TREND ANALYSIS OF EFFECTIVE TESTING OF ROTAVIN-M1 VACCINE IN VIETNAM IN 2021

Abstract

Rotavirus is a leading cause of acute diarrhea and child death globally. Currently, active disease prevention with vaccines for the community is the most effective. Rotavin-M1 vaccine is researched and produced by Centrer for Research and Production of vaccines and Biologicals and has been licensed for circulation since 2012. Therefore, monitoring the effectiveness of the vaccine to ensure the quality of the vaccine. It is the responsibility of the National Institute for Control of Vaccines and Biologicals (NICVB) recommended by the World Health Organization (WHO). Retrospective method of potency outcome data at POLYVAC and NICVB from 2013-2021. The average potency results at the POLYVAC  and NICVB from 2013-2020 were 6.28 log₁₀PFU/ml and 6.26 log₁₀PFU/ml. In particular, the potency results between POLYVAC and NICVB on the same 15 lots of Rotavin-M1 vaccines produced in 2021 gave an average result of 6.26 log₁₀PFU/ml and 6.24 log₁₀PFU/ml. The potency results of the batches were all stable within the warning range (±2SD) and there was no statistically significant difference (P=0.167 > 0.05) between the two laboratories. From the results of analyzing the potency of Rotavin-M1 vaccine, the  results are stable and there is no difference between POLYVAC and NICVB.