Against the Covid-19 background, vaccine safety has aroused the wild attention of all social areas. However, the factors that cause vaccine safety risks are complicated and meanwhile, data is difficult to obtain, making it a challenge for analyzing vaccine safety risks quantitatively. This paper concretises the issue of vaccine system safety by creatively proposing an analytical framework for the problem of uncertainty. First, the paper focuses on the whole process of vaccine safety, analyses risk factors affecting vaccine safety in development, approval, production, transportation, and supervision of vaccines in order to build a vaccine risk assessment system. The proposed framework is then used to construct a Bayesian network early warning system for vaccine risk. To address the difficulty of obtaining data, the probability of safety risks occurring throughout the process is calculated by combining expert knowledge and fuzzy set theory to obtain uncertainty data. In response to structural complexity, a comprehensive framework is constructed using fault trees and Bayesian networks to capture the correlation between risk factors. This analytical framework can provide guidance to governments and vaccine-related companies in their decision-making to prevent vaccine safety issues. Finally, sensitivity analysis revealed a high probability of vaccine risk in the transport process. © 2021 IEEE.
A Fuzzy Bayesian Network Based on Fault Tree for Vaccine Safety Risks Analysis