Requirements for Hepatitis A vaccines (inactivated), Annex 2, TRS No 858

Overview

The isolation and propagation of HAV in cell culture were critical steps in the successful idevelopment of hepatitis A vaccines. These Requirements relate only to the production of hepatitis A vaccine (inactivated) in human diploid cells or continuous cell lines. If any other production process is used, different requirements may apply. Each of the following sections constitutes a recommendations. To facilitate internation distribution of vaccine made in accordance with these Requirements, an example of a summary protocol for recording the results of tests is provided as Appendix 1. 

Full version of WHO Technical Report Series No. 858