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.
Digital blockchain concept.
The hacker collective known as the Dark Overlord first surfaced in June 2016, when it advertised more than 600,000 patient files from three U.S. healthcare organizations for sale on the dark web. The group, which also attempted to extort ransom from its victims, soon offered another 9 million records pilfered from health insurance companies and provider networks across the country.
Since 2009, federal regulators have counted nearly 5,000 major data breaches in the United States alone, affecting some 260 million individuals.
Last October, apparently seeking publicity as well as cash, the hackers stole a trove of potentially scandalous data from a celebrity plastic surgery clinic in London—including photos of in-progress genitalia- and breast-enhancement surgeries. "We have TBs [terabytes] of this shit. Databases, names, everything," a gang representative told a reporter. "There are some royal families in here."
Bandits like these are prowling healthcare's digital highways in growing numbers. Since 2009, federal regulators have counted nearly 5,000 major data breaches in the United States alone, affecting some 260 million individuals. Although hacker incidents represent less than 20 percent of the total breaches, they account for almost 80 percent of the affected patients. Such attacks expose patients to potential blackmail or identity theft, enable criminals to commit medical fraud or file false tax returns, and may even allow hostile state actors to sabotage electric grids or other infrastructure by e-mailing employees malware disguised as medical notices. According to the consulting agency Accenture, data theft will cost the healthcare industry $305 billion between 2015 and 2019, with annual totals doubling from $40 billion to $80 billion.
Blockchain could put patients in control of their own data, empowering them to access, share, and even sell their medical information as they see fit.
One possible solution to this crisis involves radically retooling the way healthcare data is stored and shared—by using blockchain, the still-emerging information technology that underlies cryptocurrencies such as Bitcoin. And blockchain-enabled IT systems, boosters say, could do much more than prevent the theft of medical data. Such networks could revolutionize healthcare delivery on many levels, creating efficiencies that would reduce medical errors, improve coordination between providers, drive down costs, and give researchers unprecedented insights into patterns of disease. Perhaps most transformative, blockchain could put patients in control of their own data, empowering them to access, share, and even sell their medical information as they see fit. Widespread adoption could result in "a new kind of healthcare economy, in which data and services are quantifiable and exchangeable, with strong guarantees around both the security and privacy of sensitive information," wrote W. Brian Smith, chief scientist of healthcare-blockchain startup PokitDok, in a recent white paper.
Around the world, entrepreneurs, corporations, and government agencies are hopping aboard the blockchain train. A survey by the IBM Institute for Business Value, released in late 2016, found that 16 percent of healthcare executives in 16 countries planned to begin implementing some form of the technology in the coming year; 90 percent planned to launch a pilot program in the next two years. In 2017, Estonia became the first country to switch its medical-records system to a blockchain-based framework. Great Britain and Dubai are exploring a similar move. Yet in countries with more fragmented health systems, most notably the U.S., the challenges remain formidable. Some of the most advanced healthcare applications envisioned for blockchain, moreover, raise technological and ethical questions whose answers may not arrive anytime soon.
By creating a detailed, comprehensive, and immutable timeline of medical transactions, blockchain-based recordkeeping could help providers gauge a patient's long-term health patterns in a way that's never before been possible.
What Exactly Is Blockchain, Anyway?
To understand the buzz around blockchain, it's necessary to grasp (at least loosely) how the technology works. Ordinary digital recordkeeping systems rely on a central administrator that acts as gatekeeper to a treasury of data; if you can sneak past the guard, you can often gain access to the entire hoard, and your intrusion may go undetected indefinitely. Blockchain, by contrast, employs a network of synchronized, replicated databases. Information is scattered among these nodes, rather than on a single server, and is exchanged through encrypted, peer-to-peer pathways. Each transaction is visible to every computer on the network, and must be approved by a majority in order to be successfully completed. Each batch of transactions, or "block," is date- and time-stamped, marked with the user's identity, and given a cryptographic code, which is posted to every node. These blocks form a "chain," preserved in an electronic ledger, that can be read by all users but can't be edited. Any unauthorized access, or attempt at tampering, can be quickly neutralized by these overlapping safeguards. Even if a hacker managed to break into the system, penetrating deeply would be extraordinarily difficult.
Because blockchain technology shares transaction records throughout a network, it could eliminate communication bottlenecks between different components of the healthcare system (primary care physicians, specialists, nurses, and so on). And because blockchain-based systems are designed to incorporate programs known as "smart contracts," which automate functions previously requiring human intervention, they could reduce dangerous slipups as well as tedious and costly paperwork. For example, when a patient gets a checkup, sees a specialist, and fills a prescription, all these actions could be automatically recorded on his or her electronic health record (EHR), checked for errors, submitted for billing, and entered on insurance claims—which could be adjudicated and reimbursed automatically as well. "Blockchain has the potential to remove a lot of intermediaries from existing workflows, whether digital or nondigital," says Kamaljit Behera, an industry analyst for the consulting firm Frost & Sullivan.
The possible upsides don't end there. By creating a detailed, comprehensive, and immutable timeline of medical transactions, blockchain-based recordkeeping could help providers gauge a patient's long-term health patterns in a way that's never before been possible. In addition to data entered by their caregivers, individuals could use app-based technologies or wearables to transmit other information to their records, such as diet, exercise, and sleep patterns, adding new depth to their medical portraits.
Many experts expect healthcare blockchain to take root more slowly in the U.S. than in nations with government-run national health services.
Smart contracts could also allow patients to specify who has access to their data. "If you get an MRI and want your orthopedist to see it, you can add him to your network instead of carrying a CD into his office," explains Andrew Lippman, associate director of the MIT Media Lab, who helped create a prototype healthcare blockchain system called MedRec that's currently being tested at Beth Israel Deaconess Hospital in Boston. "Or you might make a smart contract to allow your son or daughter to access your healthcare records if something happens to you." Another option: permitting researchers to analyze your data for scientific purposes, whether anonymously or with your name attached.
The Recent History, and Looking Ahead
Over the past two years, a crowd of startups has begun vying for a piece of the emerging healthcare blockchain market. Some, like PokitDok and Atlanta-based Patientory, plan to mint proprietary cryptocurrencies, which investors can buy in lieu of stock, medical providers may earn as a reward for achieving better outcomes, and patients might score for meeting wellness goals or participating in clinical trials. (Patientory's initial coin offering, or ICO, raised more than $7 million in three days.) Several fledgling healthcare-blockchain companies have found powerful corporate partners: Intel for Silicon Valley's PokitDok, Kaiser Permanente for Patientory, Philips for Los Angeles-based Gem Health. At least one established provider network, Change Healthcare, is developing blockchain-based systems of its own. Two months ago, Change launched what it calls the first "enterprise-scale" blockchain network in U.S. healthcare—a system to track insurance claim submissions and remittances.
No one, however, has set a roll-out date for a full-blown, blockchain-based EHR system in this country. "We have yet to see anything move from the pilot phase to some kind of production status," says Debbie Bucci, an IT architect in the federal government's Office of the National Coordinator for Health Information Technology. Indeed, many experts expect healthcare blockchain to take root more slowly here than in nations with government-run national health services. In America, a typical patient may have dealings with a family doctor who keeps everything on paper, an assortment of hospitals that use different EHR systems, and an insurer whose system for processing claims is separate from that of the healthcare providers. To help bridge these gaps, a consortium called the Hyperledger Healthcare Working Group (which includes many of the leading players in the field) is developing standard protocols for blockchain interoperability and other functions. Adding to the complexity is the federal Health Insurance and Portability Act (HIPAA), which governs who can access patient data and under what circumstances. "Healthcare blockchain is in a very nascent stage," says Behera. "Coming up with regulations and other guidelines, and achieving large-scale implementation, will take some time."
The ethical implications of buying and selling personal genomic data in an electronic marketplace are doubtless open to debate.
How long? Behera, like other analysts, estimates that relatively simple applications, such as revenue-cycle management systems, could become commonplace in the next five years. More ambitious efforts might reach fruition in a decade or so. But once the infrastructure for healthcare blockchain is fully established, its uses could go far beyond keeping better EHRs.
A handful of scientists and entrepreneurs are already working to develop one visionary application: managing genomic data. Last month, Harvard University geneticist George Church—one of the most influential figures in his discipline—launched a business called Nebula Genomics. It aims to set up an exchange in which individuals can use "Neptune tokens" to purchase DNA sequencing, which will be stored in the company's blockchain-based system; research groups will be able to pay clients for their data using the same cryptocurrency. Luna DNA, founded by a team of biotech veterans in San Diego, plans a similar service, as does a Moscow-based startup called the Zenome Project.
Hossein Rahnama, CEO of the mobile-tech company Flybits and director of research at the Ryerson Centre for Cloud and Context-Aware Computing in Toronto, envisions a more personalized way of sharing genomic data via blockchain. His firm is working with a U.S. insurance company to develop a service that would allow clients in their 20s and 30s to connect with people in their 70s or 80s with similar genomes. The young clients would learn how the elders' lifestyle choices had influenced their health, so that they could modify their own habits accordingly. "It's intergenerational wisdom-sharing," explains Rahnama, who is 38. "I would actually pay to be a part of that network."
The ethical implications of buying and selling personal genomic data in an electronic marketplace are doubtless open to debate. Such commerce could greatly expand the pool of subjects for research in many areas of medicine, enabling the kinds of breakthroughs that only Big Data can provide. Yet it could also lead millions to surrender the most private information of all—the secrets of their cells—to buyers with less benign intentions. The Dark Overlord, one might argue, could not hope for a more satisfying victory.
These scenarios, however, are pure conjecture. After the first web page was posted, in 1991, Lippman observes, "a whole universe developed that you couldn't have imagined on Day 1." The same, he adds, is likely true for healthcare blockchain. "Our vision is to make medical records useful for you and for society, and to give you more control over your own identity. Time will tell."
The First Cloned Monkeys Provoked More Shrugs Than Shocks
Zhong Zhong and Hua Hua, the two cloned macaques.
A few months ago, it was announced that not one, but two healthy long-tailed macaque monkeys were cloned—a first for primates of any kind. The cells were sourced from aborted monkey fetuses and the DNA transferred into eggs whose nuclei had been removed, the same method that was used in 1996 to clone "Dolly the Sheep." Two live births, females named Zhong Zhong and Hua Hua, resulted from 60 surrogate mothers. Inefficient, it's true. But over time, the methods are likely to be improved.
The scientist who supervised the project predicts that cloning, along with gene editing, will result in "ideal primate models" for studying disease mechanisms and drug screening.
Dr. Gerald Schatten, a famous would-be monkey cloner, authored a controversial paper in 2003 describing the formidable challenges to cloning monkeys and humans, speculating that the feat might never be accomplished. Now, some 15 years later, that prediction, insofar as it relates to monkeys, has blown away.
Zhong Zhong and Hua Hua were created at the Chinese Academy of Science's Institute of Neuroscience in Shanghai. The Institute founded in 1999 boasts 32 laboratories, expanding to 50 labs in 2020. It maintains two non-human primate research facilities.
The founder and director, Dr. Mu-ming Poo, supervised the project. Poo is an extremely accomplished senior researcher at the pinnacle of his field, a distinguished professor emeritus in Biology at UC Berkeley. In 2016, he was awarded the prestigious $500,000 Gruber Neuroscience Prize. At that time, Poo's experiments were described by a colleague as being "innovative and very often ingenious."
Poo maintains the reputation of studying some of the most important questions in cellular neuroscience.
But is society ready to accept cloned primates for medical research without the attendant hysteria about fears of cloned humans?
By Western standards, use of non-human primates in research focuses on the welfare of the animal subjects. As PETA reminds us, there is a dreadful and sad history of mistreatment. Dr. Poo assures us that his cloned monkeys are treated ethically and that the Institute is compliant with the highest regulatory standards, as promulgated by the U.S. National Institutes of Health.
He presents the noblest justifications for the research. He predicts that cloning, along with gene editing, will result in "ideal primate models" for studying disease mechanisms and drug screening. He declares that this will eventually help to solve Parkinson's, Huntington's and Alzheimer's disease.
But is society ready to accept cloned primates for medical research without the attendant hysteria about fears of cloned humans? It appears so.
While much of the news coverage expressed this predictable worry, my overall impression is that the societal response was muted. Where was the expected outrage? Then again, we've come a long way since Dolly the Sheep in terms of both the science and the cultural acceptance of cloning. Perhaps my unique vantage point can provide perspective on how much attitudes have evolved.
Perhaps my unique vantage point can provide perspective on how much attitudes have evolved.
I sometimes joke that I am the world's only human cloning lawyer—a great gig but there are still no clients.
I first crashed into the cloning scene in 2002 when I sued the so-called human cloning company "Clonaid" and asked in court to have a temporary guardian appointed for the alleged first human clone "Baby Eve." The claim needed to be tested, and mine was the first case ever aiming to protect the rights of a human clone. My legal basis was child welfare law, protecting minors from abuse, negligence, and exploitation.
The case had me on back-to-back global television broadcasts around the world; there was live news and "breathless" coverage at the courthouse emblazoned in headlines in every language on the planet. Cloning was, after all, perceived as a species-altering event: asexual reproduction. The controversy dominated world headlines for month until Clonaid's claim was busted as the "fakest" of fake news.
Fresh off the cloning case, the scientific community reached out to me, seeing me as the defender of legitimate science, an opponent of cloning human babies but a proponent of using cloning techniques to accelerate ethical regenerative medicine and embryonic stem cell research in general.
The years 2003 to 2006 were the era of the "stem cell wars" and a dominant issue was human cloning. Social conservative lawmakers around the world were seeking bans or criminalization not only of cloning babies but also the cloning of cells to match the donor's genetics. Scientists were being threatened with fines and imprisonment. Human cloning was being challenged in the United Nations with the United States backing a global treaty to ban and morally condemn all cloning -- including the technique that was crucial for research.
Scientists and patients were touting the cloning technique as a major biomedical breakthrough because cells could be created as direct genetic matches from a specific donor.
At the same time, scientists and patients were touting the cloning technique as a major biomedical breakthrough because cells could be created as direct genetic matches from a specific donor.
So my organization organized a conference at UN headquarters to defend research cloning and all the big names in stem cell research were there. We organized petitions to the UN and faxed 35,000 signatures to the country mission. These ongoing public policy battles were exacerbated in part because of the growing fear that cloning babies was just around the corner.
Then in 2005, the first cloned dog stunned the world, an Afghan hound named Snuppy. I met him when I visited the laboratories of Professor Woo Suk Hwang in Korea. His minders let me hold his leash -- TIME magazine's scientific breakthrough of the year. He didn't lick me or even wag his tail; I figured he must not like lawyers.
Tragically, soon thereafter, I witnessed firsthand Dr. Hwang's fall from grace when his human stem cell cloning breakthroughs proved false. The massive scientific misconduct rocked the nation of Korea, stem cell science in general, and provoked terrible news coverage.
Nevertheless, by 2007, the proposed bans lost steam, overridden by the advent of a Japanese researcher's Nobel Prize winning formula for reprogramming human cells to create genetically matched cell lines, not requiring the destruction of human embryos.
After years of panic, none of the recent cloning headlines has caused much of a stir.
Five years later, when two American scientists accomplished therapeutic human cloned stem cell lines, their news was accepted without hysteria. Perhaps enough time had passed since Hwang and the drama was drained.
In the just past 30 days we have seen more cloning headlines. Another cultural icon, Barbara Streisand, revealed she owns two cloned Coton de Tulear puppies. The other weekend, the television news show "60 Minutes" devoted close to an hour on the cloned ponies used at the top level of professional polo. And in India, scientists just cloned the first Assamese buffalo.
And you know what? After years of panic, none of this has caused much of a stir. It's as if the future described by Alvin Toffler in "Future Shock" has arrived and we are just living with it. A couple of cloned monkeys barely move the needle.
Perhaps it is the advent of the Internet and the overall dilution of wonder and outrage. Or maybe the muted response is rooted in popular culture. From Orphan Black to the plotlines of dozens of shows and books, cloning is just old news. The hand-wringing discussions about "human dignity" and "slippery slopes" have taken a backseat to the AI apocalypse and Martian missions.
We humans are enduring plagues of dementia and Alzheimer's, and we will need more monkeys. I will take mine cloned, if it will speed progress.
Personally, I still believe that cloned children should not be an option. Child welfare laws might be the best deterrent.
The same does not hold for cloning monkey research subjects. Squeamishness aside, I think Zhong Zhong and Hua Hua will soon be joined by a legion of cloned macaques and probably marmosets.
We humans are enduring plagues of dementia and Alzheimer's, and we will need more monkeys. I will take mine cloned, if it will speed the mending of these consciousness-destroying afflictions.
Scientific revolutions once took centuries, then decades, and now seem to bombard us daily. The convergence of technologies has accelerated the future. To Zhong Zhong and Hua Hua, my best wishes with the hope that their sacrifices will contribute to the health of all primates -- not just humans.