The Vaccine Rollout Failed Pregnant People

Why Exclude Pregnant People from Clinical Research?

The disaster of the morning-sickness drug thalidomide causing birth defects in the 1960s looms over all discussions of the risks of pregnancy research, even though the FDA never approved that drug for use in the US. During the 2009 H1N1, or swine flu, pandemic, Anne Lyerly, MD, an obstetrician and bioethicist at the University of North Carolina-Chapel Hill’s department of social medicine, and others noted that flu vaccine hesitancy among some pregnant people and their providers is directly tied to the exclusion of pregnant people from clinical trials.

Dr. Lyerly told Jezebel she was hopeful at the start of the COVID-19 pandemic, because it seemed like there was heightened awareness of the need to get pregnancy-specific data as early as possible in order to help stave off reticence people might have in using medications and vaccines for the virus ripping through the country. Women and pregnancy-capable people are overrepresented among frontline workers in fields like healthcare, education, retail and hospitality, and it was clear they might be among the first to want this vaccine. The early vaccine candidates, made by Pfizer and Moderna, both used mRNA technology, which doesn’t use any live virus and doesn’t have what researchers call a “theoretical risk” to pregnant people, she said. Researchers should probably be more comfortable with the mRNA vaccines than they are with the yellow fever vaccine, which contains a live, replicating virus and is still given to pregnant people at risk of catching it.

“Pregnant people have been protected from research rather than being protected through research,” Dr. Lyerly said.

And yet it didn’t happen: Pregnant people were barred from enrolling in the clinical trials, though some people got pregnant after enrolling. “This was a really important opportunity for pregnant people to be enrolled in the studies, but they weren’t,” Dr. Lyerly said. (Animal research is done before any humans are studied, the researchers told me, and after a few months of human trials, vaccine manufacturers could have seen that it’s safe for people generally and enrolled a separate arm of the trial that just follows pregnant people who opt to get the shot.)

At a country level, it seemed we learned nothing from a decade prior. We are still, Dr. Lyerly said, protecting pregnant people to death. “Pregnant people have been protected from research rather than being protected through research, which is how we attend to most other populations,” Dr. Lyerly said.

The exclusion creates a catch-22 where risk concerns keep pregnant people out of the very trials that are needed to recommend treatments for them, said Geeta K. Swamy, MD, professor of obstetrics and gynecology at Duke University, who’s also a member of the American College of Obstetrician and Gynecology’s COVID-19 expert working group. “You’re basically punishing pregnant women from the beginning,” Dr. Swamy told Jezebel. (Pfizer did start a study with pregnant women in February 2021, but it’s a randomized, placebo-controlled trial. “Why would you go get a placebo when we know that a vaccine is already working?” Dr. Swamy asked.)

ACOG and other groups were meeting with officials from the CDC, NIH, and FDA about including pregnant people in trials, but “no one really picked up this charge and carried it forward,” Dr. Swamy said. “That’s just a fact, otherwise we wouldn’t be where we are today. I don’t mean they didn’t care, and I don’t mean that they were indifferent and they didn’t understand it was a problem, but they just didn’t, for whatever reasons.” In her view, the government should pass legislation requiring researchers to justify why they aren’t enrolling pregnant people. As Dr. Perritt said, “the data that we have now about the vaccine and pregnancy is not because people were enrolled in the trials during pregnancy, but because they happened to get pregnant.”

One possible reason for this research exclusion is doctors and the state prioritizing the fetus ahead of the person carrying it when thinking about the risks of medications, vaccines, and other interventions, Dr. Lyerly said. It’s a problematic kind of protection—a misprotection, even—where researchers and government agencies ignore the fact that the health of the two beings are intertwined, and inadequate treatment can be dangerous for both. “People fail to also recognize that the best way to take care of the health of the child is to make sure its mother is as healthy as possible,” she said.

Even well-meaning people and groups sharing information around pregnancy do things that Dr. Lyerly said are “highly problematic.” In January 2021, the CDC said pregnant women should talk to their doctors about the vaccine, but at the same time, the WHO said pregnant people shouldn’t get the shot unless they were at high risk of contracting COVID because of their jobs or preexisting health conditions. The WHO message was bad for leading with precaution, rather than emphasizing the benefits of protection from the virus, she said, but the CDC’s tack wasn’t great either. “People will talk to their doctors,” she said, “but there isn’t a particular reason or set of circumstances that people should parse through with their doctor that could lead to a reasoned decision not to get vaccinated based on science.”

“Talk to your doctor” language is “in some ways an effort to sort of push responsibility for any imagined risk away from the organization and into the realm of the pregnant person and her doctor, which isn’t really fair, frankly,” Dr. Lyerly said.

One task force, which included ACOG, took a better approach, releasing guidance in February that pregnant people who want the vaccine shouldn’t be denied it by their healthcare providers—a step the Centers for Disease Control and Prevention did not take. ACOG recommended the vaccine for pregnant people at the end of July, and the CDC recommended it on August 11, shortly before the Pfizer vaccine got full FDA approval. The CDC updated its language on September 29 to “strongly” recommend the shot after seeing more pregnant people hospitalized during the late summer. When the CDC did recommend “urgent action” to get pregnant people vaccinated, it was via a rare health advisory, and Dr. Lyerly said she just wished they’d done it sooner. “A lot of pregnant people—nearly 160 at that point—had already died.”

Maven Clinic, a virtual clinic for women’s and family health, commissioned a representative survey in mid-October of 500 pregnant people in the US and the results are illuminating: Just 39 percent of respondents said they knew the CDC recommends all pregnant people get the vaccine, two full months after the agency had done so, and only 29 percent said they knew that pregnant people are more likely than others to get severely ill from COVID. Nearly 70 percent of people surveyed said at least one source advised they not get the vaccine during pregnancy and, of those people, 29 percent said a medical provider made that suggestion. (In September, Mississippi’s state health officer issued a standing order for pharmacists to vaccinate pregnant people after reports that some had refused to do so.)

Despite loads of fact–checking, a mere 35 percent said they knew the vaccine doesn’t cause infertility. The myths still persist and gain news coverage: In October, ESPN reporter Allison Williams announced she was leaving the network over concerns that its vaccine requirement would affect her future fertility, when there is no evidence of fertility problems. Days later, right-wing site The Daily Wire announced that Williams was coming on board to host a new series billed as “sports without the woke.”

The genuine vaccine hesitancy some people experienced around pregnancy due to the botched vaccine information rollout has, in effect, given birth to a more toxic brand of anti-vaxxer propaganda that is not based at all in science or reasonable thought.

The Specter (and Guilt) of Pregnancy Loss

There’s also another subconscious reason why some pregnant people are hesitant to get the vaccine, Dr. Perritt says: internalized guilt over pregnancy loss that is rampant in our culture. “So: ‘You made the decision to move forward in this way, and it harmed your baby, and that was your fault,’” she said. “There is a really tight association between othering and punishing pregnant people that I think is deeply embedded in this and never discussed in this vaccine debate.”

Black and brown pregnant people may not only face individual guilt, but they are more likely than white women to be criminalized for their pregnancy outcomes, Dr. Perritt said. In one recent Oklahoma case, a 21-year-old Native American woman, Brittany Poolaw, was convicted of first-degree manslaughter and sentenced to four years in prison after a miscarriage. (Poolaw had tested positive for drugs and the fetus had congenital abnormalities but even experts involved in the case said it was unclear what caused the miscarriage and the drugs weren’t directly responsible). While this case involved illicit substances, “whether you’re incarcerated or just simply stigmatized and blamed, I think that it’s all part and parcel of the same culture,” Dr. Perritt says. And without the (limited) protections of Roe v. Wade, even more pregnant people will be charged for miscarriages and stillbirths.

For Black women, layered on top of these concerns is the historical and often personal experience of medical providers doing them harm. “It’s not enough to say [to pregnant Black women] ‘oh go get vaccinated,’” Dr. Perritt said. “There are lots of complicated reasons why people may or may not interact with the health care system.”

Holcomb, who is white, also felt guilty when making her choice to wait to get the vaccine, noting that pregnant people are surveilled and judged when they so much as drink a cup of coffee in public. “People are so judgmental of decisions you make now,” she said. The vaccine was one of many loaded decisions. “If you got the vaccine and something did happen to your child, what does that look like?” Holcomb said. “The amount of guilt that comes along with making that decision is just tremendous.”

While she would have felt guilty for getting it, she also felt bad for waiting—it was a lose-lose situation. “I felt irresponsible for not being vaccinated. But at the same time, I did feel like it was the best decision I could make with the information that I had for my daughter,” Holcomb said, adding that she would have gotten vaccinated before giving birth if she had gotten pregnant later when there was more data available.

And the flip-flopping doctors did not help. “I could have been told not to get it at the same time somebody else could have been getting told, ‘absolutely get it.”

Dr. Swamy said we will keep having these problems until pharmaceutical companies are forced to update their practices. “If we never enroll [pregnant people] in trials, we will never improve upon pregnancy itself. We will never be able to get to a place where we have healthier mothers and healthier babies,” she said. Without it, “I’m not sure we’re going to see a significant sea change.”