Maternal interventions vigilance harmonization in low- and middle-income countries: Stakeholder meeting report; Amsterdam, May 1-2, 2018.

Although major reductions in maternal and child mortality were achieved in the Millennium Development Goals era, progress must be accelerated to meet Sustainable Development Goals health targets by 2030. An estimated 2.7 million neonatal deaths and 2.6 million stillbirths still occur annually. Over the past several years there has been renewed global interest in innovative approaches to maternal immunization to potentially decrease mortality and severe morbidity in neonates, and in the pregnant woman and her fetus. Several new vaccines are in clinical development for indications in pregnant women, e.g., vaccines against respiratory syncytial virus, and group B streptococcus. Achieving near-concurrent introduction of new maternal vaccines in high-, middle-, and low-income countries requires that mechanisms are in place for appropriate safety monitoring worldwide. The Bill & Melinda Gates Foundation convened a global expert meeting in Amsterdam on May 1-2, 2018, to discuss a framework for appropriate pharmacovigilance for vaccines used during pregnancy based on integrated maternal interventions vigilance (MIV) systems and collection of appropriate data to inform timely decision-making by and for pregnant women. Planning for MIV requires a multi-disciplinary, collaborative approach that fully leverages and builds upon existing resources, and builds new capabilities and capacity where needed. Meeting participants identified priority actions including (1) establishing background rates to better evaluate emerging safety signals and vaccine effectiveness, (2) identifying potential sentinel vaccine surveillance sites, (3) developing data sharing capabilities, (4) creating guidance documents and protocols, and (5) the advanced preparation of culturally-appropriate communication plans and risk management plans. Integrating MIV across the routine obstetric and neonatal health care delivery continuum and all relevant programs and data systems could result in fundamental improvements in maternal, neonatal and child health. Improved pregnancy pharmacovigilance platforms may strengthen other vaccine and drug product safety systems and improve maternal and child research capabilities in LMICs.