Osong Public Health and Research Perspectives

Review Article

Comparison and consideration of vaccine injury compensation programs in the Republic of Korea, Japan, and Taiwan: Cho Ryok Kang, Young June Choe, Jihyun Moon, Dooyoung Kim, Taemi Kim, Jong-Koo Lee; Osong Public Health Res Perspect. 2024;15(6):479-488. Published online November 12, 2024; DOI: https://doi.org/10.24171/j.phrp.2024.0129

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Graphical Abstract Abstract PDF: This study aimed to establish a foundation for future collaborations aimed at preparing for and responding to infectious diseases by examining the vaccine injury compensation programs (VICPs) of East Asian countries. We reviewed the current status of VICPs in the Republic of Korea, Japan, and Taiwan by searching national government websites and reviewing relevant literature. Additionally, we conducted email inquiries targeting experts from Japan and Taiwan. Through the comprehensive analysis of VICPs in these 3 countries covered various aspects, we identified several similarities and differences in the VICPs across these countries. While the governments of the Republic of Korea, Japan, and Taiwan play a central role in supporting investigations into vaccine injuries and managing compensation procedures based on legal statutes, they differ in terms of financial resources for compensation, the range of vaccines covered, and the criteria for assessing causality. In the Republic of Korea, Japan, and Taiwan, compensation is typically paid in a lump sum, although the specific benefits available vary by country. This study on VICPs in the Republic of Korea, Japan, and Taiwan provides valuable insights for the further development and management of domestic systems.

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; Osong Public Health Res Perspect. 2024;15(6):542-549. Published online October 29, 2024; DOI: https://doi.org/10.24171/j.phrp.2024.0194

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Graphical Abstract 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

Methodology of comparative studies on the relative effectiveness of COVID-19 vaccines: a systematic review: Erdenetuya Bolormaa, Jiae Shim, Young-Sook Choi, Donghyok Kwon, Young June Choe, Seung-Ah Choe; Osong Public Health Res Perspect. 2024;15(5):395-408. Published online October 15, 2024; DOI: https://doi.org/10.24171/j.phrp.2024.0063

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Graphical Abstract Abstract PDF: Objectives
This study aimed to comprehensively outline the methodological approaches used in published research comparing the vaccine effectiveness (VE) of coronavirus disease 2019 (COVID-19) vaccines.
Methods
A systematic search was conducted on June 13, 2024, to identify comparative studies evaluating the effectiveness of mRNA versus non-mRNA and monovalent versus bivalent COVID-19 vaccines. We screened titles, abstracts, and full texts, collecting data on publication year, country, sample size, study population composition, study design, VE estimates, outcomes, and covariates. Studies that reported relative VE (rVE) were analyzed separately from those that did not.
Results
We identified 25 articles comparing rVE between mRNA and non-mRNA COVID-19 vaccines, as well as between monovalent and bivalent formulations. Among the studies assessing VE by vaccine type, 126 did not provide rVE estimates. Comparative VE studies frequently employed retrospective cohort designs. Among the definitions of rVE used, the most common were hazard ratio and absolute VE, calculated as (1−odds ratio)×100. Studies were most frequently conducted in the United Kingdom and the United States, and the most common outcome was infection. Most targeted the general population and assessed the VE of mRNA vaccines using the AstraZeneca vaccine as a reference. A small proportion, 7.3% (n=11), did not adjust for any variables. Only 3 studies (2.0%) adjusted for all core confounding variables recommended by the World Health Organization.
Conclusion
Few comparative studies of COVID-19 vaccines have incorporated rVE methodologies. Reporting rVE and employing a consistent set of covariates can broaden our understanding of COVID-19 vaccines.

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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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.

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Tozinameran

Reactions Weekly.2024; 2029(1): 605. CrossRef

Special Article

The COVID-19 Vaccine Safety Research Center: a cornerstone for strengthening safety evidence for COVID-19 vaccination in the Republic of Korea: Na-Young Jeong, Hyesook Park, Sanghoon Oh, Seung Eun Jung, Dong-Hyun Kim, Hyoung-Shik Shin, Hee Chul Han, Jong-Koo Lee, Jun Hee Woo, Jaehun Jung, Joongyub Lee, Ju-Young Shin, Sun-Young Jung, Byung-Joo Park, Nam-Kyong Choi; Osong Public Health Res Perspect. 2024;15(2):97-106. Published online April 4, 2024; DOI: https://doi.org/10.24171/j.phrp.2023.0343

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Graphical Abstract Abstract PDF

The COVID-19 Vaccine Safety Research Committee (CoVaSC) was established in November 2021 to address the growing need for independent, in-depth scientific evidence on adverse events (AEs) following coronavirus disease 2019 (COVID-19) vaccination. This initiative was requested by the Korea Disease Control and Prevention Agency and led by the National Academy of Medicine of Korea. In September 2022, the COVID-19 Vaccine Safety Research Center was established, strengthening CoVaSC’s initiatives. The center has conducted various studies on the safety of COVID-19 vaccines. During CoVaSC’s second research year, from September 29, 2022 to July 19, 2023, the center was restructured into 4 departments: Epidemiological Research, Clinical Research, Communication & Education, and International Cooperation & Policy Research. Its main activities include (1) managing CoVaSC and the COVID-19 Vaccine Safety Research Center, (2) surveying domestic and international trends in AE causality investigation, (3) assessing AEs following COVID-19 vaccination, (4) fostering international collaboration and policy research, and (5) organizing regular fora and training sessions for the public and clinicians. Causality assessments have been conducted for 27 diseases, and independent research has been conducted after organizing ad hoc committees comprising both epidemiologists and clinical experts on each AE of interest. The research process included protocol development, data analysis, interpretation of results, and causality assessment. These research outcomes have been shared transparently with the public and healthcare experts through various fora. The COVID-19 Vaccine Safety Research Center plans to continue strengthening and expanding its research activities to provide reliable, high-quality safety information to the public.

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SARS-CoV-2-Vaccine-Related Endocrine Disorders: An Updated Narrative Review
Avraham Ishay, Kira Oleinikov, Elena Chertok Shacham
Vaccines.2024; 12(7): 750. CrossRef
Active Surveillance for Safety Monitoring of XBB.1.5-Containing COVID-19 mRNA Vaccines in Korea
Bomi Park, Hye Ah Lee, Yeonjae Kim, Chung Ho Kim, Hyunjin Park, Seunghee Jun, Hyelim Lee, Seunghyun Lewis Kwon, Yesul Heo, Hyungmin Lee, Hyesook Park
Journal of Korean Medical Science.2024;[Epub] CrossRef

Review Article

Psychiatric adverse events associated with the COVID-19 vaccines approved in the Republic of Korea: a systematic review: Seungeun Ryoo, Miyoung Choi, Nam-Kyong Choi, Hyoung-Shik Shin, Jun Hee Woo, Byung-Joo Park, Sanghoon Oh; Osong Public Health Res Perspect. 2024;15(2):107-114. Published online March 28, 2024; DOI: https://doi.org/10.24171/j.phrp.2023.0325

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Graphical Abstract Abstract PDF

This systematic review evaluated psychiatric adverse events (AEs) following vaccination against coronavirus disease 2019 (COVID-19). We included studies that reported or investigated psychiatric AEs in individuals who had received an approved COVID-19 vaccine in the Republic of Korea. Systematic electronic searches of Ovid-Medline, Embase, CENTRAL, and KoreaMed databases were conducted on March 22, 2023. Risk of bias was assessed using the Risk of Bias Assessment Tool for Non-randomized Studies 2.0. The study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023449422). Of the 301 articles initially selected, 7 were included in the final analysis. All studies reported on sleep disturbances, and 2 highlighted anxiety-related AEs. Sleep disorders like insomnia and narcolepsy were the most prevalent AEs, while depression was not reported. Our review suggests that these AEs may have been influenced by biological mechanisms as well as the broader psychosocial context of the COVID-19 pandemic. Although this study had limitations, such as a primary focus on the BNT162b2 vaccine and an observational study design, it offered a systematic, multi-vaccine analysis that fills a critical gap in the existing literature. This review underscores the need for continued surveillance of psychiatric AEs and guides future research to investigate underlying mechanisms, identify risk factors, and inform clinical management.

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A review of the scientific literature on experimental toxicity studies of COVID-19 vaccines, with special attention to publications in toxicology journals
Jose L. Domingo
Archives of Toxicology.2024; 98(11): 3603. CrossRef

Original Articles

COVID-19 infection among people with disabilities in 2021 prior to the Omicron-dominant period in the Republic of Korea: a cross-sectional study: Seul-Ki Kang, Bryan Inho Kim; Osong Public Health Res Perspect. 2024;15(2):150-158. Published online March 28, 2024; DOI: https://doi.org/10.24171/j.phrp.2023.0194

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Graphical Abstract Abstract PDF: Objectives
This study investigated the characteristics of coronavirus disease 2019 (COVID-19) among individuals with disabilities on a nationwide scale in the Republic of Korea, as limited research has examined this population. Methods: Between January 1 and November 30, 2021, a total of 5,687 confirmed COVID-19 cases among individuals with disabilities were reported through the Korea Disease Control and Prevention Agency’s COVID-19 web reporting system. Follow-up continued until December 24, and demographic, epidemiological, and clinical characteristics were analyzed. Results: Individuals with disabilities represented approximately 1.5% of confirmed cases, with a mean age of 58.1 years. Most resided in or near metropolitan areas (86.6%) and were male (60.6%). Frequent sources of infection included home (33.4%) and contact with confirmed cases (40.7%). Many individuals (75.9%) had underlying conditions, and 7.7% of cases were severe. People with disabilities showed significantly elevated risk of severe infection (adjusted odds ratio [aOR], 1.63; 95% confidence interval [CI], 1.47–1.81) and mortality (aOR, 1.65; 95% CI, 1.43–1.91). Vaccination against COVID-19 was associated with significantly lower risk of severe infection (aORs for the first, second, and third doses: 0.60 [95% CI, 0.42–0.85], 0.28 [95% CI, 0.22–0.35], and 0.16 [95% CI, 0.05–0.51], respectively) and death (adjusted hazard ratios for the first and second doses: 0.57 [95% CI, 0.35–0.93] and 0.30 [95% CI, 0.23–0.40], respectively). Conclusion: Individuals with disabilities showed higher risk of severe infection and mortality from COVID-19. Consequently, it is critical to strengthen COVID-19 vaccination initiatives and provide socioeconomic assistance for this vulnerable population.

Evaluation of COVID-19 vaccine effectiveness in different high-risk facility types during a period of Delta variant dominance in the Republic of Korea: a cross-sectional study: Min Jei Lee, Myung-Jae Hwang, Dong Seob Kim, Seon Kyeong Park, Jihyun Choi, Ji Joo Lee, Jong Mu Kim, Young-Man Kim, Young-Joon Park, Jin Gwack, Sang-Eun Lee; Osong Public Health Res Perspect. 2023;14(5):418-426. Published online October 19, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0188

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Graphical Abstract Abstract PDF: Objectives
We evaluated the effectiveness of coronavirus disease 2019 vaccination in high-risk facilities in the Republic of Korea during the period when the highly transmissible Delta variant was prevalent. Additionally, we aimed to explore any disparities in vaccine effectiveness (VE) across various types of institutions, specifically distinguishing between non-medical and medical establishments. Methods: We examined 8 outbreak clusters covering 243 cases and 895 contacts from 8 high-risk facilities divided into 2 groups: group A (4 non-medical institutions) and group B (4 medical institutions). These clusters were observed from July 27, 2021 to October 16, 2021 for the attack rate (AR) and VE with respect to disease severity. A generalized linear model with a binomial distribution was used to determine the odds ratio (OR) for disease severity and death. Results: AR was notably lower in group B (medical institutions). Furthermore, VE analysis revealed that group A exhibited higher effectivity for disease severity and death than group B. The OR for disease severity was 0.24 (95% confidence interval [CI], 0.03–2.16) for group A and 0.27 (95% CI, 0.12–0.64) for group B, with the OR for death at 0.12 (95% CI, 0.01–1.32) in group A and 0.34 (95% CI, 0.14–0.87) in group B. Conclusion: Although VE may vary across institutions, our findings underscore the importance of implementing vaccinations in high-risk facilities. Customized vaccination programs, tailored response plans, and competent management personnel are essential for effectively addressing and mitigating public health challenges.

Brief Report

JYNNEOS vaccine safety monitoring in the Republic of Korea, 2022: a cross-sectional study: Jaeeun Lee, Seunghyun Lewis Kwon, Jinhee Park, Hyuna Bae, Hyerim Lee, Geun-Yong Kwon; Osong Public Health Res Perspect. 2023;14(5):433-438. Published online October 18, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0182

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Graphical Abstract Abstract PDF

Objectives
With the recent global mpox outbreak, the JYNNEOS vaccine (Modified Vaccinia Ankara-Bavarian Nordic) was developed as a third-generation smallpox vaccine and initially favored for mpox immunization. Vaccine-associated side effects contribute to vaccine hesitancy. Consequently, tracking adverse events post-immunization is crucial for safety management. This study used data from the national active vaccine safety surveillance conducted in Korea from August 25 to November 24, 2022 to detect potential safety signals and adverse events. Methods: Data on health conditions following vaccination were gathered from web-based surveys and reported via active surveillance through the Immunization Registry Information System. This follow-up system functioned via a text message link, surveying adverse events and health conditions beginning on the second day post-vaccination. Information about specific adverse events, including both local and systemic reactions, was collected. Results: The study included 86 healthcare workers who had received at least 1 dose of the JYNNEOS vaccine. Among the respondents, 79.1% reported experiencing at least 1 adverse event, with the majority being local reactions at the injection site. The incidence of adverse events was higher following the first dose (67.9%) than after the second dose (34.4%). The most frequently reported adverse event for both doses was mild pain at the injection site. Conclusion: The study provides crucial information on the safety of the JYNNEOS vaccine, demonstrating that most adverse events were manageable and predominantly localized to the injection site. Nonetheless, additional research is needed on the safety of various vaccine administration techniques and the vaccine’s effects on broader demographics.

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Adverse Reactions After Intradermal Vaccination With JYNNEOS for Mpox in Korea
So Yun Lim, Yu Mi Jung, Yeonjae Kim, Gayeon Kim, Jaehyun Jeon, BumSik Chin, Min-Kyung Kim
Journal of Korean Medical Science.2024;[Epub] CrossRef
First Nationwide Mpox Vaccination Program in the Republic of Korea: Implications for an Enhanced Public Health Response
Seunghyun Lewis Kwon, Minju Song, Wonkyung Lee, Jeeyeon Shin, Su-Yeon Lee, Sang-Gu Yeo, Minjeong Kim, Sanggyun Jeong, Joonku Park, Dongwoo Lee, Sookyoung Lim
Journal of Korean Medical Science.2024;[Epub] CrossRef
Global perspectives on smallpox vaccine against monkeypox: a comprehensive meta-analysis and systematic review of effectiveness, protection, safety and cross-immunogenicity
Hao Liu, Wenjing Wang, Yang Zhang, Fuchun Wang, Junyi Duan, Tao Huang, Xiaojie Huang, Tong Zhang
Emerging Microbes & Infections.2024;[Epub] CrossRef

Original Article

Prevalence and patterns of adverse events following childhood immunization and the responses of mothers in Ile-Ife, South West Nigeria: a facility-based cross-sectional survey: Olorunfemi Akinbode Ogundele, Funmito Omolola Fehintola, Mubarak Salami, Rahmat Usidebhofoh, Mary Aderemi Abaekere; Osong Public Health Res Perspect. 2023;14(4):291-299. Published online July 27, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0071

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Graphical Abstract Abstract PDF

Objectives
This study aimed to examine the prevalence and pattern of adverse events following childhood immunization and the responses of mothers in Ile-Ife, South West Nigeria.
Methods
This descriptive cross-sectional study was conducted among 422 mothers of children aged 0 to 24 months attending any of the 3 leading immunization clinics in Ile-Ife, Nigeria. The respondents were selected using the multi-stage sampling technique. Data were collected using a pretested structured interviewer-administered questionnaire and analyzed using IBM SPSS ver. 26.0. The chi-square test was used to test associations, while binary logistic regression was used to determine the predictors of mothers’ responses to adverse events following immunization (AEFIs). A p-value of <0.05 was considered statistically significant.
Results
The mean age of the respondents was 29.99±5.74 years. About 38% of the children had experienced an AEFI. Most mothers believed that the pentavalent vaccine was the most common cause of AEFIs (67.5%). Fever (88.0%) and pain and swelling (76.0%) were the most common AEFIs. More than half of the mothers (53.7%) administered home treatment following an AEFI. Younger mothers (odds ratio [OR], 2.43; 95% confidence interval [CI], 1.20–5.01), mothers who delivered their children at a healthcare facility (OR, 3.24; 95% CI, 1.08–9.69), and mothers who were knowledgeable about reporting AEFIs (OR, 2.53; 95% CI, 1.04–7.70) were most likely to respond appropriately to AEFIs.
Conclusion
The proportion of mothers who responded poorly to AEFIs experienced by their children was significant. Therefore, strategies should be implemented to improve mothers’ knowledge about AEFIs to improve their responses.

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Advancing Immunization in Africa: Overcoming Challenges to Achieve the 2030 Global Immunization Targets
Olalekan Okesanya, Gbolahan Olatunji, Noah Olaleke, Mba Mercy, Ayodele Ilesanmi, Hassan Kayode, Emery Manirambona, Mohamed Ahmed, Bonaventure Ukoaka, Don Lucero-Prisno III
Adolescent Health, Medicine and Therapeutics.2024; Volume 15: 83. CrossRef

Brief Report

Temporal association between the age-specific incidence of Guillain-Barré syndrome and SARS-CoV-2 vaccination in Republic of Korea: a nationwide time-series correlation study: Hyunju Lee, Donghyok Kwon, Seoncheol Park, Seung Ri Park, Darda Chung, Jongmok Ha; Osong Public Health Res Perspect. 2023;14(3):224-231. Published online June 22, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0050

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Objectives
The incidence of Guillain-Barré syndrome (GBS) changed significantly during the coronavirus disease 2019 (COVID-19) pandemic. Emerging reports suggest that viral vector-based vaccines may be associated with an elevated risk of GBS.
Methods
In this nationwide time-series correlation study, we examined the age-specific incidence of GBS from January 2011 to August 2022, as well as data on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations and infections from February 2021 to August 2022. We compared the forecasted estimates of age-specific GBS incidence, using the pre-SARS-CoV-2 period as a benchmark, with the actual incidence observed during the post-vaccination period of the pandemic. Furthermore, we assessed the temporal association between GBS, SARS-CoV-2 vaccinations, and COVID-19 for different age groups.
Results
In the age group of 60 and older, the rate ratio was significantly elevated during June-August and November 2021. A significant, strong positive association was observed between viral vector-based vaccines and GBS incidence trends in this age group (r=0.52, p=0.022). For the 30 to 59 years age group, the rate ratio was notably high in September 2021. A statistically significant, strong positive association was found between mRNA-based vaccines and GBS incidence in this age group (r=0.61, p=0.006).
Conclusion
Viral vector-based SARS-CoV-2 vaccines were found to be temporally associated with an increased risk of GBS, particularly in older adults. To minimize age-specific and biological mechanism-specific adverse events, future vaccination campaigns should adopt a more personalized approach, such as recommending homologous mRNA-based SARS-CoV-2 vaccines for older adults to reduce the heightened risk of GBS.

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mRNA-LNP COVID-19 Vaccine Lipids Induce Complement Activation and Production of Proinflammatory Cytokines: Mechanisms, Effects of Complement Inhibitors, and Relevance to Adverse Reactions
Tamás Bakos, Tamás Mészáros, Gergely Tibor Kozma, Petra Berényi, Réka Facskó, Henriette Farkas, László Dézsi, Carlo Heirman, Stefaan de Koker, Raymond Schiffelers, Kathryn Anne Glatter, Tamás Radovits, Gábor Szénási, János Szebeni
International Journal of Molecular Sciences.2024; 25(7): 3595. CrossRef
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Biki Kumar Sah, Zahra Fatima, Rajan Kumar Sah, Bushra Syed, Tulika Garg, Selia Chowdhury, Bikona Ghosh, Binita Kunwar, Anagha Shree, Vivek Kumar Sah, Anisha Raut
Annals of Medicine & Surgery.2024;[Epub] CrossRef
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Soo Hyeon Cho, Dong Kyu Kim, Min Cheol Song, Euiho Lee, Seoncheol Park, Darda Chung, Jongmok Ha, Sonu Bhaskar
PLOS ONE.2024; 19(10): e0301313. CrossRef
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Josef Finsterer
Neurology India.2024; 72(5): 1100. CrossRef

Original Article

The incidence and clinical characteristics of myocarditis and pericarditis following mRNA-based COVID-19 vaccination in Republic of Korea adolescents from July 2021 to September 2022: Ju-Young Sim, Seung-Yun Kim, Eun-Kyoung Kim; Osong Public Health Res Perspect. 2023;14(2):76-88. Published online April 18, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0032

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Objectives
Age-specific information regarding myocarditis/pericarditis in adolescents following mRNA-based coronavirus disease 2019 (COVID-19) vaccination in Asia remains insufficient. This study investigated the incidence and clinical characteristics of myocarditis/pericarditis in Republic of Korea adolescents after mRNA-based COVID-19 vaccination.
Methods
This retrospective descriptive study utilized patient data from the Korea Immunization Management System. Incidence rates were calculated according to age and sex. Clinical characteristics (symptoms/signs, laboratory values, and imaging results) were compared between mild and severe cases.
Results
Between July 19, 2021 and September 30, 2022, 3,728,224 individuals aged 12 to 19 years received 6,484,165 mRNA-based COVID-19 vaccines, and 173 cases met the case definition for myocarditis/pericarditis: 151 mild (87.3%) and 22 severe (12.7%). The incidence was 3.8-fold higher in males than in females. Troponin I/ troponin T was elevated in 96% of myocarditis cases, demonstrating higher sensitivity than creatine kinase-myocardial band (67.6%) or C-reactive protein (75.2%). ST-segment or Twave on electrography abnormalities were found in 60.3% (85/141). Paroxysmal/sustained atrial/ventricular arrhythmias were more common in severe than in mild cases (45.5% vs. 16.8%, p=0.008). Edema on T2-weighted magnetic imaging occurred in 21.6% (8/37) and 62.5% (5/8) of mild and severe cases, respectively (p=0.03). Abnormal pericardial fluid collection or pericardial inflammation was found in 75.4% of pericarditis cases (49/65).
Conclusion
Myocarditis/pericarditis occurred in rare cases following mRNA-based COVID-19 vaccination. Most cases were mild, but the incidence was higher in adolescent males and after the second dose. As bivalent severe acute respiratory syndrome coronavirus 2 mRNA vaccination started in Republic of Korea in October 2022, the post-vaccination incidence of myocarditis/pericarditis should be closely monitored, considering clinical characteristics.

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Responses to Common Misconceptions Relating to COVID-19 Variant-Adapted mRNA Vaccines
George Kassianos, Pauline MacDonald, Ivan Aloysius, Shanti Pather
Vaccines.2024; 12(1): 57. 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
Epidemiological Characteristics and Outcome of Myocarditis and Pericarditis Temporally Associated With BNT162b2 COVID-19 Vaccine in Adolescents: Korean National Surveillance
Bin Ahn, Seung Hwan Shin, Myung-Jae Hwang, HyoSug Choi, Sara Na, Sangshin Park, Jue Seong Lee, Young June Choe, Yoonsun Yoon, Kyoungsan Seo, Jong Hee Kim, Hyun Mi Kang
Journal of Korean Medical Science.2024;[Epub] CrossRef
To become a more stronger and safer country
Jong-Koo Lee
Osong Public Health and Research Perspectives.2023; 14(2): 67. CrossRef

Special Article

A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee: Na-Young Jeong, Hyesook Park, Sanghoon Oh, Seung Eun Jung, Dong-Hyun Kim, Hyoung-Shik Shin, Hee Chul Han, Jong-Koo Lee, Jun Hee Woo, Byung-Joo Park, Nam-Kyong Choi; Osong Public Health Res Perspect. 2023;14(1):5-14. Published online February 28, 2023; DOI: https://doi.org/10.24171/j.phrp.2023.0026

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Graphical Abstract Abstract PDF

With the introduction of coronavirus disease 2019 (COVID-19) vaccines, the Korea Disease Control and Prevention Agency (KDCA) commissioned the National Academy of Medicine of Korea to gather experts to independently assess post-vaccination adverse events. Accordingly, the COVID-19 Vaccine Safety Research Committee (CoVaSC) was launched in November 2021 to perform safety studies and establish evidence for policy guidance. The CoVaSC established 3 committees for epidemiology, clinical research, and communication. The CoVaSC mainly utilizes pseudonymized data linking KDCA’s COVID-19 vaccination data and the National Health Insurance Service’s claims data. The CoVaSC’s 5-step research process involves defining the target diseases and organizing ad-hoc committees, developing research protocols, performing analyses, assessing causal relationships, and announcing research findings and utilizing them to guide compensation policies. As of 2022, the CoVaSC completed this research process for 15 adverse events. The CoVaSC launched the COVID-19 Vaccine Safety Research Center in September 2022 and has been reorganized into 4 divisions to promote research including international collaborative studies, long-/short-term follow-up studies, and education programs. Through these enhancements, the CoVaSC will continue to swiftly provide scientific evidence for COVID-19 vaccine research and compensation and may serve as a model for preparing for future epidemics of new diseases.

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Risk of Kawasaki Disease/Multisystem Inflammatory Syndrome Following COVID-19 Vaccination in Korean Children: A Self-Controlled Case Series Study
Suyeon Kim, Hwa Yeon Ko, Jeongin Oh, Dongwon Yoon, Ju Hwan Kim, Young June Choe, Ju-Young Shin
Journal of Korean Medical Science.2025;[Epub] CrossRef
The association between acute transverse myelitis and COVID‐19 vaccination in Korea: Self‐controlled case series study
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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

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Abstract 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
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
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
Osong Public Health and Research Perspectives.2024; 15(6): 542. 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

Presumed population immunity to SARS-CoV-2 in South Korea, April 2022: Eun Jung Jang, Young June Choe, Seung Ah Choe, Yoo-Yeon Kim, Ryu Kyung Kim, Jia Kim, Do Sang Lim, Ju Hee Lee, Seonju Yi, Sangwon Lee, Young-Joon Park; Osong Public Health Res Perspect. 2022;13(5):377-381. Published online October 14, 2022; DOI: https://doi.org/10.24171/j.phrp.2022.0209

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79 Download
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4 Crossref

Graphical Abstract Abstract PDF

Objectives
We estimated the overall and age-specific percentages of the Korean population with presumed immunity against severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) as of April 2022 using the national registry.
Methods
We used the national coronavirus disease 2019 (COVID-19) infection and vaccination registry from South Korea, as described to define individuals with a previous history of COVID-19 infection, vaccination, or both, as persons with presumed immunity.
Results
Of a total of 53,304,627 observed persons, 24.4% had vaccination and infection, 58.1% had vaccination and no infection, 7.6% had infection and no vaccination, and 9.9% had no immunity. The SARS-CoV-2 Omicron variant emerged at a time when the presumed population immunity ranged from 80% to 85%; however, nearly half of the children were presumed to have no immunity.
Conclusion
We report a gap in population immunity, with lower presumed protection in children than in adults. The approach presented in this work can provide valuable informed tools to assist vaccine policy-making at a national level.

Citations

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Realistic Estimation of COVID-19 Infection by Seroprevalence Surveillance of SARS-CoV-2 Antibodies: An Experience From Korea Metropolitan Area From January to May 2022
In Hwa Jeong, Jong-Hun Kim, Min-Jung Kwon, Jayoung Kim, Hee Jin Huh, Byoungguk Kim, Junewoo Lee, Jeong-hyun Nam, Eun-Suk Kang
Journal of Korean Medical Science.2024;[Epub] CrossRef
Epidemiology of Coronavirus Disease 2019 in Infants and Toddlers, Seoul, South Korea
JiWoo Sim, Euncheol Son, Young June Choe
Pediatric Infection & Vaccine.2024; 31(1): 94. CrossRef
Predicting adherence to COVID-19 preventive measures among South Korean adults aged 40 to 69 Years using the expanded health empowerment model
Su-Jung Nam, Tae-Young Pak
SSM - Population Health.2023; 22: 101411. CrossRef
Acute COVID-19 in unvaccinated children without a history of previous infection during the delta and omicron periods
Jee Min Kim, Ji Yoon Han, Seung Beom Han
Postgraduate Medicine.2023; 135(7): 727. CrossRef

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