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.
Could Biologically Enhancing Our Morality Save Our Species?
A human head pictured with a red heart in the place of a brain.
As a species, we are prone to weaponizing. There is a famous anecdote from Wulf Schievenhovel, a German anthropologist who was working in the highlands of New Guinea studying a local tribe. One day, he offered two tribesmen a flight in an airplane. They duly accepted but showed up with two large stones. When he asked why, they told him that they wanted to drop them on a neighboring village. Ethologist Frans de Waal later remarked on this story that Schievenhovel had effectively "witnessed the invention of the bomb."
Today you don't have to be Putin or Kim Jong Un to pose an existential threat.
Modern technology has given us access to more than just rocks. In 2011, a Swedish man was arrested after attempting a nuclear fission in his kitchen. And in the inaugural issue of this magazine, my colleague Hank Greely raised a terrifying prospect:
"do-it-yourself hobbyists can use CRISPR [gene editing]… to change the genomes of whole species of living things – domestic or wild; animal, vegetable, or microbial – cheaply, easily, and before we even know it is happening."
In science fiction, it is typically governments that take over technologies and use them for evil. That risk is of course no fiction. It is an ongoing problem that we have addressed through institutions: democracies, constitutions, legal systems and international treaties, and groups working together as checks and balances. It isn't perfect, but it has worked (so far).
Today you don't have to be Putin or Kim Jong Un to pose an existential threat. We are rapidly acquiring the technological ability for individuals and groups not just to cause major harm, but to do so exactly as Hank said: "cheaply, easily, and before we even know it is happening."
How should we address this problem? Together with Ingmar Persson, a fellow philosophy professor at Gothenburg, Sweden, I have argued that while education, institutions and good policing are important, we may need to think more radically.
We could adapt our biology so that we can appreciate the suffering of foreign or future people in the same instinctive way we do our friends and neighbors.
We evolved, along with the New Guinea tribesmen, to care about our small group and to be suspicious of outsiders. We evolved to cooperate well within our group, at a size where we could keep an eye on free riders. And we evolved to have the ability, and occasionally the desire to harm others, but with a natural limit on the amount of harm we could do—at least before others could step in to prevent, punish or kill us.
Our limitations have also become apparent in another form of existential threat: resource depletion. Despite our best efforts at educating, nudging, and legislating on climate change, carbon dioxide emissions in 2017 are expected to come in at the highest ever following a predicted rise of 2 percent. Why? We aren't good at cooperating in larger groups where freeriding is not easily spotted. We also deal with problems in order of urgency. A problem close by is much more significant to us than a problem in the future. That's why even if we accept there is a choice between economic recession now or natural disasters and potential famine in the future, we choose to carry on drilling for oil. And if the disasters and famine are present day, but geographically distant, we still choose to carry on drilling.
So what is our radical solution? We propose that there is a need for what we call moral bioenhancement. That is, for seeking a biological intervention that can help us overcome our evolved moral limitations. For example, adapting our biology so that we can appreciate the suffering of foreign or future people in the same instinctive way we do our friends and neighbors. Or, in the case of individuals, in addressing the problem of psychopathy from a biological perspective.
There is no reason in principle why humans could not be genetically modified...to make them kinder, happier, more conscientious, altruistic and just.
We have been dramatically successful at modifying various moral characteristics of non-human animals. Over ten thousand years or so, we have turned wolves into dogs by selective breeding, and those dogs into breeds with behavioural as well as physical characteristics: certain breeds can be faithful, hard working, good tempered and intelligent (or the opposite). Scientists have manipulated the expression of genes in prairie voles to cause them to form a mate bond more quickly, and in monkeys to make them work harder. There is no reason in principle why humans could not be genetically modified using gene editing, or their brains modified in other ways, to make them kinder, happier, more conscientious, altruistic and just.
One objection is that this is a pipe dream: even if it is acceptable to do this, it is so unlikely to be achievable, it is not worth pursuing. However, research has shown that we are already morally modified. This is widely accepted when it comes to negative effects. For example, we all know that alcohol can lead people to aggressive or other destructive behaviours that they would not have countenanced sober. In a 2008 case, a retired UK teacher was cleared of child pornography charges after he successfully argued his behaviour was caused by a drug prescribed for his Parkinson's disease. There is also evidence that we can be morally modified in a more positive direction. For example, SSRIs like Prozac, a class of drugs widely used to treat depression, have been shown to act on healthy volunteers to make them more cooperative and less critical.
Another objection is that we need the negative aspects of our human character. We need people who can fight wars. We need to be able to blot out the suffering of the wider world: to experience it as we would if it applied to our nearest and dearest would be unbearable. This might be so. If aggressiveness and denial, or strong bonding to small communities, are important traits, it is important that we understand how, and to what degree, they should be controlled. It is unlikely that nature has dished out exactly the right levels of all morally relevant characteristics on an individual or population level. We don't claim to have all the answers to what characteristics we need to enhance, and what characteristics we need to diminish. But we see no reason to believe that the status quo is the optimum.
We haven't argued that we should go blindly in now with half-baked moral enhancers, or that we should forget about moral education, or legal solutions. Evolution has a built-in response to existential threats through adaptation. But adaptation takes generations and can't deal with threats that take out a whole population. Some threats are too important —and too urgent—to be left to chance.
Deep Brain Stimulation for Mental Illnesses Raises Ethical Concerns
Deep brain stimulation: This neurosurgical treatment involves the implantation of electrodes in the cerebral lobes of the brain, linked through the scalp (top) to wires (down right) leading to a battery implanted below the skin. This sends electrical impulses to specific areas of the brain. DBS was developed for the treatment of Parkinson's disease, but is being investigated for use in other conditions.
Imagine that you are one of the hundreds of millions of people who suffer from depression. Medication hasn't helped you, so you're looking for another treatment option. Something powerful enough to change your mood as soon as you need a lift.
"If a participant experiences a personality change, does this change who they are or dehumanize them by altering their nature?"
Enter deep brain stimulation: a type of therapy in which one or more electrodes are inserted into your brain and connected to a surgically implanted, battery-operated medical device in your chest. This device, which is approximately the size of a stopwatch, sends electric pulses to a targeted region of your brain. The idea is to control a variety of neurological symptoms that can't be adequately managed by drugs.
Over the last twenty years, deep brain stimulation, known as DBS, has become an efficient and safe alternative for the treatment of chronic neurological diseases such as epilepsy, Parkinson's disease and neuropathic pain. According to the International Neuromodulation Society, there have been more than 80,000 deep brain stimulation implants performed around the world.
The Food and Drug Administration approved DBS as a treatment for essential tremor and Parkinson's in 1997, dystonia in 2003 and obsessive compulsive disorder in 2009. Since doctors can use drugs and treatments "off-label" (not approved by the FDA) to treat patients with any disease, DBS is now also being investigated as a treatment for chronic pain, PTSD and major depression.
And these new applications are raising profound ethical questions about individuality, personality, and even what it means to be human.
"These patients are essentially having a computer that can modify and influence emotional processing, mood and motor outputs inserted into the brain," said Gabriel Lazaro-Munoz, an assistant professor at The Center for Medical Ethics and Health Policy at Baylor College of Medicine. "These responses define us as human beings and dictate our autonomy. If a participant experiences a personality change, does this change who they are or dehumanize them by altering their nature? These are some of the questions we have to consider."
"When we are not in control of ourselves, are we ourselves?"
The U.S. government has similar concerns about DBS. The National Institutes of Health recently awarded grants to study the neuroethical issues surrounding the use of DBS in neuropsychiatric and movement disorders and appropriate consent for brain research. The grants are part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. Walter Koroshetz, director of NIH's National Institute of Neurological Disorders and Stroke said, "Neuroscience is rapidly moving toward a new frontier of research on human brains that may have long-lasting and unforeseen effects. These new awards signal our commitment to research conducted in a responsible way as to anticipate all potential consequences, and to ensure that research subjects have a clear understanding of the potential benefits and risks of participating in studies."
Dr. Lazaro-Munoz's Center was awarded one of the grants to identify and evaluate the ethical, legal and social concerns with adaptive deep brain stimulation (aDBS) technologies. Adaptive DBS is a relatively new version of the technology that enables recording of brain cell activity that is then used to regulate the brain in real time. He and his team will closely observe researchers conducting aDBS studies and administering in-depth interviews to trial participants, their caregivers, and researchers, as well as individuals who declined to participate in such studies. The goal is to gain a better understanding of the ethical concerns at stake in order to guide responsible research.
Dr. Lazaro-Munoz said one of the concerns is dehumanization. "By using this technology are we compromising what makes us human? When we are not in control of ourselves, are we ourselves?" He notes that similar concerns were raised about pharmaceutical treatments for illnesses. "Both change behaviors and emotional processing. However, there is a difference. Culturally we are more used to using drugs, not implanting devices into brain and computer interfaces. Many people think of it as science fiction."
The changes in behavior due to DBS can be dramatic, perhaps none more so than with Parkinson's disease; patients may see their chronic tremors suddenly vanish.
Pills for OCD and depression take longer than DBS to see significant improvement, sometimes months. "A DBS device is either on or off. And patients and families see changes immediately," Dr. Lazaro-Munoz said. "Family members are often startled by these changes, as are the patients." He's observed that patients feel more in control with pills because they can alter and "play" with the dose or even skip a dose.
The changes in behavior due to DBS can be dramatic, perhaps none more so than with Parkinson's disease; patients may see their chronic tremors suddenly vanish, like in this must-see video.
But surgical procedures to treat motor symptoms are also increasingly being implicated as a cause of behavioral changes, both positive and negative, in patients with Parkinson's. The personality changes reported in patients who undergo DBS include hypermania, pathological gambling, hypersexuality, impulsivity and aggressiveness. One patient who suffered from OCD fell in love with the music of Johnny Cash when his brain was stimulated. On the positive side, patients report memory enhancement.
One patient who is pleased with DBS is Greg Barstead, who was diagnosed with Parkinson's in 2003, when he was the president of Colonial Penn Life Insurance Company. He also has dystonia, which affects his neck and shoulders. Barstead said that DBS has been helpful for a range of symptoms: "My shoulder is a lot less stiff and my neck hurts less. And my tremors are under control. It is not perfect, as it doesn't relieve all the Parkinson's symptoms, but it does enough of a good job that both my wife and I are very happy I had DBS."
"We are not exactly sure what part of the brain causes depression. Doctors have not identified where to implant the device."
He said he hasn't noticed any personality changes, but noted that the disease itself can cause such changes. In fact, studies have shown that it can cause many psychiatric problems including depression and hallucinations. And, approximately a third of Parkinson's patients develop dementia.
Arthur L. Caplan, founding head of the Division of Medical Ethics at NYU School of Medicine, notes that unlike psychosurgery, DBS can be turned on and off and the device can be removed. "There are less ethical concerns around treating patients with Parkinson's disease than other illnesses because surgeons know exactly where to implant the device and have many years of experience with it," he said, adding that he is concerned about using DBS for other illnesses, such as depression. "We are not exactly sure what part of the brain causes depression. Doctors have not identified where to implant the device. And I would certainly not advocate its use in patients with mild depression."
Dr. Lazaro-Munoz said of the personality changes possible with DBS, physicians need to consider how the patients were functioning without it. "Patients who are candidates for DBS typically used many medications as well as psychotherapy before opting for DBS," he explained. "To me, the question is what is the net result of using this technology? Does the patient have regrets? Are the changes in personality significant or not? Although most DBS patients report being happy they underwent the procedure, some say they don't feel like themselves after DBS. Others feel they are more like themselves, especially if there are dramatic improvements in movement problems or relief of OCD symptoms."
And then there is the question of money. The costs of DBS are covered by most insurance companies and Medicare only for FDA-approved targets like Parkinson's. Off-label uses are not covered, at least for now.
Caplan reminds people that DBS devices are manufactured by companies that are interested in making money and the average cost per treatment is around $50,000. "I am interested in seeing DBS move forward," he said. "But we must be careful and not allow industry to make it go too fast, or be used on too many people, before we know it is effective."