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.
About BRAVATO
In recognition of the growing use of viral vectors in vaccine development and the need for a structured approach to assessing their associated safety considerations, the Brighton Collaboration established the Viral Vector Vaccines Safety Working Group (V3SWG) in 2008.
In 2020, the group was renamed Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) to reflect an expanded remit beyond viral vector vaccines. BRAVATO develops harmonized guidance for assessing potential vaccine safety issues and standardized templates that support transparent and comparable benefit-risk assessment of vaccine candidates.
The original viral vector template was designed to capture key information about the source virus, the vector itself, and the final vaccine, including nonclinical and clinical safety, toxicology, potency, and overall risk considerations. The approach has since expanded to additional vaccine platforms, including nucleic acid, protein, inactivated viral, and live-attenuated viral vaccines.
BRAVATO templates are designed to facilitate scientific discussion among vaccine developers, regulators, researchers, and other stakeholders by increasing the transparency and comparability of information. They also provide a structured, checklist-like approach for identifying and managing potentially complex benefit-risk considerations.
Where available, templates are provided in both a full publication version and a shorter, editable version intended for practical use and updating. View the template revision history →
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 live-attenuated viral 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 group members have produced a range of peer-reviewed publications describing vaccine platform templates, methodological guidance, and related safety considerations. Together with vaccine developers and other collaborators, BRAVATO has also produced dozens of vaccine safety profiles describing vaccine- or platform-specific benefit-risk considerations (e.g., vaccine design, manufacturing, safety, immunogenicity, efficacy); these are accessible below and have been transferred to web-accessible digital profiles accessible here.
Robert T. Chen, Baevin Carbery, Lisa Mac, et al. Vaccine. 2015.
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.
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.
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.
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of nucleic acid (RNA and DNA) vaccines
Kim D, Robertson JS, Excler JL, Condit RC, Fast PE, et al.
Vaccine. 2020 Jul 22;38(34):5556-5561.
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines
Kochhar S, Kim D, Excler JL, Condit RC, Robertson JS, et al.
Vaccine. 2020 Jul 31;38(35):5734-5739.
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines
Kochhar S, Excler JL, Kim D, Robertson JS, Fast PE, et al.
Vaccine. 2020 Sep 3;38(39):6184-6189.
Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines
Gurwith M, Condit RC, Excler JL, Robertson JS, Kim D, et al.
Vaccine. 2020 Nov 17;38(49):7702-7707.
The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines
Condit R, Kim D, Robertson JS, Excler JL, Gurwith M, et al.
Vaccine. 2020 Nov 17;38(49):7708-7715.
Monath TP, Seligman SJ, Robertson JS, et al. Vaccine. 2015;33(1):62-72.
Live virus vaccines based on a vesicular stomatitis virus (VSV) backbone: Standardized template with key considerations for a risk/benefit assessment
Clarke DK, Hendry RM, Singh V, et al. Vaccine. 2016;34(51):6597-6609.
rVSVΔG-ZEBOV-GP (also designated V920) recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment
Monath TP, Fast PE, Modjarrad K, et al. Vaccine: X. 2019;1:100009.
The Brighton Collaboration Standardized Templates for Collection of Key Information for Benefit-Risk Assessment of Vaccines by Technology (BRAVATO; formerly V3SWG)
Chen RT, Kochhar S, Condit RC. Vaccine. 2021.
The Brighton Collaboration standardized template for collection of key information for risk/benefit assessment of a Modified Vaccinia Ankara (MVA) vaccine platform
Volkmann A, Williamson AL, Weidenthaler H, et al. Vaccine. 2020.
Vaccines based on replication incompetent Ad26 viral vectors: Standardized template with key considerations for a risk/benefit assessment
Custers J, Kim D, Leyssen M, et al. Vaccine. 2021.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a soluble glycoprotein vaccine to prevent disease caused by Nipah or Hendra viruses
Eldridge JH, Egan MA, Matassov D, et al. Vaccine. 2021;39(38):5436-5441.
Vaccines based on the replication-deficient simian adenoviral vector ChAdOx1: Standardized template with key considerations for a risk/benefit assessment
Folegatti PM, Jenkin D, Morris S, et al. Vaccine. 2022.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for an inactivated viral vaccine against Chikungunya virus
Hernandez LM, Sumathy K, Sahastrabuddhe S, et al. Vaccine. 2022.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273)
Leav B, Straus W, White P, et al. Vaccine. 2022;40(35):5275-5293.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses
Wilkinson B, Patel KS, Smith K, et al. Vaccine. 2023;41(45):6762-6773.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Medigen COVID-19 protein vaccine
Estephan L, Liu LTC, Lien CE, et al. Vaccine. 2023;41(15):2615-2629.
A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine
Pather S, Charpentier N, van den Ouweland F, et al. Vaccine. 2024;42(22):126165.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a viral vector vaccine based on a non-replicating modified vaccinia virus Ankara viral vector
Link EK, Tscherne A, Sutter G, et al. Vaccine. 2025;43(1):126521.
A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the emergent vesicular stomatitis virus (VSV) viral vector vaccine for Lassa fever
Spurgers K, Wynn M, Charles L, et al. Vaccine. 2025;58:127137.
A Brighton Collaboration Standardized Template with Key Considerations for a Benefit/Risk Assessment for the Live-Attenuated hRVFV-4s Vaccine against Rift Valley Fever
Punt C, Wichgers Schreur P, Luyimbazi D, et al. SSRN. 2026.
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
