Minimum Data Set and Metadata for Active Vaccine Safety Surveillance: Systematic Review.

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 aims to define the minimal data scope for association studies in vaccine safety, providing a reference framework for implementing AVSS systems worldwide, especially in low- and middle-income countries.

Methods

The study systematically searched PubMed, Embase, and Web of Science for cohort and case-control studies related to AVSS published between January 1, 2018, and September 7, 2022. Guided by the WHO and Council for International Organizations of Medical Sciences guidelines (CIOMS), we developed a 4D framework for Minimum Data Sets (

SUBMITTER: Zhang M 

PROVIDER: S-EPMC12187031 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature