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 leverages existing methods and infrastructures developed by the consortium. Based on this experience, the GAIA consortium has developed in its PHASE I a series of outputs based on the standard Brighton Collaboration consensus process, which involves global consultation of professionals from key regulatory organizations, public health institutes, investigators, vaccine manufacturers and academia to promote their applicability, usefulness and acceptability especially in LMIC. Based on a Landscape analysis of available standards and guidance documents, GAIA partners developed guidance documents and tools for investigators conducting clinical triaLs of immunization in pregnancy, a basic data collection guide, 21 case definitions of key obstetric and neonatal health outcomes, an ontology of key terms, a map of pertinent disease codes, a review of observational studies, and obtained extensive investigator and stakeholder organization review and feedback. Two comprehensive special issues in the journal Vaccine are now published, making available the first set of GAIA outputs for global use.

For PHASE II, GAIA will continue to take the successful, outcome driven, structured approach guided by extensive solicitation and close collaboration with a large network of stakeholders. PHASE II will build solutions to optimize data quality early in clinical development as well as early in the process of investigating the safety and efficacy of Licensed vaccines already used in pregnancy. In support of safety assessment for vaccines already at the clinical development stage and in preparation of a solid continuum of safety assessment at the sensitive transition phase from pre- to post-licensure, GAIA will take a first step by performing an impact assessment in particular LMIC settings to analyse the immediate impacts of the GAIA guidance, standards and tools shortly after publication and to determine the need for further standards and tools.

A series of novel and connected priority standards and tools include 4 additional case definitions, MedDRA standard medical queries (SMQs), CRF templates, an obstetric risk assessment tool (ORAT), a guidance for case-based causality assessment of adverse events following immunization in pregnancy and a map of GAIA case definitions to pertinent existing disease concepts and outcome definitions.

The GAIA implementation and impact assessment track includes an inventory of clinical trials and observational studies utilizing published GAIA definitions, a utilization practice survey of the stakeholders involved, and an appraisal of currently used and recommended evaluation methods of GAIA standards and tools in LMIC. KPIs of GAIA impact will be developed and be part of the outcome measures of GAIA impact assessment. Existing and future GAIA definitions, guidance documents, and tools will benefit from the results obtained