1.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):364-374
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.
2.Analysis of Judicial Precedents on Drug Eruption in South Korea
Yoon Jin CHOI ; Kyeng Wook KIM ; Ji Yeon BYUN ; You Won CHOI ; Joo Young ROH ; Hae Young CHOI
Korean Journal of Dermatology 2023;61(3):162-169
Background:
Both medicolegal disputes and the incidence of cutaneous drug eruptions are increasing in Korea. We were unable to find research that surveyed the legal disputes involving drug eruption cases.
Objective:
This study investigates medical litigation associated with drug eruption cases in Korea.
Methods:
Judicial precedents on drug eruption cases were searched using the Supreme Court of South Korea’s Written Judgement Management System. General characteristics, results, suspected agents, and recognized negligence were analyzed.
Results:
From the search results, 50 cases were selected. Of these, 34 cases had severe cutaneous adverse reactions, including Stevens-Johnson syndrome/toxic epidermal necrolysis (n=25, 50.0%), and drug rash with eosinophilia and systemic symptoms syndrome (n=9, 18.0%). Antimicrobial agents (n=17, 34.0%), non-steroidal anti-inflammatory drugs (n=6, 12.0%), and anticonvulsants (n=6, 12.0%) were the most common drugs implicated. Death was reported in 15 patients (30.0%). In this sample, 22 cases (47.0%) were awarded to the plaintiff, and violation of the duty to inform patients of risks was the most common legal issue cited.
Conclusion
Clinicians should be aware of and advise patients of the potential for severe adverse reactions that can lead to negative outcomes and medicolegal disputes.
3.Self-reported adverse events after 2 doses of COVID-19 vaccine in Korea
Yunhyung KWON ; Insob HWANG ; Mijeong KO ; Hyungjun KIM ; Seontae KIM ; Soon-Young SEO ; Enhi CHO ; Yeon-Kyeng LEE
Epidemiology and Health 2023;45(1):e2023006-
OBJECTIVES:
In Korea, a national coronavirus disease 2019 (COVID-19) vaccination program was implemented, including 4 vaccines against COVID-19. A text messaging-based survey, in addition to a passive adverse event reporting system, was launched to quickly report unusual symptoms post-vaccination. This study compared the frequency of adverse events after COVID-19 vaccination based on the vaccine type and the type of 2-dose regimen (homologous or heterologous).
METHODS:
Self-reported adverse events were collected through a text-message survey for 7 days after each vaccination. This study included 50,950 vaccine recipients who responded to the survey at least once. Informed consent to receive surveys via text was obtained from the vaccine recipients on the date of first vaccination.
RESULTS:
The recipients of mRNA vaccines reported local and systemic reactions 1.6 times to 2.8 times more frequently after dose 2 than after dose 1 (p<0.001), whereas ChAdOx1-S recipients reported significantly fewer local and systemic reactions after dose 2 than after dose 1 (p<0.001). Local and systemic reactions were approximately 2 times and 4 times more frequent for heterologous vaccination than for BNT162b2/BNT162b2 and ChAdOx1-S/ChAdOx1-S regimens, respectively. Young individuals, female, and those receiving heterologous vaccine regimens including ChAdOx1-S/BNT162b2 vaccines reported more adverse events than older participants, male, and those with homologous vaccine regimens.
CONCLUSIONS
Although a heterologous regimen, youth, and female sex were associated with a higher risk of adverse reactions after COVID-19 vaccination, no critical issues were noted. Active consideration of heterologous schedules based on the evidence of efficacy and safety appears desirable.
4.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 and Research Perspectives 2022;13(3):230-237
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-year-olds 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.
5.Differences in accuracy of height, weight, and body mass index between self-reported and measured using the 2018 Korea Community Health Survey data
Yoonsil KO ; Sunhye CHOI ; Jisoo WON ; Yeon-Kyeng LEE ; Dong-Hyun KIM ; Seon Kui LEE
Epidemiology and Health 2022;44(1):e2022024-
OBJECTIVES:
This study aimed to determine an effective survey method for the accurate calculation of obesity prevalence by comparing the self-reported and measured height, weight, and body mass index (BMI) using the 2018 Korea Community Healthy Survey (CHS) data.
METHODS:
Raw data from the 2018 CHS were used to analyze the differences, correlation, and agreement between self-reported and measured height, weight, and BMI.
RESULTS:
The self-reported height was over-reported than the measured height (0.59 cm greater for men and 0.71 cm greater for women), while the self-reported weight was under-reported than the measured weight (0.55 kg less for men and 0.67 kg less for women). Subsequently, the self-reported BMI was under-estimated (0.35 kg/m2 lower for men and 0.49 kg/m2 lower for women) compared with the measured BMI. The kappa statistic and agreement between measured and self-reported values per BMI category (underweight, normal, overweight, and obesity) were 0.82 and 79.6%, respectively.
CONCLUSIONS
The prevalence of obesity should be calculated using the measured values provided in the CHS in order to promote local health projects based on accurate evidence.
6.Effects of Air Pollution on Chemosensory Dysfunction in COVID-19 Patients
Young-Sook CHOI ; Byeong-Su JEONG ; Yeon-Kyeng LEE ; Yong-Dae KIM
Journal of Korean Medical Science 2022;37(39):e290-
Background:
In some patients, coronavirus disease 2019 (COVID-19) is accompanied by loss of smell and taste, and this has been reportedly associated with exposure to air pollutants. This study investigated the relationship between the occurrence of chemosensory dysfunction in COVID-19 patients and air pollutant concentrations in Korea.
Methods:
Information on the clinical symptom of chemosensory dysfunction, the date of diagnosis, residential area, age, and sex of 60,194 confirmed COVID-19 cases reported to the Korea Disease Control and Prevention Agency from January 20 to December 31, 2020 was collected. In addition, the daily average concentration of air pollutants for a week in the patients’ residential area was collected from the Ministry of Environment based on the date of diagnosis of COVID-19. A binomial logistic regression model, using age and gender, standardized smoking rate, number of outpatient visits, 24-hour mean temperature and relative humidity at the regional level as covariates, was used to determine the effect of air pollution on chemosensory dysfunction.
Results:
Symptoms of chemosensory dysfunction were most frequent among patients in their 20s and 30s, and occurred more frequently in large cities. The logistic analysis showed that the concentration of particulate matter 10 (PM 10 ) and 2.5 (PM 2.5 ) up to 2 days before the diagnosis of COVID-19 and the concentration of sulfur dioxide (SO 2 ), nitrogen dioxide (NO 2 ), carbon monoxide (CO), and ozone (O 3) at least 7 days before the diagnosis of COVID-19 affected the development of chemosensory dysfunction. In the logistic regression model adjusted for age, sex, standardized smoking rate, number of outpatient visits, and daily average temperature and relative humidity, it was found that an increase in the interquartile range of PM 10 , PM 2.5 , SO 2 , NO 2 , and CO on the day of diagnosis increased the incidence of chemosensory dysfunction 1.10, 1.10, 1.17, 1.31, and 1.19-fold, respectively. In contrast, the O 3 concentration had a negative association with chemosensory dysfunction.
Conclusion
High concentrations of air pollutants such as PM 10 , PM 2.5 , SO 2 , NO 2 , and CO on the day of diagnosis increased the risk of developing chemosensory dysfunction from COVID-19 infection. This result underscores the need to actively prevent exposure to air pollution and prevent COVID-19 infection. In addition, policies that regulate activities and products that create high amounts of harmful environmental wastes may help in promoting better health for all during COVID-19 pandemic.
7.Korea National Health and Nutrition Examination Survey, 20th anniversary: accomplishments and future directions
Kyungwon OH ; Yoonjung KIM ; Sanghui KWEON ; Soyeon KIM ; Sungha YUN ; Suyeon PARK ; Yeon-Kyeng LEE ; Youngtaek KIM ; Ok PARK ; Eun Kyeong JEONG
Epidemiology and Health 2021;43(1):e2021025-
The Korea National Health and Nutrition Examination Survey (KNHANES) was initiated in 1998 to provide evidence for the development and evaluation of health policies and programs. The Korea Disease Control and Prevention Agency is responsible for the KNHANES and has conducted it as a series of surveys. Over the past 20 years, efforts to produce accurate, timely, and nationwide health statistics have been refined by establishing a continuous annual survey system with full-time field staff, incrementally expanding survey components, collaborating with relevant academic societies for quality control, and revising the survey methods. Additionally, the utility of the collected data was increased by linking the KNHANES data with related data from other government agencies or institutions and making the overall data publicly available on the official website of KNHANES (https://knhanes.kdca.go.kr). Additional long-term plans are being developed, including plans to continue producing nationwide health indicators and invigorating the utilization of the KNHANES data.
8.COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021
Hyun-kyung OH ; Eun Kyeong KIM ; Insob HWANG ; Tae Eun KIM ; Yeon-kyeong LEE ; Eunju LEE ; Yeon-Kyeng LEE
Osong Public Health and Research Perspectives 2021;12(4):264-268
Objectives:
On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
Methods:
Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021.
Results:
In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.
Conclusion
By April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.
9.COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021
Insob HWANG ; Kyeongeun PARK ; Tae Eun KIM ; Yunhyung KWON ; Yeon-Kyeng LEE
Osong Public Health and Research Perspectives 2021;12(6):396-402
Objectives:
This study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine.
Methods:
Adverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition.
Results:
By October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition.
Conclusion
The commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.
10.COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021
Hyun-kyung OH ; Eun Kyeong KIM ; Insob HWANG ; Tae Eun KIM ; Yeon-kyeong LEE ; Eunju LEE ; Yeon-Kyeng LEE
Osong Public Health and Research Perspectives 2021;12(4):264-268
Objectives:
On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
Methods:
Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021.
Results:
In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.
Conclusion
By April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.

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