The Brighton collaboration standardized module for vaccine benefit-risk assessment.

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. Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Citation

Bennett Levitan, Stephen C Hadler, William Hurst, Hector S Izurieta, Emily R Smith, Nicole L Baker, Vincent Bauchau, Rebecca Chandler, Robert T Chen, Danielle Craig, Jay King, Punnee Pitisuttithum, Walter Strauss, Sylvie Tomczyk, Joseline Zafack, Sonali Kochhar. The Brighton collaboration standardized module for vaccine benefit-risk assessment. Vaccine. 2024 Feb 06;42(4):972-986

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PMID: 38135642

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