The Global Alliance to Prevent Prematurity and Stillbirth (GAPPS), has developed a strategy for developing systems that monitor and track the safety of maternal immunization programs in low- and middle-income countries (LMICs), that is also beneficial to developing monitoring systems in higher-resource countries as well.

Successful implementation of vaccine research and programs in pregnant women requires accurate and prompt identification and response to potential adverse events following immunization, including monitoring infants after birth. However, many ways of tracking and reporting results are difficult to implement in LMICs, where basic health systems are generally lacking.

Both, the Brighton Collaboration Foundation and the GAIA Consortium are mentioned in the report as part of the pull of international organisations working on strengthening pharmacovigilance systems in LMICs. The document highlights the importance of implementing standardized, validated definitions for key variables into surveillance systems, such as the ones developed by GAIA for maternal, fetal, and neonatal death.

Furthermore, the report specifically recommends field testing, validation, and implementation of the GAIA case definitions as a key component for building systems with improved data quality and standardization, allowing for comparability across sites.

This report, developed with support from the Bill & Melinda Gates Foundation and input from a large, multidisciplinary group of experts, summarizes existing programs in pharmacovigilance and maternal, newborn, and child health (MNCH) surveillance in LMICs, identifies gaps and needs, and outlines a roadmap for program development and implementation for monitoring the safety of maternal immunizations in LMICs.

You can download the full document here.