ABSTRACT
Sera of animal origin and hyperimmunoglobulins have dominated serum therapy for a century. Although numerous monoclonal antibodies (MABs) have been developed since the end of the 1980s, particularly for the treatment of immunological and oncological diseases, it will take 20 years before the first anti-infective MAB is approved in the European Union. Interestingly, to combat the COVID-19 pandemic, numerous MABs, which are approved in particular for immunological indications, are currently being used to treat the consequences of SARS-CoV2 infection, such as pneumonia or hyperimmune reactions.The approved monoclonal antibodies for the treatment of infectious diseases are presented here. In addition, an overview of the current developments, in particular in the treatment of SARS-CoV2 infection, is provided.
Subject(s)
Antibodies, Monoclonal , Coronavirus Infections , Pandemics , Pneumonia, Viral , Animals , Antibodies, Monoclonal/therapeutic use , Antibodies, Viral , Betacoronavirus , COVID-19 , Germany , Humans , SARS-CoV-2ABSTRACT
Several live-attenuated viral vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of live-attenuated viral vaccines. This will help key stakeholders assess potential safety issues and understand the benefit-risk of such vaccines. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed live-attenuated viral vaccines.
Subject(s)
Drug Evaluation, Preclinical/standards , Vaccines, Attenuated/adverse effects , Viral Vaccines/adverse effects , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/pharmacology , Drug Evaluation, Preclinical/methods , Humans , Risk Assessment , Societies, Scientific , Vaccines, Attenuated/pharmacology , Viral Vaccines/pharmacologyABSTRACT
Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.
Subject(s)
Coronavirus Infections/prevention & control , Drug Approval/legislation & jurisprudence , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Risk Assessment , Viral Vaccines/standards , Betacoronavirus/drug effects , Betacoronavirus/immunology , Betacoronavirus/pathogenicity , COVID-19 , COVID-19 Vaccines , Civil Defense , Coronavirus Infections/epidemiology , Coronavirus Infections/immunology , Coronavirus Infections/virology , Government Regulation , Humans , Immunogenicity, Vaccine , International Cooperation , Patient Safety , Pneumonia, Viral/epidemiology , Pneumonia, Viral/immunology , Pneumonia, Viral/virology , SARS-CoV-2 , Vaccines, Inactivated , Viral Vaccines/administration & dosage , Viral Vaccines/biosynthesisABSTRACT
Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.