Media advice
Wednesday, February 10, 2021
What
Long-standing obstacles to including pregnant and lactating people in clinical trials 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 the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, and colleagues. Their point of view article appears online in JAMA.
The vaccine manufacturers currently available have excluded pregnant and lactating people 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 U.S. Centers for Disease Control and Prevention and the FDA will seek information from those who receive them about their potential impact during pregnancy, as well as information about the outcomes of infants. While these data will prove to be useful, pregnant people and their clinicians now have to make real-time vaccine decisions based on little or no scientific evidence that applies specifically to them.
In 2016, the 21st Century Cures Act established the Task Force on Research Specific to Pregnant and Lactating Women, which represents multiple federal agencies, academia, industry, and nonprofit organizations. The Task Force has developed recommendations for safely and ethically involving pregnant and lactating people in clinical research. These recommendations must now be implemented to ensure that pregnant people 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 carries a higher risk of complications during pregnancy. Pregnant people need protection by research instead of from research, the authors state.
WHO
NICHD Director Diana W. Bianchi, MD, is available for comment.
Reference
About the Eunice Kennedy Shriver National Institute for 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 skills for all. For more information, visit https://www.nichd.nih.gov.
About the National Institutes of Health (NIH):
NIH, the national medical research agency, includes 27 institutes and centers and is part of the United States Department of Health and Human Services. NIH is the premier federal agency that conducts and supports basic, clinical and translational medical research, investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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