The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines

Vaccine. 2020 Jul 22;38(34):5556-5561. doi: 10.1016/j.vaccine.2020.06.017. Epub 2020 Jun 19.

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.

Keywords: Benefit-risk; Brighton Collaboration; CEPI; COVID-19; DNA; Nucleic acid; RNA; Safety; Template; Vaccine.

Publication types

  • Review

MeSH terms

  • COVID-19 Vaccines
  • Coronavirus Infections / genetics
  • Coronavirus Infections / prevention & control
  • Humans
  • Public Opinion
  • Risk Assessment / methods*
  • Risk Assessment / standards
  • Vaccines, DNA / adverse effects*
  • Vaccines, DNA / genetics
  • Vaccines, DNA / standards*
  • Viral Vaccines / adverse effects
  • Viral Vaccines / genetics*
  • Viral Vaccines / standards*

Substances

  • COVID-19 Vaccines
  • Vaccines, DNA
  • Viral Vaccines