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 article presents the results of a retrospective analysis of viral hepatitis B incidence in the Russian Federation from 2013 to 2017, taking into account the use of vaccines included into the National Immunisation Schedule and the Immunisation Programme in Case of Epidemic Outbreaks. The analysis of the data revealed a trend towards a reduction in the incidence of acute and chronic forms of hepatitis B in the territory of the Russian Federation during the past five years. The reduction of viral hepatitis B incidence was achieved thanks to a higher vaccination coverage of both children and adults. The article presents an overview of monovalent and combination recombinant hepatitis B vaccines licensed in the Russian Federation. It describes the WHO position on preventive vaccination against viral hepatitis B, and pays special attention to vaccination of people at risk. The article considers promising areas for improving immunobiological products for hepatitis B prevention, including new technologies used in vaccine production, development and introduction of new adjuvants or adjuvants systems, and development of therapeutic vaccines.
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.
В статье приведен анализ эффективности и безопасности вакцин для профилактики клещевого энце-фалита (КЭ), разрешенных для применения на территории Российской Федерации. Показано, что ис-пользуемые в настоящее время вакцины КЭ отечественного и зарубежного производства обеспечивают высокую иммуногенность, безопасность и эпидемиологическую эффективность в регионах с массовым охватом вакцинацией. Все зарегистрированные вакцины соответствуют основным принципам взаимо-заменяемости по показаниям к применению с учетом возрастных ограничений, перечню медицинских противопоказаний, схемам вакцинации, составу вакцин, а также показателям безопасности, иммуноло-гической активности и эффективности. Своевременные меры специфической профилактики приводят к снижению заболеваемости КЭ в эндемичных регионах. This article provides a review on efficacy and safety of tick-borne encephalitis vaccines licensed in the Russian Federation. It highlights that both Russian and imported tick-borne encephalitis vaccines demonstrate high immunogenicity, safety and epidemiological effectiveness in regions with high vaccine coverage. All licensed tick-borne encephalitis vaccines meet interchangeability criteria in terms of indications for use (with due regard to age limits), medical contraindications, vaccination schedules, vaccine composition, as well as safety, immunological activity and efficacy parameters. Timely and specific prophylaxis help reduce the incidence of tick-borne encephalitis in endemic regions.
The rotavirus infection causes acute gastroenteritis and is a major cause of lethal severe dehydrating diarrhoea in children under 5 years of age worldwide. Live attenuated rotavirus vaccines are the only means of preventing severe forms of the disease. The aim of the study was to analyse the twenty-year international experience of prophylactic immunisation against rotavirus infection. The paper summarises safety and efficacy data on the long-term use of Rotarix® (Belgium) and RotaTeq® (USA) for the prevention of rotavirus infection in the WHO European Region, the European Union and other countries. It addresses the development of correlates of immune protection for vaccines as well as evaluation of efficacy and safety of the new vaccines Rotavac® and Rotasiil® (India) in clinical trials. The authors analysed international experience of using the vaccines in countries that do not keep records of infant mortality from diarrhoea. The study summarises the results of clinical studies on the use of new vaccines prequalified by WHO in 2018 in regions with high rates of infant mortality from diarrhoea. It was demonstrated that vaccination not only reduces the rates of hospital admission of immunised children, but also contributes to the development of herd immunity. Rotarix® and RotaTeq® vaccines are authorised or included in the national immunisation schedules of many countries, but this type of vaccination is not mandatory in most of these countries. Vaccination coverage in the EU countries is about 24 %. Alternative vaccination schemes using live attenuated vaccines based on strains derived from newborn children, and parenteral rotavirus vaccines which do not replicate in the intestine may help reduce existing risks. It was concluded that the introduction of live rotavirus vaccines in immunisation schedules should be accompanied by the analysis of incidence of intussusception of the small intestine before and after the introduction of mass immunisation, and by active pharmacovigilance.
Chitosan-based adjuvants combine effectiveness, safety and economic feasibility and thus are quite promising for enhancement of influenza control via vaccination, however, problems of characterization and reproducibility remain unresolved; data on relations between physical-chemical characteristics (PCC) of the polymer and immunogenicity of chitosan-based adjuvants, as well as comparative evaluation with other adjuvants are needed. Groups of mice were immunized intramuscularly with inactivated influenza vaccines based on A/California/07/2009 (H1N1) strain with characterized adjuvants based on chitosan with varying PCC (molecular mass 700 and 10 kDa, deacetylation degree 85%; HMC and LMC, respectively) and its derivative (succinylated chitosan (SC)). Experimental formulations were also studied: an «oil-in-water» emulsion (ME) and a multi-component adjuvant (MS). Different adjuvants increased immunogenicity of the inactivated influenza vaccines by hemagglutinin inhibiting sera antibodies in varying patterns. HMC was more immunogenic than LMC, whereas SC even reduced immunogenicity of the vaccine. HMC was comparable to MS by immunogenicity, and LMC - to ME. PCC of chitosan and its derivatives play an important role in immunogenicity of the respective adjuvants, and perspective and characterized chitosan-based adjuvants are comparable or even more immunogenic than adjuvants from other groups.
The experience with the influenza pandemic caused by strain A (H1N1) 2009 and the existing gaps in standardizing and evaluating the quality and effectiveness of vaccines for influenza prevention have led the European Union (EU) to recognize the need to review / update the current guidelines on requirements for the development, quality, and preclinical and clinical research. In February 2018 Guideline on influenza vaccines -quality module (EMA/CHMP/BWP/310834/2012 Rev.l) came Into effect In the EU countries. The formation of the Eurasian Economic Union (EAEU) and the creation of a single market for pharmaceutical products entails the need to amend the current and the formation of new legislation, as well as changes in the rules and regulations regarding the pharmaceutical circulation processes in the Russian Federation: development, quality assurance in preclinical and clinical trials, monitoring the safety of medicines for medical use, in this regard, it seems appropriate to develop scientific and technical guidelines that are harmonized with international standards and approaches in the pharmaceutical field. The aim of the review was to conduct a comparative analysis of approaches to assessing the quality of vaccines for prevention influenza based regulatory requirements in the Russian Federation and European Union. Conclusion. In this article discusses the features of the requirements for the development and quality control of inactivated influenza vaccines in the Russian Federation and the EU. The article provides a comparative analysis of the requirements of the State Pharmacopoeia of the Russian Federation and the European Pharmacopoeia for quality indicators, which should be included in the regulatory documentation when registering the vaccine. The main changes in the EMA document «Guidelines for influenza vaccines - Quality module» consist of new approaches to standardizing vaccines for influenza prevention, in particular, determining the specific activity of inactivated influenza vaccines using adequate alternative methods and studying biological, immunological and physicochemical characteristics HA antigen using a wide range method. The results of the analysis of approaches to assessing the quality of vaccines for influenza prevention can be useful in developing harmonized with international norms and approaches scientific and technical guidelines in the pharmaceutical field.
At present, there are not much data on the clinical use of live recombinant viral vector vaccines. Characteristics of new vaccines should be factored into requirements/recommendations for quality control, preclinical and clinical studies of vaccines in order to enable further risk/benefit assessment. The aim of this study was to analyse current approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines. The paper provides an overview of the licensed live viral vector vaccines and those at various stages of clinical trials. The authors analysed Russian, European, American, and Japanese guidelines related to quality issues, preclinical and clinical studies of live viral vector vaccines. The analysis demonstrated that the regulatory requirements for live recombinant viral vector vaccines include assessment of a detailed rationale for vaccine development, including information on the choice of the vector, the origin of the heterologous antigen gene(s), elements related to the transgene(s) expression, as well as assessment of the genetic and phenotypic stability of the recombinant virus, the risk of reversion to virulence or recombination with wild type strains, the potential for virus genome integration into the host cell chromosome, the pre-existing immunity to the vector, the intensity of the immune response elicited by the vector, and the reusability of the vector. The choice and number of applicable toxicological and pharmacological models will depend on these aspects. The results of the analysis of approaches to quality control, preclinical and clinical studies of live recombinant viral vector vaccines may be used in the development of Russian regulatory guidelines harmonised with the international norms and regulations.
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