Recently, the Drug Evaluation Center of the State Drug Administration issued the “Guiding Principles for Classification Criteria for Adverse Events in Vaccine Clinical Trials”. The guidelines apply to the classification of adverse events in vaccine clinical trials for the purpose of domestic registration. Adverse events are classified into five levels from grade 1 to grade 5 according to severity. All deaths due to adverse events were grade 5. The purpose of this guideline is to standardize the classification of adverse events and improve the scientific nature of vaccine safety assessments through rational analysis and determination of the severity of adverse events. At the same time, it can also provide a reference for emergency blindness detection and suspension/termination of clinical trials in vaccine clinical trial design.

Recently, the Drug Evaluation Center of the State Drug Administration issued the “Guiding Principles for Classification Criteria for Adverse Events in Vaccine Clinical Trials”. The guidelines apply to the classification of adverse events in vaccine clinical trials for the purpose of domestic registration. Adverse events are classified into five levels from grade 1 to grade 5 according to severity. All deaths due to adverse events were grade 5. The purpose of this guideline is to standardize the classification of adverse events and improve the scientific nature of vaccine safety assessments through rational analysis and determination of the severity of adverse events. At the same time, it can also provide a reference for emergency blindness detection and suspension/termination of clinical trials in vaccine clinical trial design.