Establishment of the national reference standard of acellular pertussis vaccine

Abstract

Currently, Viet Nam is in need of a national acellular pertussis reference standard to use in the quality control of vaccines that contain acellular pertussis component. In 2017, National Institute for Control of Vaccine and Biologicals conducted a research with two aims: develop the specifications for the national reference standard of acellular pertussis vaccine suitable for the condition of Vietnam, and establish a lot of that reference standard. The research has given specifications for the national reference standard of acellular pertussis vaccine, produced a candidate lot of the reference. Upon manufacture, the candidate was evaluated for quality, calibrated against the international standard. The results: The candidate meets the requirements with potency of 72 (30,67- 113,97) IU/ampoule, was recognized as a national reference standard, lot as MCQG.aP.01.