Sarah Tabatabaei, Class of 2023
It was not until 1993 that the National Institutes of Health Revitalization Act was signed into law mandating the inclusion of women, racial minorities, and ethnic minorities in NIH-funded research. While there has been progress in adding minorities and women to clinical trials and research samples, some subgroups, such as pregnant and nursing women, do not share the same luxury. Pregnancy is regarded as a distinct immunological state where the maternal body is in protection of a developing fetus. Dr. Catherine Spong at UT Southwestern Medical Center reveals that this distinction leads to “a major missed opportunity as results with therapies studied in men and nonpregnant women may not be generalizable” (Spong 2020). Additionally, the systematic exclusion of pregnant women from clinical trials in the U.S. is thought to make trials run simply and more rapidly (Wamsley 2020). The typical reasoning for excluding this particular subset of women is that uncertainty about a vaccine’s effect in pregnant women could halt the process of administering vaccines to a general population who had shown successful responses during trials.
In light of recent vaccination clinical trials, COVID-19 has brought to the fore this “longstanding neglect of women's health research” (Afshar and Parchem 2021). Women’s health providers are left with a daunting task of navigating the pandemic and patient care amidst data-free zones and delayed studies. Since much of the pregnancy-related data was very slow to emerge, many national hospitals and universities, such as UCLA Health’s Obstetrics and Gynecology department, were in search of answers themselves in collaboration with other institutions dedicated to addressing the questions unacknowledged in national vaccination clinical trials. Physicians describe having felt “unable to provide the meaningful counsel patients are seeking,” and became motivated to fill the information gaps themselves (Afshar and Parchem 2021). It is crucial that pregnant and lactating women are included at the onset of preliminary vaccination trials in order to prevent data-free periods where physician counsel carries less confidence. That is not to say institutional research is unnecessary, rather, this research can more accurately address patient-specific concerns, allow physicians to stay current with rapidly evolving data, and ultimately ensure more confident counseling.
Not only are pregnant women at higher risk to respond unexpectedly to generalized vaccinations, but pregnant women often fall into other high-risk groups. Similar to the effects of vaccinations on certain immunocompromised groups, underlying health conditions have tremendous unknown concerns that may further complicate the effects of vaccines in pregnant and nursing women. Dr. Ruth Faden, founder of Johns Hopkins University's bioethics institute, reveals that there is also a disproportionate predisposition to the burden of disease in pregnancy “that seems to be hitting women who are low-income, women who are from communities of color, women who are otherwise disadvantaged” (Faden 2020). In light of such predispositions, many pregnant and lactating individuals are very eager to participate in clinical research (Cunningham 2021). When creating an even larger picture considering predisposition to disease, disparities in access to treatment, and additional underlying clinical prioritizations, the impact of vaccines within pregnant and nursing women becomes increasingly complicated. The inclusion of pregnant and nursing women in clinical investigation is consequential in navigating external health influences quickly and efficiently.
Regardless of said concerns, the time-sensitive nature of vaccine trials makes absolute inclusion very challenging. For instance, if a vaccine trial determines that pregnant and nursing women respond poorly to vaccination while non-pregnant subjects respond successfully, the vaccine’s inconsistent response may delay delivery or induce fear in the public placing their trust in research. To navigate these concerns, vaccination trials for pregnant and nursing women can be carried out independently yet simultaneously to those performed on non-pregnant and non-nursing women. By doing so, investigation methodology may be amended according to research findings while preventing the emergence of “data-free” zones.
For now, amidst rapidly evolving data and a delayed foundation of knowledge pertaining to the effects of vaccinations on pregnant and nursing women, essential conversations should be held between pregnant and nursing women with their healthcare providers about whether the vaccine is safe for themselves and their babies. In the inevitable instance of future vaccination clinical trials, it is imperative to note that truly inclusive research must be dedicated to clinical trial research investigating pregnant and lactating women. Though pregnancy is regarded as a immunologically distinct state and a possible threat to generalizable data, this distinction should be regarded as a stronger incentive for exploration rather than a deterrence from inclusion in clinical research.
References
Spong, C. Y. (2020, August 11). Addressing Inequalities in Women's Health Research. Contemporary OB/GYN. https://www.contemporaryobgyn.net/view/addressing-inequalities-in-women-s-health-res earch.
Afshar, Y., & Parchem, J. G. (2021, February 24). Pregnant during the pandemic: United in motherhood. EClinical Medicine . https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00040-7/fulltext.
Cunningham, J. (2021, March 25). Pregnant and lactating women show robust immune response to COVID vaccines, pass antibodies to newborns. Massachusetts General Hospital. https://www.massgeneral.org/news/press-release/Pregnant-women-show-robust-immune response-to-covid-vaccines-pass-antibodies-to-newborns.
Heard on: Weekend Edition Saturday. (2020, December 5). Initial Distribution Of COVID-19 Vaccine Won't Include Pregnant People. NPR. https://www.npr.org/2020/12/05/943454034/initial-distribution-of-covid-19-vaccine-wont -include-pregnant-people.
Wamsley, L. (2020, December 11). Pregnant People Haven't Been Part Of Vaccine Trials. Should They Get The Vaccine? NPR. https://www.npr.org/2020/12/11/945196602/pregnant-people-havent-been-part-of-vaccine -trials-should-they-get-the-vaccine.
In light of recent vaccination clinical trials, COVID-19 has brought to the fore this “longstanding neglect of women's health research” (Afshar and Parchem 2021). Women’s health providers are left with a daunting task of navigating the pandemic and patient care amidst data-free zones and delayed studies. Since much of the pregnancy-related data was very slow to emerge, many national hospitals and universities, such as UCLA Health’s Obstetrics and Gynecology department, were in search of answers themselves in collaboration with other institutions dedicated to addressing the questions unacknowledged in national vaccination clinical trials. Physicians describe having felt “unable to provide the meaningful counsel patients are seeking,” and became motivated to fill the information gaps themselves (Afshar and Parchem 2021). It is crucial that pregnant and lactating women are included at the onset of preliminary vaccination trials in order to prevent data-free periods where physician counsel carries less confidence. That is not to say institutional research is unnecessary, rather, this research can more accurately address patient-specific concerns, allow physicians to stay current with rapidly evolving data, and ultimately ensure more confident counseling.
Not only are pregnant women at higher risk to respond unexpectedly to generalized vaccinations, but pregnant women often fall into other high-risk groups. Similar to the effects of vaccinations on certain immunocompromised groups, underlying health conditions have tremendous unknown concerns that may further complicate the effects of vaccines in pregnant and nursing women. Dr. Ruth Faden, founder of Johns Hopkins University's bioethics institute, reveals that there is also a disproportionate predisposition to the burden of disease in pregnancy “that seems to be hitting women who are low-income, women who are from communities of color, women who are otherwise disadvantaged” (Faden 2020). In light of such predispositions, many pregnant and lactating individuals are very eager to participate in clinical research (Cunningham 2021). When creating an even larger picture considering predisposition to disease, disparities in access to treatment, and additional underlying clinical prioritizations, the impact of vaccines within pregnant and nursing women becomes increasingly complicated. The inclusion of pregnant and nursing women in clinical investigation is consequential in navigating external health influences quickly and efficiently.
Regardless of said concerns, the time-sensitive nature of vaccine trials makes absolute inclusion very challenging. For instance, if a vaccine trial determines that pregnant and nursing women respond poorly to vaccination while non-pregnant subjects respond successfully, the vaccine’s inconsistent response may delay delivery or induce fear in the public placing their trust in research. To navigate these concerns, vaccination trials for pregnant and nursing women can be carried out independently yet simultaneously to those performed on non-pregnant and non-nursing women. By doing so, investigation methodology may be amended according to research findings while preventing the emergence of “data-free” zones.
For now, amidst rapidly evolving data and a delayed foundation of knowledge pertaining to the effects of vaccinations on pregnant and nursing women, essential conversations should be held between pregnant and nursing women with their healthcare providers about whether the vaccine is safe for themselves and their babies. In the inevitable instance of future vaccination clinical trials, it is imperative to note that truly inclusive research must be dedicated to clinical trial research investigating pregnant and lactating women. Though pregnancy is regarded as a immunologically distinct state and a possible threat to generalizable data, this distinction should be regarded as a stronger incentive for exploration rather than a deterrence from inclusion in clinical research.
References
Spong, C. Y. (2020, August 11). Addressing Inequalities in Women's Health Research. Contemporary OB/GYN. https://www.contemporaryobgyn.net/view/addressing-inequalities-in-women-s-health-res earch.
Afshar, Y., & Parchem, J. G. (2021, February 24). Pregnant during the pandemic: United in motherhood. EClinical Medicine . https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00040-7/fulltext.
Cunningham, J. (2021, March 25). Pregnant and lactating women show robust immune response to COVID vaccines, pass antibodies to newborns. Massachusetts General Hospital. https://www.massgeneral.org/news/press-release/Pregnant-women-show-robust-immune response-to-covid-vaccines-pass-antibodies-to-newborns.
Heard on: Weekend Edition Saturday. (2020, December 5). Initial Distribution Of COVID-19 Vaccine Won't Include Pregnant People. NPR. https://www.npr.org/2020/12/05/943454034/initial-distribution-of-covid-19-vaccine-wont -include-pregnant-people.
Wamsley, L. (2020, December 11). Pregnant People Haven't Been Part Of Vaccine Trials. Should They Get The Vaccine? NPR. https://www.npr.org/2020/12/11/945196602/pregnant-people-havent-been-part-of-vaccine -trials-should-they-get-the-vaccine.
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