Global alignment of immunization safety assessment in pregnancy - The GAIA project.

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Vaccine. 2016 Dec 1;34(49):5993-5997. doi: 10.1016/j.vaccine.2016.07.006. Epub 2016 Oct 14.

Global alignment of immunization safety assessment in pregnancy - The GAIA project

Bonhoeffer J¹, Kochhar S², Hirschfeld S³, Heath PT⁴, Jones CE⁴, Bauwens J⁵, Honrado Á⁶, Heininger U⁷, Muñoz FM⁸, Eckert L⁹, Steinhoff M¹⁰, Black S¹⁰, Padula M¹¹, Sturkenboom M¹², Buttery J¹³, Pless R¹⁴, Zuber P¹⁵; GAIA project participants.

Author information

• ¹Brighton Collaboration Foundation, Basel, Switzerland; University of Basel Children´s Hospital, Basel, Switzerland. Electronic address: contact@brightoncollaboration.org.
• ²Global Healthcare Consulting, Delhi, India.
• ³Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.
• ⁴St George´s, University of London, London, UK.
• ⁵Brighton Collaboration Foundation, Basel, Switzerland.
• ⁶Synapse Research Management Partners, Barcelona, Spain.
• ⁷University of Basel Children´s Hospital, Basel, Switzerland.
• ⁸Baylor College of Medicine, Houston, USA.
• ⁹University of Washington, Seattle, USA.
• ¹⁰Cincinnati Children´s Hospital Medical Center, USA.
• ¹¹The Children´s Hospital of Philadelphia, PA, USA.
• ¹²Erasmus University Medical Center, Rotterdam, The Netherlands.
• ¹³Monash University, Melbourne, Australia.
• ¹⁴Public Health Agency of Canada, Ottawa, Canada.
• ¹⁵World Health Organization, Geneva, Switzerland.

Abstract below; full text is at http://www.sciencedirect.com/science/article/pii/S0264410X16305692

Immunization in pregnancy provides a promising contribution to globally reducing neonatal and under-five childhood mortality and morbidity. Thorough assessment of benefits and risks for the primarily healthy pregnant women and their unborn babies is required. The GAIA project was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC. In the first year of the project, a large and functional network of experts was created. The first outputs include a guidance document for clinical trials of immunization in pregnancy, a basic data collection guide, ten case definitions of key obstetric and neonatal health outcomes, an ontology of key terms and a map of pertinent disease codes. The GAIA Network is designed as an open and growing forum for professionals sharing the GAIA vision and aim. Based on the initial achievements, tools and services are developed to support investigators and strengthen immunization in pregnancy programs with specific focus on LMIC.