title: Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.
abstract: Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied.
authors.affiliation: National Center for ADR Monitoring, China.
authors.forename: Yali
authors.initials: Y
authors.lastname: Wang
authors.affiliation: National Center for ADR Monitoring, China.
authors.forename: Duo
authors.initials: D
authors.lastname: Dong
authors.affiliation: National Center for ADR Monitoring, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Cheng
authors.affiliation: China Office of World Health Organization, China.
authors.forename: Shuyan
authors.initials: S
authors.lastname: Zuo
authors.affiliation: Chinese Center for Disease Control and Prevention, China.
authors.forename: Dawei
authors.initials: D
authors.lastname: Liu
authors.affiliation: National Center for ADR Monitoring, China. Electronic address: duxiaoxi@cdr.gov.cn.
authors.forename: Xiaoxi
authors.initials: X
authors.lastname: Du
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D002675:Child, Preschool; D002681:China; D005260:Female; D006801:Humans; D007223:Infant; D022321:Japanese Encephalitis Vaccines / Q000009:adverse effects*; D008297:Male; D011159:Population Surveillance; D011358:Product Surveillance, Postmarketing
chemical_list: D022321:Japanese Encephalitis Vaccines
keywords: Live-attenuated Japanese encephalitis vaccine; Post-marketing surveillance; Safety