The Brighton collaboration standardized module for vaccine benefit-risk assessment.
Vaccine
; 42(4): 972-986, 2024 Feb 06.
Article
in En
| MEDLINE
| ID: mdl-38135642
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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Vaccines
Limits:
Humans
Language:
En
Journal:
Vaccine
Year:
2024
Document type:
Article
Affiliation country:
Estados Unidos