With Trial Data Still Limited, Pregnant Women Consider The COVID-19 Vaccine
Scientists and researchers have been talking about COVID-19 vaccines since last spring when the virus first surged through communities. But the timeline for development was really unknown.
“So it was there in my mind, but it wasn’t something I was counting on in terms of protection or timing with pregnancy,” said Samantha Morris.
Morris, who lives in Glastonbury, is about 37 weeks pregnant with her second child. In December, she was notified that she was eligible for a vaccine under phase 1A distribution due to her profession as a psychologist.
“Up until that point in my mind, I either wasn’t getting it while I was pregnant because I wouldn’t have access,” she said, “or I wasn’t going to do it because there wasn’t the data.”
Federal agencies and national organizations recommend that most adults get a COVID-19 vaccine when it’s their turn. That’s because large-scale trials have shown that the vaccines are safe and effective. But pregnant people were left out of these initial studies.
Acknowledging the lack of early safety and efficacy data for this population, the U.S. Food and Drug Administration and Centers for Disease Control and Prevention say that the vaccines should be offered to those who are pregnant but that final decisions should be made on an individual basis.
That has left pregnant and lactating patients with a less straightforward decision, one they said can be stressful and frustrating.
“Everything is so unclear,” Morris said. “Sometimes you just want someone to tell you what to do, just an expert to tell you what the recommendations are.”
Weighing the risks and benefits
Dr. Ilona Goldfarb, a high-risk obstetrician at Massachusetts General Hospital in Boston, and her colleagues are having these discussions with pregnant patients and their families multiple times a day to help them process unknown risks and the benefits of vaccination.
“Some patients are ready to go. They’re looking for this discussion with me, but they’re primed and ready, they want the vaccine,” said Goldfarb, who is the COVID-19 lead for the hospital’s OB/GYN department. “And other patients are really on the fence and they need more time, and we work through that time.”
She said there are also patients who won’t get it during pregnancy, who will instead elect to wait until the postpartum period, or even until after they’ve finished breastfeeding.
All these decisions are valid given the circumstances, Goldfarb said, as long as they’re informed ones made with the correct facts, information and personal considerations. Part of that involves going over the science behind an mRNA vaccine and emphasizing that it does not contain live virus.
“And we know that other vaccines given routinely during pregnancy that do not contain live virus, vaccines such as influenza vaccine, Tdap booster [whooping cough], are effective during pregnancy at creating the immune response that we want to protect the pregnant individual and the offspring,” Goldfarb said.
Formal clinical trials of COVID-19 vaccines in pregnant people and children are underway. In the meantime, medical experts say anecdotal evidence is promising.
During a White House media briefing earlier this month, Dr. Anthony Fauci said about 20,000 pregnant people have self-reported their vaccinations and any immediate reactions since mid-December through the CDC’s v-safe smartphone program.
“With no red flags, as we say,” Fauci added. “And this is being monitored by the CDC and the FDA.”
Dr. Audrey Merriam, a maternal-fetal medicine physician and associate professor of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, said those early findings make her hopeful.
And while everyone waits for more vaccine data to come in, Merriam said providers already know a lot about COVID-19 illness in pregnant patients. Yale and other institutions across the country have been studying health outcomes in infected patients since the beginning of the pandemic.
“And because of that, we were able to see by maybe late summer, early fall that pregnant individuals who were symptomatic with COVID-19 did have a more severe illness and a higher rate of mortality compared to our nonpregnant patients,” Merriam said.
Although these severe and deadly cases are still rare overall, Merriam said she has to present these possible and known risks to her patients.
“If it’s winding up in the ICU and separated from your family and potentially other children at home, or potentially an early delivery, and being intubated or having the breathing tube in, all those things in the case of severe infection versus getting the vaccine,” she said.
Health providers help their patients assess their individual risk for exposure to COVID-19 by factoring in someone’s living situation, community interactions and job responsibilities.
Goldfarb said some patients may work at home, live with a partner who also works at home, have no contact with children attending school and can stay in with minimal hardship.
“That patient might choose to wait, particularly if that patient is overwhelmingly concerned about the unknown [vaccine] risks,” she said.
Other patients may have jobs on the front lines, a partner who works outside the home, children attending school or other commitments that put them at a higher risk of exposure and illness.
“Somebody who it’s their first baby and works from home primarily now is at a different risk than one of my patients who has two kids but is also working in the medical field and seeing their own patients every day,” Merriam said.
Making an informed decision
Bianca Noroñas began factoring in all of these things when she was thinking about her own pregnancy. Noroñas lives in Meriden and is a case worker for pregnant and postpartum women, but she’s been able to work from home for several months.
“The first time that I heard that women can have the vaccine, but they don’t make the studies in this population, I was very concerned,” she said. “I was like, no, I’m not going to have the vaccine, [not] during breastfeeding, either.”
But Noroñas began doing more research in between working, caring for her 6-year-old daughter and studying for a master’s degree in public health.
She also consulted her certified nurse midwife, and saw national medical organizations like the American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine issue reassuring guidance on the vaccines.
“When I started to receive more information from different organizations that have good reputations in this topic, I started to normalize the vaccine,” Noroñas said. “It’s very important that the community receives the information so we can make a proper decision.”
Noroñas has chosen not to get a vaccine before her April due date, with the missing trial data being a key concern, but she has decided to get vaccinated soon after birth and while she is breastfeeding.
“And I know that vaccines are good in other situations with other diseases, so I have to trust the COVID-19 vaccine. That’s why I say yes, I’m going to try, but later,” she said. “Because we need to stop the pandemic, and the vaccines are right now the only tool we have.”
For Samantha Morris, her decision on whether to get a vaccine became clearer after talking with her obstetrician, especially about the risks of getting ill while pregnant.
“There was always this piece of me in the back of my mind that was worried for what would happen if I caught COVID,” she said, “or was thinking about this baby in terms of what would happen if I was really sick.”
Since then, Morris has gotten both doses of a COVID-19 vaccine and reported few to no side effects.
“I think the biggest thing is just for people to know that no matter what they decide, it’s the right choice for them,” she said. “There’s just too much unknown right now to say anything more.”
Current COVID-19 vaccine recommendations and guidelines for pregnant and lactating women can be found at the CDC, the American College of Obstetricians and Gynecologists, and the national Society for Maternal-Fetal Medicine, among other organizations.