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

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October 16, 2017

The first 28 days of life (the neonatal period) are the most vulnerable for a child’s survival. Worldwide, almost half of all deaths in children under five years old occur during the first 28 days of life. Despite progress in recent decades, neonatal mortality remains the highest in low- and middle-income countries (LMICs), and 99% of all neonatal deaths occur in LMICs.

Maternal immunization is a key strategy for reducing morbidity and mortality in both newborns and pregnant women, especially in LMICs which face the greatest burden of vaccine preventable diseases and have the most limited access to health services. Vaccinating pregnant women can offer protection for the mother, the developing fetus, and the newborn through transfer of maternal antibodies across the placenta, protecting both mother and baby from vaccine-preventable life-threatening infections.

 Maternal immunization is a key strategy for reducing morbidity and mortality in both newborns and pregnant women, especially in LMICs...

As global momentum is increasing to develop and deploy new vaccines for use in pregnant women, there is a need to strengthen systems that monitor vaccine safety in LMICs. Pharmacovigilance systems, which identify, evaluate, and respond to potential adverse events following immunization are weak in many LMICs. When functional, these systems can help can help gain the confidence of providers, pregnant women, and the general population by rapidly and effectively identifying and assessing potential safety issues. However, they can be difficult to implement in LMICs, where basic health surveillance and regulatory systems for medical products are often rudimentary or generally lacking.

In response to this need, the Global Alliance to Prevent Prematurity and Stillbirth (GAPPS), with support from the Bill & Melinda Gates Foundation and input from a broad array of coauthors and stakeholders, developed a landmark report that summarizes the literature and existing systems for monitoring the safety of maternal immunizations in LMICs. The report includes an analysis of MNCH surveillance in LMICs, identifies gaps, and outlines a roadmap for program development and implementation of safety monitoring for maternal immunizations in LMICs. This landscape analysis was a catalytic process, demonstrating the breadth of efforts in this area and bringing together a range of organizations and stakeholders from industry, academia, regulatory agencies, governmental and nongovernmental organizations, WHO, UNICEF, and the maternal, newborn, and child health (MNCH) organizations to develop a cohesive strategy.

On the basis of this analysis, the report outlines several key needs, including the need for guidelines for detecting, reviewing, and responding to events related to the health of pregnant women and their offspring; establishing better linkages among pharmacovigilance systems and stakeholders; enhanced training of personnel; and the creation of models for data sharing and communication. It also presents a roadmap for program development which outlines a cohesive strategy, building on existing systems and leveraging existing investments and technical expertise.

 Successful implementation of maternal immunization safety monitoring programs requires leadership, coordination, and the mobilization of financial and human resources at the national and international levels.

Successful implementation of maternal immunization safety monitoring programs requires leadership, coordination, and the mobilization of financial and human resources at the national and international levels. Safety monitoring systems play a critical role in the adoption and implementation of new vaccines for use in pregnant women and are essential to protecting public health and advancing vaccine programs to reduce the global burden of maternal and newborn morbidity and mortality.

This report provides a roadmap for moving forward for all of us who are committed to improving the health of mothers and infants.

 

 
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