Research On Biosafety Control Of Virus Vaccine Development Process Based On Bow-Tie Model

Plague is closely related to the development process of human beings and has a profound and huge impact on human history.Especially since the emergence of COVID-19 and its huge impact on the world,vaccines have become one of the most effective measures for epidemic prevention and control in the face of public health problems such as the spread of various viruses.The main raw materials of virus vaccines are pathogenic microorganisms,such as viruses,whose inherent characteristics determine the threat to public health.The resulting leakage risk of various primitive microorganisms has attracted extensive attention from people and attracted great attention from all countries in the world.The biosafety management of pathogenic microbiology laboratories has been widely used in the world.However,the biosafety control of the whole life cycle,such as large-scale virus vaccine production,is not perfect and needs to be further studied.The biosafety control of virus vaccine development process involving pathogenic microorganisms is studied in the thesis.mainly focuses on the whole-process management and control of viral vaccine biosafety risks involving pathogenic microorganisms.Firstly,by summarizing the research status of virus vaccine biosafety management at home and abroad,the relevant concepts and theoretical basis of virus vaccine biosafety control were elaborated,and the risk management theory based on Bow-Tie model was selected to study the virus vaccine biosafety control.Secondly,the paper analyzes the risks of biological safety of viruses in the vaccine development process of every key link,respectively for virus vaccine viruses introduced,production preparation,sample test,waste disposal,to identify the virus in the vaccine development process there may be risks of all kinds of biological safety,together with the present situation of biological safety control,The problems existing in the biosafety control of virus vaccines were put forward and the causes were analyzed.Thirdly,through the biosafety management cases at home and abroad,the application practice of biosafety policies,regulations and standards at home and abroad,the relevant enlightenment on the biosafety control of the whole process of virus vaccine development was obtained.Finally,based on the Bow-Tie risk management and control model based on the risk management theory,the various links of virus vaccine biosafety are analyzed,and the threats of biosafety accidents that may be caused by it are summarized and sorted out.Based on this,two types of risk barriers,risk prevention and accident mitigation,are established.Through biosafety incident prevention barrier,accident mitigation barrier,barrier failure degradation control measures,so as to reduce the possibility of virus vaccine biosafety accident and the severity of consequences.Through the above theoretical research,the whole antecedents and consequences of the risks or accidents of virus vaccine biosafety are comprehensively described,and the optimization strategy of biosafety control should be adopted in the future.The combined effect of these strategies is expected to provide systematic whole-process control support for virus vaccine biosafety in China.