JMIR Publications

ABSTRACT

Background:

Active vaccine safety surveillance (AVSS) stands as a top priority for the World Health Organization (WHO), serving as a critical indicator of the fourth maturity level for national regulatory agencies.

Objective:

This review delineates the minimal data scope from association studies in vaccine safety, aiming to offer a reference for conducting AVSS systems worldwide, particularly in low- and middle-income countries.

Methods:

The study systematically searched PubMed, Embase, and Web of Science, identifying all cohort and case-control studies related to AVSS. Guided by the WHO and Council for International Organizations of Medical Sciences guidelines (CIOMS), we developed a four-dimension and three-level framework of Minimum Data Sets (MDS), including "vaccines", "outcomes", "demographics", and "covariates". Variables with a frequency of at least 5% are defined as the MDS.

Results:

Of the 123 included studies, 102 (82.93%) were cohort studies, 98 (79.67%) originated from developed countries and covered the entire life-course population. The MDS for COVID-19 vaccines identified 65 level-three variables. Meanwhile, for the maternal, it encompasses 50. The WHO guidelines were more in line with actual use than the other, but both need to be further optimized using this MDS. Regrettably, the Metadata associated with these essential variables lacked descriptions.

Conclusions:

This MDS offers specific guidance and succinct requirements for the data scope of AVSS. It is imperative to establish a globally standardized MDS and Metadata based on these findings to advance the global vaccine safety ecosystem. Clinical Trial: PROSPERO CRD42023449920