Department of Biostatistics, Epidemiology, and Population Health, Faculty of Medicine, Public Health, and Nursing, Gadjah Mada University, Yogyakarta, Indonesia.
Departement of Child Health, Faculty of Medicine, Public Health, and Nursing, Gadjah Mada University, DR. Sardjito Hospital, Yogyakarta, Indonesia.
Front Public Health. 2022 Oct 25;10:999354. doi: 10.3389/fpubh.2022.999354. eCollection 2022.
Starting in December 2021, the Indonesian Government has recommended inactivated SARS-CoV-2 vaccine (CoronaVac) for children aged 6-11 years. This study aims to determine the prevalence and determinant factors of adverse events following immunization (AEFI) of the first dose and the second dose of the COVID-19 vaccine among children aged 6-11 years old.
We conducted a cross-sectional study in Bantul District, Yogyakarta, Indonesia, in February-March 2022. Data were collected by trained interviews with 1,093 parents of children 6-11 years old who received the first dose and the second dose of the COVID-19 vaccine. Data were analyzed with chi-square and logistic regression.
The prevalence of AEFI in the first dose of the COVID-19 vaccine was 16.7%, while the second dose was 22.6%. The most common symptoms of AEFI at the first dose were local site pain and fever, while at the second dose were cough and cold. Determinants of AEFI of COVID-19 vaccination among children were girls with OR 1.31 (95% CI 1.0-1.7; 0.04), mass-setting of vaccination with OR 0.70 (95% CI 0.5-0.9; 0.01), the history of AEFI in childhood vaccination with OR 1.63 (95% CI 1.2-2.2; < 0.01) and administering other vaccines within 1 month before COVID-19 vaccination, with OR 5.10 (95% CI 2.1-12.3 < 0.01).
The prevalence of AEFI in the first and the second dose of inactivated COVID-19 vaccine was comparable to that reported in the clinical trial study and the communities. Risk communication should be provided to the child and their parents regarding the risk of mild AEFI of the COVID-19 vaccine, especially for children with a history of AEFI in childhood vaccination and who received other vaccines containing the same adjuvant with CoronaVac within 1 month. A mass-setting of vaccination should be taken as an advantage to educate parents about the risk of AEFI and also about the reporting pathways.
自 2021 年 12 月起，印度尼西亚政府建议为 6-11 岁儿童接种灭活的 SARS-CoV-2 疫苗（科兴疫苗）。本研究旨在确定 6-11 岁儿童接种第一剂和第二剂 COVID-19 疫苗后不良事件（AEFI）的流行率和决定因素。
我们于 2022 年 2 月至 3 月在印度尼西亚日惹特区班图尔区进行了一项横断面研究。通过培训访谈收集了 1093 名 6-11 岁儿童家长的数据，这些儿童接受了第一剂和第二剂 COVID-19 疫苗。采用卡方检验和逻辑回归进行数据分析。
第一剂 COVID-19 疫苗的 AEFI 发生率为 16.7%，第二剂为 22.6%。第一剂 AEFI 最常见的症状是局部疼痛和发热，第二剂是咳嗽和感冒。儿童 COVID-19 疫苗接种 AEFI 的决定因素是女孩，比值比（OR）为 1.31（95%置信区间（CI）为 1.0-1.7；0.04），集体接种疫苗，OR 为 0.70（95%CI 为 0.5-0.9；0.01），儿童期疫苗接种 AEFI 史，OR 为 1.63（95%CI 为 1.2-2.2；<0.01），在 COVID-19 疫苗接种前 1 个月内接种其他疫苗，OR 为 5.10（95%CI 为 2.1-12.3；<0.01）。
灭活 COVID-19 疫苗第一剂和第二剂的 AEFI 发生率与临床试验和社区报告的相似。应向儿童及其家长提供有关 COVID-19 疫苗轻度 AEFI 风险的风险沟通，特别是对于有儿童期疫苗接种 AEFI 史且在 1 个月内接种过含有科兴疫苗相同佐剂的其他疫苗的儿童。集体接种疫苗应作为优势，对家长进行 AEFI 风险教育，以及报告途径教育。
