On behalf of the Brighton Collaboration BRAVATO (Benefit-Risk Assessment of VAccines by TechnolOgy) Working Group, please find enclosed a manuscript and accompanying case study that has been developed to support the evaluation of the benefit-risk of vaccines. Please review and email backtracked edits/comments to firstname.lastname@example.org by May 16th.
- The Manuscript “The Brighton Collaboration Standardized Module for Vaccine Benefit-Risk Assessment”
- A case study on “Myocarditis following mRNA COVID-19 Vaccines in Males: A Case Study based on US data from June 2021” utilizing the BRAVATO Module for Vaccine Structured Benefit-Risk Assessment version 1, 31 March 2023. The case study will serve as an on-line supplement to the manuscript. All source data used in the case study is in the public domain.
The motivation for this module is based on the increasingly critical role of benefit-risk (B-R) assessment in vaccines. Evaluation of the B-R balance is a key element in the life cycle of a vaccine product. It supports decision-making during development milestones, regulatory approval, policy recommendations, and following emerging signals during post-authorization surveillance. Its role became a public phenomenon during the years of the COVID-19 pandemic, with the enormous pressure for emergency use authorizations and the rapid expansion of scientific literature. The Brighton Collaboration Benefit-Risk Assessment Module Working Group was convened to develop this module to support advance planning, conduct and reporting of vaccine B-R.
A test case has been developed to provide an example of how the B-R assessment module might be used to develop a real-world B-R calculation, using an example of a generic COVID-19 mRNA vaccine versus no vaccination.
Sonali Kochhar and Bennett Levitan
Dr Sonali Kochhar, MD
Medical Director, Global Healthcare Consulting
Clinical Associate Professor
Department of Global Health
University of Washington, Seattle
Bennett Levitan, M.D.-Ph.D.
Senior Director, Benefit-risk Assessment, Global Epidemiology
Johnson & Johnson
Office of the Chief Medical Officer
Janssen Research & Development, LLC
1125 Trenton-Harbourton Road
Titusville, NJ 08560