Media recommendation
Wednesday, February 10, 2021
What the
Prolonged barriers to including pregnant and lactating women 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 Eunice Kennedy Shriver The National Institute for Child Health and Human Development (NICHD), part of the National Institutes of Health, and its colleagues. Their point of view article appears online in JAMA.
Currently available vaccine manufacturers have excluded pregnant and breastfeeding individuals from clinical trials required to obtain emergency use authorizations from the US Food and Drug Administration. Now that the vaccines have been distributed, the US 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 on infant outcomes. While these data will prove useful, pregnant women and their doctors need to make real-time decisions about the vaccine based on little or no scientific evidence that specifically applies to them.
In 2016, 21St. The Century Cures Act established the Working Group for Research Specific to Pregnant and Breastfeeding Women, representing several federal agencies, academia, industry, and nonprofits. The Task Force has 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 in order to make informed decisions about their healthcare.
Recent findings from a study by the National Institutes of Health suggest that COVID-19 may have a higher risk of complications during pregnancy. Pregnant people must be protected through research rather than from research, the authors argue.
WHO
NICHD Director Diana W. Bianchi, MD, is available for comment.
Reference
About Eunice Kennedy Shriver National Institute for 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 national medical research agency, includes 27 institutes and centers and is a component of the US 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 of both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
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