Wednesday, February 10, 2021
Long-standing obstacles to including pregnant and lactating people in clinical research have led this population to decide now 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. His point of view article appears online at JAMA.
Manufacturers of currently available vaccines excluded pregnant and lactating people from clinical trials necessary to obtain Emergency Use Authorizations from the US Food and Drug Administration. Now that the vaccines have been distributed, the Centers for and the US Disease Prevention and FDA will obtain information from recipients about their potential impact during pregnancy, as well as information on infant outcomes. While this data will be helpful, pregnant people and their doctors must now make real-time vaccine decisions based on little or no scientific evidence that applies specifically to them.
In 2016, the 21S t The Century Cures Act established the Task Force on Specific Investigations for Pregnant Women and Lactating Women, which represents multiple federal agencies, academia, industry, and non-profit organizations. The Task Force developed recommendations on how to safely and ethically include pregnant and lactating people in clinical research. These recommendations must now be implemented to ensure that pregnant people receive the same evidence that non-pregnant adults receive to make informed decisions about their health care.
Recent findings from a study by the National Institutes of Health suggest that COVID-19 during pregnancy may carry an increased risk of complications. Pregnant people need protection through research instead of of research, the authors argue.
NICHD Director Diana W. Bianchi, MD, is available for comment.
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 the capabilities of all. For more information, visit https://www.nichd.nih.gov.
About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services.The NIH is the primary federal agency conducting and supporting basic, clinical, and medical research. translational, and is researching the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
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