Benefit-risk (B-R) assessment consists of evaluating the benefits and risks of a vaccine and making a judgment on whether the expected key benefits outweigh the potential key risks associated with the vaccine’s expected use. Its role became a public phenomenon during the first two years of the COVID-19 pandemic, with the enormous pressure for emergency use authorizations and the rapid expansion of scientific literature.
Formal assessment of B-R is crucial throughout the vaccine lifecycle.
In August 2021, the Benefit-Risk Assessment Module Working Group was formed to develop a standard module to support the planning, conduct and evaluation of structured B-R assessments for multiple vaccine platforms. The working group is led by Dr Sonali Kochhar and Dr Bennett Levitan and has members with significant B-R, vaccine safety and vaccine regulatory expertise from industry, regulatory bodies, public health authorities, academia and consulting. The module is designed for use by vaccine developers, funders, regulators and policy makers. It is intended to help inform decision-making and facilitate transparent communication and scientific dissuasion concerning development, licensure, deployment and other lifecycle decisions for vaccines.
This module can be used as an independent document for planning, conducting, or reporting vaccine B-R assessments or an optional supplemental B-R add-on to the standardized Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) vaccine templates. It has the flexibility to accommodate stakeholders with limited B-R experience.
A case study of a generic COVID-19 mRNA vaccine has been developed to provide an example of how the B-R assessment module might be used to conduct a real-world B-R assessment. An interactive visualization tool is also being developed for the module.
The latest version of the module in text form, including all introductory text, formatted for easy completion is available at
- Sonali Kochhar, Hector S. Izurieta, Rebecca E. Chandler, Adam Hacker, Robert T. Chen, Bennett Levitan. Benefit-risk assessment of vaccines, Vaccine, 2023, https://doi.org/10.1016/j.vaccine.2023.07.041. https://www.sciencedirect.com/science/article/pii/S0264410X23008721
Modules for specific vaccines will be added once completed.