Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (8): 464-469.

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Review and Analysis of Active Post-marketing Surveillance Modes for Vaccine Safety

CAI Ting1, YANG Yu1, WANG Ya-li2, DONG Duo2, ZHAN Si-yan1*   

  1. 1.School of Public Health, Peking University, Beijing 100191, China;
    2. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2017-09-26 Revised:2017-09-26 Online:2017-08-20 Published:2017-09-26

Abstract: In the late 20 th century, active surveillance occurred as a novel method of post-marketing surveillance for vaccine safety, to recover the deficiency of traditional passive surveillance. Nowadays, active post-marketing surveillance is still in an initial stage of development, with various definitions and performance around the world. There have been active surveillance systems of vaccine safety established in developed countries and their achievements indicate the great advantages of active surveillance method. However, the primary surveillance mode of vaccine safety in China is currently in a passive way, as the most of developing countries. In view of the increasing amountof new vaccines and the enhanced public attention on vaccine safety, there is an insistent demand for conducting active surveillance for vaccine safety in Chinese population. This study will reviewthe development of active post-marketing surveillance for vaccine safety, analyze the different modes of active surveillance and explore the typical surveillance systems, with the aim to accelerate the foundation of active surveillance system for vaccine safety in China.

Key words: vaccine, safety, post-marketing surveillance, active surveillance, review

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