Policy strategies for inclusion of pregnant and lactating women in vaccine research.

Pregnant and lactating women (PLW) have historically been excluded from vaccine research, creating inequities in vaccine access and uptake for PLW. US federal research policies create the framework for inclusion of diverse populations, including PLW, in research. We conducted a policy analysis and interviews ( = 29) with experts in vaccine research for PLW to characterize the existing policy landscape and to identify policy strategies to promote inclusion of PLW in vaccine trials. We integrated policy analysis and interview results to inform 5 policy recommendations. Current federal policy does not require or incentivize the inclusion of PLW in vaccine trials. The Food and Drug Administration (FDA) guidance on inclusion of PLW in vaccine and other clinical research is nonbinding and lacks clarity. Extant policies do not adequately allay liability concerns among vaccine developers. To address these concerns, we recommend that US Congress pass legislation authorizing the FDA to require inclusion of PLW in vaccine research; incentivize sponsors to complete timely vaccine studies in PLW; create a national no-fault compensation program for clinical research participants, including PLW; remove pregnancy from the "vulnerable population" designation in FDA human subjects regulations; and clarify existing federal regulations pertaining to clinical research with PLW.