The efficacy of medicinal products based on plasma immunoglobulins and monoclonal antibodies for the treatment and prevention of COVID-19

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.