Pregnant & Breastfeeding Women Who Get the COVID-19 Vaccine Are Protecting Their Infants, Research Suggests
Becky Cummings, who got vaccinated in December, snuggles her newborn, Clark, while he takes a nap.
Becky Cummings had multiple reasons to get vaccinated against COVID-19 while tending to her firstborn, Clark, who arrived in September 2020 at 27 weeks.
The 29-year-old intensive care unit nurse in Greensboro, North Carolina, had witnessed the devastation day in and day out as the virus took its toll on the young and old. But when she was offered the vaccine, she hesitated, skeptical of its rapid emergency use authorization.
Exclusion of pregnant and lactating mothers from clinical trials fueled her concerns. Ultimately, though, she concluded the benefits of vaccination outweighed the risks of contracting the potentially deadly virus.
"Long story short," Cummings says, in December "I got vaccinated to protect myself, my family, my patients, and the general public."
At the time, Cummings remained on the fence about breastfeeding, citing a lack of evidence to support its safety after vaccination, so she pumped and stashed breast milk in the freezer. Her son is adjusting to life as a preemie, requiring mother's milk to be thickened with formula, but she's becoming comfortable with the idea of breastfeeding as more research suggests it's safe.
"If I could pop him on the boob," she says, "I would do it in a heartbeat."
Now, a study recently published in the Journal of the American Medical Association found "robust secretion" of specific antibodies in the breast milk of mothers who received a COVID-19 vaccine, indicating a potentially protective effect against infection in their infants.
The presence of antibodies in the breast milk, detectable as early as two weeks after vaccination, lasted for six weeks after the second dose of the Pfizer-BioNTech vaccine.
"We believe antibody secretion into breast milk will persist for much longer than six weeks, but we first wanted to prove any secretion at all after vaccination," says Ilan Youngster, the study's corresponding author and head of pediatric infectious diseases at Shamir Medical Center in Zerifin, Israel.
That's why the research team performed a preliminary analysis at six weeks. "We are still collecting samples from participants and hope to soon be able to comment about the duration of secretion."
As with other respiratory illnesses, such as influenza and pertussis, secretion of antibodies in breast milk confers protection from infection in infants. The researchers expect a similar immune response from the COVID-19 vaccine and are expecting the findings to spur an increase in vaccine acceptance among pregnant and lactating women.
A COVID-19 outbreak struck three families the research team followed in the study, resulting in at least one non-breastfed sibling developing symptomatic infection; however, none of the breastfed babies became ill. "This is obviously not empirical proof," Youngster acknowledges, "but still a nice anecdote."
Leaps.org inquired whether infants who derive antibodies only through breast milk are likely to have a lower immunity than infants whose mothers were vaccinated while they were in utero. In other words, is maternal transmission of antibodies stronger during pregnancy than during breastfeeding, or about the same?
"This is a different kind of transmission," Youngster explains. "When a woman is infected or vaccinated during pregnancy, some antibodies will be transferred through the placenta to the baby's bloodstream and be present for several months." But in the nursing mother, that protection occurs through local action. "We always recommend breastfeeding whenever possible, and, in this case, it might have added benefits."
A study published online in March found COVID-19 vaccination provided pregnant and lactating women with robust immune responses comparable to those experienced by their nonpregnant counterparts. The study, appearing in the American Journal of Obstetrics and Gynecology, documented the presence of vaccine-generated antibodies in umbilical cord blood and breast milk after mothers had been vaccinated.
Natali Aziz, a maternal-fetal medicine specialist at Stanford University School of Medicine, notes that it's too early to draw firm conclusions about the reduction in COVID-19 infection rates among newborns of vaccinated mothers. Citing the two aforementioned research studies, she says it's biologically plausible that antibodies passed through the placenta and breast milk impart protective benefits. While thousands of pregnant and lactating women have been vaccinated against COVID-19, without incurring adverse outcomes, many are still wondering whether it's safe to breastfeed afterward.
It's important to bear in mind that pregnant women may develop more severe COVID-19 complications, which could lead to intubation or admittance to the intensive care unit. "We, in our practice, are supporting pregnant and breastfeeding patients to be vaccinated," says Aziz, who is also director of perinatal infectious diseases at Stanford Children's Health, which has been vaccinating new mothers and other hospitalized patients at discharge since late April.
Earlier in April, Huntington Hospital in Long Island, New York, began offering the COVID-19 vaccine to women after they gave birth. The hospital chose the one-shot Johnson & Johnson vaccine for postpartum patients, so they wouldn't need to return for a second shot while acclimating to life with a newborn, says Mitchell Kramer, chairman of obstetrics and gynecology.
The hospital suspended the program when the Food and Drug Administration and the Centers for Disease Control and Prevention paused use of the J&J vaccine starting April 13, while investigating several reports of dangerous blood clots and low platelet counts among more than 7 million people in the United States who had received that vaccine.
In lifting the pause April 23, the agencies announced the vaccine's fact sheets will bear a warning of the heightened risk for a rare but serious blood clot disorder among women under age 50. As a result, Kramer says, "we will likely not be using the J&J vaccine for our postpartum population."
So, would it make sense to vaccinate infants when one for them eventually becomes available, not just their mothers? "In general, most of the time, infants do not have as good of an immune response to vaccines," says Jonathan Temte, associate dean for public health and community engagement at the University of Wisconsin School of Medicine and Public Health in Madison.
"Many of our vaccines are held until children are six months of age. For example, the influenza vaccine starts at age six months, the measles vaccine typically starts one year of age, as do rubella and mumps. Immune response is typically not very good for viral illnesses in young infants under the age of six months."
So far, the FDA has granted emergency use authorization of the Pfizer-BioNTech vaccine for children as young as 16 years old. The agency is considering data from Pfizer to lower that age limit to 12. Studies are also underway in children under age 12. Meanwhile, data from Moderna on 12-to 17-year-olds and from Pfizer on 12- to 15-year-olds have not been made public. (Pfizer announced at the end of March that its vaccine is 100 percent effective in preventing COVID-19 in the latter age group, and FDA authorization for this population is expected soon.)
"There will be step-wise progression to younger children, with infants and toddlers being the last ones tested," says James Campbell, a pediatric infectious diseases physician and head of maternal and child clinical studies at the University of Maryland School of Medicine Center for Vaccine Development.
"Once the data are analyzed for safety, tolerability, optimal dose and regimen, and immune responses," he adds, "they could be authorized and recommended and made available to American children." The data on younger children are not expected until the end of this year, with regulatory authorization possible in early 2022.
For now, Vonnie Cesar, a family nurse practitioner in Smyrna, Georgia, is aiming to persuade expectant and new mothers to get vaccinated. She has observed that patients in metro Atlanta seem more inclined than their rural counterparts.
To quell some of their skepticism and fears, Cesar, who also teaches nursing students, conceived a visual way to demonstrate the novel mechanism behind the COVID-19 vaccine technology. Holding a palm-size physical therapy ball outfitted with clear-colored push pins, she simulates the spiked protein of the coronavirus. Slime slathered at the gaps permeates areas around the spikes—a process similar to how our antibodies build immunity to the virus.
These conversations often lead hesitant patients to discuss vaccination with their husbands or partners. "The majority of people I'm speaking with," she says, "are coming to the conclusion that this is the right thing for me, this is the common good, and they want to make sure that they're here for their children."
CORRECTION: An earlier version of this article mistakenly stated that the COVID-19 vaccines were granted emergency "approval." They have been granted emergency use authorization, not full FDA approval. We regret the error.
Technology is Redefining the Age of 'Older Mothers'
Scientists are working on technologies that would enable more 70-year-old women to have babies.
In October 2021, a woman from Gujarat, India, stunned the world when it was revealed she had her first child through in vitro fertilization (IVF) at age 70. She had actually been preceded by a compatriot of hers who, two years before, gave birth to twins at the age of 73, again with the help of IVF treatment. The oldest known mother to conceive naturally lived in the UK; in 1997, Dawn Brooke conceived a son at age 59.
These women may seem extreme outliers, almost freaks of nature; in the US, for example, the average age of first-time mothers is 26. A few decades from now, though, the sight of 70-year-old first-time mothers may not even raise eyebrows, say futurists.
“We could absolutely have more 70-year-old mothers because we are learning how to regulate the aging process better,” says Andrew Hessel, a microbiologist and geneticist, who cowrote "The Genesis Machine," a book about “rewriting life in the age of synthetic biology,” with Amy Webb, the futurist who recently wondered why 70-year-old women shouldn’t give birth.
Technically, we're already doing this, says Hessel, pointing to a technique known as in vitro gametogenesis (IVG). IVG refers to turning adult cells into sperm or egg cells. “You can think of it as the upgrade to IVF,” Hessel says. These vanguard stem cell research technologies can take even skin cells and turn them into induced pluripotent stem cells (iPSCs), which are basically master cells capable of maturing into any human cell, be it kidney cells, liver cells, brain cells or gametes, aka eggs and sperm, says Henry T. “Hank” Greely, a Stanford law professor who specializes in ethical, legal, and social issues in biosciences.
Mothers over 70 will be a minor blip, statistically speaking, Greely predicts.
In 2016, Greely wrote "The End of Sex," a book in which he described the science of making gametes out of iPSCs in detail. Greely says science will indeed enable us to see 70-year-old new mums fraternize with mothers several decades younger at kindergartens in the (not far) future. And it won’t be that big of a deal.
“An awful lot of children all around the world have been raised by grandmothers for millennia. To have 70-year-olds and 30-year-olds mingling in maternal roles is not new,” he says. That said, he doubts that many women will want to have a baby in the eighth decade of their life, even if science allows it. “Having a baby and raising a child is hard work. Even if 1% of all mothers are over 65, they aren’t going to change the world,” Greely says. Mothers over 70 will be a minor blip, statistically speaking, he predicts. But one thing is certain: the technology is here.
And more technologies for the same purpose could be on the way. In March 2021, researchers from Monash University in Melbourne, Australia, published research in Nature, where they successfully reprogrammed skin cells into a three-dimensional cellular structure that was morphologically and molecularly similar to a human embryo–the iBlastoid. In compliance with Australian law and international guidelines referencing the “primitive streak rule," which bans the use of embryos older than 14 days in scientific research, Monash scientists stopped growing their iBlastoids in vitro on day 11.
“The research was both cutting-edge and controversial, because it essentially created a new human life, not for the purpose of a patient who's wanting to conceive, but for basic research,” says Lindsay Wu, a senior lecturer in the School of Medical Sciences at the University of New South Wales (UNSW), in Kensington, Australia. If you really want to make sure what you are breeding is an embryo, you need to let it develop into a viable baby. “This is the real proof in the pudding,'' says Wu, who runs UNSW’s Laboratory for Ageing Research. Then you get to a stage where you decide for ethical purposes you have to abort it. “Fiddling here a bit too much?” he asks. Wu believes there are other approaches to tackling declining fertility due to older age that are less morally troubling.
He is actually working on them. Why would it be that women, who are at peak physical health in almost every other regard, in their mid- to late- thirties, have problems conceiving, asked Wu and his team in a research paper published in 2020 in Cell Reports. The simple answer is the egg cell. An average girl in puberty has between 300,000 and 400,000 eggs, while at around age 37, the same woman has only 25,000 eggs left. Things only go downhill from there. So, what torments the egg cells?
The UNSW team found that the levels of key molecules called NAD+ precursors, which are essential to the metabolism and genome stability of egg cells, decline with age. The team proceeded to add these vitamin-like substances back into the drinking water of reproductively aged, infertile lab mice, which then had babies.
“It's an important proof of concept,” says Wu. He is investigating how safe it is to replicate the experiment with humans in two ongoing studies. The ultimate goal is to restore the quality of egg cells that are left in patients in their late 30s and early- to mid-40s, says Wu. He sees the goal of getting pregnant for this age group as less ethically troubling, compared to 70-year-olds.
But what is ethical, anyway? “It is a tricky word,” says Hessel. He differentiates between ethics, which represent a personal position and may, thus, be more transient, and morality, longer lasting principles embraced across society such as, “Thou shalt not kill.” Unprecedented advances often bring out fear and antagonism until time passes and they just become…ordinary. When IVF pioneer Landrum Shettles tried to perform IVF in 1973, the chairman of Columbia’s College of Physicians and Surgeons interdicted the procedure at the last moment. Almost all countries in the world have IVF clinics today, and the global IVF services market is clearly a growth industry.
Besides, you don’t have a baby at 70 by accident: you really want it, Greely and Hessel agree. And by that age, mothers may be wiser and more financially secure, Hessel says (though he is quick to add that even the pregnancy of his own wife, who had her child at 40, was a high-risk one).
As a research question, figuring out whether older mothers are better than younger ones and vice-versa entails too many confounding variables, says Greely. And why should we focus on who’s the better mother anyway? “We've had 70-year-old and 80-year-old fathers forever–why should people have that much trouble getting used to mothers doing the same?” Greely wonders. For some women having a child at an old(er) age would be comforting; maybe that’s what matters.
And the technology to enable older women to have children is already here or coming very soon. That, perhaps, matters even more. Researchers have already created mice–and their offspring–entirely from scratch in the lab. “Doing this to produce human eggs is similar," says Hessel. "It is harder to collect tissues, and the inducing cocktails are different, but steady advances are being made." He predicts that the demand for fertility treatments will keep financing research and development in the area. He says that big leaps will be made if ethical concerns don’t block them: it is not far-fetched to believe that the first baby produced from lab-grown eggs will be born within the next decade.
In an op-ed in 2020 with Stat, Greely argued that we’ve already overcome the technical barrier for human cloning, but no one's really talking about it. Likewise, scientists are also working on enabling 70-year-old women to have babies, says Hessel, but most commentators are keeping really quiet about it. At least so far.
New Cell Therapies Give Hope to Diabetes Patients
Researchers are developing new cell therapies that could cure Type 1 diabetes and make constant management of the disease a way of the past.
For nearly four decades, George Huntley has thought constantly about his diabetes. Diagnosed in 1983 with Type 1 (insulin-dependent) diabetes, Huntley began managing his condition with daily finger sticks to check his blood glucose levels and doses of insulin that he injected into his abdomen. Even now, with an insulin pump and a device that continuously monitors his glucose, he must consider how every meal will affect his blood sugar, checking his monitor multiple times each hour.
Like many of those who depend on insulin injections, Huntley is simultaneously grateful for the technology that makes his condition easier to manage and tired of thinking about diabetes. If he could wave a magic wand, he says, he would make his diabetes disappear. So when he read about biotechs like ViaCyte and Vertex Pharmaceuticals developing new cell therapies that have the potential to cure Type 1 diabetes, Huntley was excited.
You also won’t see him signing up any time soon. The therapies under development by both companies would require a lifelong regimen of drugs for suppressing the immune system to prevent the body from rejecting the foreign cells. It’s a problem also seen in the transplant of insulin-producing cells of the pancreas – called islet cells – from deceased donors. To Howard Foyt, chief medical officer at ViaCyte, a San Diego-based biotech specializing in the development of cell therapies for diabetes, the tradeoff is worth it.
“A lot of the symptoms of diabetes are not something that you wear on your arm, so to speak. You’re not necessarily conscious of them until you’re successfully treated, and you feel better,” Foyt says.
For many with diabetes, managing these symptoms is a constant game of Whack-a-Mole. “Any form of treatment that gets someone closer to feeling good is a victory,” he says.
“Am I going to be trading diabetes for cancer? That’s not a chance I
want to take."
But not everyone is convinced. What’s more, it’s likely that the availability of these cell therapies will be limited to those with life-threatening diabetes symptoms, such as hypoglycemia unawareness. To Huntley, these therapies remain a bit of a Faustian bargain.
“Am I going to be trading diabetes for cancer? That’s not a chance I want to take,” he says.
The discovery of insulin in 1921 transformed Type 1 diabetes from a death sentence into a potentially manageable condition. Even as better versions of insulin hit the market—ones that weren’t derived from pigs and wouldn’t provoke an allergic response, longer-acting insulin, insulin pens—they didn’t change the reality that those with Type 1 diabetes remained dependent on insulin. Even the most advanced continuous glucose monitors (which tests blood sugar levels every few minutes, 24/7) and insulin pumps don’t perform as well as a healthy pancreas.
Whether by injection or pump, someone with diabetes needs to administer the insulin their body no longer makes. With advances in organ transplantation, the concept of transplanting insulin-producing pancreatic beta cells seemed obvious. After more than a decade of painstaking work, James Shapiro, who directs the Islet Transplant Program at the University of Albania, honed a process called the Edmonton Protocol for pancreas transplants. For a few patients who couldn’t control their blood sugars any other way, the Edmonton Protocol became a life saver. Some of these patients were even able to stop insulin completely, Shapiro says. But the high cost of organ transplant and a chronic shortage of donor organs, pancreas or otherwise, meant that only a small handful of patients could benefit.
Stem cells, however, can be grown in vats, meaning that supply would never be an issue. “We would be going from a very successful treatment of today to a potential cure tomorrow,” Shapiro says.
In 2014, spurred by his own children’s diagnoses with Type 1 Diabetes, stem cell biologist Doug Melton of Harvard University figured out a way to differentiate embryonic stem cells into functional pancreatic beta cells. It was a long process, explains immunoengineer Alice Tomei at the University of Miami, because “the islet is not one cell, it's like a mini-organ that has its own needs.”
Add on the risk of rejection and autoimmunity, and Tomei says that scientists soon realized that chronic and systemic immunosuppression was the only way forward. Over the next several years, Melton improved his approach to yield more cells with fewer impurities. Melton partnered with Boston-based Vertex Pharmaceuticals to create a cell therapy called VX-880.
The first patient received his dose earlier in 2021. In October, Vertex released 90-day results from the Phase 1/2 trial, which revealed the patient was able to reduce his insulin usage from an average of 34 units per day to just 2.9 units per day. The tradeoff is a lifelong need for immunosuppressive drugs to prevent the body from attacking both foreign cells and pancreatic beta cells. It’s what recipients of ViaCyte’s first-gen PEC-Direct will also need. For Foyt, it’s an easy choice.
“At this point in time, immunosuppression is the necessary evil,” he says. “For parents, would you like to worry about going into your child’s bedroom every morning and not knowing if they’re going to be alive or dead? It’s uncommon, but it does occur.”
Not everyone, however, finds the trade-off easy to swallow. Especially with COVID-19 cases reaching record highs, the prospect of reducing his immune function at a time when he needs it most doesn’t sit well with Huntley. The risks of immunosuppression also mean that diabetes cell therapies are limited to those patients with life-threatening complications.
It’s why ViaCyte has created two new iterations of cellular therapies that would eliminate this need. The ViaCyte-Encap contains the cells in a permeable container that allows oxygen, insulin, and nutrients to flow freely but prevents immune system access. Their latest model, PEC-QT, just began safety trials with Shapiro’s lab at the University of Alberta and uses gene editing to eliminate any cellular markers that would trigger an immune response.
Sanjoy Dutta, vice president of research at JDRF International, a nonprofit that funds the study of diabetes, is thrilled with the progress that’s been made around cell therapies, but he cautions it’s still early days. “We have proven that these cells can be made. What we haven’t seen is are they going to work for six months, two years, five years? It’s a challenge we still need to overcome,” he says.
Iowa social worker Jodi Lynn’s concerns echo Dutta’s. Lynn was diagnosed with diabetes in 1998 at age 14 after a bout of severe influenza, spends each day inventorying supplies, planning her food intake, and maintaining her insulin pump and glucose monitor. These newer technologies dramatically improved her blood sugar control but, like everyone with diabetes, Lynn remains at high risk for complications, such as diabetic ketoacidosis, heart disease, vision loss, and kidney failure. Lynn, already considered immunocompromised due to medications she takes for another autoimmune condition, is less concerned with immune suppression than the untested nature of these therapies.
“I want to know that they will work long-term,” she says.