ABSTRACT
The development of the COVID-19 pandemic initiated the search for effective drugs for the treatment and prevention of infection. Of particular importance for the fight against the pandemic is the timing of the introduction of drugs into clinical practice. Therefore, countries with developed healthcare systems (EU, USA, Russian Federation, etc.), issue conditional marketing authorizations of drugs for treatment and prevention of COVID-19, based on regulatory requirements for the circulation of medicines in emergency situations. The approval is issued on the basis of limited clinical data, with the condition that the full evaluation of safety and effectiveness will be carried out after the issuance of the authorization in the post-registration period. The COVID-19 pandemic has revolutionized the design and time frame of clinical trials, including phase I, II, and III adaptive trials, which has led to the approval of biologics for the treatment and prevention of COVID-19 in record time in most advanced pharmaceutical countries. At the same time, regulatory/healthcare authorities or international organizations constantly monitor the safety and effectiveness of used drugs and, if necessary, make adjustments (changes to the indications for use, dosage change, drug discontinuation etc.). Since the beginning of the pandemic, in fact, in conditions where the use of medicines was allowed based on very limited data, studies have begun to substantiate the safety and effectiveness of the use of immunoglobulin preparations and monoclonal antibodies for the treatment and prevention of COVID-19. As new data became available, changes were made regarding the indications for use, doses, and other characteristics of preparations of immunoglobulins and monoclonal antibodies for the treatment and prevention of COVID-19. The review presents a critical analysis of the results of evaluation the safety and effectiveness of the use of immunoglobulin preparations and monoclonal antibodies in a pandemic. Copyright © 2022 Meditsina Publishers. All rights reserved.
ABSTRACT
The progress of the COVID-19 pandemic initiated research to develop vaccines against this novel coronavirus infection. The WHO and national regulatory authorities in many countries have elaborated guidelines to speed up the development and authorisation of COVID-19 vaccines. The aim of the study was to analyse international and Russian regulatory recommendations for the development and fast-track approval of COVID-19 vaccines in the context of the pandemic, as well as to summarise the preliminary published results of the first stages of preclinical and clinical studies. The paper analyses approaches to fast-track approval of medicines in the face of the pandemic in Russia, the European Union, and the United States. It summarises regulatory requirements for the quality of COVID-19 vaccines, as well as for preclinical, and clinical studies. It describes the first results of COVID-19 vaccine development. The analysed regulatory documents allow for accelerated authorisation due to reduction of time spent on evaluation of vaccine quality, safety, and efficacy. Another option is the so-called conditional marketing authorisation when a vaccine is registered based on incomplete preclinical and clinical data provided that all the studies will be completed after the vaccine authorisation. The paper summarises the results of clinical trials of COVID-19 vaccines. The few published preliminary results of the first phases of COVID-19 vaccine clinical trials demonstrate the vaccines' good tolerability, safety, and immunogenicity. Evaluation of adenovirus-based vaccines showed that almost half of the volunteers had had high antibody titers to adenovirus before the study, which resulted in milder adverse reactions and low immunogenicity. In addition, the immune response was weaker in the older group of subjects (45-60 years) as compared to the subjects younger than 45 years. The results of the analysis of regulatory requirements for the development and marketing authorisation of COVID-19 vaccines in the context of the pandemic, as well as of national and international regulatory approaches to vaccine development and authorisation can be used as a basis for the development of Russian requirements for COVID-19 vaccines in the context of the pandemic.