Benefit–Risk Assessment of VAccines by TechnolOgy (BRAVATO) is a Brighton Collaboration initiative that develops standardized templates and tools to support structured evaluation of vaccine platforms.
BRAVATO supports the development and use of standardized approaches for evaluating the benefits and risks of vaccines across different technology platforms. Originally established as the Viral Vector Vaccines Safety Working Group (V3SWG) in 2008, the initiative expanded in 2020 to address a broader range of vaccine technologies.
BRAVATO brings together global experts to develop templates, modules, and supporting resources that enable consistent and transparent benefit–risk assessment throughout vaccine development and use.
BRAVATO develops standardized templates and supporting resources that help stakeholders conduct structured benefit-risk assessments for vaccine platforms.
What BRAVATO provides
Standardized Templates
Structured templates that capture key information needed for benefit-risk assessment of vaccine technologies.
Assessment Modules
Supplemental tools supporting structured benefit-risk analysis across vaccine platforms.
Scientific Publications
Peer-reviewed outputs documenting BRAVATO methodology and platform-specific templates.
TEMPLATES BY PLATFORM
Viral Vector Vaccines Template
Standardized template supporting benefit-risk assessment of viral vector vaccine technologies.
Nucleic Acid Vaccines
Standardized template supporting benefit–risk assessment of nucleic acid vaccine platforms, including RNA and DNA vaccines.
Protein Subunit Vaccines Template
Standardized template supporting benefit–risk assessment of protein-based vaccine platforms, including recombinant and subunit vaccines.
Inactivated Viral Vaccines
Standardized template supporting benefit–risk assessment of inactivated viral vaccine platforms.
Live-attenuated Viral Vaccines Templates
Standardized template supporting benefit-risk assessment of viral vector vaccine technologies.
BRAVATO MODULES
BRAVATO modules provide structured tools that complement platform templates and support benefit–risk assessment across different use cases.
Benefit-Risk Assessment Module
Structured module supporting the planning, conduct, and reporting of vaccine benefit–risk assessments across vaccine platforms.
Maternal Immunization Module
Template tool supporting benefit–risk assessment for vaccines intended for use in pregnant and breastfeeding women.
Pathogen-Specific Reference Templates
To support consistency and reduce duplication of effort, BRAVATO provides editable reference materials for selected pathogens. These Word documents may be adapted when completing the Target Pathogen and Population section of a BRAVATO template.
BRAVATO Publications
BRAVATO working groups have produced a range of peer-reviewed publications describing vaccine platform templates, methodological guidance, and related safety considerations.
The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)
Robert T. Chen, Baevin Carbery, Lisa Mac, et al. Vaccine. 2015.
Link: https://doi.org/10.1016/j.vaccine.2014.09.035
Adventitious agents and live viral vectored vaccines: Considerations for archiving samples of biological materials for retrospective analysis
Bettina Klug, James S. Robertson, Richard C. Condit, et al. Vaccine. 2016.
Link: https://doi.org/10.1016/j.vaccine.2016.02.015
Unique safety issues associated with virus-vectored vaccines: Potential for and theoretical consequences of recombination with wild type virus strains
Richard C. Condit, Anna-Lise Williamson, Rebecca Sheets, et al. Vaccine. 2016.
Link: https://doi.org/10.1016/j.vaccine.2016.04.060
Defining the interval for monitoring potential adverse events following immunization after receipt of live viral vectored vaccines
Sonali Kochhar, Jean-Louis Excler, Karin Bok, et al. Vaccine. 2019.
Link: https://doi.org/10.1016/j.vaccine.2018.08.085
Live virus vaccines based on a yellow fever vaccine backbone: Standardized template with key considerations for a risk/benefit assessment
Thomas P. Monath, Stephen J. Seligman, James S. Robertson, et al. Vaccine. 2015.
Link: https://doi.org/10.1016/j.vaccine.2014.10.004
Live virus vaccines based on a vesicular stomatitis virus backbone: Standardized template with key considerations for a risk/benefit assessment
David K. Clarke, R. Michael Hendry, Vidisha Singh, et al. Vaccine. 2016.
Link: https://doi.org/10.1016/j.vaccine.2016.06.071
rVSVΔG-ZEBOV-GP recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment
Thomas P. Monath, Patricia E. Fast, Kayvon Modjarrad, et al. Vaccine X. 2019.
Link: https://doi.org/10.1016/j.jvacx.2019.100009
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid vaccines
Denny Kim, James S. Robertson, Jean-Louis Excler, et al. Vaccine. 2020.
Link: https://doi.org/10.1016/j.vaccine.2020.06.017
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines
Sonali Kochhar, Denny Kim, Jean-Louis Excler, et al. Vaccine. 2020.
Link: https://doi.org/10.1016/j.vaccine.2020.06.044
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines
Sonali Kochhar, Jean-Louis Excler, Denny Kim, et al. Vaccine. 2020.
Link: https://doi.org/10.1016/j.vaccine.2020.07.028
The Brighton Collaboration Standardized Templates for Collection of Key Information for Benefit-Risk Assessment of Vaccines by Technology (BRAVATO)
Robert T. Chen, Sonali Kochhar, Richard C. Condit. Vaccine. 2021.
Link: https://doi.org/10.1016/j.vaccine.2020.10.072
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines
Richard C. Condit, Denny Kim, James S. Robertson, et al. Vaccine. 2020.
Link: https://doi.org/10.1016/j.vaccine.2020.08.009
Brighton Collaboration Viral Vector Vaccines Safety Working Group standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines
Marc Gurwith, Richard C. Condit, Jean-Louis Excler, et al. Vaccine. 2020.
Link: https://doi.org/10.1016/j.vaccine.2020.09.042
Researchers, regulators, and other stakeholders interested in contributing to BRAVATO activities or learning more about available templates and modules are welcome to contact the Brighton Collaboration team at bc-coordinator@gmail.com
