Update on Feb. 8, 2021:
On February 3, 2021, White House health advisor Dr. Anthony Fauci said that at least 10,000 pregnant women, mostly healthcare workers, had received the Pfizer or Moderna COVID vaccines so far, with “no red flags” to report. “The FDA, as part of the typical follow-up you have following the initial issuing of any emergency use authorization, have found, thus far—and we’ve got to be careful—but thus far, no red flags about pregnant women,” he told the editor-in-chief of the Journal of the American Medical Association.
It’s been a whirlwind few months for researchers working furiously on COVID vaccines, and for the frontline healthcare workers who were, in many places, first in line to suddenly receive them in the days just before Christmas. But there’s one group that has struggled with mixed messages and unclear guidance about COVID vaccine safety: anyone who’s pregnant, planning to be pregnant soon, or breastfeeding. For healthcare workers who are also nursing moms, or for young people of childbearing age who work high-risk jobs but are hoping to conceive in the near future, the lack of clear answers around COVID vaccination during pregnancy and breastfeeding has been frustrating.
Public health authorities and advisory groups in different countries have weighed the risks and benefits and communicated their guidance about vaccine safety for pregnant women differently: In the UK, health officials decided that without detailed information on safety, they are not comfortable with pregnant people being vaccinated at all. In the US, the Centers for Disease Control and Prevention (CDC) decided that American women should get to choose for themselves, after discussing the benefits and the risks with their doctors, and the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal and Fetal Medicine strongly agreed. Meanwhile, the World Health Organization issued guidance for pregnant women that they swiftly changed a day later, after an outcry from women’s health advocates.
In fact, many women’s health advocates are arguing that it is actually unethical to exclude or prohibit pregnant people from getting a vaccine, since pregnant people are at higher risk of severe disease and hospitalization if they do get COVID-19. (The CDC reported that in a study of 23,000 pregnant women with symptomatic COVID, pregnant women were about three times more likely to need ICU care or a ventilator.) The known, well-documented side effects and poor outcomes for pregnant people with COVID are a greater risk than the unknown, still-hypothetical side effects of a vaccine.
In Canada, the National Advisory Committee on Immunizations (NACI) initially declared that the “COVID-19 vaccine should not be offered to populations excluded from clinical trials until further evidence is available,” which led to headlines saying it wasn’t recommended here. However, their official statement goes on to say that it’s really all about doing a risk assessment for each person. A COVID vaccine may be offered if the “benefits of vaccine outweigh the potential risks for the individual.” Clear as mud, right?
On December 21, The Society of Obstetricians and Gynaecologists of Canada (SOGC) issued their statement for pregnant and breastfeeding Canadians: “For individuals who are at high risk of infection and/or morbidity from COVID-19, it is the SOGC’s position that the documented risk of not getting the COVID-19 vaccine outweighs the theorized and undescribed risk of being vaccinated during pregnancy or while breastfeeding and vaccination should be offered.”
By January 6, they had updated their stance to be more definitive: “All provincial governments should grant access to the COVID-19 vaccine to pregnant and lactating individuals as a means to protect both mother and baby from the virus,” the SOGC press release states.
“Based on what we know so far, the risks of serious complications, for both mother and her baby, are greater if she develops COVID-19 during pregnancy,” Jennifer Blake, the SOGC CEO, said in a statement. “The benefits of getting vaccinated for individuals at higher risk during pregnancy or while breastfeeding outweighs the risks of not receiving the vaccine.”
Examples of being high-risk—or situations where the risk of COVID infection is “considerable”—include healthcare workers, frontline workers, those who live in Indigenous communities, anyone living in a setting with an outbreak, and pregnant people with “underlying comorbidities” such as obesity, maternal age, respiratory diseases or autoimmune conditions, all of which could make you more vulnerable to COVID-19.
“A lot of different bodies have made recommendations that are somewhat different, but we’re all working with the same information—or lack of information,” says OB/GYN Vanessa Poliquin, who specializes in reproductive infectious diseases and is the co-chair of the SOGC’s Infectious Diseases Committee. She’s also an assistant professor at the Max Rady College of Medicine, University of Manitoba.
In a panel on vaccine safety for the Ontario Medical Association (OMA), Mariam Hanna, an immunotherapist and paediatric allergist, said that unfortunately, this lack of data is often the case for pregnant women.
“We don’t have enough absolute, real-world data, and that’s not unusual, I hate to say it, when it comes to pregnant women,” says Hanna. “So it’s about the risks of what we don’t know versus the risks of what we do know. And this is where shared decision-making with a patient and care provider comes to the forefront.”
Simply put, pregnant people and lactating people were not included in any of the vaccine clinical trials out of caution, which means we don’t have much safety data to go on. But there are several important things we do know:
Fortunately, we do know a lot about vaccinations during pregnancy, in general.
While we don’t have a ton of great safety-during-pregnancy data for the Pfizer-BioNTech COVID-19 vaccine and the newly-approved Moderna vaccine, we do know a lot about other similar vaccines. We know that the flu shot is safe during pregnancy, and ever since 2018, the pertussis (whooping cough) inoculation has been recommended for pregnant people in Canada, too. “We have several decades of information now about flu vaccines and the safety for pregnant woman,” says Deshayne Fell, an associate professor of epidemiology at the University of Ottawa who specializes in the safety and effectiveness of maternal immunization, as well as short- and long-term outcomes of infants and perinatal exposures (meaning before and after birth).
The COVID vaccines are not live vaccines.
The COVID-19 vaccines do not contain live virus, explains Poliquin. “We try to avoid live vaccines in pregnancy, and this is not a live vaccine—it won’t ‘give you COVID,’” says Poliquin. “It also doesn’t alter our DNA or change your baby’s DNA.”
She explains that it’s what’s called a mRNA vaccine, which stands for messenger RNA. “MRNA is like the language our cells need to make the proteins we need,” says Poliquin. “With the vaccine, it’s like we’re sending a little message to our cells that teaches your body and your cells how to make a spike protein, how to put it on the surface of cells where it will be recognized as foreign, and to drive the immune system to mount a response against the spike protein.” This mRNA never enters the nucleus of a cell, so it can’t interact with a mom’s DNA or a fetus’s DNA.
The American Society for Reproductive Medicine, which has a COVID-19 Task Force, words their clinical recommendations this way: “Because COVID-19 mRNA vaccines are not composed of live virus, they are not thought to cause an increased risk of infertility, first or second trimester loss, stillbirth or congenital abnormalities. […] Since the vaccine is not a live virus, there is no reason to delay pregnancy attempts because of vaccine administration. Patients undergoing fertility treatments and pregnant patients should be encouraged to receive vaccination based on eligibility criteria.”
This type of vaccine technology has actually been under development with researchers worldwide for a lot longer than the COVID-19 epidemic.
It’s important to remember that this “vaccine technology” didn’t just suddenly emerge this year, says Poliquin. “It’s been built upon for years with other viruses, building on existing mRNA technology that had already been under development.” She says that some of the existing research and work for the Zika vaccine (remember Zika?) is what developed the same mRNA technology, or platform, and that expedited research doesn’t mean it was rushed or that crucial steps were skipped. “This is just the first time it’s been brought to fruition in a marketable vaccine,” says Poliquin.
(The Oxford AstraZeneca vaccine in development isn’t an mRNA vaccine, but it uses the same technology or platform that’s in the Ebola vaccine, which has already been administered to pregnant and lactating people.)
Fell adds that although the first two vaccines approved show promise, “remember that we’re going to have other products become available as time goes on. While it’s unfortunate that pregnant people weren’t included in the initial clinical trials, I think‚ and I’m hoping, that the process from here on out will be more expedited.”
Some people who got the vaccine in the initial clinical trials got pregnant inadvertently, and are OK so far.
In the Pfizer BioNtech trials, 23 people of the 44,000 participants got pregnant, even though they weren’t supposed to. (All participants had to have a negative pregnancy test before enrolling.) Only 12 of the pregnant people received the actual vaccine—the other 11 pregnant participants got a placebo saline shot—and no one reported an adverse event or miscarriage. (None of the participants have delivered their babies yet.)
Remember that as more and more people get vaccinated, and additional vaccines move through clinical trials, there will be more data accumulated along the way, says Poliquin. “Some pregnancies will happen. That will help to bolster information and be a really important source of safety data moving forward.”
Is it better to be vaccinated before trying to conceive, during pregnancy, or when you’re breastfeeding?
The short answer is, we don’t know yet. But the American Society for Reproductive Medicine COVID-19 Task Force “does not recommend withholding the vaccine from patients who are planning to conceive, who are currently pregnant, or who are lactating.”
There’s a high likelihood that COVID vaccines administered during pregnancy could be more effective than vaccines administered to breastfeeding moms. Babies get “a more robust passive protection through the placenta than they would through breastmilk,” explains Fell.
“We do know that if you vaccinate a pregnant woman for pertussis and influenza during pregnancy, usually in the second or early third trimester, there are antibodies passed through the placenta, and the baby is born with protection on board,” says Poliquin. Those babies are at lower risk of flu and pertussis (whooping cough) for the first couple months of their lives, until they can start their own inoculation schedule around two months old. “But it remains to be seen whether we’re going to see a similar response for the COVID vaccine,” she explains.
A study that came out in November 2020 suggested that nursing moms who had beaten COVID infections did pass antibodies to their babies through their breast milk, but we don’t yet know for sure how much passive protection a baby in utero would get from a mother who receives a COVID vaccine, versus fighting off a COVID infection while pregnant.
A reassuring statement from the Academy of Breastfeeding Medicine (an organization of doctors who study breastfeeding) concluded that there is “little plausible risk for the child,” and a “biologically plausible benefit. Antibodies and T-cells stimulated by the vaccine may passively transfer into milk.” With vaccinations against other viruses, IgA antibodies are detectable in milk within five to seven days, which lead them to conclude that the same may happen with COVID-19.
We should get more data in the months to come: Many lactating healthcare workers who already received a COVID vaccine are pumping milk samples and signing up for new studies that are tracking any side effects and analyzing breast milk at various time points post-vaccination.
If you’re not a frontline health-care worker, you probably won’t have access to the vaccine in Canada for many more months anyway.
For many young parents of childbearing age, you may not be eligible for a vaccine for many more months anyway. (Unless you’re in a high-risk priority group, like living in an Indigenous community or working in healthcare.) It’s great to do your research in the meantime, of course—but the fact is, you really won’t have to make any big decisions right away. It’s more of a wait and see situation.
“Truthfully, it’ll be different from jurisdiction to jurisdiction, and what the supply chains are like,” says Poliquin. “But with every day that goes by, we will learn a little bit more. And even in weeks, potentially, and in months and in years, we will have accrued more information that’s relevant to pregnant women and breastfeeding moms.”
Vaccine trials in pregnant women, and in kids over age 12, are underway, or scheduled to begin in the new year.
“There’s now a lot of momentum around designing separate studies for pregnant women,” says Fell. “The other thing that’s happening in real time, in addition to the highly controlled clinical studies and healthcare workers getting vaccinated, is that there are 300 million people getting the vaccine in India already. In two months’ time, I think we’ll have a lot more information.”
Public health experts (and headline watchers) are also keeping an eye on what’s called DART studies, which stands for developmental and reproductive toxicology. Essentially, these studies use animal testing to look at drug exposure risks, fetal abnormalities and developmental effects with future offspring to determine whether a new drug is safe for pregnant women, infants and young children. (A Moderna DART study that came out in early December did not raise any red flags.)
Many of us are impatient for a faster vaccine rollout and eager for an end to the pandemic, but the silver lining is that by the time COVID vaccines are actually being offered to the majority of Canadian women in their 20s, 30s and 40s, we are likely to know a lot more about their safety.
No one can say when unvaccinated young parents with unvaccinated little kids can reunite with vaccinated grandparents.
If you’re a new mom, or will be welcoming a baby in 2021, you’re probably wondering if vaccinations will allow families that have been separated to reunite sometime in the next six to nine months. It’s reasonable for exhausted young parents to wonder if Grandma will be able to help with the new baby, especially if she receives a COVID vaccination many months before most healthy Canadian adults do.
Poliquin is sympathetic, but says there are no clear timelines yet.
“When will the vaccine be available?’ is obviously one of the top questions I get from my pregnant patients,” she says. “I think the logistics are going to be different for everyone, depending on your job and where you work, where you live, and your age.”
“There’s a lot of moving pieces that need to settle, and unfortunately, we can’t really predict when all of this is going to settle back to normal. People are really grieving that loss of control and I wish I could provide that for my patients, but I can’t.”
With time, we should know more about the vaccine rollout, and we’ll see how much the vaccinations improve our infection rates, and then, in turn, impact our local lockdown rules. But until then, we should continue to follow the public health guidance where we live: follow your city’s rules for bubbles, indoor and outdoor gatherings, and not mixing households, says Fell.
For those who are struggling to cope as the pandemic drags on, Poliquin counsels young parents to consider their mental health and support systems, as well.
“It’s not that you’re not allowed to ask for support at all during COVID lockdowns, especially when it comes to child care and your mental health. I think that childcare is looked at differently than a social visit,” says Poliquin.
“I will say it takes a special kind of courage to grow your family and bring a new life into the world during a pandemic—so my heart and my sympathy go out to everybody. And I encourage everyone to tap into that special kind of strength we all need to use right now.”
This story was originally published on Dec. 27, 2020.