유럽의 백신 유익성-위해성 감시를 위한 ADVANCE 프로젝트 소개

정나영; 이해인; 김민주; 김희진; 최남경

doi:10.21032/jhis.2021.46.4.369

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자료유형: 학술저널

저자정보: 정나영 (이화여자대학교) 이해인 (이화여자대학교 제약산업학과) 김민주 (이화여자대학교 제약산업학과) 김희진 (이화여자대학교 융합보건학과) 최남경 (이화여자대학교 융합보건학과)

저널정보: 한국보건정보통계학회 보건정보통계학회지 보건정보통계학회지 제46권 제4호

발행연도: 2021.11

수록면: 369 - 377 (9page)

DOI: 10.21032/jhis.2021.46.4.369

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The vaccine benefit-risk assessment entails comprehensive and systematic evaluation of the major benefits and risks of vaccine based on information after a marketing authorization. In 2009, the influenza A (H1N1) pandemic led to the licensing of new H1N1 vaccines in many countries including Europe. The post-marketing evaluation and monitoring of H1N1 vaccines was carried out based on a project previously conducted in Europe. In 2013, the Accel erated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) project was launched with the support of Innovative Medicines Initiative (IMI) to address the limitations reported in the previous project. ADVANCE consisted of seven Work Packages (WPs), each indicating the vaccine benefit risk monitoring readiness across four areas: Governance, Data source, Methods, and Study. First, a model for vaccine surveillance and governance with various functions such as decision making, quality management, execution, and financial administration was established. Also, the project developed a tool to identify, collect, and link the data sources available for vaccine surveillance. In addition, various methodologies were reviewed to assess the infec tious disease burden, vaccine coverage, and benefit-risk based on linked data sources in Europe. Guidelines were proposed for real-world vaccine surveil lance studies. Accordingly, a variety of tools and programs were developed, including a code of conduct related to the benefit-risk assessment of vac cines, ADVANCE International Research Readiness (AIRR), CodeMapper, and VaccO. Since the end of the ADVANCE project in 2019, the Vaccine Monitor ing Collaboration for Europe (VAC4EU) has been conducting effective and sustainable vaccine benefit-risk monitoring programs based on the vision and ideology of ADVANCE. This study explains the contents and findings of ADVANCE with emphasis on WPs and proposes directions for establishing a vac cine benefit-risk assessment system in Korea.

#Vaccine #Benefit-risk #Post-marketing surveillance #Real-world evidence #Europe

참고문헌 (38)

참고문헌 신청

정소현 / 2019 / 국내외 의약품 유익성-위해성 평가 기법에 대한 고찰 / 약 학 회 지 63(2):103~112

Lee EK / 2013 / Evidence-based benefit-risk assessment of medication / J Health Tech Assess 1:22~26

Ledent E / 2016 / Post-marketing benefit-risk assessment of rotavirus vaccination in Japan : a simulation and modelling analysis / Drug Saf 39(3):219~230

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Sturkenboom M / 2020 / Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines / Vaccine 38(Suppl 2):B1~B7

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