EVALUATING THE CONSISTANCY OF THE SECOND NATIONAL STANDARD OF TETANUS VACCINE

Abstract

Regarding to quality control of tetanus-containing-vaccine, the standard of tetanus vaccine is used as a reference to ascess the test sample quality. The second national standard of tetanus vaccine (code MCQG.UV.02) has been established and used since 2020, but has not been evaluated for its consistancy. The study was carried out to evaluated the consistancy of MCQG.UV.02 by applying trend analysis of ED₅₀ values of the standards each time the potency test of tetanus-containing-vaccine was performed in accordance to the Shewhart chart. Results: The geometric mean (GM) value of ED₅₀ of MCQG.UV.02 was 1,56; GM ± 3SD range was 1,56 ± 0,87, there was no value outside of 3SD action limits; GM ± 2SD range was 1.56 ± 0.58, there were no 2 consecutive points outside of 2SD warning limits; GM ± 1SD range was 1.56 ± 0.29, there were no 4 consecutive points outside of 1SD limits, there were no 6 consecutive points increase or decrease; there were no 8 consecutive points on same side of the mean line. Conclusion: The second national standard of tetanus vaccine MCQG.UV.02 meets the requirements for quality consistancy according to the World Health Organization’s standards.