КОНТРОЛЬ КАЧЕСТВА И СТАБИЛЬНОСТЬ ВАКЦИН ПРОТИВ MPOX: СОВРЕМЕННЫЕ КРИТЕРИИ И ПОДХОДЫ

This article presents a comparative analysis of current requirements for stability assessment and quality control of mpox vaccines in accordance with the recommendations of the World Health Organization (WHO), the regulatory framework of the Eurasian Economic Union (EAEU), the International Council for Harmonisation (ICH), and the Republic of Kazakhstan. The main approaches to stability testing of immunobiological products are discussed, including long-term and accelerated studies, their objectives, testing conditions, and their role in establishing vaccine shelf life. The review systematizes the principal quality attributes used in vaccine stability assessment, including physicochemical parameters (appearance, pH, and homogeneity), biological characteristics (infectious titer, antigen content, immunogenicity, and genetic stability), safety indicators (toxicity, pyrogenicity, and reversion to virulence), and microbiological purity. It is shown that deviations from recommended storage temperatures, as well as exposure to light and moisture and disruptions in the cold chain, may lead to degradation of antigenic components and a decline in vaccine immunogenicity. Additional attention is given to the characteristics of currently available mpox vaccines, including ACAM2000, JYNNEOS, LC16m8, and OrthopoxVac, with emphasis on vaccine platform, replicative properties, and storage conditions. The analysis demonstrated that international and regional regulatory requirements are generally harmonized; however, certain differences remain in approaches to stability studies and quality control procedures. The findings highlight the need for further improvement of the national regulatory framework and the implementation of advanced methods for assessing vaccine biological activity.