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.Mahidol University2024-02-082024-02-082023-01-01Vaccine (2023)0264410Xhttps://repository.li.mahidol.ac.th/handle/20.500.14594/95987Vaccine 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.Biochemistry, Genetics and Molecular BiologyMedicineImmunology and MicrobiologyVeterinaryArticleSCOPUS10.1016/j.vaccine.2023.09.0392-s2.0-8518058969418732518