The Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference took place at the NIH Campus on March 29-30 2016.
The meeting was centred around the GAIA Project and its first outcomes and brought together 142 people from all over the world (including representatives from the FDA, NIH, CDC, ACOG, the Pharmaceutical Industry, Maternal Immunization trial investigators from low and high resource settings, Bill & Melinda Gates Foundation, NVPO, stakeholder organizations, etc.) with the objective of highlighting the progress made in harmonizing safety monitoring of immunization in pregnancy and developing consensus recommendations for a globally concerted approach.
The conference received financial support from Sanofi Pasteur, Novavax and GSK. Funding from the Bill & Melinda Gates Foundation helped ensuring attendance of investigators and stakeholders from Low and Middle Income Countries (LMICs).
The work performed by the GAIA partners, supported by a growing highly-committed global network of experts, was acknowledged as a key driver for addressing the practical challenges of safety monitoring for Immunization in Pregnancy and helping to support capacity building in the different settings with the aim of increasing efficiency and data quality. It was felt that the definitions of key obstetric and neonatal terms being developed would have broad applicability beyond Immunization in Pregnancy clinical trials.
All presentations and video recordings will be available on the conference’s website soon. Furthermore, the report of the Conference, summarizing the most important discussions and agreements, will be made available in a few months.