Jaely Turner describes herself as “covid-conscious” and pro-vaccine. She and her young son are up-to-date on all of their shots. Turner wants to keep it that way.
But, as the United States inches closer to making a coronavirus vaccine available to the public, Turner says she won’t be rushing out the door to get it for herself. That’s because the Virginia-based doula is 10 weeks pregnant.
“I just have concerns about the safety of the vaccine long term and especially for myself as a pregnant and soon-to-be nursing woman,” she says. “I just am unsure of what the implications would be for me.”
And until she gets answers to her questions, she says, “I feel inclined to wait it out until I’m done nursing.”
Jenn Topper, a D.C.-based communications director, feels similarly. Topper is 24 weeks pregnant and has questions, too: Are there risks specific to pregnancy? Is it safe for breastfeeding women?
She’s been avoiding Google and turning to her doctor for answers, but not much is known yet about what a potential vaccine may mean for her. Instead, her doctor has strictly advised her to avoid holiday travel and to continue to self-quarantine.
“I think I would have to see some solid data that the benefits far outweigh the risks to both myself and to my baby,” Topper says.
None of the three companies that say they’ve developed effective coronavirus vaccines enrolled pregnant or breastfeeding people in their clinical trials. And that means initial guidance on who should get vaccinated likely won’t include pregnant people, public health experts say. Pregnant people have long been typically left out of major vaccine trials because of concerns that the women and their fetuses might face increased risk. That protocol has come into question in recent years as experts increasingly make the argument that leaving them out of trials puts them at greater risk.
Pfizer, Moderna and AstraZeneca have all said they have coronavirus vaccines that are at least 90 percent effective based on clinical trials. The Food and Drug Administration is planning to meet Dec. 10 to discuss granting emergency use authorization to Pfizer. And on Monday, Moderna announced it would also file for emergency use authorization.
It’s possible that one or more of these vaccine candidates, likely Pfizer or Moderna’s, could be distributed to high-risk individuals as early as mid-December, The Washington Post reports. As both Turner and Topper know, their pregnancies have made them high-risk people: According to a Centers for Disease Control and Prevention report, pregnant women face higher risks of severe covid-19 complications.
“Ever since I became pregnant, it has changed covid into being something that is more scary for me on a personal level,” Turner says.
Paul Offit, director of the vaccine education center and an attending physician in the division of infectious diseases at the Children’s Hospital of Philadelphia, says it’s likely we will have a better understanding of how the vaccine affects pregnant people soon.
Offit is also serving on the FDA committee overseeing the covid-19 vaccines, but spoke on behalf of himself and not in an official capacity.
He says while the vaccine will likely not be recommended for pregnant populations during its initial rollout, the CDC will be closely following and studying vaccine impacts on people who get vaccinated and then later find out they’re pregnant. He says there are three different federal reporting systems set up to collect potential data on vaccines and pregnancy.
“When you do these big trials in adults, you exclude people who are known to be pregnant, but there are invariably women who didn’t know they were pregnant at the time that they were inoculated,” Offit says. Both Pfizer and Moderna have conducted large-scale trials, Offit says, which means there are bound to be people who got pregnant during the course of the trial.
June guidance from the FDA recommended that pharmaceutical companies first conduct developmental and reproductive toxicity (DART) studies of their vaccine candidate before enrolling pregnant women or women who aren’t actively avoiding pregnancy in their trials.
Jerica Pitts, director of global media relations for Pfizer, said the company is following that guidance and conducting DART studies. Moderna didn’t respond to comment.
Advocates for pregnant and breastfeeding women are looking forward to seeing that data.
Rahul Gupta, chief medical and health officer at March of Dimes and a leading advocate for maternal and infant health, says the organization is recommending that health officials prioritize collecting and releasing data on the safety of the vaccines for pregnant and breastfeeding patients once a vaccine is available.
Pregnancy “is already a high-risk category. We have to keep that in mind,” he says.
In the meantime, pregnant people should consult their doctors for advice. The American College of Obstetricians and Gynecologists’s vice president of practice activities, Christopher Zahn, says the lack of data on pregnancy and the vaccine will need to lead conversations between pregnant patients and their doctors.
“Any decisions made should be based on any available data and recommendations for use in pregnancy, patients’ individual risk factors and the potential benefits, and their unique needs, desires and values,” Zahn says.
Without data available on the vaccines, Gupta says he doesn’t see doctors making recommendations that pregnant patients get vaccinated.
“This is one of the costs of rapid development of the vaccine,” he says.
However, he notes that doctors will also be able to provide individualized guidance on a case-by-case basis.
“We also shouldn’t look at pregnancy as a homogenous category,” he says, noting that health-care providers may have different recommendations for pregnant front-line health-care workers.
Both Turner and Topper say until more data is available, they will just continue to self-quarantine, mask up and practice social distancing.
“It just means prolonging the pain and means that we have to be more careful longer … I think it’s the right thing to do. But it does mean just extending this period of kind of isolation,” Topper says.
Turner, who will be strictly isolating with her husband in the two weeks leading up to her due date in June, says she wants her loved ones to know they can still support her, even in a prolonged quarantine.
“This is a time where pregnant and especially newly postpartum people need more support than they ever have. And there are lots of ways to extend that support that don’t necessarily involve coming to someone’s house and holding their baby.”