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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]
  • 242 View
  • 16 Download
AbstractAbstract 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
  • 1,203 View
  • 64 Download
  • 1 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract 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

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  • Tozinameran

    Reactions Weekly.2024; 2029(1): 605.     CrossRef
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
  • 2,822 View
  • 148 Download
  • 1 Web of Science
Graphical AbstractGraphical Abstract AbstractAbstract 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 Reports
Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years
Seontae Kim, Yeseul Heo, Soon-Young Seo, Do Sang Lim, Enhi Cho, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2022;13(5):382-390.   Published online October 14, 2022
DOI: https://doi.org/10.24171/j.phrp.2022.0233
  • 3,187 View
  • 125 Download
  • 2 Web of Science
  • 4 Crossref
AbstractAbstract PDF
Objectives
This study aimed to identify potential safety signals and adverse events following the primary Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccination series among children and adolescents aged 5 to 17 years in the Republic of Korea. Methods: Adverse events reported through the COVID-19 vaccination management system (CVMS, a web-based passive vaccine safety surveillance system) and adverse events and health conditions collected from a text message-based survey were analyzed. Results: A total of 14,786 adverse events among 5 to 17-year-old children and adolescents were reported in the CVMS; 14,334 (96.9%) were non-serious and 452 (3.1%) were serious, including 125 suspected cases of acute cardiovascular injury and 101 suspected cases of anaphylaxis. The overall reporting rate was lower in 5 to 11-year-old children (64.5 per 100,000 doses) than in 12 to 17-year-old adolescents (300.5 per 100,000 doses). The text message survey identified that local and systemic adverse events after either dose were reported less frequently in 5 to 11-year-old children than in 12 to 17-year-old adolescents (p<0.001). The most commonly reported adverse events were pain at the injection site, myalgia, headache, and fatigue/tiredness. Conclusion: The overall results are consistent with the results of controlled trials; serious adverse events were extremely rare among 5 to 17-year-old children and adolescents following Pfizer-BioNTech COVID-19 vaccination. Adverse events were less frequent in children aged 5 to 11 years than in adolescents aged 12 to 17 years.

Citations

Citations to this article as recorded by  
  • The descriptive epidemiology of adverse events following two doses of mRNA COVID-19 vaccination in Curaçao, the Caribbean
    Jonathan Lambo, Sirving Keli, Shaheen Khan Kaplan, Temiloluwa Njideaka-Kevin, Sireesha Bala Arja, Alaa Khedir Omer Altahir, Itunu Olonade, Rohit Kumar
    Infectious Diseases.2024; : 1.     CrossRef
  • Myocarditis and Pericarditis are Temporally Associated with BNT162b2 COVID-19 Vaccine in Adolescents: A Systematic Review and Meta-analysis
    Yongyeon Choi, Jue Seong Lee, Young June Choe, Hyeran Lee, Yoonsun Yoon, Seung Hwan Shin, Myung-Jae Hwang, HyoSug Choi, Sara Na, Jong Hee Kim, Hyun Mi Kang, Bin Ahn, Kyoungsan Seo, Sangshin Park
    Pediatric Cardiology.2024;[Epub]     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
  • Effectiveness of the BNT162b2 vaccine in preventing morbidity and mortality associated with COVID-19 in children aged 5 to 11 years: A systematic review and meta-analysis
    Sumayyah Ebrahim, Ntombifuthi Blose, Natasha Gloeck, Ameer Hohlfeld, Yusentha Balakrishna, Rudzani Muloiwa, Andy Gray, Andy Parrish, Karen Cohen, Ruth Lancaster, Tamara Kredo, Julia Robinson
    PLOS Global Public Health.2023; 3(12): e0002676.     CrossRef
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
  • 5,230 View
  • 151 Download
  • 9 Web of Science
  • 10 Crossref
Graphical AbstractGraphical Abstract AbstractAbstract 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
  • 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

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