The evaluation of the possibility of the estimation the amount of hemagglutininin in the final lots of inactivated adjuvanted influenza vaccines.

Abstract

Introduction: The main quality indicator for inactivated influenza vaccines is their potency (the amount of hemagglutinin). The potency test for the influenza vaccine with the SOVIDON adjuvant is carried out in a trivalent bulk vaccine before the addition of the adjuvant. This approach has its fair share of drawbacks. The analysis of the statistical process control and stability by control charts plays an important role in the release of influenza vaccines. The aim of the study is to compare the results of hemagglutinin quanitation in the trivalent bulk vaccine and in the final lots of influenza vaccine with SOVIDON adjuvant; as well as the analysis of the potency test results to evaluate the statistical process control.

Materials and methods: This study covered the inactivated influenza vaccine with the SOVIDON adjuvant. Both the trivalent bulks vaccine before the addition of the adjuvant and the final lots were investigated by single radial immunodiffusion assay. The software SIAMS Photolab was used to calculate the amount of hemagglutinin. Microsoft Excel was used to create the control charts using the data of the manufacturer.

Results: The data of the study confirm the absence of statistically significant differences (p < 0.05) of the content of hemagglutinin in the trivalent bulks and the final lots of the influenza vaccine. The analysis of control charts showed the presence of out-of-control signals.

Conclusion: The study has shown the possibility and feasibility of the potency testing of the influenza vaccine with the SOVIDON adjuvant. The presence of out-of-control signals on the control charts is the basis for the identification of the reasons behind the changes and for the analysis of risks of the release of a defective influenza vaccine.