Public availability and completeness of vaccine product labeling in China

Publicly accessible vaccine package inserts are essential for regulatory transparency and informed clinical decision-making. However, the public availability and completeness of vaccine labeling in China remain unclear. We conducted a cross-sectional study of all vaccines approved by the National Medical Products Administration (NMPA) to evaluate the availability and completeness of publicly accessible package inserts, including both domestic and imported vaccines. Package inserts were retrieved from the NMPA vaccine labeling database as of 22 August 2026. Vaccines with at least one lot-release record during the preceding 3 years were classified as market-active. Labeling completeness was assessed using a predefined framework comprising 26 items derived from NMPA regulatory guidance. Completeness scores were calculated as the mean applicable item score. Among 309 unique approved vaccines, package inserts were publicly available for 163 (52.8%) vaccines and for 151 of 175 (86.3%) currently marketed vaccines. The median completeness score was 0.89 (interquartile range, 0.83–0.93). Deficiencies were most pronounced in clinically relevant sections, including drug interactions, special populations, and clinical trials. Completeness scores were higher for imported than domestic vaccines and for package inserts last revised on or after 20 May 2022 than for those revised before that date. Despite recent regulatory efforts to improve transparency gaps remain in public availability and the completeness of clinically relevant information in vaccine package inserts in China. Strengthening the timely disclosure and updating of vaccine labeling may improve regulatory transparency and support informed vaccination decisions.