Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
10.24171/j.phrp.2024.0081
- Author:
Mijeong KO
1
;
Seontae KIM
;
Seok-Kyoung CHOI
;
Seung Hwan SHIN
;
Yeon-Kyeng LEE
;
Yunhyung KWON
Author Information
1. Capital Regional Center for Disease Control and Prevention, Korea Disease Control and Prevention Agency, Seoul, Republic of Korea
- Publication Type:Original Article
- From:
Osong Public Health and Research Perspectives
2024;15(4):364-374
- CountryRepublic of Korea
- Language:English
-
Abstract:
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. Weaimed 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 incidencerates per 100,000 person-days were calculated for confirmed cases of myocarditis andpericarditis 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 issueswere identified. However, the reporting rates for AEs were low.
