severity in healthcare administrative records. Clin Kidney J 11:254–258 Sun JW, Bourgeois FT, Haneuse S, Hernández-Díaz S, Landon JE, Bateman BT, Huybrechts KF (2020) Development and Validation of a Pediatric Comorbidity Index. Am J Epidemiol 190:918–927 COVID-19 Vaccines in Children and Adolescents. Pediatrics 148 Krishnasamy S, Mantan M, Mishra K, Kapoor K, Brijwal M, Kumar M, Sharma S, Swarnim S, Gaind R, Khandelwal P, Hari P, Sinha A, Bagga A (2022) SARS-CoV-2 infection in children with chronic kidney disease. Pediatr Nephrol 37:849–857 Cheng FWT, Fan M, Wong CKH, Chui CSL, Lai FTT, Li X, Wan EYF, Tang SCW, Chan EWY, Wong ICK (2022) The effectiveness and safety of mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccines among individuals with chronic kidney diseases. Kidney Int 102:922–925 Glenn DA, Hegde A, Kotzen E, Walter EB, Kshirsagar AV, Falk R, Mottl A (2021) Systematic Review of Safety and Efficacy of COVID-19 Vaccines in Patients With Kidney Disease. Kidney Int Rep 6:1407–1410 Bouwmans P, Messchendorp AL, Sanders JS, Hilbrands L, Reinders MEJ, Vart P, Bemelman FJ, Abrahams AC, van den Dorpel MA, Ten Dam MA, de Vries APJ, Rispens T, Steenhuis M, Gansevoort RT, Hemmelder MH (2022) 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 23:55 Lee M, Seo S, Choi S, Park JH, Kim S, Choe YJ, Choi EH, Kwon GY, Shin JY, Choi SY, Jeong MJ, Lee H, You M (2022) Parental Acceptance of COVID-19 Vaccination for Children and Its Association With Information Sufficiency and Credibility in South Korea. JAMA Netw open 5:e2246624 Cite Share Download PDF Status: Published Journal Publication published 25 Oct, 2023 Read the published version in Pediatric Nephrology → Version 1 posted Editorial decision: Major Revisions Needed 13 Jun, 2023 Reviewers agreed at journal 26 May, 2023 Reviewers invited by journal 23 May, 2023 Editor assigned by journal 23 May, 2023 First submitted to journal 21 May, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2962301","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":203281405,"identity":"f2c14f1b-cad1-4a7a-b6bd-9f96d94e5eb4","order_by":0,"name":"Young June Choe","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAxklEQVRIiWNgGAWjYDACCRBRkQDnGxCp5QzJWhjbSNHCP7v54GPeeWly5u3NDxh+1DAYmzcQsuTOsWRj3m05xjJnjhkw9hxjMJM5QECLgUSOmTTvtorEGRIJBgy8DQw2EoQcBtRi/pt3DlCL/PMPjH+J1GLGzNuQA7SFxwDIYDAjqEXiRlqy5JxjacYSPDkFh2WOSRgT1MI/I/nghzc1yXIS7Mc3PnxTY2M4g5AWEGDigTIOQGOWMGD8QZy6UTAKRsEoGKkAANzlNxC/BAuxAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-2733-0715","institution":"Korea University Anam Hospital","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Young","middleName":"June","lastName":"Choe","suffix":""},{"id":203281406,"identity":"a94851c4-3d1d-4a53-8951-cb015f04c260","order_by":1,"name":"Yo-Han Ahn","email":"","orcid":"","institution":"Seoul National University College of Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Yo-Han","middleName":"","lastName":"Ahn","suffix":""},{"id":203281407,"identity":"e1d14772-5e24-434b-af8e-da30cc43d4bf","order_by":2,"name":"Eunsun Kwak","email":"","orcid":"","institution":"Korea University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Eunsun","middleName":"","lastName":"Kwak","suffix":""},{"id":203281408,"identity":"b8f1e278-6daf-4105-9053-7c8e75876600","order_by":3,"name":"Eunseo Jo","email":"","orcid":"","institution":"Zarathu","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Eunseo","middleName":"","lastName":"Jo","suffix":""},{"id":203281409,"identity":"aa80ccdf-43d3-48bc-afc1-d220c800fd7a","order_by":4,"name":"Jinseob Kim","email":"","orcid":"","institution":"Zarathu","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jinseob","middleName":"","lastName":"Kim","suffix":""},{"id":203281410,"identity":"6daeb200-2ab4-4a37-9163-34e570fc85e3","order_by":5,"name":"Seung-Ah Choe","email":"","orcid":"","institution":"Korea University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Seung-Ah","middleName":"","lastName":"Choe","suffix":""}],"badges":[],"createdAt":"2023-05-21 10:08:39","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2962301/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2962301/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00467-023-06195-3","type":"published","date":"2023-10-25T15:01:29+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":45453712,"identity":"e153ae6a-6f06-4d8a-a69b-cf0d1cc65404","added_by":"auto","created_at":"2023-10-30 15:04:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":265486,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2962301/v1/9da2b9cf-72da-4815-9deb-2f3b17c47af5.pdf"}],"financialInterests":"","formattedTitle":"Safety of BNT162b2 mRNA COVID-19 Vaccine in children with chronic kidney disease: a national population study of South Korea","fulltext":[{"header":"Introduction","content":"\u003cp\u003eChildren with underlying medical conditions are at risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its complications. The coronavirus disease-19 (COVID-19) vaccine therefore is particularly important for these children to prevent from severe illness or hospitalization. While the first COVID-19 mRNA vaccines were initially authorized for emergency use in adult population in December 2020, they were not available for children and adolescents under the age of 16 at the time due to the lack of safety data in this age group [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn South Korea, mass vaccination of BNT162b vaccine targeting adolescents aged 12\u0026ndash;15 years started since November 2021. Despite of evidence indicating the protective effectiveness of COVID-19 vaccine in children, the parent\u0026rsquo;s willingness to vaccinate their children was low [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Parents of children with chronic kidney disease (CKD) may show more hesitancy to vaccinate their children [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Given the low COVID-19 vaccination coverage among children and the need for additional vaccination [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e], reassurance of the vaccine safety in children and adolescents with CKD is important.\u003c/p\u003e \u003cp\u003eIn this study, we aimed to assess the incidence of severe adverse events among children with CKD, using a national population data of South Korea.\u003c/p\u003e "},{"header":"Methods","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003cdiv id=\"Sec3\" class=\"Section3\"\u003e \u003ch2\u003eData source and cohort construction\u003c/h2\u003e \u003cp\u003eWe used the Korea Disease Control and Prevention Agency-COVID19-National Health Insurance Service (K-COV-N) cohort data established by linking the National Health Insurance System (NHIS) data to the information of COVID-19 infection and vaccination of the Korea Disease Control and Prevention Agency, as described in a previous study [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The NHIS database contains information on socio-demographics, including age, premium percentiles (proxy for income percentile), residential district, and clinical information on diagnoses, prescribed medications, procedures, and treatments covered by the NHIS for every visit to health institutions. Because the NHIS covers almost all the Korean population as a universal health insurance system, this database captures all the health care service use.\u003c/p\u003e \u003cp\u003eWe constructed a cohort of children aged 12\u0026thinsp;\u0026minus;\u0026thinsp;15 years who were diagnosed with CKD (n\u0026thinsp;=\u0026thinsp;2,127). We identified pediatric CKD patients using operational definition based on the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and prior treatment codes [\u003cspan additionalcitationids=\"CR7\" citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]: primary or first secondary diagnosis of chronic kidney disease or end stage kidney disease (ICD-10 codes E102, 'E112', 'E142', 'N08', 'N19', 'N18'), dependence on dialysis (Z992), transplant (Z940), D638 (anemia of renal failure), and either 1) undergoing regular dialysis (hemodialysis and/or peritoneal dialysis) treatment code or prescription code for longer than one month or 2) who had undergone kidney transplantation (R3280). We excluded those with SARS-CoV-2 infection between August 1 and December 31 in 2021 (n\u0026thinsp;=\u0026thinsp;25) from the analysis due to the possible association between the serious adverse event and the infection. Furthe excluding death from other than COVID-19 infection (n\u0026thinsp;=\u0026thinsp;24), the final study population was 2,078 adolescents.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section4\"\u003e \u003ch2\u003eDefinition of adverse events\u003c/h2\u003e \u003cp\u003eFollowing the a priori knowledge, four adverse events: purpura and other hemorrhagic conditions, Guillain-Barr\u0026eacute; syndrome, myocarditis and/or pericarditis, and anaphylaxis, were analyzed. We identified these conditions based on hospital admission with the corresponding ICD-10 codes (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Adverse events that occurred between 0 and 60 days after BNT162b2 vaccination, within the observation period (between November 1 and December 31 in 2021), were counted as adverse events.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eInternational Classification of Diseases 10th Revision (ICD-10) codes used for identifying the four severe adverse events of special interest.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse events\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eICD-10 codes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePurpura and other hemorrhagic conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eD690, D691, D692, D693, D694, D695, D696, D698, D699\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGuillain-Barr\u0026eacute; syndrome\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eG610\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMyocarditis/pericarditis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eI51.4, I30, I31.9, I32.8, I40, I41.8, I51.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnaphylaxis or anaphylactic shock\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT78.2, T88.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eIn the final study population, we compared the baseline characteristics between vaccinated and unvaccinated CKD children in the pooled data. We matched vaccinated CKD children to unvaccinated control CKD children (who were not vaccinated or infected in the relevant exposure period). Matching was done based on the demographic and clinical risk factors including age, sex, medical aid, Seoul capital area residence, and pediatric comorbidity index (PCI). We calculated the PCI based on the methodology developed and validated in a prior study [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eUsing the Cox proportional hazard model, we estimated the safety of COVID-19 immunization by calculating hazard ratio (HR) of four adverse events in the vaccinated group with that of matched unvaccinated group. The protocol of this study was approved by the institutional review board of Korea University College of Medicine (KUIRB-2023-0030-01). This study was carried out in accordance with the REporting of studies Conducted using Observational Routinely-collected Data (RECORD) guidelines.\u003c/p\u003e \u003c/div\u003e"},{"header":"Result","content":"\u003cp\u003eBetween January 1, 2021, and October 31, 2021, a total of 2,078 pediatric CKD patients were identified. Among those, 69.2% (n\u0026thinsp;=\u0026thinsp;1,437) had received BNT-162b2 vaccine between November 1 and December 31 in 2021 (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Mean age was 15 and 14 years in the vaccinated and unvaccinated patients. Twenty percent of pediatric CKD patients lived in Seoul capital area and 5\u0026ndash;7% were medical aid beneficiaries. The PCI was higher in unvaccinated group (4.2 vs 4.0). After matching in accordance to the PCI, a total of 641 unvaccinated patients were matched to 1,282 vaccinees and the baseline characteristics were comparable between the two groups (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographic and clinical characteristics of 2,078 children with chronic kidney disease\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eBefore matching\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e \u003cp\u003eAfter matching\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003cp\u003eN (%)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFrequency\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1437\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1282\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years), mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15.2 (1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14.2 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15.0 (1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14.2 (1.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e739 (51.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e361 (56.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e694 (54.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e361 (56.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSeoul capital area\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e300 (20.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e137 (21.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e260 (20.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e137 (21.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedical aid beneficiaries\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e108 (7.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32 (5.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e76 (5.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e32 (5.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eComorbidities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAny malignancy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e43 (3.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e58 (9.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e43 (3.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e58 (9.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDepression\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e77 (5.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22 (3.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e76 (5.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22 (3.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e469 (32.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e124 (19.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e436 (34.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e124 (19.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEpilepsy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e31 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31 (4.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e29 (2.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e31 (4.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDrug abuse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (0.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0 (0.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (0.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0 (0.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePsychotic disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 (1.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 (1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e28 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e10 (1.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnemia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e155 (10.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e93 (14.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e140 (10.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e93 (14.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCardiovascular conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e325 (22.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e232 (36.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e304 (23.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e232 (36.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChromosomal anomalies\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (0.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (0.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (0.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (0.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCongenital malformations\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e107 (7.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e93 (14.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e96 (7.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e93 (14.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMenstrual disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e57 (4.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e50 (3.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e20 (3.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeight loss\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (0.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (1.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (0.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e7 (1.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnxiety\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e52 (3.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22 (3.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e48 (3.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22 (3.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsthma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e51 (3.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (3.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e47 (3.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e25 (3.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConduct disorder\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (0.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (0.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (0.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (0.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDevelopmental delays\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 (1.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 (0.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14 (2.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEating disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (0.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (0.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (0.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2 (0.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGI conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e944 (65.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e393 (61.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e846 (66.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e393 (61.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eJoint disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23 (1.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22 (3.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22 (1.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e22 (3.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNausea and vomiting\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e167 (11.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e78 (12.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e152 (11.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e78 (12.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePain conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e480 (33.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e199 (31.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e428 (33.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e199 (31.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSleep disorder\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (1.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (1.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e13 (1.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 (1.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePediatric comorbidity index, mean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.0 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.2 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.1 (3.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4.2 (3.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eCKD, chronic kidney disease; SD, standard deviation; GI, gastrointestinal.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAmong the four adverse events of special interest, Guillain-Barr\u0026eacute; syndrome and anaphylaxis or anaphylactic shock did not occur in the study population, therefore were excluded from analysis. Purpura and hemorrhagic conditions were more frequent in the unvaccinated group compared to vaccinated group (5/641 vs 1/1,437) while three cases of myocarditis/pericarditis were observed in vaccinated group (0/641 vs 3/1437) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The HR in vaccinated group in reference to unvaccinated group for purpura and hemorrhagic conditions was 0.19 (95% CI, 0.02\u0026ndash;1.67, P\u0026thinsp;=\u0026thinsp;0.135). Myocarditis and/or pericarditis occurred only in vaccinated adolescents with an odds ratio of infinity. Any of the two adverse events was 0.71 (95% CI, 0.18\u0026ndash;2.70, P\u0026thinsp;=\u0026thinsp;0.610).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAdverse events of special interest after vaccination among children with chronic kidney disease who received BNT162b2 mRNA COVID-19 Vaccine and unvaccinated matched control in South Korea from November 1 in 2021 to December 31 in 2021\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse event\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccination status\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEvent\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ePerson-year\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eHR (95% CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eP\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eBefore matching\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ePurpura and hemorrhagic conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e104\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.00 (Reference)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1437\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e178\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.16 (0.02\u0026ndash;1.40)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.098\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eMyocarditis or pericarditis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e105\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.00 (Reference)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1437\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e177\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eHigh (0-Inf)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAny of the two\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e104\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.00 (Reference)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1437\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e177\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.60 (0.16\u0026ndash;2.27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.448\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cem\u003eAfter matching\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ePurpura and hemorrhagic conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e104\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.00 (Reference)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1282\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.19 (0.02\u0026ndash;1.67)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.135\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eMyocarditis or pericarditis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e105\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.00 (Reference)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1282\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eHigh (0-Inf)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eAny of the two\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnvaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e641\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e104\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.00 (Reference)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eVaccinated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1282\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e150\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.71 (0.18\u0026ndash;2.70)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e0.610\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eHR, hazard ratio; CI, confidence interval.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this study, we found no increased risk of purpura and hemorrhagic disease, myocarditis/pericarditis in children with CKD who received BNT162b2 vaccine. The COVID-19 vaccine is the most important measure to prevent severe SARS-CoV-2 infection in children with risk factors [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. A previous study showed that the children with CKD presenting with moderate-to-severe COVID-19 are at risk of severe complications, including severe acute kidney injury and mortality [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. However, limited data on vaccine safety in children with CKD were available. Similar results were found in previous studies in Asia [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], in U.S. [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], and in European countries [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Children with CKD were reported to have a higher risk of serious COVID-19 compared to otherwise healthy persons [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In our data, among 1282 vaccinated children with CKD, 3 had a record of myocarditis and/or pericarditis during the observation period. However, when we compared the risk of occurrence of 2 myocarditis/pericarditis in 641 CKD patients without vaccination history, no increased risk was observed, suggesting that vaccination did not increase the risk of heart complication in children with CKD.\u003c/p\u003e \u003cp\u003eIn the real-world setting, misinformation about the safety of COVID-19 vaccines can lead to vaccine hesitancy, causing low vaccination rates and increasing the risk of infection especially for children with underlying disease [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Because of this, there had been vaccine hesitance among parents of children with CKD. In a previous study, 64% of parents of children with CKD revealed that they were worried of COVID-19 vaccine's safety [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In sum, 30% of our children with CKD were not vaccinated likely due to various concerns about vaccines. As a previous survey showed a significant association between self-reported sufficiency and credibility of vaccine-related information [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], the findings of this study may aid in parental decision-making regarding COVID-19 vaccination for their children with CKD.\u003c/p\u003e \u003cp\u003eDespite evidence from clinical trials that focused on healthy adults, a real-world safety data is needed for children with underlying diseases. Although the children with CKD are at higher risk of complications if infected SARS-CoV-2, there is a public health gap to address this low vaccine coverage, likely due to vaccine hesitancy. Based on our result, vaccination is a safe intervention to prevent COVID-19 in children with CKD; hence the benefits of vaccination in this population must be emphasized. To the best of our knowledge, this is the largest safety data of BNT162b2 in children with CKD. This finding can contribute to pediatrician's and parent's understanding of the safety profile of BNT162b2 vaccine for children with CKD.\u003c/p\u003e \u003cp\u003eThis study has number of limitations. First, our dataset does not have detailed clinical data, and we were unable to further stratify the analysis by the disease severity. Second, although the data we used covers all healthcare utilization records in Korea, we were unable to include data for prescriptions not reimbursed by the national health insurance. Third, our results of the risk period of 0\u0026ndash;60 days might indicate a healthy vaccinee effect. Despite these limitations, the population-representativeness of data and important public health implications is a main strength of this study.\u003c/p\u003e \u003cp\u003eIn this national cohort study among 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 and highlight the importance of vaccination to prevent potential severe outcomes if infected.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study used the KDCA and NHIS databases for policy and academic research (KDCA-NHIS-2022-1-587). The conclusions of this study are not related to this institution.\u003c/p\u003e\n\u003cp\u003eThis research was supported by a grant (22183MFDS433) from the Ministry of Food and Drug Safety in 2022-2025\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFDA (2020) FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. FDA news release. U.S. Food \u0026amp; Drug Administration\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCho HK, Lee H, Choe YJ, Kim S, Seo S, Moon J, Choi EH, Kwon GY, Shin JY, Choi SY, Jeong MJ, You M (2022) Parental concerns on COVID-19 vaccine safety and hesitancy in Korea: Implications for vaccine communication. Epidemiol health :e2023004\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang CS, Doma R, Westbrook AL, Johnson J, Anderson EJ, Greenbaum LA, Rana SA, George RP, Garro R, Khanna-Farber A, Escoffery C, Bednarczyk RA (2023) Vaccine Attitudes and COVID-19 Vaccine Intention Among Parents of Children With Kidney Disease or Primary Hypertension. Am J kidney diseases: official J Natl Kidney Foundation 81:25\u0026ndash;35e21\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBabel N, Hugo C, Westhoff TH (2022) Vaccination in patients with kidney failure: lessons from COVID-19. Nat Rev Nephrol 18:708\u0026ndash;723\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOh J, Lee W, Kim CJ, Kim YJ, Park H, Lee JH, Park MH, Lee S, Ha E, Lee KA (2023) COVID-19, maternal, and neonatal outcomes: National Mother-Child Cohort (NMCC) of K-COV-N cohort in South Korea. PLoS ONE 18:e0284779\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSood MM, Murphy MSQ, Hawken S, Wong CA, Potter BK, Burns KD, Tsampalieros A, Atkinson KM, Chakraborty P, Wilson K (2018) Association Between Newborn Metabolic Profiles and Pediatric Kidney Disease. Kidney Int Rep 3:691\u0026ndash;700\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBjornstad EC, Marshall SW, Mottl AK, Gibson K, Golightly YM, Charles A, Gower EW (2020) Racial and health insurance disparities in pediatric acute kidney injury in the USA. Pediatr Nephrol 35:1085\u0026ndash;1096\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFriberg L, Gasparini A, Carrero JJ (2017) A scheme based on ICD-10 diagnoses and drug prescriptions to stage chronic kidney disease severity in healthcare administrative records. Clin Kidney J 11:254\u0026ndash;258\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSun JW, Bourgeois FT, Haneuse S, Hern\u0026aacute;ndez-D\u0026iacute;az S, Landon JE, Bateman BT, Huybrechts KF (2020) Development and Validation of a Pediatric Comorbidity Index. Am J Epidemiol 190:918\u0026ndash;927\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCOVID-19 Vaccines in Children and Adolescents. Pediatrics 148\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKrishnasamy S, Mantan M, Mishra K, Kapoor K, Brijwal M, Kumar M, Sharma S, Swarnim S, Gaind R, Khandelwal P, Hari P, Sinha A, Bagga A (2022) SARS-CoV-2 infection in children with chronic kidney disease. Pediatr Nephrol 37:849\u0026ndash;857\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCheng FWT, Fan M, Wong CKH, Chui CSL, Lai FTT, Li X, Wan EYF, Tang SCW, Chan EWY, Wong ICK (2022) The effectiveness and safety of mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccines among individuals with chronic kidney diseases. Kidney Int 102:922\u0026ndash;925\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGlenn DA, Hegde A, Kotzen E, Walter EB, Kshirsagar AV, Falk R, Mottl A (2021) Systematic Review of Safety and Efficacy of COVID-19 Vaccines in Patients With Kidney Disease. Kidney Int Rep 6:1407\u0026ndash;1410\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBouwmans P, Messchendorp AL, Sanders JS, Hilbrands L, Reinders MEJ, Vart P, Bemelman FJ, Abrahams AC, van den Dorpel MA, Ten Dam MA, de Vries APJ, Rispens T, Steenhuis M, Gansevoort RT, Hemmelder MH (2022) 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 23:55\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLee M, Seo S, Choi S, Park JH, Kim S, Choe YJ, Choi EH, Kwon GY, Shin JY, Choi SY, Jeong MJ, Lee H, You M (2022) Parental Acceptance of COVID-19 Vaccination for Children and Its Association With Information Sufficiency and Credibility in South Korea. JAMA Netw open 5:e2246624\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pediatric-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pnep","sideBox":"Learn more about [Pediatric Nephrology](http://link.springer.com/journal/467)","snPcode":"467","submissionUrl":"https://www.editorialmanager.com/pnep/default2.aspx","title":"Pediatric Nephrology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"COVID-19, vaccination, safety, children, chronic kidney disease, CKD","lastPublishedDoi":"10.21203/rs.3.rs-2962301/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2962301/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eIn South Korea, COVID-19 vaccination has been recommended to children since October 2021, targeting all teenagers aged 12\u0026ndash;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.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe 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-Barr\u0026eacute; syndrome (GBS), myocarditis and/or pericarditis, and anaphylaxis incidence in children with CKD, after BNT162b2 vaccination.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAmong the 2,078 children with CKD, 69.2% (n\u0026thinsp;=\u0026thinsp;1,437) had received BNT-162b2 vaccine. Guillain-Barr\u0026eacute; 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.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eIn 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.\u003c/p\u003e","manuscriptTitle":"Safety of BNT162b2 mRNA COVID-19 Vaccine in children with chronic kidney disease: a national population study of South Korea","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-05-25 17:13:52","doi":"10.21203/rs.3.rs-2962301/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major Revisions Needed","date":"2023-06-13T10:22:33+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2023-05-26T12:44:36+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-05-24T03:21:58+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-05-23T12:22:14+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pediatric Nephrology","date":"2023-05-21T06:08:32+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pediatric-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pnep","sideBox":"Learn more about [Pediatric Nephrology](http://link.springer.com/journal/467)","snPcode":"467","submissionUrl":"https://www.editorialmanager.com/pnep/default2.aspx","title":"Pediatric Nephrology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"880e1f49-047d-480f-8add-142a6035deff","owner":[],"postedDate":"May 25th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-30T15:03:05+00:00","versionOfRecord":{"articleIdentity":"rs-2962301","link":"https://doi.org/10.1007/s00467-023-06195-3","journal":{"identity":"pediatric-nephrology","isVorOnly":false,"title":"Pediatric Nephrology"},"publishedOn":"2023-10-25 15:01:29","publishedOnDateReadable":"October 25th, 2023"},"versionCreatedAt":"2023-05-25 17:13:52","video":"","vorDoi":"10.1007/s00467-023-06195-3","vorDoiUrl":"https://doi.org/10.1007/s00467-023-06195-3","workflowStages":[]},"version":"v1","identity":"rs-2962301","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2962301","identity":"rs-2962301","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}