“You First”: Who Will Be Front in Line to Get a COVID Vaccine?
There is a huge amount riding on the discovery of a vaccine effective against the Covid-19 virus.
Making 660 million of anything without a glitch is—to put it mildly—a tall order in a nation that remains short on masks, gowns, and diagnostic tests despite months of trying to meet demand.
The world is waiting for a vaccine that can liberate everyone from the constraints on liberty required by existing efforts to fight the virus with public health measures such as masks, isolation, and quarantining. President Trump, for the most part, has rejected tough public health measures. Instead he has staked his political future and those of the governors and Congressional Republicans who have followed his lead on delivering a vaccine before Election Day as the solution to the COVID-19 pandemic in the USA. Many scientific experts have been sounding encouraging notes about having a vaccine by the end of this year or early next, as have many CEOs among the more than 160 companies chasing various strategies to identify a safe and effective vaccine.
But the reality is that no matter how fast a vaccine appears, those who might benefit will face a significant period of time before they could receive one. This is due to a variety of realities. Any vaccine faces various regulatory hurdles to insure safety and efficacy. This means completing large-scale studies in tens of thousands of subjects hoping for enough cases of blunted natural infection versus a large placebo control group to determine that a vaccine works. And that takes time--plus adding in delays in manufacturing and delivery, which will create logjams for most prospective recipients.
Shipping is not going to be easy with cold chain storage requirements from -20 to -70 degrees Celsius, from factory to a doctor's office, depending on the vaccine. In addition, many of the vaccines under development require two doses--that is 660 million shots to cover just those in the United States. Making 660 million of anything without a glitch is—to put it mildly—a tall order in a nation that remains short on masks, gowns, and diagnostic tests, despite months of trying to meet demand.
There are three scenarios under which a vaccine can appear but without being in any way available to all Americans.
The first is a vaccine under development in the USA or with some USA financing begins to show promise before a full clinical trial is completed. Current vaccine trials are supervised by Data Safety and Monitoring Boards and those committees could tell a CEO eager to be first to market that their vaccine is looking good at the study's half-way point.
The CEO and vaccine manufacturing company's board then let the White House know that a magic bullet which can ensure the President's reelection is in hand. The President, as he has done many times with other COVID treatments, most recently convalescent plasma, intervenes with the FDA and demands approval using an Emergency Use Authorization, or invoking the Federal Right to Try law he and Mike Pence are constantly touting. FDA Commissioner Steve Hahn folds and an extremely limited supply of vaccine, maybe only 100,000 doses, is available just before Election Day.
The second scenario is that another nation discovers a vaccine that looks safe and effective and the USA is able to buy some supply of it. But again, we are likely, initially, to get an extremely limited amount.
Lastly, the vaccine is approved in a standard manner. A full randomized trial is done, the endpoints are met, and no serious adverse events are identified. It is a USA-funded vaccine so most of it is coming here first. Still the vials and needles and plugs need to be quality-controlled and shipped and stored at the right temperatures. Information sheets and consent forms need to be readied, offered, and signed. Odds are you won't see any of this vaccine until late next year. So, who is going to get the first shots?
Some people under all of these scenarios are going to say, "Count me out." They don't trust vaccines or they don't trust the government to provide a safe one. Others may say, "The first one out of the box may be OK, but I am going to wait for the 'best' one before I take one." Even if those numbers are large, it is still certain that there will be more takers than can be vaccinated.
If you look at the discussion of vaccine rationing, almost everybody — including government officials, FDA officials, advisory panelists and ethicists — says the first group that should get vaccinated are at-risk healthcare workers. They say it, although they're not always clear about why.
One reason is that you need to give it to health care workers first because they will keep the healthcare system going. Another is that you need to give it to them first because they face more risk and they should get rewarded for having done and continuing to do that -- their bravery ought to be rewarded and their risk reduced.
A subset of hospitals and institutions in high risk areas will [go first] and that will be it for a significant period of time.
Both of these arguments for health care worker priority are not completely convincing. Food and power and vaccine manufacturing are arguably as important as health care, but workers in those areas don't get priority attention in most guidelines. And many Americans face risks from COVID comparable to health care workers, especially those who are not on the front lines in ERs and ICUs. Prisoners, military personnel who work on warships, the elderly, nursing home residents, and poor minorities are disproportionately affected by COVID. However, none of them are going first, nor is it clear how to weigh their claims in competing against one another for a scarce vaccine.
But, there's something else that's interesting in deciding who goes first. When people all agree, as they almost always do, that it's health care workers who must go first, a huge problem remains. What is the definition of who's a healthcare worker? You could easily get millions and millions of people designated as healthcare workers who would have a claim to go first.
We normally think that health care worker means doctors and nurses. But, if we go beyond those who work in ERs and ICUs, the number is big. And we must, because no ER or ICU can run without huge numbers of supporting individuals.
If you don't vaccinate lab technicians, people who clean the rooms, make food, transport patients, provide security, do the laundry, run the IT, students, volunteers and so on, you're not going to have a functioning hospital. If you don't include those working in nursing homes, home care and hospices along with those making and supplying vital equipment and bringing in patients via ambulances, police cars, and fire trucks, you don't have a functioning ICU, much less a health care system.
The total number involved could easily exceed tens of millions depending on how broadly the definition is set.
So, what is likely to happen is that health care workers will not go first. A subset of hospitals and institutions in high risk areas will and that will be it for a significant period of time. Health care institutions in hot spots, plus the supporting services they need will go first and then vaccine availability will slowly expand to other health care institutions and the essential workers needed to keep them functioning. Then consideration will also be given to how best to control the spread of the virus in selecting hot spots versus saving prisoners or the poor. And you can be sure, whatever the guidelines are, that the military and security folks will demand their share.
For many, many months if not a year or more, most people will not have to face a choice about vaccinating. The supply just won't be there for the general public. It is a small sample of high-risk health care workers including vaccine manufacturing employees and shippers, plus essential workers to keep hospitals and nursing homes going, who will be first in line. Odds are you and your family will still be wearing masks and social distancing well into next year.
When doctors couldn’t stop her daughter’s seizures, this mom earned a PhD and found a treatment herself.
Twenty-eight years ago, Tracy Dixon-Salazaar woke to the sound of her daughter, two-year-old Savannah, in the midst of a medical emergency.
“I entered [Savannah’s room] to see her tiny little body jerking about violently in her bed,” Tracy said in an interview. “I thought she was choking.” When she and her husband frantically called 911, the paramedic told them it was likely that Savannah had had a seizure—a term neither Tracy nor her husband had ever heard before.
Over the next several years, Savannah’s seizures continued and worsened. By age five Savannah was having seizures dozens of times each day, and her parents noticed significant developmental delays. Savannah was unable to use the restroom and functioned more like a toddler than a five-year-old.
Doctors were mystified: Tracy and her husband had no family history of seizures, and there was no event—such as an injury or infection—that could have caused them. Doctors were also confused as to why Savannah’s seizures were happening so frequently despite trying different seizure medications.
Doctors eventually diagnosed Savannah with Lennox-Gaustaut Syndrome, or LGS, an epilepsy disorder with no cure and a poor prognosis. People with LGS are often resistant to several kinds of anti-seizure medications, and often suffer from developmental delays and behavioral problems. People with LGS also have a higher chance of injury as well as a higher chance of sudden unexpected death (SUDEP) due to the frequent seizures. In about 70 percent of cases, LGS has an identifiable cause such as a brain injury or genetic syndrome. In about 30 percent of cases, however, the cause is unknown.
Watching her daughter struggle through repeated seizures was devastating to Tracy and the rest of the family.
“This disease, it comes into your life. It’s uninvited. It’s unannounced and it takes over every aspect of your daily life,” said Tracy in an interview with Today.com. “Plus it’s attacking the thing that is most precious to you—your kid.”
Desperate to find some answers, Tracy began combing the medical literature for information about epilepsy and LGS. She enrolled in college courses to better understand the papers she was reading.
“Ironically, I thought I needed to go to college to take English classes to understand these papers—but soon learned it wasn’t English classes I needed, It was science,” Tracy said. When she took her first college science course, Tracy says, she “fell in love with the subject.”
Tracy was now a caregiver to Savannah, who continued to have hundreds of seizures a month, as well as a full-time student, studying late into the night and while her kids were at school, using classwork as “an outlet for the pain.”
“I couldn’t help my daughter,” Tracy said. “Studying was something I could do.”
Twelve years later, Tracy had earned a PhD in neurobiology.
After her post-doctoral training, Tracy started working at a lab that explored the genetics of epilepsy. Savannah’s doctors hadn’t found a genetic cause for her seizures, so Tracy decided to sequence her genome again to check for other abnormalities—and what she found was life-changing.
Tracy discovered that Savannah had a calcium channel mutation, meaning that too much calcium was passing through Savannah’s neural pathways, leading to seizures. The information made sense to Tracy: Anti-seizure medications often leech calcium from a person’s bones. When doctors had prescribed Savannah calcium supplements in the past to counteract these effects, her seizures had gotten worse every time she took the medication. Tracy took her discovery to Savannah’s doctor, who agreed to prescribe her a calcium blocker.
The change in Savannah was almost immediate.
Within two weeks, Savannah’s seizures had decreased by 95 percent. Once on a daily seven-drug regimen, she was soon weaned to just four, and then three. Amazingly, Tracy started to notice changes in Savannah’s personality and development, too.
“She just exploded in her personality and her talking and her walking and her potty training and oh my gosh she is just so sassy,” Tracy said in an interview.
Since starting the calcium blocker eleven years ago, Savannah has continued to make enormous strides. Though still unable to read or write, Savannah enjoys puzzles and social media. She’s “obsessed” with boys, says Tracy. And while Tracy suspects she’ll never be able to live independently, she and her daughter can now share more “normal” moments—something she never anticipated at the start of Savannah’s journey with LGS. While preparing for an event, Savannah helped Tracy get ready.
“We picked out a dress and it was the first time in our lives that we did something normal as a mother and a daughter,” she said. “It was pretty cool.”
A sleek, four-foot tall white robot glides across a cafe storefront in Tokyo’s Nihonbashi district, holding a two-tiered serving tray full of tea sandwiches and pastries. The cafe’s patrons smile and say thanks as they take the tray—but it’s not the robot they’re thanking. Instead, the patrons are talking to the person controlling the robot—a restaurant employee who operates the avatar from the comfort of their home.
It’s a typical scene at DAWN, short for Diverse Avatar Working Network—a cafe that launched in Tokyo six years ago as an experimental pop-up and quickly became an overnight success. Today, the cafe is a permanent fixture in Nihonbashi, staffing roughly 60 remote workers who control the robots remotely and communicate to customers via a built-in microphone.
More than just a creative idea, however, DAWN is being hailed as a life-changing opportunity. The workers who control the robots remotely (known as “pilots”) all have disabilities that limit their ability to move around freely and travel outside their homes. Worldwide, an estimated 16 percent of the global population lives with a significant disability—and according to the World Health Organization, these disabilities give rise to other problems, such as exclusion from education, unemployment, and poverty.
These are all problems that Kentaro Yoshifuji, founder and CEO of Ory Laboratory, which supplies the robot servers at DAWN, is looking to correct. Yoshifuji, who was bedridden for several years in high school due to an undisclosed health problem, launched the company to help enable people who are house-bound or bedridden to more fully participate in society, as well as end the loneliness, isolation, and feelings of worthlessness that can sometimes go hand-in-hand with being disabled.
“It’s heartbreaking to think that [people with disabilities] feel they are a burden to society, or that they fear their families suffer by caring for them,” said Yoshifuji in an interview in 2020. “We are dedicating ourselves to providing workable, technology-based solutions. That is our purpose.”
Shota Kuwahara, a DAWN employee with muscular dystrophy. Ory Labs, Inc.
Wanting to connect with others and feel useful is a common sentiment that’s shared by the workers at DAWN. Marianne, a mother of two who lives near Mt. Fuji, Japan, is functionally disabled due to chronic pain and fatigue. Working at DAWN has allowed Marianne to provide for her family as well as help alleviate her loneliness and grief.Shota, Kuwahara, a DAWN employee with muscular dystrophy, agrees. "There are many difficulties in my daily life, but I believe my life has a purpose and is not being wasted," he says. "Being useful, able to help other people, even feeling needed by others, is so motivational."