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The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines.
Kochhar, Sonali; Excler, Jean-Louis; Kim, Denny; Robertson, James S; Fast, Patricia E; Condit, Richard C; Drew, Stephen; Wood, David; Gurwith, Marc; Klug, Bettina; Whelan, Mike; Khuri-Bulos, Najwa; Mallett Moore, Tamala; Smith, Emily R; Chen, Robert T.
  • Kochhar S; Global Healthcare Consulting, New Delhi, India; University of Washington, Seattle, WA, USA.
  • Excler JL; International Vaccine Institute, Seoul, Republic of Korea.
  • Kim D; Janssen Pharmaceuticals, Titusville, NJ, USA.
  • Robertson JS; Independent Adviser, UK.
  • Fast PE; International AIDS Vaccine Initiative, New York, NY, USA; Stanford School of Medicine, Palo Alto, CA, USA.
  • Condit RC; Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL, USA.
  • Drew S; Independent Adviser, USA.
  • Wood D; Independent Adviser, UK.
  • Gurwith M; Brighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
  • Klug B; Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
  • Whelan M; Project Leader, CEPI, UK.
  • Khuri-Bulos N; University of Jordan, Amman, Jordan.
  • Mallett Moore T; Sanofi Pasteur, Swiftwater, PA, 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.
Vaccine ; 38(39): 6184-6189, 2020 09 03.
Article in English | MEDLINE | ID: covidwho-701883
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Viral Vaccines / Drug Approval / Coronavirus Infections / Risk Assessment / Pandemics Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2020 Document Type: Article Affiliation country: J.vaccine.2020.07.028

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Viral Vaccines / Drug Approval / Coronavirus Infections / Risk Assessment / Pandemics Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2020 Document Type: Article Affiliation country: J.vaccine.2020.07.028