STABILITY ASSESSMENT OF THE FIRST NATIONAL STANDARD FOR ROTAVIRUS VACCINE

Abstract

In early 2019, the National Institute for Control of Vaccines and Biologicals (NICVB) implemented a national-level project to establish the first national standard for rotavirus vaccines to be used in the quality control of rotavirus vaccines, code MCQG.Ro.01. However, a stability assessment of the national standard has not been carried out yet. NICVB had performed a study entitled "Stability assessment of the first national standard for rotavirus vaccine" with the purpose of providing the prediction shelf life through a thermally accelerated degradation study. In this study, the first national standard for rotavirus vaccine was stored at 4 °C, 25 °C, and 37 °C. At each temperature, the potency of the vaccine was evaluated after 3 days, 5 days, 7 days and 10 days. The stability data were analysed by JMP Pro13 software, the software used to predict the expiry date of vaccines and biological products based on the Arrhenius equation. As a result, the first national standard for rotavirus vaccine, code MCQG.Ro.01, has a predicted shelf life of 27 years when stored at -70 °C.