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 COVID-19 pandemic accelerated the rapid development and distribution of various vaccine platforms, resulting in a significant reduction in disease severity, hospitalizations, and mortality. However, persistent challenges remain concerning the durability and breadth of vaccine-induced protection, especially in the face of emerging SARS-CoV-2 variants. This review aimed to evaluate the factors influencing the immunogenicity and effectiveness of COVID-19 vaccines to inform future vaccine advancement strategies. A narrative review with systematic approach was conducted following PRISMA guidelines for narrative review. Literature was sourced from databases including PubMed, Embase, and Web of Science for studies published between December 2019 and May 2025. Encompassed studies assessed vaccine efficacy, immunogenicity, and safety across various populations and vaccine platforms. Data were collected qualitatively, with quantitative data from reviews highlighted where available. We have uncovered a decline in vaccine efficacy over time and weakened protection against novel variants such as Delta and Omicron. Booster doses, specifically heterologous regimens, improved immunogenicity and increased protection. Vaccine-induced neutralizing antibody titers have been found to correlate with clinical protection, although the long-term correlates of immunity remain poorly defined. The induction of IgG4 antibodies after repeated mRNA vaccinations raised concerns about potential modulation of the immune response. COVID-19 vaccines have contributed significantly to pandemic control; however, their efficacy is limited by the evolution of the virus and declining immunity. Forthcoming vaccine strategies should focus on broad-spectrum, variant-adapted formulations and defining robust comparisons of protection. Recognizing the immunological basis of vaccine response, including the role of specific antibody subclasses, is fundamental for optimizing long-term protection.
17 September 2019 in Biological Products. Prevention, Diagnosis, Treatment
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.
16 June 2019 in Biological Products. Prevention, Diagnosis, Treatment
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.
10 March 2022 in Biological Products. Prevention, Diagnosis, Treatment
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.
3 October 2024 in Biological Products. Prevention, Diagnosis, Treatment
INTRODUCTION. Respiratory syncytial virus (RSV) is one of the most widespread pathogens that typically cause acute upper and lower respiratory tract infections in children and adults. Monoclonal antibody products have long been used for passive immunoprophylaxis in premature infants with bronchopulmonary dysplasia. However, vaccines have recently been licensed for the prophylactic immunisation of older adults with various risk factors for severe RSV infection (primarily, chronic cardiovascular and respiratory diseases and diabetes mellitus).AIM. This study aimed to review the current status of the development of vaccines for active immunisation against RSV infection, including the epidemiological rationale for their development, clinical trial results for licensed vaccines, recommendations for vaccination, and promising pipeline vaccines for RSV prevention.DISCUSSION. Initially hindered by the unique immunopathogenesis of RSV infection and the genetic hypervariability of RSV for a long time, attempts to develop an RSV vaccine succeeded when international researchers managed to identify a conservative neutralising antibody target capable of inducing specific immunity against RSV. This target, the RSV capsid protein stabilised in its prefusion (pre-F) conformation, can mediate viral entry into the cell following a conformational change. Several subunit vaccines based on recombinant pre-F proteins have successfully passed clinical trials and have been approved for the immunisation of older adults. In addition, one of these vaccines has been recommended for use during pregnancy to prevent RSV infection in newborns and infants. Currently, programmes are being implemented to develop novel RSV vaccines based on messenger RNA (mRNA) and non-replicating attenuated influenza vectors. This article examines and summarises the efficacy and safety parameters of two RSV vaccines approved in multiple countries around the world. Both vaccines have satisfactory safety profiles and comparable prophylactic efficacy parameters.CONCLUSIONS. Prelicensure clinical trials of novel RSV vaccines, including those being developed in the Russian Federation, should include prophylactic efficacy assessments in target patient populations. For vaccines approved by leading international regulators, clinical trials required for approval in the Russian Federation will be limited to bridging studies confirming the immunogenicity and safety of the vaccines.