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All the presentations, videos, and conference-related material can be downloaded at: IABS website
The International Alliance for Biological Standardization (IABS) organized this meeting that was inspired by the work performed by GAIA project partners and volunteers worldwide. It brought together 142 registered participants coming from regulatory authorities, public health institutes, academia and industry to help resolve existing challenges of safety monitoring of immunization in pregnancy and to reach conclusions that will be valuable to a globally concerted approach.
The objectives of the meeting were to discuss new safety data from immunization in pregnancy studies, to identify converging stakeholder needs and requirements for high quality data, to review new standards and tools for safety monitoring, including terminology, and to build consensus on the best practice guidance for monitoring vaccine safety in pregnancy.
As a result of 32 presentations and 7 panel discussions in 7 sessions, this meeting has enhanced a shared understanding of the challenges of monitoring immunization in pregnancy. It allowed for in depth discussion on solutions for a collaborative way forward and yielded consensus on the need for a globally concerted approach.
The need for systems for prompt identification and response to adverse events following immunization (AEFI) in pregnancy was generally agreed on. This primarily rests on moving from minimal to enhanced safety monitoring throughout the vaccine life cycle.
Specifically, it was highlighted that similar safety standards should apply to everyone exposed, no matter where they live in the world. This should be supported by standardized terminology case definitions, harmonized study protocols, a minimal core set of safety variables to be collected and a globally concerted effort to move towards enhanced surveillance. It was agreed that many efforts are ongoing around the globe towards this aim. However, these efforts are fragmented and would benefit from harmonization to increase data comparability, bring analytic power to the next level, and propel scientific progress.
One of the key outcomes was the agreement on the need and benefits of regulatory convergence on shared data collection requirements, harmonized use of terms, concepts and definitions of safety outcomes and assessment methods during the conduct of clinical trials, including follow-up times. It was further recommended to determine the applicability of GAIA outputs in other perinatal health arenas.
GAIA outputs were generally deemed relevant and useful in the different settings (high, middle and low income country settings (LMICs)). There was a clear call for an increased number of case definitions for key obstetric and neonatal terms to be developed, as well as for guidelines that are applicable to observational studies of immunization in pregnancy. The need of structured field testing and validation of GAIA outputs in different settings was highlighted as well as the need to promote their use and implementation by making available the guidelines, definitions, terminologies and tools in a resource center and via training and implementation modules for investigators, Data Safety Monitoring Board (DSMB) and National Immunization Technical Advisory Groups (NITAGs).
The GAIA platform was deemed useful and the growing global network of experts should be leveraged for next steps towards addressing practical challenges of monitoring, promoting learnings from the best approaches and improving data quality. There is a need for metrics of data quality in the emerging field of immunization in pregnancy.
Building capacity for observational studies is critical and should include a landscaping of available data sources beyond spontaneous reporting and the development of approaches to epidemiological study designs in LMICs. There is a series of unmet methodological challenges of high quality observational studies in LMICs, including the challenge of mother-child record linkage.
Dissemination strategies should include a published conference report, special issues in the Journal Vaccine, and targeted information to stakeholder groups, presentation at various scientific venues, and when feasible, implementation and validation of available key term definitions in new and ongoing clinical trials of vaccines in pregnancy.