Interpretation of the standard Specification for Safety Follow-up of Vaccine Clinical Trials (T/JPMA 023—2024)

The standard Specification for Safety Follow-up of Vaccine Clinical Trials (T/JPMA 023—2024) was published by Jiangsu Preventive Medicine Association on September 2, 2024 and officially implemented on September 9, 2024. This standard specifies the main procedures and key contents for safety follow-up after vaccination in vaccine clinical trials, and it is applicable to the follow-up of adverse events after vaccination in such trials. The safety of prophylactic vaccines is a critical focus in clinical trials and an important aspect of the vaccine registration review process. The quality of safety follow-up directly impacts the scientific validity of vaccine evaluations. This article interprets the key points of the standard and provides guidance for vaccine clinical trial institutions, trial sites, and professionals to enhance their understanding and promote the effective application of this standard.