Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines

Vaccine. 2020 Nov 17;38(49):7702-7707. doi: 10.1016/j.vaccine.2020.09.042. Epub 2020 Oct 16.

Abstract

Several live-attenuated viral 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 live-attenuated viral vaccines. This will help key stakeholders assess potential safety issues and understand the benefit-risk of such vaccines. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed live-attenuated viral vaccines.

Keywords: Attenuated; Benefit-risk; Brighton Collaboration; CEPI; COVID-19; Live; Safety; Template; Vaccine; Viral.

Publication types

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

MeSH terms

  • COVID-19 Vaccines / adverse effects
  • COVID-19 Vaccines / pharmacology
  • Drug Evaluation, Preclinical / methods
  • Drug Evaluation, Preclinical / standards*
  • Humans
  • Risk Assessment
  • Societies, Scientific
  • Vaccines, Attenuated / adverse effects*
  • Vaccines, Attenuated / pharmacology
  • Viral Vaccines / adverse effects*
  • Viral Vaccines / pharmacology

Substances

  • COVID-19 Vaccines
  • Vaccines, Attenuated
  • Viral Vaccines