Recommendations to assure the quality, safety and efficacy of BCG vaccines, Annex 3, TRS No 979

Overview

The last revision of the Requirements for dried bacille Calmette–Guérin (BCG) vaccine for human use was in 1985, and an amendment which updated the section on the expiry date was published in 1988. Recent WHO consultation meetings have addressed issues concerning the improvement of vaccine characterization and quality control assays of BCG vaccine to reflect current stateof-the-art technology. In addition, a recommendation to replace the International Reference Preparation for BCG vaccine by substrain-specific Reference Reagents evaluated by collaborative studies has been proposed.

This document provides: recommendations for the production and control of BCG vaccines (Part A); guidelines for nonclinical evaluation (Part B); guidelines for the content of the clinical development programme applicable to BCG vaccines (Part C); and recommendations for NRAs (Part D). The guidelines for nonclinical evaluation apply to classic BCG vaccine products that are still in need of such evaluation, including newly manufactured products requiring clinical trial studies or those produced following changes in the manufacturing process. The clinical part of this document aims to provide a basis for assessment of efficacy and safety of BCG vaccines in pre-licensing clinical trials as well as in post-marketing surveillance, monitoring consistency of production and clinical testing of new classic BCG vaccine products. If important changes have been introduced to an authorized production process, the need for preclinical and clinical testing should be considered on a case-by-case basis in consultation with the NRA(s) concerned.

Full version of   WHO Technical Report Series No. 979