Pregnant People Are Not in Covid-19 Vaccine Trials — and That’s a Problem
Pregnant and breastfeeding people have not been included in any of the Covid-19 vaccine clinical trials for the U.S. market, and it’s not clear what this will mean for that population when vaccines are rolled out. For example, will their exclusion delay rollout for them, or will it affect pregnant people’s trust that the vaccine is safe for them? How comprehensively will their reactions to the vaccines be recorded?
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The benefits of vaccinating pregnant people are high because Covid-19 can pose risks for both pregnant people and their fetuses, although scientists don’t know (again because of lack of research) whether a Covid-19 vaccine given to a pregnant person would confer antibodies to a fetus. Medical and bioethics experts have written at least six articles since April in prominent medical journals like The Lancet and British Medical Journal urging that clinical trials for these vaccines include pregnant people. “Are they being included enough? Not at all,” says Atul Malhotra, a neonatologist at Monash Children’s Hospital in Melbourne, Australia.
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Excluding pregnant people from clinical trials is not new. It’s the default, largely out of concern for fetuses, ever since the anti-morning-sickness drug thalidomide — which went straight from lab animal testing to commercial over-the-counter approval with no testing in any humans or pregnant animals — caused severe birth defects in fetuses in the 1950s and 1960s. But experts have been calling for including pregnant people in phase 3 vaccine trials for some time, citing a host of reasons: testing and regulatory control are much tighter than during the thalidomide era, scientists have a lot of information about the safety of vaccines during pregnancy, clinical trials would collect more comprehensive data than just giving pregnant people the vaccine later, and the risks of infectious disease for both pregnant people and fetuses are real. “The maternal and fetal risks of Covid during pregnancy are much higher than any vaccine,” says David Baud, the head of obstetric service at the University of Lausanne in Switzerland. However, these experts have been largely ignored. Experts urged Ebola vaccine trials to include pregnant people, for example, but it did not happen.
Phase 3 trials would be the best time to include pregnant people because phase 1 and 2 trials have already tested the vaccine’s safety and established the recommended dose, large enough to be effective and small enough to minimize side effects. Phase 3 trials could measure pregnant women’s immune responses to the vaccine, which “cannot be assumed from that of non-pregnant women,” wrote Paul Heath, director of the Vaccine Institute at St George’s, University of London, and two other experts in The Lancet. But phase 3 trials for the Covid-19 vaccines are well underway or in some cases complete.
Risks, known and unknown
Vaccination, like every medical intervention, is a balance of risks. It may have a risk of side effects for pregnant people or their fetuses — there’s not enough information yet to quantify this risk. But not getting vaccinated also carries a risk — the risk of getting Covid-19.
Data on the impact of Covid-19 on pregnant people is mixed. As the pandemic has progressed, data suggests that they are more likely to end up in the ICU or on ventilation than non-pregnant people, according to the Centers for Disease Control. About 11 per 1,000 pregnant people with Covid-19 need ICU care, compared with four per 1,000 non-pregnant people. Similarly, about three per 1,000 pregnant people need ventilation, compared with one per 1,000 non-pregnant people. However, other data, like a recent study published in the journal JAMA reports that 95% of people who tested positive for Covid-19 during pregnancy had no adverse outcomes; 5% of infected pregnant people experienced severe complications such as pneumonia and respiratory distress.
Vaccination, like every medical intervention, is a balance of risks.
Some data suggests that the fetuses of pregnant people with Covid-19 have about a 13% chance of premature birth, up from the usual 10% chance of premature birth, according to the CDC. For an individual fetus, this not a very large increased risk, but on a population level, 44,183 pregnant people have been documented to have Covid-19 in the U.S. so far, and among this group, the additional risk of premature birth translates, in theory, to 1,325 additional babies born premature. Premature birth carries health risks ranging from mild to severe, says Baud. Among the more severe risks are “brain damage, lung damage, intestine damage,” Baud says, “and this might have serious long-term effects on these children.”
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The main concern with enrolling pregnant people in vaccine clinical trials is that the vaccine might act differently in pregnant people or fetuses, potentially causing some harm or side effect that wasn’t observed in phase 1 or 2 trials in non-pregnant people. But Baud says scientists know a lot about how vaccination plays out during pregnancy, and most vaccines are safe. “You can vaccinate with almost everything except live vaccines,” he says, and the Covid-19 vaccines are not live. People routinely get flu vaccines, TDAP (tetanus, diphtheria, pertussis) vaccines, and hepatitis B vaccines during pregnancy, says Baud.
Johnson & Johnson’s Covid-19 vaccine uses the same underlying technology as its Ebola vaccine, which has been given to pregnant people and is found to be safe. Pfizer and Moderna’s vaccines use newer technology. Although none of the trials have enrolled pregnant people, some volunteers may become pregnant over the course of the trial after they have signed up. Bill Gruber, senior vice president of vaccine clinical research and development at Pfizer, told Reuters that he expected about 1% of women in Pfizer’s phase 2/3 trial, or about 150 women, would become pregnant. That data has not been released.
Ethical issues
There are several ethical concerns with excluding pregnant people from vaccine trials. For one, it may affect how quickly a Covid-19 vaccine could be rolled out for pregnant people. “We have to remember that when we vaccinate a pregnant woman, we protect two people,” says Baud, because it also protects the fetus from the increased risk of premature birth.
If pregnant people are not included in trials or vaccination, Baud argues that ethically, “you have to offer them another type of protection.” This includes benefits like paid leave from their jobs. He says he can’t think of any country that’s prepared to do that for all pregnant people.
Excluding pregnant people from clinical trials also affects the comprehensiveness of the data collected on how their bodies react to the vaccine, says Malhotra. Even though the FDA plans to collect data after vaccine rollout on how pregnant people will react, the kind of data that’s collected in a clinical trial “is likely to be much more comprehensive,” he says. After rollout, if you got the vaccine and noticed a symptom like aches or fever, you would tell your doctor, who would enter it in the surveillance log. A trial would include regular blood tests, swabs, and other analyses that would measure not just what side effects you notice, “but also how your body is responding to it from an immune response point of view, from an antibody production point of view,” Malhotra says. So by excluding pregnant people from clinical trials, “You are not actually getting a comprehensive look into it. What you’re getting is just the tip of the iceberg.”
Hallie Spierings, a financial analyst in Marblehead, Massachusetts, is pregnant, due in mid-March. Like Molly Cohen, Spierings believes in science and vaccines, but “until it’s tested on pregnant folk, I’m not interested” in the vaccine. Though she probably won’t have to make the decision — she will likely deliver her baby before vaccines are available for pregnant people who aren’t frontline workers — she wants the vaccine to be tested for its effects on fetal development before she’d take it while pregnant. “It is sort of a dealbreaker for me.”
