As they rush to vaccinate millions of Americans, health officials are struggling to collect critically important information — such as race, ethnicity and occupation — of every person they jab.
The data being collected is so scattered that there's little insight into which healthcare workers, or first responders, have been among the people getting the initial vaccines, as intended — or how many doses instead have gone to people who should be much further down the list.
The gaps — which experts say reflect decades of underfunding of public health programs — could mean that well-connected people and health personnel who have no contact with patients are getting vaccines before front-line workers, who are at much higher risk for illness. Federal and state officials prioritized health workers plus residents and staffs of nursing homes for the first wave of shots.
Although officials leading President Joe Biden's covid response have pledged to tackle racial inequities as they seek to control the pandemic, lapses in reporting race or ethnicity could hinder efforts to identify and track whether minorities hit especially hard by the pandemic are getting shots at a high-enough rate to achieve hoped-for levels of herd immunity. So far, limited data in multiple states shows Black residents are getting vaccinated at lower rates than whites.
"Every state knows where they've sent vaccine, and every provider has to report inventory. But as far as who is being vaccinated, that one is a little more tricky," said Claire Hannan, executive director of the Association of Immunization Managers.
Data that eventually makes its way to the Centers for Disease Control and Prevention and other federal systems is "only going to be as good as whatever you can get out of the vaccine registries" that vary by state, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials. "They're all different and, going into this, they were all at different stages of how robust they were."
There are 64 immunization registries in the United States that gather information for states, territories and a handful of large cities — and they aren't connected. Meanwhile, real-time data in the U.S. public health system is virtually nonexistent, Plescia said.
Reporters at KHN examined the data being gathered versus what the CDC says is supposed to be collected for every person vaccinated, which includes: name, address, sex, date of birth, race and ethnicity, the date and location where they were vaccinated, and the shot they received (currently only two products are available, from Pfizer-BioNTech and Moderna). Not on its list: occupation, even though initial vaccine distribution largely hinges on place of work, prioritizing healthcare personnel, long-term care facilities and then other essential workers such as teachers, grocery store workers and firefighters.
Dr. Katherine Poehling, a pediatrician at the Wake Forest School of Medicine who's on the CDC advisory committee that issued vaccine priority recommendations, declined to comment on whether occupation should have been a required element for reporting to the CDC.
"I think you can always wish for more data, but really what we're going for is vaccinating everybody that wants to be vaccinated," she said. "The fact that there was something available on day one was really remarkable," she said, referring to a database that could track vaccine shipments and allocations by state.
Still, gaps are evident, including holes in CDC rules for reporting race and ethnicity. Race and ethnicity information are missing from at least hundreds of thousands of vaccine doses that have already been administered and reported to state public health authorities.
Texas' vaccine data on Wednesday showed that race or ethnicity was unknown for more than 700,000 people. Virginia's dashboard shows that data was missing for nearly 300,000 vaccinations, or 52% of vaccine doses, as of Tuesday. The same was true for tens of thousands of vaccinations in Colorado and Maryland.
In Minnesota, state law prohibits the sharing of data on race and ethnicity.
"It is important how many shots are administered, but it is critical that we get good race and ethnicity information about who is receiving it so we can identify disparities and other problems," said Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.
The CDC declined to say how many of the vaccine records it had received were missing the information. In response to questions, CDC spokesperson Kristen Nordlund said the agency plans to publish race, ethnicity and other demographic data next week.
The Department of Health and Human Services did not respond to multiple requests for comment.
Dr. Marcella Nunez-Smith, chair of the Biden administration's covid-19 health equity task force, on Wednesday conceded that the racial and ethnicity data is "incomplete" but said it wasn't the only way to gauge progress of the vaccine rollout on the ground.
"We can think about things like neighborhoods and communities as metrics and ways to track as well," she said. "We're building our equity dashboard right now, and we'll rely on government sources as well as sources of data external to government."
The ongoing struggle for complete data shows how little has changed for the CDC since the virus appeared in the U.S. one year ago and its early efforts to collect data identifying covid-infected people were widely panned.
So far, the CDC has publicly stated how many vaccines have been distributed nationwide and how many doses administered. Its dashboard includes a breakdown of how many shots have been given by state and in long-term care facilities. Walgreens and CVS together have given more than 2.5 million doses in nursing homes and other long-term care facilities, though neither company has released data on race or whether the shots were given to patients or staffers.
State and federal health officials know where vaccines go as officials must track inventory by facility. Several states have released breakdowns of doses administered by the type of institution, providing a window into how many shots are being used in hospitals, nursing homes, pharmacies, primary care practices, public health departments and tribal health sites. And when signing up for an appointment, individuals may be asked to provide their occupation to attest they qualify for a shot under a state's rules at a given time.
Maryland and Ohio require providers to submit data on the occupations of vaccine recipients, in a break with CDC practice. But several states contacted by KHN said they do not collect that information, such as Idaho, Michigan, Minnesota, Texas and Virginia.
Electronic health records manufacturers that provide software to hospitals and other facilities said they are scrambling to modify the software to accommodate data reporting requirements that vary by state.
Occupation is one example. Another: Texas law requires the state to collect information on all medications given "in response to a declared disaster or public health emergency," said State Health Services spokesperson Chris Van Deusen.
Leigh Burchell, vice president of policy and government affairs at the EHR firm Allscripts, said these variations are "obstacles none of us has tackled before," though she thinks that, overall, "successes outweigh failures" as companies have had to adjust quickly during the pandemic.
EHR systems can connect to state registries, which ultimately send vaccine tracking data to the CDC. A lack of "a coordinated, national public health infrastructure" continues to be a problem that "forces everyone to work less efficiently than would be optimal," Burchell said.
Health IT consultant Reed Gelzer said the situation reflects the 30-year-plus failure of the public health system to modernize data collection. He said officials need look no further than chronic problems tracking childhood immunizations, handled in some states at the county level, and in others at the state level, often poorly. A national system to track immunizations has never existed, which he argues should have been discussed before the vaccine rollout.
"As far as I know, even in the earliest days of the pandemic, nobody did stress-testing of the information system," Gelzer said.
Cerner, a major electronic health records company, says that some hospitals are using an existing workplace health system to track employees who have been vaccinated while others create a patient record for vaccinated employees as well as for patients. The systems can capture demographic details, but the data fields to do that have to be turned on and it's unclear whether its client hospitals have done so.
The CDC and other federal agencies rely on a complicated web of systems to get data about who's been vaccinated. State and local vaccine registries, known as immunization information systems, are the most comprehensive source of records and the "source of truth," Hannan said.
Those registries have long-standing connections to providers' electronic health records, said Rebecca Coyle, executive director of the American Immunization Registry Association. But they aren't meant to capture certain information, such as a patient's medical history and occupation.
Those state and local registries transmit data to an HHS-owned clearinghouse, where personal details are redacted.
The clearinghouse gets data from other sources, too. These include a new CDC vaccination clinic mobile app called VAMS, as well as pharmacies, prisons and federal agencies like the Department of Veterans Affairs and the Indian Health Service.
A limited slice of the data then moves to another CDC repository known as the "Data Lake," where it can be analyzed and reported to the CDC and Tiberius, a separate software platform developed by federal contractor Palantir for former President Donald Trump's Operation Warp Speed effort. The Data Lake also receives information on shipment and vaccine orders from the CDC's VTrckS system.
On top of that dizzying array of tools, many states use another, third-party software system, PrepMod, to manage vaccine inventory, appointments and reporting.
When asked whether not having data on occupations could hinder tracking whether priority groups have received their shots, Nordlund of the CDC said it's unnecessary to vaccinate all individuals in one phase before initiating the next.
"This means ideally hitting a sweet spot that maximizes getting vaccine into arms while also being mindful of the priority groups," Nordlund said, "especially because these are people who are higher risk for complications from covid-19 or are more likely to be exposed to the virus because of their jobs."
Lawmakers recently attempted to address the nation's antiquated public health data infrastructure, partly by appropriating $500 million under the CARES Act to the CDC. In an August letter to Rep. Lucy McBath (D-Ga.), former CDC director Dr. Robert Redfield said the agency would use the funds to update how state and health departments report data to federal officials, improve the CDC's own data infrastructure, and develop new standards for public health reporting.
Additionally, tucked into the massive year-end spending bill Congress passed in late December was a requirement that HHS expand and improve public health data systems used by the CDC and award grants to state and local health departments to upgrade their infrastructure.
The Biden administration has made promises to strengthen the federal government's approach to data collection on vaccination efforts.
KHN data reporter Hannah Recht and KHN correspondent Lauren Weber contributed to this report.
The covid-19 variants that have emerged in the United Kingdom, Brazil, South Africa and now Southern California are eliciting two notably distinct responses from U.S. public health officials.
First, broad concern. A variant that wreaked havoc in the U.K., leading to a spike in cases and hospitalizations, is surfacing in a growing number of places in the U.S. This week, another worrisome variant seen in Brazil surfaced in Minnesota. If these or other strains significantly change the way the virus transmits and attacks the body, as scientists fear they might, they could cause yet another prolonged surge in illness and death in the U.S., even as cases have begun to plateau and vaccines are rolling out.
On the other hand, variants aren't novel or even uncommon in viral illnesses. The viruses that trigger common colds and flus regularly evolve. Even if a mutated strain of SARS-CoV-2, the virus that causes covid, makes it more contagious or makes people sicker, the basic public health response stays the same: Monitor the virus, and any mutations, as it moves across communities. Use masking, testing, physical distancing and quarantine to contain the spread.
The problem is that the U.S. has struggled with every step of its public health response in its first year of battle against covid-19. And that raises the question of whether the nation will devote the attention and resources needed to outflank the virus as it evolves.
Researchers are quick to stress that a coronavirus mutation in itself is no cause for alarm. In the course of making millions and billions of copies as part of the infection process, small changes to a virus's genome happen all the time as a function of evolutionary biology.
"The word 'variant' and the word 'mutation' have these scary connotations, and they aren't necessarily scary," said Kelly Wroblewski, director of infectious disease programs for the Association of Public Health Laboratories.
When a mutation rings public health alarms, it's typically because it has combined with other mutations and, collectively, changed how the virus behaves. At that point, it may be named a variant. A variant can make a virus spread faster, or more easily jump between species. It can make a virus more successful at making people sicker, or change how our immune systems respond.
SARS-CoV-2 has been mutating for as long as we've known about it; mutations were identified by scientists throughout 2020. Though relevant scientifically — mutations can actually be helpful, acting like a fingerprint that allows scientists to track a virus's spread — the identified strains mostly carried little concern for public health.
Then came the end of the year, when several variants began drawing scrutiny. One of the most concerning, first detected in the United Kingdom, appears to make the virus more transmissible. Emerging evidence suggests it also could be deadlier, though scientists are still debating that.
We know more about the U.K. variant than others not because it's necessarily worse, but because the British have one of the best virus surveillance programs in the world, said William Hanage, an epidemiologist and a professor at Harvard University.
By contrast, the U.S. has one of the weakest genomic surveillance programs of any rich country, Hanage said. "As it is, people like me cobble together partnerships with places and try and beg them" for samples, he said on a recent call with reporters.
Other variant strains were identified in South Africa and Brazil, and they share some mutations with the U.K. variant. That those changes evolved independently in several parts of the world suggests they might present an evolutionary advantage for the virus. Yet another strain was recently identified in Southern California and flagged due to its increasing presence in hard-hit cities like Los Angeles.
The Southern California strain was detected because a team of researchers at Cedars-Sinai, a hospital and research center in Los Angeles, has unfettered access to patient samples. They were able to see that the strain made up a growing share of cases at the hospital in recent weeks, as well as among the limited number of other samples haphazardly collected at a network of labs in the region.
Not only does the U.S. do less genomic sequencing than most wealthy countries, but it also does its surveillance by happenstance. That means it takes longer to detect new strains and draw conclusions about them. It's not yet clear, for example, whether that Southern California strain was truly worthy of a press release.
Vast swaths of America's privatized and decentralized system of healthcare aren't set up to send samples to public health or academic labs. "I'm more concerned about the systems to detect variants than I am these particular variants," said Mark Pandori, director of Nevada's public health laboratory and an associate professor at the University of Nevada-Reno School of Medicine.
Limited genomic surveillance of viruses is yet another side effect of a fragmented and underfunded public health system that's struggled to test, track contacts and get covid under control throughout the pandemic, Wroblewski said.
The nation's public health infrastructure, generally funded on a disease-by-disease basis, has decent systems set up to sequence flu, foodborne illnesses and tuberculosis, but there has been no national strategy on covid. "To look for variants, it needs to be a national picture if it's going to be done well," Wroblewski said.
Last week, the Biden administration outlined a strategy for a national response to covid, which included expanded surveillance for variants.
So far, vaccines for covid appear to protect against the known variants. Moderna has said its vaccine is effective against the U.K. and South African strains, though it yields fewer antibodies in the face of the latter. The company is working to develop a revised dose of the vaccine that could be added to the current two-shot regimen as a precaution.
But a lot of damage can be done in the time it will take to roll out the current vaccine, let alone an update.
Even with limited sampling, the U.K. variant has been detected in more than two dozen U.S. states, and the Centers for Disease Control and Prevention has warned it could be the predominant strain in the U.S. by March. When it took off in the United Kingdom at the end of last year, it caused a swell in cases, overwhelmed hospitals and led to a holiday lockdown. Whether the U.S. faces the same fate could depend on which strains it is competing against, and how the public behaves in the weeks ahead.
Already risky interactions among people could, on average, get a little riskier. Many researchers are calling for better masks and better indoor ventilation. But any updates on recommendations likely would play at the margins. Even if variants spread more easily, the same recommendations public health experts have been espousing for months — masking, physical distancing and limiting time indoors with others — will be the best way to ward them off, said Dr. Kirsten Bibbins-Domingo, a physician and professor at the University of California-San Francisco.
"It's very unsexy what the solutions are," Bibbins-Domingo said. "But we need everyone to do them."
That doesn't make the task simple. Masking remains controversial in many states, and the public's patience for maintaining physical distance has worn thin.
Adding to the concerns: Though case numbers have stabilized in many parts of the U.S. in recent weeks, they have stabilized at rates many times what they were during previous periods in the pandemic or in other parts of the world. Having all that virus in so many bodies creates more opportunities for new mutations and new variants to emerge.
"If we keep letting this thing sneak around, it's going to get around all the measures we take against it, and that's the worst possible thing," said Nevada's Pandori.
Compared with less virulent strains, a more contagious variant likely will require that more people be vaccinated before a community can see the benefits of widespread immunity. It's a bleak outlook for a nation already falling behind in the race to vaccinate enough people to bring the pandemic under control.
"When your best solution is to ask people to do the things that they don't like to do anyway, that's very scary," said Bibbins-Domingo.
A dozen states are reporting drops of 25% or more in new covid-19 cases and more than 1,200 counties have seen the same, federal data released Wednesday shows. Experts say the plunge may relate to growing fear of the virus after it reached record-high levels, as well as soaring hopes of getting vaccinated soon.
Nationally, new cases have dropped 21% from the prior week, according to Department of Health and Human Services data, reflecting slightly more than 3,000 counties. Corresponding declines in hospitalization and death may take days or weeks to arrive, and the battle against the deadly virus rages on at record levels in many places.
Health officials, data modeling experts and epidemiologists agreed it's too early to see a bump from the vaccine rollout that started with healthcare workers in late December and has, in many states, moved on to include older Americans.
Instead, they said, the factors involved are more likely behavior-driven, with people settling back home after the holidays, or reacting to news of hospital beds running out in places like Los Angeles. Others are finding the resolve to wear masks and physically distance with the prospect of a vaccine becoming more immediate.
A single reason is hard to pinpoint, said Adriane Casalotti, chief of government and public affairs for the National Association of County and City Health Officials. She said it may be due in part to people hoping to avoid the new, more contagious variants of the virus, which some experts say appear to be deadlier as well.
She also said so many people got sick in the last surge that more people may be taking precautions: "There's a better chance you know someone who had it," Casalotti said.
Eva Lee, a mathematician and engineering professor at the Georgia Institute of Technology, works on models predicting covid patterns. She said in an email that the decline reflects the natural course of the virus as it infects a social web of people, exhausts that cluster, dies down and then emerges in new groups.
She also said the national trend, with even steeper drops in California, also reflects restrictions in that state, which included closing indoor dining and a 10 p.m. curfew in hard-hit regions. She said those measures take a few weeks to show up in new-case data.
"It is a very unstable equilibrium at the moment," Lee wrote in the email. "So any premature celebration would lead to another spike, as we have seen it time and again in the US."
Four California counties were among the five large U.S. counties seeing the steepest case drops, including Los Angeles County, where new cases declined nearly 40% in the week ending Jan. 25, compared with the week before.
Dr. Karin Michels, chair of epidemiology at the UCLA Fielding School of Public Health, said the lower numbers in L.A. after the virus infected 1 in 8 county residents likely mirror what happened after New York City's surge: People got very scared and changed their behavior.
"People are beginning to understand we really need to get our act together in L.A., so that helps," she said. "The big fear [now] is 'Is it really going in this direction, is it plateauing, or where is it going to go?' We need to go further down, because it is really high."
Michels said herd immunity would not explain the declines, since we're nowhere near the level of 70% of the population having had the disease or been vaccinated. She said the declines may also reflect a drop in testing, as Dodger Stadium has been converted from a mass testing site to a mass vaccination center.
Officials with the California Department of Public Health acknowledged that testing has fallen off, but overall rates of positive covid tests are falling, suggesting the change is real.
New cases also fell significantly in Wyoming, Oregon, South Dakota and Utah, with each state recording at least 30% fewer new cases. Each of those states reported having vaccinated 8% or more of their adult population by Tuesday, putting them among the top 20 states in terms of vaccination rate.
Alaska leads the states currently, at nearly 15%, according to HHS. It's also logged a new-case drop of 24% in recent days.
Yet experts aren't willing to say yet that the vaccines are driving cases down.
"Most people in public health don't think we'll see the benefit of the vaccine until a few months from now," said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.
The number of deaths continues to remain high weeks after high case rates as the virus variably attacks the heart, kidneys, lungs and nervous system. Many patients remain unconscious and on a ventilator for weeks as doctors search for signs of improvement.
The death rate fell by only 5% in the data posted Wednesday, reflecting 21,790 patients who died of the virus Jan. 19-25.
Anxiety about new strains of the virus from the U.K., Brazil and South Africa remains high in Portland's Multnomah County, Oregon, which saw a drastic 43% new-case decline in recent days.
"The concern is that everything could change," said Kate Yeiser, spokesperson for the Multnomah County Health Department.
While the $900 billion that lawmakers included for urgent pandemic relief got most of the attention, some even bigger changes for healthcare were buried in the other parts of that huge legislative package.
This article was published on Thursday, January 28, 2021 in Kaiser Health News.
By Emmarie Huetteman Late last month, before President Joe Biden took office and proposed his pandemic relief plan, Congress passed a nearly 5,600-page legislative package that provided some pandemic relief along with its more general allocations to fund the government in 2021.
While the $900 billion that lawmakers included for urgent pandemic relief got most of the attention, some even bigger changes for healthcare were buried in the other parts of that huge legislative package.
The bundle included a ban on surprise medical bills, for example — a problem that key lawmakers had been wrestling with for two years. Starting in 2022, because of the new law, patients generally will not pay more for out-of-network care in emergencies and at otherwise in-network facilities.
But surprise bills weren't the only healthcare issue Congress addressed as it ended a tumultuous year. Lawmakers also answered pleas from strained health facilities in rural areas, agreed to cover the cost of training more new doctors, sought to strengthen efforts to equalize mental health coverage with that of physical medicine and instructed the federal government to collect data that could be used to rein in high medical bills.
Here are some details about those big changes Congress made in December.
Rural Hospitals Get a Boost
Throwing a lifeline to struggling rural health systems — and, it appears, a bone to an outgoing congressional committee chairman — lawmakers gave rural hospitals a way to get paid by Medicare for their services regardless of whether they have patients in beds.
The law creates a new category of provider, known as a "rural emergency hospital." Starting in 2023, some hospitals will qualify for this designation by maintaining full-time emergency departments, among other criteria, without being required to provide in-patient care. The Department of Health and Human Services will determine how the program is implemented and which services are eligible.
Medicare, the federal insurance program that covers more than 61 million Americans 65 and older or with certain disabilities, currently does not reimburse hospitals for emergency or hospital outpatient services unless the hospital also offers in-patient care.
That requirement has exacerbated financial problems for rural hospitals, many of which balance serving communities with fewer patients — and less need for full in-patient services — with the need for emergency and outpatient services. One study last year found 120 rural hospital facilities had closed in the past 10 years, with more at risk.
Hospital groups have praised the change, which was introduced by Sen. Chuck Grassley (R-Iowa), who has championed rural health issues and ended his term as chairman of the Senate Finance Committee this month. "I worked to ensure rural America would not go overlooked," he said in a statement.
Medicare Invests in More Doctors
Hoping to address a national shortage of doctors that has reached critical levels during the pandemic, Congress created an additional 1,000 residency positions over the next five years.
Medicare will fund the positions, which involve supervised training to medical school graduates going into specialties like emergency medicine and are distributed among hospitals most in need of personnel, including rural hospitals.
Critics like The Wall Street Journal's editorial board have noted this is Congress' attempt to fix a problem it created in the late 1990s, when lawmakers capped the number of Medicare-funded residency positions in the United States, fearing too many doctors would inflate the cost of Medicare.
While Medicare is not the only source of educational funding and hospitals may add their own residency slots as needed, Medicare generally will reimburse hospitals for the number of residents they had at the end of 1996. Among other consequences of that 1996 cap, most Medicare-funded residencies are clumped at Northeastern hospitals, a 2014 study showed.
In contrast to the 1,000 positions created as part of the stimulus package, one bipartisan proposal in 2019 that was never enacted would have added up to 15,000 positions over five years.
Strengthening Mental Health Parity
The legislative package strengthens protections for mental health coverage, requiring federal officials to study the limitations insurance companies place on coverage for mental health and substance use disorder treatments.
In 1996 Congress passed the first law barring health insurers from passing along more of the cost for mental healthcare to patients than they would for medical or surgical care. The Affordable Care Act, building on earlier laws, made mental health and substance use disorder treatments an "essential health benefit" — in other words, it required most health insurance plans to cover mental healthcare.
But enforcing that standard has been a challenge, in part because violations can be hard to spot and the system has often relied on patients to notice — and report — them.
In December, lawmakers approved a measure requiring insurers to analyze their coverage and provide their findings to state and federal officials upon request.
They also instructed federal officials to request the findings from at least 20 plans per year that may have violated mental health parity laws and tell insurers how to correct any problems they find — under penalty of having insurer violations reported to their customers if they do not comply.
The law requires federal officials to publish an annual report summarizing the analyses they collect.
More Transparency in Cost and Quality
Americans often do not know how much they will be expected to pay when they enter a doctor's office, an ambulance or an emergency room.
Taking another modest step toward transparency, Congress banned so-called gag clauses in contracts between health insurers and providers.
Among other things, these sorts of "gag" restrictions previously have prevented insurers and group health plans from sharing with patients and others — such as employers — information about a provider's prices or quality. The December legislation also prohibited insurers from agreeing to contracts that prevent them from getting access electronically to claims and other information from providers on behalf of the insurer's enrollees.
In 2018, Congress banned gag clauses in contracts between pharmacies and insurers or pharmacy benefit managers. Those gag clauses had prevented pharmacists from sharing cost information with patients, like whether they could pay a lower price for a prescription by paying out-of-pocket rather than using their insurance coverage.
The proposal approved in December's legislation came from a big, bipartisan package of healthcare cost fixes passed in 2019 by the Senate Health, Education, Labor and Pensions Committee, but not by the rest of Congress. The committee's Republican chairman, Sen. Lamar Alexander of Tennessee, retired from Congress this month. His Democratic partner on that package, Sen. Patty Murray of Washington, will take over the chairmanship as Democrats assume control of the Senate and has vowed to focus on healthcare affordability.
Consumers First, a health consumer-focused alliance of health professionals, labor unions and others, led by Families USA, praised the ban. The change is "a significant step forward" to stop "the abusive practices from hospitals and health systems and other segments of the healthcare sector that are driving up healthcare costs and making healthcare unaffordable for our nation's families, workers, and employers," it said in a statement.
KHN senior correspondent Sarah Jane Tribble contributed to this report.
Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions.
This article was published on Wednesday, January 27, 2021 in Kaiser Health News. This story also ran on CNN.
As public demand grows for limited supplies of covid-19 vaccines, questions remain about the vaccines’ appropriateness for older adults with various illnesses. Among them are cancer patients receiving active treatment, dementia patients near the end of their lives and people with autoimmune conditions.
Recently, a number of readers have asked me whether older relatives with these conditions should be immunized. This is a matter for medical experts, and I solicited advice from several. All strongly suggested that people with questions contact their doctors and discuss their individual medical circumstances.
Experts’ advice may be helpful since states are beginning to offer vaccines to adults over age 65, 70 or 75, including those with serious underlying medical conditions. Twenty-eight states are doing so, according to the latest survey by The New York Times.
Q: My 80-year-old mother has chronic lymphocytic leukemia. For weeks, her oncologist would not tell her “yes” or “no” about the vaccine. After much pressure, he finally responded: “It won’t work for you, your immune system is too compromised to make antibodies.” She asked if she can take the vaccine anyway, just in case it might offer a little protection, and he told her he was done discussing it with her.
First, some basics. Older adults, in general, responded extremely well to the two covid-19 vaccines that have received special authorization from the Food and Drug Administration. In large clinical trials sponsored by drugmakers Pfizer and Moderna, the vaccines achieved substantial protection against significant illness, with efficacy for older adults ranging from 87% to 94%.
But people 65 and older undergoing cancer treatment were not included in these studies. As a result, it’s not known what degree of protection they might derive.
Dr. Tobias Hohl, chief of the infectious diseases service at Memorial Sloan Kettering Cancer Center in New York City, suggested that three factors should influence patients’ decisions: Are vaccines safe, will they be effective, and what is my risk of becoming severely ill from covid-19? Regarding risk, he noted that older adults are the people most likely to become severely ill and perish from covid, accounting for about 80% of deaths to date — a compelling argument for vaccination.
Regarding safety, there is no evidence at this time that cancer patients are more likely to experience side effects from the Pfizer-BioNTech and Moderna vaccines than other people. Generally, “we are confident that these vaccines are safe for [cancer] patients,” including older patients, said Dr. Armin Shahrokni, a Memorial Sloan Kettering geriatrician and oncologist.
The exception, which applies to everyone, not just cancer patients: people who are allergic to covid-19 vaccine components or who experience severe allergic responses after getting a first shot shouldn’t get covid-19 vaccines.
Efficacy is a consideration for patients whose underlying cancer or treatment suppresses their immune systems. Notably, patients with blood and lymph node cancers may experience a blunted response to vaccines, along with patients undergoing chemotherapy or radiation therapy.
Even in this case, “we have every reason to believe that if their immune system is functioning at all, they will respond to the vaccine to some extent,” and that’s likely to be beneficial, said Dr. William Dale, chair of supportive care medicine and director of the Center for Cancer Aging Research at City of Hope, a comprehensive cancer center in Los Angeles County.
Balancing the timing of cancer treatment and immunization may be a consideration in some cases. For those with serious disease who “need therapy as quickly as possible, we should not delay [cancer] treatment because we want to preserve immune function and vaccinate them” against covid, said Hohl of Memorial Sloan Kettering.
One approach might be trying to time covid vaccination “in between cycles of chemotherapy, if possible,” said Dr. Catherine Liu, a professor in the vaccine and infectious disease division at Fred Hutchinson Cancer Research Center in Seattle.
In new guidelines published late last week, the National Comprehensive Cancer Network, an alliance of cancer centers, urged that patients undergoing active treatment be prioritized for vaccines as soon as possible. A notable exception: Patients who’ve received stem cell transplants or bone marrow transplants should wait at least three months before getting vaccines, the group recommended.
The American Cancer Society’s chief medical and scientific officer, Dr. William Cance, said his organization is “strongly in favor of cancer patients and cancer survivors getting vaccinated, particularly older adults.” Given vaccine shortages, he also recommended that cancer patients who contract covid-19 get antibody therapies as soon as possible, if their oncologists believe they’re good candidates. These infusion therapies, from Eli Lilly and Co. and Regeneron Pharmaceuticals, rely on synthetic immune cells to help fight infections.
Q: Should my 97-year-old mom, in a nursing home with dementia, even get the covid vaccine?
The federal government and all 50 states recommend covid vaccines for long-term care residents, most of whom have Alzheimer’s disease or other types of cognitive impairment. This is an effort to stem the tide of covid-related illness and death that has swept through nursing homes and assisted living facilities — 37% of all covid deaths as of mid-January.
The Alzheimer’s Association also strongly encourages immunization against covid-19, “both for people [with dementia] living in long-term care and those living in the community, said Beth Kallmyer, vice president of care and support.
“What I think this question is trying to ask is ‘Will my loved one live long enough to see the benefit of being vaccinated?’” said Dr. Joshua Uy, medical director at a Philadelphia nursing home and geriatric fellowship director at the University of Pennsylvania’s Perelman School of Medicine.
Potential benefits include not becoming ill or dying from covid-19, having visits from family or friends, engaging with other residents and taking part in activities, Uy suggested. (This is a partial list.) Since these benefits could start accruing a few weeks after residents in a facility are fully immunized, “I would recommend the vaccine for a 97-year-old with significant dementia,” Uy said.
Minimizing suffering is a key consideration, said Dr. Michael Rafii, associate professor of clinical neurology at the University of Southern California’s Keck School of Medicine. “Even if a person has end-stage dementia, you want to do anything you can to reduce the risk of suffering. And this vaccine provides individuals with a good deal of protection from suffering severe covid,” he said.
“My advice is that everyone should get vaccinated, regardless of what stage of dementia they’re in,” Rafii said. That includes dementia patients at the end of their lives in hospice care, he noted.
If possible, a loved one should be at hand for reassurance since being approached by someone wearing a mask and carrying a needle can evoke anxiety in dementia patients. “Have the person administering the vaccine explain who they are, what they’re doing and why they’re wearing a mask in clear, simple language,” Rafii suggested.
Q: I’m 80 and I have Type 2 diabetes and an autoimmune disease. Should I get the vaccine?
There are two parts to this question. The first has to do with “comorbidities” — having more than one medical condition. Should older adults with comorbidities get covid vaccines?
Absolutely, because they’re at higher risk of becoming seriously ill from covid, said Dr. Abinash Virk, an infectious diseases specialist and co-chair of the Mayo Clinic’s covid-19 vaccine rollout.
“Pfizer’s and Moderna’s studies specifically looked at people who were older and had comorbidities, and they showed that vaccine response was similar to [that of] people who were younger,” she noted.
The second part has to do with autoimmune illnesses such as lupus or rheumatoid arthritis, which also put people at higher risk. The concern here is that a vaccine might trigger inflammatory responses that could exacerbate these conditions.
Philippa Marrack, chair of the department of immunology and genomic medicine at National Jewish Health in Denver, said there’s no scientifically rigorous data on how patients with autoimmune conditions respond to the Pfizer and Moderna vaccines.
So far, reasons for concern haven’t surfaced. “More than 100,000 people have gotten these vaccines now, including some who probably had autoimmune disease, and there’s been no systematic reporting of problems,” Marrack said. If patients with autoimmune disorders are really worried, they should talk with their physicians about delaying immunization until other covid vaccines with different formulations become available, she suggested.
Last week, the National Multiple Sclerosis Society recommended that most patients with multiple sclerosis — another serious autoimmune condition — get the Pfizer or Moderna covid vaccines.
“The vaccines are not likely to trigger an MS relapse or to worsen your chronic MS symptoms. The risk of getting COVID-19 far outweighs any risk of having an MS relapse from the vaccine,” it said in a statement.
We’re eager to hear from readers about questions you’d like answered, problems you’ve been having with your care and advice you need in dealing with the health care system. Visit khn.org/columnists to submit your requests or tips.
About half of those who said they want the shot as soon as possible know someone who has already gotten a dose, a much larger share than among those who said they'll get it only if required (29%) or will refuse to get it (36%).
This article was published on Wednesday, January 27, 2021 in Kaiser Health News.
By Phil Galewitz Americans' reluctance to get vaccinated for covid-19 is waning, according to a poll released Wednesday.
Nearly half of adults surveyed in January said they have either already been vaccinated or want the vaccine as soon as they can, up from about a third of adults polled in December, according to the latest KFF survey. (KHN is an editorially independent program of KFF.)
About 20 million Americans have been vaccinated for covid since distribution of the first vaccines began in mid-December. The pace has also picked up in recent weeks, with more than a million Americans on average getting vaccinated every day. The survey found that when people know someone close to them who has been vaccinated, they are more likely to want the shots.
About half of those who said they want the shot as soon as possible know someone who has already gotten a dose, a much larger share than among those who said they'll get it only if required (29%) or will refuse to get it (36%).
Nearly half (47%) of adults said they have personally received at least one vaccine dose or know someone who has. People posting their vaccination status on social networks such as Facebook and Twitter has helped spread the word.
Racial, ethnic and economic disparities continue, however. White adults (51%) are more likely than Black (38%) or Hispanic (37%) respondents to have either been vaccinated or know someone who has, and those with annual household incomes of at least $90,000 are almost twice as likely as those with incomes under $40,000 to say so (64% vs. 34%). (Hispanics can represent any race or combination of races.)
About 3 in 10 adults said they want to wait until the vaccine "has been available for a while to see how it is working for others" before getting it themselves. About 7% of adults said they will get the vaccine only "if required to do so for work, school or other activities," and just 13% said they will "definitely not get" the vaccine, not a significant change.
The poll also found about 1 in 3 health care workers planned to wait to see how the vaccine is working or would get it only if required to.
The percentage of people who said they want the vaccine immediately is up among the racial and ethnic groups surveyed, although white (53%) adults remained more likely to say so than Black (35%) and Hispanic (42%) adults. Black (43%) and Hispanic (37%) adults were more likely than white adults (26%) to say they want to "wait and see" before getting vaccinated, according to the poll.
Democrats and independents also showed increased enthusiasm, though Republicans' views were little changed since December.
Republicans remained the least enthusiastic political group, with 32% saying they have already been vaccinated or want the vaccine as soon as they can, 33% saying they want to wait and see how it works for others, and 25% saying they will definitely not get the vaccine.
The KFF survey of 1,563 adults was conducted Jan. 11-18 and had a margin of error of +/-3 percentage points.
As U.S. infections climb above 24 million, doctors with no other FDA-approved treatment options are now prescribing remdesivir to half the covid patients in U.S. hospitals.
This article was published on Wednesday, January 27, 2021 in Kaiser Health News.
It was the end of April — just as the U.S. confirmed its millionth covid-19 case and 50,000 deaths — when White House adviser Dr. Anthony Fauci announced "highly significant" news about a drug called remdesivir.
That was surprising because the antiviral drug, owned by Gilead Sciences and developed with investment from the federal government, had languished for years with no apparent commercial use. It had struck out as a treatment for hepatitis C and Ebola.
But early in 2020, when the first global cases of a new pneumonia-like viral illness emerged in China, Gilead resurfaced the compound, branded as Veklury, and shared it with scientists across the globe. From the Oval Office, Fauci, director of the National Institute of Allergy and Infectious Diseases, said remdesivir would be the "standard of care" for treating coronavirus disease.
Its emergency-use approval by the Food and Drug Administration immediately drew a storm of criticism. Clinical trials suggested it was only modestly helpful to covid patients. The World Health Organization recommended against its use. Politicians railed at its $3,120 price tag.
Yet, nine months later, it appears Fauci was right: As U.S. infections climb above 24 million, doctors with no other FDA-approved treatment options are now prescribing remdesivir to half the covid patients in U.S. hospitals.
"We want to shorten their hospital stay," said Dr. Jade Le, an infectious diseases specialist with Access Physicians in Texas, where hospitals have been at capacity for weeks. Le prescribes remdesivir on average three to five times a day, always in concert with a low-cost steroid.
This month, Gilead chief executive Daniel O'Day raised the company's profit estimates, noting that remdesivir alone would deliver about $2.8 billion in 2020 sales, bolstered by its use in U.S. and European markets. The company is proud of the role the treatment is playing during the pandemic, he said.
Still, controversies abound. Tension mounted last summer as shortages of remdesivir taxed the global medical community and raised urgent questions about how the federal government could step in. While doctors rationed the drug, politicians and advocates said U.S. taxpayers had invested enough in remdesivir's development to merit a lower price.
"The remdesivir story is actually a story that is all too common," said Zain Rizvi, law and policy researcher at the consumer advocacy group Public Citizen. Rizvi — and other advocates — say the drug would not have come to market if it wasn't for federal grants and the help of U.S. scientists.
They said the rags-to-riches story of remdesivir, a losing prospect turned blockbuster, holds lessons in how Americans end up paying more for medicine than anyone else in the world. Remdesivir used taxpayer dollars to be developed but, in a public health emergency, patients have no option but to pay whatever the pharmaceutical giant demands.
Rizvi has estimated that federal grants of "at least" $70 million supported the scientific discovery of remdesivir. He pointed to early research done, including a collaboration between Gilead and university scientists, using federal grants, to test remdesivir's antiviral compounds against coronaviruses, such as MERS and SARS. Others figure the investment could be much higher.
Kathryn Ardizzone, legal counsel for the patent rights group Knowledge Ecology International, is among those, though she agreed the amount is at least $70 million and declined to estimate the total amount of federal dollars used for remdesivir's discovery. There is no publicly available database of how much the government has spent to develop any drug, including remdesivir.
The NIH said in an emailed statement that it "did not develop remdesivir." The agency confirmed it funded research on the drug's uses as well as providing money to institutions that worked with Gilead to develop the drug.
KEI filed a Freedom of Information Act request to view the grants and clinical trials related to remdesivir. In October, the group sued the National Institutes of Health because it had failed to respond. Ardizzone said she expects the records will counter Gilead's justification of remdesivir's price: "When the government has played such a critical role at every step of the way, that argument falls apart."
Gilead, in an emailed statement, said its investment in the drug predates any government involvement and "disagrees with the premise that the government has any rights to Gilead's remdesivir intellectual property." No federal scientists are named on remdesivir's patents.
The company has defended the price of the drug, saying it invested more than $1 billion in 2020 to support clinical trials as well as to manufacture and distribute remdesivir. Gilead priced it at $3,120 for a five-day course of treatment in the U.S. market, and $2,340 for other developed countries. Some smaller U.S. government entities, like the Indian Health Service, pay the lower price as well. Noting the price for developed countries, Gilead spokesperson Arran Attridge said the drug is priced "significantly below the potential value" it delivers.
But U.S. Sen. Ron Wyden, a top-ranking Democrat from Oregon on the Senate Finance Committee, said he has been concerned about Gilead's price for a five-day course of treatment since it was announced. "My previous investigative work … has shown Gilead's willingness to put profits over patients," Wyden said. Wyden, along with Sen. Chuck Grassley (R-Iowa), released an investigation in 2015 of Gilead's hepatitis C drug prices and marketing.
At its core, remdesivir is a simple, "small molecule" drug. Generics manufacturers in India have copied the design and priced it at $53.34 per vial, or $320 for a course of treatment.
The U.S. government, so far, has not exerted its intellectual property rights. But there are signals that could change.
In late summer, California Attorney General Xavier Becerra led a group of more than 30 attorneys general calling for the federal government to license remdesivir to another manufacturer, such as a lower-cost provider from overseas. President Joe Biden nominated Becerra to lead the Department of Health and Human Services.
Another Biden pick, Dr. Rochelle Walensky, an infectious diseases specialist who has been tasked to lead the Centers for Disease Control and Prevention, co-authored a New York Times opinion piece suggesting that HHS could buy the drug from another company (including a generics maker overseas) and pay royalties to Gilead. This fall, U.S. Rep. Lloyd Doggett (D-Texas) held a news conference supporting the approach Walensky and others proposed.
Neither maneuver, however, was meant as a lever to lower its price for patients, said Adam Mossoff, a law professor at George Mason University. Mossoff doubted that either of the strategies would hold up in court and noted there are plenty of congressional proposals to lower drug prices and sometimes "people get ahead of themselves." They try to use the law to advocate for what should be a policy goal, he said.
Underlying Becerra's and Walensky's proposals is the deeper, nagging question of whether Gilead should fully own the rights to remdesivir if the U.S. funded research and its scientists worked with Gilead to discover the drug.
Doggett put it this way: "Gilead is overcharging on a drug that was saved from the scrap heap of failed drugs only because of taxpayer-funded research."
Sen. Debbie Stabenow (D-Mich.) and Rep. Carolyn Maloney (D-N.Y.) have asked the government's federal watchdog agency, the Government Accountability Office, to investigate "what legal rights do federal agencies have" in relation to remdesivir. Gilead said it is cooperating with the investigation; government officials expect the review to be completed this spring.
Gilead, in an emailed statement in response to a question about the GAO review, called the government's involvement "limited." In response to questions about the patents, Gilead said its own investments predate any government involvement and its inventors identified the drug's antiviral activity, optimized the formula and scaled up the manufacturing process.
Gilead confirmed it has eight listed patents on remdesivir, with the last expiring in 2038.
In the abstracts of two patents, filed in 2014 and 2015, the CDC and USAMRIID, the U.S. Army Medical Research Institute of Infectious Diseases, are mentioned as places studies were conducted. Each patent emphasizes its focus on treating the Ebola virus and other filoviruses that cause fatal hemorrhagic fevers.
Christopher Morten, deputy director of technology law and policy clinic at New York University School of Law, said those two patents should list government scientists as co-inventors. Referring to one patent (No. 9,724,360), Morten said its earliest filing was October 2014. "Which makes perfect sense, because the U.S. government collaboration started in 2013 with Ebola and the CDC," Morten said. While not attaching specific government investment dollars to its descriptions, Gilead confirms the collaboration, as well, saying it "worked with the U.S. government to confirm remdesivir's preclinical activity against Ebola."
Morten, who previously represented pharmaceutical companies as a patent lawyer, said he believes the question of inventorship should be raised in court, using the legal tactic proposed by CDC chief Walenksy. Morten co-authored a white paper on remdesivir with the HIV advocacy group PrEP4All.
Notably, PrEP4All also challenged Gilead's patents for the HIV drug Truvada. In 2019, the U.S. Departments of Justice and Health and Human Services sued Gilead over patent rights for Truvada. The case is ongoing.
Back on the pandemic's front lines, U.S. doctors administer remdesivir even after the World Health Organization recommended against the drug in November. The WHO's recommendation, which referenced results from an international trial called Solidarity, found remdesivir did not improve a covid patient's chance of survival.
The Food and Drug Administration gave remdesivir full regulatory approval in October, making it the only approved U.S. treatment for the deadly disease.
Dr. Rajesh Gandhi, a member of the Infectious Diseases Society of America's panel on covid-19 treatment guidelines, pointed to another clinical trial of more than 1,000 hospitalized patients run by the National Institutes of Health. The trial, called ACTT-1, showed hospital stays of about 10 days for those who received remdesivir compared with 15 days for those who did not, he said.
"Many of us believe remdesivir has a role," Gandhi said, "though we wish it had a greater effect." He noted that the trial showed one group of patients saw the biggest benefit: those who need supplemental oxygen but are not yet on a ventilator. It's clear, he said, "we need better drugs than remdesivir."
Remdesivir — along with a steroid — was enough for Shirley Lewis.
The 69-year-old Florida resident said she was sick for about a week when she found herself unable to breathe and went to the hospital.
"I'm telling you, I was like half-dead and half-alive … all I could do was pray," Lewis said. Doctors put her on supplemental oxygen and began IV bags of remdesivir paired with steroids. Lewis said she felt the difference right away.
"I said, Oh, thank God," Lewis recalled about a month after being released from the hospital. "I thought it was some kind of miracle, I really did. So don't let them say it doesn't work, because it did."
Computer science teacher Suzy Lebo saw covid-19 dangers frequently in her Indiana high school: classes with about 30 students sitting less than 18 inches apart. Students crowding teachers in hallways. Students and staff members taking off their masks around others.
“I'm concerned,” said Lebo, who teaches at Avon High School in the Indianapolis suburbs. “We're not controlling the virus in our county. We're not controlling it in our state. And we're not controlling it in our schools.”
President Joe Biden's covid response proposes $130 billion to improve school safety, offers federal guidance for making schools safer and improves workplace protections to safeguard teachers and other workers from covid.
This comes after many school districts and states holding in-person classes have ignored recommendations from public health officials or written their own questionable safety rules — creating a tinderbox where covid can sicken and kill.
A KHN analysis of federal and state Occupational Safety and Health Administration data found more than 780 covid-related complaints covering more than 2,000 public and private K-12 schools. But those pleas for help likely represent only a small portion of the problems, because a federal loophole prevents public school employees from lodging them in 24 states without their own OSHA agencies or federally approved programs for local and state employees. Still, the complaints filed provide a window into the safety lapses: Employees reported sick children coming to school, maskless students and teachers less than 6 feet apart, and administrators minimizing the dangers of the virus and punishing teachers who spoke out.
KHN also found that practices contradicting safety experts' advice are codified into the patchwork of covid rules put out by states and districts. For instance, about half of states don't require masks for all students — including 11 that have exempted schoolchildren of various ages from mandatory masks, with New Hampshire excluding all K-12 students. Districts can craft stricter rules than their states but often don't.
“The response to the virus has been politicized,” said Dr. Chandy John, an expert in pediatric infectious diseases at the Indiana University School of Medicine. “There's a willingness to ignore data and facts and go with whatever you're hearing from the internet or from political leaders who don't have any scientific knowledge.”
But even with Biden's rollout of new school safety steps, struggles over balancing the need for education with covid safety are sure to continue, since it will be months before the nationwide vaccine rollout reaches all school staff members, and the shots haven't yet been approved for kids.
Meanwhile, the scope of covid in schools remains unknown. Biden's order calls for tracking it on the federal level, which wasn't happening. States haven't collected uniform data either. The Covid Monitor, a project launched by volunteers and public health researchers, has counted more than 505,000 cases in K-12 schools — more than a quarter of them among staffers. Although kids are less likely than adults to become seriously ill, recent research suggests they can spread the virus even if asymptomatic. The American Federation of Teachers estimates covid-19 has killed at least 325 school employees, though it's unclear whether they caught it at school.
Among them was Susanne Michael, 47, a fourth grade teacher at Harrisburg Elementary School in northeastern Arkansas. As a cancer survivor with diabetes, she rarely went anywhere outside her home this past fall, according to her husband, Keith. She told him she worried about catching the coronavirus while teaching, but she “went and did it because she loved it.”
She tried her best to keep more than 20 students 6 feet apart, he said, but told him it was nearly impossible.
Though she always wore a mask, he doesn't know if every student did. According to the district's website, masks are required in grades 4-12 “when social distancing is not feasible,” and “physical distancing will be practiced to the extent practical.” District leaders did not respond to requests for comment.
Michael wound up hospitalized on a ventilator. Doctors let her husband visit in protective gear because he, too, had the virus. He held her hand as she slipped away Oct. 1.
The loss hits him hardest at night. “For 27 years, I always had somebody there next to me,” he said. “It's difficult and weighs on your mind and heart a lot when you're laying there in an empty bed and your best friend's gone.”
She left five children, ages 3 to 22, including a former student and her two siblings adopted in July.
A Litany of Lapses
Doctors said covid risks can be drastically reduced by following straightforward safety practices.
“First and foremost, mask mandate, mask mandate, mask mandate,” said Dr. Jason Newland, a pediatrics and infectious diseases professor at Washington University in St. Louis.
But school employees across the nation complain such measures don't exist or aren't enforced.
“School officials openly scoff at covid-19 and believe it is a hoax. This attitude trickles down to staff, so hardly anyone has been wearing their mask or wearing it correctly,” an unidentified employee of Hart Public Schools, in rural western Michigan, wrote in an OSHA complaint in September. The complaint also described large crowds of students sitting too close in cafeterias. The employee alleges being terminated for whistleblowing.
Hart Superintendent Mark Platt said in an email that he won't comment on personnel matters, but “takes seriously its health and safety protocols for students and staff.” The district's covid preparedness and response plan requires staffers and older students to wear masks in classrooms, common areas and buses, while K-5 students must wear them everywhere except in their own classrooms with their own class.
At the public Avon Community School Corp. in Indiana, Lebo said, problems festered since the beginning of the fall semester in July, when an OSHA complaint was lodged. In addition to crowding in the halls and difficulty keeping students 6 feet apart in classrooms, Lebo said, the school's many extracurricular activities — including football, wrestling and show choir — brought their own risks.
Avon schools spokesperson Kevin Carr wouldn't comment except to say students and staff members have tried their best to abide by the district's health and safety protocols.
Over the semester ending in December, Avon schools reported 346 covid cases among nearly 9,800 in-person students and staffers, a rate of 3.5% compared with 2.1% for 1,412 remote learners. The covid rate reached 5.5% at the high school, which went remote briefly in the fall after the number of people quarantining skyrocketed.
Like the vast majority of school OSHA complaints, the one about Avon was closed without an inspection. Across all industries, research shows, just a small percentage of pandemic-related complaints have led to inspections or fines.
A Biden executive order on worker safety calls for OSHA to bolster enforcement and work with states and local governments to ensure workers, including those in the public sector, are protected from covid.
Without strong laws, “workers are facing big challenges: Do I speak up? Do I show up to work?” said Rebecca Reindel, director of occupational safety and health for the AFL-CIO. “They're making a decision between needing a paycheck and risking bringing the virus home.”
Varied, Questionable Guidance
That decision gets even harder when potentially unsafe practices are written into official recommendations.
Missouri and Iowa, for example, advise that students exposed to covid don't need to be quarantined as long as infected and exposed children are both wearing masks correctly — which goes against Centers for Disease Control and Prevention advice to quarantine anyone who has had close contact with a person who has the virus.
Some districts in South Carolina, Tennessee, Florida and Nebraska — with green lights from the Trump administration and their states — classified teachers as “critical infrastructure workers,” allowing them to keep working after exposure if they don't develop symptoms.
A superintendent in Billings, Montana, told administrators in October to “disrupt the 15-minute timeline” required to be deemed a close contact “through movement, distancing or masking.” Following media reports, he issued a statement saying he hadn't intended to “game the system” and no one should move students to avoid quarantines.
In many communities, mask rules are lax.
In Missouri, where there's no statewide mask rule, Ozark School District requires them only “when social distancing is not an option,” according to its website, which describes spacing desks and using barriers to give people a “break” from masks.
Lakeland Joint School District in Idaho recommends masks when physical distancing isn't possible. Dacia Chaffee, parent of an eighth grader and a high school freshman in the district, said “it's almost like normal,” with few students wearing masks. Her kids don't either, she said; they don't want to stand out.
Public health experts said making schools safer will require clear, consistent data and guidance — and political will. They said governments also need to give public schools enough resources to keep more than 50 million students and 3.2 million teachers safe. A recent CDC report estimated that the cost of covid mitigation measures for the 2020-21 school year ranges from $55 per student for items such as masks, plexiglass barriers and face shields to $442 per student with added custodians and transportation, such as buses and drivers, to allow for better physical distancing.
And crucially, experts said, covid policies for schools must be rooted in science, not politics.
“Behaviors and attitudes flow from the top down,” said Dr. Mark Schleiss, a pediatrics professor at the University of Minnesota Medical School. “We have to hold people accountable. This is a life-and-death situation.”
As states await the promise of a renewed federal pandemic response and expand the number of Americans who qualify for a shot, some governors are trying to scale up their covid vaccine operations — and smooth out the kinks — with the help of the private sector.
In Washington state, Starbucks, Microsoft and Costco are lending logistical expertise and manpower to public health agencies that are trying to dispatch their doses of vaccines more efficiently.
Over the weekend, thousands of people filed through the Charlotte Motor Speedway in North Carolina — now serving as a mass vaccine site — run by Honeywell and other local businesses that have partnered with the state.
And on Monday, Google pledged $150 million to "promote vaccine education and equitable distribution" and to make it easier for people to find "when and where to get the vaccine."
This backup from businesses comes as states continue to navigate uncertainty around when they'll receive doses. A patchwork of vaccination eligibility rules and ways to sign up for a shot have left many Americans confused, frustrated and even frightened, as those at high risk of serious complications from the covid virus continue to wait with little news on when they'll be inoculated.
Washington Gov. Jay Inslee calls private enterprise the "arsenal" of the coronavirus vaccination campaign, comparing the partnership to the production of battleships during World War II, but even Inslee, a Democrat, did not oversell the immediate impact.
"This is not going to be an expectation of an Amazon delivery system," Inslee said while announcing his state's plan last week. "There will be times when people will not have dosages available in their community because there isn't enough being delivered."
Washington and more than half of all states have opened up vaccines to anyone 65 and older — greatly spiking demand — yet a major hang-up continues to be making use of all the delivered vaccines.
Of the approximately 41 million vaccines delivered to states, more than 19 million have not yet been given, according to data from the Centers for Disease Control and Prevention.
"It's a dance that requires a lot of complex choreography," said Alison Buttenheim, an associate professor of nursing and health policy at the University of Pennsylvania.
"We aren't always so innovative and nimble in public health and this is the moment where we need that — we need innovation and we need states trying different things."
The Washington state partnership is using Starbucks to streamline the vaccine clinics, Microsoft to provide tech support and space on its campus, and Costco to manage logistics around delivering the shots.
Every state should be looking to its businesses to fill gaps in the vaccination operations, whether around online scheduling, public messaging or the nitty-gritty details of coordinating delivery and clinics, Buttenheim said.
"There's no one corporate entity that's going to solve this, but most have something to offer," she said.
Many public health departments have struggled with making the vaccine process "customer friendly" because they don't typically provide this kind of direct service, said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials (ASTHO), which represents state health directors.
"It has been challenging to scale those kinds of things up," he said. "Then you add in that public health departments have been dealing with covid for a year, with limited resources and people are tired."
In North Carolina, Atrium Health, a nonprofit health care system, is part of the business partnership with Honeywell that aims to give 1 million shots by July.
"It allows us as the health care system to focus on what we do best — getting the shots in the arms and making sure people are tolerating it and the aftercare," said Dr. Scott Rissmiller, Atrium's executive vice president.
"Our hospitals are full, and it's the same people that are working in our hospitals that we are needing to redeploy for the vaccines."
Looking Ahead
The Biden administration has pledged more transparency around the availability of doses and enlisted the Federal Emergency Management Agency to set up mass vaccination sites, as many as 100 in the next month.
While the pace of vaccination has picked up, public health experts warn the U.S. must move faster as at least one more contagious variant of the virus shows up in a growing number of states and threatens to drive another devastating surge.
A federal partnership with large pharmacies has faced criticism for not moving more quickly. Some states have gone through the majority of their doses, while others have used fewer than half of what's been delivered.
Public health can get a boost from the private sector, but there are limits to what can be outsourced, said epidemiologist Jennifer Nuzzo of Johns Hopkins University.
"This isn't just handing somebody a package; this is a clinical encounter," said Nuzzo.
Data entry involves sensitive personal information, and the actual vaccinators need to be trained and credentialed.
Nuzzo, who has studied the U.S. capacity for mass vaccination, estimates the U.S. will need anywhere from 100,000 to 184,000 people to staff vaccine clinics, of which 17,000 would have to be vaccinators, to meet the Biden administration's goal of 100 million shots in 100 days.
"I think it would be extraordinarily difficult to just find those vaccinators," she said.
The private sector may be able to contribute, but Nuzzo cautioned that any partnerships cannot appear to favor the employees of the company.
Last week, Amazon offered to assist the Biden administration on the vaccine rollout and has signaled it hopes to vaccinate its own front-line workers as soon as possible.
The shaky supply has limited the ability of some states to pursue mass vaccine sites, and many providers are still hesitant to schedule vaccines too far in advance. A hospital in Arlington, Virginia, canceled 10,000 appointments after the state changed how it allocates its supply of vaccines.
In Arizona, which has two mass vaccine sites so far, appointments are already booked through February.
Since the early days of the vaccine rollout — when the Trump administration promised 20 million doses before 2021 — the public has received confusing messages about when they'll be able to get a shot.
States still face the challenge of how to set realistic expectations. Many are ramping up their capacity for giving vaccines, even before the supply has caught up.
"The worry I have is that if we create expectations for how quickly people can get vaccinated and then don't deliver, people will become perhaps jaded or disappointed or, worse, mistrustful of vaccination efforts," she said.
More than half of unvaccinated Americans say they need more information about when or where they'll get vaccinated, according to a national survey from the Kaiser Family Foundation. (KHN is an editorially independent program of KFF.)
At his grocery store in Everett, Wash., Wil Peterson, a cashier, hears this confusion around the vaccine process from his co-workers.
"There's a lot of information that's been floating around, so I'm just trying to keep up with the latest developments," said Peterson, who's in his 50s and expects his turn to get a shot will come sometime in February.
Peterson worries about catching the virus every day he goes to work and still deals with customers who refuse to wear masks, so he's eager to get vaccinated.
But he also knows it may not go smoothly, after hearing from a friend who tried to sign up for his shot.
"But the site crashed, so I'm kind of bracing for maybe that happening when I try to do it, but I'm hoping that won't be the case," he said.
This story is part of a partnership that includes NPR and KHN.
SACRAMENTO — As intensive care units filled and coronavirus cases surged over the holidays, Carmela Coyle invoked a World War II-era quote attributed to British Prime Minister Winston Churchill to rally her own troops: "If you're going through hell, keep going."
Coyle is head of the California Hospital Association, and her "troops" are the highly paid hospital executives she represents. Throughout the pandemic, as in the December memo in which she quoted Churchill, she has employed battlefield rhetoric to galvanize their massive political and financial clout.
That's because Coyle believes hospitals are quite simply "in battle conditions" — a sentiment she has impressed upon the state's top healthcare officials.
While Coyle, 60, is unknown to many Californians, she is a power player in the state Capitol, one whose profile and influence have grown in the past year. She has used her position as president and CEO of the association to lobby for the multibillion-dollar hospital industry, including asking officials to temporarily relax guidelines intended to safeguard patients and workers.
Along the way, she has been granted personal access to Gov. Gavin Newsom and other top officials, helping shape the state's response to covid-19.
"Having spent many, many hours embedded with the Governor's team in the state's Office of Emergency Services, everyone is working 18-plus hours a day," she wrote to hospital executives in March, "and the dedication to supporting what hospitals need to do their jobs is impressive."
Though she hasn't won every battle, Coyle has scored some big wins for the industry.
She successfully petitioned the Newsom administration to relax nurse-to-patient ratios and allow healthcare workers exposed to the coronavirus to continue to work — critical but contentious rule changes intended to keep hospitals staffed that were approved over union objections.
When hospitals started to fill with covid patients last summer, Newsom agreed with Coyle that hospitals could care for them while also performing moneymaking elective surgeries, which hospitals had voluntarily canceled in the spring.
Newsom invited her to a July press briefing to explain that logic to the public. At the briefing, he described Coyle as an "outstanding partner" and a leader with a "seriousness of purpose."
"I just can't thank her enough, more publicly than I have in the past, but I need to repeat it yet again," Newsom said. "We're all being put to the test, particularly our hospital system at this moment."
That Coyle, a relative newcomer to Sacramento politics, is such an influential advocate in the Capitol comes partly with the job. She represents more than 400 hospitals that provide not just critical care, but also jobs to Californians in every corner of the state.
In the first three quarters of 2019, California's hospitals earned about $101.7 billion in net patient revenue, according to financial data filed with the Office of Statewide Health Planning and Development. During the same time last year, they earned about $97.6 billion — representing a 4% decline — despite the loss of elective surgeries and a drop in emergency room visits early in pandemic.
The California Hospital Association is a healthcare heavyweight in Sacramento, along with the doctors' lobby, the dialysis industry and others. It spent nearly $5.3 million on lobbying from Jan. 1, 2019, to Sept. 30, 2020, and $4.3 million to support state and local political campaigns, according to filings with the California secretary of state's office.
In 2019, the association paid Coyle $1.4 million, it said.
"The hospitals are such a big player that you have to be working with them," especially during a public health outbreak, said David Panush, a Sacramento healthcare policy consultant who worked in state government for 35 years.
Coyle also has the ear of Mark Ghaly, secretary of the state Health and Human Services Agency. Ghaly and Coyle have corresponded often since March — sometimes multiple times a day — by phone and email about the state's response to the pandemic, according to emails obtained by California Healthline.
For instance, in March, Coyle shared a letter with Ghaly that she had sent to hospital executives, in which she warned them — and by extension, him — that "we are in battle conditions, and it's all hands on deck to turn the tide."
In other letters and emails, Coyle pressed Ghaly to allow healthcare workers exposed to the virus to continue working as long as they didn't show symptoms. Newsom later issued the rule in an executive order.
"Nurses are the heartbeat of the hospital," said Stephanie Roberson, government relations director of the California Nurses Association — whose leaders, unlike Coyle, have not been invited into the governor's state operations center since it was activated in March. "Instead, we have someone who basically represents the opposite of nursing interests standing alongside the governor discussing the importance of public health."
In a recent statement, Ghaly said the pandemic has required the state to work not only with hospitals but also with doctors, nurses, public health departments, nursing homes, laboratories and emergency services agencies to save lives.
"I am grateful to Carmela and our hospital partners for their tremendous work, particularly during this current surge when hospitals are overwhelmed with patients and intensive care units are filled," Ghaly said.
It took the administration six months to direct hospitals to test healthcare workers for covid at least once a week after requiring nursing homes to do so — a testament, critics say, to the hospital industry's political and economic impact.
"The association exists to increase profits for hospitals, increase the bottom line," said Sal Rosselli, president of the National Union of Healthcare Workers. The union lobbied for the mandatory testing rule, which took effect in December. "That's why they oppose every patient care advocacy issue, every worker issue."
Coyle countered that hospitals have no choice but to make trade-offs while they provide crisis care. She emphasized that the hospitals' requests for exemptions are temporary.
"If we don't flex some of these requirements, it means that people will not get the care they need and, worse, people may die," she said at a news conference earlier this month.
Coyle, a Minnesota native, is known for her intelligence and the expertise she has honed working on healthcare policy for more than 30 years.
As head of the Maryland Hospital Association for nine years before she took the California job in 2017, Coyle built a reputation as a consensus builder even as she looked out for her constituency. For instance, she cultivated relationships with Maryland's congressional delegation and lobbied it for federal funding in 2014 to help the state's hospitals prepare for and treat Ebola patients, most of whom were American healthcare workers who had contracted the virus in Africa.
"She really understood the old maxim that there's no such thing as permanent friends or permanent enemies. There are only permanent interests," said Stan Dorn, a senior fellow at the advocacy group Families USA, who previously served on a Maryland commission on healthcare costs with Coyle. "She understood that it's good to have good relationships with everybody because you never know, day after tomorrow, who is going to be important to your cause."
Along with her credentials comes a strong streak of determination. After Coyle graduated from Minnesota's Carleton College with degrees in economics and Spanish literature, she worked at a Washington, D.C., flower shop until the Congressional Budget Office offered her a two-year internship. She had called to check on her application every Friday for three months.
Coyle "was raised to know" such perseverance as she grew up in a working-class family, the daughter of a Colombian immigrant father.
"Kids teased me and called me names when I was a kid, my father being dark-skinned and having a heavy accent," Coyle said. "I was dark-skinned as well, and they just thought we were so strange."
Laughed at for the way her father spoke, Coyle today unabashedly harnesses the power of language to sway government officials and public opinion — and to marshal her own hospital forces to lobby "with one voice."
In the waning days of last year's legislative session, Coyle warned hospital executives of the battles before them in the Capitol: bills that would come with hefty costs to hospitals should they pass.
In the end, the industry succeeded in blocking a bill that would have made it harder for hospitals to consolidate. But they didn't get legislative approval to delay seismic retrofits at hospitals, as they had wanted. Lawmakers also passed a bill opposed by hospitals that requires them to maintain a 45-day stockpile of personal protective equipment, which Coyle had argued was unreasonable given that it has been in short supply.
"They're not all-powerful, but certainly they're influential," said state Sen. Richard Pan (D-Sacramento), who chairs the Senate Health Committee. "And during covid, they're taking care of patients. They're the ones saving the lives of people who are intubated."
When Coyle readied her troops for the legislative fights, she acknowledged they weren't going to win every battle. She borrowed another World War II quote, this time from Gen. Douglas MacArthur, to explain to hospital executives that they may need to compromise.
"In war, you win or lose, live or die," she wrote. "And the difference is just an eyelash."
California Healthline correspondent Angela Hart and KHN data editor Elizabeth Lucas contributed to this report.