INTERCHANGEABILITY OF VIRAL VACCINES FOR IMMUNIZATION

The review presents the results of the analysis of domestic and foreign scientific literature on the interchangeability of hepatitis A, B and influenza vaccines. The WHO materials, regulatory documents, data from scientific literature of foreign countries and Russia about the vaccine interchangeability are summarized. The problem of objective assessment of interchangeability of drugs is relevant worldwide. The definition of an “interchangeable drug” does not draw a clear line between the interoperability criteria for chemical and immunobiological drugs. The official guidance documents on immunization adopted in several countries define “interchangeability” as the practice of transition from a vaccine available from a certain manufacturer to a similar vaccine available from another manufacturer. The term “interchangeable” can be applied to immunobiological drugs if one of the drugs can be replaced with the other in the course of vaccination. The concept of interchangeability applies to vaccines that do not differ in efficacy (immunological, preventive, epidemiological) and safety and are used in an immunization course involving multiple administration of these vaccines. The definition of interchangeability is important in order to address the problem of replacing unidirectional vaccines available from different manufacturers when purchasing vaccines included in the national schedule of preventive vaccinations and in the schedule of preventive vaccination on epidemic indications. One of the most important conditions for “interchangeability” of vaccines is their application in accordance with the recommended schedule of administration and the dosage indicated by the manufacturer. Research data show that vaccines can be interchangeable if used in accordance with the recommended schedule of administration and the dosage specified by the manufacturer. Control agencies of many countries issue recommendations regulating the procedure of vaccine replacement in case of necessity. However, there are no special regulations of vaccine interchangeability in Russia. The concept of vaccine “interchangeability” should be extended to the continuation of a course of vaccinations in a particular person with a vaccine of another manufacturer and the possibility of applying similar vaccines available from different manufacturers.

review, interchangeability, vaccine, immunobiological drug, vaccination