Maternal Immunization Safety Monitoring in Low- and Middle-Income Countries: A Roadmap for Program Development

Oct 16, 2017

Maternal immunization holds the promise of further reducing morbidity and mortality among pregnant women and infants, particularly in low- and middle-income countries where there is the greatest burden of vaccine-preventable disease. This report from a Bill and Melinda Gates Foundation (BMGF)-funded project, developed with input from a large, multidisciplinary group of experts, summarizes existing programs in pharmacovigilance and maternal, newborn, and child health 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. Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting was part of the Core Advisory Group for the project, and an Author and Reviewer for the report.

Special Issue of Vaccine Published

Global Healthcare Consulting co-led the scientific coordination of the international Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project with the Brighton Collaboration Foundation. The multi-year Bill and Melinda Gates Foundation (BMGF) funded GAIA project consisted of 13 partners from 8 countries (including the National Institute of Health, WHO, Erasmus University Medical Centre, St George’s University of London, Baylor College of Medicine etc). The GAIA project outputs are being utilized in Interventional and Observational studies and AEFI surveillance for Vaccines and Maternal and Child Health Research for adverse maternal and perinatal birth outcomes assessments globally. They include a core set of over 21 globally standardized case definitions of selected key obstetric and neonatal terms, a glossary of enabling terms critical to these obstetric and neonatal case definitions (e.g., an algorithm for the determination of gestational age) to support stakeholders using the definitions, guidelines for the standardized conduct of clinical trials of vaccines in pregnant women (including a landscape analysis of regulatory guidance available for immunization in pregnancy from the Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conference on Harmonization) and guidance on study design and the standardization of data collection etc. These have been published in a special issue of Vaccine ( A standardized approach to safety data collection and reporting is likely to improve the acceptability and implementation of immunizations in pregnancy and subsequently help reduce illness and death among pregnant women and young infants globally.