Recommendations for the production & control of Haemophilus influenzae type b conjugate vaccines, Annex 1, TRS No 897

Overview

The 1991 Requirements for Haemophilus influenzae type b vaccines adopted by the WHO ECBS in 1990 embodied recommendations made by an informal consultation held in 1989. Much experience has been gained with the preparation and control of these vaccines since that time, including recognition that some vaccine lots that complied with the Requirements had reduced immunogenicity in children. This emphasized a need to reassess vaccine control strategies and for continued post-marketing surveillance. A revision of the 1991 recommendations has therefore been prepared, which takes into account the above-mentioned considerations. 

Full version of WHO Technical Report Series No. 897