Aims and Objectives
In an era of successful global immunization programs, high quality and globally concerted data collection, analysis and communication are paramount. Comparability of safety data across products, programs, and populations is a pivotal aim for effective and efficient strengthening of immunization programs in pregnant women. As a first step, GAIA (Global Alignment of Immunization Safety Assessment in pregnancy) will provide standards and tools to establish a globally shared understanding of outcomes and approaches to monitoring vaccine safety with specific focus on LMIC needs and requirements.
The GAIA project will leverage existing methods and infrastructures developed by the consortium. For example, the Brighton Collaboration (BC) method of developing globally standardized case definitions is characterized by a structured approach of bringing together all relevant stakeholder groups including public health institutes, regulatory authorities, academic and patient care organizations as well as manufacturers to gather available evidence and build consensus on standards for global use with specific awareness of LMIC needs. Based on this experience, the GAIA consortium will develop a core set of globally standardized case definitions of key outcomes, and also create case identification algorithms and data collection tools for monitoring immunization programs in pregnancy. Guidance for harmonized data collection, analysis and presentation of these events will also be developed. Through a stringent public consultation process including partners from LMIC and close interaction with investigators of ongoing trials and parallel projects operational in LMIC, the GAIA consortium will evaluate the usefulness and practicability of the draft outputs prior to recommendation for wider implementation.