Assessment of Safety in Newborns of Mothers Participating in Clinical Trials of Vaccines Administered During Pregnancy

Abstract

A panel of experts convened by the Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, developed proposed guidelines for the evaluation of adverse events in newborns of women participating in clinical trials of maternal immunization in the United States.

Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

“…Adverse pregnancy outcomes, including neonatal death, can coincide temporally with immunization of pregnant women, and are therefore reported as adverse events in clinical trials. Clinical trials involving immunization of pregnant women have not, to date, shown any increase in incidence of neonatal deaths in infants of vaccine recipients compared to placebo recipients, or any increase above local incidence rate [10], [11], [12].…”

“…This is a missed opportunity, as data comparability across trials or surveillance systems would facilitate data interpretation and promote the scientific understanding of the event. The focus of vaccine safety monitoring in currently licensed vaccines has been on foetal death, pregnancy outcome (live birth or stillbirth), congenital anomalies and growth and development of the infant [12].…”

“…Although the WHO and the International Classification of Disease (ICD) have published definitions and recommendations for recording and reporting of live births and neonatal deaths, reporting criteria varies between countries. This is largely dependent on the understanding of the term at local/regional level, availability of resources, cultural and religious perceptions and practices [1], [12].…”

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

“…These are available on the Brighton Collaboration website (www.brightoncollaboration.org). The current guidelines also build on specific guidance documents developed for harmonizing safety assessment in trials of vaccines in pregnant women in the United States [36–39] and specifically aim for applicability in all resource settings.…”

“…The review did not identify any publications on the standardization of data collection in trials of vaccines in pregnant women until 2012. Since then, four publications have become available based on the work surrounding vaccines in pregnant women at the U.S. National Institutes of Health [36–39]. In addition to the peer-reviewed scientific literature, the systematic review identified the available regulatory and other professional guidance documents (listed in Appendix 1).…”