Biden's No-Jab-No-Job Order Creates Quandary for Nursing Homes

KFF Health News, August 20, 2021

Although 83% of residents in the average nursing facility are vaccinated, only 61% of a home's workers are likely to be.

This article was published on Friday, August 20, 2021 in Kaiser Health News.

By Jordan Rau and Andy Miller  

President Joe Biden's edict that nursing homes must ensure their workers are vaccinated against COVID-19 presents a challenge for an industry struggling to entice its lowest-paid workers to get shots without driving them to seek employment elsewhere.

Although 83% of residents in the average nursing facility are vaccinated, only 61% of a home's workers are likely to be, according to data submitted by homes and published by the Centers for Medicare & Medicaid Services as of the week ending Aug. 8. More than 602,000 staff members have contracted COVID and more than 2,000 have died from it.

That led Biden to declare Wednesday that the government would require employee vaccinations as a condition for nursing homes to receive Medicare and Medicaid reimbursements, which account for most of the industry's income.

"More than 130,000 residents in nursing homes have, sadly, over the period of this virus, passed away," Biden told reporters. "At the same time, vaccination rates among nursing home staff significantly trail the rest of the country."

Nursing homes in Florida and Louisiana have the lowest average staff vaccination rates among states, with 46% of workers in a facility fully vaccinated. Rates are highest in Hawaii, with an average of 87% of workers vaccinated by facility, and California, with 81% vaccinated on average, the data shows.

The American Healthcare Association, a nursing home lobby, said it appreciated the order but that the mandate should apply to other healthcare providers as well so that workers who refuse vaccination won't have a reason to change jobs within the industry.

"Focusing only on nursing homes will cause vaccine hesitant workers to flee to other healthcare providers and leave many centers without adequate staff to care for residents," Mark Parkinson, president and CEO of the association, said in a statement. "It will make an already difficult workforce shortage even worse."

David Grabowski, a professor of healthcare policy at Harvard Medical School, said that, because many nursing home aides are paid only the minimum wage or slightly higher, they would be more likely to seek out work at retail establishments. "The risk isn't that they go to the hospital down the street — the risk is they go to Starbucks or Target," he said in an interview. "It's great if you want to mandate the vaccine, but you also want to make sure these workers are making a living wage.

Jon Green, CEO of Pinewood Manor Nursing and Rehabilitation in rural Hawkinsville, Georgia, said the "vaccines are necessary for control of the virus," but "if we would have mandated it ourselves, it would have caused [many workers] to leave.'' His facility, which is a nonprofit home, has about 85 employees.

Just over half of nursing home workers in Georgia, on average, are vaccinated.

Some facilities have already placed vaccination requirements on employees, including PruittHealth, a large Southern nursing home chain. The company set an Oct. 1 deadline for employees to have received at least an initial dose of vaccine. About 45% of its nursing home workforce has received a shot. PruittHealth said only medical and religious exemptions to its vaccine mandate will be considered on a case-by-case basis.

Lori Smetanka, executive director of Consumer Voice, a nonprofit that advocates for people receiving long-term care services, said that if nursing homes succeed in getting more employees to accept vaccinations, it might make it easier for them to retain and recruit others who have been fearful of catching COVID at the homes.

"We did see that a number of workers fairly early on in the pandemic had quit because they were worried about their own safety," Smetanka said. "This is one opportunity to attract people who have not been willing to work in the facilities."

CMS said it would issue an emergency rule in the coming weeks that adds staff vaccination to the requirements for nursing homes to receive Medicare and Medicaid reimbursements. That rule would presumably spell out the criteria for compliance.

In practice, nursing homes rarely are thrown out of the Medicare and Medicaid programs for violating the government's conditions of participation. The government generally gives facilities multiple opportunities to correct violations before proposing termination, even when facilities have repeatedly flouted the rules.

Jordan Rau: jrau@kff.org, @JordanRau

Andy Miller: amiller@kff.org, @gahealthnews

'We Sent a Terrible Message': Scientists Say Biden Jumped the Gun With Vaccine Booster Plan

KFF Health News, August 20, 2021

Some scientists see the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines with no clear benefit of controlling the pandemic.

This article was published on Friday, August 20, 2021 in Kaiser Health News.

By Rachana Pradhan 

The Biden administration's plans to make COVID-19 booster shots available next month has drawn a collective scream of protest from the scientific community.

As some scientists see it, the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines with no clear benefit of controlling the pandemic. Meanwhile, more information is needed on potential side effects or adverse effects from a booster shot, they say.

Perhaps even worse, the announcement has fueled deeper confusion about what Americans need to do to protect themselves from COVID.

"I think we've scared people," 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 the Food and Drug Administration.

"We sent a terrible message," he said. "We just sent a message out there that people who consider themselves fully vaccinated were not fully vaccinated. And that's the wrong message, because you are protected against serious illness."

As of Thursday, 51% of the U.S. population was fully vaccinated, Centers for Disease Control and Prevention data shows. Biden administration officials ― citing data from Israel, a study from the Mayo Clinic that is not yet peer-reviewed and new CDC studies ― say it's necessary to plan for boosters to prevent a worsening of the pandemic as the delta variant powers a surge in cases and overwhelms hospital intensive care units.

In essence, officials are caught between a rock and a hard place ― trying to be prepared while simultaneously not undermining messaging about how well the existing vaccines work.

Officials must weigh two unknowns: the risks of moving ahead aggressively with booster shots versus the risks of waiting to learn much more about the virus and the power of the vaccines. The government's normal path to regulatory approval is, by design, slow and deliberate. The virus has its own schedule, fast and unpredictable.

"Arguably, I think that the federal government is simply trying to stay ahead of the curve," said Dr. Joshua Barocas, associate professor of medicine at the University of Colorado. But, he said, "I have not seen robust data yet to suggest that it is better to boost Americans who have gotten two vaccines than invest resources and time in getting unvaccinated people across the world vaccinated."

Beginning in late September, boosters would be made available to adults (age 18 and up) eight months after they received the second dose of a Pfizer-BioNTech or Moderna COVID vaccine, President Joe Biden said. But his plan comes with big caveats: It does not yet have the blessing of a CDC advisory panel, and the FDA has not authorized boosters for all adults.

The urgent question is whether the vaccines are losing their power against COVID.

"We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death," Surgeon General Vivek Murthy said.

But many scientists and public health experts say the data doesn't demonstrate a clear benefit to the public in making booster shots widely available, and the Biden administration's message confuses people about what the COVID vaccines were designed to do.

"They're not a force field. They don't repel the virus from your body. They train your immune system to respond when you become infected … with the goal of keeping you out of the hospital," said Jennifer Nuzzo, an epidemiologist and associate professor at the Johns Hopkins Bloomberg School of Public Health.

Meanwhile, questions abound. Will boosters for fully vaccinated adults make the virus less transmissible ― that is, slower or less likely to spread to others?

"I certainly hope that's the case … but the bottom line, with full transparency, we don't know that right now," Dr. Anthony Fauci, Biden's chief medical adviser, said Wednesday.

What about side effects? "It would be nice to understand what side effects people have after their third dose," Nuzzo said.

"We don't have any reason to believe, based on the safety profile of the vaccine itself, that we're going to see significant adverse events with booster shots," Barocas said. However, those things are "just now being studied."

The concerns are real. While serious side effects from COVID vaccines have been rare, some have caused alarm ― including mRNA vaccines being linked to cases of myocarditis, or inflammation of the heart.

"At the individual level, we need to know the side effect profile of a 3rd dose, especially in younger people. Until now, the benefits of vaccination have far outweighed the potential side effects," Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women's Hospital in Boston, wrote in a blog post outlining why he was skeptical about a plan to give boosters to everyone.

Even in light of the new CDC studies published Wednesday, experts say one thing is clear: The vaccines still work very well at what they were meant to do, which is to protect people against the worst outcomes of getting infected with the virus.

One study, relying on data from 21 hospitals in 18 states, found no significant change in the vaccines' effectiveness against hospitalization between March and July, which coincides with delta becoming the prevalent COVID strain. Another, using data from New York, also found the vaccines highly effective in preventing hospitalization, even as there was a decline in effectiveness against new infections. The third, evaluating the Pfizer and Moderna vaccines in nursing home residents, saw a drop in how effective they were at preventing infection ― but the research didn't distinguish between symptomatic and asymptomatic cases.

"It's like we're engaged in friendly fire against these vaccines," Nuzzo said. "What are we trying to do here? Are we just trying to reduce overall transmission? Because there's no evidence that this is going to do it."

Fauci, in outlining the case for boosters, highlighted data showing that antibody levels decline over time and higher levels of antibodies are associated with higher vaccine efficacy. But antibodies are only one component of the body's defense mechanisms against a COVID infection.

When the antibodies decrease, the body compensates with a cellular immune response. "A person who has lost antibodies isn't necessarily completely susceptible to infection, because that person has T-cell immunity that we can't measure easily," said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA's vaccine advisory panel.

John Wherry, director of the Penn Institute of Immunology at the University of Pennsylvania, recently published a study finding that the mRNA vaccines provoked a strong response by the immune system's T cells, which researchers said could be a more durable source of protection. Wherry is working on a second study based on six months of data.

"We're seeing very good durability for at least some components of the non-antibody responses generated by the vaccines," he said.

For protection against serious disease, "really all you need is immunological memory, and these vaccines induce immunological memory and immunological memory tends to be longer-lived," Offit said. Federal scientists also are studying T-cell response, Fauci said.

Pfizer and Moderna have said they think boosters for COVID will be necessary. But it's up to the government to authorize them. Federal officials say they are sifting through new data from the companies and elsewhere as it becomes available.

There's not a deep playbook for this: Emergency use authorization, or EUA, of vaccines has been sparingly used. The FDA has already amended Pfizer's prior EUA clearance twice, first in May to expand the vaccines to adolescents 12 to 15 years old and, again, this month to allow immunocompromised people to obtain a third dose. The FDA did not respond to questions about the process for authorizing widespread booster shots.

Pfizer announced in July that it expects $33.5 billion in COVID vaccine revenue this year. Its stock has risen 33% this year, closing at $48.80 Thursday. Moderna reported sales of $5.9 billion through June 30 for 302 million doses of its vaccine. The company's stock has skyrocketed 236% year-to-date, closing at $375.53 Thursday.

In applying for emergency authorization, the FDA requires vaccine manufacturers to submit clinical efficacy data and all safety data from phase 1 and phase 2 clinical trials as well as two months of safety data from phase 3 studies. For full approval, the FDA requires manufacturers to submit six months of data.

Pfizer this week announced it has submitted phase 1 clinical trial data to the FDA as part of an evaluation for future approval of a third dose. The company said phase 3 results are "expected shortly."

Pfizer said its preliminary trial results showed a third dose was safe and increased antibody levels against the original virus and the delta variant. Moderna found a third dose had safety results similar to a second dose and produced a strong antibody response. 

Typically, any distribution of shots would occur after the CDC's Advisory Committee on Immunization Practices also developed recommendations. But with the Biden administration's announcement about boosters, public health experts worry the message suggests the outcome is preordained.

"They have completely and unfairly jammed FDA and ACIP. They've left them no choice. If there's no booster program, FDA gets blamed and that's not appropriate," said Dr. Nicole Lurie, a former senior Health and Human Services official in the Obama administration and U.S. director of the Coalition for Epidemic Preparedness Innovations, the global epidemic vaccines partnership.

KHN senior correspondent Sarah Jane Tribble and editor Arthur Allen contributed to this report.

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

School or 'Russian Roulette'? Amid Delta Variant and Lax Mask Rules, Some Parents See No Difference

KFF Health News, August 20, 2021

Even though the CDC recommends "universal indoor masking" in schools regardless of vaccination status, schools across the country are not embracing mask requirements.

This article was published on Friday, August 20, 2021 in Kaiser Health News.

By Rae Ellen Bichell 

The child had just started kindergarten. Or, as her mother called it, "Russian roulette." That's because her school district in Grand Junction, Colorado, experienced one of the nation's first delta-variant outbreaks last spring, and now school officials have loosened the rules meant to protect against COVID-19.

The mother, Venessa, who asked not to be named in full for fear of repercussions for her family, is part of a group of parents, grandparents, medical professionals and community members who assembled in the past few weeks to push back.

The group calls itself "S.O.S.," which stands for "Supporters for Open and Safe Schools," while nodding to the international signal for urgent help. It's made up of Republicans and Democrats, Christians and atheists, and its main request: Require masks.

Venessa said the concept is not complicated for her 5-year-old. "She just puts it on, like her shoes."

But just two weeks into this school year, 30 classrooms already have reports of exposure to COVID-positive students, district spokesperson Emily Shockley said. And three more classrooms were quarantined because they'd had at least three students in them test positive. Masks are still not universally required.

Even though the Centers for Disease Control and Prevention recommends "universal indoor masking" in schools regardless of vaccination status, schools across the country are not embracing mask requirements, including for students under 12 who aren't yet eligible for protective vaccines.

Mesa County, where Venessa lives, was one of the places where the variant arrived before school let out for summer. A report published in early August by the CDC found that from late April through late June, as the delta variant spread there, schools were the most common setting for outbreaks aside from residential care facilities, even though masks were required in schools for students age 11 and older. Schools were bigger virus hubs than correctional facilities.

Susan Hassig, an infectious disease epidemiologist at Tulane University in New Orleans, views the report on Mesa County as a warning shot of what's to come, showing high spread of the variant among schoolchildren.

Prior assumptions that kids weren't likely to get or spread the virus no longer apply, she said: Kids are back to their regular in-person activities, and with a highly transmissible variant circulating to boot. "We've got a lot more kids that are getting exposed, and with delta, a lot more kids getting infected," Hassig said this month. "And now we've got full children's hospitals here in Louisiana."

Politicians in eight states, including Texas and Florida, have prohibited mask mandates in public schools, but some school districts — including in big cities such as Dallas, Houston, Austin and Fort Lauderdale and small ones such as Paris, Texas — are rebelling against those orders and mandating masks anyway, despite the threat of fines.

The Biden administration has supported those local jurisdictions that have gone rogue, with offers to pay the salaries of Florida school board members going against their governor. The administration is also considering investigations into states and districts for potentially violating civil rights that guarantee access to education.

"We're not going to sit by as governors try to block and intimidate educators from protecting our children," said President Joe Biden.

Dr. Jyoti Kapur, a pediatrician with Schoolhouse Pediatrics in Austin, Texas, and mother of two children under 12, was part of a group that persuaded the school district there to enact a mask mandate. Kapur said her kids are "ecstatic" about starting school again in person.

"We want all the school superintendents and their boards of trustees to know everywhere in Texas — and in the country — that the experts are with you," said Kapur. "Let's do our best. If it doesn't work, we will go down knowing we did our best to protect our children."

In Louisiana, Hassig pointed to the "nearly vertical" case rates and hospitalization rates in her state as evidence of how seriously schools should take the virus this year.

As a grandmother, she wants her granddaughter to be able to attend second grade in person. As an epidemiologist, she worries about not just the immediate effects of the delta variant on hospitals and economies, but also the opportunity its spread gives to the emergence of new strains that may be even more contagious, or able to evade vaccines. To Hassig, masks are part of the toolkit that could assuage both fears.

"What may have been sufficient to reduce widespread problems last spring is not necessarily going to work with delta, because delta is different," Hassig said. "Be ready to take it up a notch."

However, the Mesa County Valley School District 51 is ratcheting measures down a notch — despite its experience last spring with outbreaks. Without a state mask mandate in place this school year, the decision was punted to county public health officials and individual school districts. And the school district in Mesa County is not requiring masks for students or staffers.

Venessa, the mom of the kindergartner, said she had assumed guidelines would be more stringent this school year than last because of the delta variant's pervasiveness. "Why not start with the horse on a lead rope?" she said. "Not just open the corral, let it run out, and then try to go catch it?"

Federal guidelines around public transportation mean students do have to wear masks on school buses, but when they get to school, those masks can come off. According to Joel Sholtes, a member of the S.O.S. group and the father of a second grader, that's exactly what's happening since school started for his kid on Aug. 9.

"Unmasked kids are telling our masked kids that they don't need to mask and should take them off. Some kids are because they don't want to stand out," said Sholtes, who, as a civil engineer, believes it's as important for schools to hew to public health guidance as it is for him to hew to expert guidance on how to safely design a bridge.

"It's not who can be loudest at a public meeting. There's some things that we need expert opinion on, and we have to follow those," he said. "Public health shouldn't be different."

Police escorted school board members to their cars after a public meeting Tuesday because they felt threatened by some parents who wanted more time to voice anti-mask and anti-vaccine concerns, according to the Grand Junction Daily Sentinel.

Brian Hill, the Mesa County district's assistant superintendent, said the school system is "highly recommending" indoor masking. He said he saw a mixture of masked and unmasked students in his rounds of campuses during the first week of class.

"We'll also support students and staff within our schools, with whatever decision they make around that," he said. "Whether they make the decision to wear a mask or not, we're going to support that in the campuses in a way that we don't want students to feel bullied or feel judged for the decision that they're making."

Hill pointed to numbers from last school year showing that family members — and not school interactions — were the primary culprits in passing COVID on to the 1,293 students who tested positive out of the district's 21,000 students.

"It's a very tiny, tiny percentage that were traced back to any sort of in-school transmission," he said. "So, we weren't really seeing transmission in our schools. It was happening out in the community."

During the past school year, about 7% of those age 18 and under who tested positive for COVID in the county had exposure through an institutional facility like a school or child care site, according to a district presentation.

As of late July, about two weeks before the school year started, fewer than 60% of school district staffers were fully vaccinated, and fewer than 23% of eligible students were fully vaccinated, the presentation said.

Democratic Gov. Jared Polis sent a letter to district superintendents imploring them to adopt strategies such as mask requirements, though he has avoided imposing a statewide order. Polis also recently announced that Colorado is offering weekly rapid testing — considered a useful screening tool when done frequently — to all schools in the state, and might even pay students between $5 and $25 to take the tests, though they'd need consent from a parent. Hill said it's too early to say if his district will opt in.

Blythe Rusling taught fifth grade at one of about a dozen schools in Mesa County that had an outbreak last spring. That was back when students 11 and older were required to wear masks.

"The kids might grouse a bit about wearing a mask, but at the end of the day they understood that it was something we could do to keep each other healthy," said Rusling, who is working as a reading interventionist this school year.

Now, though, she said, she noticed the tenor had changed among the adults. As staffers prepped for school, she said, she was one of the few to wear a mask. "It almost feels like you're not the cool kid when you're wearing a mask," she said.

Still, two messages brightened her view of the future. They were from former students who had turned 12 and couldn't wait to tell her the news: They'd gotten COVID vaccines.

Rae Ellen Bichell: rbichell@kff.org, @raelnb

The White House Says Boosters for All. Here's What You Need to Know.

KFF Health News, August 19, 2021

White House officials emphasized that the rollout of boosters was pending review of evidence by the FDA and the CDC. 

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

By Sarah Jane Tribble  

The Biden administration announced plans Wednesday to offer boosters to all U.S. adults as soon as next month, saying that recent data, including some made available only in the past few days, played a role in that decision.

"If you wait for something bad to happen before you respond to it, you find yourselves considerably behind," Dr. Anthony Fauci said during a White House briefing. "You want to stay ahead of the virus."

White House officials emphasized that the rollout of boosters was pending review of evidence by officials at the Food and Drug Administration as well as the advisory committee to the Centers for Disease Control and Prevention.

The rollout would begin the week of Sept. 20. U.S. residents 18 and older who received the Moderna or Pfizer-BioNTech vaccines would be eligible for a third shot eight months after their second dose. The timing would mean that healthcare workers, long-term care residents and older residents would be first in line for boosters.

"If you are fully vaccinated, you still have a high degree of protection from the worst outcomes — we are not recommending you go out and get a booster today," U.S. Surgeon General Vivek Murthy said. Johnson & Johnson vaccines were not distributed until March and a plan for those booster shots will come later, officials said.

Political and corporate pressure to offer a booster to U.S. citizens has been mounting over the summer months, as the highly contagious delta variant has spread nationally and filled hospital beds. On Wednesday, Biden officials offered slides filled with charts of recent data, talked about antibody response, and noted that research showing waning vaccine strength in Israel played a key role in their decision as did a study from Mayo Clinic that is not yet peer-reviewed.

"Stick to the advice from the CDC and the FDA, because they 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.

There was no discussion Wednesday of any potential side effects of a third dose.

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 will be free regardless of immigration or health insurance status, according to White House officials. No identification or insurance will be required.

In July, White House press secretary Jen Psaki announced that the federal government bought 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

To Stoke Rural Vaccination Rates, Trusted Farmers Are Asked to Spread Word

KFF Health News, August 19, 2021

Boosting COVID-19 vaccination rates in rural America is now less a problem of access and more an issue of trust.

This article was published on Thursday, August 19, 2021 in Kaiser Health News.

By Christine Herman, WILL / Illinois Public Media  

When he became eligible for the coronavirus vaccine in Illinois, Tom Arnold, 68, said he didn't need any convincing. He raises cattle, hogs and chickens in Elizabeth, a small town in the state's northwestern corner.

After all, who better to understand why herd immunity matters than a herdsman?

"Being a livestock producer, I'm well aware of vaccinations and vaccines," he said. "That's how we develop immunity in our animals. We're always vaccinating the breeding stock to pass on immunity to the little ones."

Boosting COVID-19 vaccination rates in rural America is now less a problem of access and more an issue of trust. Only about 40% of people in Jo Daviess County, where Arnold lives, are fully vaccinated. Arnold said he doesn't get why people are acting as if the pandemic were over. Scientists say those under-vaccinated parts of the country like Jo Daviess are at serious risk, especially as the highly contagious delta variant spreads rapidly.

It's why farmers and ranchers need to speak openly about why they've chosen to be vaccinated, said Carrie Cochran-McClain, chief policy officer with the National Rural Health Association.

"One of the hardest things about the vaccination effort is that it really, at this point, is almost down to those one-on-one kinds of conversations," she said.

Cochran-McClain's association has teamed up with the National Farmers Union to try to get more farmers to promote the vaccine in their communities. They've created an online toolkit for farmers with information and talking points for starting conversations.

Ryan Goodman, 32, is giving it a try. He's a cattle rancher in Virginia and self-described "agriculture advocate." On Instagram and Twitter, he's known as "Beef Runner."

Goodman, who lived in Colorado until recently, has been using his social media accounts to promote the vaccine, as part of a paid content partnership with the Colorado Department of Public Health and Environment.

The agency provides him with information about the vaccines to share online, and he responds to questions with support from the department's public health experts.

He said he's not sure he's changed any minds, but he's encouraged when skeptics return to chat more.

"I'm a fan of saying no one conversation changes someone's mind, especially when you disagree on a topic that might be as hot or as political as vaccines," Goodman said.

He'd like to see more farmers speak up, because in rural towns farmers have long roots, extending back generations — making them more trusted than even health experts, he said.

"Everybody looks at Joe down the road and thinks, 'Hey, you know, what might be his experiences on this topic or this issue?'" Goodman said. "[And they] listen to what he or she may say."

Larry Lieb farms 92 acres of soybeans and timber in central Illinois and also raises a few cows and pigs.

He said he wondered whether the vaccine could be safe, given how quickly it came to market — and he got it for only one reason.

"My daughter's a respiratory therapist, and she told me I was gonna get it," Lieb said. "Plain and simple."

Unlike some of his relatives, Lieb said, he does not buy into conspiracy theories about the vaccine. But he said he avoids those conversations altogether.

"It's their own personal choice," he said. "On issues where they're set in their ways, you know, it's futile to try."

The pandemic has had a huge economic impact on farmers, said Mike Stranz, vice president of advocacy for the National Farmers Union.

"There's been so much upheaval in the agricultural economy and in our communities," Stranz said. "We need to start moving past that, and vaccines are the way towards that [goal]."

Vaccination rates have consistently lagged in rural communities, and an analysis from NPR and Johns Hopkins University in June found new COVID hot spots are cropping up in areas with dangerously low vaccination rates — especially in the South, Midwest and West.

Urban and rural areas have been seeing similar rates of new COVID cases lately, according to an analysis from the University of Iowa. But some states — including Illinois, Missouri and Utah — are seeing higher rates in nonmetropolitan areas.

Recent polls suggest most unvaccinated people don't want the vaccine.

But Cochran-McClain said she hopes farmers don't get discouraged, and she has this message for people like Lieb: "He may not feel like his voice is much, but we believe it's very strong and important."

Arnold said he believes the vaccine saves lives, but he doesn't think it's his job to try to convince his neighbors or friends. And, he said, he has limited capacity for new challenges.

"I'm already overworked and underpaid," Arnold said. The vaccine rollout, so far, has coincided with some of the busiest times of the year for farmers.

If he gets into a conversation with someone about the vaccine, he said, he'll express to them that he's a livestock producer and understands how they work.

"But I don't elaborate," Arnold said. "Unless people are asking me. And usually they don't."

This story is part of a reporting partnership that includes Illinois Public Media, Side Effects Public Media, NPR and KHN.

If the Unvaccinated Want to Work, They Face a Series of Hurdles

KFF Health News, August 19, 2021

Employers, fearing a backlash, frame the policy as a choice, with both sides of the equation seen as effective in reducing the spread of COVID.

This article was published on Thursday, August 19, 2021 in Kaiser Health News.

By Julie Appleby  

With the delta variant surging, a growing number of employers are tiring of merely cajoling workers to get vaccinated against COVID-19 and are following President Joe Biden's protocol for federal workers: Either show proof of vaccination, or mask up and get regular testing if you want to work on-site.

The federal government — the nation's largest employer — will require unvaccinated employees to wear masks while working, get regular testing and take other precautions, like maintaining physical distance from co-workers and restricting work travel. Several states, including California, Hawaii, Maryland, Virginia and Washington, also say unvaccinated state workers must get regular tests.

On Wednesday, California Gov. Gavin Newsom broadly extended such a mandate to teachers and all school employees, the first state to do so.

Those programs, with their testing alternative, differ from outright mandates to get vaccinated, as some healthcare organizations — including the healthcare workforce of the Department of Health and Human Services, hospitals and the U.S. military — are requiring.

Employers, fearing a backlash, frame the policy as a choice, with both sides of the equation seen as effective in reducing the spread of COVID. Do public health experts think this approach will help?

All agreed the best solution is universal vaccination. Short of that, many said, the moves by employers will add a layer of protection — although how much remains to be seen.

Test results are "really only a snapshot in time," said Dr. Gigi Kwik Gronvall, an associate professor at Johns Hopkins' Bloomberg School of Public Health. Even testing every day, as was the standard in the Trump White House — without other measures like masking — didn't prevent staffers from falling ill last fall.

And daily testing is cumbersome and costly.

Employers hope the hassles required to remain unvaccinated in the workplace will encourage the reluctant to just get a vaccine. "It's a forceful nudge," said Dr. Georges Benjamin, executive director of the American Public Health Association.

But there are challenges, too. Here's what several experts had to say:

Universal Vaccination Remains the Gold Standard

Getting all eligible people vaccinated is "the perfect way out of this whole situation," said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officers. "But, given the realities of the current situation, I think it's reasonable that employers and others who are setting up vaccine requirements offer some accommodations."

But much depends, he and others said, on how well the rules are enforced.

"If [unvaccinated] people are wearing masks all day at work, even in the break room, that alone is pretty strong," he said. "When you add in the testing, it's an alternative that is going to have some value."

Some employers, he noted, are reluctant to set such edicts because they fear losing employees, particularly in areas already suffering shortages, such as nursing homes.

This Approach Relies Somewhat on the Honor System

Some states, healthcare organizations and New York City say they'll require proof of vaccination — a copy of an employee's vaccination certificate or a version uploaded into an app on a person's phone. But other employers say they will allow workers to self-attest that they've had the vaccine.

"There will be some folks who fib, no doubt about that," said Dr. William Schaffner, professor of medicine in the division of infectious diseases at Vanderbilt University School of Medicine, in Nashville.

"That will raise the issue of annoyance and concern by the vaccinated people," said Schaffner. "They will say, 'Wait a minute. Charlie is here and he's not wearing a mask and we know he's not vaccinated.' People know that sort of stuff about their co-workers."

There are other consequences.

There is online traffic in buying forged vaccination cards, designed to look like the real thing from the Centers for Disease Control and Prevention — even though that is illegal and can lead to fines or even jail time, the FBI has warned. Employers could also discipline workers who falsely state they've been vaccinated.

As for test results, it's less clear how the honor system will apply. Some workers — especially those in healthcare organizations — may well be able to get their tests done in-house. Other companies may allow workers to find (and pay for) outside testing. It isn't known whether employers will allow the use of self-administered home tests. And what kind of test companies require matters, since the rapid antigen tests are not as reliable as the standard PCR versions. To complicate matters, rising demand for tests during the surge has led to long lines for both kinds of tests in some parts of the country, and results for the more accurate PCR version may take days.

Frequency of Testing Will Vary and May Not Be Ideal

Many of the workplace edicts — including the one for federal workers — call for weekly or twice-a-week testing. Is that enough? It's hard to give an exact answer.

Dr. Robert Wachter, professor and chair of the department of medicine at the University of California-San Francisco, prefers tests be performed twice a week, especially given the explosion of cases in many parts of the country.

"If you're only testing once a week, there will be some cases that slip through," said Wachter. "You could get tested on a Monday, infected on Tuesday and could infect someone else that Friday or Saturday."

Who's Paying?

While some employers may pick up the cost, at least initially, not all will. And workers should not count on testing being fully covered by their health insurers, either. They may well have to pay out-of-pocket for employer-required tests.

"Generally, health insurance providers are covering COVID tests that are taken for diagnosing or treating a patient — if they are displaying symptoms or have had contact with someone who has been diagnosed with COVID," said Kristine Grow, a spokesperson for AHIP, the industry's lobbying group.

But, she noted, guidance issued last year by several federal agencies said insurers don't have to cover testing "conducted to screen for general workplace health and safety, for public health surveillance, or for any other purpose not primarily intended for diagnosis or treatment."

Bottom line: Employees could have to go through a lot of hoops to remain unvaccinated in the workplace. "That will get old very quickly for a lot of people," Schaffner said. "That will push a lot of people off the fence and onto the vaccination side."

Julie Appleby: jappleby@kff.org, @Julie_Appleby

COVID Politics and Fatigue Work Against Contact-Tracing Foot Soldiers

KFF Health News, August 19, 2021

State and local health departments are trying to build back operations with depleted resources, as COVID fatigue among their workers and the public alike complicate those efforts.

This article was published on Thursday, August 19, 2021 in Kaiser Health News.

By Amanda Michelle Gomez  

Health departments nationwide scaled back their contact tracing in late spring or early summer when COVID-19 cases started to decrease as vaccination efforts took center stage.

Then delta hit.

Now state and local health departments are trying to build back operations with depleted resources, as COVID fatigue among their workers and the public alike complicate those efforts.

"Contact tracing from the start of this pandemic provided us with really kind of invaluable information," said Dr. Amanda Castel, a professor of epidemiology at George Washington University. Castel said it's still "a fundamental part of our response." As is COVID testing, especially for those who are vulnerable or unvaccinated, such as children under age 12. Yet numerous departments now find themselves with fewer contact tracers and less robust programs. Like testing, contact tracing seems to have fallen by the wayside.

Contact tracing is a resource-intensive operation, requiring workers to quickly call people who test positive for a disease and offer medical advice, and then to identify and reach out to anyone with whom the infected people came in close contact. The hope during the pandemic is to prevent spread of the COVID virus, and to observe how the virus is changing. The process has been used for decades by public health officials to stop disease transmission.

But many public health departments were overwhelmed by the onslaught of COVID. Last winter — before vaccines provided relief — they were unable to stay ahead of the virus through contact tracing. And as case counts dropped by virtue of increased vaccination rates in the spring and early summer, more than a dozen state health departments scaled back the workforce, said Crystal Watson, a senior scholar and assistant professor at the Johns Hopkins Center for Health Security. The resources were needed for vaccination initiatives and to restart other public health programs.

The situation has grown critical in a number of states during the past month or so as local health officials find themselves once again behind the curve as the delta variant drives up case counts. Resources are already stretched, and the politicization of COVID-19 has left these local officials making tough calls regarding whom to trace in places like Missouri and Texas. And some states just don't have enough personnel to do the job. The army of disease detectives more often than not included temporary staff or civil servants from outside the health department. In Kentucky, the former contact-tracing director is now the aviation department commissioner. The state health department said he has a successor but declined to name them.

The highly contagious delta variant makes the job harder. Cases can stack up quickly. Public health departments, which are chronically understaffed and underfunded, must pick and choose which tools will serve them the best.

"Some places have done a good job at retaining a kind of reserve workforce that they could call back up. And I'm sure that's coming in handy right now. Other places did not. And they're probably going to be quickly overwhelmed," Watson said. "It's also hard to say because there's not a lot of public reporting."

Arkansas, where Republican Gov. Asa Hutchison now says it was an error to sign a law in April banning mask mandates, is averaging around 2,000 new cases a day, one of the steepest upsurges among states. But the state health department has significantly fewer contact tracers now — 192 compared with 840 in December, when case counts were at the same level, according to the department and data collected by Johns Hopkins.

Danyelle McNeill, an Arkansas health department public information officer, said contractors performing this work have been authorized to increase their staff size. She also said that the agency is triaging cases, prioritizing those who tested positive for or were diagnosed with COVID within six days of specimen collection or symptom onset, which the Centers for Disease Control and Prevention has recommended when capacity is limited, and that its vendors are not calling all positive cases the same day they receive lists when infections near 2,000.

In states that have opted to downplay contact tracing, county and city health officials are left to fend for themselves. In hard-hit southwestern Missouri, the flood of cases has overwhelmed a staff already stretched thin, said Springfield-Greene County Health Department Director Katie Towns, so the department pivoted to conducting contact tracing only in cases involving children younger than 12, who aren't eligible for vaccination, Towns said.

Lisa Cox, a spokesperson for the state health department, said that "local health departments will work to triage and prioritize case investigations and will work with them if assistance is needed." Her department expects financial support through the federal American Rescue Plan, but funds have yet to be appropriated. Ultimately, local strategies will come down to priorities. "We've made it clear that local jurisdictions need to make decisions locally based on their unique situation."

The Springfield-Greene County Health Department's surge capacity has diminished as team members have been redeployed to other health programs, which had been neglected during the pandemic. But even if Towns had unlimited resources, she said, she questions how effective investing it all in contact tracing would be: COVID is rampant and compliance with public health measures has waned. She would likely deploy more people to perform vaccine outreach and distribution.

Kelley Vollmar, executive director of the Jefferson County Health Department in eastern Missouri, said the delta surge is hitting a community polarized against public health efforts. "You have a public who is really not supportive of contact tracing and quarantine, as well as the funding for contact tracing and infrastructure is not there like it was last year," she said.

In Texas, the Department of State Health Services is "winding down" the contact-tracing program to meet the requirements of the budget. In the new budget, which takes effect Sept. 1, taxpayer dollars are expressly banned from being used for COVID contact tracing. "We will still be doing case investigations and other public health follow up," said Chris Van Deusen, the state health department's director of media relations, via email, "but won't be providing contact tracing for local health departments." The Texas Education Agency, which oversees primary and secondary education, also said earlier this month that schools are not required to conduct contact tracing.

Contact tracing has been clouded by controversy in Texas. Five legislators sued Republican Gov. Greg Abbott and the health department in August 2020 for awarding a contract to conduct the program. "The contract tracing policy has never been established as a policy accepted or supported by the Texas Legislature," the suit said. Another lawsuit filed the same month by dozens of Texans alleges that the adoption of contact tracing violates their constitutional right to privacy.

In Texas' Williamson and Bexar counties, where community COVID transmission is high, local health officials are troubled by the lack of statewide tracing.

Williamson County turned to the state health department for help in contact tracing and case investigation as 50 to 100 new cases per day were being reported.

The county health department, which is separate from the county government, also trained more than half its staff to do contact tracing, everyone from clinical staff to press, said Allison Stewart, lead epidemiologist at Williamson County and Cities Health District, but the 65 people, including external staff and volunteers, couldn't keep up with cases. Some worked seven days a week or 12-hour days, but now the county relies on the state for that work. "We can't return to those days now, because all the people that we used actually are doing their real jobs," she said. "We're trying to figure out right now what the plan is come Sept 1. And it may mean the plan is that we don't do case investigation or contact tracing."

"Honestly, we don't know," she said.

San Antonio, one of the country's largest cities and located in Bexar County, has its own contact tracers but leans on the state whenever there is a surge, said Rita Espinoza, the city's chief of epidemiology. San Antonio is currently relying on the state and thus able to handle the load without backlogs, Espinoza said. She worries about what will happen in the fall, after school starts and there are more opportunities for transmission. The staff is already operating at a reduced capacity of 80 people.

"The specific impacts are unknown, but it may impact efforts to enhance other infectious disease investigations," said Espinoza.

Florida, where COVID has become a political buzzword, is another state where this tension is playing out. Broward County Mayor Steve Geller said he's asked about contact-tracing capabilities, including how many investigators the state health department has, but he said he's only ever told, "We're working on it. It's under control." Contact-tracing data is not publicly available, but Republican Gov. Ron DeSantis once told local reporters contact tracing "has just not worked."

Geller has not pushed health officials for information, given that "contact tracing doesn't work well when everyone has COVID" and that COVID data has become contentious in Florida. "I'm not looking to create any new martyrs," he said.

Midwest correspondent Lauren Weber contributed to this story.

Amanda Michelle Gomez: amandag@kff.org, @amanduhgomez

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

Pages