Post-marketing safety surveillance for inactivated and live-attenuated Japanese encephalitis vaccines in China, 2008–2013. Issue 29 (22nd June 2017)

• Record Type: Journal Article
• Authors: Wu, Wendi; Liu, Dawei; Li, Keli; Nuorti, J. Pekka; Nohynek, Hanna M.; Xu, Disha; Ye, Jiakai; Zheng, Jingshan; Wang, Huaqing
• Is Part Of: Vaccine. Volume 35:Issue 29(2017)
• Page Start: 3666
• Page End: 3671
• Publication Date: 2017-06-22
• Subjects: Vaccine safety -- Adverse events following immunization -- Febrile convulsion -- Japanese encephalitis vaccine -- Disproportionality analysis -- Surveillance system -- China; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2017.05.021
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Both an inactivated Japanese encephalitis vaccine (JE-I) and live-attenuated Japanese encephalitis vaccine (JE-L) are used in China, JE-L, produced by a Chinese manufacturer, was prequalified by WHO in 2013. Passive adverse events surveillance for JE-I and JE-L vaccines in China from 2008 to 2013 did not identify apparent safety soncerns. Further study should evaluate JE-I and febrile convulsion, discern effects of concurrent vaccination with other vaccines, and employ more sensitive signal detection methods. Abstract: Introduction: Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was prequalified by WHO in 2013. We assessed the safety of JE vaccines in China during 2008–2013 using the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) data. Methods: We retrieved AEFI reporting data about JE vaccines from CNAEFIS, 2008–2013, examined demographic characteristics of AEFI cases, and used administrative data on vaccine doses as denominator to calculate and compare crude reporting rates. We also used disproportionality reporting analysis between JE-I and JE-L to assess potential safety signals. Results: A total of 34, 879 AEFIs related with JE-I and JE-L were reported, with a ratio of male to female as 1.3:1; 361 (1.0%) cases were classified as serious. JE vaccines were administered concurrently with one or more other vaccines in 13, 592 (39.0%) of cases. The overall AEFI reporting rates were 214.4 per million vaccination doses for JE-L and 176.9 for JE-I (rate ratio [RR]: 1.2, 95% confidence interval [CI]: 1.1–1.3) in 2010–2013. Febrile convulsions (FC) following JE-I was found as a signal of disproportionate reporting (SDR). However, there was no significant difference between the reporting rates of FC of JE-I and JE-L (0.3 per million vaccination doses for JE-L, 0.4 for JE-I, p = 0.05). Conclusions: While our analysis did not find apparent safety concern of JE vaccines in China, further study should consider JE-I vaccines and febrile convulsion, and taking more sensitive methods to detect signals.