The emergency authorization of the Pfizer-BioNtech and Moderna COVID-19 vaccines has prompted distribution across the country, giving hope that the end of the pandemic is in sight. This is great news for all of us, and especially for the millions of women who are health care and other essential workers, caregivers — and all women just doing whatever we can to hold ourselves and our families together.
But the promise represented by the vaccines currently leaves at least one group with more questions than answers. Both vaccine trials have, to date, excluded pregnant people from their study. This gap in safety data specific to pregnant people is concerning.
The COVID-19 pandemic has resulted in almost 50,000 cases and more than 60 deaths among pregnant people across the United States. And these numbers will surely increase as infections continue to surge over the winter months.
Neither Pfizer nor Moderna actively recruited pregnant people for their trials, so there is no concrete data about the safety and efficacy of the vaccine in this population. Experts expect the vaccine’s safety and efficacy in pregnant and lactating people will be similar to non-pregnant people, and professional recommendations state that the COVID-19 vaccines should not be withheld from pregnant or lactating people who meet the criteria for vaccination. As such, a shared decision-making approach is recommended for pregnant and lactating people considering vaccination.
At this critical inflection point, as the U.S. undertakes the biggest vaccination campaign in its history, understanding the implications of the COVID-19 vaccines for pregnant people is vital.
We rely heavily on data collection and analysis — demographic, health outcomes, and economic — to inform our policies. But how useful is that if the data is not comprehensive and inclusive? We can only act on the trends we observe, and when certain groups — especially marginalized communities — are made invisible by the absence of data, we risk doing great harm.
The CDC estimates of COVID-19 cases among pregnant people mentioned above are likely underestimates, as only 17 states and territories are reporting data to the CDC and only a third of case report forms include information on pregnancy status. Consequently, any resource allocation or clinical decision-making based on this data alone would be irresponsible.
And doesn’t just apply to COVID-19 — there is a broader history and pattern of excluding pregnant and lactating people from a wide range of medical studies, leaving important data sets incomplete and making informed decision making around health care options very challenging. This gap emphasizes the importance of collecting high-quality data that is intersectional and nuanced. This is a critical opportunity to correct past mistakes of exclusion and instead enact a research framework that is centered on equity.
The maternal health crisis continues.
The pandemic and its impact on pregnant people is happening against the backdrop of — and further compounding — the maternal morbidity and mortality crisis in this country. Before the pandemic, Native and Black women were dying at a rate two to three times higher than white women. And some subgroups of Hispanic women, like Puerto Rican women, are also disproportionately likely to experience pregnancy-related death.
And we know that rural and low-income communities face the widening maternal health gap with decreased access to health care and social support, a gap that also has impacts for access to care during the pandemic.
Both maternal health and COVID-19 outcomes are in large part shaped by the confluence of social determinants of health (for example, poor air quality in low-income neighborhoods) and deep structural racism within society and throughout the health care system. Addressing both the blatant and subtle racism in health care is necessary — not only to improve maternal health and to vaccinate people and bring an end to the pandemic, but also to address the health disparities that will no doubt remain.
Intersectionality must guide our actions.
Women, and especially women of color, have borne the brunt of the COVID-19 pandemic as essential workers — and it is also clear that they are on the front lines of the vaccination effort. There is also significant overlap between pregnant people and health care workers — the highest priority group for vaccination. Women account for 75 percent of the health care workforce, and an estimated 330,000 health care workers will be pregnant or postpartum during vaccination efforts. In addition, 90 percent of the home care workforce are women, and almost one-third of all nursing assistants and home health aides are Black women.
Many pregnant health care workers continue to be forced to work in hazardous environments without paid parental leave, inadequate COVID-19 testing, and a shortage of personal protective equipment. Inadequate workplace protections and those most likely to be in these positions create a compounded effect on who is most vulnerable to COVID-19 — namely, women of color, and perhaps especially pregnant women of color.
As of now, we are learning about the vaccine’s impact and effectiveness for pregnant women almost by happenstance, based largely on anecdotal information from these women. Instead, we should be using intentional, structured clinical research to understand the benefit and potential risks of vaccines on pregnant people, rather than relying on trial and error with our frontline workers.
Who is at constant threat of erasure?
The United States has historically excluded pregnant people from vaccine trials, and continues to do so with the development of both the Pfizer and Moderna vaccine. This exclusion undermines our knowledge regarding the efficacy and safety of the vaccine in pregnant people. With the overlap in our health care workforce and COVID-19’s impact on the maternal health crisis, we must understand what vaccination implies for pregnant people.
As of November 2020, 42 percent of Black Americans planned to get the COVID-19 vaccine when it is available. This statistic sits against a backdrop of decades of exploitation at the hands of the medical establishment and a resulting mistrust in the health care system, as well as the government. However, this is not only historical — 50 percent of Black adults report race-based discrimination with their health care providers within the last year. More than one-third of Black mothers report health care providers talking down to them, being blamed for their health problems, or not being treated with respect in the past year. Not only do policy and clinical care decisions need to address the trust between patients and providers, we need to actively dismantle the racism that is embedded in our health care system.
Pregnant people have repeatedly faced many barriers in ensuring their rights — to health, and to equity in the workplace and beyond. We must understand the implications of a new treatment on pregnant people, while being cognizant of the history of exploitation and experimentation in modern medicine. Advocating for the inclusion for pregnant people in medical research and trials is critical to advancing inclusivity, intersectionality, and health equity.Back