Media Advisory
Wednesday 10 February 2021
what
Longstanding obstacles to including pregnant and lactating women in clinical research have led this population to decide whether or not to receive a SARS-CoV-2 vaccine without the benefit of scientific evidence, writes Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, and colleagues. The article from their point of view appears online at JAMA.
Manufacturers of the vaccines currently available have excluded pregnant and lactating women from the clinical trials necessary to obtain Emergency Use Authorizations from the U.S. Food and Drug Administration. Now that the vaccines have been distributed, the United States Centers for Disease Control and Prevention and the FDA will obtain information from those who receive them about their potential impact during pregnancy, as well as information about the babies’ results. While this data is useful, pregnant women and their doctors must make real-time decisions about the vaccine now based on little or no scientific evidence that applies specifically to them.
In 2016, the 21st The Century Cures Act established the Specific Research Task Force for Pregnant Women and Lactating Women, representing various federal agencies, universities, industries and non-profit organizations. The Task Force 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 that non-pregnant adults receive to make informed decisions about their medical care.
Recent findings from a National Institutes of Health study suggest that COVID-19 during pregnancy may be at an increased risk of complications. Pregnant women need to be protected through research rather than from research, say the authors.
Who
NICHD director Diana W. Bianchi, MD, is available for comment.
Reference
Regarding the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts research and training to understand human development, improve reproductive health, improve the lives of children and adolescents and optimize skills for all. For more information, visit https://www.nichd.nih.gov.
About the National Institutes of Health (NIH):
NIH, the country’s medical research agency, includes 27 institutes and centers and is a component of the United States Department of Health and Human Services. The NIH is the leading federal agency that conducts and supports basic, clinical and translational medical research, and is investigating the causes, treatments and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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