Osong Public Health and Research Perspectives

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.

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.

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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4 Web of Science
3 Crossref

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.

Citations

Citations to this article as recorded by

Risk of encephalitis and meningitis after COVID-19 vaccination in South Korea: a self-controlled case series analysis
Ju Hwan Kim, Dongwon Yoon, Hwa Yeon Ko, Kyungyeon Jung, Jun-Sang Sunwoo, Won Chul Shin, Jung-Ick Byun, Ju-Young Shin
BMC Medicine.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
Risk of lymphadenopathy from SARS-CoV-2 vaccination in Korea: a self-controlled case series analysis
Mi-Sook Kim, Bongyoung Kim, Jeong Pil Choi, Nam-Kyong Choi, Jung Yeon Heo, Jun Yong Choi, Joongyub Lee, Sang Il Kim
Epidemiology and Health.2023; 45: e2023090. CrossRef

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