Why AstraZeneca and J&J's Vaccines, In Use the World Over, Are Still on Hold in America

KFF Health News, February 26, 2021

As COVID deaths mount daily, critics say the FDA is moving too slowly.

The World Health Organization greenlighted emergency use of AstraZeneca and Oxford’s covid-19 vaccine this month, following in the steps of the United Kingdom, the European Union and others, who are already injecting it as quickly as possible into the masses.

But the United States is still waiting.

As covid deaths mount daily, critics say the Food and Drug Administration is moving too slowly. Meanwhile, the novel coronavirus is evolving, with new variants stalking populations the world over.

“We are truly in a race and this race is real — the more we get people vaccinated, the more it will tamp down the virus that is mutating,” said Dr. Monica Gandhi, an infectious diseases specialist and professor of medicine at the University of California-San Francisco.

The world has seven vaccines with completed clinical trials, yet the U.S. has approved only two, Gandhi and others lament.

AstraZeneca — after global trials that included some mistaken dosing — has not filed an application in the U.S., saying it first needs to finish its phase 3 U.S. trial. Simply put: AstraZeneca hasn’t applied for the U.S. job.

The company knows that the FDA doesn’t merely accept results from trials in other countries. And its confusing trial results pooled from differently designed clinical trials in Brazil and the U.K. raised questions about dosing as well as how well it works for people 65 and older. Germany and France have said not to administer the vaccine to older residents, while the World Health Organization said it was fine to do so.

The FDA — one of the oldest drug approval agencies on the globe — issued emergency use authorizations late last year for two vaccines manufactured by Moderna and Pfizer-BioNTech. It is reviewing an application from Johnson & Johnson, which filed Feb. 3, and the advisory panel is scheduled to discuss it at a Feb. 26 meeting.

“The FDA is not the villain here,” said Dr. Cody Meissner, a pediatric infectious diseases specialist at Tufts University who sits on the FDA’s vaccine advisory panel.

Drug approvals usually take months once an application is filed, but the FDA’s emergency authorizations for covid vaccines have been granted within weeks. FDA spokesperson Abigail Capobianco said its staff is working nights, weekends and holidays to prepare for the meeting — moving with a sense of urgency.

“FDA staff are mothers, fathers, grandparents, daughters, sons, sisters, brothers and more,” Capobianco said. “They and their families are also directly impacted by the work that they do.”

J&J’s vaccine, which received a billion dollars in development funds through Operation Warp Speed, uses an adenovirus — a vector that produces cold-like symptoms — to deliver a piece of genetic code that triggers an immune response in the body. It would be the first single-dose vaccine authorized in the U.S. — a possible game changer in getting more Americans vaccinated.

“People have been clamoring for it to be approved and everybody wants it to go faster,” said Dr. Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security who has called for more harmonization between approvals from the U.S., U.K. and European Medicines Agency.

“The question would be from a policy standpoint,” Adalja said. “Would the FDA be willing to say that what the EMA does is equivalent to them and they would have full confidence in the EMA decision?”

Despite the need for speed, the FDA said it will not cut corners. Before last fall, vaccines typically went through a full licensing process before being distributed to the public. The use of emergency authorization to give a vaccine to millions of otherwise healthy people has “never been done” before, said Norman Baylor, a former director of the FDA’s vaccine research and review office who now consults with pharmaceutical companies.

To prepare for J&J’s advisory committee, FDA staff members as well as the independent advisory panel will have analyzed thousands of data points to consider whether the benefit of a vaccine outweighs the risk of injecting it into millions of otherwise healthy people. The FDA is not required to follow the panel’s recommendation but usually does.

Meissner, who abstained in the vote for the Pfizer-BioNTech vaccine, said, “We want every vaccine to succeed.” Everyone on the planet needs immunization — billions of people.

“The more manufacturers that can provide vaccines, the better,” Meissner said. “I don’t think anyone would be against additional manufacturers.”

This moment — as Americans question why more tested vaccines like AstraZeneca and J&J’s vaccines aren’t approved — punctuates how the FDA’s drug approval process, honed over decades, is independent of other global agencies. Dr. Henry Miller, a senior fellow at the Pacific Research Institute who was the founding director of the FDA’s office of biotechnology, said it’s difficult to compare international vaccine development.

“It’s not like a footrace where everyone begins together,” he said. “From country to country, there are a lot of variables.”

Some are trivial, such as different application processes and whether the companies completed the forms properly. Others are more substantial — while many countries depend on academics on contract, the U.S. relies on full-time staffers who spend their careers focused on drug development, Miller said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a recent radio interview that the “FDA gets involved very early on in the process, that makes us unique among global agencies.”

FDA staff members have had discussions with some vaccine makers “about how they would do the work” even before the vaccines went to early clinical trials in humans. They are in contact through the various stages of manufacturing, Marks said.

Technically, AstraZeneca and the other vaccine makers have filed what are called “investigational new product” applications with the FDA. That means the companies early on submit the details of drug formulation, stability and laboratory work. They also provide results data at the end of each clinical trial phase.

AstraZeneca, which was awarded up to $1.2 billion through Operation Warp Speed to develop a vaccine, “remains in close, regular communication” with federal agencies, said AstraZeneca spokesperson Brendan McEvoy.

There are differences in what each country needs from the vaccines. The AstraZeneca vaccine will be “for a very different population than the Pfizer and Moderna vaccines,” former FDA staffer Miller said. The Pfizer and Moderna vaccines are more costly and demand cold-storage infrastructure that many developing countries can’t afford.

Plus, Miller said he believes the international agencies were eager to approve AstraZeneca. “Circumstances suggest they are willing to accept a somewhat lower standard — much like a drug intended to cure cancer makes you willing to accept greater side effects because the need is so great and the benefit is so great. It’s all risk, benefit and probability,” he said.

AstraZeneca’s acceptance abroad is enough for some people. “Why wait for another clinical trial to be completed?” asked Dr. Martin Makary, a professor of surgery and health policy at the Johns Hopkins University School of Medicine in Baltimore. “You have the real-world observation of the vaccine being given to millions of people.”

Gandhi, who has followed the clinical trials from across the globe, expressed more urgency. “The U.K. will get to herd immunity faster,” she said. “All of these wonderful things the FDA is doing that we are all so impressed by are taking too long.”

In October, the FDA released guidance for companies that seek approval in the U.S. It’s “pretty clear what designs were needed in the studies and what the FDA’s expectations were for the data,” said Dr. Jesse Goodman, former director of the FDA’s Center for Biologics Evaluation and Research, which regulates vaccines. He was also the FDA’s chief scientist from 2009 to 2014, leading its response to the 2009 H1N1 pandemic.

The agency asked for evidence that the vaccine’s benefits outweigh its risks based on data from at least one well-designed phase 3 clinical trial. To pass muster, it will need to prevent disease or decrease the severity of the disease in at least 50% of people vaccinated. Both Moderna and the Pfizer-BioNTech vaccines are well above that threshold, at 94.5% and 95% respectively.

Dr. Stanley Plotkin, a scientist and vaccine developer, said Pfizer and Moderna’s vaccines were greenlighted after large U.S. trials with “very clear results, high efficacy.” One challenge for AstraZeneca will be the variation in data — different trials with different dosages and population numbers. Clinical trials found the vaccine had an efficacy of 82.4% when two doses were given 12 weeks apart.

The FDA will dig into any incoming research numbers to determine how well each vaccine works with different doses and schedules. They will question whether they prevent serious or mild disease, while accounting for varying age groups of the trial populations, including subsets that may be more likely to get sick. Other aspects up for analysis will be the immunogenicity, or antibody response, and the safety data.

“Asking questions and asking for more data, that is exactly what they are supposed to do,” said Plotkin, now a professor emeritus at the University of Pennsylvania who consults for Moderna and others.

And, since multiple vaccine investigations are underway, FDA staff members will have reviewed the data from various applications — and may have questions that are not obvious to company researchers working on individual projects, said former vaccine regulator Goodman, who is now a Georgetown University professor.

FDA staffs work beyond the numbers as well and often do a “thorough investigation and validation of the plant” where vaccines will be produced, said Kevin Gilligan, a virologist and former unit chief at the federal government’s Biomedical Advanced Research and Development Authority. “You want to make sure there aren’t any remaining pathogens in there and all the equipment used is thoroughly clean and reevaluated,” Gilligan said.

Novavax, which received $1.6 billion through Operation Warp Speed in July, is developing a two-shot protein-based vaccine. After addressing FDA questions, Novavax ramped up full-scale manufacturing operations. Novavax spokesperson Silvia Taylor said the company has been in “ongoing contact” with the FDA and is “already beginning to submit” various parts of its application and data to agency officials. It expects initial results of its U.S. phase 3 trial before summer.

Taylor said Novavax has already “locked” its manufacturing process at scale and will be ready to distribute in the U.S. as soon as emergency use is approved.

KHN editor Arthur Allen contributed to this report.

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

With GOP Back at Helm, Montana Renews Push to Sniff Out Welfare Fraud

KFF Health News, February 25, 2021

Montana is considering becoming the latest state to aggressively check welfare eligibility to cut costs. While supporters of the move say it's about what’s fair, opponents say it will impact enrollees who need help, especially amid the pandemic. 

This article was published on Thursday, February 25, 2021 in Kaiser Health News.

By Katheryn Houghton

Montana is considering becoming the latest state to intensify its hunt for welfare overpayments and fraud, a move expected to remove more than 1,500 enrollees from low-income health coverage at a time when the pandemic has left more people needing help.

With Republicans now controlling both chambers of the Montana legislature and the governor’s office, a lawmaker is reviving an effort to both broaden and increase the frequency of eligibility checks to search for welfare fraud, waste and abuse. Proponents say it’s about what’s fair — weeding out people who don’t qualify, protecting safety nets for those who do, and saving the state millions. But advocates for low-income people who rely on such services and some policy analysts say such changes would unfairly drop eligible people who need the aid.

“We’re not looking to do anything mean. We’re taking the emotion out of it,” state Sen. Cary Smith, a Republican, said during a Jan. 20 hearing on his bill, the Provide for the Welfare Fraud Prevention Act. “If you don’t qualify, then you shouldn’t be participating in that program.”

The Montana bill, and measures underway in Ohio and Utah, are similar to earlier efforts undertaken to cut costs in states such as Illinois and Michigan. But this year’s bills come even as Congress offers states more Medicaid dollars if they ensure people have continuous coverage through the pandemic because of its economic shock waves.

The Montana proposal would create a system potentially run by third-party vendors that would mine a large swath of data to see if someone, for example, has assets like a boat, has won the lottery or has filed for benefits in another state. The vendor could earn a bonus for flagging more cases than the state projected. State employees would have the final say in cutting someone from Medicaid, the Children’s Health Insurance Program, food stamps or other aid programs.

The state estimates the measure could save Montana’s treasury between $1.4 million and $2.3 million each year over the next four years by dropping more than 1,500 people on Medicaid and 277 children covered by CHIP.

This isn’t Smith’s first effort to create such a law. He sponsored a similar bill in 2015 that was vetoed by the state’s then-governor, Democrat Steve Bullock. In the veto letter, Bullock said the measure duplicated steps the state already took and unfairly stigmatized Montanans who are poor. Opponents of Smith’s latest proposal have repeated those concerns. Smith didn’t respond to several requests for an interview.

But this time, the potential legislation has a clearer path. The state has a new governor, Greg Gianforte, a Republican who called for heightened Medicaid eligibility checks throughout his 2020 campaign.

During Montana’s first hearing for the renewed effort, Scott Centorino of Opportunities Solutions Project was the sole person to testify in support of the bill.

“I’ve seen this play out in state after state,” Centorino said. “Turns out, the less you look for welfare, fraud and waste, the less you find.”

Opportunity Solutions Project, the lobbying wing of the Foundation for Government Accountability, a right-leaning think tank, has backed similar efforts elsewhere that followed FGA model legislation. The organizations have also been major forces in trying to link food assistance to work requirements and block states from expanding Medicaid.

Opportunity Solutions Project’s attempts to influence laws at the federal level, too, appear to be growing. The nonprofit spent $25,500 lobbying the federal government in 2017 and $420,000 last year, according to the Center for Responsive Politics.

Opponents of the Montana bill have said the focus on welfare recipients is misplaced. Nationally, most Medicaid payments deemed improper last year were tied to states not collecting information that federal standards already call for, not necessarily for covering ineligible enrollees, according to a U.S. Department of Health and Human Services financial report.

Michele Gilman, a University of Baltimore law professor, said the potential bonus Montana would pay a company finding more savings than expected is especially concerning.

“The goal should not be to create some bounty hunter system to find alleged cheats that don’t exist,” Gilman said. “This is built on an unfounded mistrust of poor people and undermines public support for social programs.”

If states do move to undertake broad data searches, she said, they need to start with a pilot program to test for errors in its design. Gilman called Michigan the ultimate cautionary tale. The state, which had used a new computer program to spot cheaters, ended up mired in lawsuits after it falsely charged thousands with unemployment fraud between 2013 and 2015.

The Trump administration and federal agencies encouraged states to increase eligibility checks. According to a KFF analysis, as of January 2019 more than half of states were conducting checks more often than during annual renewals, with some doing so quarterly. (KHN is an editorially independent program of KFF.)

Robin Rudowitz, co-director of KFF’s Program on Medicaid and the Uninsured, said Medicaid and CHIP enrollment dropped across the nation from late 2017 through 2019. Rudowitz said it’s hard to untangle all the reasons the enrollment declines occurred, but increased verification efforts that add to administrative hurdles create barriers to coverage.

Jennifer Wagner, with the left-leaning Center on Budget and Policy Priorities, said people may not realize they’re still eligible when notified that their benefits are in question or may not even receive the notice. She said a search for benefits filed in a separate state may flag aid that can cross states, such as food stamps, and such searches can pull up property someone no longer owns. Frequent wage checks may not take into account inconsistent jobs. The onus would fall to the aid recipient to prove they are still eligible in each scenario, she said.

One state that Opportunity Solutions Project points to as a success is Illinois, which in 2012 hired a company to identify Medicaid recipients who might not be eligible. Wagner, who was an associate director with the Illinois Department of Human Services at the time of the change, said Illinois is unique because the state knew it had a backlog of status checks. Within a year, Illinois had canceled benefits for nearly 150,000 people. But the state reported that more than 75% of cancellations were due to clients’ failure to respond to a state letter asking for more information. Wagner said similar issues have occurred in other states.

“In many cases, those individuals remain eligible, but they have a gap in coverage and they have to reapply and do what they can to get back on the program,” said Wagner. “There’s a large cohort of people who never get that done.”

Of all the people Illinois dropped, nearly 20% had reenrolled by the end of the year. That issue — people getting knocked off when they’re eligible — already happens in annual renewals. But Wagner said more checks means more people losing benefits, and more work for states to bring those people back onboard.

Centorino, with Opportunity Solutions Project, said systems that remove qualified people aren’t being implemented properly, but added it’s not too heavy of a lift to respond to an eligibility question.

“The alternative is not is not resolving the discrepancy at all and just assuming that there is no discrepancy and continuing to fund benefits for somebody who may be ineligible,” he said.

In Montana, even with the bill’s clearer shot at becoming law, some elements that opponents criticized were rolled back after the state estimated it would need to hire 42 employees to run the new system. Smith reduced how many programs would fall under its scrutiny and pulled back eligibility checks to twice a year instead of quarterly. He removed a rule that the system pay for itself, and he cut a section that would have disenrolled people who don’t respond to eligibility questions or notices within 10 business days.

Nonetheless, if a new system flags issues in people’s enrollment, the state will have to go out searching for why. The bill is under consideration in the Senate and must also pass the House before it goes to Gianforte for signing.

Have a Case of a COVID Variant? No One Is Going to Tell You

KFF Health News, February 25, 2021

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the FDA or under federal rules governing university labs.

This article was published on Thursday, February 25, 2021 in Kaiser Health News.

By Christina Jewett and JoNel Aleccia and Rachana Pradhan

COVID-19 infections from variant strains are quickly spreading across the U.S., but there's one big problem: Lab officials say they can't tell patients or their doctors whether someone has been infected by a variant.

Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can't do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

"It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don't know what we don't know," Hamilton said. The group has asked federal officials to waive the rules. "Time is ticking."

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs ― meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.

Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That's worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.

Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants ― in accordance with arcane regulations governing clinical labs ― could hamper efforts to investigate pressing questions about the variants.

The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to "urgently" relax certain rules that apply to clinical labs.

Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn't provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, "legally we can't" tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.

"However, we are actively looking into what we can do," she said.

Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a COVID-19 diagnostic test was delayed while the virus spread undetected.

The limitations also put lab professionals and epidemiologists in a bind as public health officials attempt to trace contacts of those infected with more contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. "You want to be able to tell [patients] a variant was detected," he said.

Complying with the lab rules "is not feasible in the timeline that a rapidly evolving virus and responsive public health system requires," the organizations wrote.

Hamilton also said telling patients they have a novel strain could be another tool to encourage cooperation ― which is waning ― with efforts to trace and sample their contacts. She said notifications might also further encourage patients to take the advice to remain isolated seriously.

"Can our investigations be better if we can disclose that information to the patient?" she said. "I think the answer is yes."

Public health experts have predicted that the B117 variant, first found in the United Kingdom, could be the predominant variant strain of the coronavirus in the U.S. by March.

As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, which was first identified in South Africa, in 14 states; and five cases of the P.1 variant initially detected in Brazil in four states, Dr. Rochelle Walensky, the CDC director, told reporters Wednesday.

A Feb. 12 memo from North Carolina public health officials to clinicians stated that because genome sequencing at the CDC is done for surveillance purposes and is not an approved test under the Clinical Laboratory Improvement Amendments program ― which is overseen by the U.S. Centers for Medicare & Medicaid Services ― "results from sequencing will not be communicated back to the provider."

Earlier this week, the topic came up in Illinois as well. Notifying patients that they are positive for a COVID variant is "not allowed currently" because the test is not CLIA-approved, said Judy Kauerauf, section chief of the Illinois Department of Public Health communicable disease program, according to a record obtained by the Documenting COVID-19 project of Columbia University's Brown Institute for Media Innovation.

The CDC has scaled up its genomic sequencing in recent weeks, with Walensky saying the agency was conducting it on only 400 samples weekly when she began as director compared with more than 9,000 samples the week of Feb. 20.

The Biden administration has committed nearly $200 million to expand the federal government's genomic sequencing capacity in hopes it will be able to test 25,000 samples per week.

"We'll identify COVID variants sooner and better target our efforts to stop the spread. We're quickly infusing targeted resources here because the time is critical when it comes to these fast-moving variants," Carole Johnson, testing coordinator for President Joe Biden's COVID-19 response team, said on a call with reporters this month.

Hospitals get high-level information about whether a sample submitted for sequencing tested positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Yet patients and their doctors will remain in the dark about who exactly was infected.

"It's relevant from a systems-based perspective," Gilpin said. "If we have a bunch of B117 in my backyard, that's going to make me think a little differently about how we do business."

It's the same in Washington state, McCallion said. Health officials may share general numbers, such as 14 out of 16 outbreak specimens at a facility were identified as B117 ― but not who those 14 patients were.

There are arguments for and against notifying patients. On one hand, being infected with a variant won't affect patient care, public health officials and clinicians say. And individuals who test positive would still be advised to take the same precautions of isolation, mask-wearing and hand-washing regardless of which strain they carried.

"There wouldn't be any difference in medical treatment whether they have the variant," said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that "in a public health emergency it's really important for doctors to know this information."

Pandori estimated there may be only 10 or 20 labs in the U.S. capable of validating their laboratory-based variant tests. One of them doing so is the lab at the University of Washington in Seattle.

Dr. Alex Greninger, assistant director of the clinical virology laboratories there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing tests last fall.

Within the next few weeks, he said, he anticipates having a federally authorized test for whole-genome sequencing of COVID. "So all the issues you note on notifying patients and using [the] results will not be a problem," he said in an email.

Companies including San Diego-based Illumina have approved COVID-testing machines that can also detect a variant. However, since the add-on sequencing capability wasn't specifically approved by the FDA, the results can be shared with public health officials ― but not patients and their doctors, said Dr. Phil Febbo, Illumina's chief medical officer.

He said they haven't asked the FDA for further approval but could if variants start to pose greater concern, like escaping vaccine protection.

"I think right now there's no need for individuals to know their strains," he said.

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

COVID Vaccine Websites Violate Disability Laws, Create Inequity for the Blind

KFF Health News, February 25, 2021

In at least seven states, blind residents said they were unable to register for the vaccine through their state or local governments without help.

This article was published on Thursday, February 25, 2021 in Kaiser Health News.

By Lauren Weber and Hannah Recht

Many COVID vaccination registration and information websites at the federal, state and local levels violate disability rights laws, hindering the ability of blind people to sign up for a potentially lifesaving vaccine, a KHN investigation has found.

Across the country, people who use special software to make the web accessible have been unable to sign up for the vaccines or obtain vital information about COVID-19 because many government websites lack required accessibility features. At least 7.6 million people in the U.S. over age 16 have a visual disability.

WebAIM, a nonprofit web accessibility organization, checked COVID vaccine websites gathered by KHN from all 50 states and the District of Columbia. On Jan. 27, it found accessibility issues on nearly all of 94 webpages, which included general vaccine information, lists of vaccine providers and registration forms.

In at least seven states, blind residents said they were unable to register for the vaccine through their state or local governments without help. Phone alternatives, when available, have been beset with their own issues, such as long hold times and not being available at all hours like websites.

Even the federal Centers for Disease Control and Prevention's Vaccine Administration Management System, which a small number of states and counties opted to use after its rocky rollout, has been inaccessible for blind users.

Those problems violate the Rehabilitation Act of 1973, which established the right to communications in an accessible format, multiple legal experts and disability advocates said. The federal Americans with Disabilities Act, a civil rights law that prohibits governments and private businesses from discriminating based on disability, further enshrined this protection in 1990.

Doris Ray, 72, who is blind and has a significant hearing impairment, ran into such issues when she tried to sign up for a vaccine last month with the CDC's system, used by Arlington County in Virginia. As the outreach director for the ENDependence Center of Northern Virginia, an advocacy center run by and for people with disabilities, she had qualified for the vaccine because of her in-person work with clients.

When she used screen-reading technology, which reads a website's text aloud, the drop-down field to identify her county did not work. She was unable to register for over two weeks, until a colleague helped her.

"This is outrageous in the time of a public health emergency, that blind people aren't able to access something to get vaccinated," Ray said.

Mark Riccobono, president of the National Federation of the Blind, wrote to the U.S. Health and Human Services Department in early December, laying out his concerns on vaccine accessibility.

"A national emergency does not exempt federal, state, and local governments from providing equal access," he wrote.

Dr. Robert Redfield, who was then leading the CDC, responded that the interim vaccine playbook for health departments included a reminder of the legal requirements for accessible information.

CDC spokesperson Jasmine Reed said in an email that VAMS is compliant with federal accessibility laws and that the agency requires testing of its services.

But more than two months into a national vaccine campaign, those on the ground report problems at all levels.

Some local officials who use VAMS are aware of the ongoing problems and blame the federal government. Arlington Assistant County Manager Bryna Helfer said that because VAMS is run by the federal government the county cannot access the internal workings to troubleshoot the system for blind residents.

Connecticut Department of Public Health spokesperson Maura Fitzgerald said the state was aware of "many accessibility issues" with VAMS. She said it had staffed up its call center to handle the problems and was working with the federal government "to improve VAMS and enable the functionality that was promised."

Deanna O'Brien, president of the National Federation of the Blind of New Hampshire, said she had heard from blind people unable to use the system. New Hampshire's health department did not answer KHN questions about the problems.

Blind people are particularly vulnerable to contracting the COVID virus because they often cannot physically distance themselves from others.

"When I go to the grocery store, I do not have the option of walking around and not being near a person," said Albert Elia, a blind attorney who works with the San Francisco-based TRE Legal Practice on accessibility cases. "I need a person at the store to assist me in shopping."

There is no standardized way to register for a COVID vaccine nationwide — or fix the online accessibility problems. Some states use VAMS; some states have centralized online vaccination registration sites; others have a mix of state-run and locally run websites, or leave it all to local health departments or hospitals. Ultimately, state and local governments are responsible for making their vaccination systems accessible, whether they use the VAMS system or not.

"Once those portals open, it's a race to see who can click the fastest," Riccobono said. "We don't have time to do things like file a lawsuit, because, at the end of the day, we need to fix it today."

Common programming failures that make sites hard to use for the visually impaired included text without enough contrast to distinguish words from the page's background and images without alternative text explaining what they showed, the WebAIM survey showed. Even worse, portions of the forms on 19 states' pages were built so that screen readers couldn't decipher what information a user should enter on search bars or vaccine registration forms.

The new vaccine pages had more errors than states' main coronavirus pages but slightly fewer than state government websites in general, said WebAIM Associate Director Jared Smith.

In Alameda County, California, when Bryan Bashin, 65, who is blind and CEO of the LightHouse for the Blind and Visually Impaired in San Francisco, tried to sign up on Feb. 9 for his vaccine appointment, he encountered multiple hurdles. The appointments slipped away. That night he received an email from the city of Berkeley offering vaccinations. But after two hours struggling with its inaccessible website, all the slots were again taken, he said in an email.

He was only able to get an appointment after his sighted sister signed him up and has since received his first shot.

"It's an awful bit of discrimination, one as stinging as anything I've experienced," Bashin said.

Susan Jones, a blind 69-year-old in Indianapolis, had to rely on the Aira app, which allows a sighted person to operate her computer remotely, when she tried to register for her vaccine appointment.

"I resent that the assumption is that a sighted fairy godmother ought to be there at all times," said Sheela Gunn-Cushman, a 49-year-old also in Alameda County, who also had to rely on Aira to complete preregistration for a vaccine.

Emily Creasy, 23, a visually impaired woman in Polk County, Oregon, said she tried unsuccessfully for a month to make the scheduling apparatus work with her screen reader. She finally received her first shot after her mother and roommate helped her.

Even Sachin Dev Pavithran, 43, who is blind and executive director of the U.S. Access Board, an independent agency of the federal government that works to increase accessibility, said he struggled to access vaccine registration information in Logan, Utah.

The Indiana Health Department, Public Health Division of Berkeley and Oregon's Polk County Public Health did not respond to requests for comment. Utah's Bear River Health Department did not answer questions on the issue.

After Alameda County received complaints from users that its site was not compatible with screen readers, officials decided to move away from its preregistration technology, Health Department spokesperson Neetu Balram said in mid-February. The county has since switched to a new form.

If vaccine accessibility issues are not fixed across the country, though, lawsuits could come next, Elia said. Members of the blind community recently won landmark lawsuits against Domino's Pizza and the Winn-Dixie grocery chain after being unable to order online.

And, Elia said, "this is not ordering a pizza — this is being able to get a potentially lifesaving vaccine."

Lauren Weber: LaurenW@kff.org, @LaurenWeberHP

Hannah Recht: hrecht@kff.org, @hannah_recht

Lessons From California Prison Where COVID 'Spread Like Wildfire'

KFF Health News, February 24, 2021

The virus continues to devastate prison populations and employees.

This article was published on Wednesday, February 24, 2021 in Kaiser Health News.

By Kerry Klein, Valley Public Radio

When news of the pandemic first reached the men incarcerated at Avenal State Prison in central California, inmate Ed Welker said the prevailing mood was panic. "We were like, 'Yeah, it's going to come in here and it's going to spread like wildfire and we're all going to get it,'" he said. "And that's exactly what happened."

Almost a year later, 94% of Avenal's incarcerated men have contracted COVID-19 and eight have died. With more than 3,600 confirmed cases among prisoners and staff members, the facility tops the list of the country's largest COVID clusters in prisons compiled by The New York Times and the UCLA COVID-19 Behind Bars Data Project.

Calling the prison system's response to the pandemic "nonchalant," "incompetent" and at times "negligent," Welker and his fellow inmates described a crowded and dangerous living situation. Inmates interviewed by Valley Public Radio said physical distancing was nearly impossible, and constant moves in and out of quarantine were confusing and disruptive. The postponement of visits and rehabilitative programs left the men with little opportunity to vent their frustrations.

"It's chaos over here, man," said John Walker, 50, an inmate interviewed via the prison system's collect-calling service during the fall surge in cases. "That's why the mental health program's blowing up."

Similar grievances have been voiced by prisoners across the country, who have contracted the virus at a rate more than three times that of the general population, according to an analysis by The Associated Press and the Marshall Project, a nonprofit newsroom dedicated to the U.S. criminal justice system. Lawsuits and criminal justice advocates detail a pandemic response in prisons and jails that has ranged from careless to egregious.

California's prison authority denies many of these men's claims and instead points to the long list of precautions the agency has adopted since the pandemic began. Dana Simas, press secretary at the California Department of Corrections and Rehabilitation, wrote in an email that state and Avenal officials "are continuously working with public health and healthcare experts to address this unprecedented pandemic and protect those who live and work in our state prisons."

The virus continues to devastate prison populations and employees. Despite a dramatic drop in new infections since the holidays, more than 15,000 inmates nationwide have contracted the virus in the past three weeks, according to the Marshall Project. California's facilities serve as a case study in which outbreaks recur while prison advocates argue that officials failed to enact a critical precaution: relieving overcrowding.

"There has not been the political will to do what's necessary to keep people safe, which is to dramatically reduce prison and jail populations," said Aaron Littman, a teaching fellow at UCLA School of Law and deputy director of the COVID-19 Behind Bars Data Project.

Early in the pandemic, corrections agencies across the country put in place measures to prevent outbreaks, mandating masks and physical distancing, setting aside housing units specifically for quarantined inmates, and establishing testing protocols for staffers and the incarcerated.

"The measures are important, the measures help … but those are not sufficient," said Littman.

Horrific errors occurred. In late May, for instance, a transfer of a handful of inmates later discovered to have been COVID-positive sparked an outbreak that killed 29 people and infected 2,600 others at San Quentin State Prison in Northern California.

Decision-makers disagree about what's safe. At Avenal, as in all of California's prisons, labor contracts permit guards to work different shifts in different buildings, despite the fact that many academic experts and the Centers for Disease Control and Prevention discourage the practice.

The public health director of Kings County, where Avenal is located, tried to order the prison to temporarily freeze staff assignments in May, but the state prison authority politely informed him the county has no jurisdiction over a state-run facility. "The response to us was, 'Well, because of labor agreements, we can't do that,'" said Kings County Supervisor Craig Pedersen. "It was one of the most frustrating interactions we had, I think, in this process."

Workplace culture may also undermine well-intentioned precautions. In a review published in October, California's Office of the Inspector General, the state prison watchdog, reported that staff members failed to properly wear masks at two-thirds of the prisons it inspected. The report concluded lax enforcement was to blame.

Still, like Littman, many advocates and academics say preventive measures can accomplish little in such tightly packed environments. "Our review of the evidence indicates that relieving population pressures in jails, prisons, and detention centers greatly facilitates adherence to CDC guidelines, controlling COVID-19 outbreaks, and reducing health risks, particularly for medically vulnerable people," members of the National Academies of Sciences, Engineering, and Medicine wrote in an October report. "Smaller populations make it easier for correctional officials to place individuals in single cells, have sufficient resources for testing, and safely quarantine individuals after exposure to an infected person."

When the pandemic began, 1.5 million inmates were housed in roughly 1,900 state and federal prisons, many of which were not just crowded but overcrowded. California's prisons were stuffed with an average of 30% more inmates than they were designed to house. Avenal's occupancy was nearly 50% beyond capacity.

Since March, the state corrections department has granted early releases to 19,000 inmates due to medical and other circumstances, but a federal judge argued it hasn't been enough. "I have cajoled, begged and pleaded with the governor and the secretary to release a very significantly higher number of inmates beyond their current release efforts," U.S. District Judge Jon Tigar said during a January hearing for an ongoing court case regarding medical care within the state's prisons. "With all appreciation for the efforts they have made, those requests have fallen on deaf ears."

It's not just the incarcerated who are contracting COVID at alarming rates. Throughout the country, nearly 103,000 prison employees have tested positive for the virus and 184 have died, a sum that doesn't begin to account for the infections transmitted beyond prison walls to families and communities.

"It's a huge concern," said Jeff Garner, executive director of the nonprofit Kings Community Action Organization in rural Kings County, where three state prisons provide jobs for more than 4,300 people. "The prisons are a huge employer in our county. Whether it's employees or clients, it's kind of like those six degrees of separation."

Just 40 miles from Avenal, on the other side of this agricultural county in the San Joaquin Valley, is the California Substance Abuse Treatment Facility and State Prison, Corcoran, ranked by The New York Times as the country's second-largest cluster of COVID in prison. Kings County health officials have not responded to multiple requests for comment about how these two prison outbreaks have contributed to community transmission of the virus.

Could the arrival of the vaccines finally put a stop to COVID in prisons? In December, nearly 500 academics and public health experts signed a letter to the CDC calling for prisoners and correctional employees to receive priority access. At least nine states included incarcerated people in the first tier of vaccination plans, while 15 included prison staffers, according to the Prison Policy Initiative, a research organization that studies mass incarceration.

California began offering vaccines to medically vulnerable inmates at a limited number of facilities in December. By mid-February, the state had vaccinated close to 35,800 inmates and 24,900 correctional staffers.

Ed Welker, 58, hasn't been offered a vaccine yet, but he said he's not interested. Despite the 63 million doses that have already been shot into American arms, he's wary of long-term side effects — and he also feels that, at Avenal, the vaccine is obsolete. "For this particular population, I think it's a waste of time and money, because everybody here for the most part has had" COVID, he said.

Although Welker said many inmates share his views, they appear to be in a minority: In a recent court filing, state officials reported that more than two-thirds of incarcerated people who've been offered the vaccine have accepted it.

Still, Welker argues that getting vaccinated, like masking and physical distancing, is a moral imperative for correctional staffers, who could bring the virus back to the prison. "They signed up for this," he said. "It's their job to protect us."

Kerry Klein is a reporter with Valley Public Radio.

This story is from a reporting partnership that includes Valley Public Radio, NPR and KHN, an editorially independent program of KFF.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Healthcare Foundation.

'It Doesn't Feel Worth It': COVID Is Pushing New York's EMTs to the Brink

KFF Health News, February 24, 2021

Nearly half of New York City's 4,400 emergency medical technicians and paramedics have tested positive for the COVID virus. Five have died, though that figure doesn't account for first responders who worked for private emergency response companies.

This article was published on Wednesday, February 24, 2021 in Kaiser Health News.

By Martha Pskowski, The Guardian

 In his 17 years as an emergency medical provider, Anthony Almojera thought he had seen it all. "Shootings, stabbings, people on fire, you name it," he said. Then came COVID-19.

Before the pandemic, Almojera said it was normal to respond to one or two cardiac arrests calls a week; now he's grown used to several each shift. One day last spring, responders took more than 6,500 calls — more than any day in his department's history, including 9/11.

An emergency medical services lieutenant and union leader with the New York City Fire Department, Almojera said he has seen more death in the past year than in his previous decade of work. "We can't possibly process the traumas, because we're still in the trauma," he said.

EMS work has long been grueling and poorly paid. New FDNY hires make just over $35,000 a year, or $200 more than what is considered the poverty threshold for a four-person household in New York City. (That figure is on par with national averages.) Employee turnover is high: In fiscal year 2019, more than 13% of EMTs and paramedics left their jobs.

But COVID-19 has added a new layer of precarity to the work. According to Oren Barzilay, the Local 2507 union president, nearly half of its 4,400 emergency medical technicians and paramedics have tested positive for the COVID virus. Five have died, though that figure doesn't account for first responders who worked for private emergency response companies. Nationwide, at least 128 medical first responders have died of COVID, according to Lost on the Frontline, an investigation by KHN and The Guardian.

The problem of EMS pay was in the spotlight in December, when the New York Post outed paramedic Lauren Caitlyn Kwei for relying on an OnlyFans page to make extra money. Kwei, who works for a private ambulance company, wrote on Twitter: "My First Responder sisters and brothers are suffering … exhausted for months, reusing months old PPE, being refused hazard pay, and watching our fellow healthcare workers dying in front of our eyes." She added: "EMS are the lowest paid first responders in NYC which leads to 50+ hour weeks and sometimes three jobs."

Almojera earns $70,000 annually as a lieutenant, but his paramedic colleagues' salaries in non-leadership roles are capped at around $65,000 after five years on the job. He earns extra income as a paramedic at area racetracks and conducting defibrillator inspections. He has colleagues who drive for Uber, deliver for GrubHub and stock grocery shelves on the side. "There are certain jobs that deserve all your time and effort," Almojera said. "This should be your only job."

For Liana Espinal, a paramedic, union delegate and 13-year veteran of the FDNY, a sense of camaraderie and the opportunity to serve her fellow Brooklynites compensated for low pay and exhausting shifts. For years she was willing to take on overtime and even a second job with a private ambulance company to make ends meet.

But COVID changed that. The department switched from eight- to 12-hour shifts last summer, leaving Espinal, a single mother of three, too exhausted to pick up overtime. Like many healthcare workers, she isolated from her children at the outset of the pandemic to avoid potentially exposing them to the coronavirus, leaving them in the care of her own mother; she described being separated from her 1-year-old son as "devastating." Despite working round-the-clock to get the city through the early days of the pandemic, she often had to choose between paying rent on time or paying utility bills.

"After working this year, for me personally, it doesn't feel worth it anymore," she said. She is two exams shy of finishing a nursing degree she started studying for before the pandemic. She said the last year has only strengthened her resolve to shift careers.

The pandemic has disproportionately claimed Black and brown lives — Black and Hispanic people were significantly more likely than white people to die of COVID — and those disparities extend to healthcare workers. Lost on the Frontline has found that nearly two-thirds of healthcare workers who have died of COVID were non-white.

All five of the department's EMS employees who died of COVID were non-white.

They included Idris Bey, 60, a former Marine and 9/11 first responder who was known to stay cool under pressure. He was an avid reader who bought new books each time he got a paycheck.

Richard Seaberry, 63, was looking forward to retiring to the Atlanta area to be near his young granddaughter.

Evelyn Ford, 58, left behind four children when she died in December, just as the coronavirus vaccine became available to first responders in New York City. According to the City Council's finance division, 59% of EMS workers are minorities.

Almojera and Espinal see a racial component to pay disparities within the FDNY. Firefighters with five years on the job can make more than $100,000, including overtime and holiday pay, whereas paramedics and EMTs cap out at $65,000 and $50,000, respectively. According to the City Council finance division, 77% of New York firefighters are white.

"My counterpart fire lieutenants make almost $40,000 more than me," Almojera said. "I've delivered 15 babies. I've been covered head to toe in blood. I mean, what do you pay for that? You can at least pay us like the other 911 agencies."

A spokesperson for the FDNY declined to comment on pay.

The last year has also exacted an emotional toll on an already stressed workforce. Three of the FDNY's EMS workers died by suicide in 2020. John Mondello Jr, 23, a recent EMS academy graduate, died in April. Matthew Keene, 38, a nine-year veteran, died in June. Brandon Dorsa, 36, who had struggled with injuries from a 2015 workplace accident, died in July.

Family and colleagues told local news outlets that Mondello and Keene were struggling with trauma as a result of the pandemic. Last spring, New York Mayor Bill de Blasio and first lady Chirlane McCray announced a partnership between the U.S. Department of Defense and city agencies to help front-line health workers cope with the stress of working through the pandemic. But many EMS workers have said that the program has been difficult to access.

"There aren't a lot of resources for people, so a lot of EMS internalize what they go through," Almojera said. "It's not normal to see the things that we see."

Issues regarding pay and mental health challenges predate the pandemic: A national survey conducted in 2015 found EMS providers were much more likely than the general population to struggle with stress and contemplate suicide.

Almojera knew Keene and last spoke with him a week before his death. "You can't say enough nice things about the guy," he said. "I wish he had mentioned even a hint of [his struggles] on the phone. And I would have shared how I was feeling through all this."

He said he has felt a mix of pride, exhaustion and resignation over the past year. "I've seen the magic that you can do on the job," Almojera said. "And I've seen my brothers and sisters on this job cry after calls."

Almojera is now representing his union in talks with the city to renegotiate EMS and paramedic contracts. He said he hopes that city officials will think of the hardships he and his fellow first responders endured over the past year when they come to the negotiating table to discuss pay raises. But early talks have not been encouraging.

"After all the sacrifices made by our members," he said. "I don't know whether to be angry, flip the table, or just shrug my shoulders and give up."

This story is part of "Lost on the Frontline," an ongoing project from The Guardian and Kaiser Health News that aims to document the lives of healthcare workers in the U.S. who die from COVID-19, and to investigate why so many are victims of the disease. If you have a colleague or loved one we should include, please share their story.

'It's a Minefield': Biden Health Pick Must Tread Carefully on Abortion and Family Planning

KFF Health News, February 24, 2021

Women's health advocates are looking to Xavier Becerra to help swiftly unwind Trump-era funding cuts and rules that decimated the nation's network of reproductive health providers.

This article was published on Wednesday, February 24, 2021 in Kaiser Health News.

By Noam N. Levey and Rachel Bluth

As President Joe Biden works to overhaul U.S. healthcare policy, few challenges loom larger for his health secretary than restoring access to family planning while parrying legal challenges to abortion proliferating across the country.

Physicians, clinics and women's health advocates are looking to Xavier Becerra, Biden's nominee to run the Department of Health and Human Services, to help swiftly unwind Trump-era funding cuts and rules that decimated the nation's network of reproductive health providers over the past four years.

But Becerra, who as California's attorney general fought the Trump administration's family planning restrictions, faces increasingly conservative federal courts that have backed efforts to restrict reproductive health services, including a Supreme Court dominated by Republican appointees.

The new administration must also contend with an energized anti-abortion movement looking to leverage political power in red state legislatures to finally achieve its decades-long quest to ban abortion outright.

Any Biden administration moves to preserve abortion and other family planning services could set up new legal battles between the federal government and states.

"It's a minefield," said Mary Ziegler, a law professor at Florida State University who has written extensively about the history of the nation's abortion debate. 

"Expectations on both sides are extremely high," she said. "And the Supreme Court may force the issue to the top of the agenda if it does something aggressive to restrict abortion."

The outlines of the brewing showdown came further into focus Tuesday as Becerra faced opposition from a number of Republicans on the Senate health committee on the first of two days of confirmation hearings.

"For many of us, your record has been … very extreme," Sen. Mike Braun (R-Ind.) told Becerra at the hearing, accusing him of being "against pro-life." More than three dozen groups opposed to abortion rights have urged the Senate to reject Becerra, who has been a longtime advocate of abortion rights and federal support for contraceptives.

By contrast, Becerra has drawn strong support from abortion rights groups, which have applauded his efforts challenging Trump restrictions on family planning services. "He will be a great partner," said Alexis McGill Johnson, president of the Planned Parenthood Federation of America.

Becerra, whose wife, Dr. Carolina Reyes, is an obstetrician, is scheduled to appear before the Senate Finance Committee on Wednesday, after which his nomination is expected to move to the floor or the Senate for consideration by the whole body.

Successive presidential administrations since the 1980s have restricted or expanded federal support for family planning, depending on which party controlled the White House.

But tensions between the two sides intensified under President Donald Trump, making the task before Biden and Becerra that much more delicate.

Trump, who relied heavily on political backing from religious conservatives, moved more aggressively than his GOP predecessors to curtail access to abortion and clamp down on federal funding for clinics that provide reproductive care.

Organizations such as Planned Parenthood that long received federal money through the half-century-old Title X program were forced out of it when the Trump administration effectively barred recipients of federal aid from providing abortions or counseling women about the procedure.

That, in turn, led to widespread cutbacks at clinics across the country and huge drops in the number of people able to get family planning services, according to healthcare providers.

"We're seeing so many fewer clients," said Brenda Thomas, chief executive of Arizona Family Health Partnership, which coordinates the state's Title X program. Thomas said the number of patients in Arizona's program dropped 24% in 2019 after the Trump administration issued the new rules and declined an additional 40% in 2020, as the COVID-19 pandemic further hampered services.

In Missouri, a provider operating three family planning clinics left the program, leading to a 14% decrease in patients getting services through Title X, according to the Missouri Family Health Council.

And in California, the Title X restrictions led to a 40% reduction in patients in 2019, said Lisa Matsubara, general counsel at Planned Parenthood Affiliates of California.

Like many other family planning advocates, Matsubara said Biden needs to do more than just reverse the cuts. "We don't want to just, like, go back to what it was before the Trump administration," she said. "We're really looking and hoping that the administration really takes the necessary steps to expand access."

Biden has pledged to rewrite the family planning regulations so clinics providing reproductive health services can return to the program.

Within days of taking office, Biden issued an executive order to reverse other family planning restrictions imposed by the last administration, including rescinding the so-called global gag rule that prevented international aid groups that receive U.S. funding from counseling pregnant patients about abortion.

Rolling back some federal policies, like the restrictions on international aid, are relatively simple. Biden and Becerra likely also could quickly reverse Trump-era restrictions on mifepristone, a pill used to induce abortion early in a pregnancy.

But rewriting rules on funding for family planning or reissuing other complex regulations could be considerably more fraught, experts say.

"Both sides have really learned how to maximize use of courts," said Alina Salganicoff, who directs women's health policy at KFF, a health policy nonprofit. (KHN is an editorially independent program of KFF.) 

"If anyone understands the legal challenges, it's Becerra," Salganicoff said. "But these are thorny issues. There are questions about how the Biden administration can move forward and how fast. And there's no question they are going to be sued."

After taking office, Biden said his administration would review the Title X restrictions, which are also under review by the Supreme Court.

As California attorney general, Becerra sued to stop the Trump administration rules. The case was rejected by lower federal courts, though a separate lawsuit in Maryland challenging the rules was successful, setting up the case for the Supreme Court.

Last month, the court issued its first abortion-related decision since Trump appointee Amy Coney Barrett replaced Ruth Bader Ginsburg, upholding a Trump-era rule that blocked mail delivery of mifepristone. 

Many legal experts see more substantial court fights on the horizon as conservative-leaning states pass increasingly restrictive abortion laws.

Just last week, South Carolina Gov. Henry McMaster, a Republican, signed a bill barring abortions as soon as a fetal heartbeat can be detected with ultrasound, or about five or six weeks after a pregnancy begins.

The South Carolina law was temporarily blocked by a federal judge after Planned Parenthood filed a lawsuit. 

The Supreme Court has never upheld a law as restrictive as South Carolina's. But the high court is the most conservative it has been in decades, raising the prospect that justices may reconsider the landmark 1973 Roe v. Wade decision, which recognized the right to an abortion.

That could force Biden — and potentially Becerra — to step much more directly into efforts in Congress to safeguard abortion rights, said Ziegler, the Florida law professor.

"There will be huge pressure on the Biden administration to do big, bold things," she said. 

Noam N. Levey: nevey@kff.org, @NoamLevey

Rachel Bluth: rbluth@kff.org, @RachelHBluth

DeSantis Advances Questionable Link Between Lockdowns and Despair

KFF Health News, February 24, 2021

DeSantis has suggested that states that had instituted heavy restrictions on residents experienced severe repercussions for residents without reducing the number of COVID deaths.

This article was published on Wednesday, February 24, 2021 in Kaiser Health News.

By Phil Galewitz  

The result of lockdowns "has been the destruction of millions of lives across America as well as increased deaths from suicide, substance abuse and despair without any corresponding benefit in COVID mortality."

Florida Gov. Ron DeSantis, Feb. 2, 2020

For months, Florida Gov. Ron DeSantis has boasted about his state's "open for business" strategy in dealing with COVID-19 and how it's working better than so-called lockdown states.

Unlike in some other states, all Florida public schools are open for in-person learning, restaurants and bars have few restrictions, and the state has barred local governments from penalizing individuals for not wearing a mask in public.

In a recent rant against social network companies such as Facebook and Twitter, DeSantis suggested that states that had instituted heavy restrictions on residents experienced severe repercussions for residents without reducing the number of COVID deaths.

"Lockdowns at the time of the pandemic were favored by the, quote, 'narrative' and so, in the name of, quote, 'science,' articles and posts warning against lockdowns were taken down and censored," said DeSantis. "The result has been the destruction of millions of lives across America, as well as increased deaths from suicide, substance abuse and despair, without any corresponding benefit in COVID mortality."

We wondered whether that was true. Have state restrictions done such significant harm without providing any boost in the fight against COVID deaths? So we dug in.

Locking In on Lockdowns

To reduce the spread of the coronavirus, states have enacted — and then sometimes relaxed or lifted — various restrictions, including mask mandates, limits on restaurant capacity, stay-at-home orders and bans on large gatherings.

DeSantis, a Republican, has bristled at such statewide orders, even resisting pleas from local officials in Florida and criticizing other jurisdictions for implementing them. He has consistently questioned their effectiveness. Late last year, for instance, he claimed that states with lockdowns had COVID transmission rates twice as high as Florida's. We rated that Half True.

We asked DeSantis' office for any evidence supporting his more recent claim. The response reveals a mixed bag of information.

Check the Data: Did Florida's Path Lead to Less 'Despair'?

To support the governor's claim that other states have seen higher numbers of deaths from suicide, substance abuse and despair than Florida has during the pandemic, DeSantis' office sent information from the Centers for Disease Control and Prevention showing "all cause" mortality rates increased slower in Florida in 2020 — coinciding with the pandemic's first months through June 3 — over 2019 rates than in California and New York — two states that have opted for more regulations on public gatherings and mask-wearing. DeSantis' analysis showed Florida's rate rose 15% compared with 16% in California and 29% in New York.

But the "all causes" category goes far beyond deaths associated with suicide and drug abuse. It includes deaths from cancer, heart disease, lung disease and dementia, for example.

DeSantis' office did not provide any data showing how rates of suicide and drug abuse in Florida compared with those in so-called lockdown states. It sent us a Miami Herald article that said in Florida, according to preliminary medical examiners' statistics, 2,975 people died by suicide in 2020, down 13% from the previous year. But the article did not have nationwide data or figures from California or New York.

Concerning overdose deaths, DeSantis' office did not provide specific information. However, health experts said the pandemic likely did increase opioid overdoses. But the latest, provisional CDC data on drug overdose deaths shows Florida's numbers rising faster than the national average.

Comparing the 12-month period ending in June 2020 to the prior 12 months, the period for which data is available, Florida had a 34% increase in the rate of overdose deaths compared with a 20% national average among states. California had a 23% increase and New York had an 18% increase.

Meanwhile, federal suicide data reflecting the months in which the pandemic has transpired will not likely be available until 2022. Experts say that anecdotal evidence suggests a possible uptick in suicide rates during the pandemic. In addition, an online tool offered by the nonprofit Mental Health America to help screen for mental health issues showed a slight increase last year in people having suicidal thoughts.

Nonetheless, Paul Gionfriddo, the group's CEO, said he knows of no studies showing that so-called lockdown states have higher rates of suicide than those with fewer restrictions.

Gionfriddo said DeSantis may think he is mitigating the harmful effects of loneliness by not limiting public gatherings. But loneliness is not the only reason people cite in considering suicide, he said. Grief, financial insecurity and other factors also play a role, he said.

John Auerbach, president and CEO of Trust for America's Health, a nonprofit think tank, said it's difficult to pinpoint the psychological impact of restrictions to reduce infection because rules vary by state and within states, and such regulations have been imposed and lifted at different times.

Auerbach said he knows of no evidence that links states' COVID restrictions to suicides or drug overdose deaths.

"There are many contributing factors to suicide and drug overdoses," he said. The pandemic itself is having the biggest effect on heightening people's risk of dying from suicide and drug abuse — not the states' different approaches to prevent the transmission of infection, he added.

"It is the underlying pandemic that is at the root of increased risks," Auerbach said.

Factoring In COVID Mortality Rates

DeSantis also argued that statewide restrictions did not bring any corresponding benefit in limiting COVID mortality.

We asked his office for evidence. They again pointed to the CDC increase in "all cause" mortality data that showed California's rate was slightly higher than Florida's. But those statistics cover all causes of death, and people are still dying of diseases and conditions besides COVID.

We then consulted three epidemiologists to get their take. They all said the governor was playing loose with the facts. They stressed varying factors that affect states' mortality rates — from the weather to socioeconomic indicators to access to health services.

The epidemiologists pointed to the latest CDC data, which indicated that Florida's COVID mortality rate is higher than California's and seemed to undercut DeSantis' position that lockdowns have only hurt states.

As of Feb. 22, Florida ranked 28th in COVID death rates while California ranked 33rd, according to the latest CDC data, as compiled by Statista.

"That would bolster the argument that restrictions are one factor involved in lowering death rates," said Nicole Gatto, an associate professor of public health at Claremont Graduate University in California.

Numerous others also have an effect, Gatto said, so it is impossible to compare states using current data based on their strategies.

"I do think it is an oversimplification to make the assertion that the governor did without further study of the numerous variables involved, characteristics of the population, timing of interventions and the limitations of the data," she said.

Our Ruling

DeSantis said lockdown states have seen "increased deaths from suicide, substance abuse and despair without any corresponding benefit in COVID mortality."

The pandemic certainly has caused anxiety and distress across the country, and state and local restrictions designed to tamp down on the coronavirus's spread have also affected people's financial and emotional well-being. But currently, no clear data supports DeSantis' strongly worded claim. Researchers agreed that more research is necessary before such broad conclusions could be drawn. In addition, experts said that COVID death rates vary by state and numerous factors beyond state strategies to combat the virus affect this metric.

We rate the statement Mostly False.

Sources:

Gov. Ron DeSantis news conference, Feb. 2, 2021

Telephone interview with Paul Gionfriddo, president and CEO of Mental Health America, Feb. 12, 2021

Mental Health America, Take a Mental Health Test, Mental Health America online screening tool, accessed Feb. 12, 2021

Centers for Disease Control and Prevention, Vital Statistics Rapid Release: Provisional Drug Overdose Death Counts — CDC data on overdose deaths, Feb. 7, 2021

Email correspondence with Meredith Beatrice, DeSantis spokesperson, Feb. 10 and 11, 2021

Telephone interview with John Auerbach, president and CEO of Trust for America's Health, Feb. 12, 2021

Email interview with Nicole Gatto, MPH, Ph.D., associate professor of public health at Claremont Graduate University, Feb. 18, 2021

Email interview with William Miller, professor of epidemiology at the Ohio State University, Feb. 18, 2021

Telephone interview with Dr. Robert Murphy, professor of medicine and biomedical engineering and executive director, Northwestern University's Institute for Global Health, Feb. 18, 2021

Statista, Death rates from coronavirus (COVID-19) in the United States as of Feb. 17, 2021, by state, accessed Feb. 22, 2021

Miami Herald, "One Pandemic Positive: Suicides in Florida Actually Plummeted. Experts Worry It Won't Last," Feb. 10, 2021

PolitiFact, "Is Florida Doing Better on COVID-19 than 'Locked Down' States? Dec. 2, 2020

Phil Galewitz: pgalewitz@kff.org, @philgalewitz

Covid Strikes Clergy as They Comfort Pandemic's Sick and Dying

KFF Health News, February 23, 2021

Spiritual work is key to the work of hospital chaplains, but it can expose them to viruses being spread in the air or sometimes through touch.

This article was published on Tuesday, February 23, 2021 in Kaiser Health News. This story also ran on The Washington Post.

By Bruce Alpert

The Rev. Jose Luis Garayoa survived typhoid fever, malaria, a kidnapping and the Ebola crisis as a missionary in Sierra Leone, only to die of covid-19 after tending to the people of his Texas church who were sick from the virus and the grieving family members of those who died.

Garayoa, 68, who served at El Paso’s Little Flower Catholic Church, was one of three priests living in the local home of the Roman Catholic Order of the Augustinian Recollects who contracted the disease. Garayoa died two days before Thanksgiving.

Garayoa was aware of the dangers of covid, but he could not refuse a congregant who sought comfort and prayers when that person or a loved one fought the disease, according to retired hairstylist Maria Luisa Placencia, one of the priest’s parishioners.

“He could not see someone suffering or worried about a child or a parent and not want to pray with them and show compassion,” Placencia said.

Garayoa’s death underscores the personal risks taken by spiritual leaders who comfort the sick and their families, give last rites or conduct funerals for people who have died of covid. Many also face challenges in leading congregations that are divided over the seriousness of the pandemic.

Ministering to the ill or dying is a major role of spiritual leaders in all religions. Susan Dunlap, a divinity professor at Duke University, said covid creates an even greater feeling of obligation for clergy, because many patients are isolated from family members, she said.

People near death often want to interact with God or make things right, Dunlap said, and a clergy member “can help facilitate that.”

Such spiritual work is key to the work of hospital chaplains, but it can expose them to virus being spread in the air or sometimes through touch. Jayne Barnes, a chaplain at the Billings Clinic in Montana, said she tries to avoid physical contact with covid patients, but it can be difficult to resist a brief touch, which is often the best way to convey compassion.

“It’s almost an awkward moment when you see a patient in distress, but you know you shouldn’t hold their hand or give them a hug,” Barnes said. “But that doesn’t mean that we can’t be there for them. These are people who cannot have visitors, and they have a lot they want to say. Sometimes they are angry with God, and they let me know about that. I’m there to listen.”

Still, there are times, Barnes said, that the despair is so profound she cannot help but “put on a glove and hold a patient’s hand.”

Barnes was diagnosed with covid near Thanksgiving. She has recovered and has a “better understanding” of what patients are enduring.

Dealing with so much suffering affects even the most hardened doctors and nurses, she said. Billings Clinic staffers were devastated when a beloved physician died of covid, and rallied behind a popular nurse who was seriously ill but recovered.

“We’re not only taking care of the patients; we are also there for the staff, and I think we have been an important asset,’’ she said of the hospital’s chaplains.

In Abington, Pennsylvania, Pastor Marshall Mitchell of Salem Baptist Church said he believes part of his spiritual duty is to persuade his congregation and the broader African American community to take precautions to avoid covid. That is why Mitchell allowed photographers to capture the moment in December when he received his first dose of a vaccine.

“As pastor of one of the largest churches in the Philadelphia region, it is incumbent on me to demonstrate the powers of both science and faith,” he said.

Mitchell said he might have credibility in convincing other African Americans, who have been disproportionately affected by covid, that a vaccine can save lives. Many are skeptical.

The politicization of covid precautions such as masks and social distancing has put many pastors in a difficult position.

Mitchell said he has no patience for people who refuse to wear masks.

“I keep them the hell away from me,” he said.

Jeff Wheeler, lead pastor of Central Church in Sioux Falls, South Dakota, said that his church encourages mask-wearing and that most congregants comply. However, the underlying tension is reflected in his message to members on the church’s website:

“As we move forward, we simply ask you to avoid shaming, judging or making critical comments to those wearing or not wearing masks,” it reads.

Sheikh Tarik Ata, who leads the Orange County Islamic Foundation in California, said that the Quran calls for Muslims to take actions to ensure their health and that congregants largely comply with covid guidelines

“So, our members don’t have a problem with mask mandates,” he said.

Covid has hit the Orange County Muslim population hard, Ata said. Religion has become an important source of comfort for members who have lost their jobs and struggled with illness or finding child care.

“Our faith says that no matter how difficult the situation, we always have access to God and the future will be better,” Ata said.

Adam Morris, the rabbi at Temple Micah in Denver, said he has turned to online video to meet with congregants sick with the coronavirus. When meeting with his congregation members in person, such as during graveside services, he worries that with his mask on people might miss seeing the concern and compassion he feels for their plight.

He conducts in-person graveside funerals for a small number of mourners but requires all participants to wear masks.

Observant Muslims and Jews believe it is important to bury the dead quickly after death, Morris said.

“Some traditions and rituals must go forward,” Morris said, “covid or not.”

Calling All Vaccinators: Closing the Next Gap in COVID Supply and Demand

KFF Health News, February 23, 2021

As an increasing number of vaccine vials are shipped in coming weeks, the concern about shortages may well shift to human capital: the vaccinators themselves.

This article was published on Tuesday, February 23, 2021 in Kaiser Health News.

By Julie Appleby

Beating back COVID right now comes down to balancing supply and demand.

With hopes pinned to vaccines, demand has far outstripped the supply of doses.

But, as an increasing number of vaccine vials are shipped in coming weeks, the concern about shortages may well shift to human capital: the vaccinators themselves.

"We need to mobilize more medical units to get more shots in people's arms," Jeff Zients, coordinator of President Joe Biden's COVID-19 task force, said at a briefing earlier this month.

Already, there have been scattered reports that vaccinators are in short supply in some areas.

"Absolutely, we do need more," said Tom Kraus, vice president of government relations for the American Society of Health-System Pharmacists, whose members work in hospitals, clinics and large physician practices.

After all, vaccinating America is a huge undertaking.

"We are planning to vaccinate a lot more people over a shorter period of time than we've ever done before," said L.J Tan, chief strategy officer of the Immunization Action Coalition, which distributes educational materials for healthcare professionals and the public across a range of vaccination topics.

Each year the U.S. vaccinates 140 million to 150 million residents against influenza, "but what we're talking about now is much more intensive," he said. For COVID, the goal is to get vaccines out quickly to all those eligible in a country of 330 million people.

A state-by-state survey would be required to estimate how many total vaccinators are needed nationally, Tan said.

Still, experts are cautiously optimistic that this won't be a hard problem to fix, pointing to efforts underway to recruit current and retired medical professionals, as well as medical students and nurses in training.

"As long as we continue to see this interest in volunteering, we should have a sufficient workforce to do it," said Deb Trautman, president and CEO of the American Association of Colleges of Nursing.

Not just anyone can be a vaccinator. One can't merely walk into a center and offer to help give shots. The training requirements vary by state.

To boost the effort, both the Trump and Biden administrations, using an emergency preparedness law first adopted in 2005, expanded liability protections.

With the recent expansions, those qualifying include pharmacy interns and recently retired doctors and nurses, as well as physicians, nurses and pharmacists. The government estimates there are about half a million inactive physicians and 350,000 inactive registered nurses and practical nurses in the United States.

States are also greenlighting dentists, paramedics and other first responders, said Kim Martin, director of immunization policy at the Association of State and Territorial Health Officials.

Some are also turning to nursing and medical schools, where faculty and students are often eager to participate. More than 300 schools nationally have signed a pledge offering to help administer the vaccine, according to the American Association of Colleges of Nursing.

The University of Houston College of Nursing, for example, altered its curriculum specifically to prepare students for administering COVID vaccines — and teams of students and faculty have helped at community vaccination sites.

Others are joining the effort.

The Medical Reserve Corps, a national network of volunteer groups, has more than 200 units in about 40 states, Puerto Rico, American Samoa and the Northern Mariana Islands assisting with various vaccination efforts, including administering the shots, according to a Health and Human Services spokesperson.

And the military is pitching in, too, with the Pentagon approving the use of more than 1,000 active-duty service members to help the Federal Emergency Management Agency with mass vaccinations sites, the first one set for California.

Although some of these groups give ballpark figures of volunteers, it's hard to tally just how many have stepped forward in recent months to help vaccinate.

Becoming a Vaccinator

"It should not be left to just anyone that is willing, as there are clinical skills and preparedness that is required," said Katie Boston-Leary, director of nursing programs at the American Nurses Association.

Even those skilled in giving shots may need a training booster in the war against COVID.

When she volunteered, Boston-Leary said, she was required to complete four to six hours of online training across a wide range of topics, from the optimal way to administer intramuscular injections, to specific information about the two vaccines now on the market.

"Even a nurse like me has to go through that training," said Boston-Leary.

To aid states in setting up training, the Centers for Disease Control and Prevention offered recommendations that all healthcare staff members receive training in COVID vaccination "even if they are already administering routinely recommended vaccines."

The CDC has different training modules, based on experience level. For instance, there's a module for those who have given vaccinations in the previous year, but a different one for those who haven't done so for more than a year. The time required to complete programs varies — people with the most recent experience require less total training time.

Tan said training laypeople with no medical background to give vaccines "is not the way to go."

Instead, such volunteers can be used to help with logistics, such as directing people to the right areas, managing traffic, moving supplies around and similar duties.

Training programs exist even for people who aren't vaccinators but assist with storing, handling or transporting the vaccines. That's important because the two vaccines currently in use — one from Pfizer-BioNTech and one from Moderna — have different storage requirements.

They are shipped in multidose vials, which is not unusual for vaccines. The vaccinators themselves often draw up the syringes out of the vials, said Tan.

To avoid slowdowns as patients move through the lines, some vaccination centers have other trained staffers pre-fill individual syringes. Anyone doing this task should be "someone trained in administering vaccines as well," said Tan.

At the clinic where Katie Croft-Walsh, 65, volunteered recently in San Antonio, her only job was to administer the vaccine. Other volunteers took care of registering patients, pre-filling the individual syringes and other logistical efforts.

She decided to volunteer after hearing that help was needed. The move came with a bonus: She would get the vaccine herself at the end of her first day participating, something she already qualified for based on her age but had been unable to secure.

A practicing lawyer, Croft-Walsh previously worked as a registered nurse and kept her license current by taking required courses each year since leaving her hospital job in 1998.

Training occurred on her first day at the mass vaccination site and covered details about each type of vaccine, along with the types of syringes available, the right place to inject the dose and other information. Her group, which she said included nurses, dentists, pharmacists and upper-level nursing students, were trained and overseen by health department physicians.

The patients were all thrilled to get a dose.

"Everyone was very kind and nice," even if they had to wait a bit in line, she said.

She liked the experience so much that she has volunteered at more clinics — and plans to start volunteering with fire departments as they begin community clinics in her city.

"It made me remember why I went into nursing in the first place," said Croft-Walsh.

Remember, No Squeezing!

To ensure safety, training is important, Martin of the state health officers group said. It's not that hard to give an intramuscular injection, but you need to place it in the right spot. For adults, that area is in the deltoid muscle, "not too far up the shoulder, not too far down," she said, both to avoid injury and to make sure the vaccine goes into the muscle.

Training videos show vaccinators how to find the ideal location, first locating the bony point in the shoulder, then measuring two or three finger widths down and placing the needle in the middle of the arm.

Administering an intramuscular vaccine too high on the shoulder can cause a rare and painful injury. Such injuries were more common years ago when influenza vaccines were first rolling out, said Tan of the immunization coalition. Training on proper technique helped reduce cases since then, he said, and is also part of current efforts to train vaccinators.

It's also important not to pinch patients' arms when administering the vaccine, said Tan, responding to a question about a hashtag making the rounds on Twitter called #DoNotSqueezeMyArm.

For intramuscular injections to be most effective, the needle needs to penetrate the muscle, not fat.

"When you squeeze the arm, it pushes up the fat layers," said Tan.

Those getting the vaccines, he said, can play a role, too.

"I encourage patients to ask questions," said Tan. "If they're concerned their arm is being squeezed, speak up. Not in a hostile manner, but say something like, 'Hey, I read this thing about not squeezing arms. Can you explain why you're squeezing mine?'"

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Pages