Osong Public Health Res Perspect.  2023 Feb;14(1):5-14. 10.24171/j.phrp.2023.0026.

A framework for nationwide COVID-19 vaccine safety research in the Republic of Korea: the COVID-19 Vaccine Safety Research Committee

Affiliations
  • 1COVID-19 Vaccine Safety Research Center, Seoul, Korea
  • 2Department of Health Convergence, College of Science & Industry Convergence, Ewha Womans University, Seoul, Korea
  • 3Department of Preventive Medicine, College of Medicine, Graduate Program in System Health Science & Engineering, Ewha Womans University, Seoul, Korea
  • 4National Academy of Medicine of Korea, Seoul, Korea
  • 5Department of Psychiatry, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Korea
  • 6Department of Radiology, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 7Department of Social and Preventive Medicine, Hallym University College of Medicine, Chuncheon, Korea
  • 8Department of Infectious Diseases, Daejeon Eulji Medical Center, Eulji University School of Medicine, Daejeon, Korea
  • 9Department of Physiology, Korea University College of Medicine, Seoul, Korea

Abstract

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.

Keyword

Committees; COVID-19; Research; Safety; Vaccines
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