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The urgency of optimization of evaluation of safety and efficacy of vaccination is shown. The basic criteria for evaluating the effectiveness of vaccination are described. The concepts of epidemiological and immunological effectiveness of vaccination are explained on influenza example . The article describes difference between potential and actual effectiveness. It has been determined that the greater the difference between these two kinds of efficiency, the more reason to questioin this means of immunization and strengthen the control of vaccine prophylaxis. It is suggested that the creation of a uniform system for assessing the safety and efficacy of medical immunobiological preparations (MIP), based on the principles of evidence-based medicine, increase the credibility and, consequently, lead to an increase in coverage among the general population and among health workers.