Coronaviruses are the largest group of known positive-strand RNA viruses. Coronavirus infection can affect various animal species, as well as humans. Over the past two decades, coronaviruses have caused epidemic outbreaks of two respiratory diseases: the Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. At the end of 2019, a new type of virus was detected in China. The virus has been spread by humantohuman transmission and has caused a viral pneumonia outbreak. The emergence of a new coronavirus proves that the diseases caused by this group of viruses pose a threat to global health due to the potential for a pandemic, and, therefore, need careful monitoring. The objective of the study was to analyse the current epidemic situation for the new coronavirus infection (COVID-19) caused by SARS-CoV-2, taking into account previous outbreaks of infections caused by MERS-CoV and SARS-CoV β-coronaviruses which pose the greatest threat to human health. The review briefly describes two epidemic outbreaks caused by SARS-CoV (2002–2004) and MERS-CoV (2012–present), summarises the current epidemic situation for the new SARS-CoV-2 coronavirus, describes the main restrictive measures undertaken to prevent the spread of infection in Russia. The paper considers aspects of potential specific therapy and the development of prophylactic vaccines against the new coronavirus infection. The review concludes that SARS-CoV-2 has pandemic potential and that new strains of β-coronaviruses are likely to cause outbreaks in the future. The paper points to the need for careful monitoring of the disease and conducting preventive anti-epidemic measures to curb the spread of infection.

The review analyses measles incidence in Russia at the elimination stage. Epidemiological studies have revealed changes in the measles epidemic process in Russia. It was shown that whereas the specificity of the epidemic process in the pre-vaccination period was mainly determined by the influence of the infectious agent, lately the impact of the social factor has increased. There was an increase in the impact of decreed groups on maintaining the circulation of the virus in the Russian Federation. The aim of the study was to analyse the specificity of the measles epidemic process in Russia, to identify the major current problems of measles vaccination, to reveal reasons that prevent measles elimination in the country given the present environment, and to formulate possible ways of solving them. The article demonstrates the role of migration processes within the country and infection importation from neighboring territories in the rise of disease outbreaks. The article discusses Russian regulatory documents that are devoted to combating the spread of measles, their consistent replacement and refinement bearing in mind the changing epidemiological situation and the current WHO criteria and guidelines for the infection elimination. High-level epidemiological surveillance of the infection is a key factor in choosing the optimal strategy of measles vaccination. The article lists indicators of epidemiological surveillance effectiveness. It also highlights the importance of molecular genetic monitoring of the measles pathogen. The authors outline measures that are necessary to achieve measles elimination in the Russian Federation given the current epidemiological situation.

Rotavirus infection is a widespread cause of severe gastroenteritis in children in low-income countries. Specific prophylaxis in young children has become the most important means of combating severe rotavirus gastroenteritis. The review presents current data on the molecular biology and genetic diversity of rotaviruses, interaction of viral proteins with host cell receptors, molecular aspects of infectivity and pathogenesis of rotavirus infection, and the development of immunity. It addresses a new approach to the epidemiology of rotavirus infection which regards it as a manageable infection, it illustrates the specificity of the epidemic process based on data gained from extensive experience in vaccination, and summarises relevant information on the introduction of rotavirus vaccines into the international healthcare practice. The paper summarises risks associated with the use of vaccines based on the analysis of WHO statistics, scientific publications on the epidemiology of rotavirus infection, and the results of vaccination. It analyses approaches of the competent authorities of some countries to the tactics of vaccination against rotavirus infection and the WHO stance on the use of existing vaccines for the prevention of rotavirus infection. A conclusion was made that it is necessary to further improve the tactics of vaccine prevention of rotavirus infection in Russia, to study the incidence of idiopathic intussusception, and to conduct further studies aimed at characterisation of existing and newly emerging genotypes of rotavirus.

There are a lot of diseases known today, which are caused by genetic abnormalities. Advances in genetics and biotechnology brought about gene editing technologies that can produce almost any gene, which ultimately led to the emergence of a new class of medicines - gene therapy products (GTPs). The aim of the study was to analyse international experience in development and authorisation of GTPs. The review highlights the challenges in GTP development, related to the search for an optimal approach to therapeutic gene delivery to the target cells. Viral vectors were shown to be a promising gene delivery system, with adenovirus- (AV) and adeno-associated virus- (AAV) based products demonstrating the highest efficacy and safety. The paper reviews current approaches to gene editing that allow modification of AVs and AAVs to improve GTP efficacy and safety. These modifications are carried out with the aim of, e.g., including a large therapeutic gene into a viral vector, decreasing viral protein expression levels, and decreasing viral vector immunogenicity. The review summarises GTP authorisation procedures in the USA and the European Union, including data on FDA and EMA subcommittees and departments entrusted with advisory functions. The paper mentions that there is one Russian-produced GTP authorised in the Russian Federation, and some other GTPs are in the pipeline. Therefore, the Russian regulatory framework and the Eurasian regulations and recommendations should be updated in order to accommodate for GTP development and authorisation.

The management of post-approval changes to registration dossiers for medicinal products is one of the most important factors for ensuring sustainable quality, safety and effi cacy of medicines. Competent authorities that use the module format of the registration dossier, i. e. the regulatory authorities of the European Union, USA and other members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Eurasian Economic Union (EEU), issue guidelines on changes to registration dossiers for pharmaceuticals and biologicals (immunological products). Vaccines (fi nished dosage forms) and vaccine antigens (active ingredients) are a specifi c group of immunobiological products which have great prophylactic importance for healthcare, and which are associated with challenging development and specifi c methods of manufacturing and quality control. The procedure of introducing post-approval variations to dossiers for immunobiological medicinal products is poorly refl ected in the current Russian and EEU regulations. The World Health Organization (WHO) established a procedure described in the «Guidelines on procedures and data requirements for changes to approved vaccines». The purpose of the present study was to compare current Russian and international legislation in terms of regulatory requirements for post-approval сhanges to dossiers for immunobiological products. The Federal State Budgetary Institution «Scientifi c Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation is drafting Guideline on introducing CC BY 4.0 Внесение изменений в документы регистрационных досье на вакцины: анализ нормативно-методических подходов... Post-approval Variations to Dossiers for Vaccines: Analysis of Regulatory and Methodological Approaches Used... Ведомости Научного центра экспертизы средств медицинского применения 2019. Т. 9, № 1 The Bulletin of the Scientifi c Centre for Expert Evaluation of Medicinal Products 2019. V. 9, No. 1 42 ОБЗОРЫ / REVIEWS post-approval changes into dossiers for immunobiological medicines. The draft includes a detailed review of various categories of changes based on their importance, and a list of conditions and required documents for specifi c groups of medicines. This article summarises scientifi c and methodological approaches to evaluation of changes introduced in registration dossiers for vaccines in order to further improve the regulatory framework of the Russian Federation and the EEU.