[Analysis of the scientific-methodologic basis for vaccine standardization using cholerogen-toxoid as a model]

The author discusses methodical principles of the vaccine standardization on the basis of experience in the standardization of the cholerogen-toxoid, a principally new vaccine preparation for the immunoprophylaxis of cholera. The author substantiated the statement according to which the following should serve as the task of primary importance in the program of investigations: elaboration of a system laboratory-immunological methods for the measurement of properties and quality of preparation, and primarily of its efficacy, strictly adequate to the biological nature of the vaccine (correct), highly-reproducable and of a high informative value. Data are presented proving the fact that without solving the problem of standardization of the vaccine it is practically impossible to lay scientific foundation under the choice of the optimal vaccination doses, under the immunization scheme, and introduction into the association with other preparations etc. At the same time it is emphasized that the absence of the system of measurement of the properties responsible for the biological activity of the vaccine also excludes a possibility of successive improvement of the technology of its production.