Browsing by Author "Strauss W."

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    The Brighton collaboration standardized module for vaccine benefit-risk assessment
    (2023-01-01) Levitan B.; Hadler S.C.; Hurst W.; Izurieta H.S.; Smith E.R.; Baker N.L.; Bauchau V.; Chandler R.; Chen R.T.; Craig D.; King J.; Pitisuttithum P.; Strauss W.; Tomczyk S.; Zafack J.; Kochhar S.; Levitan B.; Mahidol University
    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.