Recommendations to assure the quality, safety and efficacy of Japanese encephalitis vaccines (live, attenuated) for human use, Annex 7, TRS No 980

Replacement of Annex 3 of WHO TRS No. 910

Overview

These WHO recommendations are intended to provide national regulatory authorities and vaccine manufacturers with guidance on evaluating the quality, safety and efficacy of live-attentuated Japanese Encephalitis vaccines for use in humans to facilitate their international license and use. 

The Recommendations replace the WHO Guidelines for the production and control of Japanese encephalitis vaccine (live) for human use, and should be read in conjunction with the other WHO Recommendations and Guidelines referred to in each part. 

The scope of these Recommendations is limited to live-attentuated JE vaccines for human use. Other types of JE vaccines are outside the scope of these Recommendations. Revised WHO Recommendations for inactivated JE vaccines are available separately. 

Full version of the WHO Technical Report Series N° 980

 

 

 

WHO Team
Health Product Policy and Standards (HPS), Norms and Standards for Biological Products (NSB)
Number of pages
80
Reference numbers
WHO Reference Number: WHO TRS N°980
Copyright
World Health Organization