[The consideration about safety data analysis and expression in instructions of vaccine clinic trials]

The safety of prophylactic vaccine is one of the key points both in clinical trials and evaluation. Based on the review practice of vaccine registration clinical trials in recent years, we summarized the common problems in safety analysis and report and accordingly puts forward a series of thoughts and suggestions, including discussing the role of statistics in safety analysis, putting forward the framework of safety analysis and report involved analysis content, analysis index and analysis dimension, in which attention is paid to the severity analysis; emphasizing the initiative analysis on risk signal and encouraging the evidence-based initiative safety evaluation. At the same time, this paper discusses the basic principles of the presentation of safety data in the package inserts, as well as the comprehensive consideration of the safety data of each phase of the trial and different subjects. It can be used for reference by sponsor to promote vaccine clinical research and evaluation in China.