Longstanding obstacles to include pregnant and lactating people in clinical research have led to this population now deciding whether or not to receive a SARS-CoV-2 vaccine without the benefit of scientific evidence, writes Diana W. Bianchi, M.D., 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 viewpoint article appears online in the Journal of the American Medical Association (JAMA).
The manufacturers of currently available vaccines excluded pregnant and lactating people from the clinical trials needed 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 obtain information from those who receive them on their potential impact during pregnancy, as well as information on infant outcomes. While these data will prove useful, pregnant people and their clinicians must make real-time decisions now about the vaccine 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 Women and Lactating Women, representing 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 pregnant people 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 COVID-19 during pregnancy can carry a higher risk for complications. Pregnant people need to be protected through research rather than from research, the authors contend.
NICHD Director Diana W. Bianchi, M.D., is available for comment.
Bianchi DW, et al. "Involving Pregnant Individuals in Clinical Research on COVID-19 Vaccines." JAMA. 2021.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for 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. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.