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Biologicals. 2013 Nov;41(6):450-7. doi: 10.1016/j.biologicals.2013.06.001. Epub 2013 Jul 25.

WHO working group on the quality, safety and efficacy of japanese encephalitis vaccines (live attenuated) for human use, Bangkok, Thailand, 21-23 February 2012.

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1
University of Texas Medical Branch, Galveston, TX, USA.

Abstract

Japanese encephalitis (JE) is one of the most important viral encephalitides in Asia. Two live-attenuated vaccines have been developed and licensed for use in countries in the region. Given the advancement of immunization of humans with increasing use of live-attenuated vaccines to prevent JE, there is increased interest to define quality standards for their manufacture, testing, nonclinical studies, and clinical studies to assess their efficacy and safety in humans. To this end, WHO convened a meeting with a group of international experts in February 2012 to develop guidelines for evaluating the quality, safety and efficacy of live-attenuated JE virus vaccines for prevention of human disease. This report summarizes collective views of the participants on scientific and technical issues that need to be considered in the guidelines.

KEYWORDS:

Efficacy; Japanese encephalitis vaccine; Quality; Safety; World Health Organization

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