Theo, an 18-month-old in rural Nebraska, walks with his father in their backyard. For many toddlers, the barriers to accessing COVID-19 vaccines are many, such as few locations giving vaccines to very young children.
It’s Theo’s* first time in the snow. Wide-eyed, he totters outside holding his father’s hand. Sarah Holmes feels great joy in watching her 18-month-old son experience the world, “His genuine wonder and excitement gives me so much hope.”
In the summer of 2021, two months after Theo was born, Holmes, a behavioral health provider in Nebraska lost her grandparents to COVID-19. Both were vaccinated and thought they could unmask without any risk. “My grandfather was a veteran, and really trusted the government and faith leaders saying that COVID-19 wasn’t a threat anymore,” she says.” The state of emergency in Louisiana had ended and that was the message from the people they respected. “That is what killed them.”
The current official public health messaging is that regardless of what variant is circulating, the best way to be protected is to get vaccinated. These warnings no longer mention masking, or any of the other Swiss-cheese layers of mitigation that were prevalent in the early days of this ongoing pandemic.
The problem with the prevailing, vaccine centered strategy is that if you are a parent with children under five, barriers to access are real. In many cases, meaningful tools and changes that would address these obstacles are lacking, such as offering vaccines at more locations, mandating masks at these sites, and providing paid leave time to get the shots.
Children are at risk
Data presented at the most recent FDA advisory panel on COVID-19 vaccines showed that in the last year infants under six months had the third highest rate of hospitalization. “From the beginning, the message has been that kids don’t get COVID, and then the message was, well kids get COVID, but it’s not serious,” says Elias Kass, a pediatrician in Seattle. “Then they waited so long on the initial vaccines that by the time kids could get vaccinated, the majority of them had been infected.”
A closer look at the data from the CDC also reveals that from January 2022 to January 2023 children aged 6 to 23 months were more likely to be hospitalized than all other vaccine eligible pediatric age groups.
“We sort of forced an entire generation of kids to be infected with a novel virus and just don't give a shit, like nobody cares about kids,” Kass says. In some cases, COVID has wreaked havoc with the immune systems of very young children at his practice, making them vulnerable to other illnesses, he said. “And now we have kids that have had COVID two or three times, and we don’t know what is going to happen to them.”
Jumping through hurdles
Children under five were the last group to have an emergency use authorization (EUA) granted for the COVID-19 vaccine, a year and a half after adult vaccine approval. In June 2022, 30,000 sites were initially available for children across the country. Six months later, when boosters became available, there were only 5,000.
Currently, only 3.8% of children under two have completed a primary series, according to the CDC. An even more abysmal 0.2% under two have gotten a booster.
Ariadne Labs, a health center affiliated with Harvard, is trying to understand why these gaps exist. In conjunction with Boston Children’s Hospital, they have created a vaccine equity planner that maps the locations of vaccine deserts based on factors such as social vulnerability indexes and transportation access.
“People are having to travel farther because the sites are just few and far between,” says Benjy Renton, a research assistant at Ariadne.
Michelle Baltes-Breitwisch, a pharmacist, and her two-year-old daughter, Charlee, live in Iowa. When the boosters first came out she expected her toddler could get it close to home, but her husband had to drive Charlee four hours roundtrip.
This experience hasn’t been uncommon, especially in rural parts of the U.S. If parents wanted vaccines for their young children shortly after approval, they faced the prospect of loading babies and toddlers, famous for their calm demeanor, into cars for lengthy rides. The situation continues today. Mrs. Smith*, a grant writer and non-profit advisor who lives in Idaho, is still unable to get her child the bivalent booster because a two-hour one-way drive in winter weather isn’t possible.
It can be more difficult for low wage earners to take time off, which poses challenges especially in a number of rural counties across the country, where weekend hours for getting the shots may be limited.
Protect Their Future (PTF), a grassroots organization focusing on advocacy for the health care of children, hears from parents several times a week who are having trouble finding vaccines. The vaccine rollout “has been a total mess,” says Tamara Lea Spira, co-founder of PTF “It’s been very hard for people to access vaccines for children, particularly those under three.”
Seventeen states have passed laws that give pharmacists authority to vaccinate as young as six months. Under federal law, the minimum age in other states is three. Even in the states that allow vaccination of toddlers, each pharmacy chain varies. Some require prescriptions.
It takes time to make phone calls to confirm availability and book appointments online. “So it means that the parents who are getting their children vaccinated are those who are even more motivated and with the time and the resources to understand whether and how their kids can get vaccinated,” says Tiffany Green, an associate professor in population health sciences at the University of Wisconsin at Madison.
Green adds, “And then we have the contraction of vaccine availability in terms of sites…who is most likely to be affected? It's the usual suspects, children of color, disabled children, low-income children.”
It can be more difficult for low wage earners to take time off, which poses challenges especially in a number of rural counties across the country, where weekend hours for getting the shots may be limited. In Bibb County, Ala., vaccinations take place only on Wednesdays from 1:45 to 3:00 pm.
“People who are focused on putting food on the table or stressed about having enough money to pay rent aren't going to prioritize getting vaccinated that day,” says Julia Raifman, assistant professor of health law, policy and management at Boston University. She created the COVID-19 U.S. State Policy Database, which tracks state health and economic policies related to the pandemic.
Most states in the U.S. lack paid sick leave policies, and the average paid sick days with private employers is about one week. Green says, “I think COVID should have been a wake-up call that this is necessary.”
Maskless waiting rooms
For her son, Holmes spent hours making phone calls but could uncover no clear answers. No one could estimate an arrival date for the booster. “It disappoints me greatly that the process for locating COVID-19 vaccinations for young children requires so much legwork in terms of time and resources,” she says.
In January, she found a pharmacy 30 minutes away that could vaccinate Theo. With her son being too young to mask, she waited in the car with him as long as possible to avoid a busy, maskless waiting room.
Kids under two, such as Theo, are advised not to wear masks, which make it too hard for them to breathe. With masking policies a rarity these days, waiting rooms for vaccines present another barrier to access. Even in healthcare settings, current CDC guidance only requires masking during high transmission or when treating COVID positive patients directly.
“This is a group that is really left behind,” says Raifman. “They cannot wear masks themselves. They really depend on others around them wearing masks. There's not even one train car they can go on if their parents need to take public transportation… and not risk COVID transmission.”
Yet another challenge is presented for those who don’t speak English or Spanish. According to Translators without Borders, 65 million people in America speak a language other than English. Most state departments of health have a COVID-19 web page that redirects to the federal vaccines.gov in English, with an option to translate to Spanish only.
The main avenue for accessing information on vaccines relies on an internet connection, but 22 percent of rural Americans lack broadband access. “People who lack digital access, or don’t speak English…or know how to navigate or work with computers are unable to use that service and then don’t have access to the vaccines because they just don’t know how to get to them,” Jirmanus, an affiliate of the FXB Center for Health and Human Rights at Harvard and a member of The People’s CDC explains. She sees this issue frequently when working with immigrant communities in Massachusetts. “You really have to meet people where they’re at, and that means physically where they’re at.”
Equitable solutions
Grassroots and advocacy organizations like PTF have been filling a lot of the holes left by spotty federal policy. “In many ways this collective care has been as important as our gains to access the vaccine itself,” says Spira, the PTF co-founder.
PTF facilitates peer-to-peer networks of parents that offer support to each other. At least one parent in the group has crowdsourced information on locations that are providing vaccines for the very young and created a spreadsheet displaying vaccine locations. “It is incredible to me still that this vacuum of information and support exists, and it took a totally grassroots and volunteer effort of parents and physicians to try and respond to this need.” says Spira.
Kass, who is also affiliated with PTF, has been vaccinating any child who comes to his independent practice, regardless of whether they’re one of his patients or have insurance. “I think putting everything on retail pharmacies is not appropriate. By the time the kids' vaccines were released, all of our mass vaccination sites had been taken down.” A big way to help parents and pediatricians would be to allow mixing and matching. Any child who has had the full Pfizer series has had to forgo a bivalent booster.
“I think getting those first two or three doses into kids should still be a priority, and I don’t want to lose sight of all that,” states Renton, the researcher at Ariadne Labs. Through the vaccine equity planner, he has been trying to see if there are places where mobile clinics can go to improve access. Renton continues to work with local and state planners to aid in vaccine planning. “I think any way we can make that process a lot easier…will go a long way into building vaccine confidence and getting people vaccinated,” Renton says.
Michelle Baltes-Breitwisch, a pharmacist, and her two-year-old daughter, Charlee, live in Iowa. Her husband had to drive four hours roundtrip to get the boosters for Charlee.
Michelle Baltes-Breitwisch
Other changes need to come from the CDC. Even though the CDC “has this historic reputation and a mission of valuing equity and promoting health,” Jirmanus says, “they’re really failing. The emphasis on personal responsibility is leaving a lot of people behind.” She believes another avenue for more equitable access is creating legislation for upgraded ventilation in indoor public spaces.
Given the gaps in state policies, federal leadership matters, Raifman says. With the FDA leaning toward a yearly COVID vaccine, an equity lens from the CDC will be even more critical. “We can have data driven approaches to using evidence based policies like mask policies, when and where they're most important,” she says. Raifman wants to see a sustainable system of vaccine delivery across the country complemented with a surge preparedness plan.
With the public health emergency ending and vaccines going to the private market sometime in 2023, it seems unlikely that vaccine access is going to improve. Now more than ever, ”We need to be able to extend to people the choice of not being infected with COVID,” Jirmanus says.
*Some names were changed for privacy reasons.
Ordinary people are living better with chronic conditions thanks to a recent explosion of developments in medical implants.
The demand for transplantable organs dwarfs their availability. There are currently over 100,000 people on the transplant waiting list in the U.S., compared to 40,000 transplants completed in 2021. But even this doesn’t reflect the number of people in dire straits who don’t qualify for a transplant because of things like frailty, smoking status and their low odds of surviving the surgery.
My journey to becoming a cyborg came about because of a lifelong medical condition characterized by pathologically low motility of the digestive system, called gastroparesis. Ever since I was in my teens, I’ve had chronic problems with severe nausea. Flareups can be totally incapacitating and last anywhere from hours to months, interspersed with periods of relief. The cycle is totally unpredictable, and for decades my condition went both un- and misdiagnosed by doctors who were not even aware that the condition existed. Over the years I was labeled with whatever fashionable but totally inappropriate medical label existed at the time, and not infrequently, hypochondria.
Living with the gastric pacer is easy. In fact, most of the time, I don’t even know it’s there.
One of the biggest turning points in my life came when a surgeon at the George Washington University Hospital, Dr. Frederick Brody, ordered a gastric emptying test that revealed gastroparesis. This was in 2009, and an implantable device, called a gastric pacer, had been approved by the FDA for compassionate use, meaning that no other treatments were available. The small device is like a pacemaker that’s implanted beneath the skin of the abdomen and is attached to the stomach through electrodes that carry electrical pulses that stimulate the stomach, making it contract as it’s supposed to.
Dr. Brody implanted the electrical wires and the device, and, once my stomach started to respond to the pulses, I got the most significant nausea relief I’d had in decades of futile treatments. It sounds cliché to say that my debt to Dr. Brody is immeasurable, but the pacer has given me more years of relative normalcy than I previously could have dreamed of.
I should emphasize that the pacer is not a cure. I still take a lot of medicine and have to maintain a soft, primarily vegetarian diet, and the condition has progressed with age. I have ups and downs, and can still have periods of severe illness, but there’s no doubt I would be far worse off without the electrical stimulation provided by the pacer.
Living with the gastric pacer is easy. In fact, most of the time, I don’t even know it’s there. It entails periodic visits with a surgeon who can adjust the strength of the electrical pulses using a wireless device, so when symptoms are worse, he or she can amp up the juice. If the pulses are too strong, they can cause annoying contractions in the abdominal muscles, but this is easily fixed with a simple wireless adjustment. The battery runs down after a few years, and when this happens the whole device has to be replaced in what is considered minor surgery.
Such devices could fill gaps in treating other organ failures. By far most of the people on transplant waiting lists are waiting for kidneys. Despite the fact that live donations are possible, there’s still a dire shortage of organs. A bright spot on the horizon is The Kidney Project, a program spearheaded by bioengineer Shuvo Roy at the University of California, San Francisco, which is developing a fully implantable artificial kidney. The device combines living cells with artificial materials and relies not on a battery, but on the patient’s own blood pressure to keep it functioning.
Several years into this project, a prototype of the kidney, about the size of a smart phone, has been successfully tested in pigs. The device seems to provide many of the functions of a biological kidney (unlike dialysis, which replaces only one main function) and reliably produces urine. One of its most critical components is a special artificial membrane, called a hemofilter, that filters out toxins and waste products from the blood without leaking important molecules like albumin. Since it allows for total mobility, the artificial kidney will provide patients with a higher quality of life than those on dialysis, and is in some important ways, even better than a biological transplant.
The beauty of the device is that, even though it contains kidney cells sourced, as of now, from cadavers or pigs, the cells are treated so that they can’t be rejected and the device doesn’t require the highly problematic immunosuppressant drugs a biological organ requires. “Anti-rejection drugs,” says Roy, “make you susceptible to all kinds of infections and damage the transplanted organ, causing steady deterioration. Eventually they kill the kidney. A biological transplant has about a 10-year limit,” after which the kidney fails and the body rejects it.
Eventually, says Roy, the cells used in the artificial kidney will be sourced from the patient himself, the ultimate genetic match. The patient’s adult stem cells can be used to produce some or all of the 25 to 30 specialized cells of a biological kidney that provide all the functions of a natural organ. People formerly on dialysis could drastically improve their functionality and quality of life without being tethered to a machine for hours at a time, three days a week.
As exciting as this project is, it suffers from a common theme in early biomedical research—keeping a steady stream of funding that will move the project from the lab, into human clinical trials and eventually to the bedside. “It’s the issue,” says Roy. “Potential investors want to see more data indicating that it works, but you need funding to create data. It’s a Catch-22 that puts you in a kind of no-man’s land of funding.” The constant pursuit of funding introduces a variable that makes it hard to predict when the kidney will make it to market, despite the enormous need for such a technology.
Another critical variable is if and when insurance companies will decide to cover transplants with the artificial kidney, so that it becomes affordable for the average person. But Roy thinks that this hurdle, too, will be crossed. Insurance companies stand to save a great deal of money compared to what they ordinarily spend on transplant patients. The cost of yearly maintenance will be a fraction of that associated with the tens of thousands of dollars for immunosuppressant drugs and the attendant complications associated with a biological transplant.
One estimate that the multidisciplinary team of researchers involved with The Kidney Project are still trying to establish is how long the artificial kidney will last once transplanted into the body. Animal trials so far have been looking at how the kidney works for 30 days, and will soon extend that study to 90 days. Additional studies will extend much farther into the future, but first the kidneys have to be implanted into people who can be followed over many years to answer this question. But unlike the gastric pacer and other implants, there won’t be a need for periodic surgeries to replace a depleted battery, and the stark improvements in quality of life compared to dialysis add a special dimension to the value of whatever time the kidney lasts.
Another life-saving implant could address a major scourge of the modern world—heart disease. Despite significant advances in recent decades, including the cardiac implants mentioned above, cardiovascular disease still causes one in three deaths across the world. One of the most promising developments in recent years is the Total Artificial Heart, a pneumatically driven device that can be used in patients with biventricular heart failure, affecting both sides of the heart, when a biological organ is not available.
The TAH is implanted in the chest cavity and has two tubes that snake down the body, come out through the abdomen and attach to a 13.5-pound external driver that the patient carries around in a backpack. It was first developed as a bridge to transplant, a temporary alternative while the patient waited for a biological heart to replace it. However, SynCardia Systems, LLC, the Tucson-based company that makes it, is now investigating whether the heart can be used on a long-term basis.
There’s good reason to think that this will be the case. I spoke with Daniel Teo, one of the board members of SynCardia, who said that so far, one patient lived with the TAH for six years and nine months, before he died of other causes. Another patient, still alive, has lived with the device for over five years and another one has lived with it for over four years. About 2,000 of these transplants have been done in patients waiting for biological hearts so far, and most have lived mobile, even active lives. One TAH recipient hiked for 600 miles, and another ran the 4.2-mile Pat Tillman Run, both while on the artificial heart. This is a far cry from their activities before surgery, while living with advanced heart failure.
Randy Shepard, a recipient of the Total Artificial Heart, teaches archery to his son.
Randy Shepard
If removing and replacing one’s biological heart with a synthetic device sounds scary, it is. But then so is replacing one’s heart with biological one. “The TAH is very emotionally loaded for most people,” says Teo. “People sometimes hold back because of philosophical, existential questions and other nonmedical reasons.” He also cites cultural reasons why some people could be hesitant to accept an artificial heart, saying that some religions could frown upon it, just as they forbid other medical interventions.
The first TAHs that were approved were 70 cubic centimeters in size and fit into the chest cavities of men and larger women, but there’s now a smaller, 50 cc size meant for women and adolescents. The FDA first cleared the 70 cc heart as a bridge to transplant in 2004, and the 50 cc model received approval in 2014. SynCardia’s focus now is on seeking FDA approval to use the heart on a long-term basis. There are other improvements in the works.
One issue being refined deals with the external driver that holds the pneumatic device for moving the blood through a patient’s body. The two tubes connecting the driver to the heart entail openings in the skin that could get infected, and carrying the backpack is less than ideal. The driver also makes an audible sound that some people find disturbing. The next generation TAH will be quieter and involve wearing a smaller, lighter device on a belt rather than carrying the backpack. SynCardia is also working toward a fully implantable heart that wouldn’t require any external components and would contain an energy source that can be recharged wirelessly.
Teo says the jury is out as to whether artificial hearts will ever obviate the need for biological organs, but the world’s number one killer isn’t going away any time soon. “The heart is one of the strongest organs,” he says, “but it’s not made to last forever. If you live long enough, the heart will eventually fail, and heart failure leads to the failure of other organs like the kidney, the lungs and the liver.” As long as this remains the case and as long as the current direction of research continues, artificial organs are likely to play an ever larger part of our everyday lives.
Oh, wait. Maybe we cyborgs will take over the world after all.
