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The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines.
Kim, Denny; Robertson, James S; Excler, Jean-Louis; Condit, Richard C; Fast, Patricia E; Gurwith, Marc; Pavlakis, George; Monath, Thomas P; Smith, Jonathan; Wood, David; Smith, Emily R; Chen, Robert T; Kochhar, Sonali.
  • Kim D; Janssen Pharmaceuticals, Titusville, NJ, USA.
  • Robertson JS; Independent Adviser, United Kingdom.
  • Excler JL; International Vaccine Institute, Seoul, Republic of Korea.
  • Condit RC; Department of Molecular Genetics and Microbiology, University of Florida, Gainesville, FL 32610, USA.
  • Fast PE; International AIDS Vaccine Initiative, New York, NY 10004, USA; Stanford School of Medicine, Palo Alto, CA 94305, USA.
  • Gurwith M; Brighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
  • Pavlakis G; National Cancer Institute, National Institutes of Health, Frederick, MD 21702, USA.
  • Monath TP; Crozet BioPharma LLC, Devens, MA 01434, USA.
  • Smith J; VLP Therapeutics, Gaithersburg, MD 20878, USA.
  • Wood D; Independent Adviser, United Kingdom.
  • 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(34): 5556-5561, 2020 07 22.
Article in English | MEDLINE | ID: covidwho-617212
ABSTRACT
Nucleic acid (DNA and RNA) vaccines are among the most advanced 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 nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Vaccines / Risk Assessment / Vaccines, DNA Type of study: Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2020 Document Type: Article Affiliation country: J.vaccine.2020.06.017

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Viral Vaccines / Risk Assessment / Vaccines, DNA Type of study: Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2020 Document Type: Article Affiliation country: J.vaccine.2020.06.017