Pregnant & Breastfeeding Women Who Get the COVID-19 Vaccine Are Protecting Their Infants, Research Suggests
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.
Your Genetic Data Is The New Oil. These Startups Will Pay to Rent It.
Perhaps you're one of the 12 million people who has spit into a tube in recent years to learn the secrets in your genetic code, like your ancestry, your health risks, or your carrier status for certain diseases. If you haven't participated in direct-to-consumer genetic testing, you may know someone who has.
It's for people who want more control over their genetic data--plus a share of the proceeds when and if that data is used.
Mountains of genomic data have been piling up steeply over the last several years, but according to some experts, not enough research and drug discovery is being done with the data collected, and customers rarely have a say in how their data is used. Now, a slew of ambitious startup companies are bringing together the best of blockchain technology and human genomics to help solve these problems.
But First, Why Is Your Genome So Valuable?
Access to genetic information is an obvious boon to scientific and medical progress. In the right hands, it has the potential to save lives and reduce suffering — by facilitating the development of better, safer, more targeted treatments and by shedding light on the role of genetics in countless diseases and medical conditions.
Research requiring access to direct-to-consumer (DTC) genomic data is already well underway. For example, 23andMe, the popular California-based DTC genetic testing company, has published 107 research articles so far, as of this May, using data from their five million-plus customers around the world. Their website states that, on average, of the 80 percent of their customers who have opted to share their genomic data for research purposes, each "individual contributes to 200 different research studies."
And this July, a new collaboration was announced between 23andMe and GlaxoSmithKline, the London-based pharmaceutical company. GlaxoSmithKline will be using data from 23andMe customers to develop new medical treatments, while 23andMe will receive $300 million from the four-year deal. Both companies are poised to profit significantly from their union.
Should 23andMe's customers share in the gains? Peter Pitts, president of the Center for Medicine in the Public Interest, believes they should. "Are they going to offer rebates to people who opt in, so their customers aren't paying for the privilege of 23andMe working with a for-profit company in a for-profit research project?" Pitts told NBC. So far, 23andMe has not announced any plans to share profits with their customers.
But outside of such major partnerships, many researchers are frustrated by the missed opportunities to dig deeper into the correlations between genetics and disease. That's because people's de-identified genomic information is "essentially lying fallow," siloed behind significant security blockades in the interest of preserving their anonymity. So how can both researchers and consumers come out ahead?
Putting Consumers Back in Control
For people who want more control over their genetic data -- plus a share of the proceeds when and if that data is used -- a few companies have paired consumer genomics with blockchain technology to form a new field called "blockchain genomics." Blockchain is a data storage technology that relies on a network of computers, or peer-to-peer setup, making it incredibly difficult to hack. "It's a closed loop of transactions that gets protected and encrypted, and it cannot be changed," says Tanya Woods, a blockchain thought leader and founder of Kind Village, a social impact technology platform.
The vision is to incentivize consumers to share their genomic data and empower researchers to make new breakthroughs.
"So if I agree to give you something and you agree to accept it, we make that exchange, and then that basic framework is captured in a block. … Anything that can be exchanged can be ledgered on blockchain. Anything. It could be real estate, it could be the transfer of artwork, it could be the purchase of a song or any digital content, it could be recognition of a certification," and so on.
The blockchain genomics companies' vision is to incentivize consumers to share their genomic data and empower researchers to make new breakthroughs, all while keeping the data secure and the identities of consumers anonymous.
Consumers, or "partners" as these companies call them, will have a direct say regarding which individuals or organizations can "rent" their data, and will be able to negotiate the amount they receive in exchange. But instead of fiat currency (aka "regular money") as payment, partners will either be remunerated in cryptocurrency unique to the specific company or they will be provided with individual shares of ownership in the database for contributing DNA data and other medical information.
Luna DNA, one of the blockchain genomics companies, "will allow any credible researcher or non-profit to access the databases for a nominal fee," says its president and co-founder, Dawn Barry. Luna DNA's infrastructure was designed to embrace certain conceptions of privacy and privacy law "in which individuals are in total control of their data, including the ability to have their data be 'forgotten' at any time," she said. This is nearly impossible to implement in pre-existing systems that were not designed with full control by the individual in mind.
One of the legal instruments to which Barry referred was the European Union's General Data Protection Regulation, which "states that the data collected on an individual is owned and should be controlled by that individual," she explained. Another is the California Privacy Act that echoes similar principles. "There is a global trend towards more control by the individual that has very deep implications to companies and sites that collect and aggregate data."
David Koepsell, CEO and co-founder of EncrypGen, told Forbes that "Most people are not aware that your DNA contains information about your life expectancy, your proclivity to depression or schizophrenia, your complete ethnic ancestry, your expected intelligence, maybe even your political inclinations" — information that could be misused by insurance companies and employers. And though DTC customers have been assured that their data will stay anonymous, some data can be linked back to consumers' identities. Blockchain may be the answer to these concerns.
Both blockchain technology and the DTC genetic testing arena have a glaring diversity problem.
"The security that's provided by blockchain is tremendous," Woods says. "It's a significant improvement … and as we move toward more digitized economies around the world, these kinds of solutions that are providing security, validity, trust — they're very important."
In the case of blockchain genomics companies like EncrypGen, Luna DNA, Longenesis, and Zenome, each partner who joins would bring a digital copy of their genetic readout from DTC testing companies (like 23andMe or AncestryDNA). The blockchain technology would then be used to record how and for what purposes researchers interact with it. (To learn more about blockchain, check out this helpful visual guide by Reuters.)
Obstacles in the Path to Success
The cryptocurrency approach as a method of payment could be an unattractive lure to consumers if only a limited number of people make transactions in a given currency's network. And the decade-old technology underlying it -- blockchain -- is not yet widely supported, or even well-understood, by the public at large.
"People conflate blockchain with cryptocurrency and bitcoin and all of the concerns and uncertainty thereof," Barry told us. "One can think of cryptocurrency as a single expression of the vast possibilities of the blockchain technology. Blockchain is straightforward in concept and arcane in its implementation."
But blockchain, with its Gini coefficient of 0.98, is one of the most unequal "playing fields" around. The Gini coefficient is a measure of economic inequality, where 0 represents perfect equality and 1 represents perfect inequality. Around 90 percent of bitcoin users, for example, are male, white or Asian, between the ages of 18 and 34, straight, and from middle and upper class families.
The DTC genetic testing arena, too, has a glaring diversity problem. Most DTC genetic test consumers, just like most genetic study participants, are of European descent. In the case of genetic studies, this disparity is largely explained by the fact that most research is done in Europe and North America. In addition to being over 85 percent white, individuals who purchase DTC genetic testing kits are highly educated (about half have more than a college degree), well off (43 percent have a household income of $100,000 or more per year), and are politically liberal (almost 65 percent). Only 14.5 percent of DTC genetic test consumers are non-white, and a mere 5 percent are Hispanic.
Since risk of genetic diseases often varies greatly between ethnic groups, results from DTC tests can be less accurate and less specific for those of non-European ancestry — simply due to a lack of diverse data. The bigger the genetic database, wrote Sarah Zhang for The Atlantic, the more insights 23andMe and other DTC companies "can glean from DNA. That, in turn, means the more [they] can tell customers about their ancestry and health…" Though efforts at recruiting non-white participants have been ongoing, and some successes have been made at improving ancestry tools for people of color, the benefits of genomic gathering in North America are still largely reaped by Caucasians.
So far, it's not yet clear who or how many people will choose to partake in the offerings of blockchain genomics companies.
So one chief hurdle for the blockchain genomics companies is getting the technology into the hands of those who are under-represented in both blockchain and genetic testing research. Women, in particular, may be difficult to bring on board the blockchain genomics bandwagon — though not from lack of interest. Although women make up a significant portion of DTC genetic testing customers (between 50 and 60 percent), their presence is lacking in blockchain and the biotech industry in general.
At the North American Bitcoin Conference in Miami earlier this year, only three women were on stage, compared to 84 men. And the after-party was held in a strip club.
"I was at that conference," Woods told us. "I don't know what happened at the strip club, I didn't observe it. That's not to say it didn't happen … but I enjoyed being at the conference and I enjoyed learning from people who are experimenting in the space and developing in it. Generally, would I have loved to see more women visible? Of course. In tech generally I want to see more women visible, but there's a whole ecosystem shifting that has to happen to make that possible."
Luna's goal is to achieve equal access to a technology (blockchain genomics) that could potentially improve health and quality of life for all involved. But in the merging of two fields that have been unequal since their inception, achieving equal access is one tall order indeed. So far, it's not yet clear who or how many people will choose to participate. LunaDNA's platform has not yet launched; EncrypGen released their beta version just last month.
Sharon Terry, president and CEO of Genetic Alliance — a nonprofit organization that advocates for access to quality genetic services — recently shared a message that reflects the zeitgeist for all those entering the blockchain genomics space: "Be authentic. Tell the truth, even about motives and profits. Be transparent. Engage us. Don't leave us out. Make this real collaboration. Be bold. Take risks. People are dying. It's time to march forward and make a difference."
Genital Transplants: Is Science Going Too Far, Too Fast?
Thanks to the remarkable evolution of organ transplantation, it's now possible to replace genitals that don't work properly or have been injured. Surgeons have been transplanting ovarian tissue for more than a decade, and they're now successfully transplanting penises and wombs too.
Rules and regulations aren't keeping up with the rapid rise of genital transplants.
Earlier this year, an American soldier whose genitals were injured by a bomb in Afghanistan received the first-ever transplant of a penis and scrotum at Johns Hopkins Medicine.
Rules and regulations aren't keeping up with the rapid rise of genital transplants, however, and there's no consensus about how society should handle a long list of difficult and delicate questions.
Are these expensive transplants worth the risk when other alternatives exist? Should men, famously obsessed with their penises, be able to ask for a better model simply because they want one? And what happens when transplant technology further muddles the concept of biological parenthood?
"We need to remember that the human body is not a machine with interchangeable parts," says bioethicist Craig M. Klugman of DePaul University. "These are complicated, difficult and potentially dangerous surgeries. And they require deep consideration on a physical, psychological, spiritual, and financial level."
From Extra Testicles to Replacement Penises
Tinkering with human genitalia -- especially the male variety -- is hardly a new phenomenon. A French surgeon created artificial penises for injured soldiers in the 16th century. And a bizarre implant craze swept the U.S. in the 1930s when a quack physician convinced men that, quite literally, the more testicles the merrier – and if the human variety wasn't available, then ones from goats would have to do.
Now we're more sophisticated. Modern genital transplants are designed to do two things: Treat infertility (in women) and restore the appearance and function of genitals (in men).
In women, surgeons have successfully transplanted ovarian tissue from one woman to another since the mid-2000s, when an Alabama woman gave birth after getting a transplant from her identical twin sister. Last year, for the first time in the U.S., a young woman gave birth after getting a uterus transplant from a living donor.
"Where do you draw the line? Is pregnancy a privilege? Is it a right?"
As for men, surgeons in the U.S. and South Africa have successfully transplanted penises from dead men into four men whose genitals were injured by a botched circumcision, penile cancer or a wartime injury. One man reportedly fathered a child after the procedure.
The Johns Hopkins procedure was the first to include a scrotum. Testicles, however, were not transplanted due to ethical concerns. Surgeons have successfully transplanted testicles from man-to-man in the past, but this procedure isn't performed because the testes would produce sperm with the donor's DNA. As a result, the recipient could father a baby who is genetically related to the donor.
Are Transplants Worth the Expense and Risk?
Genital transplants are not simple procedures. They're extremely expensive, with a uterus transplant estimated to cost as much as $250,000. They're dangerous, since patients typically must take powerful drugs to keep their immune systems from rejecting their new organs. And they're not medically necessary. All have alternatives that are much less risky and costly.
Dr. Hiten D. Patel, a urologist at Johns Hopkins University, believes these types of factors make penis transplants unnecessary. As he wrote in a 2018 commentary in the journal European Urology, "What in the world are we doing?"
There are similar questions about female genital transplants, which allow infertile women to become pregnant instead of turning to alternatives like adoption or surrogacy. "This is not a life-saving transplant. A woman can very well live without a uterus," says McGill University's Dr. Jacques Balayla, who studies uterine transplantation. "Where do you draw the line? Is pregnancy a privilege? Is it a right? You don't want to cause harm to an individual unless there's an absolute need for the procedure."
But Johns Hopkins urologist Dr. Arthur L. Burnett II, who served on the surgical team that performed the penis-and-scrotum procedure, says penis transplants can be appropriate when other alternatives – like a "neophallus" created from forearm skin and tissue – aren't feasible.
It's also important to "restore normalcy," he says. "We want someone to be able to have sense of male adequacy and a normal sense of bodily well-being on both physical and psychological levels."
Surgical team members who performed the penis transplant, including W. P. Andrew Lee, director of the department of plastic and reconstructive surgery, center.
As for the anonymous recipient, he's reportedly doing "very well" five months after the transplant. An update on Johns Hopkins' website states that "he has normal urinary functions and is beginning to regain sensation in the transplanted tissues."
When the Organ Donors Do It Live
Some peculiar messages reached Burnett's desk after his institution announced it would begin performing penis transplants. Several men wanted to donate their own organs. But for now, transplanted penises are only coming from dead donors whose next of kin have approved the donation.
Burnett doesn't expect live donors to enter the penis transplant picture. But there are no guidelines or policies to stop surgeons from transplanting a penis from a live donor or, for that matter, a testicle.
Live women have already donated wombs and ovarian tissue, forcing them to face their own risks from transplant surgery. "You're putting the donor at risk because she has to undergo pretty expensive surgery for a procedure that is not technically lifesaving," McGill University's Balayla says.
When it comes to uterus transplants, the risk spreads even beyond donor and recipient. Balayla notes there's a third person in the equation: The fetus. "Immunosuppressant medication may harm the baby, and you're feeding the baby with a [uterine] blood vessel that's not natural, held together by stitches," he says.
It's up to each medical institution that performs the procedures to set its own policies.
Bioethicists are talking about other issues raised by genital transplants: How should operations for transgender people fit in? Should men be able to get penis transplants for purely cosmetic reasons? And then there's the looming question of genetic parenthood.
It's up to each medical institution that performs the procedures to set its own policies.
Let's say a woman gets a transplant of ovarian tissue, a man gets a testicle transplant, and they have a baby the old-fashioned way.* The child would be genetically linked to the donors, not the parents who conceived him or her.
Call this a full-employment act not just for bioethicists but theologians too. "Catholicism is generally against reproductive technologies because it removes God from the nature of the procreative act. This technology, though, could result in conception through the natural act. Would their concern remain?" DePaul University's Klugman asked. "Judaism is concerned with knowing a child's parentage, would a child from transplanted testes be the child of the donor or the recipient? Would an act of coitus with a transplanted penis be adultery?"
Yikes. Maybe it's time for the medical field or the law to step in to determine what genital transplants surgeons can and can't -- or shouldn't -- do.
So far, however, only uterus transplants have guidelines in place. Otherwise, it's up to each medical institution that performs the procedures to set its own policies.
"I don't know if the medical establishment is in the position to do the best job of self-regulation," says Lisa Campo-Engelstein, a bioethicist with Albany Medical College. "Reproductive medicine in this country is a huge for-profit industry. There's a possibility of exploitation if we leave this to for-profit fertility companies."
And, as bioethicist Klugman notes, guidelines "aren't laws, and people can and do violate them with no effect."
He doesn't think laws are the solution to the ethical issues raised by genital transplants either. Still, he says, "we do need a national conversation on these topics to help provide guidance for doctors and patients."
[Correction: The following sentence has been updated: "Let's say a woman gets a transplant of ovarian tissue, a man gets a testicle transplant, and they have a baby the old-fashioned way." The original sentence mistakenly read "uterus transplant" instead of "ovarian tissue."]