Establishment and production of the national reference standard of Vi typhoid vaccine in Vietnam

Abstract

Vietnam uses many batches of typhoid Vi vaccine produced domestically as well as imported from abroad. However, there isn’t any national reference standard for using in quality control test of typhoid Vi vaccine available yet. The purpose of this research is to establish a batch of typhoid vaccines reference standard meets WHO requirements by giving specifcation for the standard, and to produce a candidate standard lot according to a given specifcation, controlling its quality, determining Vi content by calibrating it against the international standard of typhoid Vi vaccine. National Institute for Control of Vaccine and Biologicals has collaborated with StateOwned One Member Limited Company vaccine Pasteur Da Lat to produce a candidate typhoid Vi vaccines reference standard. The study results revealed that the candidate meets the specifcation, was recognized as a national reference standard of typhoid Vi vaccine, with content of (23.54 ± 1.42) µg Vi antigen polysaccharide per vial.