Vaccine Passports Are a Premature Solution to A Challenging Problem
Vaccine passports, if required by businesses and universities, may give people a false sense of security, one expert cautions.
Vaccines are one of the greatest public health accomplishments of all time. For centuries, public health has relied on vaccinations to prevent and control disease outbreaks for a plethora of infectious scourges, with our crowning achievement being the successful eradication of smallpox.
The purpose of vaccine documentation is to provide proof of an individual's protection from either becoming infected or transmitting a vaccine-preventable disease. Vouching for these protections requires a firm knowledge about the epidemiology of the disease, as well as scientific knowledge concerning the efficacy of the vaccine. The vaccines we currently require be documented have met these tests; the vaccine for COVID-19 has not yet been proven to do so.
Let's acknowledge that the term "vaccine passport" is a poor choice of words. Passports are a legal travel document created by nations and governed by law for identification of the bearer to control entry and exit from nation states. They often serve as legal forms of identification and as a record of international travel. They are generally very sophisticated documents that have been created in a secure manner and may include a range of electronic and, in some cases, biometric measures such as fingerprints to ensure the holder is indeed who they say they are. Vaccine passports are medical documents used to document the vaccination status of an individual. They do not undergo the same level of administrative scrutiny and cannot be used to verify that the presenter is indeed the vaccinated individual. Some companies do have electronic methods to address concerns about verification; however, most people currently have paper records that can be easily falsified.
"Vaccine passports" as currently proposed risk giving people a false sense of security.
Successful disease control from vaccination programs relies on the ability to vaccinate at a level that prevents large-scale disease spread and the ability to rapidly identify the presence of disease outbreaks. It requires reliable, safe, and effective vaccines that are easily delivered in clinical and nonclinical settings. Keeping vaccination information as a part of the medical record, and even having a separate specialized vaccine record for personal use, is a time-honored tradition.
Keeping a vaccination record provides a method to keep track of the many shots one receives and serves as a visual reminder to help ensure the appropriate vaccine shot schedule is maintained for vaccines requiring multiple doses. The vaccine record, when combined with vaccine safety monitoring systems, serves as a mechanism to track adverse events to monitor and ensure the safety of vaccines as a consumer product. The record also serves as the official record of vaccination when required for administrative or legally prescribed purposes.
"Vaccine passports" as currently proposed risk giving people a false sense of security. In the case of the COVID-19 vaccines currently approved for use, many of the essential questions remain unanswered. While we do know the current three vaccines are highly protective against severe disease and death, and there is some evidence that these vaccinations do reduce infections and virus transmission of SARS-CoV-2, we do not yet know the full degree to which this occurs.
For example, we know there have been some cases of people that have been infected in close proximity to getting their full vaccination and rare cases of breakthrough reinfections. A breakthrough infection in a restaurant is a challenge for contact tracing, but an outbreak from a movie theater exposure or a baseball game could spark a major outbreak at our current level of vaccination. Current CDC guidance recommends continued mask wearing in order to address these concerns.
We also do not yet know how long the protections will last and if or when a booster or revaccination is required. In effect, it is too soon to know. Should an annual booster shot be required, then a vaccine passport would require annual updating, a process more frequent than renewal of a driver's license.
We also know that the current SARS-CoV-2 virus is mutating briskly. While the current approved vaccines have remained effective overall, there is evidence of some degree of degradation in vaccine effectiveness against some of the circulating strains. We also have sparse data on many of the other emerging strains of concern because we have not had the surveillance capacity in the U.S. to gain an adequate sense of how the virus is changing to fully align vaccine effectiveness with viral capabilities.
The risk of people misusing these "passports" is troubling. The potential for using these documents for hiring, firing or job limitation is a serious concern. Unvaccinated workers are at risk of this form of discrimination even from well-meaning employers or supervisors. Health insurers are prohibited by the Affordable Care Act from discriminating based on preexisting conditions, but they could probably charge a higher premium for unvaccinated individuals. There also is a risk of stigmatizing individuals who are not vaccinated or have left their vaccine documentation at home. Another concern: the opportunity to discriminate based on race, gender, sexual orientation, or religion, using one's vaccination status as an excuse.
These "passports" are being discussed as a "ticket verification" for entry to many activities, including dining at restaurants, flying domestically and/or internationally, going to movie theaters and sporting events, etc. These are all activities we already are doing at reduced levels and for which wearing a mask, hand hygiene and physical distancing are effective disease control practices. COVID-19 vaccines are indeed the measure that will make the ability to totally reopen our society complete, but we are not there yet. Documentation of one's COVID-19 vaccine status may be useful in selected situations in the future. That remains to be seen.
Finally, inadequate vaccine supply and disparities in vaccine delivery have created enormous challenges in providing equal access to vaccination. Also, the amount of misinformation, disinformation, and lingering vaccine hesitancy continue to limit the speed at which we will reach the level of vaccination of the population that would make this documentation meaningful. The requirement for "vaccine passports" is already alienating people who are opposed to vaccinations for a variety of reasons, paradoxically risking reduced vaccine uptake. This politicization of the vaccination effort is of concern. There are indeed people who, due to medical contraindications or legal exemptions, will not be vaccinated, and we do not yet have a national framework on how to address this.
Vaccine passports are not the solution for reopening our society — a robust vaccination program is. The requirement to document one's vaccination status for COVID-19 may one day have its place. For now, it is an idea whose time has not yet come.
Editor's Note: This op/ed is part of a "Big Question" series on the ethics of vaccine passports. Read the flip side argument here.
A new way to help kids with ADHD: Treat adult ADHD
Adults who have ADHD can benefit from treatment, and some researchers think their kids' ADHD symptoms may get better as a result.
When a child is diagnosed with attention deficit hyperactivity disorder (ADHD), it can often be a surprise to the parents that one of them has ADHD as well. They may have experienced some of the symptoms but never had the condition diagnosed.
Physicians, however, are usually less surprised because they know that ADHD is a very heritable disorder. According to a 2015 study, if a parent has ADHD, the child has up to a 57 percent chance of having it, and the child’s risk is 32 percent if their sibling has it.
“There have been 20 to 30 twin studies that show that the heritability of ADHD is about 70 percent,” meaning that both twins have it, says Stephen Faraone, distinguished professor and vice chair for research at SUNY Upstate Medical University. “It is as heritable as schizophrenia, bipolar disorder, autism or other psychiatric disorders that people tend to think are more biological than ADHD for some reason.”
More attention needed for adult ADHD
Brad McAlister, CMSE, executive director of the American Professional Society of ADHD & Related Disorders, or APSARD, explains that the consequences of untreated ADHD in adults are very well documented. The prevalence of ADHD in U.S. adults is 4.4 percent or about 11 million people.
Many adults go undiagnosed for decades or are misdiagnosed by providers. McAlister says that 75 percent are not receiving treatment. “The U.S. economic burden of adult ADHD is $105 to $194 billion annually,” he says. “The negative consequences on peoples’ lives include higher risks of dropping out of school, losing jobs, financial debt, divorce, fractured relationships, substance use disorders, and co-occurring depression/anxiety.”
One of the negative impacts of undiagnosed ADHD in adults is the effect that it can have on their children who have ADHD.
Adult ADHD is currently treated by a broad range of health care providers with different educational backgrounds and in different practice settings. In August, APSARD published the first U.S. guidelines for adult ADHD. “The creation of guidelines for ADHD in adults will allow all practitioners to benefit from the best evidence about diagnosing and treating the disorder,” McAlister says.
Faraone explains that the guidelines are intended to help practitioners understand the best practices for adults with ADHD, including screening and other ways of evaluating whether someone has it. He recently completed a study of what he calls the Metrics of Quality Care for adults with ADHD.
“We looked at a sizable group of primary care practices in the U.S., and we learned that although quality care for adults with ADHD has been gradually improving over the past decade, there are many areas where it is still far behind where it needs to be,” he says. “That’s consistent with other studies that show that in primary care for adults, ADHD is not treated nearly as well as it is treated in specialty and psychiatry care.”
How kids with ADHD are affected
One of the negative impacts of undiagnosed ADHD in adults is the effect that it can have on their children who have ADHD because their ability to care for that child’s special needs may be impaired.
“The treatments that are most effective in treating children with ADHD are medication and behavioral interventions as their reward bait, and at home, it’s the parent that administers them,” says Mark A. Stein, director of the ADHD and Related Disorders Program at Seattle Children’s Hospital. “Adults with ADHD have difficulties with time management and organization skills, so they will have a hard time making sure their child is ready for school, has breakfast, has their medications, etcetera.”
Even more challenging than getting a prescription, Stein adds, is finding a psychologist or therapist who is skilled in evaluating and working with children with ADHD and their parents. If left undiagnosed and untreated, adult ADHD may also interfere with getting a good evaluation for the child.
“If you have ADHD and your mind is wandering and you don’t have all of the forms from the school for your provider, and you’re focused on the bad day you’re having rather than giving a history of your child, all of that is going to delay getting an effective treatment for your child,” Stein says. “So that’s why it’s important to identify ADHD in parents.”
Promising research and training
After delays due to the pandemic, Stein and his colleague Andrea Chronis-Tuscano, professor and director of the Maryland ADHD Program at the University of Maryland, are now about two years into what they anticipate will be a six-year study that involves treating parents who have children with untreated ADHD symptoms. The goal is to see whether treating the parent first with medication and training, or just the training, helps the child’s symptoms due to improved parenting. They are also studying whether they can postpone the need for medication until children are older, when it’s more effective.
“Pediatricians are more aware of ADHD in parents because of our study,” Stein says. “They’re also more aware of the shortcomings in our healthcare delivery system in terms of how hard it is to find providers who are comfortable treating adult ADHD.”
“Besides depression, ADHD is the other disorder that parents have that really impacts kids significantly," Stein says. “With treatment, many people with ADHD do very well."
That said, he’s seen a significant improvement in the past decade with increased recognition of ADHD in adults. “It started with pediatricians recognizing that post-partum depression impacted the mother’s ability to care for her children and making it routine to screen for depression in parents of kids,” he says. “Besides depression, ADHD is the other disorder that parents have that really impacts kids significantly, so it’s important for them to be aware of characteristics of [ADHD in] parents and have resources they can give parents to help them.”
Stein emphasizes that even if someone displays symptoms of ADHD, that does not mean that they have it. They should seek a physician’s evaluation to confirm a diagnosis, which would enable them to get the medication and behavioral treatment they need.
The medication can take effect in parents within an hour. Meanwhile, when parents participate in the behavioral parent training courses, their kids with ADHD start showing significant improvement within about four to five weeks, according to Stein.
“With treatment, many people with ADHD do very well,” he says. “Especially if they get through formal schooling, find the right fit with their job, and if they make the right choices with their relationships, those three things can go a long way to make their ADHD fade into the background.”
Patients voice hope and relief as FDA gives third-ever drug approval for ALS
On Sept. 29, the FDA approved Relyvrio, a new drug for ALS, even though a study of 137 ALS patients did not result in “substantial evidence” that Relyvrio was effective.
At age 52, Glen Rouse suffered from arm weakness and a lot of muscle twitches. “I first thought something was wrong when I could not throw a 50-pound bag of dog food over the tailgate of my truck—something I use to do effortlessly,” said the 54-year-old resident of Anderson, California, about three hours north of San Francisco.
In August, Rouse retired as a forester for a private timber company, a job he had held for 31 years. The impetus: amyotrophic lateral sclerosis, or ALS, a progressive neuromuscular disease that is commonly known as Lou Gehrig’s disease, named after the New York Yankees’ first baseman who succumbed to it less than a month shy of his 38th birthday in 1941. ALS eventually robs an individual of the ability to talk, walk, chew, swallow and breathe.
Rouse is now dependent on ventilation through a nasal mask and uses a powerchair to get around. “I can no longer walk or use my arms very well,” he said. “I can still move my wrists and fingers. I can also transfer from my chair to the toilet if I have two of my friends help me.”
It’s “shocking” that modern medicine has very little to offer to people with this devastating condition, Rouse said. But there is hope on the horizon. Yesterday, the U.S. Food and Drug Administration approved Relyvrio, a drug made up of two parts, sodium phenylbutyrate and taurursodiol, to treat patients with ALS.
“This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” said Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a statement. “The FDA remains committed to facilitating the development of additional ALS treatments.”
Until this point, the FDA had approved only two other medications—Riluzole (rilutek) in 1995 and Radicava (edaravone) in 2017—to extend life in patients with ALS, which typically kills within two to five years after diagnosis. That’s why earlier this week, Rouse was optimistic about the FDA’s likely approval of a controversial new drug for ALS.
When Relyvrio is taken in addition to Riluzole, it appears to slow functional decline by an additional 25 percent and extend life by another 6 to 10 months, said Richard Bedlak, director of the Duke ALS Clinic. “It is not a cure, but it is definitely a step forward.”
“The whole ALS community is extremely excited about it,” he said the day before Relyvrio’s expected approval. “We are very hopeful. We’re on pins and needles.”
A study of 137 ALS patients did not result in “substantial evidence” that Relyvrio was effective, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee concluded in March. However, after some persuasion from FDA officials, patients and their families, the committee met again and decided to recommend approving the drug.
In January 2019, following an ALS diagnosis at age 58 in October the previous year, Jeff Sarnacki, of Chester, Maryland, was accepted into a trial for Relyvrio. “Because of the trial, we did experience hope and a greater sense of help than had we not had that opportunity,” said Juliet Taylor, his wife and caregiver. They both believed the drug “worked for him in giving him more time.”
In June 2019, Sarnacki chose an open-label extension, offered to patients by drug researchers after a study ends, and took the active drug until he died peacefully at home under hospice care in May 2020, five days after his 60th birthday. A retired agent with the federal Bureau of Alcohol, Tobacco, Firearms and Explosives who later worked as a security consultant, Sarnacki lived about 19 months after diagnosis, which is shorter than the typical prognosis.
His symptoms began with leg cramps in fall 2017 and foot drop in early 2018. A feeding tube was placed in 2019, as it became necessary early in his illness, Taylor said. He also took Radicava and Riluzole, the two previously approved drugs, for his ALS. “We were both incredulous that, so many years after Lou Gehrig’s own diagnosis, there were so few treatments available,” she said.
The dearth of successful treatments for ALS is “certainly not for lack of trying,” said Karen Raley Steffens, a registered nurse and ALS support services coordinator at the Les Turner ALS Foundation in Skokie, Ill. “There are thousands of researchers and scientists all over the world working tirelessly to try to develop treatments for ALS.”
Unfortunately, she added, research takes time and exorbitant amounts of funding, while bureaucratic challenges persist. The rare disease also manifests and progresses in many different ways, so many treatments are needed.
As of 2017, the Centers for Disease Control and Prevention estimated that more than 31,000 people in the U.S. live with ALS, and an average of 5,000 people are newly diagnosed every year. It is slightly more common in men than women. Most people are diagnosed between the ages of 55 and 75.
Most cases of ALS are sporadic, meaning that doctors don’t know the cause. There is about a one-year interval between symptom onset and an ALS diagnosis for most patients, so many motor neurons are lost by the time individuals can enroll in a clinical trial, said Richard Bedlack, professor of neurology and director of the Duke ALS Clinic in Durham, North Carolina.
Bedlack found the new drug, Relyvrio, to be “very promising,” which is why he testified to the FDA in favor of approval. (He’s a consultant and disease state speaker for multiple companies including Amylyx, manufacturer of Relyvrio.)
The “drug has different mechanisms of action than the currently approved treatments,” Bedlack said. He added that, when Relyvrio is taken in addition to Riluzole, it appears to slow functional decline by an additional 25 percent and extend life by another 6 to 10 months. “It is not a cure, but it is definitely a step forward.”
T. Scott Diesing, a neurohospitalist and director of general neurology at the University of Nebraska Medical Center in Omaha, said he hopes the drug is “as good as people anticipated it should be, because there are not too many options for these patients.”
"FDA went out on a limb in approving Relyvrio based on limited results from a small trial while a larger study remains in progress," said Florian P. Thomas, co-director of the ALS Center at Hackensack University Medical Center and Hackensack Meridian School of Medicine in New Jersey. "While it is definitely promising, clearly, the last word on this drug has not been spoken."
So far, Rouse's voice is holding up, but he knows the day will come when ALS will steal that and much more from him.
ALS is 100 percent fatal, with some patients dying as soon as a year after diagnosis. A few have lasted as long as 15 years, but those are the exceptions, Diesing said.
“If this drug can provide even months of additional life, or would maintain quality of life, that’s a big deal,” he noted, adding that “the patients are saying, ‘I know it’s not proven conclusively, but what do we have to lose?’ So, they would like to try it while additional studies are ongoing.” The drug has already been conditionally approved in Canada.
As his disease progresses, Rouse hopes to get a speech-to-text voice-generating computer that he can control with his eyes. So far, his voice is holding up, but he knows the day will come when ALS will steal that and much more from him. He works at I AM ALS, a patient-led community, and six of his friends have already died of the disease.
“Every time I lose a friend to ALS, I grieve and am sad but I resolve myself to keep working harder for them, myself and others,” Rouse said. “People living with ALS find great purpose in life advocating and trying to make a difference.”