1.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;39(43):e309-
The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.
2.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;39(43):e309-
The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.
3.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;39(43):e309-
The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.
4.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;39(43):e309-
The emergence of the omicron variant and its sub-lineages has necessitated vaccine updates for coronavirus disease 2019. In September 2023, the U.S. Food and Drug Administration approved an updated BNT162b2 vaccine targeting the omicron XBB.1.5 variant, which was initiated in Korea in October 2024. This study demonstrates the adverse events reported through active nationwide surveillance after XBB.1.5 vaccination in Korea. Since October 19, 2023, the Korea Disease Control and Prevention Agency has conducted daily Short Message Service surveys to collect data on health issues, fever, vaccination site reactions, systemic symptoms, impact on daily life, and healthcare visits. Among 20,180 respondents, 27.9% reported health issues. Adverse reactions peaked on day 1 (28.7%), including pain at the vaccination site, muscle pain, fatigue, and fever. These findings elucidate the short-term safety of the XBB.1.5 vaccine and support its co-administration with the influenza vaccine, reducing vaccine hesitancy and achieving herd immunity.
5.Expert Consensus on the Structure, Role, and Procedures of the Korea Expert Committee on Immunization Practices
Cho Ryok KANG ; Bin AHN ; Young June CHOE ; So Yun LIM ; Han Wool KIM ; Hyun Mi KANG ; Ji Young PARK ; Hyungmin LEE ; Seungho LEE ; Sumin JEONG ; Sunghee KWON ; Eun Hwa CHOI
Journal of Korean Medical Science 2024;39(21):e166-
Background:
The Korea Expert Committee on Immunization Practices (KECIP) is a key advisory body the government to develop guidelines and provide technical advisory activities on immunization policies in Korea. A recent policy study, inspired by global best practices, aims to enhance KECIP's functionality for providing timely and transparent recommendations in the face of evolving vaccine science and emerging infectious diseases like COVID-19.
Methods:
This study reviewed the current status of KECIP and collected expert opinions through surveys and consultations. Among the 40 panel members who were surveyed, 19 responded to a questionnaire specifically designed to assess the potential areas of improvement within KECIP.
Results:
The majority of respondents favored maintaining the current member count and emphasized the need for a subcommittee. Opinions varied on issues such as the length of KECIP’s term, the representation of vaccine manufacturers’ perspectives, and the chairperson’s role. However, there was a consensus on the importance of expertise, transparency, and fair proceedings within the committee.
Conclusion
This study underscores the pivotal role of KECIP in shaping national immunization policies, emphasizing the necessity for informed guidance amidst evolving vaccine science and emerging infectious diseases. Furthermore, it stressed the importance of enhancing KECIP’s capacity to effectively address evolving public health challenges and maintain successful immunization programs in South Korea.
6.Nationwide Target Trial Emulation Evaluating the Clinical Effectiveness of Oral Antivirals for COVID-19 in Korea
Kyungmin HUH ; Youngji JO ; Gi Hwan BAE ; Hyejin JOO ; Munkhzul RADNAABAATAR ; Hyungmin LEE ; Jungyeon KIM ; Dong-Hwi KIM ; Min-Gyu YOO ; Il Uk JO ; Poong Hoon LEE ; Geun Woo LEE ; Hee Sun JUNG ; Jaehun JUNG
Journal of Korean Medical Science 2024;39(42):e272-
Background:
Despite the proven effectiveness of oral antivirals against severe acute respiratory syndrome coronavirus 2 in randomized trials, their clinical reevaluation is vital in the context of widespread immunity and milder prevalent variants. This study aimed to assess the effectiveness of oral antivirals for coronavirus disease 2019 (COVID-19).
Methods:
This retrospective cohort study utilized a target trial emulation framework to analyze patients with COVID-19 aged 60+ from January to December 2022. Data were obtained from the Korea Disease Control and Prevention Agency and Health Insurance Review and Assessment Service. The study involved 957,036 patients treated with nirmatrelvir/ritonavir and 243,360 treated with molnupiravir, each compared with the matched control groups. Primary outcome was progression to critical COVID-19 requiring advanced respiratory support. Secondary outcomes included progression to severe COVID-19, need for supplemental oxygen, and death within 30 days of the onset of COVID-19.Number needed to treat (NNT) derived from the absolute risk reduction.
Results:
Nirmatrelvir/ritonavir was significantly associated with a reduced risk of severe (adjusted odds ratio [aOR], 0.823; 95% confidence interval [CI], 0.803–0.843), critical (aOR, 0.560; 95% CI, 0.503–0.624), and fatal COVID-19 (aOR, 0.694; 95% CI, 0.647–0.744).Similarly, molnupiravir reduced the risk of severe (aOR, 0.895; 95% CI, 0.856–0.937), critical (aOR, 0.672; 95% CI, 0.559–0.807), and fatal cases (aOR, 0.679; 95% CI, 0.592–0.779).NNTs for nirmatrelvir/ritonavir were 203.71 (severe), 1,230.12 (critical), and 691.50 (death);for molnupiravir, they were 352.70 (severe), 1,398.62 (critical), and 862.98 (death). Higher effectiveness was associated with older adults, unvaccinated individuals, and the late pandemic phase.
Conclusion
Nirmatrelvir/ritonavir and molnupiravir are effective in preventing progression to severe disease in elderly adults with COVID-19.
7.Effectiveness of Paxlovid, an Oral Antiviral Drug, Against the Omicron BA.5 Variant in Korea: Severe Progression and Death Between July and November 2022
Jong Mu KIM ; Min-Gyu YOO ; Soon Jong BAE ; Jungyeon KIM ; Hyungmin LEE
Journal of Korean Medical Science 2023;38(27):e211-
Background:
Paxlovid is an oral antiviral drug that received emergency use authorization in South Korea for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) on January 14, 2022. Since the onset of the severe acute respiratory syndrome coronavirus 2 pandemic, the virus has continued to evolve. The emergence of new variants has raised concerns about possible reductions in the effectiveness of vaccines and drugs. The effectiveness of Paxlovid in patients infected with the omicron variant and subvariants has not yet been determined. This study assessed the effectiveness of Paxlovid at reducing the risk of severe/critical illness or death and death in patients with mild-to-moderate COVID-19 caused by omicron subvariant BA.5.
Methods:
In this nationwide retrospective cohort study, data on 8,902,726 patients were collected from four sources (the Drug Utilization Review database, COVID-19 Patient Information Management System, confirmed patient information, and basic epidemiological investigation data) between July 1 and November 30, 2022. Multivariable logistic regression analysis was conducted, with adjustment for age, sex, severe acute respiratory syndrome coronavirus 2 immunity (vaccination), and comorbidities.
Results:
A total of 1,936,925 patients with COVID-19 were included in the analysis, including 420,996 patients treated with Paxlovid, and 1,515,959 patients not treated with Paxlovid. Paxlovid treatment in patients aged ≥ 60 years of age was associated with significantly reduced risk of severe/critical illness or death (46.0%), and death rate (32.5%), and its effectiveness was high, regardless of vaccination status.
Conclusion
Paxlovid is effective at reducing the risk of death due to COVID-19 in patients with omicron BA.5 infection, especially in older patients, regardless of vaccination status. This suggests that older patients with COVID-19-related symptoms should be administered Paxlovid, regardless of their vaccination status, to reduce severity and risk of death.
8.Management of Contacts of the First Imported Monkeypox Case in Korea
Minjoung SHIN ; Ja Eun KIM ; Hye Young LEE ; Su-Yeon LEE ; Sang-Eun LEE ; Young-Joon PARK ; Hyungmin LEE
Journal of Korean Medical Science 2022;37(37):e285-
On 22 June, a man who returned to South Korea from Germany tested positive for the monkeypox virus using real-time polymerase chain reaction. We identified 49 contacts concerning the first monkeypox case and classified them into two groups based on risk exposure levels. Through active monitoring of eight people in the medium-risk group and passive monitoring of 41 people in the low-risk group, we identified that no secondary transmission occurred over 21 days. The prompt active or passive monitoring of the index case of imported monkeypox could prevent community transmission in Korea.
9.Sodium-Glucose Cotransporter-2 Inhibitor-Related Diabetic Ketoacidosis: Accuracy Verification of Operational Definition
Dong Yoon KANG ; Hyunah KIM ; SooJeong KO ; HyungMin KIM ; Jiwon SHINN ; Min-Gyu KANG ; Sun-ju BYEON ; Jeong-Hee CHOI ; Soo-Yong SHIN ; Hun-Sung KIM
Journal of Korean Medical Science 2022;37(7):e53-
Background:
The most important aspect of a retrospective cohort study is the operational definition (OP) of the disease. We developed a detailed OP for the detection of sodiumglucose cotransporter-2 inhibitors (SGLT2i) related to diabetic ketoacidosis (DKA). The OP was systemically verified and analyzed.
Methods:
All patients prescribed SGLT2i at four university hospitals were enrolled in this experiment. A DKA diagnostic algorithm was created and distributed to each hospital;subsequently, the number of SGLT2i-related DKAs was confirmed. Then, the algorithm functionality was verified through manual chart reviews by an endocrinologist using the same OP.
Results:
A total of 8,958 patients were initially prescribed SGLT2i. According to the algorithm, 0.18% (16/8,958) were confirmed to have SGLT2i-related DKA. However, based on manual chart reviews of these 16 cases, there was only one case of SGLT2i-related DKA (positive predictive value = 6.3%). Even after repeatedly narrowing the diagnosis range of the algorithm, the effect of a positive predictive value was insignificant (6.3–10.0%, P > 0.999).
Conclusion
Owing to the nature of electronic medical record data, we could not create an algorithm that clearly differentiates SGLT2i-related DKA despite repeated attempts. In all retrospective studies, a portion of the samples should be randomly selected to confirm the accuracy of the OP through chart review. In retrospective cohort studies in which chart review is not possible, it will be difficult to guarantee the reliability of the results.
10.A review of low-intensity focused ultrasound for neuromodulation.
Hongchae BAEK ; Ki Joo PAHK ; Hyungmin KIM
Biomedical Engineering Letters 2017;7(2):135-142
The ability of ultrasound to be focused into a small region of interest through the intact skull within the brain has led researchers to investigate its potential therapeutic uses for functional neurosurgery and tumor ablation. Studies have used high-intensity focused ultrasound to ablate tissue in localised brain regions for movement disorders and chronic pain while sparing the overlying and surrounding tissue. More recently, low-intensity focused ultrasound (LIFU) that induces reversible biological effects has been emerged as an alternative neuromodulation modality due to its bi-modal (i.e. excitation and suppression) capability with exquisite spatial specificity and depth penetration. Many compelling evidences of LIFU-mediated neuromodulatory effects including behavioral responses, electrophysiological recordings and functional imaging data have been found in the last decades. LIFU, therefore, has the enormous potential to improve the clinical outcomes as well as to replace the currently available neuromodulation techniques such as deep brain stimulation (DBS), transcranial magnetic stimulation and transcranial current stimulation. In this paper, we aim to provide a summary of pioneering studies in the field of ultrasonic neuromodulation including its underlying mechanisms that were published in the last 60 years. In closing, some of potential clinical applications of ultrasonic brain stimulation will be discussed.
Brain
;
Chronic Pain
;
Deep Brain Stimulation
;
Movement Disorders
;
Neurosurgery
;
Sensitivity and Specificity
;
Skull
;
Therapeutic Uses
;
Transcranial Magnetic Stimulation
;
Ultrasonics
;
Ultrasonography*

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