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.