Abstract
Background: Pregnant women and neonates represent one of the most vulnerable groups, especially in low- and middle-income countries (LMICs). A recent analysis reported that most vaccine pharmacovigilance systems in LMICs consist of spontaneous (passive) adverse event reporting. Thus, LMICs need effective active surveillance approaches, such as pregnancy registries. We intend to identify currently active maternal and neonatal data collection systems in LMICs, with the potential to inform active safety electronic surveillance for novel vaccines using standardized definitions. Methods: A scoping review will be conducted based on established methodology. Multiple databases of indexed and grey literature will be searched with a specific focus on existing electronic and paper-electronic systems in LMICs that collect continuous, prospective, and individual-level data from antenatal care, delivery, neonatal care (up to 28 days), and postpartum (up to 42 days) at the facility and community level, at the national and district level, and at large hospitals. Also, experts will be contacted to identify unpublished information on relevant data collection systems. General and specific descriptions of Health Information Systems (HIS) extracted from the different sources will be combined and duplicated HIS will be removed, producing a list of unique statements. We will present a final list of Maternal, Newborn, and Child Health systems considered flexible enough to be updated with necessary improvements to detect, assess and respond to safety concerns during the introduction of vaccines and other maternal health interventions. Selected experts will participate in an in-person consultation meeting to select up to three systems to be further explored in situ. Results and knowledge gaps will be synthesized after expert consultation.
Highlights
Pregnant women and neonates are two of the most vulnerable groups globally
A systematic analysis for the Global Burden of Disease Study reports that respiratory infections and sepsis are among the leading causes of neonatal deaths in 195 countries across the world[2]
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require extensive post-licensure safety monitoring commitments, active surveillance, from market authorization holders for health products that could be used during pregnancy[3]
Summary
Pregnant women and neonates are two of the most vulnerable groups globally. Despite significant achievements in reducing preventable maternal, newborn, and child morbidity and mortality, in line with the Sustainable Development Goals, further progress is still needed, especially in low- and middle-income countries (LMICs)[1]. New vaccine development requires robust systems to collect and assess maternal, newborn, and child health (MNCH) outcomes, including safety information, following the use of novel vaccines, drugs, and biological products during pregnancy. The Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) project proposed case definitions for key events in MNCH and piloted them in 24 sentinel sites across four World Health Organization (WHO) regions[7]. We intend to identify existing electronic and mixed paper-electronic systems that collect continuous maternal and neonatal data in LMICs, using a scoping review, with the potential to inform active safety electronic surveillance for novel vaccines using standardized definitions. Given the importance of improving maternal interventions vigilance, the scoping review will identify active safety surveillance systems in LMICs as applied to MNCH
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.