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.
Michio Kaku Talks Life on Mars, Genetic Engineering, and Immortality
Dr. Michio Kaku
Today is the release of THE FUTURE OF HUMANITY, the latest book by the world-renowned physicist Dr. Michio Kaku. In it, he explores the astonishing technologies that could propel us to live on other planets and even to live forever. LeapsMag Editor-in-Chief Kira Peikoff recently chatted with Dr. Kaku about some of the ethical implications we need to consider as we hurtle toward our destiny among the stars. Our interview has been edited and condensed for clarity.
"Technology is like a double-edged sword. The question is, who wields it?"
A big part of your book discusses living on Mars, and you mention that nanotech, biotech and AI could help us do so in the next 100 years. But you also note that efforts to make the Red Planet habitable could backfire, such as using genetic engineering to produce an ideal fertilizer, which could make one life form push out all the others. How should we judge when a powerful new technology is ready to be tested?
Technology is like a double-edged sword. One side can cut against ignorance, poverty, disease. But the other side can cut against people. The question is, who wields the sword? It has to be wielded by people's interests. We have to look not at the needs of the military or corporations, but society as a whole, and we have to realize that every technology, not just the ones I mentioned in the book, has a dark side as well as a positive side.
On the positive side, you could terraform Mars using genetic engineering to create algae, plants that could thrive in the Martian atmosphere, and a self-sustaining agriculture where we could raise food crops. However, it has to be done carefully, because we don't want to have it overrun Mars, just like we have certain plants that overrun the natural environment here on Earth. So we have to do it slowly. It cannot be done all of a sudden in a crash program. We have to see what happens if we begin to terraform stretches of Martian landscape.
Elon Musk of SpaceX, who has pioneered much of these technologies, has stated that we can jumpstart terraforming Mars by detonating hydrogen bombs over the polar ice caps. Later he had to qualify that by saying that they are airbursts, not ground bursts, to minimize radiation. Other people have said, we don't know what a nuclear weapon would do. Would it destabilize Mars? Would it open cracks in the ice caps? So we have to think things through, not just make proposals. Another proposal is to use silver mirrors in space to reflect sunlight down to melt the ice caps, and that would be more environmentally friendly than using hydrogen bombs.
"Our grandkids, when they hit the age of 30, they may just decide to stop aging, and live at age 30 for many decades to come."
As far as colonizing Mars, you also talk about technologies that could potentially help us end aging, but you note that this could exacerbate overpopulation and an exodus from Earth -- the double-edged sword again. What's your personal view on whether anti-aging research should be pursued?
Anti-aging research is accelerating because of the human genome. We're now able to map the genomes of old people, compare them with the genomes of young people, and we can see where aging takes place. For example, in a car, aging takes place in the engine, because that's where we have moving parts and combustion. Where do we find that in a cell? The mitochondria, and so we do see a concentration of error build-up in the mitochondria, and we can envision one day repairing the mistakes, which could in turn increase our life span. Also we're discovering new enzymes like telomerase which allow us to stop the clock. So it's conceivable, I think not for my generation, but for the coming generations, perhaps our grandkids, when they hit the age of 30, they may just decide to stop aging, and live at age 30 for many decades to come.
The other byproduct of this of course is overpopulation. That's a social problem, but realize in places like Japan, we have the opposite problem, under-population, because the birth rate has fallen way below the replacement level, people live too long, and there's very little immigration there. Europe is next. So we have this bizarre situation where some places like Sub-Saharan Africa are still expanding, but other places we're going to see a contraction. Overall, the population will continue to rise, but it's going to slow down. Instead of this exponential curve that many people see in the media, it's going to be shaped like an "S" that rises rapidly and then seals off. The UN is now beginning to entertain the possibility that the population of the Earth may seal off sometime by the end of the century--that we'll hit a steady state.
"In the future, that composite image may be holographic, with all your videotapes, your memories, to create a near approximation of who you are, and centuries from now, you may have digital immortality."
Later in the book, you talk about achieving immortality through storing your digital consciousness, uploading your brain to a computer. Many people today find that notion bizarre or even repulsive, but you also wisely note that "what seems unethical or even immoral today might be ordinary or mundane in the future." What do you think is the key to bridging the gap between controversial breakthroughs and public acceptance?
I imagine that if someone from the Middle Ages, who is fresh from burning witches and heretics and torturing non-believers, were to wind up today in our society, they might go crazy. They might think all of society is a product of the Devil, because attitudes toward morality change. So we humans today cannot dictate what morality will be like 100 years from now. For example, test tube babies. When Louise Brown (the first test tube baby) was first born, the Catholic Church denounced it. Now, today, your wife, husband, you may be a test tube baby and we don't even blink.
There's a Silicon Valley company today that will take what is known about you on the Internet, your credit card transactions, your emails, and create a composite image of you. In the future, that composite image may be holographic, with all your videotapes, your memories, to create a near approximation of who you are, and centuries from now, you may have digital immortality—your memories, your sensations, will be recorded accurately, and an avatar will recreate it. Like for example, I wouldn't mind talking to Einstein. I wouldn't mind sitting down with the guy and having a great conversation about the universe.
And the Connectome Project, by the end of the century, will map the entire brain--that's every neuron--just like the genome project has mapped every gene. And we live with it, we don't even think twice about the fact that our genome exists. In the future, our connectome will also exist. And the connectome can reproduce your thoughts, your dreams, your sensations. We'll just live with that fact; it will be considered ordinary.
"A hundred years from now, we may want to merge with some of these technologies, rather than have to compete with robots."
Wow. In such a "post-human" era, our bodies could be replaced by robots or maintained by genetic engineering. Once these technologies become commercially available, do you think people should have the freedom to make changes or enhancements to themselves?
I think there should be laws passed at a certain point to prevent parents from going crazy trying to genetically engineer their child. Once we isolate the genes for studying, for good behavior, things like that, we may be tempted to tinker with it. I think a certain amount of tinkering is fine, but we don't want to let it get out of control. There has to be limits.
Also, we are in competition with robots of the future. A hundred years from now, robots are going to become very intelligent. Some people think they're going to take over. My attitude is that a hundred years from now, we may want to merge with some of these technologies, rather than have to compete with robots. But we're not going to look like some freaky robot because we're genetically hardwired to look good to the opposite sex, to look good to our peers. Hundreds of thousands of years ago, and hundreds of thousands of years into the future, we'll still look the same. We'll genetically modify ourselves a little bit, but we'll basically look the same.
That's an interesting point. It's amazing how fast technology is moving overall. Like at one point in the book, you mention that primates had never been cloned, but a few weeks ago, news broke that this just happened in China. Do you think we should slow down the dramatic pace of acceleration and focus on the ethical considerations, or should we still move full-steam ahead?
Well, CRISPR technology has accelerated us more than we previously thought. In the past, to tinker with genes, you had to cut and splice, and it was a lot of guesswork and trial and error. Now, you can zero in on the cutting process and streamline it, so cutting and splicing genes becomes much more accurate, and you can edit them just like you edit a book. Within the field of bioengineering, they have set up their own conferences to begin to police themselves into figuring out which domains are ethically dangerous and which areas can provide benefits for humanity, because they realize that this technology can go a little bit too fast.
"Where does truth come from? Truth comes from interaction with incorrect ideas."
You cannot recall a life form. Once a life form is created, it reproduces. That's what life does. If it reproduces outside the laboratory, it could take over. So we want to make sure that we don't have to recall a life form, like you would recall a Ford or a Chevrolet. Eventually governments may have to slow down the pace because it's moving very rapidly.
Lastly, you talk about the importance of democratic debate to resolve how controversial technology should be used. How can science-minded people bring the rest of society into these conversations, so that as much of society as possible is represented?
It's a question of where does truth come from? Truth comes from interaction with incorrect ideas--the collision of truth and untruth, rumors and fact. It doesn't come from a machine where you put in a quarter, and out comes the answer. It requires democratic debate. And that's where the Internet comes in, that's where the media comes in, that's where this interview comes in. You want to stimulate and educate the people so they know the dangers and promises of technology, and then engage with them about the moral implications, because these things are going to affect every aspect of our life in the future.
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
Society Needs Regulations to Prevent Research Abuses
A tension exists between scientists/doctors and government regulators.
[Editor's Note: Our Big Moral Question this month is, "Do government regulations help or hurt the goal of responsible and timely scientific innovation?"]
Government regulations help more than hurt the goal of responsible and timely scientific innovation. Opponents might argue that without regulations, researchers would be free to do whatever they want. But without ethics and regulations, scientists have performed horrific experiments. In Nazi concentration camps, for instance, doctors forced prisoners to stay in the snow to see how long it took for these inmates to freeze to death. These researchers also removed prisoner's limbs in order to try to develop innovations to reconnect these body parts, but all the experiments failed.
Researchers in not only industry, but also academia have violated research participants' rights.
Due to these atrocities, after the war, the Nuremberg Tribunal established the first ethical guidelines for research, mandating that all study participants provide informed consent. Yet many researchers, including those in leading U.S. academic institutions and government agencies, failed to follow these dictates. The U.S. government, for instance, secretly infected Guatemalan men with syphilis in order to study the disease and experimented on soldiers, exposing them without consent to biological and chemical warfare agents. In the 1960s, researchers at New York's Willowbrook State School purposefully fed intellectually disabled children infected stool extracts with hepatitis to study the disease. In 1966, in the New England Journal of Medicine, Henry Beecher, a Harvard anesthesiologist, described 22 cases of unethical research published in the nation's leading medical journals, but were mostly conducted without informed consent, and at times harmed participants without offering them any benefit.
Despite heightened awareness and enhanced guidelines, abuses continued. Until a 1974 journalistic exposé, the U.S. government continued to fund the now-notorious Tuskegee syphilis study of infected poor African-American men in rural Alabama, refusing to offer these men penicillin when it became available as effective treatment for the disease.
In response, in 1974 Congress passed the National Research Act, establishing research ethics committees or Institutional Review Boards (IRBs), to guide scientists, allowing them to innovate while protecting study participants' rights. Routinely, IRBs now detect and prevent unethical studies from starting.
Still, even with these regulations, researchers have at times conducted unethical investigations. In 1999 at the Los Angeles Veterans Affairs Hospital, for example, a patient twice refused to participate in a study that would prolong his surgery. The researcher nonetheless proceeded to experiment on him anyway, using an electrical probe in the patient's heart to collect data.
Part of the problem and consequent need for regulations is that researchers have conflicts of interest and often do not recognize ethical challenges their research may pose.
Pharmaceutical company scandals, involving Avandia, and Neurontin and other drugs, raise added concerns. In marketing Vioxx, OxyContin, and tobacco, corporations have hidden findings that might undercut sales.
Regulations become increasingly critical as drug companies and the NIH conduct increasing amounts of research in the developing world. In 1996, Pfizer conducted a study of bacterial meningitis in Nigeria in which 11 children died. The families thus sued. Pfizer produced a Nigerian IRB approval letter, but the letter turned out to have been forged. No Nigerian IRB had ever approved the study. Fourteen years later, Wikileaks revealed that Pfizer had hired detectives to find evidence of corruption against the Nigerian Attorney General, to compel him to drop the lawsuit.
Researchers in not only industry, but also academia have violated research participants' rights. Arizona State University scientists wanted to investigate the genes of a Native American group, the Havasupai, who were concerned about their high rates of diabetes. The investigators also wanted to study the group's rates of schizophrenia, but feared that the tribe would oppose the study, given the stigma. Hence, these researchers decided to mislead the tribe, stating that the study was only about diabetes. The university's research ethics committee knew the scientists' plan to study schizophrenia, but approved the study, including the consent form, which did not mention any psychiatric diagnoses. The Havasupai gave blood samples, but later learned that the researchers published articles about the tribe's schizophrenia and alcoholism, and genetic origins in Asia (while the Havasupai believed they originated in the Grand Canyon, where they now lived, and which they thus argued they owned). A 2010 legal settlement required that the university return the blood samples to the tribe, which then destroyed them. Had the researchers instead worked with the tribe more respectfully, they could have advanced science in many ways.
Part of the problem and consequent need for regulations is that researchers have conflicts of interest and often do not recognize ethical challenges their research may pose.
Such violations threaten to lower public trust in science, particularly among vulnerable groups that have historically been systemically mistreated, diminishing public and government support for research and for the National Institutes of Health, National Science Foundation and Centers for Disease Control, all of which conduct large numbers of studies.
Research that has failed to follow ethics has in fact impeded innovation.
In popular culture, myths of immoral science and technology--from Frankenstein to Big Brother and Dr. Strangelove--loom.
Admittedly, regulations involve inherent tradeoffs. Following certain rules can take time and effort. Certain regulations may in fact limit research that might potentially advance knowledge, but be grossly unethical. For instance, if our society's sole goal was to have scientists innovate as much as possible, we might let them stick needles into healthy people's brains to remove cells in return for cash that many vulnerable poor people might find desirable. But these studies would clearly pose major ethical problems.
Research that has failed to follow ethics has in fact impeded innovation. In 1999, the death of a young man, Jesse Gelsinger, in a gene therapy experiment in which the investigator was subsequently found to have major conflicts of interest, delayed innovations in the field of gene therapy research for years.
Without regulations, companies might market products that prove dangerous, leading to massive lawsuits that could also ultimately stifle further innovation within an industry.
The key question is not whether regulations help or hurt science alone, but whether they help or hurt science that is both "responsible and innovative."
We don't want "over-regulation." Rather, the right amount of regulations is needed – neither too much nor too little. Hence, policy makers in this area have developed regulations in fair and transparent ways and have also been working to reduce the burden on researchers – for instance, by allowing single IRBs to review multi-site studies, rather than having multiple IRBs do so, which can create obstacles.
In sum, society requires a proper balance of regulations to ensure ethical research, avoid abuses, and ultimately aid us all by promoting responsible innovation.
[Ed. Note: Check out the opposite viewpoint here, and follow LeapsMag on social media to share your perspective.]