The Brighton collaboration standardized module for vaccine benefit-risk assessment
2
Issued Date
2023-01-01
Resource Type
ISSN
0264410X
eISSN
18732518
Scopus ID
2-s2.0-85180589694
Journal Title
Vaccine
Rights Holder(s)
SCOPUS
Bibliographic Citation
Vaccine (2023)
Suggested Citation
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. The Brighton collaboration standardized module for vaccine benefit-risk assessment. Vaccine (2023). doi:10.1016/j.vaccine.2023.09.039 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/95987
Title
The Brighton collaboration standardized module for vaccine benefit-risk assessment
Author's Affiliation
Faculty of Tropical Medicine, Mahidol University
Novavax, Inc.
Moderna Therapeutics
GlaxoSmithKline Pharmaceuticals SA/NV
Janssen Research & Development
Public Health Agency of Canada
University of Washington
Sanofi S.A.
Food and Drug Administration
AstraZeneca
Coalition for Epidemic Preparedness Innovations
Independent Consultant
Global Healthcare Consulting
Task Force for Global Health
Independent Consultant
Novavax, Inc.
Moderna Therapeutics
GlaxoSmithKline Pharmaceuticals SA/NV
Janssen Research & Development
Public Health Agency of Canada
University of Washington
Sanofi S.A.
Food and Drug Administration
AstraZeneca
Coalition for Epidemic Preparedness Innovations
Independent Consultant
Global Healthcare Consulting
Task Force for Global Health
Independent Consultant
Corresponding Author(s)
Other Contributor(s)
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.