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NTIS 바로가기Pediatric infection and vaccine: PIV, v.23 no.2, 2016년, pp.117 - 127
차지혜 (이화여자대학교 의학전문대학원 소아과학교실) , 김한울 (이화여자대학교 의과학연구소 백신효능연구센터) , 이소영 (이화여자대학교 의학전문대학원 소아과학교실) , 조혜경 (가천의과학대학교 소아과학교실) , 안종균 (이화여자대학교 의학전문대학원 소아과학교실) , 김경효 (이화여자대학교 의학전문대학원 소아과학교실)
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, effectiv...
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핵심어 | 질문 | 논문에서 추출한 답변 |
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우리나라에서 처음 백신 접종을 한 년도와 그 백신은 무엇인가? | 백신 접종은 감염 및 감염과 관련된 질병을 예방하기 위한 가장 효과적인 전략으로 비용 효과 측면에서도 가장 우수한 방법이다1). 우리나라에서 예방접종은 1912년 두창과 콜레라 백신이 처음 실시된 이래 DPT, 폴리오, 홍역, 일본뇌염, MMR 백신 등이 외국에서 도입되어 사용되었다2). 이후 B형 간염 백신이 1985년에 국내에서 생산되어 접종이 가능해졌고 1997년 인플루엔자 백신이 도입되었으며 그 후 다양한 백신들이 현재까지 우리나라에 도입되어 사용되고 있다2). | |
백신 유용성 평가의 개념과 활용 방법은 무엇이 있는가? | 또한 백신 시장의 성장에 따라 국내 백신개발에 대한 적극적 지원이 요구되어 식품의약품안전처에서는 국내 주요백신에 대한 임상평가 자료를 확보하고 국내 임상평가 인프라 및 평가기술을 마련하기 위해 지난 2006년에서 2014년 까지 11종의 국내 필수ᆞ·비필수 예방접종 백신에 대한 면역원성, 안전성 평가 및 면역원성 평가기술 개발 등 표준화 기반구축 연구인 ‘백신 유용성 평가 사업’을 수행하게 되었다3). ‘백신 유용성 평가’란 국내 유통 중인 백신에 대한 안전성ᆞ·유효성 평가로 면역원성, 면역지속능, 효능ᆞ·효과평가, 안전성 평가를 포함하는 개념으로, 이를 통해 인구 집단의 질병부담률, 국가의 사회 경제적 상태 및 비용효과 분석 등을 종합적으로 고려하여 국가의 백신정책 수립에 중요하게 활용될 수 있다3). | |
백신 유용성 평가 항목 중 백신의 효능은 무엇인가? | 면역지속능(persistence of immunity)은 백신 투여에 의해 생성된 접종자의 항체 보유 및 면역원성의 지속력을 의미한다. 백신의 효능(efficacy)은 대조군 대비 백신 투여 군의 질환 발생 위험비를 뜻하고, 효과(effective ness)는 지정집단에서 백신 접종에 따른 방어 비율로 직접적 방어와 간접적 방어 즉 백신 접종 집단에 의한 미접 종자의 방어 모두를 포함한다. 개발된 백신의 품질을 평가 하는 방법 기술 및 분석은 유효성 평가기술 영역으로 분류 하였다. |
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Cheong HJ. Guideline for manufacture and quality control of pandemic influenza vaccine. Ministry of Food and Drug Safety, 2008.
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Ki M. Risk analysis of aseptic meningitis after measles, mumps and rubella (MMR) vaccine. Ministry of Food and Drug Safety, 2001.
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Ki M. Vaccine effectiveness of mumps in Korea. Centers for Disease Control and Prevention, 2006.
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