March 11, 2020

Senators Warren and Murray Urge NIH and FDA to Incorporate the Needs of Pregnant People and Other Underrepresented Populations as Companies Develop Vaccines and Therapeutics for COVID-19

“Pregnant people have historically been left out of research agendas and clinical trials due to the added complexities of ensuring their safety and that of their children”; “We urge you to account for the unique risks and concerns of populations that have historically been excluded from pandemic research agendas”

Washington, D.C. -- United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, and HELP Committee Ranking Member Patty Murray (D-Wash.) sent a letter to the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) urging the agencies to consider the needs of pregnant people and other underrepresented populations as they work with pharmaceutical companies to develop a pipeline for COVID-19 vaccines and therapeutics. Their letter encourages the agencies to incentivize the development of vaccine and treatment candidates suitable for use in pregnancy, consult with the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), and increase representation of other underrepresented populations in clinical trials of treatments and vaccines for COVID-19.

“As your agencies work to combat this public health emergency, we urge you to account for the unique risks and concerns of populations that have historically been excluded from pandemic research agendas and investments, including pregnant people,” wrote the lawmakers. “Early investment in this commitment will be crucial in allowing pregnant people to have access to preventive measures in the face of this emerging pandemic threat.”

Previous pandemics, including the Ebola outbreaks, have revealed that this is a particular problem in the midst of fast-moving public health emergency response efforts. During the West African Ebola epidemic, for example, pregnant people were “systematically excluded from essentially all” clinical trials.

The Centers for Disease Control and Prevention notes that information on the susceptibility of pregnant people to COVID-19 is limited and cautions that “[p]regnant women experience immunologic and physiologic changes which might make them more susceptible to viral respiratory infections, including COVID-19.” If they are not included in trials, pregnant people and other underrepresented populations might not fully benefit from future vaccine development.
“We invite your agencies to stay in touch with our offices regarding Congressional actions needed to support efforts to ensuring that every American can access essential medicines, treatments, and vaccines for COVID-19,” the senators concluded.

Senator Warren is a champion of promoting the inclusion of women and minorities in clinical research. In 2016, she was the lead Democratic cosponsor of Senator Collins’ Advancing NIH Strategic Planning and Representation in Medical Research Act, which called for the establishment of PRGLAC.