Analysis of Batch to Batch Consistency of a Locally Produced Influenza Vaccine for the 2017–2018 Influenza Season

Abstract

The efficacy of influenza vaccines has been a matter of considerable debate ever since the development of the first influenza vaccine. The efficacy of currently used influenza vaccines depends on many  factors, including the strain composition, the degree of homology  between the produced and epidemic influenza viruses, the  vaccination coverage, and many other factors. Assessment of quality, i.e. determination of compliance of the product’s quality  characteristics with the specification requirements, and assessment  of risks associated with the use of the product were considered only  in the context of general requirements for the quality of biologicals.  The article summarises the results of analysis of batch to batch  consistency of the influenza inactivated polymer-subunit vaccine. The study included a retrospective assessment of the data  obtained during the product release control and testing performed by an accredited testing centre as part of mandatory certification. The  data obtained may be used to improve the production method and  the system of statistical management of the production process, as  well as to assess the risks accompanying the production of influenza vaccine at each of the stages.