Without Official Vaccine Guidance, Pregnant People Are Left to Do Their Own Research

Without Official Vaccine Guidance, Pregnant People Are Left to Do Their Own Research

Kolina Watt de Garcia, a high school teacher in Oregon, was apprehensive when she learned in January that she’d be returning to the classroom after teaching for much of 2020 virtually. She knew that as a teacher, she’d soon be offered a COVID-19 vaccine. But there was one complication: She was pregnant—and she worried that the shots could harm her developing fetus.

“My options were essentially: Take a leave of absence or return to school,” she said. “With a baby on the way it does not seem fiscally responsible to reduce our household to a single income, but going back into the classroom is daunting.”

In the early stages of her first trimester, overjoyed to be pregnant after trying to conceive for seven years, Watt de Garcia asked her OB for advice, but the answer she received wasn’t the direct answer she’d hoped for. “My OBGYN was very clear that I was the only one who could decide what is best for me and my baby,” she said. “She did not tell me one way or another to get, or not to get the vaccine.”

The decision of whether to get the COVID-19 vaccine while pregnant is one that many are struggling to make. The Centers for Disease Control and Prevention lists pregnancy as a high-risk category for COVID-19 in the same group as people with cancer or heart conditions. Pregnant people are three times likelier to end up in the ICU and in need of a ventilator. More worrisome, they are 70 percent likelier to die from COVID-19, compared with people the same age who are not pregnant, according to the CDC. There are also potentially severe consequences for the unborn baby, such as a slightly increased risk of premature birth.

Meanwhile, a growing body of evidence suggests the vaccines are safe for both the birthing parent and the fetus during pregnancy. During the trials, at least a dozen of the participants who received the vaccine instead of the placebo became unexpectedly pregnant, with no ill effects. Dr. Anthony Fauci, the nation’s top infectious disease expert, said last month that so far there have been “no red flags” since more than 20,000 pregnant women received the vaccine in the past few months.

Yet despite the risks of contracting COVID-19 while pregnant and the increasing evidence of the vaccines’ safety during pregnancy, in most states pregnant people are not included in groups that get priority access to the vaccine. In fact, to date, no public health group has actually recommended that they get the vaccine at all. The American College of Obstetricians and Gynecologists’ guidelines just say that the Pfizer and Moderna vaccines “should not be withheld from pregnant individuals.” The Society for Maternal-Fetal Medicine and the CDC use similar language. In early February the World Health Organization reversed its original advisory opposing the use of the vaccine during pregnancy, saying instead that only “pregnant women at high risk of exposure may be vaccinated in consultation with their health care provider.”

The lack of clear guidance around pregnancy has ripple effects. Despite abundant evidence that the vaccines are safe for lactating parents and their babies, last month the Chicago Tribune reported that a new mom who was breastfeeding was denied the COVID-19 vaccine by her county’s health department. Officials said they decided not to allow pregnant or lactating women to receive the vaccine, citing a lack of data.

Dr. Peter Hotez, a vaccinologist and dean of the National School of Tropical Medicine at Baylor College of Medicine, told me he was appalled by the mixed messaging around vaccines in pregnancy, which he said leaves patients “reading the tea leaves.” The government “has not made a good faith effort to take down the anti-vaccine misinformation and disinformation,” he said. “So by telling a pregnant woman to do her own research online means you’re basically telling her not to get vaccinated.”

As vaccination appointments became available to pregnant people across the country, I put out a call on social media to hear directly from parents-to-be. Many expressed confusion over the lack of guidance they’ve received. Some said they wished the CDC and other public health groups would reassure them it’s safe to get vaccinated.

Itzel Carreon, from Mesa, Arizona, was 12 weeks pregnant when she told me, “My pregnancy is high-risk, and from what I’ve been reading about the vaccine, we don’t know any of the long-term effects of the vaccine—not only for me but potentially our child.” As an accountant she can work from home, and her husband has also been working from home, minimizing their risk. While she’s concerned with the relaxed COVID-19 restrictions in her home state, if Carreon had to decide today, she would not get vaccinated. She is open to seeing more data from pregnant patients who are participating in studies as time goes on.

Brittney Jackson, a young pregnant woman I spoke to in New York, said that posts she saw on social media suggested the vaccines weren’t safe, so she plans not to get vaccinated. She told me she also refused the flu shot when it was offered to her after she found out she was pregnant, even though most doctors have been recommending the flu shot to pregnant patients for years. 

Others told me that while they were confused about the vaccines at first, frank conversations with their health care providers had helped them come to a decision. Liz Bellamy, who was 25-weeks pregnant when we spoke, is a university librarian in Williamsburg, Virginia. She told me she’d been feeling isolated during the pandemic, especially because her husband hasn’t been able to go with her to doctor appointments, see the baby in ultrasounds, or hear the baby’s heartbeat. “This is our first baby and we’re really excited, but my husband hasn’t been able to really have the full experience, so it’s been really tough.”

Bellamy is expecting to have to return to work in-person soon. “It feels like I’m hearing all these things that are like ‘No, don’t get the vaccine,’ but it wasn’t until I actually talked to my doctor about it this past Friday, and my doctor recommended that I get it if I want to be able to work in person,” Bellamy said. “There are so many thoughts swirling around in my head all the time about whether or not I should get it. I think probably when I’m given the option, I’ll get vaccinated.”

A Washington, DC–based consultant who works from home told me she plans to get the vaccine as soon as possible. She trusted what she’d read and discussed her decision with her midwife. While she’s less likely to be exposed to the virus because she can work from home, she’d rather get protected than fall ill while pregnant.

In the absence of clear federal guidelines, Hotez says, physicians play a key role in helping pregnant people decide whether to get vaccinated. “It’s incumbent upon the obstetrician or the family medicine doctor to make a recommendation.” 

Dr. Kjersti Aagaard, a maternal fetal medicine specialist at Texas Children’s Pavilion for Women in Houston and professor and vice chair of research at Baylor College of Medicine, says she doesn’t hesitate to recommend the vaccine to her patients: “I believe pregnant women will benefit from being vaccinated, and that is a perfectly reasonable assessment given all the evidence to date.”

A key point Aagaard makes with her patients is that the absence of data does not equal presence of harm. The real harm, she said, is getting COVID-19 while pregnant. “We can’t ever make decisions for our patients, that’s not ethical and it’s not within the moral construct we train under,” Aagaard said. “But what we can do is make sure the framework under which they are making that decision is ethically consistent, morally responsible, and will get them to feeling that they have autonomy and have made a good decision.”

The specialists I spoke to said that when a patient is skeptical of a vaccine, it often helps to explain how it works. The two mRNA vaccines approved for use in the United States can’t alter the DNA of the pregnant person or the developing fetus. The vaccine travels to the lymph nodes and creates a protein that helps your body mount an immune response, and it gets degraded very quickly in the bloodstream, said Dr. Linda Eckert, a professor of obstetrics and gynecology at the University of Washington: “What we can say is from the mechanism of the vaccine and from the data in animals, that we don’t really have any reason to have particular concerns.”

Dr. Aagaard also pointed to the Moderna Zika vaccine, which was designed exclusively around pregnancy and was also an mRNA vaccine. It showed no harm in pregnant animal models (though it has not yet been tested on pregnant people). With the COVID-19 vaccine, she said there’s no science to support a higher risk of miscarriage, stillbirth, or birth anomalies.

For breastfeeding women, too, the vaccines appear to be safe. Antibodies in breast milk from vaccinated parents even offer some additional protection to newborns, says Dr. Aagaard. “Our hope is that once vaccinated, you will continue to help supply that early protection of immunity to your baby,” she said. “That has yet to be proven definitively but think of it as a twofer protecting mom and baby.”

In addition to reducing the health risks associated with contracting COVID-19 during pregnancy, the vaccine could also ease some of the stress of having a baby during a pandemic. Carreon told me she’s nervous about labor and delivery: “These hospitals are still places where moms are going to bring life into this world,” not just places where the coronavirus has taken lives. “You’ll only have one person with you, you’ll have a mask on your face, and you won’t have your family’s support around you.” Dr. Eckert said the toll from isolation for pregnant women during a pandemic can increase their risk for postpartum depression. She hopes that future studies will help determine whether vaccinated new parents feel less fear of getting infected than their unvaccinated counterparts and therefore have access to more resources and community.

The COVID-19 vaccine isn’t the only medical product that hasn’t been studied during pregnancy. As my colleague Nina Liss-Schultz reported in 2018, “Only a handful of medications, all for conditions of pregnancy like morning sickness and preterm labor, have been explicitly approved by the FDA for use by expectant mothers.” 

The vaccine could soon change the status quo for research in pregnancy: Last month, Pfizer launched a large-scale clinical trial to assess the safety and efficacy of the COVID-19 vaccine in pregnant people and their babies. “It’s time to take the next step and extend our clinical program to other vulnerable populations such as pregnant women,” the company said in a statement.

Another hopeful sign: Earlier this week the CDC’s Advisory Committee on Immunization Practices released initial data from more than 55 million people who have received at least one dose of the Moderna and Pfizer vaccines. Of those, 30,494 were pregnant. The data, which was collected through the CDC’s V-Safe tracking program, showed no significant increase in risk of complications. Most negative outcomes fell within the normal rate for all pregnant people pre-pandemic. 

“I hope we’re at an inflection point where we’re really going to ask the question, how do we protect pregnant women with research versus how do we protect pregnant women from research?” Dr. Eckert said. “In the past there was just this whole pendulum swing toward having to protect pregnant women and their fetuses from research, but now we’re realizing that is actually not smart, nor is it particularly ethical to take the decision away from pregnant women.”

We won’t see results from the Pfizer trial until 2023—the study will follow approximately 4,000 pregnant people starting as early as week 24 of their pregnancies, and also monitor their infants for about six months after birth. In the meantime, registries at the CDC and several sites around the country are collecting data on people who have been vaccinated during pregnancy and breastfeeding. Dr. Aagaard is interested to see specific data from these trials to show if the vaccines are as efficacious as they’re believed to be. “We may find out that if you’ve got the vaccine during pregnancy, maybe you need an extra booster shot when you’re no longer pregnant,” she said. “But the idea that we’re going to hold off getting this vaccine until we have safety data is not what’s going to happen. Because we would have to wait to vaccinate hundreds of millions of women until we answered that question.”

With more transmissible variants looming, that’s simply not an option. Baylor’s Hotez emphasizes the urgent need for clearer messaging from the US government, public health experts, and their own OBGYNs. Pregnant women, he said, “should not feel that they have to make that decision alone.”

In late January, Watt de Garcia, the high school teacher in Oregon, had the option to get vaccinated as appointments for teachers became available. So at home, she went online to read some of the links her doctor provided. After talking it over with her husband, she concluded that her risk of getting severely ill with COVID-19 would be greatly diminished by getting vaccinated. And at week 13 of her pregnancy, she received her first dose. 

“In the end, only time will tell if I made the best decision,” Watt de Garcia said. “But for now, I am comfortable believing that I will be able to safely bring my future daughter into this world.”