Friday, 23rd of December 2016 |
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.
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.
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