By Linda Eckert and Sonali Kochar
Edited by Ewelina Rogozińska
Maternal immunisation (MI) is a rapidly evolving field. The safety of vaccines in pregnancy is a key consideration for pregnant women, healthcare providers, vaccine manufacturers, regulators and ethics committees. There is a need for a globally concerted approach to harmonise and actively monitor the safety of vaccines and global immunisation programs.
The Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project, coordinated by the Brighton Collaboration Foundation (BCF) and funded by the Bill and Melinda Gates Foundation was initiated in 2015. GAIA key aim is to help establish a globally shared understanding of outcomes and approaches to monitoring the safety of vaccines used in pregnancy with specific focus on low and middle-income countries (LMICs) needs and requirements.
GAIA project brings together experts from 13 organisations such as US National Institute of Health, World Health Organization, Monash Institute of Medical Research, Public Health Agency Canada, etc. to develop:
- a core set of 21+ globally standardised case definitions of selected key obstetric and neonatal terms,
- a glossary of terms to be used in obstetric and neonatal outcome definitions which are critical to the key term definitions (e.g. algorithm for determination of gestational age etc.),
- a map of disease codes across coding terminologies to enable pooling of data from various sources,
- a searchable database of terms and concept definitions, an ontology of over 3000 terms related to key events for monitoring immunisation in pregnancy, case identification algorithms, and
- data collection tools for monitoring immunisation programs in pregnancy.
Ultimately, an online tool for automated case classification of events according to the standardised case definitions will be made available to the public.
The GAIA consortium has developed guidelines entitled “Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women” to provide guidance on the prioritisation of the data to be collected in studies of the use of vaccines in pregnancy and to assist in their applicability in various settings.
The first globally standardised case definitions of key obstetric and neonatal terms, the Guidelines document and the Guidance on the prioritisation of the data to be collected can be found in the special issue of the Vaccine journal.
The use of these definitions, guidelines, and tools has the potential to lead to enhanced surveillance in MI PV systems in LMICs pre- and post-licensure and help support enhanced surveillance and collection of safety data that can be consolidated and compared across sites, countries, and programs worldwide.