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.
5 Key Questions to Consider Before Sending Your Child Back to School
Consider community, school district policies, family health, risks/benefits, and necessity of schools before making the difficult decision.
[Editor's Note: This essay is in response to our current Big Question, which we posed to several experts: "Under what circumstances would you send a child back to school, given that the virus is not going away anytime soon?"]
It is August. The start date of school is quickly approaching. Decisions must be made about whether to send our children back. As a physician, a public health researcher, and the mother of two school-aged children, I have few clear answers.
To add insult to injury, a spate of recent new data suggests that - as many of us suspected all along - kids are susceptible to COVID-19, they transmit COVID-19, and they can get really sick from COVID-19.
Let me start with the obvious. My kids, and all kids, deserve a safe, in-person school year. We know the data on the adverse effects of school closure on kids, particularly for those who are already vulnerable. I also know, on a personal level, that distance learning is no substitute for in-person schooling. Homeschooling may be great for those with the privilege to do it, but I - like many Americans - am unable to quit my job, and children need more than a screen to learn.
Moreover, safe school reopening should not be an impossible dream. I and many other physicians, teachers, and scientists have described the bare minimum that we need to safely reopen schools: a stable, low rate of COVID-19 in the community; funding and mandates for basic public health precautions (like universal masking and small, stable classes) in the schools; and easy access to testing for kids and teachers. This has been achieved, successfully, in other countries.
Unfortunately, the United States has squandered its opportunity to do right by families. Across our country, rates of COVID-19 are rising. Few states have been able to sustain a test positivity rate of less than 5 percent - the maximum that most of us, in the public health world, would tolerate. Delays in testing are rampant. Systemic under-funding of public schools means that many schools simply can't afford to put basic public health measures in place. Worst, science denialism (and the spread of quack conspiracy theories online) means that many communities are fighting even the most basic of safety precautions.
To add insult to injury, a spate of recent new data suggests that - as many of us suspected all along - kids are susceptible to COVID-19, they transmit COVID-19, and they can get really sick from COVID-19. This data increases the risk calculus. Our kids are not immune, and neither are we.
Given that the necessary societal interventions simply have not happened, most American families are therefore left making an individual choice: do I send my kid to school? Or not? There are five key questions for parents to ponder when making the difficult choice about what to do.
First, we must look at our community. Knowing that testing is difficult to obtain, a true estimate of community prevalence of COVID-19 is nearly impossible. But with a test positivity rate of more than 5 percent, it's safe to assume that in a school of 500 people, at least 1 will be positive for COVID-19. That is too high for safety. Whether or not the local government does the right thing, I would not send my child to in-person school if my community had these high rates of test positivity.
Second, we must look at our school district's policies. Will the school mandate masks? Are they cohorting students and teachers in small, stable groups? Do they have contact tracing and isolation policies in place for when a student or teacher inevitably tests positive? Do they have procedures to protect vulnerable teachers and staff? If not, I would not send my child to school. If the district is doing all of the above, I would consider it.
Third, we must look at the health profile of our own kids and families. If my child had chronic medical issues, or if I lived with my elderly parents or were myself at high risk of severe disease, I would not send my child to in-person school.
It is therefore unlikely that schools anywhere in the U.S. will be open by October.
Fourth, we must do the difficult, ethical weighing of the non-zero risk of infection (even in the safest communities) with the needs of our children. Even in low-prevalence states, there will be infections in the school setting. That said, the small risk of a severe infection may be outweighed by the social, emotional, and financial risk of keeping a child home. This decision must be made on a family-by-family basis. I know my answer; but I cannot provide this answer for others.
Finally, we must call attention to the fact that many kids and families have no options. There are far too many American children who literally depend on their school system for physical, nutritional, emotional, and academic safety. There are too many parents who have no way to earn an income and keep their kids safe without in-person learning. If anyone deserves to be prioritized for in-person schooling, it should be them. (And yes, we should also work to fix the social safety net that leaves these children high and dry.)
As I write this on August 2nd, 2020, I am planning to send my two children back to our public schools for in-person education. We have low rates of infection in our community, we have masking and stable cohorts in place, and my family is relatively healthy. We also depend on the schools to keep my children safe and engaged while I'm working in the ER! I will not hesitate, however, to pull my children out of school should any of these considerations change, if local test positivity rates go up, or if my children report that masking is not the norm in the classroom.
And sadly, I expect that this discussion will soon be a moot point. We continue to fail as a nation at basic public health policies. It is therefore unlikely that schools anywhere in the U.S. will be open by October. Our country has not shown the willpower to control the virus, leaving us all with, literally, no choice to make.
[Editor's Note: Here's the other essay in the Back to School series: Masks and Distancing Won't Be Enough to Prevent School Outbreaks, Latest Science Suggests.]
The Only Hydroxychloroquine Story You Need to Read
Hydroxychloroquine has been shown not to provide benefit for COVID-19 patients in multiple randomized controlled trials, despite continuous misinformation asserting its alleged effectiveness.
In the early days of a pandemic caused by a virus with no existing treatments, many different compounds are often considered and tried in an attempt to help patients.
It all relates back to a profound question: How do we know what we know?
Many of these treatments fall by the wayside as evidence accumulates regarding actual efficacy. At that point, other treatments become standard of care once their benefit is proven in rigorously designed trials.
However, about seven months into the pandemic, we're still seeing political resurrection of a treatment that has been systematically studied and demonstrated in well-designed randomized controlled trials to not have benefit.
The hydroxychloroquine (and by extension chloroquine) story is a complicated one that was difficult to follow even before it became infused with politics. It is a simple fact that these drugs, long approved by the Food and Drug Administration (FDA), work in Petri dishes against various viruses including coronaviruses. This set of facts provided biological plausibility to support formally studying their use in the clinical treatment and prevention of COVID-19. As evidence from these studies accumulates, it is a cognitive requirement to integrate that knowledge and not to evade it. This also means evaluating the rigor of the studies.
In recent days we have seen groups yet again promoting the use of hydroxychloroquine in, what is to me, a baffling disregard of the multiple recent studies that have shown no benefit. Indeed, though FDA-approved for other indications like autoimmune conditions and preventing malaria, the emergency use authorization for COVID-19 has been rescinded (which means the government cannot stockpile it). Still, however, many patients continue to ask for the drug, compelled by political commentary, viral videos, and anecdotal data. Yet most doctors (like myself) are refusing to write the prescriptions outside of a clinical trial – a position endorsed by professional medical organizations such as the American College of Physicians and the Infectious Diseases Society of America. Why this disconnect?
It all relates back to a profound question: How do we know what we know? In science, we use the scientific method – the process of observing reality, coming up with a hypothesis about what might be true, and testing that hypothesis as thoroughly as possible until we discover the objective truth.
The confusion we're seeing now stems from an inability to distinguish between anecdotes reported by physicians (observational data) and an actual evidence base. This is understandable among the general public but when done by a healthcare professional, it reveals a disdain for reason, logic, and the scientific method.
The Difference Between Observational Data and Randomized Controlled Trials
The power of informal observation is crucial. It is part of the scientific method but primarily as a basis for generating hypotheses that we can test. How do we conduct medical tests? The gold standard is the double-blind, randomized, placebo-controlled trial. This means that neither the researchers nor the volunteers know who is getting a drug and who is getting a sugar pill. Then both groups of the trial, called arms, can be compared to determine whether the people who got the drug fared better. This study design prevents biases and the placebo effect from confounding the data and undermining the veracity of the results.
For example, a seemingly beneficial effect might be seen in an observational study with no blinding and no control group. In such a case, all patients are openly given the drug and their doctors observe how they do. A prime example is the 36-patient single-arm study from France that generated a tremendous amount of interest after President Trump tweeted about it. But this kind of a study by its nature cannot answer the critical question: Was the positive effect because of hydroxychloroquine or just the natural course of the illness? In other words, would someone have recovered in a similar fashion regardless of the drug? What is the role of the placebo effect?
These are reasons why it is crucial to give a placebo to a control group that is as similar in every respect as possible to those receiving the intervention. Then we attempt to find out by comparing the two groups: What is the side effect profile of the drug? Are the groups large enough to detect a relatively rare safety concern? How long were the patients followed for? Was something else responsible for making the patients get better, such as the use of steroids (as likely was the case in the Henry Ford study)?
Looking at the two major hydroxychloroquine trials, it is apparent that, when studied using the best tools of clinical trials, no benefit is likely to occur.
All of these considerations amount to just a fraction of the questions that can be answered more definitively in a well-designed large randomized controlled trial than in observational studies. Indeed, an observational study from New York failed to show any benefit in hospitalized patients, showing how unclear and disparate the results can be with these types of studies. A New York retrospective study (which examined patient outcomes after they were already treated) had similar results and included the use of azithromycin.
When evaluating a study, it is also important to note whether conflicts of interest exist, as well as the quality of the peer review and the data itself. In the case of the French study, for example, the paper was published in a journal in which one of the authors was editor-in-chief, and it was accepted for publication after 24 hours. Patients who fared poorly on hydroxychloroquine were also left out of the study altogether, skewing the results.
What Randomized Controlled Trials Have Shown
Looking at the two major hydroxychloroquine trials, it is apparent that, when studied using the best tools of clinical trials, no benefit is likely to occur. The most important of these studies to announce results was part of the Recovery trial, which was designed to test multiple interventions in the treatment of COVID-19. This trial, which has yet to be formally published, was a randomized controlled trial that involved over 1500 hospitalized patients being administered hydroxychloroquine compared to over 3000 who did not receive the medication. Clinical testing requires large numbers of patients to have the power to demonstrate statistical significance -- the threshold at which any apparent benefit is more than you would expect by random chance alone.
In this study, hydroxychloroquine provided no mortality benefit or even a benefit in hospital length of stay. In fact, the opposite occurred. Hydroxychloroquine patients were more likely to stay in the hospital longer and were more likely to require mechanical ventilation. Additionally, smaller randomized trials conducted in China have not shown benefit either.
Another major study involved the use of hydroxychloroquine to prevent illness in people who were exposed to COVID-19. These results, published in The New England Journal of Medicine, included over 800 patients who were studied in a randomized double-blind controlled trial and also failed to show any benefit.
But what about adding the antibiotic azithromycin in conjunction with hydroxychloroquine? A three-arm randomized controlled study involving over 500 patients hospitalized with mild to moderate COVID-19 was conducted. Its results, also published in The New England Journal of Medicine, failed to show any benefit – with or without azithromycin – and demonstrated evidence of harm. Those who received these treatments had elevations of their liver function tests and heart rhythm abnormalities. These findings hold despite the retraction of an observational study showing similar results.
Additionally, when used in combination with remdesivir – an experimental antiviral – hydroxychloroquine has been shown to be associated with worse outcomes and more side effects.
But what about in mildly ill patients not requiring hospitalization? There was no benefit found in a randomized double-blind placebo-controlled trial of 400 patients, the majority of whom were given the drug within one day of symptoms.
Some randomized controlled studies have yet to report their findings on hydroxychloroquine in non-hospitalized patients, with the use of zinc (which has some evidence in the treatment of the common cold, another ailment that can be caused by coronaviruses). And studies have yet to come out regarding whether hydroxychloroquine can prevent people from getting sick before they are even exposed. But the preponderance of the evidence from studies designed specifically to find benefit for treating COVID-19 does not support its use outside of a research setting.
Today – even with some studies (including those with zinc) still ongoing – if a patient asked me to prescribe them hydroxychloroquine for any severity or stage of illness, with or without zinc, with or without azithromycin, I would refrain. I would explain that, based on the evidence from clinical trials that has been amassed, there is no reason to believe that it will alter the course of illness for the better.
Failing to recognize the reality of the situation runs the risk of crowding out other more promising treatments and creating animosity where none should exist.
What has been occurring is a continual shifting of goalposts with each negative hydroxychloroquine study. Those in favor of the drug protest that a trial did not include azithromycin or zinc or wasn't given at the right time to the right patients. While there may be biological plausibility to treating illness early or combining treatments with zinc, it can only be definitively shown in a randomized, controlled prospective study.
The bottom line: A study that only looks at past outcomes in one group of patients – even when well conducted – is at most hypothesis generating and cannot be used as the sole basis for a new treatment paradigm.
Some may argue that there is no time to wait for definitive studies, but no treatment is benign. The risk/benefit ratio is not the same for every possible use of the drug. For example, hydroxychloroquine has a long record of use in rheumatoid arthritis and systemic lupus (whose patients are facing shortages because of COVID-19 related demand). But the risk of side effects for many of these patients is worth taking because of the substantial benefit the drug provides in treating those conditions.
In COVID-19, however, the disease apparently causes cardiac abnormalities in a great deal of many mild cases, a situation that should prompt caution when using any drugs that have known effects on the cardiac system -- drugs like hydroxychloroquine and azithromycin.
My Own Experience
It is not the case that every physician was biased against this drug from the start. Indeed, most of us wanted it to be shown to be beneficial, as it was a generic drug that was widely available and very familiar. In fact, early in the pandemic I prescribed it to hospitalized patients on two occasions per a hospital protocol. However, it is impossible for me as a sole clinician to know whether it worked, was neutral, or was harmful. In recent days, however, I have found the hydroxychloroquine talk to have polluted the atmosphere. One recent patient was initially refusing remdesivir, a drug proven in large randomized trials to have effectiveness, because he had confused it with hydroxychloroquine.
Moving On to Other COVID Treatments: What a Treatment Should Do
The story of hydroxychloroquine illustrates a fruitless search for what we are actually looking for in a COVID-19 treatment. In short, we are looking for a medication that can decrease symptoms, decrease complications, hasten recovery, decrease hospitalizations, decrease contagiousness, decrease deaths, and prevent infection. While it is unlikely to find a single antiviral that can accomplish all of these, fulfilling even just one is important.
For example, remdesivir hastens recovery and dexamethasone decreases mortality. Definitive results of the use of convalescent plasma and immunomodulating drugs such as siltuxamab, baricitinib, and anakinra (for use in the cytokine storms characteristic of severe disease) are still pending, as are the trials with monoclonal antibodies.
While it was crucial that the medical and scientific community definitively answer the questions surrounding the use of chloroquine and hydroxychloroquine in the treatment of COVID-19, it is time to face the facts and accept that its use for the treatment of this disease is not likely to be beneficial. Failing to recognize the reality of the situation runs the risk of crowding out other more promising treatments and creating animosity where none should exist.
Dr. Adalja is focused on emerging infectious disease, pandemic preparedness, and biosecurity. He has served on US government panels tasked with developing guidelines for the treatment of plague, botulism, and anthrax in mass casualty settings and the system of care for infectious disease emergencies, and as an external advisor to the New York City Health and Hospital Emergency Management Highly Infectious Disease training program, as well as on a FEMA working group on nuclear disaster recovery. Dr. Adalja is an Associate Editor of the journal Health Security. He was a coeditor of the volume Global Catastrophic Biological Risks, a contributing author for the Handbook of Bioterrorism and Disaster Medicine, the Emergency Medicine CorePendium, Clinical Microbiology Made Ridiculously Simple, UpToDate's section on biological terrorism, and a NATO volume on bioterrorism. He has also published in such journals as the New England Journal of Medicine, the Journal of Infectious Diseases, Clinical Infectious Diseases, Emerging Infectious Diseases, and the Annals of Emergency Medicine. He is a board-certified physician in internal medicine, emergency medicine, infectious diseases, and critical care medicine. Follow him on Twitter: @AmeshAA