EVALUATION OF THE FIRST NATIONAL STANDARD DIPHTHERIA VACCINE

Abstract

The efficacy testing of diphtheria vaccines is a mandatory requirement according to WHO recommendations and the standards of the Vietnamese Pharmacopoeia V. This study aims to evaluate of the first national standard diphtheria vaccine, coded MCQG.BH.01, through the analysis of the Slope value when performing efficacy testing of diphtheria vaccines using Shewhart charts. The slope value is an important index showing the slope of the standard sample graph calculated on the number of live/dead cell wells corresponding to each dilution, which is a decisive index showing us the stability of the diphtheria standard sample. The study used 21 data from 2021 to 2023. The results showed that the average Slope value was 4.251; no values fell within the action zone, no two consecutive points fell within the warning zone, and no four consecutive points were beyond the control limits. According to the evaluation criteria, there were no signs of instability trends in six or eight consecutive points. Therefore, the MCQG.BH.01 standard fully meets the requirements for stability and quality according to WHO standards, ensuring efficacy in diphtheria vaccine efficacy testing at NICVB and for manufacturers