1. The Brighton collaboration standardized module for vaccine benefit-risk assessment.
- Author
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Levitan, Bennett, Hadler, Stephen C., Hurst, William, Izurieta, Hector S., Smith, Emily R., Baker, Nicole L., Bauchau, Vincent, Chandler, Rebecca, Chen, Robert T., Craig, Danielle, King, Jay, Pitisuttithum, Punnee, Strauss, Walter, Tomczyk, Sylvie, Zafack, Joseline, and Kochhar, Sonali
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VACCINE development , *LOW-income countries , *TECHNOLOGY assessment , *VACCINES , *CLINICAL trials - Abstract
Vaccine Benefit-Risk (B-R) assessment consists of evaluating the benefits and risks of a vaccine and making a judgment whether the expected key benefits outweigh the potential key risks associated with its expected use. B-R supports regulatory and public health decision-making throughout the vaccine's lifecycle. In August 2021, the Brighton Collaboration's Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Benefit-Risk Assessment Module working group was established to develop a standard module to support the planning, conduct and evaluation of structured B-R assessments for vaccines from different platforms, based on data from clinical trials, post-marketing studies and real-world evidence. It enables sharing of relevant information via value trees, effects tables and graphical depictions of B-R trade-offs. It is intended to support vaccine developers, funders, regulators and policy makers in high-, middle- or low-income countries to help inform decision-making and facilitate transparent communication concerning development, licensure, deployment and other lifecycle decisions. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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