scholarly journals Vaccine interchangeability: problems and prospects

2021 ◽  
Vol 21 (3) ◽  
pp. 142-157
Author(s):  
N. A. Gavrilova ◽  
Yu. V. Olefir ◽  
V. A. Merkulov ◽  
V. P. Bondarev ◽  
E. M. Rychikhina ◽  
...  

Vaccines by different manufacturers are available for most of the vaccine-preventable infections covered by the National Immunisation Schedule of the Russian Federation. Determination of the possibility of replacing a vaccine in the case of routine or emergency vaccination still remains a challenging issue. The aim of the study was to substantiate the problem of vaccine interchangeability, outline specific challenges and ways of solving them, analyse criteria underlying evaluation of vaccine interchangeability in Russia, and international experience in this area. The procedure for determining the interchangeability of biological products, including vaccines, was established in the Decree of the Government of the Russian Federation of 5 September 2020, No. 1360 “On the procedure for determination of interchangeability of medicinal products for human use”. The paper analyses the applicability of the official criteria for interchangeability of biological products, including vaccines. It outlines the main problems of performing evaluation of vaccine interchangeability in accordance with the established criteria. It is concluded that the vaccine interchangeability criteria need to be clarified in order to allow for assessment of comparability of active substances, and comparison of efficacy, safety, and immunogenicity of vaccines, taking into account vaccination schedules for different age groups. The possibility of evaluating interchangeability based on the results of post-authorisation studies also needs clarification. It is also necessary to align patient information leaflets for interchangeable vaccines.

Lex Russica ◽  
2019 ◽  
pp. 71-83
Author(s):  
A. V. Savoskin

Personal reception represents a way of submitting citizens’ complaints and one of the forms of implementation of the constitutional right of citizens to appeal (complain). However, the legislative regulation of the issue under consideration seems insufficient, which has given rise to adverse law enforcement practice.The article determines signs of personal reception that allow us to distinguish it from other types of citizen’s communication with officials. The paper makes a thorough analysis of the duty of officials to conduct personal reception. Two models of performing the reception are highlighted: 1) personal reception is carried out only by chairpersons (of the government agency as a whole, its deputies or heads of structural divisions); 2) personal reception is carried out not only by chairpersons, but also by other authorized officials or specialized units. Moreover, the paper focuses on the problem of delegation of the obligation to perform personal reception to other officials.The paper investigates the procedure of personal reception that includes four stages: registration for personal reception (optional stage); arrival of a citizen at the place and time provided for personal reception, identification and determination of the order of personal reception; personal intercourse with the official, including a statement of the essence of the oral request or submission of a written application; registration of a personal reception card. Special attention is paid to the issue of registration of a personal reception, which allowed to formulate conclusions about the most relevant content of a personal reception card. The procedure of holding the all- Russian day of personal reception and experience of introduction of regional uniform days of personal reception in constituent entitities of the Russian Federation is analyzed.Also, the author scrutinizes the experience of organizing personal receptions in various governmental bodies and authorities in order to generalize additional guarantees of the rights of citizens during personal reception, as well as to develop an approximate list of feasible constrains.


2021 ◽  
Vol 100 (3) ◽  
pp. 97-106
Author(s):  
A.Yu. Popova ◽  
◽  
E.E. Andreeva ◽  
E.A. Babura ◽  
S.V. Balakhonov ◽  
...  

The aim of the study is to summarize the results of a study of seroprevalence of children to SARS-CoV-3, obtained during the implementation of the Rospotrebnadzor program to assess seroprevalence to the NC antigen SARS-CoV-2 of the population of 26 regions of the Russian Federation, conducted during the COVID-19 epidemic in 2020. Research methods: the study of seroprevalence in 26 model territories of the Russian Federation was carried out according to a unified methodology developed by Rospotrebnadzor with the participation of the St. Petersburg Pasteur Institute of Epidemiology and Microbiology. The method provided for the formation of a group of volunteers in a model federative entity, including children aged 1–17 years, in which the presence of antibodies to the SARS-CoV-2 nucleocapsid was determined in venous blood plasma by the enzyme-linked immunosorbent assay (ELISA). The examination of volunteers was carried out in 3 stages: June-August, September-October, December. Results: the study found that in most of the areas surveyed, children had a higher level of seroprevalence than adults. It is shown that high seroprevalence is accompanied by statistically significant decrease in morbidity (p0.05). The analysis of seroprevalence at all three stages revealed at least 3 variants of its dynamics: 1) continuous growth of seroprevalence in parallel with the development of the epidemic process; 2) an episodic change in the periods of increase and decrease in the level of seroprevalence; 3) a continuous decrease in seroprevalence at the level of the epidemic process. Comparative determination of seroconversion levels in three age groups – 1–6, 7–13 and 14–17 years – revealed no statistically significant differences between these age groups have been identified. Conclusion: children aged 1–17 years in most of the surveyed territories of the Russian Federation have a higher seroprevalence to SARS-CoV2 than adults. The increase in seroprevalence in children is accompanied by a decrease in the incidence of COVID-19.


2019 ◽  
Vol 17 (2) ◽  
pp. 101-112
Author(s):  
Nataliya A. Ilyushina

In the Russian Federation about 600 active ingredients of pesticides are currently registered. A large share among them is occupied by analogous pesticides (generics), which may differ in their properties from the original products due to an increased level or altered composition of impurities. Therefore, to ensure the safe use of analogous pesticides, it is necessary to evaluate their chemical and toxicological equivalence. The analysis of algorithms described in international documents and implemented in practice in some countries for determination of the equivalence of technical materials of analog pesticides is presented. Particular attention is paid to the evaluation of pesticide safety on the basis of the mutagenicity criterion. The applicability of different methods for genotoxic activity determination to confirm the equivalence of active substances of pesticides-analogues to patented products is discussed. A brief review of the results of the researches confirming the need to assess the genotoxicity of all technical materials of analogous pesticides with a view to preventing the entry of hazardous substances into the consumer market is presented.


Author(s):  
Stanislav Vladimirovich Kalashnikov

The subject of this this research is the normative legal and legal acts of the government bodies of the constituent entities of the Russian Federation included into the Ural Federal District (Kurgan, Sverdlovsk, Tyumen, Chelyabinsk regions, Khanty-Mansi Autonomous Okrug, Ugra and Yamalo-Nenets Autonomous Okrug) that regulate the administrative legal mechanism for exercising the right of citizens to appeal to the government bodies in the indicated regions. Special  attention is given to the importance and need for legal regulation of the issues associated with arranging additional guarantees and exercising the right of citizens to appeal to government bodies, particularly on the level of the constituent entities of the Russian Federation included into the Ural Federal District. Based on the comprehensive analysis of the aforementioned normative legal act and legal acts, the author reveals the peculiarities of legal regulation of the administrative legal mechanism for exercising the right of citizens to appeal to government bodies in the constituent entities of the Russian Federation included into the Ural Federal District, the limits of norm-setting authorities of the listed regions of the Russian Federation, specificities of securing additional guarantees of the rights of citizens to appeal to government bodies in the corresponding regional laws, approaches towards consolidation of the categorical and conceptual apparatus, determination of parties to legal relations in the area of exercising the right of citizens to appeal to government bodies, the role of normative legal and legal acts of the constituent entities of the Russian Federation included into the Ural Federal District within the mechanism of exercising the right of citizens to appeal to government bodies. The conclusion is formulated on the prospect of the approaches of certain constituent entities of the Russian Federation towards legal regulation of the mechanism for exercising the right of citizens to appeal government. The author also makes recommendation for its improvement.


2020 ◽  
pp. 42-48
Author(s):  
Violetta Sergeevna Neznanova

The subject of this article is the process of interaction between the government and civil society. The goal is to prove that a promising legal framework for the development of dialogue between the government and civil society exists not only in Russia overall, but in separate regions as well. The author achieves the set goal by analyzing the evolution of civil society in Russia and understanding peculiarities of the process of interaction between the government and civil society in Saint Petersburg. The article leans on the data provided by the center “Strategy”, Civic Chamber of the Russian Federation, Civic Chamber of Saint Petersburg , “Center for the Development of Nonprofit Organizations”, etc. The scientific novelty consists in determination of peculiarities influencing the process of interaction between the government and civil society in Saint Petersburg. The main conclusion lies in the statement that Saint Petersburg has a decent legal and social framework for further advancement of interaction between the government and civil society: presence of normative legal base for regulating such interaction; presence of a relatively large number of registered nonprofit organizations in Saint Petersburg; active work of a number of nonprofit organizations reflected in mass media; existence of community boards on the territory of Saint Petersburg. Overall, Saint Petersburg offers all conditions for effective interaction between the government and civil society.


Author(s):  
Georgii Pavlovich Kornev ◽  
Larisa Stepanovna Korneva

The subject of this research is the matters of reforming the federal structure of Russia in the aspect of unification and consolidation of the constituent entities of the Russian Federation that are under discussion in the current political discourse. The object this research is the transformation of the constituent structure of the Russian Federation based on the strategy of spatial development of Russia, federal legislative acts that laid the groundwork for the unification process, primarily the Federal Constitutional Law “On the Procedure of Admission into the Russian Federation and Creation of a New Constituent Entity". The authors explore such aspects of the topic as the results of unification processes of the constituent entities of the Russian Federation of 2003-2008, gaps in their legislative regulation, political errors and risks, including of ethnic nature, which impeded planned consolidation of the constituent structure of the Russian Federation, as well as strategy for the future unification processes. The novelty of the author's position is that the unification processes scenarios of the constituent entities of the Russian Federation are founded on the declared by the government “Strategy of Spatial Development of the Russian Federation until 2025”. The research methodology employs comprehensive interdisciplinary political, economic and legal approach. The drawn conclusions are related to the description of these scenarios, determination of the constitutional legal status of the new consolidated entity formed at the premises on an economic macroregion, considering such significant characteristics of the macroregion, as the number of constituent entities of the Russian Federation therein, size of their territories, population density, and peculiarities of the ethnic composition. It is proposed to fill the gaps in determination of the status of a constituent entity that ceased to exist as such and became a part of the consolidated entity by introducing amendments to the federal constitutional and current legislation without changing the fundamentals of the Constitution of the Russian Federation.


Author(s):  
Tatyana Yur'evna Feofilova ◽  
Evgenii Vladimirovich Radygin ◽  
David Zurabovich Amirbegi ◽  
Ul'yana Dmitrievna Bezdelova

The subject of this research is the key changes in the institutional provision of national security. The object of this research is the national security management. Provision of national security is an inextricable element of state administration. The article examines the system of views that reflect state’s position on the question of national security protection, presented in the legislative acts, conceptual and strategic documents considering amendments thereto. The goal of this study consists in determination of transformation of approach of the government of the Russian Federation towards ensuring national security. Federal laws, conceptual and strategic documents of the Russian Federation served as the information base for this research. The scientific novelty consists in systematization of approaches of the state towards understanding of boundaries and organization of national security protection of the Russian Federation. The conducted retrospective analysis allows tracing the changes in approaches of the states towards ensuring national security, observing the transformation of government’s priorities within and outside the country, as well as determining interdependence of the system of national security protection and its structure on the power of state’s authority and the status of development of administration in the Russian Federation. The overall conclusion of this research lies in the statement that the system of national security management is dynamic; its transformation depends on the international relations and factors outside the Russian Federation, as well as on the level of development and stability of the national system of administration.


Author(s):  
E.V. Klovach ◽  
◽  
A.S. Pecherkin ◽  
V.K. Shalaev ◽  
V.I. Sidorov ◽  
...  

In Russia, the reform of the regulatory guillotine is being implemented in the field of control and supervisory activity. It should result in a new regulatory system formed according to the principles specified in the key federal laws: «On state control (supervision) and municipal control in the Russian Federation» (Law on Control) and «On mandatory requirements in the Russian Federation» (Law on Mandatory Requirements) adopted in August 2020. In the field of industrial safety, this process was launched by the Decree of the Government of the Russian Federation № 1192, which will come into force on January 1, 2021. The main provisions are discussed in the article, which are related to the Law on Control and the Law on Mandatory Requirements. The Law on Control establishes the priority of preventive measures aimed at reducing the risk of causing harm in relation to the control activities, the grounds for carrying out control (supervisory) activities, the types of these activities in the forms of interaction with the controlled person and without such, the procedure for presentation of the results of control (supervisory) activity. The Law on Mandatory Requirements establishes that the provisions of regulatory legal acts should enter into force either from March 1 or September 1, but not earlier than 90 days after their official publication, and their validity period should not exceed 6 years. The drafts of regulatory legal acts developed by the federal executive bodies are subject to regulatory impact assessment. With a view to ensuring systematization of mandatory require ments, their register is kept. The federal executive body prepares a report on the achievement of the goals of mandatory requirements introduction. By January 1, 2021, 10 resolutions of the Government of the Russian Federation, 48 federal norms and rules in the field of industrial safety and 9 other regulatory legal acts of Rostechnadzor should be adopted. The drafts of all the documents are already prepared, some of the acts are completing the process of discussion and approval.


2020 ◽  
Vol 1 (10(79)) ◽  
pp. 12-18
Author(s):  
G. Bubyreva

The existing legislation determines the education as "an integral and focused process of teaching and upbringing, which represents a socially important value and shall be implemented so as to meet the interests of the individual, the family, the society and the state". However, even in this part, the meaning of the notion ‘socially significant benefit is not specified and allows for a wide range of interpretation [2]. Yet the more inconcrete is the answer to the question – "who and how should determine the interests of the individual, the family and even the state?" The national doctrine of education in the Russian Federation, which determined the goals of teaching and upbringing, the ways to attain them by means of the state policy regulating the field of education, the target achievements of the development of the educational system for the period up to 2025, approved by the Decree of the Government of the Russian Federation of October 4, 2000 #751, was abrogated by the Decree of the Government of the Russian Federation of March 29, 2014 #245 [7]. The new doctrine has not been developed so far. The RAE Academician A.B. Khutorsky believes that the absence of the national doctrine of education presents a threat to national security and a violation of the right of citizens to quality education. Accordingly, the teacher has to solve the problem of achieving the harmony of interests of the individual, the family, the society and the government on their own, which, however, judging by the officially published results, is the task that exceeds the abilities of the participants of the educational process.  The particular concern about the results of the patriotic upbringing served as a basis for the legislative initiative of the RF President V. V. Putin, who introduced the project of an amendment to the Law of RF "About Education of the Russian Federation" to the State Duma in 2020, regarding the quality of patriotic upbringing [3]. Patriotism, considered by the President of RF V. V. Putin as the only possible idea to unite the nation is "THE FEELING OF LOVE OF THE MOTHERLAND" and the readiness for every sacrifice and heroic deed for the sake of the interests of your Motherland. However, the practicing educators experience shortfalls in efficient methodologies of patriotic upbringing, which should let them bring up citizens, loving their Motherland more than themselves. The article is dedicated to solution to this problem based on the Value-sense paradigm of upbringing educational dynasty of the Kurbatovs [15].


Author(s):  
Timur Minasov ◽  
Radik Nurlygayanov ◽  
Angela Vershinina ◽  
Yulia Soboleva ◽  
Damir Akhmeldinov ◽  
...  

The results of a study of the concentration of vitamin D in blood serum of 3455 residents of Ufa are presented. Physiological values of 25(OH)D were observed in 34.9 % (274) of men and 31.7 % (847) of women, which is 32.4 % (1121) of all examined. Vitamin D deficiency was detected in 67.1 % of the examined. The level of 25(OH)D in the blood serum of residents is on average 75 nmol/L, which is the upper limit of vitamin D deficiency. Vitamin D deficiency is extremely common among residents of this region of the Russian Federation (67.1 %).


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