May 03 | 2021
Pregnant & Breastfeeding Women Who Get the COVID-19 Vaccine Are Protecting Their Infants, Research Suggests
Susan Kreimer is a New York-based freelance journalist who has followed the landscape of health care since the late 1990s, initially as a staff reporter for major daily newspapers. She writes about breakthrough studies, personal health, and the business of clinical practice. Raised in the Chicago area, she holds a B.A. in Journalism/Mass Communication and French, with minors in German and Russian, from the University of Iowa and an M.S. from the Columbia University Graduate School of Journalism.
Becky Cummings, who got vaccinated in December, snuggles her newborn, Clark, while he takes a nap.
Photo credit: Rachel Walter
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.
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Susan Kreimer is a New York-based freelance journalist who has followed the landscape of health care since the late 1990s, initially as a staff reporter for major daily newspapers. She writes about breakthrough studies, personal health, and the business of clinical practice. Raised in the Chicago area, she holds a B.A. in Journalism/Mass Communication and French, with minors in German and Russian, from the University of Iowa and an M.S. from the Columbia University Graduate School of Journalism.
February 07 | 2020
Clever Firm Predicts Patients Most at Risk, Then Tries to Intervene Before They Get Sicker
Health firm Populytics tracks and analyzes patient data, and makes care suggestions based on that data.
(Photo by National Cancer Institute (left) and Andrew Leu on Unsplash)
The diabetic patient hit the danger zone.
Ideally, blood sugar, measured by an A1C test, rests at 5.9 or less. A 7 is elevated, according to the Diabetes Council. Over 10, and you're into the extreme danger zone, at risk of every diabetic crisis from kidney failure to blindness.
In three months of working with a case manager, Jen's blood sugar had dropped to 7.2, a much safer range.
This patient's A1C was 10. Let's call her Jen for the sake of this story. (Although the facts of her case are real, the patient's actual name wasn't released due to privacy laws.).
Jen happens to live in Pennsylvania's Lehigh Valley, home of the nonprofit Lehigh Valley Health Network, which has eight hospital campuses and various clinics and other services. This network has invested more than $1 billion in IT infrastructure and founded Populytics, a spin-off firm that tracks and analyzes patient data, and makes care suggestions based on that data.
When Jen left the doctor's office, the Populytics data machine started churning, analyzing her data compared to a wealth of information about future likely hospital visits if she did not comply with recommendations, as well as the potential positive impacts of outreach and early intervention.
About a month after Jen received the dangerous blood test results, a community outreach specialist with psychological training called her. She was on a list generated by Populytics of follow-up patients to contact.
"It's a very gentle conversation," says Cathryn Kelly, who manages a care coordination team at Populytics. "The case manager provides them understanding and support and coaching." The goal, in this case, was small behavioral changes that would actually stick, like dietary ones.
In three months of working with a case manager, Jen's blood sugar had dropped to 7.2, a much safer range. The odds of her cycling back to the hospital ER or veering into kidney failure, or worse, had dropped significantly.
While the health network is extremely localized to one area of one state, using data to inform precise medical decision-making appears to be the wave of the future, says Ann Mongovern, the associate director of Health Care Ethics at the Markkula Center for Applied Ethics at Santa Clara University in California.
"Many hospitals and hospital systems don't yet try to do this at all, which is striking given where we're at in terms of our general technical ability in this society," Mongovern says.
How It Happened
While many hospitals make money by filling beds, the Lehigh Valley Health Network, as a nonprofit, accepts many patients on Medicaid and other government insurances that don't cover some of the costs of a hospitalization. The area's population is both poorer and older than national averages, according to the U.S. Census data, meaning more people with higher medical needs that may not have the support to care for themselves. They end up in the ER, or worse, again and again.
In the early 2000s, LVHN CEO Dr. Brian Nester started wondering if his health network could develop a way to predict who is most likely to land themselves a pricey ICU stay -- and offer support before those people end up needing serious care.
Embracing data use in such specific ways also brings up issues of data security and patient safety.
"There was an early understanding, even if you go back to the (federal) balanced budget act of 1997, that we were just kicking the can down the road to having a functional financial model to deliver healthcare to everyone with a reasonable price," Nester says. "We've got a lot of people living longer without more of an investment in the healthcare trust."
Popultyics, founded in 2013, was the result of years of planning and agonizing over those population numbers and cost concerns.
"We looked at our own health plan," Nester says. Out of all the employees and dependants on the LVHN's own insurance network, "roughly 1.5 percent of our 25,000 people — under 400 people — drove $30 million of our $130 million on insurance costs -- about 25 percent."
"You don't have to boil the ocean to take cost out of the system," he says. "You just have to focus on that 1.5%."
Take Jen, the diabetic patient. High blood sugar can lead to kidney failure, which can mean weekly expensive dialysis for 20 years. Investing in the data and staff to reach patients, he says, is "pennies compared to $100 bills."
For most doctors, "there's no awareness for providers to know who they should be seeing vs. who they are seeing. There's no incentive, because the incentive is to see as many patients as you can," he says.
To change that, first the LVHN invested in the popular medical management system, Epic. Then, they negotiated with the top 18 insurance companies that cover patients in the region to allow access to their patient care data, which means they have reams of patient history to feed the analytics machine in order to make predictions about outcomes. Nester admits not every hospital could do that -- with 52 percent of the market share, LVHN had a very strong negotiating position.
Third party services take that data and churn out analytics that feeds models and care management plans. All identifying information is stripped from the data.
"We can do predictive modeling in patients," says Populytics President and CEO Gregory Kile. "We can identify care gaps. Those care gaps are noted as alerts when the patient presents at the office."
Kile uses himself as a hypothetical patient.
"I pull up Gregory Kile, and boom, I see a flag or an alert. I see he hasn't been in for his last blood test. There is a care gap there we need to complete."
"There's just so much more you can do with that information," he says, envisioning a future where follow-up for, say, knee replacement surgery and outcomes could be tracked, and either validated or changed.
Ethical Issues at the Forefront
Of course, embracing data use in such specific ways also brings up issues of security and patient safety. For example, says medical ethicist Mongovern, there are many touchpoints where breaches could occur. The public has a growing awareness of how data used to personalize their experiences, such as social media analytics, can also be monetized and sold in ways that benefit a company, but not the user. That's not to say data supporting medical decisions is a bad thing, she says, just one with potential for public distrust if not handled thoughtfully.
"You're going to need to do this to stay competitive," she says. "But there's obviously big challenges, not the least of which is patient trust."
So far, a majority of the patients targeted – 62 percent -- appear to embrace the effort.
Among the ways the LVHN uses the data is monthly reports they call registries, which include patients who have just come in contact with the health network, either through the hospital or a doctor that works with them. The community outreach team members at Populytics take the names from the list, pull their records, and start calling. So far, a majority of the patients targeted – 62 percent -- appear to embrace the effort.
Says Nester: "Most of these are vulnerable people who are thrilled to have someone care about them. So they engage, and when a person engages in their care, they take their insulin shots. It's not rocket science. The rocket science is in identifying who the people are — the delivery of care is easy."
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Anne Miller is an editor and writer based in Brooklyn who is particularly curious about how technology impacts our daily lives. Her byline has appeared in the New York Times, the Washington Post, the Wall Street Journal and Slate, and she's a regular contributor to Dell Perspectives — when she's not managing editorial projects for Fortune 500 firms. She holds a master's degree in Human-Computer Interaction from the Rensselaer Polytechnic Institute.
February 04 | 2020
In The Fake News Era, Are We Too Gullible? No, Says Cognitive Scientist
Cognitive scientist Hugo Mercier says the real challenge is not fighting fake news, but figuring out "how to make it easier for people who say correct things to convince people."
(© EvgeniyBobrov/Adobe)
One of the oddest political hoaxes of recent times was Pizzagate, in which conspiracy theorists claimed that Hillary Clinton and her 2016 campaign chief ran a child sex ring from the basement of a Washington, DC, pizzeria.
To fight disinformation more effectively, he suggests, humans need to stop believing in one thing above all: our own gullibility.
Millions of believers spread the rumor on social media, abetted by Russian bots; one outraged netizen stormed the restaurant with an assault rifle and shot open what he took to be the dungeon door. (It actually led to a computer closet.) Pundits cited the imbroglio as evidence that Americans had lost the ability to tell fake news from the real thing, putting our democracy in peril.
Such fears, however, are nothing new. "For most of history, the concept of widespread credulity has been fundamental to our understanding of society," observes Hugo Mercier in Not Born Yesterday: The Science of Who We Trust and What We Believe (Princeton University Press, 2020). In the fourth century BCE, he points out, the historian Thucydides blamed Athens' defeat by Sparta on a demagogue who hoodwinked the public into supporting idiotic military strategies; Plato extended that argument to condemn democracy itself. Today, atheists and fundamentalists decry one another's gullibility, as do climate-change accepters and deniers. Leftists bemoan the masses' blind acceptance of the "dominant ideology," while conservatives accuse those who do revolt of being duped by cunning agitators.
What's changed, all sides agree, is the speed at which bamboozlement can propagate. In the digital age, it seems, a sucker is born every nanosecond.
The Case Against Credulity
Yet Mercier, a cognitive scientist at the Jean Nicod Institute in Paris, thinks we've got the problem backward. To fight disinformation more effectively, he suggests, humans need to stop believing in one thing above all: our own gullibility. "We don't credulously accept whatever we're told—even when those views are supported by the majority of the population, or by prestigious, charismatic individuals," he writes. "On the contrary, we are skilled at figuring out who to trust and what to believe, and, if anything, we're too hard rather than too easy to influence."
He bases those contentions on a growing body of research in neuropsychiatry, evolutionary psychology, and other fields. Humans, Mercier argues, are hardwired to balance openness with vigilance when assessing communicated information. To gauge a statement's accuracy, we instinctively test it from many angles, including: Does it jibe with what I already believe? Does the speaker share my interests? Has she demonstrated competence in this area? What's her reputation for trustworthiness? And, with more complex assertions: Does the argument make sense?
This process, Mercier says, enables us to learn much more from one another than do other animals, and to communicate in a far more complex way—key to our unparalleled adaptability. But it doesn't always save us from trusting liars or embracing demonstrably false beliefs. To better understand why, leapsmag spoke with the author.
How did you come to write Not Born Yesterday?
In 2010, I collaborated with the cognitive scientist Dan Sperber and some other colleagues on a paper called "Epistemic Vigilance," which laid out the argument that evolutionarily, it would make no sense for humans to be gullible. If you can be easily manipulated and influenced, you're going to be in major trouble. But as I talked to people, I kept encountering resistance. They'd tell me, "No, no, people are influenced by advertising, by political campaigns, by religious leaders." I started doing more research to see if I was wrong, and eventually I had enough to write a book.
With all the talk about "fake news" these days, the topic has gotten a lot more timely.
Yes. But on the whole, I'm skeptical that fake news matters very much. And all the energy we spend fighting it is energy not spent on other pursuits that may be better ways of improving our informational environment. The real challenge, I think, is not how to shut up people who say stupid things on the internet, but how to make it easier for people who say correct things to convince people.
"History shows that the audience's state of mind and material conditions matter more than the leader's powers of persuasion."
You start the book with an anecdote about your encounter with a con artist several years ago, who scammed you out of 20 euros. Why did you choose that anecdote?
Although I'm arguing that people aren't generally gullible, I'm not saying we're completely impervious to attempts at tricking us. It's just that we're much better than we think at resisting manipulation. And while there's a risk of trusting someone who doesn't deserve to be trusted, there's also a risk of not trusting someone who could have been trusted. You miss out on someone who could help you, or from whom you might have learned something—including figuring out who to trust.
You argue that in humans, vigilance and open-mindedness evolved hand-in-hand, leading to a set of cognitive mechanisms you call "open vigilance."
There's a common view that people start from a state of being gullible and easy to influence, and get better at rejecting information as they become smarter and more sophisticated. But that's not what really happens. It's much harder to get apes than humans to do anything they don't want to do, for example. And research suggests that over evolutionary time, the better our species became at telling what we should and shouldn't listen to, the more open to influence we became. Even small children have ways to evaluate what people tell them.
The most basic is what I call "plausibility checking": if you tell them you're 200 years old, they're going to find that highly suspicious. Kids pay attention to competence; if someone is an expert in the relevant field, they'll trust her more. They're likelier to trust someone who's nice to them. My colleagues and I have found that by age 2 ½, children can distinguish between very strong and very weak arguments. Obviously, these skills keep developing throughout your life.
But you've found that even the most forceful leaders—and their propaganda machines—have a hard time changing people's minds.
Throughout history, there's been this fear of demagogues leading whole countries into terrible decisions. In reality, these leaders are mostly good at feeling the crowd and figuring out what people want to hear. They're not really influencing [the masses]; they're surfing on pre-existing public opinion. We know from a recent study, for instance, that if you match cities in which Hitler gave campaign speeches in the late '20s through early '30s with similar cities in which he didn't give campaign speeches, there was no difference in vote share for the Nazis. Nazi propaganda managed to make Germans who were already anti-Semitic more likely to express their anti-Semitism or act on it. But Germans who were not already anti-Semitic were completely inured to the propaganda.
So why, in totalitarian regimes, do people seem so devoted to the ruler?
It's not a very complex psychology. In these regimes, the slightest show of discontent can be punished by death, or by you and your whole family being sent to a labor camp. That doesn't mean propaganda has no effect, but you can explain people's obedience without it.
What about cult leaders and religious extremists? Their followers seem willing to believe anything.
Prophets and preachers can inspire the kind of fervor that leads people to suicidal acts or doomed crusades. But history shows that the audience's state of mind and material conditions matter more than the leader's powers of persuasion. Only when people are ready for extreme actions can a charismatic figure provide the spark that lights the fire.
Once a religion becomes ubiquitous, the limits of its persuasive powers become clear. Every anthropologist knows that in societies that are nominally dominated by orthodox belief systems—whether Christian or Muslim or anything else—most people share a view of God, or the spirit, that's closer to what you find in societies that lack such religions. In the Middle Ages, for instance, you have records of priests complaining of how unruly the people are—how they spend the whole Mass chatting or gossiping, or go on pilgrimages mostly because of all the prostitutes and wine-drinking. They continue pagan practices. They resist attempts to make them pay tithes. It's very far from our image of how much people really bought the dominant religion.
"The mainstream media is extremely reliable. The scientific consensus is extremely reliable."
And what about all those wild rumors and conspiracy theories on social media? Don't those demonstrate widespread gullibility?
I think not, for two reasons. One is that most of these false beliefs tend to be held in a way that's not very deep. People may say Pizzagate is true, yet that belief doesn't really interact with the rest of their cognition or their behavior. If you really believe that children are being abused, then trying to free them is the moral and rational thing to do. But the only person who did that was the guy who took his assault weapon to the pizzeria. Most people just left one-star reviews of the restaurant.
The other reason is that most of these beliefs actually play some useful role for people. Before any ethnic massacre, for example, rumors circulate about atrocities having been committed by the targeted minority. But those beliefs aren't what's really driving the phenomenon. In the horrendous pogrom of Kishinev, Moldova, 100 years ago, you had these stories of blood libel—a child disappeared, typical stuff. And then what did the Christian inhabitants do? They raped the [Jewish] women, they pillaged the wine stores, they stole everything they could. They clearly wanted to get that stuff, and they made up something to justify it.
Where do skeptics like climate-change deniers and anti-vaxxers fit into the picture?
Most people in most countries accept that vaccination is good and that climate change is real and man-made. These ideas are deeply counter-intuitive, so the fact that scientists were able to get them across is quite fascinating. But the environment in which we live is vastly different from the one in which we evolved. There's a lot more information, which makes it harder to figure out who we can trust. The main effect is that we don't trust enough; we don't accept enough information. We also rely on shortcuts and heuristics—coarse cues of trustworthiness. There are people who abuse these cues. They may have a PhD or an MD, and they use those credentials to help them spread messages that are not true and not good. Mostly, they're affirming what people want to believe, but they may also be changing minds at the margins.
How can we improve people's ability to resist that kind of exploitation?
I wish I could tell you! That's literally my next project. Generally speaking, though, my advice is very vanilla. The mainstream media is extremely reliable. The scientific consensus is extremely reliable. If you trust those sources, you'll go wrong in a very few cases, but on the whole, they'll probably give you good results. Yet a lot of the problems that we attribute to people being stupid and irrational are not entirely their fault. If governments were less corrupt, if the pharmaceutical companies were irreproachable, these problems might not go away—but they would certainly be minimized.
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Kenneth Miller is a freelance writer based in Los Angeles. He is a contributing editor at Discover, and has reported from four continents for publications including Time, Life, Rolling Stone, Mother Jones, and Aeon. His honors include The ASJA Award for Best Science Writing and the June Roth Memorial Award for Medical Writing. Visit his website at www.kennethmiller.net.