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The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines.
Condit, Richard C; Kim, Denny; Robertson, James S; Excler, Jean-Louis; Gurwith, Marc; Monath, Thomas P; Pavlakis, George; Fast, Patricia E; Smith, Jonathan; Smith, Emily R; Chen, Robert T; Kochhar, Sonali.
Afiliação
  • Condit RC; Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL 32610, USA.
  • Kim D; Janssen Pharmaceuticals, Titusville, NJ, USA.
  • Robertson JS; Independent Adviser, United Kingdom.
  • Excler JL; International Vaccine Institute, Seoul, Republic of Korea.
  • Gurwith M; Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.
  • Monath TP; Crozet BioPharma LLC, Devens, MA 01434, USA.
  • Pavlakis G; National Cancer Institute, National Institutes of Health, Frederick, MD 21702, USA.
  • Fast PE; International AIDS Vaccine Initiative, New York, NY 10004, USA; Stanford School of Medicine, Palo Alto, CA 94305, USA.
  • Smith J; VLP Therapeutics, Gaithersburg, MD 20878, USA.
  • Smith ER; Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.
  • Chen RT; Brighton Collaboration, a Program of the Task Force for Global Health, Decatur, GA, USA.
  • Kochhar S; Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA 98195, USA.
Vaccine ; 38(49): 7708-7715, 2020 11 17.
Article em En | MEDLINE | ID: mdl-32907759
ABSTRACT
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas Atenuadas / Vacinas Virais / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Vacinas Atenuadas / Vacinas Virais / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Animals / Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article