Above photo provided by the Bill & Melinda Gates Foundation.
Maternal Interventions Vigilance may speed progress against the Sustainable Development Goals’ maternal, neonatal, and child health targets By Ajoke Sobanjo-ter Meulen
Over the past three decades, major reductions in maternal and child deaths were achieved, but continued progress is needed to meet the Sustainable Development Goals by 2030.
The burden remains significant: while maternal and under-five child mortality has been reduced by half during the past decade, an estimated 2.7 million neonatal deaths, 2.6 million stillbirths and 300,000 maternal deaths still occur each year, primarily in low- and middle-income countries (LMICs). Compared to overall infant and under-five deaths, reductions in newborn deaths have declined at a slower pace. Achieving further reductions will require new solutions to address one of the most significant causes of deaths in LMICs: infections.
Vaccines already prevent many of the deadliest childhood infections among children under the age of five, and new vaccines are on the horizon. In the past, introducing new vaccines in LMICs has oftentimes occurred years or a decade or more after launch in high-income countries, allowing for extensive post-approval safety monitoring in high-income country populations first. Closing this gap to enable a near simultaneous launch of new maternal vaccines in both high- and low-income countries will require active safety surveillance in the period immediately after launch in LMICs.
New maternal immunizations could help address unmet need.
To address the particularly high burden of mortality among newborns, momentum is growing to develop new maternal immunizations – vaccines given to women during pregnancy to protect their newborn infant during the first few months of life. Indeed, promising maternal vaccine candidates against two pathogens that cause significant burden of disease – group B streptococcus (GBS) and respiratory syncytial virus (RSV) – are in clinical development, with a recent RSV vaccine trial marking the first time a vaccine is in phase III clinical development in pregnant women.
Achieving timely introduction of these new vaccines in LMICs will require strengthened pharmacovigilance systems specifically focused on interventions given during pregnancy.
Strengthening and harmonizing Maternal Interventions Vigilance would enable introduction of new maternal immunizations.
Maternal Interventions Vigilance (MIV) refers to the safety monitoring of health care interventions that are administered to pregnant women primarily in the antenatal care setting. Building functional MIV partnerships between the maternal health and vaccine expert communities in LMICs is important to assess the benefits and potential risks of new maternal vaccines, which ultimately supports their recommendation by governments and health care providers – and importantly, their uptake by pregnant women. Pre-licensure vaccine safety assessment is supported by large safety databases in pregnant women. Even in the absence of any intervention, background adverse pregnancy and births outcomes are common, including in pregnancies that are identified as “low risk”, and may vary substantially in different populations. Against this background, effective post-launch active maternal vaccine safety surveillance in LMICs serves to generate the necessary data in pregnant women to help reduce the time to introduction of new maternal vaccines into routine immunization programs.
To address these challenges, the Bill & Melinda Gates Foundation convened a group of experts to develop a framework for how to harmonize and strengthen MIV in LMICs. A diverse group of stakeholders – from maternal and vaccine safety experts, researchers, and policymakers to clinicians, regulators and vaccine manufacturers – agreed that building capacity in risk identification, evaluation, management, and communication is essential to ensure good-quality data collection and timely decision-making when new maternal vaccines are introduced.
However, experts also identified several more immediate opportunities that could be leveraged by tapping into the already deeply engaged maternal, newborn, and child health stakeholder networks and existing pharmacovigilance and pregnancy surveillance resources. By comprehensively mapping existing resources in industry, research communities, and international agencies as well as how data between them could be shared more effectively, we could take steps needed toward strengthening and harmonizing MIV systems in LMICs. Indeed, while harmonizing MIV systems would facilitate future maternal vaccine introductions in LMICs, and most importantly, contribute to more rapid reductions in maternal and child deaths, it may have ancillary benefits. Strengthening MIV systems could enable more rapid introduction of new interventions for pregnant women and children across a multitude of other drug classes and interventions, beyond maternal immunization. Further, it would improve routine maternal and child health research capacity in LMICs by creating more reliable platforms for data collection.
To strengthen MIV systems, a multi-disciplinary and cross-cutting approach is necessary. And now is the time to come together, as we advance toward achieving the Sustainable Development Goals.
Ajoke Sobanjo-ter Meulen is a Senior Program Officer with the Bill and Melinda Gates Foundation, and leads the global maternal immunization strategy and its implementation through industry, academic and global health partners. Dr. Sobanjo-ter Meulen manages a broad portfolio of investments comprising vaccine research and development, epidemiology, vaccine implementation research projects.