Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea

Objectives 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 p...

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Main Authors: Mijeong Ko, Seontae Kim, Seok-Kyoung Choi, Seung Hwan Shin, Yeon-Kyeng Lee, Yunhyung Kwon
Format: Article
Language:English
Published: Korea Disease Control and Prevention Agency 2024-08-01
Series:Osong Public Health and Research Perspectives
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Online Access:http://ophrp.org/upload/pdf/j-phrp-2024-0081.pdf
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author Mijeong Ko
Seontae Kim
Seok-Kyoung Choi
Seung Hwan Shin
Yeon-Kyeng Lee
Yunhyung Kwon
author_facet Mijeong Ko
Seontae Kim
Seok-Kyoung Choi
Seung Hwan Shin
Yeon-Kyeng Lee
Yunhyung Kwon
author_sort Mijeong Ko
collection DOAJ
description Objectives 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. Methods 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. Results 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, 98.3% were non-serious and 1.7% 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). Conclusion 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.
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spelling doaj-art-f98e1ed135ed4f25b14f1ff2d6802b272025-08-20T02:14:44ZengKorea Disease Control and Prevention AgencyOsong Public Health and Research Perspectives2233-60522024-08-0115436437410.24171/j.phrp.2024.0081782Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of KoreaMijeong Ko0Seontae Kim1Seok-Kyoung Choi2Seung Hwan Shin3Yeon-Kyeng Lee4Yunhyung Kwon5 Capital Regional Center for Disease Control and Prevention, Korea Disease Control and Prevention Agency, Seoul, Republic of Korea Bureau of Public Health Emergency Preparedness, Korea Disease Control and Prevention Agency, Cheongju, Republic of Korea Honam Regional Center for Disease Control and Prevention, Korea Disease Control and Prevention Agency, Gwangju, Republic of Korea Compensation and Support Center for COVID-19 Vaccine Injury, Korea Disease Control and Prevention Agency, Cheongju, Republic of Korea Korea Disease Control and Prevention Agency, Cheongju, Republic of Korea Bureau of Public Health Emergency Preparedness, Korea Disease Control and Prevention Agency, Cheongju, Republic of KoreaObjectives 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. Methods 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. Results 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, 98.3% were non-serious and 1.7% 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). Conclusion 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.http://ophrp.org/upload/pdf/j-phrp-2024-0081.pdfadolescentcovid-19mrna vaccinessafety
spellingShingle Mijeong Ko
Seontae Kim
Seok-Kyoung Choi
Seung Hwan Shin
Yeon-Kyeng Lee
Yunhyung Kwon
Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
Osong Public Health and Research Perspectives
adolescent
covid-19
mrna vaccines
safety
title Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
title_full Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
title_fullStr Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
title_full_unstemmed Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
title_short Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
title_sort comparative safety of monovalent and bivalent mrna covid 19 booster vaccines in adolescents aged 12 to 17 years in the republic of korea
topic adolescent
covid-19
mrna vaccines
safety
url http://ophrp.org/upload/pdf/j-phrp-2024-0081.pdf
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