Senate Co-Sponsorship Memoranda

In the near future, I plan to offer a resolution that would urge Congress to provide for the presumptive inclusion of pregnant individuals in vaccine research.  Current federal regulations automatically exclude expectant persons from participating in clinical studies of vaccines.  By disregarding such individuals in medical research considerations, their health and safety, as well as that of their fetuses, is being jeopardized needlessly. 

 

A recent Senate Democratic Policy Committee Hearing on maternal outcomes during the COVID-19 pandemic revealed pregnant persons infected with COVID are suffering disproportionately from severe illness and death and experiencing adverse pregnancy outcomes; yet, they have not been included in early stages of vaccine trials, creating a dearth of information about the effects of available immunization measures on both pregnant individuals and their fetuses.  As such, for expecting individuals, concerns regarding vaccine access are preempted by those of data.  Without evidence of the vaccine’s effects on themselves and their fetuses, these persons are faced with the difficult decision of risking infection from COVID or receiving a vaccine that poses unknown risks.  Individuals cannot afford further obstacles in their struggle to achieve a healthy pregnancy and delivery.   

 

According to the Centers for Disease Control and Prevention (CDC), of the 700 individuals who die from pregnancy in the U.S. each year, three in five deaths are preventable.  Additionally, Black, American Indian and Alaska Native individuals are more likely to experience maternal mortality than White individuals as a result of disparities in healthcare.  During the current pandemic, pregnant persons are at high risk of suffering severe illness and adverse pregnancy outcomes from COVID-19.  The probability of being hospitalized from COVID infection is greater for Black individuals who are pregnant than for those who are White.   

 

It is time to provide expectant persons with equal consideration and representation in medical research. The wellbeing of such individuals has been ignored too often to their detriment.  Allowing for this population to participate in early stages of vaccine trials will not only eliminate delays in inoculation data and deployment, but also, it will save lives during health emergencies, such as COVID.  Efforts to normalize medical research measures for pregnant persons are supported by the medical community, including hearing testifiers Dr. Richard Beigi of UPMC Magee-Women’s Hospital, Dr. Elizabeth Morgan of Baystate Health and Drs. Catherine Paules and Richard Legro of Penn State Health, as well as the National Institutes of Health, the Pregnancy Research Ethics for Vaccines Epidemics and New Technologies (PREVENT) working group and the Second Wave Initiative.  Please join me in supporting the automatic inclusion of pregnant individuals in vaccine studies.