1.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
2.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
3.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
4.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
5.Interim Estimates of 2023–2024Seasonal Influenza Vaccine Effectiveness Among Adults in Korea
Yu Jung CHOI ; Jang Wook SOHN ; Won Suk CHOI ; Seong-Heon WIE ; Jacob LEE ; Jin-Soo LEE ; Hye Won JEONG ; Joong Sik EOM ; Eliel NHAM ; Hye SEONG ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Hee Jin CHEONG ; Woo Joo KIM
Journal of Korean Medical Science 2024;39(15):e146-
In the 2023–2024 season, the influenza epidemic in South Korea peaked earlier than in recent years. In this study, we aimed to estimate the interim vaccine effectiveness (VE) of the influenza vaccination to prevent influenza during the early season. From November 1, 2023, to December 31, 2023, we enrolled 2,632 subjects with influenza-like illness from eight hospitals participating in hospital-based influenza morbidity and mortality surveillance. A retrospective test-negative case-control study was conducted to estimate the VE. The results showed an adjusted VE of 22.5% (95% confidence interval [CI], 6.6 to 35.8) for the total population. The adjusted VE was 22.3% (95% CI, 6.1 to 35.7) for influenza A and 9.4% (95% CI, −51.3 to 45.7) for influenza A/H1N1. Full results of the analysis will be reported.
6.Establishment of Safety Monitoring System for Vaccines Not Included in the National Immunization Program in Korea
Eliel NHAM ; Jin Gu YOON ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Won Suk CHOI ; Hakjun HYUN ; Hye SEONG ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Hee Jin CHEONG
Journal of Korean Medical Science 2024;39(5):e45-
Background:
In Korea, there are no surveillance programs for vaccines that are not included in the national immunization program (NIP), and vaccine safety monitoring in the adult population is inadequate. This study aimed to establish a safety monitoring system for nonNIP vaccines in adults.
Methods:
Frequently administered non-NIP vaccines were selected. Individuals were included if they received at least one of the selected vaccines at a participating institution and provided informed consent. Solicited and unsolicited adverse events were monitored using questionnaires sent through text messages on days 1, 3, 7, 28, and 90 post-vaccination.Selected adverse events of special interest (AESIs) were monitored monthly by retrospective review of electronic medical records. Causality was assessed according to the Korea Disease Control and Prevention Agency guidelines.
Results:
Four vaccines (tetanus-diphtheria-pertussis [Tdap], pneumococcal conjugate 13-valent [PCV13], live zoster vaccine [ZVL], and recombinant zoster vaccine [RZV]) were selected, and their safety profiles were monitored at four tertiary hospitals and 10 primary care clinics. The response rates of the questionnaires on post-vaccination days 1, 7, 28, and 90 were 99.2%, 93.6%, 81.0%, and 48.7%, respectively. Of 555 AESI identified over 10 months, 10 cases received one of the selected non-NIP vaccines within 90 days of the event.
Conclusion
We are establishing the first safety monitoring system for selected non-NIP vaccines in Korea since September 2022 and report its progress as of July 2023. However, continuous government support is essential for its maintenance and improvement.
7.Effectiveness of Bivalent mRNA Booster Vaccine Against COVID-19 in Korea
Jin Gu YOON ; Jang Wook SOHN ; Won Suk CHOI ; Seong-Heon WIE ; Jacob LEE ; Jin-Soo LEE ; Hye Won JEONG ; Joong Sik EOM ; Hye SEONG ; Eliel NHAM ; Yu Jung CHOI ; Ji Yun NOH ; Joon Young SONG ; Hee Jin CHEONG ; Woo Joo KIM
Journal of Korean Medical Science 2024;39(3):e15-
Background:
Bivalent booster mRNA vaccines containing the omicron-variant strains have been introduced worldwide in the autumn of 2022. Nevertheless, the omicron subvariants evoked another large coronavirus disease 2019 (COVID-19) pandemic wave in late 2022 and early 2023.
Methods:
A retrospective, test-negative, case-control study was conducted to estimate the vaccine effectiveness (VE) of bivalent COVID-19 vaccines in 8 university hospitals between January and February 2023. The case and control groups were divided based on nasopharyngeal COVID-19 real-time polymerase chain reaction results and matched based on age, sex, hospital, and date (week) of the test performed. The VE of the BA.1- or BA.4/BA.5-based mRNA vaccines were estimated. VE was calculated using the 1−adjusted odds ratio from multivariable logistic regression.
Results:
In total, 949 patients and 947 controls were enrolled in this study. VE for the BA.4/ BA.5-based bivalent mRNA vaccine was 43% (95% confidence interval [CI], 17, 61%). In subgroup analysis based on age and underlying medical conditions, BA.4/BA.5-based bivalent mRNA vaccine was effective against old adults aged ≥ 65-years (VE, 55%; 95% CI, 23, 73%) and individuals with comorbidities (VE, 54%; 95% CI, 23, 73%). In comparison, the BA.1-based bivalent mRNA vaccine did not demonstrate statistically significant effectiveness (VE, 25%; 95% CI, −8, 49%).
Conclusion
The BA.4/BA.5-based bivalent mRNA booster vaccine provided significant protection against COVID-19 in the Korean adults, especially in the older adults aged ≥ 65 years and in individuals with underlying medical conditions.
8.Vessel-Derived Decellularized Extracellular Matrices (VdECM):Novel Bio-Engineered Materials for the Wound Healing
Chae Rim LEE ; Yoon Jae LEE ; Bo Young KWON ; Su Jin LEE ; Yeon Hee RYU ; Jong-Won RHIE ; Suk-Ho MOON
Tissue Engineering and Regenerative Medicine 2023;20(1):59-67
BACKGROUND:
Decellularized extracellular matrix (dECM) is a non-cellular scaffold with various functions in tissue engineering and regenerative medicine. Elastin is related to tissue elasticity and scarless wound healing, abundantly found in lung and blood vessel tissues. We studied the characteristics of blood vessel-derived dECM (VdECM) and its effect in wound healing.
METHODS:
VdECM was prepared from porcine blood vessel tissue. Weight percentages of elastin of VdECM and atelocollagen were analyzed. Migratory potential of VdECM was tested by scratch assay. VdECM in hydrogel form was microscopically examined, tested for fibroblast proliferation, and examined for L/D staining. Cytokine array of various growth factors in adipocyte-derived mesenchymal stem cell (ASC) media with VdECM was done. Animal wound model showed the wound healing effect of VdECM hydrogel in comparison to other topical agents.
RESULTS:
VdECM contained 6.7 times more elastin than atelocollagen per unit weight. Microscopic view of 0.35% VdECM hydrogel showed consistent distribution. Compared to 3% atelocollagen, 0.35% VdECM showed superior results in fibroblast migration. Fluorescent microscopic findings of L/D assay had highest percentage of cell survival in 1% VdECM compared to atelocollagen. Growth factor expression was drastically amplified when VdECM was added to ASC media. In the animal study model, epithelialization rate in the VdECM group was higher than that of control, oxytetracycline, and epidermal growth factor ointments.
CONCLUSION
VdECM contains a high ratio of elastin to collagen and amplifies expressions of many growth factors. It promotes fibroblast migration, proliferation, and survival, and epithelialization comparable to other topical agents.
9.Community-Acquired Pneumococcal Pneumonia in Highly Vaccinated Population: Analysis by Serotypes, Vaccination Status, and Underlying Medical Conditions
Hakjun HYUN ; A-Yeung JANG ; Jin Woong SUH ; In-Gyu BAE ; Won Suk CHOI ; Yu Bin SEO ; Jacob LEE ; Jin Gu YOON ; Ji Yun NOH ; Hee Jin CHEONG ; Woo Joo KIM ; Min Ja KIM ; Joon Young SONG
Journal of Korean Medical Science 2023;38(42):e330-
Background:
Targeted risk population has been highly vaccinated against pneumococcal diseases in South Korea. Despite this, the pneumococcal serotype distribution is evolving, which impedes efficient roll-out of vaccines.
Methods:
This prospective cohort study included patients aged ≥ 19 years with communityacquired pneumonia (CAP) from five university hospitals in South Korea between September 2018 and July 2021. The outcomes of interest were the demographic and clinical characteristics of patients with CAP, pneumococcal serotype distribution, and risk factors of 30-day mortality in patients with pneumococcal CAP (pCAP). Considering the high seroprevalence, we analyzed the clinical characteristics of serotype 3 pCAP.
Results:
A total of 5,009 patients hospitalized with CAP was included (mean age ± standard deviation, 70.3 ± 16.0 years; 3,159 [63.1%] men). Streptococcus pneumoniae was the leading causative agent of CAP (11.8% overall, 17.7% in individuals aged < 65 years with chronic medical conditions). Among the 280 serotyped Streptococcus pneumococcus, serotype 3 was the most common (10.0%), followed by serotypes 19A (8.9%), 34 (8.9%), and 35B (8.9%).Non-vaccine serotypes (serotype 35B [13.9%] and 34 [12.0%]) were the most prevalent in 108 individuals vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23).Serotype 3 was prevalent, irrespective of PPSV23 vaccination status, and more common in individuals with chronic lung disease (P = 0.008). Advanced age (adjusted odds ratio [aOR], 1.040; 95% confidence interval [CI], 1.011–1.071), long-term care facility residence (aOR, 2.161; 95% CI, 1.071–4.357), and bacteremia (aOR, 4.193; 95% CI, 1.604–10.962) were independent risk factors for 30-day mortality in patients with pCAP. PPSV23 vaccination reduced the risk of mortality (aOR, 0.507; 95% CI, 0.267–0.961).
Conclusion
Serotype 3 and 19A were still the most common serotypes of pCAP in South Korea despite the national immunization program of 13-valent pneumococcal conjugated vaccine in children and PPSV23 in old adults. PPSV23 vaccination might reduce the risk of mortality in patients with pCAP.
10.Comparison of the International Normalized Ratio Between a Point-of-Care Test and a Conventional Laboratory Test: the Latter Performs Better in Assessing Warfarin-induced Changes in Coagulation Factors
Ye-Seul KIM ; Jae-Woong CHOI ; Sang Hoon SONG ; Ho Young HWANG ; Suk Ho SOHN ; Ji Seong KIM ; Yoonjin KANG ; Ja-Yoon GU ; Kyung Hwan KIM ; Hyun Kyung KIM
Annals of Laboratory Medicine 2023;43(4):337-344
Background:
Point-of-care testing (POCT) coagulometers are increasingly used for monitoring warfarin therapy. However, in high international normalized ratio (INR) ranges, significant discrepancy in the INR between POCT and conventional laboratory tests occurs. We compared the INR of POCT (CoaguChek XS Plus; Roche Diagnostics, Mannheim, Germany) with that of a conventional laboratory test (ACL TOP 750; Instrumentation Laboratory SpA, Milan, Italy) and explored possible reasons for discrepancy.
Methods:
Paired POCT and conventional laboratory test INRs were analyzed in 400 samples from 126 patients undergoing warfarin therapy after cardiac surgery. Coagulation factor and thrombin generation tests were compared using the Mann–Whitney U test. Correlations between coagulation factors and INRs were determined using Pearson correlation coefficients.
Results:
The mean difference in the INR between the tests increased at high INR ranges. Endogenous thrombin potential levels were decreased at INR <2.0 for CoaguChek XS Plus and 2.0< INR <3.0 for ACL TOP 750 compared with those at INR <2.0 for both tests, indicating a better performance of ACL TOP 750 in assessing thrombin changes. The correlation coefficients of coagulation factors were stronger for ACL TOP 750 INR than for CoaguChek XS Plus INR. Vitamin K-dependent coagulation factors were found to contribute to the INR discrepancy.
Conclusions
Decreases in vitamin K-dependent coagulation and anticoagulation factors can explain the significant discrepancy between the two tests in high INR ranges. Since conventional laboratory test INR values are more reliable than POCT INR values, a confirmatory conventional laboratory test is required for high INR ranges.

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