[Scientific-methodological foundations of the study and assessment of vaccine side-effects]

It is emphasized that against the background of significant changes in the epidemic situation and technical possibilities of mass vaccinations the injurious action of a number of traditionally used vaccines served as the cause of revision of the strategy and tactics of their use. The conept according to which the character of the changes in the organism of individuals inoculated with the liver vaccines should display a principal difference from such in the individuals vaccinated with the preparations of the antigenic level (which also points to the differences in the methodical principles of the study and the assessment of the indices of their damaging action) is discussed. The author believes that the study of the side-effects of the "candidates for the position" of the live vaccine should be realized at the pathogenetic level under the motto of the high similarity to the processes developing after their administration or natural infection with wild strains, with consideration to the special organization of investigations for the detection of the frequency and the spectrum of the possible remote sequelae of the immunization (encephalitogenicity, etc.). For the study of the injurious action of the vaccine preparations of the antigenic level the authors recommend a complex of methods giving information on the quantitative characteristics of their pharmacological, pharmacodynamic and toxicological action, and also of the biological tolerance of their different doses on the experimental and clinical levels. It is emphasized that the information collected traditionally on the vaccine reactogenicity parameters is primarily necessary for the elaboration of a system of methods of their production control for the purpose of timely rejection of non-standard batches.