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

Area of Science:

• Pharmacovigilance and Public Health
• Epidemiology
• Regulatory Science

Background:

• Active vaccine safety surveillance (AVSS) is a World Health Organization (WHO) priority, indicating regulatory agency maturity.
• Effective AVSS is critical for ensuring vaccine safety globally, especially in resource-limited settings.

Purpose of the Study:

• To define the minimal data scope for association studies in vaccine safety.
• To establish a reference framework for implementing AVSS systems worldwide.
• To support low- and middle-income countries in developing robust vaccine safety monitoring.

Main Methods:

• Systematic literature review of cohort and case-control studies on AVSS (2018-2022).
• Development of a 4D framework for Minimum Data Sets (MDS): Vaccine, Outcome, Demographic Data, Covariate.
• Inclusion of variables with >= 5% frequency, guided by WHO and CIOMS guidelines.

Main Results:

• 123 studies were included; 82.9% were cohort studies, 79.7% from high-income countries.
• Identified 54 variables for COVID-19 vaccine MDS and 96 for maternal population MDS.
• WHO guidelines showed better practical alignment than CIOMS; metadata description was inadequate.

Conclusions:

• The proposed MDS offers clear requirements for AVSS data scope.
• A globally standardized MDS and comprehensive metadata are vital for improving the global vaccine safety ecosystem.
• Further optimization of guidelines and metadata is needed based on MDS findings.