WHO/BS/2019.2374 Evaluation of Candidate International Standards for Meningoccal Capsular Group W and Y Polysaccharides

Overview

Until the introduction of International Standards for MenC, MenA and MenX polysaccharides, the standardization of measurement of polysaccharide content within these vaccines was problematic. This was due to the variety of methods and standards employed by different manufacturers and control laboratories in the physicochemical assays to test polysaccharide or conjugate vaccines. For determining the MenW and MenY polysaccharide content in vaccines, these problems remain.

For this study, two candidate International Standards for meningococcal capsular group W (MenW) and Y (MenY) polysaccharides were assessed for their suitability as quantitative standards in various physicochemical assays. The intention is that these standards will be used to standardize the quantification of the respective polysaccharide content in meningococcal polysaccharide (conjugate) vaccines and their intermediate components. Twelve laboratories from eleven different countries participated in the collaborative study of candidate International Standard MenW and MenY polysaccharide preparations (coded 16/152 and 16/206, respectively).