ABSTRACT
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/pharmacologySubject(s)
Biomedical Research/organization & administration , COVID-19/therapy , Clinical Trials as Topic , Pandemics , Biomedical Research/history , Biomedical Research/standards , COVID-19/diagnosis , COVID-19/epidemiology , Canada/epidemiology , Clinical Trials as Topic/methods , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Community Networks/organization & administration , Community Networks/standards , Drug Evaluation, Preclinical/methods , Drug Evaluation, Preclinical/standards , Europe/epidemiology , History, 21st Century , Humans , International Cooperation , Learning , Neural Networks, Computer , Organizational Innovation , Pandemics/history , Patient Selection , Pragmatic Clinical Trials as Topic/methods , Pragmatic Clinical Trials as Topic/standards , Research Design , Scandinavian and Nordic Countries/epidemiology , United Kingdom/epidemiology , World Health Organization/organization & administrationABSTRACT
Many of the vaccines under development for COVID-19 involve the use of viral vectors. The Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO, formerly the Viral Vector Vaccine Safety Working Group, V3SWG) working group has prepared a standardized template to describe the key considerations for the benefit-risk assessment of viral vector vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would also help improve communication and public acceptance of licensed viral vector vaccines.