The Impossibility of an "Informed Choice": The Covid-19 Vaccine and Pregnant Women

"Pregnancy could be a rewarding yet challenging and stressful experience for women," writes Tanjeem. "Pregnant women need not the additional burden of dealing with the impossible "choice" of getting the vaccine in the absence of reliable clinical trial data." (Photo: John Moore/Getty Images)

The Impossibility of an "Informed Choice": The Covid-19 Vaccine and Pregnant Women

And why scientific protocols should move away from protecting women from research and support women through research.

Women's struggle for reproductive justice has historically involved complex layers of negotiation. In the 1960s and the 1970s, "My body, my choice" became a widely popular slogan to fight for women's bodily integrity and autonomy regarding issues such as abortion, birth control, and reproductive and sexual health. No one can and should deny the importance of enacting women's individual choice over matters that impact their sexual and reproductive experience, specifically in a context where that choice has been targeted again and again in campaigns for restricting access to abortion, birth control methods, and sex-positive sex education.

Nevertheless, it is also important to think about how the "choice" over sexual and reproductive decision-making processes women have long fought for may serve the purpose of the profit-driven health care industry, health insurance companies, and pharmaceutical industries. An individual woman is now expected be an all-compassing knower and the risk-bearer of the "choice" she makes based on a few sessions with the healthcare service provider or a few pages of information booklets. Historically, "informed consent" has been promoted to secure women from the paternalistic and exploitative attitudes of the healthcare industry and physicians. It still serves the practical purpose of offering agency to individual patients. However, many feminist scholars have argued that the practice of providing "informed consent" in a capitalist society is often designed to extend legal protection and commercial benefits to the industries that obtain it from women. By shifting the control from healthcare providers to individual women, "informed consent" ascribes the responsibility of risk screening and refusing the service to women. The service provider and the service-providing industry remain off the hook from any legal and commercial liabilities (Ikemoto 2009).

"Since there is not much data available, the burden of making the crucial decision falls on the individual women who often find it impossible to make an "informed choice" because the information supported by data is simply unavailable."Being pregnant now comes with the responsibility of making a wide range of "informed choices." As soon as a woman discovers she is pregnant, she is asked to make a series of choices: Do you want to choose a midwife or an OB-GYN? Do you want to perform genetic screening of the fetus? If there is a higher odd or a diagnosis that the fetus has a chromosomal or congenital disorder, would you like to continue or terminate the pregnancy? In an article on genetic counseling and the fiction of choice, Silja Samerski argues that a pregnant woman constantly faces the social pressure of making the "right" choice for herself and her fetus. Pregnancy is no longer accepted as a natural process that involves some occasional dangers. It is now a carefully managed experience, and the pregnant woman is expected to be the responsible manager who will mitigate risks by making "informed decisions." And she is often burdened with impossible decisions because ruling out one risk may mean having to accept another risk.

The "choice" of getting the COVID-19 vaccine is now creating an impossible scenario for pregnant women. Is it worth taking the vaccine as pregnant women are more likely to develop complications requiring intensive care if they get infected by COVID? Or should they wait until delivery or finishing breastfeeding since we have little to no data on whether and how the vaccine might affect the fetus and the baby? World Health Organization (WHO) initially recommended that pregnant women should get the vaccine only if they are at high risk of exposure or have chronic conditions. Later it dropped its opposition in the face of strong criticisms. The CDC website highlights that the decision to get a vaccine during pregnancy is a "personal choice," but it also mentions that the data on the safety of COVID-19 vaccines for pregnant women is limited. Both WHO and CDC emphasize the theoretical safety of COVID-19 vaccines for pregnant women. However, since there is not much data available, the burden of making the crucial decision falls on the individual women who often find it impossible to make an "informed choice" because the information supported by data is simply unavailable.

Why is the data unavailable? There is a long history of exploiting racialized, gendered, and other marginalized communities for pursuing biomedical and behavioral experiments. The Tuskegee Syphilis Study, the Nazi experiments during the holocaust, human radiation experiments, or the Milgram Study pinpointed the significance of enacting research ethics protocols. The use of cervical cancer cells of Henrietta Lacks for producing HeLa cell lines without her consent or the way the "father of modern gynecology" J. Marion Sims used enslaved Black women's bodies without anesthesia to invent important gynecological tools and techniques or thousands of birth defects in children whose mothers were prescribed thalidomide for relieving morning sickness during pregnancy demonstrated the need for regulating biomedical research involving women.

Biomedical and behavioral research ethics guidelines were initially designed to protect women -specifically pregnant women--but they went overboard in some cases. In 1977, FDA banned women of childbearing potential from participating in Phase I and early Phase II clinical trials. As a result, prescription drug testing overwhelmingly relied on data derived from male experiences, ignoring how the drugs might affect female bodies of reproductive age. In 1993, the restriction was withdrawn, but pregnant women were still considered as "vulnerable population," putting them in the same category with children, incarcerated individuals, and people with disabilities. The "vulnerable" label was removed in 2019, but this did not necessarily pave less complicated ways for including pregnant women in clinical trials.

In a capitalist economy shaped by free-market policies, it is also not profitable for big pharmaceutical industries to cover for potential expenses, liability risks, and expertise for ensuring safety during research involving pregnant women, specifically when the number of pregnant population is proportionately very small at a given time and the time spent in pregnancy is far less than a chronic condition for an individual. The politics around abortion further complicated the scenario. During the late 1970s and the 1980s, opponents of abortion - many of whom were backed by the Catholic Church - advocated against the involvement of pregnant women intending to abort their fetuses in research. Some scholars have argued that the politics of "vulnerability" of pregnant women in research ethics protocols partially originated from the intention of protecting the fetus. Such a stance automatically makes several assumptions such as the fetus is always wanted by pregnant women and has reached viability and will remain viable. It considers women as objects that incubate the fetus and prioritizes the interest of the unborn fetus over the health and well-being of all pregnant women who would have been benefitted from the research involving fetus intended for abortion. Because of the sexist and paternalistic research ethics protocols, more than 90% of drugs approved between 1980 and 2000 have no definite information on whether these drugs are safe to take during pregnancy.

COVID-19 vaccine manufacturers excluded pregnant and lactating women in their initial trials. As a result, millions of pregnant women are now bearing the brunt of making the impossible "choice" of whether to get the vaccine during pregnancy. In the absence of empirical data from clinical trials, many are currently resorting to social media and online groups where pregnant women share their experiences of getting vaccines, side effects, and how the vaccine affected or did not affect their pregnancies. Nonetheless, trying to establish a reliable trend from thousands of personal anecdotes on social media continues to make many pregnant women anxious, frustrated, and confused about making the most "responsible" decision for them and their fetuses.

The bright side is NIH has recently called for greater inclusion of pregnant and lactating women in COVID-19 vaccine research. The campaign for protecting pregnant women through research rather than from research is growing stronger day by day. As of April 6, 2021, 77960 pregnant women reported to CDC after getting their vaccines through the v-safe system, and CDC is currently monitoring 4218 pregnant women who are enrolled in the COVID-19 vaccine pregnancy registry. A recent study published in the American Journal of Obstetrics and Gynecology also reported that mRNA vaccines generate a robust immune response in pregnant and lactating women similar to non-pregnant women, indicating some level of safety of taking mRNA COVID-19 vaccines during pregnancy.

Pregnancy could be a rewarding yet challenging and stressful experience for women. Pregnant women need not the additional burden of dealing with the impossible "choice" of getting the vaccine in the absence of reliable clinical trial data. IRB protocols need to address their paternalistic attitude and they should move away from their stance of protecting women from research and support women through research. The profit-driven big pharmaceutical industries should also be pushed for gathering drug safety data for pregnant women.

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