The United States’s emergency authorization of Pfizer and Moderna’s COVID vaccines in the U.S.—shown to be 95% effective in large-scale clinical trials—feels, for many, like a turning point in the pandemic. But while questions still loom large about the availability of and accessibility to said vaccines, there are also broader concerns for some about the vaccine’s safety, specifically among people who are pregnant or trying to conceive, and for parents of younger children, all of whom have been, so far at least, excluded from clinical trials. On December 11, the FDA announced it would allow pregnant and lactating women to access the vaccine, even if it hasn’t been tested on them, but it remains unavailable for anyone under 16. Then, in January, the World Health Organization (WHO) declared that pregnant women shouldn’t get the Moderna or Pfizer vaccines unless they were at increased risk of exposure, but, after a public outcry, withdrew that advice on January 26, recommending instead that it should be offered to them. And Johnson & Johnson—at 66%, their vaccine is less effective than the Pfizer and Moderna options, but the advantage is it is a single, versus double dose—will be petitioning the FDA for emergency use authorization this month.
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Because we are still early on in the vaccine timeline, the answers for many questions remain to be seen. To walk us through what we know and what we don’t know about the vaccine as it relates to maternal health, we asked two experts whose specialties lie in treating and studying women and children—Heidi K. Leftwich, D.O., an assistant professor of obstetrics and gynecology in UMass’s Division of Maternal and Fetal Medicine, and Kelly Fradin, M.D., a New York–based pediatrician and author of the recent (and very timely) book Parenting in a Pandemic.
Why have none of the clinical trials for major COVID-19 vaccines included pregnant people?
Historically, pregnant and lactating women have been excluded from clinical and vaccine trials because of safety concerns for the mother and child. But that exclusion can pose its own risks, a point that’s been repeatedly raised by the Society of Maternal-Fetal Medicine and various medical professionals. “It’s common, and it’s a cause for concern,” says Fradin. “When the consequences of toxic medications DES and Thalidomide were noted in the 1940s and 1960s, in 1977 the FDA barred pregnant and lactating women from phase 1 and phase 2 studies. This was intended to increase the safety of pregnant women, embryos, and infants. However, functionally this leads to barriers including women of reproductive age in medical research, which leads to less knowledge, advancement, and innovation in women’s health.” It’s a problem that many national societies are working tirelessly to rectify in the future. “Many are advocating to ethically include pregnant and lactating women in future clinical trials, but until this is more commonplace, physicians and other healthcare practitioners will need to continue to monitor updates in the data to best inform their patients regarding the COVID-19 vaccines,” adds Leftwich. As of January, Pfizer announced plans to begin testing the vaccine in pregnant women in the coming months though none have been enrolled yet, and Moderna was beginning to monitor the potential side effects in women who were immunized via a registry. On February 3rd, Anthony Fauci announced that he had seen “no red flags” in the 10,000 pregnant women who had received the vaccine in the U.S.
Can COVID-19 impact pregnant women more severely?
In short, yes, simply because pregnancy itself is designated high risk for the development of severe disease, hospitalization, and even death, says Leftwich. “The MMWR [Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention] estimated that pregnant women are at three times higher risk for requiring admission to an ICU or requiring a ventilator [because of COVID-19] and that their risk of death is about 70% higher than their nonpregnant peers,” adds Fradin. That risk is compounded for pregnant women of color. The maternal death rate for black mothers is already double the rate of white mothers, and nationally Black and Latina women are disproportionately affected by COVID-19 during pregnancy. So grave are the concerns around COVID-19 and maternal mortality that legislation to address the issue was introduced this year by Massachusetts senator Elizabeth Warren and Representative Lauren Underwood of Illinois. In January, JAMA Internal Medicine published a study that found a significantly higher rate of complications (like preterm birth, preeclampsia, and blood clotting) among women who had COVID-19 and gave birth in hospitals between April and November of last year. But JAMA also published a study recently that found that the majority of women who tested positive for COVID-19 during delivery passed antibodies along to their newborns.
Should pregnant healthcare workers prioritize getting vaccinated?
“Women in healthcare face many layers of concern about the coronavirus—becoming sick due to potentially increased exposure, experiencing pregnancy complications due to infection, and infecting their family members or patients,” says Fradin. “Accordingly, these women may feel that the benefits of the vaccine for their health, their family’s health, and their patients’ health are considerable and sufficient to justify taking a vaccine that is likely safe before having access to further research.” The Society for Maternal-Fetal Medicine has been highlighting the heightened risk to pregnant healthcare workers and advocating on their behalf for vaccine access, should they elect to take it.
But without actual data about the vaccine’s safety for pregnant people, should they still opt to take it?
The U.K.’s regulatory health agency, the MHRA, advised against pregnant and lactating women using the vaccine, but the U.S. FDA has given the go-ahead. Groups including the American College of Obstetrics and Gynecology and the Society for Maternal-Fetal Medicine are supporting the vaccine being offered to pregnant and lactating individuals, and the American Society for Reproductive Medicine is recommending it. Though there isn’t currently data that offers additional reassurance, many experts say that the general CDC guidelines for vaccinating pregnant women should apply: that when the likelihood of disease exposure is high, the benefits outweigh the risks. Additionally, the results of animal studies conducted by Moderna and Pfizer are all promising. But the decision will, ultimately, come down to the pregnant individual, and whatever they decide should be supported. Like so many things that come up when you’re pregnant or trying to conceive, be prepared to talk about the merits of vaccination with your doctor or practitioner. “The most important things to discuss with your doctor are the risk of contracting the virus, the risk of severe disease due to comorbidities, and the most current safety data available,” adds Leftwich. The CDC has also created an app called V-Safe that will track any potential effects of the vaccine on people who received it while pregnant.
Can you get the vaccine and continue breastfeeding?
Despite nursing mothers being excluded from Pfizer’s clinical trials, the Academy of Breastfeeding Medicine released a statement yesterday stating that, for individuals who are vaccinated against COVID-19, they do not recommend the cessation of breastfeeding. According to Fradin, there is no reason to suspect the vaccine would be unsafe for those who are breastfeeding. “There is no component of this vaccine which poses a particular concern, nor is it a live vaccine that will replicate or spread significantly beyond locally at the injection site where it will generate spike protein,” she says. The ABM’s statement underscores that it is unlikely that the vaccine lipid would enter the bloodstream and reach breast tissue, and if it did, it would be even less likely that the intact nanoparticle or mRNA would transfer into milk. Fradin adds that the protection from the vaccine will likely extend to the nursing infant as well. “We know from experiences with other illnesses that vaccinating the caregivers and parents protects the children and infant from exposure to the virus, so this cocooning is an indirect benefit to consider.”
What about if you’re not pregnant yet but trying; should you wait to get the vaccine or not?
The limited data makes this a particularly difficult question. “Early pregnancy is the time when fetal development occurs and typically poses the largest risk to anomalies from any medical or environmental exposure,” Leftwich explains. Though there have been no specific concerns noted, Leftwich recommends that women who wish to get vaccinated obtain the vaccine, then wait two to three months before conception. “This would provide substantial protection throughout their pregnancy with minimizing even the theoretical risk,” she explains. The American Society of Reproductive Medicine stated recently that they think the vaccine must be recommended to those who are pregnant or considering pregnancy. For anyone trying to conceive, the most important thing to do is engage in a discussion with their doctor about the risks and also keep in mind that more data is becoming available every week.
What do we know about the vaccine for children?
As of now, the vaccine remains unavailable to anyone under 16, though clinical trials are beginning in adolescents. The most recent recommendations included children 16 and up, and Pfizer began enrolling children 12 years of age and older in their ongoing trials in September. Fradin suspects that we’ll start to see younger individuals enrolled in studies soon and, if they go well, vaccines will be recommended for those age groups. “While some parents may be disappointed their children can’t be vaccinated sooner, I would remind them children haven’t been prioritized because they are at lower risk for serious complications from coronavirus,” she explains. Despite that, Fradin imagines it will be recommended to prevent rare complications and to reduce community spread.
Read More: Vogue