Sarah N. Cross is an assistant professor of obstetrics, gynecology and women’s health at the University of Minnesota Medical School and medical director of the Birthplace and Pregnancy Special Care Unit at M Health Fairview University of Minnesota Medical Center.
This is not just because pregnancy clearly increases the risk of hospitalization, need for mechanical ventilation and death from covid-19. It’s also because pregnant people remain largely unvaccinated — a direct result of bad decision-making to keep them out of vaccine trials. It’s time we change these policies and let pregnant people make decisions for themselves.
It has long been known that vaccines would be our only hope of ending the pandemic. And when one became available, doctors rushed to get vaccinated. In fact, more than 96 percent of us are fully vaccinated — including me, a maternal-fetal medicine physician and breastfeeding mother to my “pandemic baby,” Sophie.
When I received my first dose on Dec. 21, 2020, I cried. I was overcome with relief for myself and my three children. Although I knew there was no data on lactation or pregnancy, I had every expectation that my vaccination would benefit Sophie by directly exposing her to helpful antibodies. I wanted protection from the real and present danger invisibly surrounding us.
But that’s not true for all pregnant or lactating people. Although they have had access to covid-19 vaccines since the Food and Drug Administration first issued its emergency use authorization, only 30 percent of currently pregnant people are fully vaccinated, compared with 64 percent of people 12 and older.
That’s because, despite the availability of the vaccine, pregnant people have received conflicting messages from the beginning. The national obstetrical medical societies, such as the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, only recently started recommending the vaccine in pregnancy.
Meanwhile, it took the Centers for Disease Control and Prevention eight months after the first emergency use authorization was granted in December to also start clearly recommending the vaccine for pregnant people. That translated to far too many months of doctors such as me trying to persuade patients to get vaccinated without these crucial endorsements.
The delay in these endorsements is because pregnant and lactating people were purposefully excluded from the initial clinical trials. Why? Regulatory bodies have safeguards in place to protect research participants. Those include children, as they cannot legally give consent, as well as prisoners who might be subject to coercion. A third group is pregnant people and fetuses, even though a pregnant adult can give consent.
But why does the pregnant person require additional protections simply as the carrier of the fetus? Are these policies really trying to protect the pregnant person or the fetus? Although we have much more blatant examples of women being reduced to incubators unfolding right now in our country, this is also an example of control.
It might seem justified by science, but by restricting them from participating in the covid-19 vaccine research, we put the burden of proof on the individual pregnant person. We excluded them from clinical trials, and then left them to decide what to do. Physicians then gave inconsistent advice. Some told their patients to wait until the end of the first trimester or until the end of the pregnancy; others encouraged vaccination from the start. At a time when they needed us most, patients were told, “It’s up to you.”
Today, the evidence could not be clearer, thanks to the thousands of pregnant individuals who did choose vaccination. These individuals allow me to tell my patients that the vaccine is safe and effective. Data published five months ago on the mRNA vaccines showed no increased risk of pregnancy complications, including miscarriage, stillbirth, preterm birth, small size for gestational age, congenital anomalies and neonatal death. Subsequent studies confirmed no increased risk of miscarriage in those who receive the vaccine.
Similarly, side effects in pregnant people were not increased. Data show no decreased pregnancy rate among those who have been vaccinated, suggesting no relationship between the vaccine and infertility. Another study shows robust immune responses in vaccinated pregnant and lactating people, and antibodies are found in cord blood and breast milk, indicating passive immunity for the newborn (similar to other vaccines).
Even still, why, in a country with rising maternal mortality and despite data demonstrating increased risk for pregnant people from covid-19, were they purposefully excluded from research that could help them? In the United States, more than 120,000 pregnant people have had covid-19. How many cases could we have prevented if we’d trusted pregnant people, science and informed consent from the beginning?
Pregnant people want to do the right thing for themselves and their family. To this day, many are still agonizing over the decision to not be vaccinated. Research protocols must change. Restrictions on participating in research due to pregnancy are unethical. Allow competent adults to make informed decisions about their bodies and their pregnancies.
I am often asked when the best time in pregnancy is to get vaccinated. The answer is today. Your life depends on it.