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KMID : 1142220230180010025
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Regulatory Research on Food, Drug & Cosmetic
2023 Volume.18 No. 1 p.25 ~ p.36
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Comparative Safety of SARS-COV-2 Vaccination in Pediatric Population with Asthma : Using WHO International Database
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Park Kyoung-Seok
Kim Dong-Hyuk
Shin Ju-Young
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Abstract
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To prevent serious mortality of COVID-19 in pediatric population, vaccination was expanded to pediatric in many countries, including South Korea, starting from March 31st, 2022. Especially, pediatric population with underlying diseases such as asthma are recommended. However in several studies investigating the safety of COVID-19 vaccines in pediatric population, with underlying medical conditions, there exists no international studies using large databases. Therefore, this study aimed to analyze the safety of COVID-19 vaccines in pediatric population, with asthma using the international pharmacovigilance database, VigiBase, from the World Health Organization (WHO). Using VigiBase of WHO's database, until October 26th, 2022 we extracted AEs (adverse events) related to COVID-19 vaccines authorized for use in pediatric population, using MedDRA Preferred Term (PT). All Other vaccines-related AEs were selected as the control group, and a disproportionality analysis was conducted. COVID-19 vaccines were categorized into four types: mRNA vaccine, viral vector vaccine, inactivated vaccine, and subunit vaccine. The AEs were classified by System Organ Class (SOC), and the relation between COVID-19 vaccines and AEs was analyzed using the Reporting Odds Ratio (ROR) with a 95% confidence interval (CI). A signal was considered to be present if the lower limit of the CI is above 1. Adverse event special interest (AESI) identified by the Centers for Disease Control and Prevention (CDC) that were more commonly observed in pediatric population were also evaluated. For the 514 reported AEs, 'General disorders and administration site conditions' had the highest number of cases (94 cases, 18.29%), followed by 'Nervous system disorders' (66 cases, 12.84%), and 'Gastrointestinal disorders' (55 cases, 10.70%). Myocarditis (ROR 49.81; 95% CI 10.85-228.72) was the most frequently observed AE that meets the criteria for signal detection by ROR, followed by ‘Vaccination site rash’ (ROR 42.36; 95% CI 4.71-380.68), Menstruation irregular (ROR 38.38; 95% CI 4.52-333.64), and Presyncope (ROR 35.08; 95% CI 4.52-333.64). In the ROR analysis of AESIs, Myocarditis/ Pericarditis (ROR 49.81; 95% CI 10.85-228.72) and Anaphylaxis (ROR 1.56; 95% CI 0.46-5.36) were observed. However, no cases of multisystem inflammatory syndrome (MIS)/Kawasaki disease (KD) were found in the study population, and therefore ROR could not be calculated for this condition. This study provides important information on the safety of COVID-19 vaccines in pediatric population with asthma, which can be used to inform public health policies and clinical practice.
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KEYWORD
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COVID-19 vaccination, Pharmacovigilance study, Safety study, Signal detection, VigiBase data, Pediatric population
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