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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

  1. Author:
    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

  2. Author Address

    Janssen Pharmaceut, Titusville, NJ 08560 USA.Int Vaccine Inst, Seoul, South Korea.Univ Florida, Dept Mol Genet & Microbiol, Gainesville, FL 32610 USA.Int AIDS Vaccine Initiat, New York, NY 10004 USA.Stanford Sch Med, Palo Alto, CA 94305 USA.Brighton Collaborat, Decatur, GA USA.NCI, NIH, Frederick, MD 21702 USA.Crozet BioPharma LLC, Devens, MA 01434 USA.VLP Therapeut, Gaithersburg, MD 20878 USA.Global Healthcare Consulting, New Delhi, India.Univ Washington, Seattle, WA 98195 USA.
    1. Year: 2020
    2. Date: JUL 22
    3. Epub Date: 2020 06 19
  2. Journal: Vaccine
  3. ELSEVIER SCI LTD,
    1. 38
    2. 34
    3. Pages: 5556-5561
  5. Type of Article: Review
  6. ISSN: 0264-410X
  1. 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. (C) 2020 The Authors. Published by Elsevier Ltd.

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External Sources

  1. View Full Text
  2. DOI: 10.1016/j.vaccine.2020.06.017
  3. PMID: 32571717
  4. PMCID: PMC7304391
  5. View record in Web of Science®
  6. WOS: 000549329000025

Library Notes

  1. Fiscal Year: FY2019-2020
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