Taking advantage of the organization of the Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference that took place at the NIH Campus on March 29-30 2016, GAIA organized a pre-Conference workshop on March 28th with a selected group of 20 experienced Immunization in Pregnancy investigators and experts working in/with LMIC settings.
The 3-hour workshop was focused on reviewing and evaluating the applicability of the first outcomes developed by the GAIA consortium: the first set of 10 case definitions of key maternal and neonatal outcomes, the guidelines for the collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women, and a data collection tool.
Through a comprehensive questionnaire and guided discussions, the process gathered critical inputs for guiding next steps and ensuring usefulness and applicability of the tools globally, with a focus on low and middle income countries (LMIC).
Specifically, the following aspects were addressed: challenges in applying the developed standards, identification of potential improvements to be taken into account for further updates/developments of the case definations, and the opportunities for implementing these standards in LMIC.
The results are being analysed and will be included as part of the Deliverable D4.3 Stakeholder recommendations on implementation options.