Media advisory

Wednesday February 10, 2021

What

Long-standing obstacles to including pregnant and breastfeeding women in clinical research have led this population to now decide whether or not to receive a SARS-CoV-2 vaccine without the benefit of scientific evidence, writes Diana W. Bianchi , MD, director of Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, and colleagues. Their viewpoint article appears online in JAMA.

Manufacturers of currently available vaccines have excluded pregnant and breastfeeding women from clinical trials needed to obtain emergency use clearances from the United States Food and Drug Administration. Now that the vaccines have been distributed, the US Centers for Disease Control and Prevention and the FDA will get information from those who receive them about their potential impact during pregnancy, as well as information on the outcome of infants. While this data is proving useful, pregnant women and their clinicians must now make real-time vaccine decisions based on little or no scientific evidence that applies specifically to them.

In 2016, the 21st The Century Cures Act created the Pregnant and Breastfeeding Women Specific Research Task Force, representing several federal, academic, industry and not-for-profit organizations. The working group developed recommendations on how to safely and ethically include pregnant and lactating women in clinical research. These recommendations must now be implemented to ensure that pregnant women receive the same evidence as non-pregnant adults to make informed decisions about their medical care.

Recent findings from a National Institutes of Health study suggest that COVID-19 during pregnancy may lead to a higher risk of complications. Pregnant people must be protected through research rather than of research, say the authors.

WHO

NICHD Director Diana W. Bianchi, MD, is available for comment.

Reference

About Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, improve the lives of children and adolescents, and optimize capacity for all. For more information, visit https://www.nichd.nih.gov.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, comprises 27 institutes and centers and is a component of the US Department of Health and Human Services. The NIH is the premier federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.

NIH… Transforming Discovery into Health®

###