Pediatric Infection and Vaccine

  • 제23권2호
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  • Pages.117-127
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  • 2016
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  • 2384-1079(pISSN)
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  • 2384-1087(eISSN)
대한소아감염학회 (The Korean Society of Pediatric Infectious Diseases)
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2000-2014년 한국에서 수행된 백신 유용성 평가 연구

Vaccine Evaluation Studies Performed in Korea from 2000 to 2014

  • 차지혜 (이화여자대학교 의학전문대학원 소아과학교실) ;
  • 김한울 (이화여자대학교 의과학연구소 백신효능연구센터) ;
  • 이소영 (이화여자대학교 의학전문대학원 소아과학교실) ;
  • 조혜경 (가천의과학대학교 소아과학교실) ;
  • 안종균 (이화여자대학교 의학전문대학원 소아과학교실) ;
  • 김경효 (이화여자대학교 의학전문대학원 소아과학교실)
  • Cha, Jihei (Department of Pediatrics, Medical Research Institute, School of Medicine, Ewha Womans University) ;
  • Kim, Han Wool (Department of Center for Vaccine Evaluation and Study, Medical Research Institute, School of Medicine, Ewha Womans University) ;
  • Lee, Soyoung (Department of Pediatrics, Medical Research Institute, School of Medicine, Ewha Womans University) ;
  • Cho, Hye Kyung (Department of Pediatrics, School of Medicine, Gachon University) ;
  • Ahn, Jong Gyun (Department of Pediatrics, Medical Research Institute, School of Medicine, Ewha Womans University) ;
  • Kim, Kyung-Hyo (Department of Pediatrics, Medical Research Institute, School of Medicine, Ewha Womans University)
  • 투고 : 2015.12.29
  • 심사 : 2016.03.09
  • 발행 : 2016.08.25
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초록

목적: 2000년부터 식품의약품안전처 주관 하에 국내 주요 백신의 안전성과 면역원성에 대한 임상평가 자료를 확보하기 위한 백신 평가 연구를 시작하였다. 본 연구는 백신의 면역원성, 효능, 효과, 안전성 및 다른 평가분야에 대해 수행된 연구 및 보고서들을 고찰하여 각 백신 별 유용성 평가 자료를 찾아 분석하고자 하였다. 방법: 지난 2000년부터 2014년까지 여러 연구자들에 의해 "백신 유용성 평가" 과제가 수행되었다. 백신 유용성 평가 자료들의 결과 및 성과들을 고찰하여 향후 국내 백신 정책에 활용할 수 있는 가능성을 분석하였다. 각 백신은 백신 평가 영역에 따라 자료를 분석하고 체계화하였다. 결과: 2000년부터 2014년까지 주요 백신에 대해 총 83개의 연구과제가 수행되었다. 각 백신 별로는 BCG 8개, DTaP/Td 14개, 폴리오 1개, Hib 5개, 폐구균 3개, 인플루엔자 11개, A형 간염 3개, MMR 11개, 수두 11개, 일본뇌염 16개였다. 평가 영역은 안전성, 면역원성, 면역도, 면역지속능, 효능평가, 효과평가, 유효성 평가기술, 품질평가 및 기타로 나누어 분석하였다. 결론: 우리나라에서 수행된 백신 유용성 평가 연구를 통해 유용한 자료가 도출되어 향후 국내 백신 평가 사업, 백신 정책 수립 및 대중/전문가 교육에 필요한 기초자료로 활용될 수 있을 것이다.

Purpose: Vaccine evaluation studies were initiated from 2000 by the Ministry of Food and Drug Safety to produce proper data about the safety and immunogenicity of vaccines. The purpose of this study was to review studies and reports on evaluation of vaccine such as immunogenicity, efficacy, effectiveness, safety and other related topics in order to find and analyze the data on the usefulness of each vaccine. Methods: From 2000 to 2014, the project "The vaccine evaluation" had been performed by several researchers, and studies and reports of vaccine evaluation. We reviewed the results and outcomes of studies regarding the evaluation of vaccine's usefulness and analyzed the possibilities of applying these data for establishing vaccine policies. For each vaccine, data analysis and organization were done according to evaluation fields. Results: A total of 83 studies were performed on vaccines from 2000 to 2014. For each vaccine, 8 studies were performed on BCG, 14 on DTaP/Td, 1 on poliovirus, 5 on Hib, 3 on pneumococcus, 11 on influenza, 3 on hepatitis A, 11 on MMR, 11 on varicella, and 16 on Japanese encephalitis. All studies were analyzed by the following evaluation area, such as safety, immunogenicity, seroprevalence, persistence of immunity, efficacy, effectiveness, vaccine evaluation methods, quality control product for vaccine, and others. Conclusions: Vaccine evaluation studies performed in Korea may be useful as references for establishing vaccination strategy and policy and could be used as baseline data for future studies on vaccine evaluation, vaccine policy establishment, and public/expert vaccine education in Korea.

키워드

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피인용 문헌

  1. Trends in Pediatric Meningitis in South Korea during 2009 to 2017: Analysis of the Health Insurance Review and Assessment Service Database vol.29, pp.1, 2016, https://doi.org/10.26815/acn.2020.00178