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.
China vs. the West: Who Will Lead the Way in Embryo Editing Research?
Junjiu Huang and his team performed a miracle. A few miracles, actually. The researchers at Sun Yat-sen University in Guangzhou, China used the precise new DNA editing tool called CRISPR-CAS9 to edit a human embryo, replacing a single base. In doing so, they edited out beta-thalassemia, a blood disorder that reduces the production of hemoglobin, which can result in pale skin, fatigue, higher risk of blood clots, and other symptoms.
The race is on, and it's one everyone is going to try to win.
Huang's group, which did not respond to an email requesting comment for this story, injected 86 embryos and observed them for 48 hours. After that period -- a time long enough for CRISPR to split the DNA, other molecules to replace the base, and the embryos to grow to eight cells -- they tested 54 of the 71 that survived. Of those, only a few had the replacement base, according to a report of the study published in Protein & Cell. The experiment stopped there as the embryos, which had been acquired from local fertility clinics, were non-viable and not implanted.
But procreation was not the point. Far from it, in fact. The point was to demonstrate that it could be done, that in some far off (or not so far off) future, doctors could use CRISPR to eliminate diseases like Tay-Sachs, Huntington's, and cystic fibrosis that are caused by genetic mutations. Going a step further, perhaps they could eventually even tailor embryos that will develop into adults with specific traits like height and IQ.
Experts agree that we are far from that point, years if not decades away from leveraging CRISPR to cure diseases and decades if not centuries from being able to build designer babies. In that frame, Huang's achievement is just a small step, a blip on the timeline of human achievement. But seen in another light, it's yet another sign that we need to start talking about DNA modification now, establishing protocols, procedures, and plans that guide the subject before we get so far down the road that momentum is impossible to stop.
"The Chinese generally don't have the religious objections to embryo research that have held back research in the West."
It's essential to do so now because the idea of DNA modification -- a realization that humanity can control its evolution -- is compelling and attractive. Imagine a world where doctors and scientists could get rid of disease before it begins or ensure a baby would arrive with an Einstein-level IQ. That's intriguing, and also terrifying. What are the rules? How do we know when to stop? What guides the process? And how can we prevent mistakes or unwanted mutations? To borrow from another famous quotation, with great power comes great responsibility.
These aren't questions for Huang and the Chinese scientific community alone. A team from Oregon recently edited viable human embryos, eliminating a mutation that can lead to heart failure while preventing any unintended consequences. Just as importantly, every embryo they edited produced the intended genetic changes, a vital step since a partial success rate, known as mosaicism, could have devastating consequences to a future child.
In London at the Francis Crick Institute, researcher Kathy Niakan used CRISPR-CAS9 to "turn off" a gene that produces the protein OCT4. Without the protein, the fertilized egg could not produce a blastocyst, which is a key structure in early mammalian development that gives rise to an embryo and placenta. The recent study wasn't designed to go further, but the use of CRISPR was important. "One way to find out what a gene does in the developing embryo is to see what happens when it isn't working," said Dr. Niakan, who was the first scientist in the world to be granted regulatory approval to edit the genes of a human embryo for research. "Now that we have demonstrated an efficient way of doing this, we hope that other scientists will use it to find out the roles of other genes. If we knew the key genes that embryos need to develop successfully, we could improve IVF treatments and understand some causes of pregnancy failure. It may take many years to achieve such an understanding. Our study is just the first step."
The point is, CRISPR is here and it's not going anywhere. Scientists will continue to use it to learn about how humans develop. Yet different rules regarding CRISPR and embryo research in countries around the world will impact who gets there first. "I've heard the U.S.-China gene editing research parallel paths as Sputnik 2.0," said Kevin Doxzen, Science Communications Specialist at the University of California, Berkeley's Innovative Genomics Institute. The race is on, and it's one everyone is going to try to win.
Based on number of researchers and ease of regulations, the Chinese are the favorites to advance the science the furthest, the fastest.
Based on number of researchers and ease of regulations, the Chinese are the favorites to advance the science the furthest, the fastest. "The Chinese generally don't have the religious (predominantly Christian) or moral objections to embryo research that have held back research in the West," said Dr. Julian Savulescu, the Uehiro Professor of Practical Ethics and Director of the Oxford Martin Programme on Collective Responsibility for Infectious Disease at the University of Oxford. "This kind of research should be done, with the right sort of ethical oversight. The concern over China leading the way is that institutional oversight mechanisms are probably not as developed as in the West but so far, there is no evidence of breaches in standards of research ethics around the published research."
Or, put another way by bioethicist Dr. Arthur Caplan, founding director of NYU Langone Health's Division of Medical Ethics: "The Chinese, because they don't care and don't have moral reservations about embryo work, are doing what they want." This lack of aversion to working with embryos manifests itself in a couple of ways. The absence of moral qualms is one. Funding is another. Huang's study, and others like it, receive funding from the government. His, for example, was supported by two grants from the National Basic Research Program and three from the National Natural Science Foundation of China.
The U.S., on the other hand, bans any federal funding for research using human embryos. A law passed in 1996 states that federal dollars can't be used for: "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses." This restriction can shift incentives as many private institutions or commercial enterprises may have financial motivations or other goals beyond furthering basic research for the sake of general knowledge.
Embryo gene modification recently performed in the U.K. would merit 15 years in prison in Australia.
The embryo research ban is even more strict elsewhere. The Oviedo Convention, enacted in 1997, effectively prohibits germline engineering in members of the European Union. "In Italy, you can't destroy an embryo for any reason," said Alessandro Bertero, a postdoctoral fellow at the University of Washington's Department of Pathology who used to study in Italy. "It's illegal, and you'll go to jail." Later, Bertero was one of the researchers who worked with Dr. Niakan in London, an investigation that was allowed by the UK's Human Fertilisation and Embryology Authority. (In Australia, Niakan and her colleagues would face 15 years in jail due to the 2002 Prohibition of Human Cloning Act, which prohibits altering the genomes of embryonic cells.)
Despite the moral and legal reservations in the Western world, every person I spoke with for this story believed that better, more advanced studies and learning is happening in the U.S. and Europe. "The best studies in my opinion are from the labs in California and Oregon," Bertero said. "The quality of the work [in the Chinese study] – not being critical, but to be scientifically critical -- was just quick and dirty. It was, 'Let's just show that we have done it and get it out.' That doesn't mean that the quality of the work was good."
"If the Chinese or someone else starts beating our brains out, we're not going to want to stand by idly and not do these things."
How long that remains the case, however, is an open question. A significant number of groups in China are working on germline editing in human embryos. The concern is that the Chinese will emerge as a leader sooner rather than later because they can do research with embryos more easily than their Western counterparts.
For Caplan, the NYU professor, the embryo ban in the U.S. isn't based on science; it's rooted in something else. "It's 96 percent political," he said, laughing. "It has basically ground to a halt because no one wants to see repercussions take place if federal funding is involved. The NIH isn't involved. And they won't be."
What, in his mind, would get Americans to start realizing the benefits that embryo research would provide? "The perception that other countries were moving quickly to get the advantages of CRISPR and other gene modification techniques, finding more industrial and more medical purposes," he said. "If the Chinese or someone else starts beating our brains out, we're not going to want to stand by idly and not do these things."
Doing so would involve difficult conversations about the role of embryos in research. But these are philosophical questions that need to be approached at some point. From a U.S. perspective, doing so sooner while the American scientists still hold the technological and informational edge, is vital. Ignoring the issue doesn't make it go away.
Experts think a few changes should be made. The ban on federal funding should be lifted. Scientists and regulators should push for things like allowing federal funds to be used for the creation of new embryos for research purposes and the use of spare IVF embryos for research when the embryo would not be implanted into a woman. (Privately funded scientists can proceed in states that encourage embryonic stem cell research, like New York, New Jersey, and California, but not in restrictive ones like Louisiana and South Dakota, which prohibit creating or destroying embryos for research.) Policymakers could ban reproductive gene editing for now but look at it again after a certain period. A highly anticipated report issued earlier this year from an international guidance committee left the door open to eventual clinical trials with edited embryos. As of now, however, Congress will not allow the Food and Drug Administration to consider such trials. This is the future and it's the scientific community's responsibility to develop the ethical framework now.
"The US and Europe have the technological history and capacity to lead this research and should do so, ethically. We ought to be revising our laws and ethical guidelines to facilitate this kind of research," Professor Savulescu said. "But the challenge is to think constructively and ethically about this new technology, and to be leaders, not followers."
Is It Possible to Predict Your Face, Voice, and Skin Color from Your DNA?
Renowned genetics pioneer Dr. J Craig Venter is no stranger to controversy.
Back in 2000, he famously raced the public Human Genome Project to decode all three billion letters of the human genome for the first time. A decade later, he ignited a new debate when his team created a bacterial cell with a synthesized genome.
Most recently, he's jumped back into the fray with a study in the September issue of the Proceedings of the National Academy of Sciences about the predictive potential of genomic data to identify individual traits such as voice, facial structure and skin color.
The new study raises significant questions about the privacy of genetic data.
His study applied whole-genome sequencing and statistical modeling to predict traits in 1,061 people of diverse ancestry. His approach aimed to reconstruct a person's physical characteristics based on DNA, and 74 percent of the time, his algorithm could correctly identify the individual in a random lineup of 10 people from his company's database.
While critics have been quick to cast doubt on the plausibility of his claims, the ability to discern people's observable traits, or phenotypes, from their genomes may grow more precise as technology improves, raising significant questions about the privacy and usage of genetic information in the long term.
J. Craig Venter showing slides from his recent study on facial prediction at the Summit Conference in Los Angeles on Nov. 3, 2017.
(Courtesy of Kira Peikoff)
Critics: Study Was Incomplete, Problematic
Before even redressing these potential legal and ethical considerations, some scientists simply said the study's main result was invalid. They pointed out that the methodology worked much better in distinguishing between people of different ethnicities than those of the same ethnicity. One of the most outspoken critics, Yaniv Erlich, a geneticist at Columbia University, said, "The method doesn't work. The results were like, 'If you have a lineup of ten people, you can predict eight."
Erlich, who reviewed Venter's paper for Science, where it was rejected, said that he came up with the same results—correctly predicting eight of ten people—by just looking at demographic factors such as age, gender and ethnicity. He added that Venter's recent rebuttal to his criticism was that 'Once we have thousands of phenotypes, it might work better.' But that, Erlich argued, would be "a major breach of privacy. Nobody has thousands of phenotypes for people."
Other critics suggested that the study's results discourage the sharing of genetic data, which is becoming increasingly important for medical research. They go one step further and imply that people's possible hesitation to share their genetic information in public databases may actually play into Venter's hands.
Venter's own company, Human Longevity Inc., aims to build the world's most comprehensive private database on human genotypes and phenotypes. The vastness of this information stands to improve the accuracy of whole genome and microbiome sequencing for individuals—analyses that come at a hefty price tag. Today, Human Longevity Inc. will sequence your genome and perform a battery of other health-related tests at an entry cost of $4900, going up to $25,000. Venter initially agreed to comment for this article, but then could not be reached.
"The bigger issue is how do we understand and use genetic information and avoid harming people."
Opens Up Pandora's Box of Ethical Issues
Whether Venter's study is valid may not be as important as the Pandora's box of potential ethical and legal issues that it raises for future consideration. "I think this story is one along a continuum of stories we've had on the issue of identifiability based on genomic information in the past decade," said Amy McGuire, a biomedical ethics professor at Baylor College of Medicine. "It does raise really interesting and important questions about privacy, and socially, how we respond to these types of scientific advancements. A lot of our focus from a policy and ethics perspective is to protect privacy."
McGuire, who is also the Director of the Center for Medical Ethics and Health Policy at Baylor, added that while protecting privacy is very important, "the bigger issue is how do we understand and use genetic information and avoid harming people." While we've taken "baby steps," she said, towards enacting laws in the U.S. that fight genetic determinism—such as the Genetic Information and Nondiscrimination Act, which prohibits discrimination based on genetic information in health insurance and employment—some areas remain unprotected, such as for life insurance and disability.
J. Craig Venter showing slides from his recent study on facial prediction at the Summit Conference in Los Angeles on Nov. 3, 2017.
(Courtesy of Kira Peikoff)
Physical reconstructions like those in Venter's study could also be inappropriately used by law enforcement, said Leslie Francis, a law and philosophy professor at the University of Utah, who has written about the ethical and legal issues related to sharing genomic data.
"If [Venter's] findings, or findings like them, hold up, the implications would be significant," Francis said. Law enforcement is increasingly using DNA identification from genetic material left at crime scenes to weed out innocent and guilty suspects, she explained. This adds another potentially complicating layer.
"There is a shift here, from using DNA sequencing techniques to match other DNA samples—as when semen obtained from a rape victim is then matched (or not) with a cheek swab from a suspect—to using DNA sequencing results to predict observable characteristics," Francis said. She added that while the former necessitates having an actual DNA sample for a match, the latter can use DNA to pre-emptively (and perhaps inaccurately) narrow down suspects.
"My worry is that if this [the study's methodology] turns out to be sort-of accurate, people will think it is better than what it is," said Francis. "If law enforcement comes to rely on it, there will be a host of false positives and false negatives. And we'll face new questions, [such as] 'Which is worse? Picking an innocent as guilty, or failing to identify someone who is guilty?'"
Risking Privacy Involves a Tradeoff
When people voluntarily risk their own privacy, that involves a tradeoff, McGuire said. A 2014 study that she conducted among people who were very sick, or whose children were very sick, found that more than half were willing to share their health information, despite concerns about privacy, because they saw a big benefit in advancing research on their conditions.
"We've focused a lot of our policy attention on restricting access, but we don't have a system of accountability when there's a breach."
"To make leaps and bounds in medicine and genomics, we need to create a database of millions of people signing on to share their genetic and health information in order to improve research and clinical care," McGuire said. "They are going to risk their privacy, and we have a social obligation to protect them."
That also means "punishing bad actors," she continued. "We've focused a lot of our policy attention on restricting access, but we don't have a system of accountability when there's a breach."
Even though most people using genetic information have good intentions, the consequences if not are troubling. "All you need is one bad actor who decimates the trust in the system, and it has catastrophic consequences," she warned. That hasn't happened on a massive scale yet, and even if it did, some experts argue that obtaining the data is not the real risk; what is more concerning is hacking individuals' genetic information to be used against them, such as to prove someone is unfit for a particular job because of a genetic condition like Alzheimer's, or that a parent is unfit for custody because of a genetic disposition to mental illness.
Venter, in fact, told an audience at the recent Summit conference in Los Angeles that his new study's approach could not only predict someone's physical appearance from their DNA, but also some of their psychological traits, such as the propensity for an addictive personality. In the future, he said, it will be possible to predict even more about mental health from the genome.
What is most at risk on a massive scale, however, is not so much genetic information as demographic identifiers included in medical records, such as birth dates and social security numbers, said Francis, the law and philosophy professor. "The much more interesting and lucrative security breaches typically involve not people interested in genetic information per se, but people interested in the information in health records that you can't change."
Hospitals have been hacked for this kind of information, including an incident at the Veterans Administration in 2006, in which the laptop and external hard drive of an agency employee that contained unencrypted information on 26.5 million patients were stolen from the employee's house.
So, what can people do to protect themselves? "Don't share anything you wouldn't want the world to see," Francis said. "And don't click 'I agree' without actually reading privacy policies or terms and conditions. They may surprise you."