Nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by government-funded research.

This article was published on Wednesday, November 18, 2020 in Kaiser Health News.

By Arthur Allen

When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic.

Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial.

Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products.

The Moderna vaccine, whose remarkable effectiveness in a late-stage trial was announced Monday morning, emerged directly out of a partnership between Moderna and Graham's NIH laboratory.

Coronavirus vaccines are likely to be worth billions to the drug industry if they prove safe and effective. As many as 14 billion vaccines would be required to immunize everyone in the world against COVID-19. If, as many scientists anticipate, vaccine-produced immunity wanes, billions more doses could be sold as booster shots in years to come. And the technology and production laboratories seeded with the help of all this federal largesse could give rise to other profitable vaccines and drugs.

The vaccines made by Pfizer and Moderna, which are likely to be the first to win FDA approval, in particular rely heavily on two fundamental discoveries that emerged from federally funded research: the viral protein designed by Graham and his colleagues, and the concept of RNA modification, first developed by Drew Weissman and Katalin Karikó at the University of Pennsylvania. In fact, Moderna's founders in 2010 named the company after this concept: "Modified" + "RNA" = Moderna, according to co-founder Robert Langer.

"This is the people's vaccine," said corporate critic Peter Maybarduk, director of Public Citizen's Access to Medicines program. "Federal scientists helped invent it and taxpayers are funding its development. … It should belong to humanity."

Moderna, through spokesperson Ray Jordan, acknowledged its partnership with NIH throughout the COVID-19 development process and earlier. Pfizer spokesperson Jerica Pitts noted the company had not received development and manufacturing support from the U.S. government, unlike Moderna and other companies.

The idea of creating a vaccine with messenger RNA, or mRNA — the substance that converts DNA into proteins — goes back decades. Early efforts to create mRNA vaccines failed, however, because the raw RNA was destroyed before it could generate the desired response. Our innate immune systems evolved to kill RNA strands because that's what many viruses are.

Karikó came up with the idea of modifying the elements of RNA to enable it to slip past the immune system undetected. The modifications she and Weissman developed allowed RNA to become a promising delivery system for both vaccines and drugs. To be sure, their work was enhanced by scientists at Moderna, BioNTech and other laboratories over the past decade.

Another key element in the mRNA vaccine is the lipid nanoparticle — a tiny, ingeniously designed bit of fat that encloses the RNA in a sort of invisibility cloak, ferrying it safely through the blood and into cells and then dissolving, thereby allowing the RNA to do its work of coding a protein that will serve as the vaccine's main active ingredient. The idea of enclosing drugs or vaccines in lipid nanoparticles arose first in the 1960s and was developed by Langer and others at the Massachusetts Institute of Technology and various academic and industry laboratories.

Karikó began investigating RNA in 1978 in her native Hungary and wrote her first NIH grant proposal to use mRNA as a therapeutic in 1989. She and Weissman achieved successes starting in 2004, but the path to recognition was often discouraging.

"I keep writing and doing experiments, things are getting better and better, but I never get any money for the work," she recalled in an interview. "The critics said it will never be a drug. When I did these discoveries, my salary was lower than the technicians working next to me."

Eventually, the University of Pennsylvania sublicensed the patent to Cellscript, a biotech company in Wisconsin, much to the dismay of Weissman and Karikó, who had started their own company to try to commercialize the discovery. Moderna and BioNTech later would each pay $75 million to Cellscript for the RNA modification patent, Karikó said. Though unhappy with her treatment at Penn, she remained there until 2013 — partly because her daughter, Susan Francia, was making a name for herself on the school's rowing team. Francia would go on to win two Olympic gold medals in the sport. Karikó is now a senior officer at BioNTech.

In addition to RNA modification and the lipid nanoparticle, the third key contribution to the mRNA vaccines — as well as those made by Novavax, Sanofi and Johnson & Johnson —- is the bioengineered protein developed by Graham and his collaborators. It has proved in tests so far to elicit an immune response that could prevent the virus from causing infections and disease.

The protein design was based on the observation that so-called fusion proteins — the pieces of the virus that enable it to invade a cell — are shape-shifters, presenting different surfaces to the immune system after the virus fuses with and infects cells. Graham and his colleagues learned that antibodies against the post-fusion protein are far less effective at stopping an infection.

The discovery arose in part through Graham's studies of a 54-year-old tragedy — the failed 1966 trial of an NIH vaccine against respiratory syncytial virus, or RSV. In a clinical trial, not only did that vaccine fail to protect against the common childhood disease, but most of the 21 children who received it were hospitalized with acute allergic reactions, and two died.

About a decade ago, Graham, now deputy director of NIH's Vaccine Research Center, took a new stab at the RSV problem with a postdoctoral fellow, Jason McLellan. After isolating and obtaining three-dimensional models of the RSV's fusion protein, they worked with Chinese scientists to identify an appropriate neutralizing antibody against it.

"We were sitting in Xiamen, China, when Jason got the first image up on his laptop, and I was like, oh my God, it's coming together," Graham recalled. The prefusion antibodies they discovered were 16 times more potent than the post-fusion form contained in the faulty 1960s vaccine.

Two 2013 papers the team published in Science earned them a runner-up prize in the prestigious journal's Breakthrough of the Year award. Their papers, which showed it was possible to plan and create a vaccine at the microscopic structural level, set the NIH's Vaccine Research Center on a path toward creating a generalizable, rapid way to design vaccines against emerging pandemic viruses, Graham said.

In 2016, Graham, McLellan and other scientists, including Andrew Ward at the Scripps Research Institute, advanced their concept further by publishing the prefusion structure of a coronavirus that causes the common cold and a patent was filed for its design by NIH, Scripps and Dartmouth — where McLellan had set up his own lab. NIH and the University of Texas — where McLellan now works — filed an additional patent this year for a similar design change in the virus that causes COVID-19.

Graham's NIH lab, meanwhile, had started working with Moderna in 2017 to design a rapid manufacturing system for vaccines. In January, they were preparing a demonstration project, a clinical trial to test whether Graham's protein design and Moderna's mRNA platform could be used to create a vaccine against Nipah, a deadly virus spread by bats in Asia.

Their plans changed rapidly when they learned on Jan. 7 that the epidemic of respiratory disease in China was being caused by a coronavirus.

"We agreed immediately that the demonstration project would focus on this virus" instead of Nipah, Graham said. Moderna produced a vaccine within six weeks. The first patient was vaccinated in an NIH-led clinical study on March 16; early results from Moderna's 30,000-volunteer late-stage trial showed it was nearly 95% effective at preventing COVID-19.

Although other scientists have advanced proposals for what may be even more potent vaccine antigens, Graham is confident that carefully designed vaccines using nucleic acids like RNA reflect the future of new vaccines. Already, two major drug companies are doing advanced clinical trials for RSV vaccines based on the designs his lab discovered, he said.

In a larger sense, the pandemic could be the event that paves the way for better, perhaps cheaper and more plentiful vaccines.

"It's a silver lining, but I think we are definitely pushing forward the way everyone is thinking about vaccines," said Michael Farzan, chair of the department of immunology and microbiology at Scripps Research's Florida campus. "Certain techniques that have been waiting in the wings, under development but never achieving the kind of funding they needed for major tests, will finally get their chance to shine."

Under a 1980 law, the NIH will obtain no money from the coronavirus vaccine patent. How much money will eventually go to the discoverers or their institutions isn't clear. Any existing licensing agreements haven't been publicized; patent disputes among some of the companies will likely last years. HHS' big contracts with the vaccine companies are not transparent, and Freedom of Information Act requests have been slow-walked and heavily redacted, said Duke University law professor Arti Rai.

Some basic scientists involved in the enterprise seem to accept the potentially lopsided financial rewards.

"Having public-private partnerships is how things get done," Graham said. "During this crisis, everything is focused on how can we do the best we can as fast as we can for the public health. All this other stuff is going to have to be figured out later."

"It's not a good look to become extremely wealthy off a pandemic," McLellan said, noting the big stock sales by some vaccine company executives after they received hundreds of millions of dollars in government assistance. Still, "the companies should be able to make some money."

For Graham, the lesson of the coronavirus vaccine response is that a few billion dollars a year spent on additional basic research could prevent a thousand times as much loss in death, illness and economic destruction.

"Basic research informs what we do, and planning and preparedness can make such a difference in how we get ahead of these epidemics," he said.

This KHN story first published on California Healthline, a service of the California Healthcare Foundation.

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

Pain patients in New York have lost access to vital medicine since July 2019, when the state implemented an excise tax on many opioids.

This article was published on Tuesday, November 17, 2020 in Kaiser Health News.

By Anastassia Gliadkovskaya

Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure.

But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had to be hospitalized.

“You just keep thinking: Am I going to get sick? Am I going to get sick?” Angevine said in a phone interview. “Am I going to be able to live off the pills I have? Am I going to be able to get them on time?”

His pharmacy did not tell him the reason for the shortage. But Angevine isn’t the only pain patient in New York to lose access to vital medicine since July 2019, when the state implemented an excise tax on many opioids.

The tax was touted as a way to punish major drugmakers for their role in the opioid epidemic and generate funding for treatment programs. But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York. Instead of the anticipated $100 million, the tax brought in less than $30 million in revenue, two lawmakers said in interviews. None of it was earmarked for substance abuse programs, they said.

The state’s Department of Health, which has twice this year delayed an expected report on the impact of the tax, did not respond to questions for this story.

The tax follows strong efforts by federal and New York officials to tamp down the use of prescription opioids, which had already cut back some supply. Now, with some medications scarce or no longer available, pain patients have been left reeling. And the law appears to have missed its target: Instead of taking a toll on manufacturers, the greater burden appears to have fallen on pharmacies that can no longer afford or access the painkillers.

Among the companies that no longer sell opioids in New York is Epic Pharma. Independent Pharmacy Cooperative, a wholesaler, confirmed it no longer sells medications subject to the tax, but still sells those that are exempt, which are treatments for opioid addiction methadone and buprenorphine and also morphine. AvKARE and Lupin Pharmaceuticals said they do not ship opioids to New York anymore. Amneal Pharmaceuticals, which manufactures Angevine’s oxymorphone, declined to comment, as did Mallinckrodt.

Since the tax went into effect, Cardinal Health, which provides health services and products, published an extensive 10-page list of opioids it does not expect to carry. Cardinal Health declined to comment.

The New York tax is slowly gaining attention in other states. Delaware passed a similar tax last year. Minnesota is assessing a special licensing fee between $55,000 and $250,000 on opioid manufacturers. New Jersey Gov. Phil Murphy proposed such a tax this year but was turned down by the legislature.

The company that makes the first point of sale within New York pays the tax. That isn’t always the drugmaker. It can mean wholesalers selling to pharmacies here are assessed, explained Steve Moore, president of the Pharmacists Society of the State of New York.

Independent Pharmacy Cooperative said about half its revenue from opioid sales in New York would have gone to taxes.

Mark Kinney, the company’s senior vice president of government relations, said the law is putting companies in a very difficult position.

When wholesalers like IPC left the opioid market, competitive prices went with them.

Without these smaller wholesalers, it’s hard for pharmacies to go back to other wholesalers “and say, ‘Hey, your prices aren’t in line with the rest of the market,’” Moore said.

Indeed, nine independent pharmacies told KHN that when they can get opioids they are more expensive now. They have little choice but to eat the cost, drop certain prescriptions or pass the expense along.

“We can trickle that cost down to the patient,” said a pharmacist at New London Pharmacy in Manhattan, “but from a moral and ethics point of view, as a health care provider, it just doesn’t seem right to do that. It’s not the right thing to ask your patient to pay more.”

In addition, Medicare drug plans and Medicaid often limit reimbursements, meaning pharmacies can’t charge them more than the programs allow.

Stone’s Pharmacy in Lake Luzerne was losing money “hand over fist,” owner Leigh McConchie said. His distributor was adding the tax directly to his pharmacy’s cost for the drugs. That helped drive down his profit margins from opioid sales between 60% and 70%. Stone’s stopped carrying drugs like fentanyl patches and oxycodone, and though that distributor now pays the tax itself, the pharmacy is still feeling the effects.

“When you lose their fentanyl, you generally lose all their other prescriptions,” he said, noting that few customers go to multiple pharmacies when they can get everything at one.

If pharmacies have few opioid customers, those price hikes have less impact on their business. But being able to manage the costs is not the only problem, explained Zarina Jalal, a manager at Lincoln Pharmacy in Albany. Jalal can no longer get generic oxycodone from her supplier Kinray, though she can still access brand-name OxyContin. New York’s Medicaid Mandatory Generic Drug Program requires insurers to provide advance authorization for the use of brand-name prescriptions, delaying the approval process. Sometimes patients wait several days to get their prescription, Jalal explained.

“When I see them suffer, it hurts more than it hurts my wallet,” she said.

One of Jalal’s customers, Janis Murphy, needs oxycodone to walk without pain. Now she is forced to buy a brand-name drug and pays up to three times what she did for generic oxycodone before the tax went into effect. She said her bill since the start of this year for oxycodone alone is $850. Lincoln Pharmacy works with Murphy on a payment plan, without which she would not be able to afford the medication at all. But the bill keeps growing.

“I’m almost in tears because I cannot get this bill down,” she said in a phone interview.

Several pharmacists raised concerns that patients who lose access to prescription opioids may turn to street drugs. High prescription prices can drive patients to highly addictive and inexpensive heroin. McConchie of Stone’s Pharmacy said he now dispenses twice as many heroin treatment drugs as he did a year ago. Former opioid customers now come in for prescriptions for substance use disorder.

Trade groups and some physicians and state legislators opposed the tax before it went into effect, voicing concerns about a slew of potential consequences, including supply problems for pharmacists and higher consumer prices.

New London Pharmacy said one of its regular distributors stopped shipping Percocet, a combination of oxycodone and acetaminophen. Instead, the pharmacy orders from a more expensive company. The pharmacist estimated that a bottle of Percocet for which it used to pay $43 now costs up to $92.

“Even if we absorb the tax, we’re not getting a break from reimbursements either,” a pharmacist who spoke on the condition of anonymity explained, adding that insurance reimbursements have not increased in proportion to rising drug costs. “We’re losing.”

Latchmin Raghunauth Mondol, owner of Viva Pharmacy & Wellness in Queens, has also seen that problem. The pharmacy used to be able to purchase 100 15-milligram tablets of oxycodone for $15, but that’s now $70, she said, and the pharmacy is reimbursed only about $21 by insurers.

Other opioids are just not available.

Mondol said she has been unable to obtain certain doses of two of the most commonly prescribed opioids, oxycodone and oxymorphone — the drug Angevine was on.

After Angevine lost access to oxymorphone, his doctor put him on morphine, but it does not give him the same relief. He’s been in so much pain that he stopped going to physical therapy appointments.

“It’s a marathon from hell,” he said.

Faculty members and student activists around the country have long called for medical schools to increase the number of students and instructors from underrepresented backgrounds to improve treatment and build inclusivity.

This article was published on Tuesday, November 17, 2020 in Kaiser Health News.

By Elizabeth Lawrence Betial Asmerom, a fourth-year medical student at the University of California-San Diego, didn't have the slightest interest in becoming a doctor when she was growing up.

As an adolescent, she helped her parents — immigrants from Eritrea who spoke little English — navigate the healthcare system in Oakland, California. She saw physicians who were disrespectful to her family and uncaring about treatment for her mother's cirrhosis, hypertension and diabetes.

"All of those experiences actually made me really dislike physicians," Asmerom said. "Particularly in my community, the saying is, 'You only go to the doctor if you're about to die.'"

But that changed when she took a course in college about health disparities. It shocked her and made her realize that what her Eritrean family and friends saw was happening to other communities of color, too. Asmerom came to believe that as a doctor she could help turn things around.

Faculty members and student activists around the country have long called for medical schools to increase the number of students and instructors from underrepresented backgrounds to improve treatment and build inclusivity. But to identify racism's roots and its effects in the health system, they say, fundamental changes must be made in medical school curriculums.

Asmerom is one of many crusaders seeking robust anti-racist education. They are demanding that the schools eliminate the use of race as a diagnostic tool, recognize how systemic racism harms patients and reckon with some of medicine's racist history.

This activism has been ongoing — White Coats for Black Lives (WC4BL), a student-run organization fighting racism in medicine, grew out of the 2014 Black Lives Matter protests. But now, as with countless other U.S. institutions since the killing of George Floyd in Minneapolis in May, medical schools and national medical organizations are under even greater pressure to take concrete action.

Debunking Race as a Diagnostic Tool

For many years, medical students were taught that genetic differences among the races had an effect on health. But in recent years, studies have found race does not reliably reflect that. The National Human Genome Research Institute notes very little genetic variation among races, and more differences among people within each race. Because of this, more physicians are embracing the idea that race is not an intrinsic biological difference but instead a social construct.

Dr. Brooke Cunningham, a physician and sociologist at the University of Minnesota Medical School, said the medical community is conflicted about abandoning the idea of race as biological. It's baked into the way doctors diagnose and measure illness, she said. Some physicians claim it is useful to take race into account when treating patients; others argue it leads to bias and poor care.

Those views have led to a variety of false beliefs, including that Black people have thicker skin, their blood coagulates more quickly than white people's or they feel less pain.

When race is factored into medical calculations, it can lead to less effective treatments and perpetuate race-based inequities. One such calculation estimates kidney function (eGFR, or the estimated glomerular filtration rate). The eGFR can limit Black patients' access to care because the number used to denote Black race in the formula provides a result suggesting kidneys are functioning better than they are, researchers recently reported in the New England Journal of Medicine. Among another dozen examples they cite is a formula that obstetricians use to determine the probability of a successful vaginal birth after a cesarean section, which disadvantages Black and Hispanic patients, and an adjustment for measuring lung capacity using a spirometer, which can cause inaccurate estimates of lung function for patients with asthma or chronic obstructive pulmonary disease.

In the face of this research, medical students are urging schools to rethink curricula that treat race as a risk factor for disease. Briana Christophers, a second-year student at Weill Cornell Medical College in New York, said it makes no sense that race would make someone more susceptible to disease, although economic and social factors play a significant role.

Naomi Nkinsi, a third-year student at the University of Washington School of Medicine in Seattle, recalled sitting in a lecture — one of five Black students in the room — and hearing that Black people are inherently more prone to disease.

"It was very personal," Nkinsi said. "That's my body, that's my parents, that's my siblings. Every time I go into a doctor's office now, I'll be reminded that they're not just considering me as a whole person but as somehow physically different than all other patients just because I have more melanin in my skin."

Nkinsi helped in a successful campaign to exclude race from the calculation of eGFR at UW Medicine, joining a small number of other health systems. She said the achievement — announced officially in late May — was largely due to Black students' tireless efforts.

Acknowledging Racism's Adverse Effects on Health

The Liaison Committee on Medical Education, the official accrediting body for medical schools in the U.S. and Canada, said faculty must teach students to recognize bias "in themselves, in others, and in the healthcare delivery process." But the LCME does not explicitly require accredited institutions to teach about systemic racism in medicine.

This is what students and some faculty want to change. Dr. David Acosta, the chief diversity and inclusion officer of the American Association of Medical Colleges, said about 80% of medical schools offer either a mandatory or elective course on health disparities. But little data exists on how many schools teach students how to recognize and fight racism, he said.

An anti-racist curriculum should explore ways to mitigate or eliminate racism's harm, said Rachel Hardeman, a health policy professor at the University of Minnesota.

"It's thinking about how do you infuse this across all of the learning in medical education, so that it's not this sort of drop in the bucket, like, one-time thing," she said. Above all, the courses that delve into systemic racism need to be required, Hardeman said.

Edwin Lindo, a lecturer at the University of Washington School of Medicine, said medicine should embrace an interdisciplinary model, allowing sociologists or historians to lecture on how racism harms health.

Acosta said the AAMC has organized a committee of experts to develop an anti-racism curriculum for every step of medical education. They hope to share their work publicly this month and talk to the LCME about developing and implementing these standards.

"Our next work is how do we persuade and influence the LCME to think about adding anti-racist training in there," Acosta said.

Recognizing Racism in Medical Education's Past and Present

Activists especially want to see their institutions recognize their own missteps, as well as the racism that has accompanied past medical achievements. Dereck Paul, a student at the University of California-San Francisco School of Medicine, said he wants every medical school to include lectures on people like Henrietta Lacks, the Black woman who was dying of cancer when cells were taken without her consent and used to develop cell lines that have been instrumental in medical research.

Asmerom said she wants to see faculty acknowledge medicine's racist past in lessons. She cited an introductory course on anatomy at her school that failed to note that in the past, as scientists sought to study the body, Blacks and other minorities were mistreated. "It's like, OK, but you're not going to talk about the fact that Black bodies were taken out of graves in order to have bodies to use for anatomy lab?" she said.

While Asmerom is glad to see her medical school actively listening to students, she feels administrators need to own up to their mistakes in the recent past. "There needs to be an admission of how you perpetuated anti-Black racism at this institution," Asmerom said.

Asmerom, who is one of the leaders of the UCSD Anti-Racism Coalition, said the administration has responded favorably so far to the coalition's demands to pour time and money into anti-racist initiatives. She's cautiously hopeful.

"But I'm not going to hold my breath until I see actual changes," she said.

Elizabeth Lawrence: elizabethla@kff.org

This year, the coronavirus has forced homeless shelters to limit the number of beds they can offer.

This article was published on Monday, November 16, 2020 in Kaiser Health News.

By Giles Bruce

Ben Barnes has slept in abandoned buildings, hallways and alleys. For the past year or so, he’s been staying at the city’s largest homeless shelter, Pacific Garden Mission, in the shadows of the famous skyline.

“I’ve always considered myself homeless because I don’t have a home,” he said on a recent crisp, fall day in the shelter’s sun-splashed courtyard. But he’s fortunate, said Barnes, 44. He’s never had to sleep outside when it was below zero or snowy. He always found a friend’s place, building or shelter to crash in. He knows others aren’t so lucky.

As winter approaches, hundreds — perhaps thousands — of people in this city of nearly 3 million are living on the streets: some in encampments, others hopping from corner to corner. And the numbers could grow without more federal aid and protections amid economic pressures from the pandemic.

This year, the coronavirus has forced homeless shelters to limit the number of beds they can offer. Pacific Garden Mission, for instance, is operating at roughly half its normal capacity of 740. And COVID-19 cases are rising as temperatures drop.

“What happens if we’re in the midst of a pandemic and a polar vortex happens?” said Doug Schenkelberg, executive director of the Chicago Coalition for the Homeless. “We’re trying to keep the contagion from spreading and keep people from dealing with hypothermia. Is there the infrastructure in place that can handle that type of dual crisis?”

Cold-weather cities across the nation are seeking creative ways to cautiously shelter homeless people this winter. Exposure to the elements kills individuals staying outside every year, so indoor refuges can be lifesaving. But fewer options exist nowadays, as coronavirus concerns limit access to libraries, public recreation facilities and restaurants. And in official shelters, safety precautions — spacing out beds and chairs, emphasizing masks and hand-washing, testing — are critical.

“The homeless check off most boxes in terms of being the most susceptible and most vulnerable to the COVID-19 pandemic, and most likely to spread and most likely to die from it,” said Neli Vazquez Rowland, founder of A Safe Haven Foundation, a Chicago nonprofit that has been operating a “medical respite” isolation facility for homeless individuals with the coronavirus.

Demand for shelter could grow. Stimulus checks helped stave off some of the pandemic’s initial economic pain, but Congress has stalled on additional relief packages. And though the Trump administration has ordered a moratorium on evictions for tenants who meet certain conditions through the end of the year, a group of landlords is suing to stop the ban. Some states have their own prohibitions on evictions, but only Illinois, Minnesota and Kansas do in the Midwest.

At the Guest House of Milwaukee, a publicly funded homeless shelter in Wisconsin, the pandemic complicates an already challenging situation.

“We’re like many communities. We never really have completely enough space for everybody who is in need of shelter,” said Cindy Krahenbuhl, its executive director. “The fact that we’ve had to reduce capacity, and all shelters have, has created even more of a burden on the system.”

She said outreach teams plan to connect individuals living outside with an open bed — whether at a shelter, a hotel or an emergency facility for homeless people at risk for COVID — and get them started with case management.

“The reality is we’ve got to make it happen. We’ve got to have space for folks because it’s a matter of life and death. You cannot be outside unsheltered in this environment too long,” said Rob Swiers, executive director of the New Life Center in Fargo, North Dakota, where the average high in January is 18 degrees.

His shelter, Fargo’s largest, plans to use an insulated, heated warehouse to provide roomy sanctuary for clients.

In Minnesota’s Ramsey County, home to St. Paul, an estimated 311 people are living on the streets, compared with “dozens” at this time in 2019, according to Max Holdhusen, the county’s interim manager of housing stability. The area just had a record snowfall for so early in the year.

The county has been using hotel rooms to make up for the reduction in shelter beds, and recently agreed to lease an old hospital to shelter an additional 100 homeless people.

The city of Chicago has set up emergency shelters in two unused public school buildings to replace beds lost to social distancing. As it does every winter, the city will also operate warming centers across Chicago, although this year with precautions such as spacing and masking.

In September, the city directed more than $35 million in funding — mostly from the federal CARES Act for coronavirus relief — to an “expedited housing” program aiming to get more than 2,500 people housed in the next few years. The initiative plans to financially incentivize landlords to take risks on renters they might normally avoid, such as those with criminal histories or poor credit. The nonprofit in charge, All Chicago, is also hosting “accelerated moving events,” in which its staffers descend on a shelter, encampment or drop-in center and work to house everyone in that facility.

“In the ideal world, we would have permanent housing for them,” said Dr. David Ansell, senior vice president of community health equity at Chicago’s Rush University Medical Center. “That is the only way we can protect people’s health. That’s the fundamental health issue. It’s a fundamental racial justice issue. It’s a fundamental social justice issue.”

Even though Black people make up only a third of Chicago’s population, they account for roughly three-fourths of those who are homeless, according to the city’s count.

Dr. Thomas Huggett, a family physician with Lawndale Christian Health Center on the city’s largely impoverished West Side, also called safely sheltering and housing people this winter a racial equity issue.

“We know that people who are African American have a higher prevalence of hypertension, of diabetes, of obesity, of smoking, of lung issues,” he said. “So they are hit harder with those predisposing conditions that make it more likely that if you get coronavirus, you’re going to have a serious case of it.”

Then add the cold. Dr. Stockton Mayer, an infectious disease specialist from the University of Illinois Hospital in Chicago, said hypothermia doesn’t increase the chances of contracting the virus but could aggravate symptoms.

As of Sept. 30, according to All Chicago, 778 people were unsheltered in the city. However, that number includes only people who are enrolled in homelessness services, and other estimates are even higher.

Some homeless people who plan to live outside this winter said they worry about staying warm, dry and healthy in the age of COVID-19. Efren Parderes, 48, has been on the streets of Chicago since he lost his restaurant job and rented room early in the pandemic. But he doesn’t want to go to a shelter. He’s concerned about catching the coronavirus and bedbugs, and doesn’t want to have to obey curfews.

He recently asked other unsheltered people what they do to keep warm during the winter. Their advice: Locate a spot that blocks the wind or snow, bundle up with many layers of clothing, sleep in a sleeping bag and use hand warmers.

“This is going to be the first time I’ll be out when it’s really cold,” he said after spending a largely sleepless night in the chilly October rain.