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.
With Mentors, Models, and #MeToo, Femtech Comes of Age
In her quest to become a tech entrepreneur, Stacy Chin has been an ace at tackling thorny intellectual challenges, mastering everything from molecules to manufacturing.
These mostly female leaders of firms with products addressing women's health concerns are winning in a big way, raising about $1.1 billion in startup funds over the past few years.
But the 28-year-old founder of HydroGlyde Coatings, based in Worcester, Mass., admitted to being momentarily stumped recently when pitching her product – a new kind of self-lubricating condom – to venture capitalists.
"Being a young female scientist and going into that sexual healthcare space, it was definitely a little bit challenging to learn how to navigate during presentations and pitches when there were a lot of older males in the audience," said Chin, whose product is of special appeal to older women suffering from vaginal dryness. "I eventually figured it out, but it wasn't easy."
Chin is at the vanguard of a new generation of "femtech" entrepreneurs heading companies with names like LOLA Tampons, Prelude Fertility, and Peach, bringing once-taboo topics like menstruation, ovulation, incontinence, breastfeeding, pelvic pain and, yes, female sexual pleasure to the highest chambers of finance. These mostly female leaders of firms with products addressing women's health concerns are winning in a big way, raising about $1.1 billion in startup funds over the past few years, according to the New York data analytics firm CB Insights.
"We are definitely at a watershed moment for femtech. But we need to remember that [it's] an overnight sensation that is decades in the making."
If the question is "Why now?", the answer may be that femtech leaders are benefiting from the current conversations around respect for women in the workplace, and long-term efforts to achieve gender equality in the male-dominated tech industry.
"We are definitely at a watershed moment for femtech," said Rachel Braun Scherl, a self-described "vaginepreneur" whose new book, "Orgasmic Leadership," profiles femtech leaders. "But we need to remember that femtech is an overnight sensation that is decades in the making."
In contrast with earlier and perhaps less successful generations of women in tech, these pioneers can point to mentors who are readily accessible, as well as more female VC and corporate heads they can directly address when making pitches. There's also a changing cultural landscape where sexual harassment is in the news and women who talk openly about sex in a business context can be taken seriously.
"Change is definitely in the air," said Kevin O'Sullivan, the president and CEO of Massachusetts Biomedical Initiatives, who sponsored Chin and has helped launch more than a hundred biotech companies in his home state since the 1980s.
Like a pinprick bursting a balloon, the #MeToo social movement and its focus on the prevalence of sexual harassment and assault is a factor in the success of femtech, some experts believe, provoking heightened awareness about the role of women in society -- including equal access to start-up capital.
"If such a difficult topic is being discussed in the open, that means more and more people are speaking out and are no longer afraid about sharing their own concerns," said Debbie Hart, president and CEO of BioNJ, a business trade group she founded in 1994. "That's empowering the whole women's movement."
The power of programs that allow young women to witness successful older women in leadership cannot be overstated.
Observers like Hart say that femtech's advent is also due to a payoff from longer-term investments in a slew of programs encouraging girls to pursue STEM careers and women to be hired as leaders, as well as changing social norms to allow female health to be part of the public discourse.
The power of programs that allow young women to witness successful older women in leadership cannot be overstated, according to Susan Scherreik of the Stillman School of Business at Seton Hall University in New Jersey.
"What I have found in entrepreneurship is that it's all about two things: role models and mentoring," said Scherreik, director of the university's Center for Entrepreneurial Studies.
One of Scherreik's top students, Madison Schott, is convinced that the availability of female mentors has been instrumental to her success and will remain so in her future. "It definitely is very encouraging," said Schott, who won the "Pirates Pitch" university-wide business start-up competition in April for an app she is developing that uses AI to guide readers to reliable news sources. "Woman to woman," she added, "you can be more open when you have questions or problems."
Programs that showcase successful females in leadership positions are beginning to bear fruit, inspiring a new generation of females in business, according to Susan Scherreik (at left), director of Seton Hall University's Center for Entrepreneurial Studies at the Stillman School of Business. Her student, Madison Schott (right), is the winner of a university-wide business start-up competition for an app she is developing.
While femtech entrepreneurs may be the beneficiaries of change, they also may be its agents. Scherl, the author, who has been working in the female healthcare sector for more than a decade, believes in persistence. In 2010, organizers of a major awards show banned a product she was marketing, Zestra Essential Arousal Oils*, from a gift bag for honorees. Two years ago, however, times changed and femtech prevailed. The company making goodie bags for Academy Awards nominees included another one of her products, Nuelle's Fiera, a $250 vibrator.
"We come from so many different perspectives when it comes to sex, whether it is cultural, religious, age-related, or even from a trauma, so we never have created a common language," Scherl said. "But we in femtech are making huge progress. We are not only selling products now, we are selling conversation, and we are selling a comfort with sexuality in all its complex forms."
[*Correction: Due to a reporting error, the product that was banned in 2010 was initially identified as Nuelle's Fiera, not Zestra Essential Arousal Oils. The article has been updated for accuracy. --Editor]
Worried About Eating GMOs? That’s Not the Real Problem
The 21st century food system is awash in ethical issues. To name just a handful: There's the environmental impacts of farming, the human health effects of diets based on animal products and processed foods, the growing clamor around food waste, and the longstanding concerns about agricultural labor. The last decade has seen the emergence of "ethical consumption," as people have been encouraged to avoid products that are associated with animal cruelty or unfair to farmers.
Misguided concerns about GMOs are missing the point altogether and distracting from a far more substantive ethical problem.
But consumers have never been so ignorant about where food comes from, and they are vulnerable to oversimplifications and faulty messaging. Many would include the first generation of crops from agricultural applications of recombinant DNA methods for genetic improvement—so called GMOs—among the foods they should avoid for ethical reasons. Unfortunately, these misguided concerns are missing the point altogether and distracting from a far more substantive ethical problem.
As we stand on the precipice of a new era in food and biotechnology – crops and animals with genomes altered through gene editing – it is more important than ever to let go of unnecessary fears and to pay attention to the real hazards of agricultural innovation.
But first, as a bioethicist with almost 40 years of experience working on issues in the food system, let me stress the overall context and rationale for trying to make changes in plant and animal genetics. Doing so, whether through conventional breeding or biotechnology, allows producers to meet the challenges of seasonal climate differences and increase yields.
And just because a food was created through ordinary plant breeding vs. genetic modification does not automatically make it safe. Things can and do go wrong in ordinary plant breeding, such as with potatoes and tomatoes. These both produce toxins in the green parts of the plant, and breeders exercise caution to ensure that toxins aren't transferred to edible parts.
Despite real risks, there is no regulatory oversight that protects us from these known hazards. We rely on the professional ethics of agricultural scientists. And GMOs are, in comparison, much more carefully tested and regulated. The claim that they are "unregulated" is just false.
We should not ignore the role that all gene technologies have played in displacing small farmers, depleting rural communities, and shifting economic control.
I do want to shift the public's attention away from the anti-GMO debate to more substantive questions about contemporary agriculture that really have little to do with where the genes in their food came from, or how they got there.
No matter how important genetic improvements might be in terms of total global food production, we should not ignore the role that all gene technologies—including breeding—have played in displacing small farmers, depleting rural communities and shifting economic control of agriculture into a small circle of powerful actors. Globally, these changes have had disproportionately harmful effects on women and people of color.
Combined with mechanization and chemicals, gene technologies have freed planters from their dependence on impoverished and poorly educated field hands, but they did nothing to help the fieldworkers transition to a new line of work. These are the real problems that deserve the public's and the science community's attention, not the overly narrow worries about eating GMOs.
But these problems are viewed as "not ours" by agricultural insiders, and they continue to be ignored by scientists whose focus is solely on biology. Many of the concerns that are today viewed as "urban problems" or "social issues" have origins in agriculture. For example, in California tomatoes, the development of mechanical harvesting led to a rapid concentration of ownership and the displacement of thousands of field hands. In the South, similar technologies displaced black farmers working land owned by whites, causing migration to urban centers and unskilled jobs. I must fault the science community for a lack of willingness to even take the thrust of these more socially oriented critiques seriously.
The new suite of tools for genetic modification that go under the name "gene editing" promise greater precision. They should allow scientists to target the locus for new genes in a plant or animal genome, and minimize the chance for causing unwanted impacts on gene functioning. This added precision is reducing some of the uncertainties in the mind of technology developers, and they have been expressing hope that their own confidence will be shared by regulators and by the public at large. In fact, the U.S. government recently issued a statement that gene-edited crops do not require additional regulation because they're just as safe as crops produced through conventional breeding.
It is indeed possible that the public doubts about genetically modified food will be assuaged by this argument. We can only wait and see. Whether or not gene editing will lead to more reflection about agriculture's complicity in problems of economic inequality or structural racism depends much more on the culture of the science community than it does on the technology itself.