Longstanding obstacles to including pregnant and lactating people in clinical research have led to a situation in which the population is deciding whether or not to receive a SARS-CoV-2 vaccine without the benefit of scientific evidence, 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 (NIH), wrote in an opinion piece with her colleagues, according to a news release from NIH.
Their viewpoint article appears online in JAMA.
The manufacturers of currently available vaccines excluded pregnant and lactating people from the clinical trials needed to obtain emergency use authorization from the U.S. Food and Drug Administration (FDA). Now that the vaccines have been distributed, the Centers for Disease Control and Prevention (CDC) and the FDA will obtain information from those who receive them on their potential impact during pregnancy, as well as information on infant outcomes, the authors said. said. 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, they wrote.
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 nonprofit 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 adults receive the same evidence that non-pregnant adults receive to make informed decisions about their medical care, according to the NIH.
Recent findings from a NIH 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.
