SWHR and other members of the Coalition to Advance Maternal Therapeutics (CAMT) urged the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to include pregnant and lactating women in all research for the development of vaccines and therapeutics related to COVID-19.
Pregnant and lactating women have been historically excluded from clinical research, leading to gaps in understanding about the impact of drugs and therapies on these populations. There needs to be a cultural shift to protect women through research rather than protecting them from research, especially during the COVID-19 crisis. To ensure the health of these populations, SWHR and CAMT call on the NIH and FDA to:
- Ensure that pregnant and lactating women are included in any clinical research related to vaccines and treatments for COVID-19.
- Invest in early nonclinical studies to provide for the eventual enrollment of pregnant and lactating women in late-stage clinical trials.
- Consult with the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC).
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