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During a prospective multicenter non-interventional observational study, a comparative assessment was made of the serotype structure of pneumococci circulating among healthy children under the age of 5 years and children of the same age group with signs of respiratory infections in the periods 2016-2018 and 2020-2022. Data on the serotype structure of pneumococci in the period from 2016-2018 were obtained from our previous works. In 2020-2022 the study included 2066 healthy children and 603 children with respiratory infections. Streptococcus pneumoniae and their DNA were detected in nasopharyngeal swabs by classical culture and molecular methods. Typing was carried out by molecular methods. On the territory of the Russian Federation, pneumococci belonging to the serotypes included in the 13-valent vaccine are being forced out of circulation and replaced by non-vaccine serotypes. Before the introduction of mass antipneumococcal vaccination (until 2015), the 13-valent conjugate vaccine covered from 66.2% to 92% of pneumococci, after the start of mass anti-pneumococcal vaccination in the period 2016-2018, coverage decreased to 57.3%. Between 2020 and 2022, coverage was less than 40%. The main “non-vaccine” serotypes/serogroups circulating in the Russian Federation are 15AF, 11AD, 23A, 9LN and 16F.

Relevance. The need to create a domestic pneumococcal polyvalent vaccine is one of the main directions of the «Strategy for the development of vaccine prevention of infectious diseases for the period up to 2035».Aim. To evaluate the immunological efficacy and safety of the pneumococcal polysaccharide conjugate adsorbed thirteen-valent (PCV13) vaccine in the immunization of adults and children in theRussian Federation.Materials and methods. The immunological efficacy and safety of the pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine were studied in a prospective comparative randomized double-blind study in parallel groups in adult volunteers aged 18 to 65 years and a multicenter open comparative study in parallel groups in young children. In a clinical study of adults, 60 volunteers were randomized into two groups according to the 1:1 scheme (groupI, n = 30; group II, n = 30). A clinical study in children included 119 volunteers aged 15 months who were divided according to the 1:1:1 scheme (group I, n = 39; group II, n = 40; group III, n = 40). The reference vaccine in both studies is Prevenar® 13 (Pfizer Inc., USA).Results. A clinical study in adults showed no statistically significant difference between the study groups according to the results of primary (the proportion of volunteers whose concentration of serotype-specific IgG to each of the 13 pneumococcal serotypes is equal to or exceeds the level of 0.35 mcg/ml (p > 0.039) before vaccination and 4 weeks after vaccination) and secondary criteria for evaluating effectiveness. Thus, the results obtained indicate a comparable level of immunogenicity of PCV13 with the comparison drug Prevenar®13 with a single intramuscular injection to healthy volunteers aged 18–65 years. Safety in both groups was comparable, 15 local reactions were registered, including 7 in group I volunteers who received the test drug, and 8 in comparison group volunteers. There were no statistically significant differences in the frequency of registered adverse events between the groups. Similar results were obtained with the immunization of children. For all 13 serotypes of the new PCV13 in relation to the reference drug, both primary and secondary criteria for assessing immunogenicity during immunization of children have been achieved (Difference ≤ 10% and GMC and GMT Ratio ≥ 0.5, respectively), which proves no less effectiveness of the pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine compared with the reference vaccine Prevenar® 13. During the clinical study, a total of 27 adverse events were registered in children, which were associated with the introduction of vaccines and were represented by local and systemic reactions (5 AEs in study participants from group I (5/39) 12.80%, 18 AEs in study participants from group II (18/40) 45.0% and 4 AEs in study participants from group III (4/40) 10%). No SAEs were registered in this study.Conclusion. The obtained results of the researches in children and adults allow us to recommend the preparation pneumococcal polysaccharide conjugate adsorbed thirteen-valent vaccine for immunization in order to prevent pneumococcal infection, both adults and children according to the 2+1 scheme within the National vaccination schedule and the calendar of preventive vaccinations according to epidemic indications of the Russian Federation.

The article presents an overview of the data of foreign and domestic literature, as well as the authors' own research on the problem of vaccination of the adult population against pneumococcal infection. The need to expand vaccination coverage against adult pneumococcal infection among atrisk populations was identified. The strategy and tactics of vaccination of the adult population against pneumococcal infection have been scientifically justified.

Background. Vaccination is considered by the world community as the main measure of the fight against pneumococcal infection [1–3]. Immunization of children has been carried out since the end of 2014. Goals. To study the compliance of the vaccination scheme against pneumococcal infection in young children and its influence on vaccination efficacy.Methodology. Evaluation of the compliance of the vaccination schedule against pneumococcal infection and the impact on morbidity in young children was carried out under the conditions of epidemiological observational descriptive and analytical («cohort») researches. Expert assessment is made of medical records of 52 patients, and 200 electronic medical cards and 200 cards of prophylactic vaccination in children were born in of 2015 and 2016.Results. The high importance of adherence to the vaccination scheme against pneumococcal infection was established not only in the prevention of disease and also in reducing carriage of S. pneumoniae. The greatest effect of pneumococcal immunization was observed in children who received the first vaccination before the age of 6 months and with a completed course of vaccination.Conclusion. Timeliness of immunization of young children against pneumococcal infection is a significant factor in ensuring preventive efficacy of immunization.

The results of foreign and Russian author`s researches about immunization of adult population are presented in article. The analysis of the vaccinal prevention state of infectious diseases in adults in different countries of the world (national guidance on adults immunization, coverage of preventive vaccinations, financing mechanisms) is given. The tasks of improving immunization in adult population of Russia are defined.

The analysis of the vaccine preventive status of infectious diseases in adults in Russia and various countries of the world is presented in the article. The problems and directions of improving the immunization of the adult population in Russia are identified.