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 (http://www.sciencedirect.com/science/journal/0264410X/34/49). 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.
