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Brief Report
- Safety of the bivalent COVID-19 mRNA booster vaccination among persons aged over 18 years in the Republic of Korea
- Seok-Kyoung Choi, Seontae Kim, Mijeong Ko, Yeseul Heo, Tae Eun Kim, Yeonkyeong Lee, Juyeon Jang, Eunok Bahng
- Received July 8, 2024 Accepted September 5, 2024 Published online October 29, 2024
- DOI: https://doi.org/10.24171/j.phrp.2024.0194 [Epub ahead of print]
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Abstract
PDF - Objectives
The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea. Methods: Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, Pfizer BA.4/5, Moderna BA.1, and Moderna BA.4/5 vaccines for adults aged 18 years and older. Adverse events (AEs) were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a self-reported text-message survey. Results: Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious AEs from vaccinated adults, along with 158 (6.3%) serious AEs, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic AEs compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported AEs were pain at the injection site, headache, fatigue, and myalgia. Conclusion: Overall, bivalent vaccines exhibited fewer AEs compared to the original vaccines. The majority of AEs were non-serious, and serious AEs were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.
Original Articles
- Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
- Mijeong Ko, Seontae Kim, Seok-Kyoung Choi, Seung Hwan Shin, Yeon-Kyeng Lee, Yunhyung Kwon
- Osong Public Health Res Perspect. 2024;15(4):364-374. Published online July 9, 2024
- DOI: https://doi.org/10.24171/j.phrp.2024.0081
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- 1 Crossref
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Graphical Abstract
Abstract
PDF 
- 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. -
Citations
Citations to this article as recorded by
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Reactions Weekly.2024; 2029(1): 605. CrossRef
- Tozinameran
- Household secondary attack rates and risk factors during periods of SARS-CoV-2 Delta and Omicron variant predominance in the Republic of Korea
- Jin Lee, Mijeong Ko, Seontae Kim, Dosang Lim, Gemma Park, Sang-Eun Lee
- Osong Public Health Res Perspect. 2023;14(4):263-271. Published online August 11, 2023
- DOI: https://doi.org/10.24171/j.phrp.2023.0133
- 2,875 View
- 148 Download
- 1 Web of Science
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Graphical Abstract
Abstract
PDF
- Objectives
The household secondary attack rate (SAR) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important indicator for community transmission. This study aimed to characterize transmission by comparing household SARs and identifying risk factors during the periods of Delta and Omicron variant predominance in Republic of Korea.
Methods
We defined the period of Delta variant predominance (Delta period) as July 25, 2021 to January 15, 2022, and the period of Omicron variant predominance (Omicron period) as February 7 to September 3, 2022. The number of index cases included was 214,229 for the Delta period and 5,521,393 for the Omicron period. To identify the household SARs and risk factors for each period, logistic regression was performed to determine the adjusted odds ratio (aOR).
Results
The SAR was 35.2% for the Delta period and 43.1% for the Omicron period. The aOR of infection was higher in 2 groups, those aged 0 to 18 years and ≥75 years, compared to those aged 19 to 49 years. Unvaccinated individuals (vs. vaccinated individuals) and individuals experiencing initial infection (vs. individuals experiencing a second or third infection) had an increased risk of infection with SARS-CoV-2.
Conclusion
This study analyzed the household SARs and risk factors. We hope that the results can help develop age-specific immunization plans and responses to reduce the SAR in preparation for emerging infectious diseases or potential new variants of SARS-CoV-2.
Brief Report
- Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea
- Seontae Kim, Insob Hwang, Mijeong Ko, Yunhyung Kwon, Yeon-Kyeng Lee
- Osong Public Health Res Perspect. 2022;13(3):230-237. Published online June 10, 2022
- DOI: https://doi.org/10.24171/j.phrp.2022.0122
- 5,282 View
- 151 Download
- 9 Web of Science
- 11 Crossref
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Graphical Abstract
Abstract
PDF
- Objectives
This study aimed to disseminate information on coronavirus disease 2019 (COVID-19) vaccine safety among adolescents aged 12 to 17 years in the Republic of Korea. Methods: Two databases were used to assess COVID-19 vaccine safety in adolescents aged 12 to 17 years who completed the primary Pfizer-BioNTech vaccination series. Adverse events reported to the web-based COVID-19 vaccination management system (CVMS) and collected in the text message-based system were analyzed. Results: From March 5, 2021 to February 13, 2022, 12,216 adverse events among 12- to 17-yearolds were reported to the CVMS, of which 97.1% were non-serious adverse events and 2.9% were serious adverse events, including 85 suspected cases of anaphylaxis, 74 suspected cases of myocarditis and/or pericarditis, and 2 deaths. From December 13, 2021 to January 26, 2022, 10,389 adolescents responded to a text message survey, and local/systemic adverse events were more common after dose 2 than after dose 1. The most commonly reported events following either vaccine dose were pain at the injection site, headache, fatigue/tiredness, and myalgia. Conclusion: The overall results are consistent with previous findings; the great majority of adverse events were non-serious, and serious adverse events were rare among adolescents aged 12 to 17 years following Pfizer-BioNTech COVID-19 vaccination. -
Citations
Citations to this article as recorded by- Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents
Mi Jin Kim, Jin Hee Kim, Hyun Ok Jun, Kyung Min Kim, Min Sub Jeung, Jun Sung Park
Journal of Pediatric Infectious Diseases.2024; 19(02): 075. CrossRef - Characterization of Brighton Collaboration criteria for myocarditis and pericarditis following COVID-19 vaccine in Korean adolescents
Jue Seong Lee, HyoSug Choi, Seung Hwan Shin, Myung-Jae Hwang, Sara Na, Jong Hee Kim, Sangshin Park, Yoonsun Yoon, Hyun Mi Kang, Bin Ahn, Kyoungsan Seo, Young June Choe
Vaccine.2024; 42(14): 3333. CrossRef - Myopericarditis following COVID-19 vaccination in children: a systematic review and meta-analysis
Ashiley Annushri Thenpandiyan, Ryan Ruiyang Ling, Robert Grignani, Megan Ruien Ling, Arthena Anushka Thenpandiyan, Bee Choo Tai, Jyoti Somani, Kollengode Ramanathan, Swee Chye Quek
Singapore Medical Journal.2024;[Epub] CrossRef - Comparative safety of monovalent and bivalent mRNA COVID-19 booster vaccines in adolescents aged 12 to 17 years in the Republic of Korea
Mijeong Ko, Seontae Kim, Seok-Kyoung Choi, Seung Hwan Shin, Yeon-Kyeng Lee, Yunhyung Kwon
Osong Public Health and Research Perspectives.2024; 15(4): 364. CrossRef - Association of new onset seizure and COVID‐19 vaccines and long‐term follow‐up: A systematic review and meta‐analysis
Ali Rafati, Melika Jameie, Mobina Amanollahi, Yeganeh Pasebani, Nastaran Salimi, Mohammad Hosein Feyz Kazemi, Mana Jameie, Mohammad Yazdan Pasebani, Delaram Sakhaei, Fateme Feizollahi, Churl‐Su Kwon
Epilepsia.2024; 65(10): 3010. CrossRef - mRNA COVID-19 vaccine safety among children and adolescents: a Canadian National Vaccine Safety Network cohort study
Phyumar Soe, Otto G. Vanderkooi, Manish Sadarangani, Monika Naus, Matthew P. Muller, James D. Kellner, Karina A. Top, Hubert Wong, Jennifer E. Isenor, Kimberly Marty, Hennady P. Shulha, Gaston De Serres, Louis Valiquette, Allison McGeer, Julie A. Bettinge
The Lancet Regional Health - Americas.2024; 40: 100949. CrossRef - Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2–18 years: an updated systematic review and meta-analysis
Peng Gao, Liang-Yu Kang, Jue Liu, Min Liu
World Journal of Pediatrics.2023; 19(11): 1041. CrossRef - Incidence of myopericarditis after mRNA COVID-19 vaccination: A meta-analysis with focus on adolescents aged 12–17 years
Bao-Qiang Guo, Hong-Bin Li, Li-Qiang Yang
Vaccine.2023; 41(28): 4067. CrossRef - Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea
Yeon-Kyeng Lee, Yunhyung Kwon, Yesul Heo, Eun Kyoung Kim, Seung Yun Kim, Hoon Cho, Seontae Kim, Mijeong Ko, Dosang Lim, Soon-Young Seo, Enhi Cho
Clinical and Experimental Pediatrics.2023; 66(10): 415. CrossRef - Risk of Coronavirus Disease 2019 Messenger RNA Vaccination-Associated Myocarditis and Pericarditis – A Systematic Review of Population-Based Data
Yen-Ching Lin, Chia-Hsuin Chang, Wei-Ju Su, Chin-Hui Yang, Jann-Tay Wang
Risk Management and Healthcare Policy.2023; Volume 16: 2085. CrossRef - COVID-19 Vaccination in Korea: Past, Present, and the Way Forward
Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim
Journal of Korean Medical Science.2022;[Epub] CrossRef
- Suspected Myocarditis after mRNA COVID-19 Vaccination among South Korean Adolescents
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