Abstract：
UNASSIGNED: This study analyzed the safety of coronavirus disease 2019 (COVID-19) bivalent and monovalent booster vaccines, including the frequency of adverse events (AEs) such as myocarditis and pericarditis, in adolescents aged 12 to 17 years in the Republic of Korea. We aimed to share the safety profile of the COVID-19 bivalent vaccine booster doses.
UNASSIGNED: We analyzed the frequencies of AEs reported to the COVID-19 vaccination management system (CVMS) or self-reported through the text message survey (TMS). Diagnostic eligibility and causality with vaccines were compared using odds ratios (ORs) by vaccine type, and incidence rates per 100,000 person-days were calculated for confirmed cases of myocarditis and pericarditis following monovalent and bivalent booster doses.
UNASSIGNED: In the CVMS, the AE reporting rate (per 100,000 doses) was lower after the bivalent booster (66.5) than after the monovalent booster (264.6). Among the AEs reported for both monovalent and bivalent vaccines, 98.2% were non-serious and 1.8% were serious. According to the TMS, both local and systemic AEs were reported less frequently after the bivalent vaccination than after the monovalent vaccination in adolescents aged 12 to 17 years (p<0.001). The incidence rates per 100,000 person-days for confirmed myocarditis/pericarditis following monovalent and bivalent booster doses were 0.03 and 0.05, respectively; this difference was not statistically significant (OR, 1.797; 95% confidence interval, 0.210-15.386).
UNASSIGNED: AEs in 12- to 17-year-olds following the bivalent booster were less frequent than those following the monovalent booster in the Republic of Korea, and no major safety issues were identified. However, the reporting rates for AEs were low.
UNASSIGNED: We analyzed the frequencies of AEs reported to the COVID-19 vaccination management system (CVMS) or self-reported through the text message survey (TMS). Diagnostic eligibility and causality with vaccines were compared using odds ratios (ORs) by vaccine type, and incidence rates per 100,000 person-days were calculated for confirmed cases of myocarditis and pericarditis following monovalent and bivalent booster doses.
UNASSIGNED: In the CVMS, the AE reporting rate (per 100,000 doses) was lower after the bivalent booster (66.5) than after the monovalent booster (264.6). Among the AEs reported for both monovalent and bivalent vaccines, 98.2% were non-serious and 1.8% were serious. According to the TMS, both local and systemic AEs were reported less frequently after the bivalent vaccination than after the monovalent vaccination in adolescents aged 12 to 17 years (p<0.001). The incidence rates per 100,000 person-days for confirmed myocarditis/pericarditis following monovalent and bivalent booster doses were 0.03 and 0.05, respectively; this difference was not statistically significant (OR, 1.797; 95% confidence interval, 0.210-15.386).
UNASSIGNED: AEs in 12- to 17-year-olds following the bivalent booster were less frequent than those following the monovalent booster in the Republic of Korea, and no major safety issues were identified. However, the reporting rates for AEs were low.
摘要：
■这项研究分析了冠状病毒病2019（COVID-19）二价和单价加强疫苗的安全性，包括不良事件（AEs）的频率，如心肌炎和心包炎，在大韩民国12至17岁的青少年中。我们的目标是分享COVID-19二价疫苗加强剂量的安全性。
■我们分析了报告给COVID-19疫苗接种管理系统（CVMS）或通过短信调查（TMS）自我报告的AE的频率。根据疫苗类型，使用比值比(ORs)比较疫苗的诊断合格性和因果关系。对于单价和二价加强剂量后确诊的心肌炎和心包炎病例,计算每100,000人日的发病率.
■在CVMS中，二价加强剂(66.5)后的AE报告率(每100,000剂)低于单价加强剂(264.6).在单价和二价疫苗报告的AE中，98.2%为非严重，1.8%为严重。根据TMS,在12~17岁青少年中,二价疫苗接种后,局部和全身AE的报告频率低于单价疫苗接种后(p<0.001).单价和二价加强剂量后确诊的心肌炎/心包炎的发病率每100,000人天分别为0.03和0.05；这种差异没有统计学意义（OR，1.797；95%置信区间，0.210-15.386）。
■在大韩民国，使用二价助推器后的12至17岁青少年的AE频率低于使用单价助推器后的AE频率，没有发现重大安全问题。然而,AE的报告率较低.
■我们分析了报告给COVID-19疫苗接种管理系统（CVMS）或通过短信调查（TMS）自我报告的AE的频率。根据疫苗类型，使用比值比(ORs)比较疫苗的诊断合格性和因果关系。对于单价和二价加强剂量后确诊的心肌炎和心包炎病例,计算每100,000人日的发病率.
■在CVMS中，二价加强剂(66.5)后的AE报告率(每100,000剂)低于单价加强剂(264.6).在单价和二价疫苗报告的AE中，98.2%为非严重，1.8%为严重。根据TMS,在12~17岁青少年中,二价疫苗接种后,局部和全身AE的报告频率低于单价疫苗接种后(p<0.001).单价和二价加强剂量后确诊的心肌炎/心包炎的发病率每100,000人天分别为0.03和0.05；这种差异没有统计学意义（OR，1.797；95%置信区间，0.210-15.386）。
■在大韩民国，使用二价助推器后的12至17岁青少年的AE频率低于使用单价助推器后的AE频率，没有发现重大安全问题。然而,AE的报告率较低.
