The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines

Vaccine. 2020 Jul 31;38(35):5734-5739. doi: 10.1016/j.vaccine.2020.06.044. Epub 2020 Jul 9.

Abstract

Several protein vaccine candidates are among the COVID-19 vaccines in 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 protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.

Keywords: Benefit-risk; Brighton Collaboration; CEPI; COVID-19; Peptide; Protein; Recombinant; Safety; Template; Vaccine.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Antigens, Viral / administration & dosage
  • Antigens, Viral / adverse effects
  • Antigens, Viral / immunology
  • COVID-19 Vaccines
  • Coronavirus Infections / immunology
  • Coronavirus Infections / prevention & control
  • Humans
  • Patient Safety
  • Risk Assessment
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / immunology
  • Viral Proteins / administration & dosage
  • Viral Proteins / adverse effects
  • Viral Proteins / immunology
  • Viral Vaccines / administration & dosage
  • Viral Vaccines / adverse effects*
  • Viral Vaccines / immunology*

Substances

  • Antigens, Viral
  • COVID-19 Vaccines
  • Vaccines, Synthetic
  • Viral Proteins
  • Viral Vaccines