A Decade of Experience in the use of 13-Valent Conjugated Polysaccharide Pneumococcal Vaccine in Russian Federation

Pneumococcal infection remains a significant global health problem, and vaccination is the main measure for its prevention. To date, the period of use of pneumococcal conjugated polysaccharide vaccines in Russia exceeds 14 years, and 13-valent conjugated polysaccharide pneumococcal vaccine (PCV13) - more than 10 years. During this time, extensive experience has been accumulated in the use of this type of vaccines, and many studies have been carried out to evaluate their effectiveness and safety.

The purpose of this review is to summarize the experience of using PCV13 in Russian Federation with an assessment of its epidemiological and clinical effectiveness. A search was made for scientific publications devoted to the study of the epidemiological efficacy, the safety as well as cost-effectiveness of PCV13 use in Russian Federation. The review included original studies published in Russian journals. The results of the studies carried out indicate the efficacy and safety of PCV13 for both adults and children. The effectiveness of immunization of children at risk (premature, suffering from congenital pathology, having chronic diseases and often ill) was demonstrated, the need and safety of the timely start of vaccination (from 2 months of age) of newborns was shown, the possibility of its combination with immunization against other infections within the framework of the national vaccination schedule, the importance of following the recommended vaccination schedule in accordance with the age of the child. The effectiveness of vaccination of adults suffering from chronic diseases has been shown both in terms of preventing the aggravation of the course of the underlying pathology and reducing the risk of pneumonia. Positive experience has been gained in immunizing adults from occupational risk groups - medical workers, conscripts and persons exposed to a harmful production factor and having occupational lung diseases. The conducted studies have shown a high cost-effectiveness of PCV13 vaccination, however, with any changes in price and epidemiological parameters, it is necessary to clarify the economic feasibility of vaccination under the changed conditions. Taking into account the positive experience gained in immunization, it seems appropriate to further maintain a high level of vaccination coverage of the child population, expanding risk groups among the adult population subject to vaccination against pneumococcal infection within the framework of the National Immunization Schedule, taking into account its epidemiological, clinical and economic efficiency.

1. GBD 2019 Antimicrobial Resistance Collaborators (2022). Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet (London, England), 400(10369), 2221–2248. https://doi.org/10.1016/S0140-6736(22)02185-7

2. Briko NI, Korshunov VA, Lomonosov KS. Pneumococcal Infection in Russia: State of the Issue. Annals of the Russian Academy of Medical Sciences. 2021;76(1):28–42. doi: https://doi.org/10.15690/vramn1404 (In Russ).

3. Epidemiologija, klinika i profilaktika pnevmokokkovoj infekcii: Uchebnoe posobie dlja vrachej. Pod red. Briko N.I.: Nizhnij Novgorod: Remedium Privolzh’e; 2017 (in Russ.).

4. Drapkina O.M., Briko N.I., Kostinov M.P., et al. Imunizacija vzroslyh. Metodicheskie rekomendacii. M., FGBU «NMIC TPM» Minzdrava Rossii: 2020. 248 p. (In Russ).

5. Chuchalin A.G., Briko N.I., Avdeev S.N., Belevskiy A.S., et al. Federal Clinical Guidelines on Preventive Vaccination Against Pneumococcal infections in Adults. PULMONOLOGIYA. 2019;29(1):19–34. (In Russ.) https://doi.org/10.18093/0869-0189-2019-29-1-19-34

6. Andrés de Roux, et al. Comparison of Pneumococcal Conjugate Polysaccharide and Free Polysaccharide Vaccines in Elderly Adults: Conjugate Vaccine Elicits Improved Antibacterial Immune Responses and Immunological Memory. Clinical Infectious Diseases, Volume 46, Issue 9, 1 May 2008, Pages 1488) https://doi.org/10.1086/588219

7. Johns Hopkins Bloomberg School of Public Health International Vaccine Access Center (IVAC) Available at: https://view-hub.org/map/?set=vaccine-product-currentplanned&group=vaccine-introduction&category=pcv Accessed: 14 June 2023.

8. Emily K Horn, Icon,Matt D, et al. Pages 1291-1309 | Received 03 Jun 2021, Accepted 19 Aug 2021, Accepted author version posted online: 23 Aug 2021, Published online: 11 Sep 2021 https://doi.org/10.1080/14760584.2021.197152

9. Instrukcija po primeneniju lekarstvennogo preparata dlja medicinskogo primenenija Prevenar 13 — vakcina trinadcativalentnaja pnevmokokkovaja polisaharidnaja konjugirovannaja adsorbirovannaja. LP 000798-031011. Available at: https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=fa171426-1eca-44bc-81f4-6031a67504f1 Accessed: 14 June 2023. (In Russ).

10. Ruban H.P., Struch S.V. Vaccination as a solution of the issue of resistance S. pneumoniae. Epidemiology and Vaccinal Prevention. 2021;20(2):83–92. (In Russ.) https://doi.org/10.31631/2073-3046-2021-20-2-83-92

11. Prikaz MZ RF ot 06 dekabrja 2021 g. № 122n «Ob utverzhdenii nacional’nogo kalendarja profilakticheskih privivok i kalendarja profilakticheskih privivok po jepidemicheskim pokazanijam» Available at: http://publication.pravo.gov.ru/Document/View/0001202112200070 Accessed: 14 June 2023. (In Russ).

12. Il’ina S.V., Beleckaja O.A., Sabitov A.U. Rezul’taty ocenki jeffektivnosti i bezopasnosti primenenija konjugirovannyh pnevmokokkovyh vakcin v Rossijskoj Federacii. Jepidemiologija i infekcionnye bolezni. Aktual’nye voprosy № 6 /2013/S.55-59 In Russ).

13. Salkina O.A., Snegova N.F., Il’ina N.I., Kostinov M.P., Leshkevich I.A. Kliniko-immunologicheskaja jeffektivnost’ vakcinacii protiv pnevmokokkovoj infekcii u detej rannego vozrasta. Detskie infekcii. 2012. №1. In Russ).

14. Kharit S.M., Okuneva M.A., Ruleva A.A., Perova A.L., Simakhodskiy A.S., Chkhidzheria I.G., Parkov O.V., Frolova E.Y. EXPERIENCE OF IMPLEMENTATION OF THE COHORT PNEUMOCOCCAL VACCINATION PROGRAM FOR INFANTS IN ST. PETERSBURG. Pediatric pharmacology. 2014;11(3):76–78. https://doi.org/10.15690/pf.v11i3.1013 (In Russ)

15. Article E. Resolution of Meeting the Public Coordinating Council for the Study on Pneumococcal Disease and Vaccination in Russia. Epidemiology and Vaccinal Prevention. 2015;14(1):75–77. (In Russ.) https://doi.org/10.31631/2073-3046-2015-14-1-75-77

16. Semerikov V.V., Zubova E.S., Sofronova L.V. The Effect of Selective and Mass Immunization Against Pneumococcal Infection on the Morbidity and Mortality due to Community-Acquired Pneumonia in Children Under 5 Years of Age. Pediatric pharmacology. 2019;16(4):216–228 (In Russ.) https://doi.org/10.15690/pf.v16i4.2051

17. Chuchalin A.G., Onishhenko G.G., Kolosov V.P. Respiratornye infekcii u detej: rezul’taty realizacii regional’noj programmy vakcinoprofilaktik PEDIATRIJa/2016/Tom 95/№ 4/S. 196–201 (In Russ)

18. Somova A.V., Romanenko V.V., Golubkova A.A. Epidemiology of S. Pneumoniae-associated Pneumonias and the Analysis of Effectiveness of Vaccination against Pneumococcal Infection in Children under the Age of Six. Epidemiology and Vaccinal Prevention. 2018;17(1):25–32. (In Russ.) https://doi.org/10.31631/2073-3046-2018-17-1-25-32

19. Resolution of conference of advisory panel on pneumococcal disease and vaccination in Russia. Pediatric pharmacology. 2016;13(6):614–616 (In Russ.). https://doi.org/10.15690/pf.v13i6.1678

20. Briko N.I., Korshunov V.A., Namazova-Baranova L.S., et al. Estimation of 13-valent Pneumococcal Conjugate Vaccine Efficiency in Infants within National Immunization Schedule. Current Pediatrics. 2019;18(3):203–211 (In Russ.). https://doi.org/10.15690/vsp.v18i3.2038

21. Briko N.I., Korshunov V.A., Namazova-Baranova L.S., et al. The Results of a Three-Year Pneumococcal Vaccination of Children in Russia. Pediatric pharmacology. 2018;15(4):287–299 (In Russ.). https://doi.org/10.15690/pf.v15i4.1943

22. Kharit S.M., Fridman I.V., Pavlyukova A.N., et al.Clinical Efficacy of Pneumococcal Conjugate 13-valent Vaccine in Young Children. Pediatric pharmacology. 2016;13(5):443– 447 (In Russ.). https://doi.org/10.15690/pf.v13i5.1639

23. Il’ina S.V., Lyisanov Y.I. Vaccination of premature infants and children with congenital heart disease in Irkutsk using conjugated pneumococcal vaccines. Pediatric pharmacology. 2013;10(3):12–16 (In Russ). https://doi.org/10.15690/pf.v10i3.692

24. Semerikov V.V., Zubova E.S., Loshkareva V.L., et al. Bronchopulmonary Pathology Prevalence Among Premature infants and Estimation of Prophylactic Efficacy and Reactogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Premature infants with Bronchopulmonary Dysplasia. Pediatric pharmacology. 2019;16(6):372–378 (In Russ.). https://doi.org/10.15690/pf.v16i6.2075

25. Vavilova V.P., Vavilov A.M., Chercaeva A.H. Prevention of Pneumococcal Infection in Children with Chronic Diseases of the Nasopharynx Reduces the Incidence of Other Respiratory Tract Infections: Results of a Comparative Prospective Study. Current Pediatrics. 2015;14(5):557–563 (In Russ.). https://doi.org/10.15690/vsp.v14i5.1439

26. Fedoseenko M.V., Novikova D.A., Tkachenko N.E., et al. Experience of application and safety assessment of the 13-valent pneumococcal conjugate vaccine in under-5 children. Pediatric pharmacology. 2014;11(5):59–64 (In Russ). https://doi.org/10.15690/pf.v11i5.1166

27. Kurdup M.K., Galitskaya M.G., Davydova I.V., et al. Pneumococcal vaccination of children with chronic heart disease. Doctor.Ru. 2022; 21(3): 17–21 (in Russian). DOI: 10.31550/1727-2378-2022-21-3-17-21

28. Rudakova A.V., Uskov A.N., Kharit S.M., Sidorenko S.V. Pharmacoeconomic aspects of vaccination against Pneumococcal Infection in Russia. Journal Infectology. 2011;3(4):78–83 (In Russ.). https://doi.org/10.22625/2072-6732-2011-3-4-78-83

29. Romanenko V.V., Somova A.V. Ocenka jekonomicheskoj jeffektivnosti vakcinoprofilaktiki pnevmokokkovoj infekcii u detej do 5 let v Sverdlovskoj oblasti. Ural’skij medicinskij zhurnal. 2012. № 10 (102). S. 98–100 (In Russ).

30. Rudakova А.V., Baranov A.A., Lobzin Yu.V., et al. Pharmacoeconomic assessment of 13-valent pneumococcal conjugate vaccine in immunization of children in Russian Federation. Current Pediatrics. 2014;13(1):51–59 (In Russ.). https://doi.org/10.15690/vsp.v13i1.911

31. Bonten, M. J., Huijts, S. M., Bolkenbaas, M., et al. (2015). Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. The New England journal of medicine, 372(12), 1114–1125. https://doi.org/10.1056/NEJMoa1408544

32. Ignatova G.L., Blinova E.V., Struch S.V., Syrochkina M.A. Risk of community acquired pneumonia in patients with diabetes mellitus: Review. Terapevticheskii arkhiv. 2022. Vol. 94. N. 3. P. 448–453 (In Russ). doi: 10.26442/00403660.2022.03.201447

33. Gosudarstvennyj doklad «O sostojanii sanitarno-jepidemiologicheskogo blagopoluchija naselenija v Rossijskoj Federacii v 2022 g.». – M.: Federal’naja sluzhba ohrany po nadzoru v sfere zashhity prav potrebitelej i blagopoluchija cheloveka, 2023. – 340 s. (In Russ)

34. Briko N.I., Korshunov V.A., Vasilyeva I.A., Vorobieva A.D. Vaccination against pneumococcal infection in adults from risk groups. Tuberculosis and Lung Diseases. 2020;98(5):15–23 (In Russ.). https://doi.org/10.21292/2075-1230-2020-98-5-15-23

35. Demko I.V., Korchagin E.E., Gordeeva N.V., et al. An experience of vaccination against pneumococcal infection of adults at Krasnoyarsk krai. PULMONOLOGIYA. 2017;27(1):21–28 (In Russ.). https://doi.org/10.18093/0869-0189-2017-27-1-21-28

36. Romashov B.B., Poljakova N.V. Osobennosti patogeneza, kliniki i lechenija sochetanija hronicheskoj obstruktivnoj bolezni legkih i saharnogo diabeta. Molodoj uchenyj. 2015;13:310–4 (In Russ).

37. Couillard A, Veale D, Muir JF. Comorbidities in COPD: a new challenge in clinical practice. Rev Pneumol Clin. 201;67(3):143–53. doi: 10.1016/j.pneumo.2010.05.003

38. Protasov A.D., Zhestkov A.V., Kostinov M.P., et al. Analiz otdalennyh rezul’tatov jeffektivnosti i formirovanija adaptivnogo immuniteta pri primenenii raznyh preparatov i shem vakcinacii protiv pnevmokokkovoj infekcii u bol’nyh s hronicheskoj obstruktivnoj bolezn’ju legkih. Terapevticheskij arhiv. 2017. T. 89. № 12-2. S. 165–174. (In Russ)

39. Protasov A.D., Zhestkov A.V., Kostinov M.P., et al. Long-term clinical efficacy and a possible mechanism of action of different modes of pneumococcal vaccination in asthma patients. Pulmonologiya. 2018;28(2):193–199 (In Russ.). https://doi.org/10.18093/0869-0189-2018-28-2-193-199

40. Kostinov M.P., Zhestkov A.V., Protasov A.D., et al. Comparison of quality of life in patients with chronic obstructive pulmonary disease vaccinated with 13-valent conjugate pneumococcal vaccine or 23-valent polysaccharide pneumococcal vaccine. PULMONOLOGIYA. 2015;25(2):163–166 (In Russ.). https://doi.org/10.18093/0869-0189-201525-2-163-166

41. Jgnatova G.L., Antonov V.N. Analysis of compliance dynamics in patients with chronic obstructive pulmonary disease on the background of vaccination against pneumococcal infection. Terapevticheskii arkhiv. 2018. Vol. 90. N. 3. P. 47–52 (In Russ). doi: 10.26442/terarkh201890347-52

42. Ignatova G.L., Antonov V.N. Efficiency of vaccine prophylaxis concentrated pneumococcal vaccine in patients with chronic obstructive lung disease and chronic heart failure. Terapevticheskii arkhiv. 2018. Vol. 90. N. 8. P. 53–62 (In Russ). doi: 10.26442/terarkh201890853-62

43. Ignatova G.L., Blinova E.V., Antonov V.N., Grebneva I.V. Analysis of the impact of vaccination of pneumococcal infection in patients with chronic obstructive pulmonary disease in combination with diabetes. Terapevticheskii arkhiv. 2019. Vol. 91. N. 11. P. 49–54 (In Russ). doi: 10.26442/00403660.2019.11.000424

44. Ignatova G.L., Antonov V.N. Impact of vaccination with pneumococcal vaccines on recurrent pneumonia in patients with chronic obstructive pulmonary disease. Terapevticheskii arkhiv. 2022. Vol. 94. N. 11. P. 1257–1261 (In Russ). doi: 10.26442/00403660.2022.11.201932

45. Grabowska K, Högberg L, Penttinen P, Svensson A., Ekdahl K. Occurrence of invasive pneumococcal disease and number of excess cases due to influenza. BMC Infect Dis. 2006;6:58. doi: 10.1186/1471-2334-6-58

46. Ignatova G.L., Antonov V.N., Blinova E.V. Analysis of the effectiveness of joint or sequential vaccination with pneumococcal and influenza vaccines in patients with chronic obstructive pulmonary disease. Terapevticheskii arkhiv. 2019. Vol. 91. N. 8. P. 12–17 (In Russ). doi: 10.26442/00403660.2019.08.000205

47. Zhestkov A.V., Zolotov M.O., Lyamin A.V., et al. Results of immunoprophylaxis of HIV-infected patients with 13-valent conjugated pneumococcal vaccine. Terapevticheskii arkhiv. 2021. Vol. 93. N. 11. P. 1300–1305 (In Russ). doi: 10.26442/00403660.2021.11.201188

48. Kulikov P.V., Zhogolev S.D., Aminev R.M., Zhogolev K.D., Kuzin A.A., Rubova S.R., Gorenchuk A.N., Mikheeva E.A. Epidemiological and etiological characteristics of community-acquired pneumonia in conscripts in the modern period. Comparative evaluation of the effectiveness of pneumococcal vaccines. Journal Infectology. 2019;11(2):116– 123 (In Russ.). https://doi.org/10.22625/2072-6732-2019-11-2-116-123

49. Shpagina, L. A., Kotova, O. S., Shpagin, I. S., et al. (2018). Efficacy of 13-valent pneumococcal conjugate vaccine in healthcare workers. Terapevticheskii arkhiv, 90(11), 55–61 (In Russ). https://doi.org/10.26442/terarkh2018901155-61

50. Ignatova G.L., Rodionova O.V., Antonov V.N., Kandakov S.G., Brovman N.M. An impact of pneumococcal vaccination on exacerbations of occupational lung diseases. Pulmonologiya. 2019;29(4):428–434 (In Russ.). https://doi.org/10.18093/0869-0189-2019-29-4-428-434

51. Ignatova G.L., Antonov V.N., Rodionova O.V. Economic efficacy of vaccination of patients with chronic obstructive pulmonary disease and coronary heart disease. Pulmonologiya. 2015;25(3):312–319 (In Russ.). https://doi.org/10.18093/0869-0189-2015-25-3-312-319

52. Ignatova G.L., Antonov V.N., Rodionova O.V. Jeffektivnost’ vakcinoprofilaktiki kon#jugirovannoj pnevmokokkovoj vakcinoj u bol’nyh hronicheskoj obstruktivnoj bolezn’ju legkih za 3 goda. Consilium Medicum. 2016; 18 (3): 42–46 (In Russ).

53. Ignatova G.L., Antonov V.N. Epidemiological characteristics of chronic respiratory diseases in patients vaccinated against pneumococcal infection. Pulmonologiya. 2017;27(3):376–383 (In Russ.). https://doi.org/10.18093/0869-0189-2017-27-3-376-383

54. Ignatova G.L., Zakharova I.A., Antonov V.N. Clinical and Economic Efficiency of Vaccination in a Pneumococcal 13-Valent Conjugate Vaccine in Patients with Chronic Bronchitis at a Young Age. Epidemiology and Vaccinal Prevention. 2017;16(2):17–22 (In Russ.). https://doi.org/10.31631/2073-3046-2017-16-2-17-22

55. Briko N.I., Batyrshina L.R., Briko A.N. Ocenka prognosticheskoj jepidemiologicheskoj i jekonomicheskoj jeffektivnosti vakcinoprofilaktiki pnevmokokkovoj infekcii u muzhchin trudosposobnogo vozrasta s razlichnymi hronicheskimi zabolevanijami. Zhurnal mikrobiologii, jepidemiologii i immunobiologii. 2018. № 1. S. 17–23 (In Russ).

56. Briko N.I., Batyrshina L.R., Briko A.N. Predpolagaemaja jeffektivnost’ vakcinoprofilaktiki pnevmokokkovoj infekcii u muzhchin trudosposobnogo vozrasta. Profilakticheskaja medicina. 2018. T. 21. № 3. S. 10–15 (In Russ).

57. Rudakova A.V., Briko N.I., Lobzin Ju.V., et al. Vakcinacija vzroslyh protiv pnevmokokkovoj infekcii v Rossijskoj Federacii: social’nye i farmakojekonomicheskie aspekty. Zhurnal infektologii. 2018. T. 10. № 3. S. 11–22 (In Russ).

58. Rudakova A.V., Kharit S.M., Lobzin Yu.V. Vaccination against Pneumococcal Infections of High-Risk People: Pharmacoeconomic Aspects. Epidemiology and Vaccinal Prevention. 2019;18(6):39–44 (In Russ.). https://doi.org/10.31631/2073-3046-2019-18-6-39-44

59. Rudakova A.V., Briko N.I., Lobzin Yu.V., et al.Cost-effectiveness of vaccination against pneumococcal infection of adults at risk within the federal and regional programs. Journal Infectology. 2019;11(4):6–18 (In Russ.). https://doi.org/10.22625/2072-6732-2019-11-4-6-18

60. Orlova E.A., Dorfman I.P., Orlov M.A., Abdullaev M.A. Pharmacoeconomic evaluation of anti-pneumococcal vaccination in risk groups for the prevention of communityacquired pneumonia among adults in the Astrakhan region. Pharmacy & Pharmacology. 2020;8(6):436–445 (In Russ). https://doi.org/10.19163/2307-9266-2020-8-6-436445

61. Rudakova AV, Briko NI, Lobzin YuV, et al.Cost-effectiveness of vaccination of elderly citizens against pneumococcal infection in the Russian Federation. Profilakticheskaya Meditsina. 2021;24(12):41–48 (In Russ.). https://doi.org/10.17116/profmed20212412141

62. Rudakova A.V., Briko N.I., Lobzin Yu.V., et al. Cost-Effectiveness of Pneumococcal Vaccination among Patients with Diabetes Mellitus. Epidemiology and Vaccinal Prevention. 2022;21(5):78–88 (In Russ.). https://doi.org/10.31631/2073-3046-2022-21-5-78-88

63. Orlova E.A., Dorfman I.P., Umerova A.R., et al. Economic damage of pneumococcal vaccination absence as a risk factor for complications of chronic obstructive pulmonary disease. Pharmacy & Pharmacology. 2022;10(2):187–197. https://doi.org/10.19163/2307-9266-2022-10-2-187-197

64. Kolosov V.P., Kurganova O.P., Perel’man Ju.M., et al. Prognoznaja ocenka jeffektivnosti vakcinoprofilaktiki ostryh respiratornyh infekcij sredi stroitelej Amurskogo gazopererabatyvajushhego zavoda. V sbornike: Sistemnyj analiz v medicine (SAM 2022). Materialy XVI mezhdunarodnoj nauchnoj konferencii. Pod obshhej redakciej V.P. Kolosova. Blagoveshhensk, 2022. S. 177–182 (In Russ).

65. Rudakova A.V., Brico N.I., Lobzin Yu.V., et al. Cost-effectiveness of pneumococcal vaccination among patients with chronic heart failure. Kardiologiia. 2023;63(5):19–26 (In Russ.) https://doi.org/10.18087/cardio.2023.5.n2378

66. Macroeconomics and health: Investing in health for economic development. Report of the commission on macroeconomics and health to the WHO [Internet]. Geneva; 2001. Available at: http://apps.who.int/iris/bitstream/10665/42435/1/924154550X.pdf Accessed: 14 June 2023.