Abstract
Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies.The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.
Highlights
Background and need for this guidelinesThree-quarters of all neonatal deaths worldwide occur during the first week of life, with the first 24 h being the most critical period [1,2]
The findings and conclusions in this paper are those of the authors and do not necessarily represent the views of the World Health Organization or the Centers for Disease Control and Prevention
Conflict of interests PTH is an investigator for clinical trials done on behalf of St Georges, University of London, London, UK, sponsored by vaccine manufacturers
Summary
In March 2004, the first International Neonatal Vaccination workshop was held in Virginia (USA) to further explore the immunology and safety of immunization strategies to expand protection of neonates against vaccine-preventable diseases [22] The participants found it difficult to draw conclusions from the studies reviewed during the workshop because of the inability to compare vaccine trial results across different studies and settings, in part because critical information was either lacking or inconsistently collected. Efforts to develop widely accepted guidelines for the assessment of safety of vaccines in pregnant women have subsequently evolved with the recognition that immunization in pregnancy appears to be a generally safe and effective strategy to protect both mothers and infants against potentially life-threatening infectious diseases [25,26,27,28]. Guidance on the prioritization of the data to be collected is provided to promote collection of at least a minimal set of highpriority parameters in various settings, including low- and middle-income countries (LMIC)
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