During the coronavirus disease 2019 (COVID-19) pandemic, conclusively evaluating possible associations between COVID-19 vaccines and potential adverse events was of critical importance. The National Academy of Medicine of Korea established the COVID-19 Vaccine Safety Research Center (CoVaSC) with support from the Korea Disease Control and Prevention Agency to investigate the scientific relationship between COVID-19 vaccines and suspected adverse events. Although determining whether the COVID-19 vaccine was responsible for any suspected adverse event necessitated a systematic approach, traditional causal inference theories, such as Hill's criteria, encountered certain limitations and criticisms. To facilitate a systematic and evidence-based evaluation, the United States Institute of Medicine, at the request of the Centers for Disease Control and Prevention, offered a detailed causality assessment framework in 2012, which was updated in the recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) in 2024.This framework, based on a weight-of-evidence approach, allows the independent evaluation of both epidemiological and mechanistic evidence, culminating in a comprehensive conclusion about causality. Epidemiological evidence derived from population studies is categorized into four levels—high, moderate, limited, or insufficient—while mechanistic evidence, primarily from biological and clinical studies in animals and individuals, is classified as strong, intermediate, weak, or lacking. The committee then synthesizes these two types of evidence to draw a conclusion about the causal relationship, which can be described as “convincingly supports” (“evidence established” in the 2024 NASEM report), “favors acceptance,” “favors rejection,” or “inadequate to accept or reject.” The CoVaSC has established an independent committee to conduct causality assessments using the weightof-evidence framework, specifically for evaluating the causality of adverse events associated with COVID-19 vaccines. The aim of this study is to provide an overview of the weight-ofevidence framework and to detail the considerations involved in its practical application in the CoVaSC.

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.

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.

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.

Purpose: In delayed myelopathy (DM) from osteoporotic vertebral compression fractures (OVCF), the mechanisms of spinal cord impingement differ according to the stability of the fractured vertebra. This study examined the availability of a posterior surgery comprised of pedicle screw augmentation with polymethylmethacrylate (PMMA) and selective anterior reinforcement (PS-PMMA+SAR) according to the stability. Materials and Methods: This was a retrospective single-center study. The consecutive patients who had a PS-PMMA+SAR for a DM from OVCF and were followed up more than two years were reviewed. Thirty patients were eligible for this study. All patients used fenestrated screws for PMMA augmentation. Anterior reinforcement was selected according to the stability. The unstable type was done by filling the vacuum cleft with bone chips or PMMA, and the stable type was done by vertebral body anterior translation with/without an interbody bone graft. The radiological and functional outcomes were evaluated. Results: There were 20 unstable and 10 stable cases. The regional kyphotic angle was improved significantly from 31.3°±10.8° to 10.4°±8.3° (p<0.001). The anterior vertebral height ratio was improved significantly from 39.4%±17.1% to 86.4%±9.2% (p<0.001). The spinal canal invasion ratio was improved significantly from 39.2%±14.8% to 19.1%±10.8% (p<0.001). The walking ability was improved mostly by two Nurick’s grades (p<0.001). The Oswestry disability index was improved from 72% to 33% (p<0.001). Conclusion Posterior surgery with PMMA-augmented pedicle screws, and selective anterior reinforcement for DM from OVCF was available to achieve a good functional and radiological outcome.

Coronavirus disease 2019 (COVID-19) is a global pandemic that had affected more than eight million people worldwide by June 2020. Given the importance of the presence of diabetes mellitus (DM) for host immunity, we retrospectively evaluated the clinical characteristics and outcomes of moderate-to-severe COVID-19 in patients with diabetes.

BACKGROUND: Spinal diseases are self-limited or non-progressive in many cases. Epidural steroid injection (ESI) is a common nonsurgical treatment option for spinal pain. Despite concerns about complications of repeated steroid injection, few studies reported on the adrenal function of spine disease patients undergoing surgery after ESI. We investigated the influence of preoperative multiple ESIs on adrenal function in spine surgery patients. METHODS: This was a retrospective study with prospective data collection. Those who underwent elective spinal operations and had a history of multiple ESIs from January to June 2017 were selected as a study group. Those who underwent knee arthroplasty and did not have a history of ESI and any kind of steroid injection in other areas during 6 months before surgery were selected as a control group. Demographic data were compared to assess homogeneity between groups. We assessed the preoperative serum cortisol level (SCL) to compare the basal adrenal function between groups. Also, we assessed the elevation of SCL postoperatively to evaluate the adrenal response to the surgical stress in each group. For subgroup analysis, we divided all patients into normal (7–28 µg/dL) and subnormal groups according to SCL and analyzed risk factors of adrenal suppression with multivariate logistic regression test. RESULTS: There were 53 patients in the study group and 130 in the control group. Age and sex were homogeneous between groups. There was significant intergroup difference in preoperative SCL (10.4 ± 4.8 µg/dL in the study group vs. 12.0 ± 4.2 µg/dL in the control group; p = 0.026).The postoperative day one SCL was 11.6 ± 5.0 µg/dL in the study group without significant increase from the preoperative level (p = 0.117), whereas the increase was significant in the control group with a postoperative level of 14.4 ± 4.4 µg/dL (p < 0.001). Among all patients, the SCL was subnormal in 18 patients and within the normal range in 165. Spine surgery was the independent risk factor irrespective of age and sex (odds ratio, 3.472; p = 0.015). CONCLUSIONS: Our results suggest that concern should be raised about the influence of preoperative multiple ESIs on adrenal suppression in spine surgery patients.
Arthroplasty, Replacement, Knee ; Data Collection ; Humans ; Hydrocortisone ; Logistic Models ; Prospective Studies ; Reference Values ; Retrospective Studies ; Risk Factors ; Spinal Diseases ; Spine

This study aimed to investigate the tick species and give background for tick-borne investigations in Korea. Ticks were collected from the area within 2 km radius of the 4 domestic animal farms, where they were located in mountainous areas and raising animals on pasture, and from animal bodies in 2014 and 2015. In total, 7,973 nymphal and adult ticks were collected from the farms
Adult ; Agriculture ; Animals ; Animals, Domestic ; Cattle ; Ecosystem ; Goats ; Humans ; Ixodes ; Korea ; Radius ; Sus scrofa ; Ticks

Cardiac arrest (CA) is sudden loss of heart function and abrupt stop in effective blood flow to the body. The patients who initially achieve return of spontaneous circulation (RoSC) after CA have low survival rate. It has been known that multiorgan dysfunctions after RoSC are associated with high morbidity and mortality. Most previous studies have focused on the heart and brain in RoSC after CA. Therefore, the aim of this research was to perform serological, physiological, and histopathology study in the lung and to determine whether or how pulmonary dysfunction is associated with low survival rate after CA. Experimental animals were divided into sham-operated group (n=14 at each point in time), which was not subjected to CA operation, and CA-operated group (n=14 at each point in time), which was subjected to CA. The rats in each group were sacrificed at 6 hours, 12 hours, 24 hours, and 2 days, respectively, after RoSC. Then, pathological changes of the lungs were analyzed by hematoxylin and eosin staining, Western blot and immunohistochemistry for tumor necrosis factor α (TNF-α). The survival rate after CA was decreased with time past. We found that histopathological score and TNF-α immunoreactivity were significantly increased in the lung after CA. These results indicate that inflammation triggered by ischemia-reperfusion damage after CA leads to pulmonary injury/dysfunctions and contributes to low survival rate. In addition, the finding of increase in TNF-α via inflammation in the lung after CA would be able to utilize therapeutic or diagnostic measures in the future.
Animals ; Blotting, Western ; Brain ; Eosine Yellowish-(YS) ; Heart ; Heart Arrest* ; Hematoxylin ; Humans ; Immunohistochemistry ; Inflammation ; Lung* ; Models, Animal* ; Mortality ; Rats* ; Survival Rate ; Tumor Necrosis Factor-alpha*