Safety of Japanese encephalitis live attenuated vaccination in post-marketing surveillance in Guangdong, China, 2005-2012

Vaccine. 2014 Mar 26;32(15):1768-73. doi: 10.1016/j.vaccine.2013.11.107. Epub 2014 Feb 4.

Abstract

We reviewed the adverse events following immunization of live attenuated Japanese encephalitis vaccine in Guangdong Province, China. During the period of 2005-2012, 23 million doses of live attenuated Japanese encephalitis vaccine were used and 1426 adverse events were reported (61.24 per million doses); of which, 570 (40%) were classified as allergic reactions (24.48 per million doses), 31 (2%) were neurologic events (1.33 per million doses), and 36 (2.5%) were diagnosed as serious adverse events (1.55 per million doses). This study suggests that the JEV-L has a reasonable safety profile, most adverse events are relatively mild, with relatively rare neurologic events being observed.

Keywords: Adverse event following immunization; Japanese encephalitis; Live attenuated vaccine; Safety.

MeSH terms

  • Adverse Drug Reaction Reporting Systems
  • Child
  • Child, Preschool
  • China
  • Encephalitis, Japanese / prevention & control
  • Female
  • Humans
  • Infant
  • Japanese Encephalitis Vaccines / adverse effects*
  • Japanese Encephalitis Vaccines / therapeutic use
  • Male
  • Product Surveillance, Postmarketing*
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / therapeutic use

Substances

  • Japanese Encephalitis Vaccines
  • Vaccines, Attenuated