Recommendations for Japanese encephalitis vaccine (inactivated) for human use, Annex 1, TRS No 963

Overview

The scope of the present Recommendations encompasses inactivated JE vaccines produced in mouse brain and in cell substrates (e.g. primary hamster kidney cells and a continuous Vero cell line). This document sets out the recommendations for manufacture and quality assessment in Part A. Guidance specific to the nonclinical and clinical evaluation of inactivated JE vaccines is provided in Parts B and C, respectively. Part  D provides recommendations for national regulatory agencies. This document should be read in conjunction with all relevant WHO guidelines including those on nonclinical (3) and clinical evaluation (4) of vaccines.

Full version of the WHO Technical Report Series N° 963