Science Shows Mask-Wearing Is Largely Safe for Children

KFF Health News, August 18, 2021

Experts say it's more plausible that the annoyances of masking could distract from in-class lessons and make it harder to hear other students or the teacher.

This article was published on Wednesday, August 18, 2021 in Kaiser Health News.

By Louis Jacobson, PolitiFact

Florida Gov. Ron DeSantis is one of a handful of Republican governors trying to block school districts from requiring masks in the classroom. 

Under DeSantis' direction, the state health department adopted a rule that lets families opt out of locally ordered school mask mandates. The State Board of Education approved another rule that allows parents to secure vouchers for their children to attend a different school if they encounter pushback on their refusal to use masks. The DeSantis administration threatened to penalize school officials financially if they bucked the rules. 

Much of DeSantis' argument was based on his belief that parents have a right to determine what's best for their child, as well as his doubts about whether mask mandates are effective at curbing the COVID virus in a school setting. (When PolitiFact looked into the latter argument, multiple experts pointed to research showing that mask-wearing is effective at protecting children from COVID-19 and preventing COVID transmission in schools.)

But DeSantis also cited specific negatives for mask wearers' health.

In an executive order, DeSantis wrote that "masking children may lead to negative health and societal ramifications" and that "forcing children to wear masks could inhibit breathing, lead to the collection of dangerous impurities including bacteria parasites, fungi, and other contaminants, and adversely affect communications in the classroom and student performance."

DeSantis' press secretary, Christina Pushaw, told PolitiFact that "there are potential downsides to masking children for eight hours per day, from a developmental, emotional, academic, and medical perspective. These potential downsides are largely unexplored."

She cited concerns raised in an op-ed by Dr. Marty Makary, a professor at the Johns Hopkins School of Medicine, and Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Children's Hospital, that said that "masks can lead to increased levels of carbon dioxide in the blood" and that they "can be vectors for pathogens if they become moist or are used for too long." Makary and Meissner also warned of impacts on verbal and nonverbal communication.

Other people aligned with DeSantis' view have put the harm of kids wearing masks in even starker terms.

During a panel discussion convened by DeSantis, clinical psychiatrist Dr. Mark McDonald said, "My position is simple: Masking children is child abuse," according to the Miami Herald. (Meissner was also on the panel.)

Rep. Madison Cawthorn (R-N.C.) spoke out against a proposed school mask mandate by the Buncombe County Board of Education, saying a mandate is "nothing short of psychological child abuse."

And on the July 27 edition of his Fox News show, Tucker Carlson asserted that it's a "scientifically established fact that masks pose a far greater threat to children than COVID does. So, strictly speaking as a scientific matter, this is lunacy."

What does science say about whether masks can harm the wearer?

Generally, we found that concerns about significant negative effects on breathing aren't well supported. Worries about masks interfering with communication and serving as a barrier to social connection in the classroom may be more reasonable, experts say.

Breathing Concerns

The first thing to note is that masks aren't recommended for everyone. The American Lung Association cautions people with lung disease, for instance, to consult their doctor before wearing a mask regularly. In addition, the CDC does not recommend that children under 2 years old wear masks. Masks are also generally not recommended during heavy exercise.

But what about people who do not fall into these categories? Could they be hurt by wearing a mask? 

Some of the most common concerns raised involve a lack of oxygen, or a buildup in carbon dioxide. We have previously found such concerns to be oversold, as have other fact-checkers. 

The issue "has been convincingly debunked," said Babak Javid, a professor of medicine at the University of California-San Francisco.

We should note that studies specific to children have been rare, so most of the scientific literature has involved research on adults. Two studies on children used N95 masks, which are more sophisticated than the masks most schoolchildren will use, but even these found no significant effect on breathing. Other peer-reviewed studies of adults have produced similar results.

A mask "will add some resistance to the breathing process, meaning it may feel like it takes a bit more work to take a breath, but it won't materially change the makeup of air that comes through the mask," said Benjamin Neuman, a biology professor at Texas A&M University and chief virologist of the university's Global Health Research Complex.

A paper published in February looked at 10 previous studies of adults or children that addressed questions of breathing while wearing a mask. The authors expressed disappointment at how few studies looked specifically at the impacts on children, and they urged that more research is needed on that specific question.

However, the paper found little reason for worry.

"The eight adult studies, including four prompted by the pandemic and one on surgeons, reported that face masks commonly used during the pandemic did not impair gas exchange during rest or mild exercise," the authors wrote.

A June study that seemed to indicate breathing challenges for masked children was retracted by the journal JAMA Pediatrics 16 days after publication because of methodological shortcomings and other concerns.

Dr. David Hill, an American Lung Association board member, has written that masks "absolutely" do not cause low oxygen levels.

"We wear masks all day long in the hospital," Hill wrote. "The masks are designed to be breathed through and there is no evidence that low oxygen levels occur."

Another reason medical experts aren't too worried is that "the world has engaged in a massive study — observational, but literally billions of people — on mass mask-wearing, and people are not dropping dead left, right and center," Javid said.  

Other Possible Risks

A few other complaints about masks sometimes surface, such as fear that they could concentrate toxins or harm the immune system. But these aren't well supported either, experts say.

As long as masks are regularly replaced or laundered, "there's no reason to worry about toxins,'' said Columbia University virologist Angela Rasmussen. And there's "no evidence that masks have any effect on the immune system or immune function," she said.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told PolitiFact that swabbing a student's backpack would probably generate as many (or more) pathogens as swabbing their mask.

And Nicole Gatto, an associate professor of public health at Claremont Graduate University, said pathogens on masks may be evidence that they're being kept "out of the mouths and noses of those who wore them, preventing people from potentially getting ill."

While the scientific evidence for specific ills such as low oxygen or high carbon dioxide is weak, experts say it's more plausible that the annoyances of masking could distract from in-class lessons and make it harder to hear other students or the teacher.

In a September 2020 paper in the International Journal of Environmental Research and Public Health, the authors wrote that "while there are minimal physiological impacts on wearing a mask … there may be consequential psychological impacts of mask wearing on the basic psychological needs of competence, autonomy, and relatedness."

Such downsides may be especially acute for students who are English-language learners, or those who are deaf or hard of hearing.

"Masks interfere with lip-reading, which has a major impact on communication," Javid said.

The reality is that "there is minimal evidence" on how severe these sorts of impacts could be for most children. "This is the first time in most of our lifetimes we have faced the prospect of continued isolation and masking, so it is not surprising we have insufficient evidence to guide us," said Amy Price, a senior research scientist at Stanford University.

Still, there is evidence that children are adaptable. In a December 2020 study of children's ability to read the facial expressions of masked people, researchers at the University of Wisconsin-Madison found that "while there may be some challenges for children incurred by others wearing masks, in combination with other contextual cues, masks are unlikely to dramatically impair children's social interactions in their everyday lives."

And child-development experts caution against assuming that any deficits from masks will linger over the long term.

Most children "don't like wearing pants or shoes at first, but they adjust, like they do for all the other things we require of them," said A.E. Learmonth, a professor with the cognition, memory and development lab at William Paterson University. "In many ways, a mask is just another article of clothing. In the beginning it could be distracting and uncomfortable, but like shoes, they will get used to it."

Meanwhile, polling suggests that parents are open to masks in schools. A KFF survey taken in July and August found that 63% of parents wanted masks required in schools for people who are unvaccinated.

PolitiFact's Gabrielle Settles and Jason Asenso contributed to this article.

Federal Vaccine Program Hasn't Helped Those Whose Lives Were Altered by COVID Shot

KFF Health News, August 18, 2021

The options are slim for people who suffer rare life-altering injuries after a COVID shot — a problem whose significance has grown as states and the federal government ponder vaccination mandates.

This article was published on Wednesday, August 18, 2021 in Kaiser Health News.

By Arthur Allen  

Angela Marie Wulbrecht jumped at the first chance to get a COVID-19 vaccine, driving three hours from her Santa Rosa, California, home to a mass-vaccination site on Jan. 19. Twelve minutes after her Moderna shot, she stumbled into the paramedic tent with soaring blood pressure and a racing heartbeat. And so began a calvary of severe fatigue, brain fog, imbalance and other symptoms that are still with her eight months later.

Wulbrecht, 46, had been a nurse for 23 years before the shot. She was healthy, ate a vegan diet and was an accomplished salsa dancer. Since January she's had to leave her job and missed out on many activities with her husband and 12-year-old daughter, Gabriella. She has spent about $35,000 on out-of-pocket medical bills, despite having insurance.

"I wanted to get vaccinated as soon as I could to help fight the pandemic," said Wulbrecht, who still supports the vaccination campaign. Her husband got his shots despite her reaction, and Gabriella was scheduled to get her first dose Wednesday. "But it would help those who are hesitant if they took care of those of us who got injured."

The options are slim for people who suffer rare life-altering injuries after a COVID shot — a problem whose significance has grown as states and the federal government increasingly ponder vaccination mandates.

A federal program compensates people experiencing vaccine injuries, but not injuries from COVID vaccines — not yet, anyway.

Such injuries are rare, but "if you're going to take one for the team, the team has to have your back," said Katharine Van Tassel, a vaccine law expert at the Case Western Reserve University School of Law in Cleveland. "That's a moral imperative."

Thirty-five years ago, Congress created the National Vaccine Injury Compensation Program, known as the vaccine court, for children hurt by routine immunizations administered as a condition of school entry — "injured recruits in the war on infectious disease," as Georgetown University bioethicist Leroy Walters once described them.

Since it began operations in 1988, the vaccine court has paid more than $4 billion to over 8,000 families who could provide a "preponderance of evidence" that vaccines against diseases like measles and pertussis hurt their kids. The court also covers vaccine injuries in pregnant women, and from the flu vaccine. But it does not cover aftereffects from COVID vaccines.

A smaller federal program, the Countermeasures Injury Compensation Program, addresses illnesses resulting from drugs or vaccines administered during a public health emergency, such as the COVID pandemic.

But that program requires evidence that's harder to pin down, does not pay attorney fees and rules by administrative fiat, while the vaccine court has judges. The countermeasures program has yet to pay a cent to anyone hurt by a COVID vaccine, and its largely invisible decisions are "an inscrutable enigma," said Brian Abramson, an expert on vaccine law.

David Bowman, a spokesperson for the Health and Human Services Department's Health Resources & Services Administration, said the countermeasures program had a total of seven staff members and contractors and was seeking to hire more. He declined to answer questions about how COVID vaccine claims could be handled in the future.

In June, a bipartisan group of lawmakers led by Reps. Lloyd Doggett (D-Texas) and Fred Upton (R-Mich.) introduced legislation to address problems with the original vaccine court, including a two-year backlog of cases. That bill would also increase the pain and suffering or death payments to people who can prove an injury, from $250,000 to $600,000.

A spokesperson for Doggett said he hopes the bill — not currently attached to a larger package moving through Congress — would eventually allow COVID vaccine-injured patients to get compensation through the vaccine court. But that's far from guaranteed.

In general, it is very difficult to prove a vaccine caused an injury that appears post-vaccination, since the ailments can be coincidental. But the rare vaccine injury can devastate a person's health and financial resources.

Wulbrecht, whose care has included five ambulance trips, each billed for $3,000, filed a claim in February with the Countermeasures Injury Compensation Program. She got a note acknowledging her claim but hasn't heard further from the program.

She's in a Facebook group created for people reporting grievous COVID vaccine-related neurological issues. It was launched by Dr. Danice Hertz, a retired gastroenterologist in Santa Monica, California, who has been diagnosed post-vaccination with mast cell activation syndrome, a rare condition in which part of the immune system goes haywire.

Hertz got her first Pfizer-BioNTech shot on Dec. 23, shortly after the Food and Drug Administration authorized the vaccine. Within 30 minutes she suffered terrible numbness and pain in her face and tongue and "felt vibrations going through my whole body," she said.

More than 90% of the 150 people in the Facebook group are women, Hertz said. She is careful to keep what she terms anti-vaccine "riffraff" off the list, but she said many of the injured people have been frustrated at being unable to get a diagnosis or find doctors who understand the nature of their injuries.

Talk of vaccine injuries is sometimes muted in public health circles because of reluctance to feed the anti-vaccine movement and its bogus claims of vaccine injury ranging from infertility to magnetism to microchips secretly implanted by Microsoft founder Bill Gates.

But rare reactions like the ones Hertz and Wulbrecht report are scattered through the vaccine literature and often attributed to a phenomenon called "molecular mimicry," in which the immune system responds to an element in the vaccine by attacking similar-looking human proteins. Guillain-Barré syndrome, or GBS, is caused by an immune attack on the nervous system in reaction to a vaccination — and to viral infections. It has been reported after influenza shots, and the single-dose Johnson & Johnson COVID vaccine.

Hertz and others have been in contact with Dr. Avindra Nath, chief of clinical medicine at the National Institute of Neurological Disorders and Stroke, whose specialty is the study of immune-modulated neurological illness. Nath told KHN he was studying some of the patients but hadn't confirmed their illnesses were caused by a COVID vaccine.

"We have to find these answers, but they aren't easy to come by," Nath said. "I know these reactions are rare, because there were 36,000 NIH employees vaccinated against COVID and, if it was common, I could study it here. But I don't have a single NIH employee" who experienced it.

Regardless of how common the reactions are, vaccine law specialists worry about the impact of a failure to help those hurt by shots administered before the products gain full FDA approval, which could come this fall.

Congress created the vaccine court to keep pharmaceutical companies from abandoning production of common childhood vaccines by protecting them from damaging lawsuits, while at the same time offering support for kids hurt by a vaccine.

The Countermeasures Injury Compensation Program, however, arose as part of the 2005 Public Readiness and Emergency Preparedness Act, and was pushed through to shield drug companies from lawsuits over products like the anthrax and smallpox vaccines, which had a relatively high rate of dangerous side effects. COVID vaccines shouldn't be in the same category, Van Tassel said.

The PREP Act is likely to set an almost insurmountable burden of proof for injury compensation, she said. Rewards depend on "compelling, reliable, valid medical and scientific evidence," which doesn't exist for COVID vaccines because they are so new.

But cause and effect appear clear to women like Brianne Dressen, a Saratoga Springs, Utah, preschool teacher who was bedridden for months with neurological symptoms that began after she got an AstraZeneca shot in a clinical trial last November.

"Vaccines are an important piece of the puzzle to get us through the pandemic," she told KHN. "But some people are going to draw the short straw with any drug or vaccine, and we need to take care of them.

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

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

Rush to Boosters Sparks Confusion, Differing Recommendations

KFF Health News, August 18, 2021

A White House press conference Wednesday is expected to address boosters.

This article was published on Wednesday, August 18, 2021 in Kaiser Health News.

By Sarah Jane Tribble 

When the Food and Drug Administration announced last week that a third dose of Moderna or Pfizer-BioNTech COVID-19 vaccine may boost the immunity of some people who are immunocompromised, officials repeated their stance that fully vaccinated, healthy people do not need another dose.

With this caveat: "The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future," said acting FDA Commissioner Dr. Janet Woodcock.

But the Biden administration reportedly said this week that most Americans will need a booster. And a White House press conference slated for 11 a.m. Wednesday was expected to address boosters.

Meanwhile, doctors and researchers caution that the public needs to stick to the advice of the FDA and the Centers for Disease Control and Prevention.

Those federal agencies "are doing their very best to ensure maximum protection and safety," said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA's vaccine advisory panel. "People have to be very careful about statements that come from Big Pharma. They have a very different goal."

Dr. Sadiya Khan, an epidemiologist and cardiologist at Northwestern University's Feinberg School of Medicine, said that taking any medication has risks and that adding an additional dose of vaccine might cause unnecessary side effects. "What we need is data," she said.

So what do we know about whether healthy, fully vaccinated people should get a booster? Here are answers to seven key questions.

1. What evidence are vaccine makers giving federal regulators to support the idea that an additional shot is needed?

It's unclear how the booster may be authorized by regulators. On Tuesday, FDA spokesperson Abby Capobianco said federal agencies are reviewing laboratory and clinical trial data as well as data from the real world. Some data will come from specific pharmaceutical companies, but the agency's analysis "does not rely on those data exclusively," she said.

The companies, for their part, are racing to produce data. On Monday, Pfizer and BioNTech submitted initial but promising results from a phase 1 study of the safety and immune response from a booster dose given at least six months after the second dose. Late-stage trial results that evaluate the effectiveness of a third dose are "expected shortly," Pfizer spokesperson Jerica Pitts confirmed this week.

Moderna President Stephen Hoge said during his company's earnings call this month that a third dose is "likely to be necessary" this fall because of the highly contagious delta variant. Moderna spokesperson Ray Jordan said Tuesday the company is in talks with regulators but hasn't provided an estimated timeline.

Johnson & Johnson, whose vaccine is administered in a single shot, hopes to share results soon from a late-stage clinical trial studying the safety and efficacy of a two-dose regimen in 30,000 adults. The study is looking at "potential incremental benefits" with a second dose, company spokesperson Richard Ferreira wrote in a Tuesday email.

2. Why might healthy people not need a booster yet?

Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and an adviser to the National Institutes of Health and FDA, said current federal guidance does not recommend a booster and there's no "science-based" reason to get an additional shot at this time — even after receiving the J&J vaccine.

The current mRNA vaccines work by inducing a certain level of neutralizing, virus-specific antibodies with the first dose. Then the second dose brings on an exponential increase in the measurable level of specific neutralizing antibodies — and, more important, there's evidence that the second dose of mRNA vaccine also gives cellular immunity, Offit said.

"That predicts relatively longer-term protection against severe critical disease," he said. A single dose of the J&J vaccine — which uses a different technology, called an adenovirus vector — has been shown to provide the equivalent response to the second dose of an mRNA vaccine, he said.

3. How do the three vaccines authorized in the U.S. compare?

A recent preprint — a paper that has not been peer-reviewed — from the Mayo Clinic suggests that the Moderna vaccine may be more protective against the delta variant than the Pfizer-BioNTech vaccine. However, that research is based on examining the vaccination history of thousands of people who got COVID, rather than a direct comparison of the vaccines, said Dr. Catherine Blish, a specialist in infectious diseases at Stanford Medicine.

"I would be hesitant to alter any practices or change behavior in any way based on that data," she said.

The Moderna and Pfizer-BioNTech vaccines are administered differently, which could factor into how much mRNA the body receives to code into protein, said Dr. Monica Gandhi, a specialist in infectious diseases at the University of California-San Francisco. Moderna's dosing is two shots of 100 micrograms delivered four weeks apart, while the Pfizer-BioNTech vaccine's two 30-microgram doses are delivered three weeks apart.

At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose their vaccine's efficacy dropped from a peak of 96% to about 84%. With its own data of fading efficacy, the Israeli government launched a vaccination campaign this month encouraging more than 1 million residents over age 50 to get a third shot.

As for J&J's one-shot vaccine, there's no evidence that recipients are being hospitalized with breakthrough infections at a higher rate than if they had received other vaccines, said Dr. Amesh Adalja, a specialist in infectious diseases at Johns Hopkins Center for Health Security.

4. Could a booster harm a healthy, fully vaccinated person?

It's unclear. Offit said he believes a booster is safe and may well become important — but "it's just not where we should be in this country right now." The best defense against delta and other variants, he said, is to first vaccinate as many people as possible.

Others, though, said the available research signaled that caution is warranted. During a media briefing reported by Reuters last month, Jay Butler, the CDC's deputy director for infectious diseases, said the agency was "keenly interested in knowing whether or not a third dose may be associated with any higher risk of adverse reactions, particularly some of those more severe — although very rare — side effects."

The CDC did not respond to questions this week about its stance on potential risks. There have been reports of blood clots and allergic reactions after regular dosing. Khan, at Northwestern, said she is also concerned about reports of myocarditis, inflammation of the heart — which is more common after the second shot than the first. She said it's not clear that the benefit of taking a booster would outweigh the risk for young, healthy people.

5. Would a booster limit a vaccinated person's ability to spread the virus?

Dr. William Moss, a professor of epidemiology at Johns Hopkins' Bloomberg School of Public Health, explained that the immune protection conferred by vaccines operates along a spectrum, from severely limiting initial virus replication to preventing widespread virus dissemination and replication within our bodies.

"Booster doses, by increasing antibody levels and enhancing other components of our immune responses, make it more likely virus replication will be rapidly prevented," Moss said. "This then makes it less likely a vaccinated individual will be able to transmit the virus."

Moss also said there are potential benefits to combinations of vaccines like those being administered in San Francisco and some European countries. German Chancellor Angela Merkel boosted her adenovirus-vectored AstraZeneca shot with Moderna in June.

Another possible step for pharmaceutical companies is to reformulate their COVID vaccines to more closely match newer variants. Pfizer has announced it could do so within 100 days of the discovery of a variant.

Hopefully, the regulatory process could be expedited for such reformulated vaccines, said Moss, who works within Johns Hopkins' International Vaccine Access Center.

6. Would we have to pay for the booster dose, or would it be free, like the previous shots?

It is expected to be free. According to Pfizer and the White House, the federal government purchased an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

7. Is there a future in which we take an annual COVID shot?

Dr. Vincent Rajkumar, a hematologist at the Mayo Clinic who studies cancers involving the immune system, said a year ago he believed immune responses to COVID may be similar to those of the measles, which create "a very long memory that protects us."

Then COVID mutated. "India changed everything for me," he said, referring to its massive second wave after delta was discovered. Many of those who were infected had already had COVID, he said.

Rajkumar now believes "we might need annual boosters — and it would be nice if such boosters can be combined with the flu vaccine."

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

Have Vaccines, Will Travel: On the Road With a COVID Entrepreneur

KFF Health News, August 17, 2021

Kyle Austin, a traveling pharmacist, set up his mobile clinic in Virginia City on a recent Saturday, the latest stop on his circuit of Montana's vaccine deserts.

This article was published on Tuesday, August 17, 2021 in Kaiser Health News.

By Katheryn Houghton  

VIRGINIA CITY, Mont. — While many businesses in this southwestern Montana "ghost town" reel in tourists with its mining and Wild West vigilante past, one businessman arrived offering a modern product: COVID-19 vaccines.

Kyle Austin, a traveling pharmacist, set up his mobile clinic in Virginia City on a recent Saturday, the latest stop on his circuit of Montana's vaccine deserts.

"In any business, going to the people is better than waiting for the people to come to you," the 38-year-old pharmacist said.

While many businesses scaled back at the height of the pandemic, Austin saw COVID as an opportunity. He opened his own shop, Pharm406, in Billings — a nod to Montana's lone area code. Then when the COVID vaccine became available, and thousands of people across Montana were stuck on waitlists, he hit cities large and small in a school bus turned vaccine clinic, offering shots with no appointment needed.

"When they started talking about COVID coming out I was like, 'All right, we're gonna create a vaccine, there's gonna be a big demand for it, and Montana doesn't have a lot of access,'" he said. "I hate to say it, but I literally took advantage of COVID-19 to open up and push forward."

Now, with demand at a trickle and the nation grappling with how to finish distributing vaccines, collecting stragglers is part of Austin's business model as he rotates among towns. He sees it as a service to rural Montana that could also pay off for him.

In some parts of the state, Austin is the only person administering Pfizer-BioNTech vaccines, the sole shot approved for those ages 12 to 17. When the mobile clinic leaves, local leaders must figure out how to fill the gaps between his visits.

Dressed in blue scrubs, Austin talks like a businessman who knows rural Montana. He's from Havre, a Montana town about 35 miles south of the U.S.-Canada border, population roughly 9,000. For years, he traveled across the state as a relief pharmacist for drugstores. That work stalled when COVID arrived.

Austin then wanted to create a mobile pharmacy, but a brick-and-mortar base was required to obtain a state pharmacy license. So, in July 2020, he opened his own shop in Billings, Montana's largest city.

There he offered rapid COVID tests, which had been in short supply. He also expanded beyond what's found in typical drugstores: After trying cryotherapy once himself, he bought a machine to add to his pharmacy's list of services. When he noticed people could rent electric scooters in town, he began selling them. Then he used flu shots to conduct a test run of his vaccine tour last fall on the slogan "Get a brew, not the flu," partnering with breweries to give a free drink to anyone getting a shot. In April, he hit the road with COVID vaccines, leaving his team of seven employees to keep his Billings drugstore running.

His mobile clinics have been the easiest way to turn a profit. He doesn't have to rent space or staff an entire pharmacy for the trips. Health departments advertise the clinics for him, and locals provide space for him to park and patients to wait. When the weather is nice, he keeps costs low by camping along the way.

And COVID vaccines have had more demand and higher reimbursement rates than any other vaccine he could have used to propel his business. In most cases, Austin said, he can break even by giving as few as 20 doses a day. So far, the government has supplied the shots for free, and he estimated he gets paid roughly $30 on average to administer a dose between payments from insurance companies and federal reimbursements — as opposed to the $17 he said he saw last year for flu vaccines.

Some days he gives out 200 shots, other days five, but said that adds up. He said it's financially possible because he doesn't pay another pharmacist to do the work.

"If I paid someone to do it, I would probably be upside down," Austin said.

Austin's recent trip to Virginia City to offer a second round of doses came at the request of the town and local health department. This time he drove a Jeep, leaving his school bus behind, because he expected only about 15 customers.

But in a town of 120 year-round residents, in a county of fewer than 9,000, a few shots can make a difference. "Even an incremental increase in uptake could have a big effect on our statistics," said Emilie Sayler, county health director.

Virginia City is at the center of Madison County, where 43% of those eligible for the COVID shot are fully vaccinated — compared with 49% statewide and 59% nationally.

Teenagers remain the county's age group with the biggest vaccine shortfall.

Virginia City doesn't have a pharmacy. The county's vaccine providers are two hospitals that don't stock Pfizer doses. At the beginning of the rollout, Sayler said, the one-nurse health department couldn't handle both vaccines and contact tracing. And as demand dwindled, she worried they wouldn't be able to use up doses — especially Pfizer's. That brand comes in shipments so large that most rural towns can't or won't offer it.

Now the department is balancing educating people about vaccines without coming off as aggressive. It's a county where many locals call incentives — like a free beer or ice cream cone for a jab — a bribe.

Brothers Nicholas and Jacob Johnson, 17 and 16, showed up first to Austin's recent clinic, coming for their second shots. Their next option was going to Bozeman, at least a 100-mile round trip.

"And we would have needed to do it for two shots," Nicholas said, adding he has a summer job and is busy with football and lacrosse.

"I just wanted to get it over with," Jacob added. "I trust the science."

Some of the county's vaccination gap can be attributed to lack of time. Dr. Douglas Young, chair on the county's Board of Health and a veterinarian, came for his shot straight from tending to a sick mule. Young said he always planned to get vaccinated but held off in case it triggered a reaction that knocked him out of work for a few days during the busy spring.

"I didn't want to be down and out during calving season," Young said.

Virginia City Mayor Justin Gatewood, a 44-year-old farmer in a pink pearl-snap shirt and work-stained jeans, stood outside the Pharm406 tent and greeted locals by name and occasionally answered questions for tourists, such as where to find Wi-Fi.

The season of visitors is booming, Gatewood said. That's a relief for the town that survives on tourism. But that traffic is also a concern as the delta variant sparks new COVID surges nationwide.

"Now we're dealing with this pandemic of the unvaccinated," said Gatewood, before nodding toward the clinic. "This brings it back into the consciousness of folks, just makes them aware and, hopefully, maybe, minds are changing."

About a block from the COVID vaccine clinic, Adam Root, 41, said he hadn't known about the clinic but wouldn't have gone anyway. He hasn't liked the federal pressure to get vaccinated.

"I'm not vaccine-hesitant, it's just a hard 'no' for me," Root said. "I don't like being told what to do, for one thing, and, two, I believe health comes from how you take care of your body."

By the time Austin headed back to his campsite along the Madison River, he had vaccinated 20 people — adding five people who got first doses. He planned to return to give them their second shots and pick up any new takers.

He's already booked for much of the fall and expects to see an uptick as schools start.

In the meantime, Gatewood said, he can direct adults in Virginia City to the county's hospitals and families with teens to locations outside the county. Otherwise, he hopes he can get people to show up when Austin returns.

"I can't stab people myself," Gatewood said.

Katheryn Houghton: khoughton@kff.org, @K_Hought

'Tainted' Blood: COVID Skeptics Request Blood Transfusions From Unvaccinated Donors

KFF Health News, August 17, 2021

With nearly 60% of the eligible U.S. population fully vaccinated, most of the nation's blood supply is now coming from donors who have been inoculated.

This article was published on Tuesday, August 17, 2021 in Kaiser Health News.

By JoNel Aleccia

The nation's roiling tensions over vaccination against COVID-19 have spilled into an unexpected arena: lifesaving blood transfusions.

With nearly 60% of the eligible U.S. population fully vaccinated, most of the nation's blood supply is now coming from donors who have been inoculated, experts said. That's led some patients who are skeptical of the shots to demand transfusions only from the unvaccinated, an option blood centers insist is neither medically sound nor operationally feasible.

"We are definitely aware of patients who have refused blood products from vaccinated donors," said Dr. Julie Katz Karp, who directs the blood bank and transfusion medicine program at Thomas Jefferson University Hospitals in Philadelphia.

Emily Osment, an American Red Cross spokesperson, said her organization has fielded questions from clients worried that vaccinated blood would be "tainted," capable of transmitting components from the COVID vaccines. Red Cross officials said they've had to reassure clients that a COVID vaccine, which is injected into muscle or the layer of skin below, doesn't circulate in the blood.

"While the antibodies that are produced by the stimulated immune system in response to vaccination are found throughout the bloodstream, the actual vaccine components are not," Jessa Merrill, the Red Cross director of biomedical communications, said in an email.

So far, such demands have been rare, industry officials said. Dr. Louis Katz, chief medical officer for ImpactLife, an Iowa-based blood center, said he's heard from "a small handful" of patients asking for blood from unvaccinated donors. And the resounding answer from centers and hospitals, he added, has been "no."

"I know of no one who has acceded to such a request, which would be an operational can of worms for a medically unjustifiable request," Katz wrote in an email.

In practical terms, blood centers have only limited access to donated blood that has not in some way been affected by COVID. Based on samples, Katz estimated that as much as 60% to 70% of the blood currently being donated is coming from vaccinated donors. Overall, more than 90% of current donors have either been infected with COVID or vaccinated against it, said Dr. Michael Busch, director of the Vitalant Research Institute, who is monitoring antibody levels in samples from the U.S. blood supply.

"Less than 10% of the blood we collect does not have antibodies," Busch noted.

In addition, outside of research studies, blood centers in the U.S. don't retain data noting whether donors have been infected with or vaccinated against COVID, and there's no federal requirement that collected blood products be identified in that manner.

"The Food and Drug Administration has determined there's no safety risk, so there's no reason to label the units," said Dr. Claudia Cohn, chief medical officer for AABB, a nonprofit focused on transfusion medicine and cellular therapies.

Indeed, the FDA does not recommend routine screening of blood donors for COVID. Respiratory viruses, in general, aren't known to spread by blood transfusion and, worldwide, there have been no reported cases of SARS-CoV-2, the virus that causes the disease, being transmitted via blood. One study identified the risk as "negligible."

All donors are supposed to be healthy when they give blood and answer basic questions about potential risks. Collected units of blood are tested for transmissible infectious diseases before they're distributed to hospitals.

But that hasn't quelled concerns for some people skeptical of COVID vaccines.

In Bedford, Texas, the father of a boy scheduled for surgery recently asked that his son get blood exclusively from unvaccinated donors, said Dr. Geeta Paranjape, medical director at Carter BloodCare. Separately, a young mother fretted about transfusions from vaccinated donors to her newborn.

Many patients expressing concerns have been influenced by rampant misinformation about vaccines and the blood supply, said Paranjape. "A lot of people think there's some kind of microchip or they're going to be cloned," she said.

Other patients have balked at getting blood from people previously infected with COVID, even though federal guidance greenlights donations two weeks after a positive test or the last symptom fades.

Last month, a woman facing a cesarean section for a high-risk pregnancy said she didn't want blood from a donor who had had COVID, recalled Cohn with AABB. "I said, 'Listen, the alternative is you don't get the blood and that's what will affect you,'" Cohn said.

Some industry experts were hesitant to discuss the vaccine-free blood requests, for fear it would fuel more such demands. But Cohn and others said correcting widely spread misinformation outweighed the risk.

Patients are free to refuse transfusions for any reason, industry officials said. But in dire situations — trauma, emergency surgery — saving lives often requires using the available blood. For patients with chronic conditions requiring transfusion, alternative treatments such as medication or certain equipment may not be as efficient or effective.

People who require transfusions also may donate their own blood in advance or request donations from designated friends and family members. But there's no evidence that the blood is safer when patients select donors than that provided by the volunteer blood system, according to the Red Cross.

Earlier in the pandemic, many blood donations were tested to see whether they contained antibodies to the COVID virus. The hope was that blood from previously infected people who had recovered from COVID could be used to treat those who were very sick with the disease. Tens of thousands of patients were treated with so-called convalescent plasma under a Mayo Clinic-led program and through authorization from the FDA.

But the much-hyped use of convalescent plasma largely fell flat after studies showed no clear-cut benefits for the broad swath of COVID patients. (Research continues into the potential benefits of treating narrowly targeted patient groups with high-potency plasma.) Most hospitals stopped testing blood and labeling units with high levels of antibodies this spring, said Busch. "It's really no longer a germane issue because we're not testing anymore," he said. "There's no way we can inform recipients."

Busch stressed that the studies also have shown no harm associated with infusing antibody-containing blood plasma into COVID patients.

Past health crises have raised similar concerns about sources of donor blood. In the mid-1980s, recipients scared by the AIDS epidemic didn't want blood donated from cities such as San Francisco with large gay populations, Busch recalled. Even now, some recipients demand not to receive blood from people of certain races or ethnicities.

Such requests, like those for vaccine-free blood, have no medical or scientific basis and are soundly refused, blood center officials said.

The most pressing issue for blood centers remains the ongoing shortage of willing donors. As of the second week of August, the national blood supply was down to two days' worth or less at a third of sites affiliated with America's Blood Centers. That can limit the blood available for trauma victims, surgery patients and others who rely on transfusions to survive.

"If for some reason we didn't want vaccinated people to donate blood, we'd be in a real problem, wouldn't we?" Karp said. "Please believe us when we tell you it's fine."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

'I Don't Want to Risk My Life for a Paycheck': Immunosuppressed People Grapple With Returning to Work

KFF Health News, August 16, 2021

Research shows that those who are immunosuppressed are at higher risk of becoming severely ill from COVID.

This article was published on Friday, August 13, 2021 in Kaiser Health News.

By Victoria Knight  

Elizabeth Groenweghe got a kidney transplant 14 years ago. She now takes several medications to prevent her body from rejecting her transplant organ. But these medications also weaken her immune system, putting her at higher risk of becoming seriously ill if she catches COVID-19.

When the pandemic began last year, Groenweghe, 29, worked from home for the first month and a half. But then in May 2020, as the chief epidemiologist for the public health department in Wyandotte County, Kansas, she returned to the office.

"Obviously, I was nervous about it because I'm so immunosuppressed," said Groenweghe.

She felt relatively safe because her co-workers wore masks and strictly followed infection control protocols. But now that vaccinations have become widely available, her workplace has stopped requiring or enforcing mask use. There is no vaccine mandate for her office, and she knows some co-workers are unvaccinated. She feels uncomfortable working around them.

"I am debating putting a sign on my door that says 'Please do not enter if you are unvaccinated,' because I am really concerned about getting COVID … and have even had a couple co-workers test positive recently," said Groenweghe.

"Knowing that I don't have any protection against COVID, I'm still wearing a mask and I'm trying to avoid in-person meetings," she added. "It has been frustrating because, at home, my bubble of protection is great; all of my family and friends are vaccinated. At work I don't have as much control."Bottom of Form

While the emergence of the delta variant in the U.S. has made many companies delay the return to in-person work or mandate vaccinations, in other offices, immunosuppressed people like Groenweghe are left to cobble together their own strategies to minimize their risks. The delta variant raises the stakes for many who were already concerned about catching COVID when they return. Those who have the option to keep working remotely have done so — but worry about what it means for their careers as their colleagues return to the workplace.

Research showing how well vaccines protect those with weakened immune systems is limited. In part that's because immunosuppressed people, who make up at least 3% of the U.S. population and include people with cancer, HIV and many chronic health conditions, were not included in the original clinical trials for the three COVID vaccines authorized for emergency use.

Scientists didn't include them because they needed to conduct the clinical trials quickly and were concerned that this group's immunosuppressive medicines and increased likelihood of developing infections in general would complicate interpreting the study results.

Research does show that those who are immunosuppressed are at higher risk of becoming severely ill from COVID, passing the virus to others in their household and getting infected even if vaccinated. A recent study reported that 44% of hospitalized "breakthrough" cases in the U.S. were in immunosuppressed people.

Concerns about her elevated COVID risk led Groenweghe to obtain a third dose of the Moderna vaccine on her own — and participate in a Johns Hopkins University research study that involved measuring transplant recipients' immune response to an extra vaccine dose. Hopkins recently told her she hadn't produced any antibodies.

But, while the third dose might not have helped Groenweghe, early research shows that a booster shot seems to strengthen the immune response for some with weakened immune systems. Israel began distributing additional doses to the immunosuppressed in July. Britain and France have said they plan to start distributing booster doses to high-risk groups in September. However, the World Health Organization recently called for a moratorium on booster shots until more vaccine could be distributed globally to countries with low vaccination rates.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a July Senate hearing that immunosuppressed people "may actually need a boost as part of their initial regimen in the sense of getting them up to the point where they are protected."

And soon, third doses may indeed become part of the regimen. The Food and Drug Administration reportedly is closing in on amending the emergency use authorization requests for the Pfizer-BioNTech and Moderna vaccines to allow third doses of those shots to be given to those with weakened immune systems. The vaccine advisory committee of the Centers for Disease Control and Prevention was set to meet Friday and is expected to vote on whether to officially recommend that doctors can prescribe third doses to immunocompromised people. Still, federal officials said these third doses would be recommended only for a small number of immunocompromised people, and it's not yet clear who will be included.

Well in advance of this green light, patients were asking their doctors about additional shots.

Andrew Clifford is one such patient. (KHN is identifying him by his first and middle names because he fears retaliation from his workplace.) Andrew, a marketing manager from Missouri, is working from home indefinitely and worries about what he might be missing. The 40-year-old has multiple sclerosis and takes immunosuppressive medication.

"The fear of missing out is a tremendous anxiety," he said. Recently his entire team went back to the office for two weeks to meet with an outside agency. While Andrew was able to go in for two days, he could tell he had missed out on things on the days he stayed home.

"I missed out on the lunchtime convos. When I did show up in the Zoom meetings, I was playing a lot of catch-up," he said. "I was trying to figure out who I was actually talking to and what they did."

Some patients, such as transplant recipient Elyse Thomas, aren't waiting for new guidance from the U.S. government. (KHN is identifying her by her middle and last names because she is worried about pushback from her employer.) Instead, Elyse, a 30-year-old social worker for a high school district in the Bay Area of California, pursued third and fourth doses of a COVID vaccine on her own since her school district had staff members return in person in early August.

"Some of us transplant patients have had to take matters into our own hands," Thomas said. "We can't wait for the recommendation while we could be dying."

She asked for an accommodation to continue working remotely during the 2021-22 school year, as she did the year before, but was told all employees must return. Thomas was offered the option to take medical leave without pay if she didn't want to come into the office, but that would strain her finances. Her workplace does have a mask mandate, but she's not sure physical distancing will be enforced and she's even more anxious now that the delta variant is circulating.

"I don't feel safe and I don't understand why I have to be there in person," Thomas said. "I don't want to risk my transplant for a paycheck. I don't want to risk my life for a paycheck."

Victoria Knight: vknight@kff.org, @victoriaregisk

In Rural America, Twisting Arms to Take a COVID Vaccine First Takes Trust

KFF Health News, August 16, 2021

Vaccine apathy is common in much of rural America, where infection rates remained low until recently.

This article was published on Monday, August 16, 2021 in Kaiser Health News.

By Cara Anthony   

CAIRO, Ill. — Lee Wright was hard at work, constructing a nail salon near the city's abandoned hospital, when Jody Johnson stopped by to introduce himself on a recent afternoon.

Johnson, who works for the University of Illinois Extension program, chatted with Wright casually in the summertime heat. For Johnson, it was the first step to building trust in this city of fewer than 2,200 people as extension programs across the U.S — long valued in many rural communities for helping farmers and supporting 4-H clubs — expand their service to include educating the public about COVID-19 vaccines.

Wright, 68, was unvaccinated and planned to remain so, even though he'd followed other public health guidelines during the pandemic. When it came to getting the shots, he decided to leave his fate to his faith.

"Doctors are good. Don't get me wrong," Wright said. "But we got to have something that we can really depend on."

Johnson didn't talk to Wright about the vaccines that day. He just listened instead. "No one wants to feel ashamed or belittled because they're not doing something," Johnson said later.

Only 16% of residents here in Alexander County are fully vaccinated against COVID-19, the lowest rate in Illinois, according to the state health department. And case counts of coronavirus infections are rising. So the Cooperative Extension System, which is tied to a network of land-grant universities, plans to spend the next two years talking about vaccines in this community and elsewhere. It may take that long or more to persuade enough people to get vaccinated.

The extension system has a tradition of bringing research-based information to communities on a wide variety of topics, including water quality, food safety and disaster preparedness. With its roots sunk deep in rural America, where vaccines have been slow to catch on, the system is now using state and federal funding to pay for immunization education efforts tailored to specific communities.Bottom of Form

Already 4-H clubs have been making masks and face shields. In Illinois, the agency has a COVID resource guide for families, business owners and farmers. The office covering the southern portion of the state is now looking to hire someone in the community to help get out the word on why vaccinations matter. Johnson also wants to team up with local churches, civic groups and business owners to get the job done.

"This is not our first global pandemic," said Carissa Nelson, a spokesperson for 4-H programs in Illinois. The organization's agents and club members nursed patients during the 1918 flu pandemic that devastated the world.

This time around, the extension service's strategy could also help in these rural communities and the urban areas it serves. But local leaders say there's no quick solution for improving vaccination rates in Cairo or across the country. Getting people vaccinated is a nuanced challenge in every community. In Cairo, a long history of racial tension dating to the Civil War still stings. Like many rural towns across the U.S., the community also feels underappreciated and misunderstood.

Vaccine apathy is common here, where infection rates remained low until recently.

"We haven't had great turnouts," said Tyrone Coleman, president and co-founder of the Alexander and Pulaski NAACP chapter, which has helped organize vaccine clinics in Cairo.

In June, he invited the health department to the city's Juneteenth celebration at St. Mary's Park. More than 300 people attended. But the event's pop-up clinic hosted by the state didn't have many seeking vaccinations during its six hours of operation.

"We only had two," Coleman said.

More than 15,000 people lived in Cairo in the early 20th century, helping it earn the nicknames "Little Chicago" and "the Gateway to the South." Old factories, antebellum homes, an ornate library and a vacant hospital remain as reminders of the city's majestic past. The city's library prominently displays the work of Samuel Clemens, the American writer best known as Mark Twain. After traveling through Cairo, Twain wrote about the city in his 1884 novel "The Adventures of Huckleberry Finn."

In the novel, Cairo represents freedom and the chance for a better life.

But the hospital shut down in 1987. The only grocery store in town closed years ago, public housing was torn down in recent years, and the only nursing home closed during the pandemic, forcing residents to find a new place to live without much notice. On top of all that, flooding has threatened to wipe the city out more than once.

Today, fewer than 2,200 people, the majority of them Black, live here. And locals say the population has continued to drop with all the closures. The city is often mislabeled by the press and travel guides as abandoned.

"Cairo is not a ghost town," said Ronnie Woods, a local pastor and retired schoolteacher. "It's not dead at all."

Tourists still stop by to see the confluence of the Mississippi and Ohio rivers. But they don't typically see the rocky riverbank where residents fish for their dinner. Beverly Davis, 60, heads there often with rod in hand and gives much of her catch away to other members of the community. The scenic waterfront, though, is carpeted with driftwood and dead fish that washed ashore.

"I guess it's meant to be like this," Davis said, standing on the riverbanks among the fish carcasses. "'Cause if not, it would be better."

But many residents continue to believe their city will return to its past glory. "The world hears that this is a negative part of the country, and it's not," Johnson said. "We've got too many good things and people here."

On this day, the only outdoor basketball court in the city, anchored by a single hoop, was busy in a rural community that was fighting to stay alive long before the pandemic hit. The men on the court didn't seem worried about catching COVID.

"I haven't had COVID, so I feel like I don't need to get vaccinated right now," said Jeffery DeWitt, 24. "I'll just take it as it goes."

Wright's son, Roman Wright, 36, said much the same thing while helping his dad build the nail salon across town. He works for the prison system, and one of its facilities nearby reported COVID cases. But he hadn't contracted the disease. Like his father, he said he didn't plan on getting the shots.

"I'm like my dad," Roman Wright said. "I was born and raised in church all my life. So I say we believe in God. I know my parents pray for me. We pray for each other and we just believe in God."

Woods, the pastor, has a different point of view. He keeps his vaccination card in a plastic sheath and carries it with him wherever he goes.

"I have strong faith," said Woods, 66. "And at my age, my risk factors, I just felt that God placed science there to help us."

But Woods said it's going to take work to persuade others in Cairo to get vaccinated, even if they know someone who died of COVID. A prominent doctor was among the dead in the community. "It's going to take more than explaining, it is going to take a cultural shift because people are just not trusting," he said.

That's one reason Johnson is searching for a local voice to lead the extension service's vaccine education program over the next year. As a 51-year-old white man who grew up in a predominantly white community 45 miles outside of Cairo, he recognizes that local residents would be more likely to share their thoughts with someone who lives here. Plus, he spends most of his time talking with community leaders and public officials. He is searching for someone who will spend time with locals who don't hold titles and positions.

"Everybody doesn't think like me," Johnson said. "So we need to take that into consideration."

Cara Anthony: canthony@kff.org, @CaraRAnthony

The Newest Disease Detection Tool for COVID and Beyond: Poop

KFF Health News, August 16, 2021

From Fresno, California, to Portland, Maine, universities, communities and businesses are monitoring human excrement for signs of COVID.

This article was published on Monday, August 16, 2021 in Kaiser Health News.

By Anna Maria Barry-Jester

Since reopening campus at the University of California-San Diego last summer, university officials have relied on the tried-and-true public health strategies of testing and contact tracing. But they have also added a new tool to their arsenal: excrement.

That tool alerted researchers to about 85% of cases in dorms before they were diagnosed, according to a soon-to-be published study, said Rob Knight, a professor of pediatrics and computer science and engineering who helped create the campus's wastewater testing program.

When COVID is detected in sewage, students, staffers and faculty members are tested, which has allowed the school to identify and isolate infected individuals who aren't yet showing symptoms — potentially stopping outbreaks in their tracks.

UC-San Diego's testing program is among hundreds of efforts around California and the nation to turn waste into valuable health data. From Fresno, California, to Portland, Maine, universities, communities and businesses are monitoring human excrement for signs of COVID.

Researchers have high hopes for this sludgy new data stream, which they say can alert public health officials to trends in infections and doesn't depend on individuals getting tested. And because people excrete virus in feces before they show symptoms, it can serve as an early warning system for outbreaks.

The Centers for Disease Control and Prevention finds the practice so promising that it has created a federal database of wastewater samples, transforming raw data into valuable information for local health departments. The program is essentially creating a public health tool in real time, experts say, one that could have a range of uses beyond the current global pandemic, including tracking other infectious diseases and germs' resistance to antibiotics.

"We think this can really provide valuable data, not just for COVID, but for a lot of diseases," said Amy Kirby, a microbiologist leading the CDC effort.

The virus that causes COVID infects many types of cells in the body, including those in the respiratory tract and gut. The virus's genetic signature, viral RNA, makes its way into feces, and typically shows up in poop days before symptoms start.

At UC-San Diego and other campuses, researchers take samples flowing from individual buildings, capturing such granular data that they can often deduce the number of infected people living or working there. But in most other settings, because of privacy concerns and resource constraints, testing is done on a much larger scale, with the goal of tracking trends over time.

Samples are drawn from wastewater, which is what comes out of our sewer pipes, or sludge, the solids that have settled out of the wastewater. They are typically extracted mechanically or by a human with a dipper on the end of a rod.

When researchers in Davis, California, saw the viral load rise in several neighborhood sewage streams in July, they sent out text message alerts and hung signs on the doors of 3,000 homes recommending that people get tested.

Before the pandemic, testing sewage to identify and ward off illness in the U.S. was largely limited to academic use. Israel used it to stave off a polio outbreak in 2013, and some communities in the U.S. were sampling sewage before the pandemic to figure out what kinds of opioids people in their communities were using, a service offered by the company Biobot.

But when COVID hit the U.S. amid political chaos and a shortage of tests, local governments scrambled for any information they could get on the virus.

In rural Lake County, California, health officials had identified a handful of cases by sending nurses out to look for infected people. They were sure there were more but couldn't get their hands on tests to prove it, so in spring 2020 they signed up for a free sewage testing program run by Biobot, which pivoted to COVID testing as the pandemic took off and now is charging to test in K-12 schools, office buildings and nursing homes, in addition to local governments and universities, said Mariana Matus, CEO and co-founder of the company.

The COVID virus turned up in samples at four wastewater treatment facilities in Lake County.

"It is a way to just get more information because we can't do testing," Gary Pace, then the county's health officer, told KHN at the time.

As sewage sampling took off around the world, the U.S. Department of Health and Human Services began awarding grants in fall 2020 to wastewater treatment plants. Biobot won a bid to run a second round of that program, currently underway through late August, testing the sewage of up to 30% of the U.S. population.

At least 25 California wastewater treatment plants are participating in the program, and numerous others are getting money from the CDC, working with local universities or paying for their own testing. While such states as Ohio and Missouri have created public dashboards to show their data, California's efforts remain scattershot.

The test data alone doesn't provide much value to health officials — it needs to be translated to be useful. Scientists are still learning how to read the data, a complicated process that involves understanding the relationships between how much virus people excrete, how many people are using a wastewater system and how much rainwater is running into the system, potentially diluting the sewage, among many other factors. Since using wastewater to track diseases was not widespread before the pandemic, there's been a steep and ongoing learning curve.

Beleaguered public health officials have struggled to incorporate the new data into their already overwhelming workloads, but the CDC hopes it can address those issues with its new national system that tracks and translates wastewater data for local governments.

Throughout 2020, Kirby, the CDC microbiologist, and engineer Mia Mattioli were a two-person wastewater team inside the agency's larger 7,000-person COVID response. During that time, academic colleagues generously shared what they knew about wastewater epidemiology, Kirby said. By September 2020, the pair had launched the National Wastewater Surveillance System, which interprets sampling data for state and local governments. Today, they lead a team of six and have a permanent place in one of the CDC's departments.

"Every piece of this system had to be built largely from scratch," Kirby said. "When I look at that, it really amazes me where we are now."

In the months since the system debuted, it has been able to detect an uptick in cases anywhere from four to six days before diagnostic testing shows an increase, Kirby said.

She hopes that by the end of next year the federal monitoring program will be used to check for a range of diseases, including E. coli, salmonella, norovirus and a deadly drug-resistant fungus called Candida auris, which has become a global threat and wreaked havoc in hospitals and nursing homes.

The longer these programs are up and running, the more useful they become, said Colleen Naughton, a professor and civil engineer at the University of California-Merced who leads COVIDPoops19, which tracks wastewater monitoring efforts globally. Naughton is working with colleagues at the University of California-Davis to launch monitoring programs near where she works in the Central Valley but is finding that some smaller communities don't have the resources to conduct testing or sufficient health personnel to analyze or use the data.

It's in these smaller communities with limited access to testing and doctors where the practice may hold the most promise, Naughton said. COVID laid bare long-standing inequities among communities that she fears will be perpetuated by the use of this new public health tool.

Privacy concerns also need to be addressed, experts said. Wastewater data hasn't traditionally been considered protected personal health information the way diagnostic tests are. Health officials have managed earlier concerns about wastewater tracking of illicit drug use by sampling from large enough sewage streams to offer anonymity. But testing for certain health problems requires looking at DNA. "I think that's going to be a challenge for public communication," Knight said, "to make sure that's not perceived as essentially spying on every individual's genetic secrets."

Public health and wastewater officials said they are thrilled by the potential of this new tool and are working on ways to address privacy concerns while taking advantage of it. Greg Kester, director of renewable resource programs at the California Association of Sanitation Agencies, wrote to CDC officials in June 2020 asking for a federal surveillance network. He can hardly believe how quickly that call became a reality. And he hopes it is here to stay, both for the ongoing pandemic and for the inevitable next outbreak.

"As vaccination rates increase and we get the variants, it's still going to be important because clinical testing is decreasing," Kester said. "We really want to make this part of the infrastructure."

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

Anna Maria Barry-Jester: annab@kff.org, @annabarryjester

 

Pfizer CEO to Public: Just Trust Us on the COVID Booster

KFF Health News, August 13, 2021

Pfizer has not yet delivered conclusive proof to back up that confidence.

This article was published on Friday, August 13, 2021 in Kaiser Health News.

By Sarah Jane Tribble   

Pfizer CEO Albert Bourla was confident in June about the ability of his company's vaccine to protect against the highly contagious delta variant, as it marched across the globe and filled U.S. hospitals with patients.

"I feel quite comfortable that we cover it," Bourla said.

Just weeks later, Pfizer said it would seek authorization for a booster shot, after early trial results showed a third dose potentially increased protection. At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose, their vaccine's efficacy dropped to about 84%.

Bourla was quick to promote a third dose after the discouraging news, saying he was "very, very confident" that a booster would increase immunity levels in the vaccinated.

There's one hitch: Pfizer has not yet delivered conclusive proof to back up that confidence. The company lacks late-stage clinical trial results to confirm a booster will work against COVID variants including delta, which now accounts for 93% of new infections across the U.S.

Pfizer announced its global phase 3 trial on a third dose in mid-July. That trial's completion date is in 2022. Phase 3 results generally are required before regulatory approval.

"We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that," Jerica Pitts, Pfizer's director of global media relations, said Monday. The financial stakes are enormous: Pfizer announced in July that it expects $33.5 billion in COVID-19 vaccine revenue this year.

Meanwhile, Pfizer recently said that if a third dose couldn't combat the delta or other variants, the drugmaker is poised to come up with a "tailor-made" vaccine within 100 days.

All of this has sown a sense of confusion about what exactly will work, and when. The pharmaceutical industry's rush to recommend boosters for the public is "a little frustrating," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and an adviser to the National Institutes of Health and Food and Drug Administration. Even if a booster is found to be safe, he said, the U.S. effort should focus on "vaccinating people who are unvaccinated."

In any case, decisions about boosters do not rest with vaccine makers, he said.

"Pharmaceutical companies aren't public health agencies, it's really not theirs to determine when or whether there should be booster dosing," Offit said. "That is the purview of the CDC."

Indeed, the Centers for Disease Control and Prevention and the FDA ― the federal agencies overseeing the authorization of COVID vaccines ― said in July that fully vaccinated Americans do not need a booster shot. Currently authorized vaccines ― from Pfizer, Moderna and Johnson & Johnson ― are working as they should: All three lower the risk of COVID severe enough to hospitalize or kill a person.

If hospitalization and death rates increase among the vaccinated, then it would be time to talk about boosters, Offit said, but "we're not there, yet."

The White House has added to the mixed messaging: Spokesperson Jan Psaki confirmed that the U.S. will buy an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

Natalie Dean, a biostatistician at Emory University in Atlanta, said the confusion is not necessarily the fault of any one institution but rather "there is genuine scientific uncertainty about how well [existing] vaccines work against the new variant."

Scientists are piecing together information from observational studies, outbreak investigations and analyses of antibody responses.

For many Americans ― especially those who struggled six months ago to find any dose, frantically hiring vaccine hunters and driving hours-long distances for their first jab ― the confusion has set off a feverish search for an illicit third dose just in case it's necessary.

"I snuck in a dose of Pfizer last week," Angie Melton, a 50-year-old mother of four, shared on Facebook. Melton received the one-dose Johnson & Johnson shot at a mass vaccination site in April and feared the highly contagious delta variant could infect her and, then, her unvaccinated 10-year-old son, who has asthma.

After consulting friends and doctors and seeing reports about mix-and-match approaches in Europe, Melton signed onto a local pharmacy site and made an appointment to get a Pfizer shot. She's scheduled for a second shot as well.

"I'm trying to keep my family safe," Melton said.

The CDC advisory panel was set to meet Friday to consider updates on whether additional vaccine doses are necessary for immunocompromised people. A presentation about boosters is also on the agenda.

Immunocompromised patients like Sarah Keitt, who has multiple sclerosis and Crohn's disease, expressed relief that federal regulators planned to recommend a third dose. Keitt, a disability rights activist who lives in Connecticut, said her neurologist told her to get a booster even after she had received two doses of Moderna. On Thursday, she said she was eager to get another dose but still frustrated about a lack of confidence in how much protection it would offer.

"If someone could definitely say there is a 95% chance you are protected" by a booster, Keitt said, "I would love it."

Despite widespread media reports of "breakthrough cases," a recent data analysis by KFF found that hospitalizations and deaths are extremely rare among the fully vaccinated ― well below 1%.

Offit points to a recent outbreak in Provincetown, Massachusetts, in which only four of the 346 fully vaccinated people infected with COVID were hospitalized, two of whom had underlying medical conditions. And no one died. "This vaccine still does an excellent job in the face of the delta variant at protecting people against severe, critical disease," he said.

Yet the effectiveness of the Pfizer vaccine against variants is still under debate. This month a new preprint study by the Mayo Clinic found that the product's effectiveness against infection dropped to 42% from January to July ― as the delta variant's prevalence markedly increased.

Pfizer and partner BioNTech announced they are developing an updated version of their vaccine in Germany to target the genomic features of the delta variant.

However, the idea that a new formulation could work better is "mostly hypothetical at this point," said Vaughn Cooper, a professor of microbiology and molecular genetics at the University of Pittsburgh.

Dr. Vincent Rajkumar, a hematologist at the Mayo Clinic who closely studies his patients' immune responses and antibody levels, said trying both strategies of using the current vaccine and testing a new version sounds reasonable.

There is one hypothesis that if "breakthrough" infections are due to a drop in antibody levels, boosting those levels will be enough, Rajkumar said. But the more worrisome hypothesis is that the delta variant, or any other variant, might respond considerably differently ― and be less threatened ― by the antibodies the current vaccine generates.

"So unless you boost [antibodies] with a vaccine that is specific to delta, it won't work," Rajkumar said. Rajkumar said testing both hypotheses is the "right thing to do in the interest of time."

At the same time, though, the push for giving booster shots to healthy populations is premature, said Dr. Sadiya Khan, an epidemiologist and cardiologist at Northwestern University Feinberg School of Medicine. That's because even if those already fully vaccinated do get a third dose or booster, the virus is still circulating among millions of unvaccinated people.

"The overwhelming majority of infections and hospitalizations and deaths are occurring among those who are unvaccinated," Khan said.

"Giving up on that greater strategy of vaccinating the population is going to lead to continued surges," she said. "The potential for harm is quite large."

KHN editor Arthur Allen contributed to this report.

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

Veterans Push for Medical Marijuana in Conservative South

KFF Health News, August 13, 2021

From California to Massachusetts, veterans have been active in the push for medical marijuana legalization for decades.

This article was published on Friday, August 13, 2021 in Kaiser Health News.

By Aneri Pattani

RALEIGH, N.C. — Each time Chayse Roth drives home to North Carolina, he notices the highway welcome signs that declare: "Nation's Most Military Friendly State."

"That's a powerful thing to claim," said Roth, a former Marine Corps gunnery sergeant who served multiple deployments to Iraq, Afghanistan and Pakistan.

Now he says he's calling on the state to live up to those words. A Wilmington resident, Roth is advocating for lawmakers to pass a bill that would legalize medical marijuana and allow veterans with post-traumatic stress disorder and other debilitating conditions to use it for treatment.

"I've lost more men to suicide since we went to Afghanistan in '01 than I have in combat," said Roth, who said he doesn't use cannabis himself but wants others to have the option. "It's just unacceptable for these guys to go overseas and win the battle and come home and lose the battle to themselves."

He is among several veterans brought together by a recently formed advocacy group called NC Families for Medical Cannabis. These veterans have testified before the legislature and visited lawmakers individually.

In a state that's home to eight military bases, one of the largest veteran populations in the country and a Republican-controlled legislature that prides itself on supporting the troops, they hope their voices will act as a crucial lever to push through a bill that has faced opposition in the past.

"If we really want to be the most veteran-friendly state in the union, this is just another thing we can do to solidify that statement," Roth said.

From California to Massachusetts, veterans have been active in the push for medical marijuana legalization for decades. But now, as the movement focuses on the remaining 14 states that have not enacted comprehensive medical marijuana programs or full marijuana legalization, their voices may have outsize influence, experts say.

Many of these remaining states are in the traditionally conservative South and dominated by Republican legislatures. "The group carrying the message here makes a huge difference," said Julius Hobson Jr., a former lobbyist for the American Medical Association who now teaches lobbying at George Washington University. "When you've got veterans coming in advocating for that, and they're considered to be a more conservative bunch of folks, that has more impact."

Veterans also have the power of numbers in many of these states, Hobson said. "That's what gives them clout."

Successes are already evident. In Texas and Louisiana, veterans played a key role in the recent expansion of medical marijuana programs. In Mississippi, they supported a successful ballot initiative for medical cannabis in 2020, though the result was later overturned by the state Supreme Court. And in Alabama, the case of an out-of-state veteran arrested and jailed for possession of medical marijuana incited national outrage and calls for legalization. The state legalized medical marijuana earlier this year.

To be sure, not every veteran supports these efforts, and the developments in red states have been influenced by other factors: advocacy from cancer patients and parents whose children have epilepsy, lawmakers who see this as a states' rights issue, a search for alternative pain relief amid the opioid epidemic and a push from industries seeking economic gains.

But the attention to the addiction and suicide epidemics among veterans, and calls to give them more treatment options, are also powerful forces.

In states like North Carolina, where statewide ballot initiatives are banned, veterans can kick-start a conversation with lawmakers who hold the power to make change, said Garrett Perdue, the son of former North Carolina Gov. Beverly Perdue and a spokesperson for NC Families for Medical Cannabis and CEO of Root Bioscience, a company that makes hemp products.

"It fits right in with the general assembly's historical support of those communities," Perdue said. "For [lawmakers] to hear stories of those people that are trusted to protect us and enforce the right of law" and see them as advocates for this policy "is pretty compelling."

Gary Hess, a Marine Corps veteran from Louisiana, said he first realized the power of his platform in 2019, when he testified in front of the state legislature about seeing friends decapitated by explosions, reliving the trauma day-to-day, taking a cocktail of prescription medications that did little to help his symptoms and finally finding relief with cannabis. His story resonated with lawmakers who had served in the military themselves, Hess said.

He recalled one former colonel serving in the Louisiana House telling him: "They're not going to say no to a veteran because of the crisis you're all in. As someone who is put together well and can tell the story of marijuana's efficacy, you have a powerful platform."

Hess has since started his own nonprofit to advocate for medical marijuana legalization and has traveled to other state and national events, including hearings before the North Carolina legislature.

"Once I saw the power my story had," he said, "the goal became: How do I expedite this process for others?"

Experts trace the push for medical marijuana legalization back to the AIDS epidemic of the 1980s and '90s, particularly in California's Bay Area.

As the movement tried to expand, medical marijuana activists realized other regions were not as sympathetic to the LGBTQ community, said Lee Hannah, an associate professor of political science at Wright State University who is writing a book about the rise of legal marijuana in the U.S. They had to find "more target populations that evoke sympathy, understanding and support," Hannah said.

Over time, the medical marijuana conversation grew from providing symptom relief for patients with AIDS to include such conditions as cancer, pediatric epilepsy and PTSD, Hannah and his colleagues noted in a 2020 research paper. With each condition added, the movement gained wider appeal.

"It helped change the view of who a marijuana user is," said Daniel Mallinson, a co-author on the 2020 paper and the upcoming book with Hannah, and an assistant professor at the Penn State-Harrisburg School of Public Affairs. "That makes it more palatable in these legislatures where it wouldn't have been before."

In 2009, New Mexico became the first state to make PTSD patients eligible for medical marijuana. The condition has since been included in most state medical marijuana programs.

The movement got another boost in 2016 when the American Legion, a veterans organization with 1.8 million members known for its conservative politics, urged Congress to remove marijuana from its list of prohibited drugs and allow research into its medical uses.

"I think knowing an organization like the American Legion supports it frankly gives [lawmakers] a little bit of political cover to do something that they may have all along supported but had concerns about voter reaction," said Lawrence Montreuil, the group's legislative director.

In Texas, when the Republican governor recently approved a law expanding the state's limited medical marijuana program, he tweeted: "Veterans could qualify for medical marijuana under new law. I will sign it."

It's smart political messaging, Hannah said. Elected officials "are always looking to paint laws they support in the most positive light, and the approval rate of veterans is universally high."

Nationally, veteran-related marijuana bills seem to be among the few cannabis-related reforms that have gained bipartisan support. Bills with Democratic and Republican co-sponsors in Congress this session deal with promoting research into medical marijuana treatment for veterans, allowing Veterans Affairs doctors to discuss cannabis with patients in states where it is legal and protecting veterans from federal penalization for using state-legalized cannabis.

Rep. Dave Joyce (R-Ohio), who has co-sponsored two bipartisan bills concerning veterans and medical marijuana this session, said the interest of veterans is "what drew me to cannabis in the first place."

In North Carolina, veterans like Roth and Hess, along with various advocacy groups, continue to drum up support for the medical marijuana bill. They know it's a long battle. The bill must clear several Senate committees, a full Senate vote and then repeat the process in the House. But Roth said he's optimistic "the veteran aspect of it will be heavily considered by lawmakers."

An early indication of that came at a Senate committee hearing earlier this summer. Standing at the podium, Roth scrolled through his phone to show lawmakers how many of his veteran contacts were now dead due to suicide. Other veterans testified about the times they had contemplated suicide and how the dozens of prescription medications they had tried before cannabis had done little to quiet those thoughts.

The hearing room was silent as each person spoke. At the end, the lawmakers stood and gave a round of applause "for those veterans who are with us today and those who are not."

The bill later passed that committee with a nearly unanimous vote.

Aneri Pattani: apattani@kff.org, @aneripattani

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