Vaccine safety surveillance in Kenya using GAIA standards: A feasibility assessment of existing national and subnational research and program systems

•Study focused on active maternal vaccine pharmacovigilance in a low middle income country.•Assessed feasibility of utilizing existing health information systems for maternal pharmacovigilance.•Tested applicability of Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case defini...

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Bibliographic Details
Published in:	Vaccine Vol. 41; no. 39; pp. 5722 - 5729
Main Authors:	Izulla, P., Wagai, JN, Akelo, V., Ombeva, A., Okeri, E., Onyango, D., Omore, R., Fuller, S., Khagayi, S., Were, J., Anderson, S., Wong, HL, Tippett Barr, BA
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Ltd 07-09-2023 Elsevier Limited
Subjects:	Babies Birth weight Capacity development Childbirth & labor Clinical trials Collating Coronaviruses COVID-19 COVID-19 vaccines Data analysis Data collection Data systems Electronic health records Feasibility studies Gestational age Health care facilities Health facilities health information systems Health surveillance HIV Human immunodeficiency virus Immunization Information systems International studies Interoperability LMIC Low birth weight maternal vaccine pharmacovigilance Medical records Medical research Mortality Neonates Pharmacovigilance Population studies population surveillance Postpartum period Pregnancy Public health Public sector Safety Small for gestational age Stillbirth sub-Saharan Africa Surveillance systems Tetanus Vaccines Kenya LMIC sub-Saharan Africa health information systems population surveillance maternal vaccine pharmacovigilance Health information systems Maternal vaccine pharmacovigilance Population surveillance Sub-Saharan Africa
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Summary:	•Study focused on active maternal vaccine pharmacovigilance in a low middle income country.•Assessed feasibility of utilizing existing health information systems for maternal pharmacovigilance.•Tested applicability of Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case definitions within the systems.•Population-based research studies provide responsive short-term option for pharmacovigilance.•Foundation exists for long-term capacity building to use the systems for maternal pharmacovigilance. Active surveillance systems for monitoring vaccine safety among pregnant women address some of the limitations of a current passive surveillance approach utilized in low- and middle-income countries (LMIC). However, few active surveillance systems in LMIC exist. Our study assessed the feasibility of utilizing three existing data collection systems in Kenya for active surveillance of maternal immunization and to assess the applicability of Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case definitions that were initially developed for clinical trials within these systems. We assessed applicability of GAIA case definition for maternal Tetanus Toxoid exposure, stillbirth, low birth weight, small for gestational age, Neonatal Invasive Blood Stream Infection (NIBSI), prematurity and neonatal death in two routine web-based health information systems (Kenya EMR and DHIS-2), and a web-based population-based pregnancy research platform (ANCOV1Antenatal, Intrapartum and Postnatal care COVID-19 Surveillance Study (ANCOV)1) in Kenya. All three HIS were capable of reporting selected outcomes to varying degrees of GAIA certainty. The ANCOV platform was the most robust in collecting and collating clinical data for effective maternal pharmacovigilance. The utilization of facility- and district-aggregated data limits the usefulness of DHIS 2 in pharmacovigilance as currently operationalized. While the Kenya EMR contained individual level data and meets the key considerations for effective pharmacovigilance, it was used primarily for HIV care and treatment records in a small proportion of health facilities and would require additional resources to expand to all antenatal care facilities and to link maternal and infant records. Population-based research studies may offer a responsive short-term option for implementing maternal vaccine pharmacovigilance in LMICs. However, the foundation exists for long-term capacity building within the national health electronic data systems to provide this critical service as well as ensure participation of the country in international studies on maternal vaccine safety.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2023.07.063