Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind

Pregnant and lactating populations are routinely left out of clinical trials, leaving these populations and their health care providers with a dearth of information about which vaccines or diagnostic devices may be safe and effective for both mother and baby.

The lack of information about the safety and efficacy of the COVID-19 vaccine for pregnant and lactating populations—due in part to poorly justified concerns about the safety of medications and vaccines during pregnancy—led to a significant delay in getting pregnant people included in clinical trials. As a result, these families missed an important health prevention opportunity, and may have suffered as a result. COVID-19, though one example, is not the only example of how excluding these populations has led to unanswered questions that could improve health outcomes for pregnant and lactating populations and their families.

During this congressional briefing and national webinar, panelists explored certain areas of research where the exclusion of these groups has resulted in an inability to support them, how federal research investments could improve outcomes, and where there is opportunity—both at the legislative and regulatory level—moving forward.

*This event is widely attended and relevant to official duties.

This event is part of a series about the inclusion of pregnant and lactating peoples in research. The full series includes:

• Addressing Concerns and Considerations Surrounding the Inclusion of Pregnant and Lactating Populations in Research (December 6, 2022)
• Pregnant and Lactating Populations in Research: How Leaving These Populations Out Leaves Them Behind (January 26, 2023)
• PRGLAC Then and Now: Where We Are and Where We’re Going (February 14, 2023)