Advice to the media
Wednesday, February 10, 2021
What
Long-standing barriers 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, he writes. Diana W. Bianchi, MD, director of Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), member of the National Institutes of Health, and colleagues. His point of view article appears online at JAMA.
Currently available vaccine manufacturers excluded pregnant and lactating individuals from the clinical trials required to obtain emergency use authorizations from the U.S. Food and Drug Administration. Now that the vaccines have been distributed, the U.S. 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 about infant outcomes. While this data will be useful, pregnant women and their doctors should make real-time decisions about the vaccine, based on little or no scientific evidence that applies specifically to them.
In 2016, the 21stc Century Cures Act established the specific research working group for pregnant and lactating women, which represented various federal agencies, academies, industries, and nonprofits. The working group developed recommendations on how to safely and ethically include pregnant and lactating people in clinical research. These recommendations should now be implemented to ensure that pregnant women receive the same tests 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 lead to an increased risk of complications. Pregnant women need to be protected through investigate instead of from research, the authors argue.
WHO
NICHD Director Diana W. Bianchi, MD is available to comment.
Reference
About 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 abilities for all. For more information, visit https://www.nichd.nih.gov.
Regarding the National Institutes of Health (NIH):
NIH, the country’s medical research agency, includes 27 institutes and centers and is a component of the U.S. Department of Health and Human Services. NIH is the leading federal agency that conducts and supports basic, clinical, and translational medical research and investigates 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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