Requirements for Hepatitis B Vaccine prepared from Plasma, Annex 8, TRS No 771

Overview

HBV has not yet been cultivated in cell culture. Because of the urgent need for hepatitis B vaccine, WHO Requirements were formulated in 1980 and revised in 1984. Since it has been shown that the separated viral coat proteins, containing hepatitis B surface antigen, lead to the production of protective antibody, it is possible to use purified , non-infectious 22nm spherical hepatitis B surface antigen particles, or subunits derived from the surface antigen, as vaccines. Each of the following sections constitutes a recommendations.

Full version of WHO Technical Report Series No. 771 (part 2)