Public law Regulation of Personalized Immunoprophylaxis

The author discusses the legal, medical, and socioeconomic aspects of considering the immune status of employees in vaccination programs as a key element of personalized medicine in public healthcare systems. The development of modern personalized medicine, based on advances in immunology and genetics, opens up new opportunities for optimizing vaccine prophylaxis. The conducted review of foreign and domestic academic literature established the significant influence of genetic factors on both the effectiveness of vaccines and the development of post-vaccination complications. However, the current Russian legislation on mandatory vaccination of employees ignores the individual characteristics of the immune system, thereby raising legal controversies and potential health risks. In this research, the author aims to identify gaps in the regulatory framework arising from the integration of immune status assessment into the system of public law regulation of vaccine prevention in the Russian Federation and to propose on its basis solutions for updating the legislation. As a result, significant gaps in the legal regulation of personalized vaccination were identified. First, the current legislation is lacking the concept of “immune status” or mechanisms for its use, which is important for determining the necessity, safety, and schedules of immunization. Second, it is necessary to introduce preventive serological testing (screening) as legally significant evidence of a sufficient level of antibodies in order to protect the labor rights of employees from unjustified dismissal for the purpose of ensuring epidemiological welfare. Third, there is the absence of reliable protection of data on the immune and genetic status of employees as a special category of personal data. Particular attention is paid to the risks of post-vaccination complications and the need for a balanced approach to individual and public health. The economic benefits of a personalized approach are considered, including the optimization of vaccination costs and the minimization of side effects. The review of international and domestic publications revealed the need to balance public and private interests in ensuring the epidemiological welfare of the population and the rights of employees. It is concluded that the Russian legislation in this field should be improved in order to introduce a scientifically substantiated mechanism for personalizing vaccination, which will increase the safety of immunization programs, develop public trust, improve the level of epidemiological control, and enhance the efficient use of healthcare resources.

1. Andrews, N., Tischer, A., Siedler, A., Pebody, R.G., Barbara, C., Cotter, S., ... Griskevicius, A. (2008). Towards elimination: measles susceptibility in Australia and 17 European countries. Bulletin of the World Health Organization, 86(3), 197–204. https://doi.org/10.2471/blt.07.041129

2. Berg, L.N. (2023). Personalized Medicine: the Organizational and Legal Framework of the Medicine of the Future. Lex Genetica, 2(1), 7–23. (In Russ.). https://doi.org/10.17803/lexgen-2023-2-1-7-23

3. Briko, N.I., Onishchenko, G.G., Pokrovsky, V.I. (2018). Handbook of epidemiology of infectious diseases (in 2 volumes). Moscow: Meditsinskoe informatsionnoe agentstvo Publ. (In Russ.).

4. Chernyaeva, E.N., Morozov, K.V., Matsvay, A.D., Guskova, M.S., Nekrasov, A.Y., Stetsenko, I.F., Nosova, A.O., Kurskaya, O.G., Shestopalov, A.M., Shipulin, G.A. (2024). Molecular and genetic characteristics from phylogenetic analysis of Russian and foreign variants of measles virus 2020–2024. Extreme Medicine, 26(3), 40–51. (In Russ.). https://doi.org/10.47183/mes.2024-26-3-40-50

5. de Swart, R.L., Yüksel, S., Osterhaus, A.D. (2005). Relative contributions of measles virus hemagglutinin-and fusion protein-specific serum antibodies to virus neutralization. Journal of Virology, 79(17), 11547– 11551. https://doi.org/10.1128/jvi.79.17.11547-11551.2005

6. Drapkina, O.M., Briko, N.I., Kostinov, M.P., Feldblyum, I.V., Alyeva, M.Kh., Andreeva N.P., ... Shepel, R.N. (2020). Immunization of adults. Methodological recommendations. Moscow: Federal State Budgetary Institution “NMITs TPM” of the Ministry of Health of Russia. (In Russ.).

7. Farina, S., Maio, A., Gualano, M. R., Ricciardi, W., Villani, L. (2024). Childhood mandatory vaccinations: Current situation in European countries and changes occurred from 2014 to 2024. Vaccines, 12(11), 1296. https://doi.org/10.3390/vaccines12111296

8. Fedorov, A.M., Tatochenko, V.K., Wundtsettel, N.N., Aleksina, S.G. (2004). Post-vaccination complications. Children Infections, (2), 17–20. (In Russ.).

9. Haviari, S., Bénet, T., Saadatian-Elahi, M., André, P., Loulergue, P., Vanhems, P. (2015). Vaccination of healthcare workers: A review. Human Vaccines & Immunotherapeutics, 11(11), 2522–2537. https://doi.org/10.1080/21645515.2015.1082014

10. Hughes, L.E., Whitehead, R.H. (1976). The Assessment of Immune Status. In: Castro, J.E. (ed.). Immunology for Surgeons (pp. 90–134). Springer, Dordrecht. https://doi.org/10.1007/978-94-011-7173-1_4

11. Hussain, S. (2019). Immunization and Vaccination. In: Huremović, D. (ed.). Psychiatry of Pandemics (pp. 153– 177). Springer, Cham. https://doi.org/10.1007/978-3-030-15346-5_13

12. Kaufmann, S. H. (2019). Immunology’s coming of age. Frontiers in Immunology, 10, 684. https://doi.org/10.3389/fimmu.2019.00684

13. Kelleher, К. (2017, July 17). Achieving the Sustainable Development Goals: six reasons why immunisation matters. Gavi. Available at: https://www.gavi.org/vaccineswork/achieving-the-sustainable-development-goals-six-reasons-why-immunisation-matters.

14. Khristenko, V. (2018, April 25). The Economy of Vaccinations. How Vaccinations Help Governments Cut Costs. Forbes. (In Russ.). Available at: https://www.forbes.ru/biznes/360625-ekonomika-privivok-kak-vakcinaciya-pomogaet-gosudarstvam-sokrashchat-rashody

15. Lakhgain B., Voronkova S.V., Choybekova, K.M. (2018). Reducing the risks of infectious diseases in workers of different professions: the concepts of Europe and Asia. Sanitary Doctor, (1), 39–46. (In Russ.).

16. Latysheva, T.V., Latysheva, E.A., Setdikova, N. Kh., Kostinova, A.M. (2020). Is it necessary to vaccinate immunodeficiency patients against influenza? Therapy, 6(2), 82–87. (In Russ.). https://doi.org/10.18565/therapy.2020.2.82-87

17. Martynova, A.V., Li, M.V., Alenitskaya, M.V. (2023). Modern approaches to assessing the effectiveness of medical organizations. Vladivostok: Publishing House of the Far Eastern Federal University. (In Russ.).

18. Maslennikova, N.P. (2021). Optimization of organizational and methodological foundations of immunoprophylaxis in the Russian Federation. [Dissertation, I.M. Sechenov First Moscow State Medical University]. Moscow. (In Russ.).

19. Medunitsyn, N.V., Mironov, A.N. (2012). Vaccines. New methods to improve the effectiveness and safety of vaccination. Problems of Virology, (S1), 43–51. (In Russ.).

20. Nafea, A.M., Wang, Y., Wang, D., Salama, A.M., Aziz, M.A., Xu, S., Tong, Y. (2024). Application of next-generation sequencing to identify different pathogens. Frontiers in microbiology, 14, 1329330. https://doi.org/10.3389/fmicb.2023.1329330

21. Nusbaum, N. J. (1991). HIV Antibody Status and Employment Discrimination: 1991 Update. JAIDS Journal of Acquired Immune Deficiency Syndromes, 4(10), 927–929. Available at: https://journals.lww.com/jaids/citation/1991/10000/hiv_antibody_status_and_employment_discrimination_.1.aspx

22. Orenstein, W.A., Offit, P.A., Edwards, K.M., Plotkin, S.A. (2022). Plotkin's Vaccines. Elsevier Health Sciences. https://doi.org/10.1016/C2019-0-00240-3

23. Plans-Rubió, P. (2012). The vaccination coverage required to establish herd immunity against influenza viruses. Preventive Medicine, 55(1), 72–77. https://doi.org/10.1016/j.ypmed.2012.02.015

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

25. Salmon, D.A., Teret, S.P., MacIntyre, C.R., Salisbury, D., Burgess, M.A., Halsey, N.A. (2006). Compulsory vaccination and conscientious or philosophical exemptions: past, present, and future. The Lancet, 367(9508), 436–442. https://doi.org/10.1016/S0140-6736(06)68144-0

26. Semenza, J.C., Sewe, M.O., Lindgren, E., Brusin, S., Aaslav, K.K., Mollet, T., Rocklöv, J. (2019). Systemic resilience to cross‐border infectious disease threat events in Europe. Transboundary and Emerging Diseases, 66(5), 1855–1863. https://doi.org/10.1111/tbed.13211

27. Shakhanina, I.L., Jasinsky A.A. (2010). The concept of determining the economic efficiency of vaccination prophylaxis. Epidemiology and Vaccinal Prevention, 4(53), 74–79. (In Russ.).

28. Svetlichnaya, S.V., Elagina, L.A., Popovich, L.D. (2023). Evaluation of the potential economic effects in the increased vaccination against meningococcal infection based on real epidemiological data. Real-World Data & Evidence, 3(2), 31–41. (In Russ.). https://doi.org/10.37489/2782-3784-myrwd-34

29. Voronkova, S.V. (2021). The Role of Administrative Procedures in the System of State Regulation of Vaccinology in the Context of the COVID-19 Pandemic. In: Amendments to the Constitution of the Russian Federation and the Tasks of Legal Science. Proceedings of the conferences within the framework of the X Moscow Legal Week: XVIII International Scientific and Practical Conference (Kutafin Readings) of the Kutafin Moscow State Law University (MSAL), XXI Annual International Scientific and Practical Conference of the Law Faculty of the Lomonosov Moscow State University (MSU). (Part 5). Moscow: RG-Press Publ. (In Russ.).

30. Wang, T.L., Jing, L., Bocchini Jr, J.A. (2017). Mandatory influenza vaccination for all healthcare personnel: a review on justification, implementation and effectiveness. Current Opinion in Pediatrics, 29(5), 606–615. https://doi.org/10.1097/MOP.0000000000000527