ABSTRACT
The International Alliance for Biological Standardization and the Coalition for Epidemic Preparedness Innovations organized a joint webinar on the use of platform technologies for vaccine development. To tackle new emerging infectious diseases, including SARS-CoV-2, rapid response platforms, using the same basic components as a backbone, yet adaptable for use against different pathogens by inserting new genetic or protein sequences, are essential. Furthermore, it is evident that development of platform technologies needs to continue, due to the emerging variants of SARS-CoV-2. The objective of the meeting was to discuss techniques for platform manufacturing that have been used for COVID-19 vaccine development, with input from regulatory authorities on their experiences with, and expectations of, the platforms. Industry and regulators have been very successful in cooperating, having completed the whole process from development to licensing at an unprecedented speed. However, we should learn from the experiences, to be able to be even faster when a next pandemic of disease X occurs.
Subject(s)
COVID-19 Vaccines/immunology , COVID-19/immunology , COVID-19/prevention & control , Drug Development , SARS-CoV-2/immunology , COVID-19 Vaccines/therapeutic use , Congresses as Topic , HumansSubject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Drug Development , Human Experimentation , SARS-CoV-2/immunology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/supply & distribution , Drug Development/ethics , Host-Pathogen Interactions , Human Experimentation/ethics , Humans , Immunogenicity, Vaccine , Patient Safety , Risk Assessment , Treatment OutcomeABSTRACT
This International Alliance for Biological Standardization COVID-19 webinar was organized to provide an update on the virology, epidemiology and immunology of, and the vaccine development for SARS-CoV-2, none months after COVID-19 was declared a public health emergency of international concern. It brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from low- and middle-income countries.
Subject(s)
COVID-19 Vaccines , COVID-19 , Pandemics , SARS-CoV-2 , Antibodies, Neutralizing/biosynthesis , Antibodies, Viral/biosynthesis , Biological Products/isolation & purification , COVID-19/epidemiology , COVID-19/etiology , COVID-19/therapy , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/isolation & purification , Clinical Trials as Topic , Drug Development/trends , Europe/epidemiology , Humans , Immunity, Cellular , SARS-CoV-2/genetics , SARS-CoV-2/immunology , SARS-CoV-2/pathogenicity , Safety , World Health OrganizationABSTRACT
This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Subject(s)
Betacoronavirus , Coronavirus Infections/prevention & control , Drug Development/ethics , Human Experimentation/ethics , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/therapeutic use , COVID-19 , COVID-19 Vaccines , Drug Development/legislation & jurisprudence , Human Experimentation/legislation & jurisprudence , Humans , Quality Control , Reference Standards , SARS-CoV-2ABSTRACT
This first International Alliance for Biological Standardization Covid-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from low- and middle-income countries, to discuss the virology, epidemiology and immunology of, and the vaccine development for SARS-CoV-2.