SA 14-14-2 LIVE JAPANESE ENCEPHALITIS (JE) VACCINE Description

The SA 14-14-2 JE vaccine is a live, attenuated vaccine. It was developed and is produced for domestic use and export by Chengdu Institute of Biological Products Co., Ltd. (CDIBP), China. The vaccine name derives from the virus strain used in the vaccine, the SA 14-14-2 JE virus. Vaccine development The SA 14-14-2 live JE vaccine strain was obtained from its wild-type SA 14 parent by serial passages in cell cultures (primary hamster kidney cells) and in animals (mice, hamsters) with successive plaque purifications (in primary chick embryo cells). The master seed virus of the SA 14-14-2 live JE virus strain was screened for and shown to be free of adventitious viruses at Q-One Biotech, United Kingdom. The primary hamster kidney cell line used to prepare the vaccine was also certified pathogen free. The manufacturer similarly tests all vaccine lots for adventitious agents as part of its quality assurance processes. Vaccine production and quality control The vaccine is produced in accordance with technical specifications in “Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use ” developed by the World Health Organization (WHO) Expert Committee on Biological Standardization.1 Although there are several producers of the vaccine in China, CDIBP is the only currently authorized export manufacturer of the WHO prequalified vaccine. CDIBP has the capacity to produce 80 million doses annually. History of vaccine use The vaccine has been used for more than 20 years, and more than 400 million doses have been administered in China and other Asian countries. Other countries that have licensed and/or used the vaccine include Nepal