Prior to COVID-19, the US already had some of the worst maternal mortality rates among high-income countries. Now, the country faces growing concerns about how the pandemic can negatively impact maternal health and exacerbate racial inequities in care and outcomes surrounding childbirth. But even as the pandemic poses new challenges to supporting healthy pregnancies and deliveries, there are also opportunities to address longstanding data gaps, break down structural barriers to quality care, and reform outmoded paradigms that leave pregnant individuals behind as medicine advances.
And there’s a move afoot in the US Congress to do just that. Senator Elizabeth Warren and Representative Lauren Underwood have introduced new legislation that aims to address shortcomings in maternal and postpartum care across the ongoing pandemic response. The Maternal Health Pandemic Response Act includes provisions authorizing much-needed funding to (1) strengthen disease surveillance and data collection related to pregnancy, (2) appropriately include pregnant people in the development of new COVID-19 therapeutics and vaccines, (3) enhance health communication efforts, and (4) monitor and address sources of structural racism that put people of color at especially high risk of preventable maternal death during the ongoing crisis and beyond.
We previously issued guidance to equitably address the health interests of pregnant women in emerging epidemics, and a call to action for COVID-19 vaccines, and are encouraged the legislation seeks to advance a number of key recommendations we put forward. Below are a few highlights from the measure.
Data Collection, Surveillance, and Research on Maternal Health Outcomes:
The bill would authorize $190 million to enhance existing surveillance programs and data collection efforts related to pregnancy and COVID-19. Routine health information systems and infectious disease surveillance systems are essential to an appropriate and rapid response to emerging threats like COVID-19. Without high-quality and timely data, there is no way to know whether or how a new infectious agent puts pregnant women and their developing babies at risk. Importantly, this bill not only calls for just this kind of data; it also calls for data to be disaggregated by race, ethnicity, State, and Tribal location. Disaggregating data in this way is critical to assessing and addressing how the COVID-19 pandemic is differentially impacting various communities and population subgroups.
Fair Inclusion of Pregnant and Lactating People in Vaccine and Therapeutic Development for COVID-19:
Section 6 of the bill incorporates several key recommendations to ensure pregnant and lactating people will not be unjustifiably excluded from participating in COVID-19 research trials. Including them in trials is the best way to generate much-needed evidence on the safe and appropriate use of new treatments and vaccines in pregnancy; they should be offered the opportunity to join trials whenever the prospect of the benefits to participating outweigh the risks. The bill’s provisions also address the importance of shaping the portfolio of investments in vaccine development to help ensure that at least one product will be suitable to their needs. For example, the legislation includes reporting requirements for all drug and vaccine developers receiving federal funds to submit their plans for evaluating safety, efficacy, and dosing of products as it relates to pregnancy and lactation. There are also provisions related to using other important sources of data, such as systematic data collection from inadvertent exposures in pregnancy, and animal studies that may shed light on potential safety signals.
Additionally, the bill addresses plans for the fair inclusion of pregnant and lactating people in clinical trials, taking the position that exclusion would require justified rationale. This reflects an important shift away from the historical trend of automatic exclusion without justification toward a default position of inclusion. Decisions to exclude pregnant or lactating women should be based on sound scientific and ethical reasoning.
This bill is incredibly timely. As of August 4, there were nearly 16,000 pregnant women in the US confirmed positive for COVID-19 and 37 maternal deaths recorded. With jurisdictions across the country exploring options to sustain essential services, re-open schools, and meet the ongoing health needs of patients affected by COVID-19, there will be many pregnant individuals among those working the front lines as essential workers–particularly true in fields like education that tend to skew highly female. Compounding concern is emerging evidence published by the CDC that COVID-19 can be more severe in pregnancy as compared to in non-pregnant populations in similar age bands, with higher rates of hospitalization and ICU admission among pregnant COVID-19 patients. Pregnant and lactating people must not be overlooked as we work to combat COVID-19. To ensure that, strengthening efforts to collect much-needed evidence on how maternal health is being affected by the pandemic–particularly among those disproportionately burdened by this disease–and shaping the pipeline for new therapies and preventives that can be safely offered to people across their reproductive journeys are both critically important to achieve that goal. And while this bill is focused on the domestic context, US efforts to enhance our understanding of COVID-19 disease in pregnancy and bring about products suitable for pregnancy could also have implications for ongoing global response efforts that address maternal health needs.