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KMID : 1155220190440040317
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Journal of the Korean Society of Health Information and Health Statistics
2019 Volume.44 No. 4 p.317 ~ p.330
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An Introduction of the Active Vaccine Safety Surveillance System in Foreign Countries
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Jeong Na-Young
Park Sang-Shin
Lim Eun-Sun
Choi Nam-Kyong
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Abstract
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Vaccines require stricter safety standards than most other medicinal products because they are given to healthy individuals. Despite various activities by national agencies, public concern about the vaccine safety often arises. Post-marketing activities for vaccine safety can be broadly classified into passive surveillance and active surveillance. Many countries as well as Korea, operate passive drug safety surveillance systems that report adverse events related to medications, including vaccines. However, the active surveillance systems operate in only several countries, such as the United States (US), Europe, Canada and Australia. In the US, Vaccine Safety Datalink (VSD) and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) were developed in 1990 and 2009 respectively for monitoring vaccine actively. In the case of Europe, the Vaccine Adverse Event Surveillance & Communication (VAESCO) consortium was launched in 2008, and after the end of VAESCO, the Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) was organized to establish a vaccine benefit-risk monitoring framework in 2013. Canada has been operating a vaccine active monitoring system called the Canadian Immunization Monitoring Program, ACTive (IMPACT) since 1991. The objective of this review is to describe and compare background, data?bases, and analysis system of various vaccine active surveillance systems in the US, Europe and Canada, including the examples of studies on the safety of influenza A (H1N1) vaccines carried out in each system. This review could help provide directions for the future development of the ideal active vac?cine safety surveillance system in Korea.
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KEYWORD
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Vaccine, Safety, Active vaccine surveillance system, Database, H1N1 influenza virus vaccine
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