The quality and stability assessment of a candidate national standard for the cell-based inactivated Japanese encephalitis vaccine Beijing-1 strain in Vietnam

Abstract

Reference standard is an indispensable reagent in quality control testing for Japanese Encephalitis vaccine. However, the world hasn’t had the cell-based inactivated Japanese Encephalitis international standard vaccines. Vietnam also hasn’t had this national standard vaccine. So, in May 2020 NICVB had ordered VABIOTECH company produced for a candidate batch of Japanese Encephalitis national standard vaccine (lot BR-520) according to the general requirements for standard vaccines that
WHO regulation. This study aims to the quality and stability assessment of a candidate national standard for the cell-based inactivated Japanese encephalitis vaccine Beijing-1 strain in Vietnam, the specifcation for release; uniformity of potency and stability of potency with time at storage temperature of 4oC and at 25oC, 37oC in the different time ranges: 1 week, 2 weeks,
3 weeksand 4 weeks. The results showed that the candidate vaccine (Lot BR-520) met the requirements of release; Uniformity of potency; thermally stable and predictable the shelflife is about 11.1 years.