Colleagues are critical of Dale Bredesen, MD, who they claim is promoting a largely unproven and costly Alzheimer's regimen

This article was published on Thursday, December 17, 2020 in Kaiser Health News.

By Linda Marsa

When her husband was diagnosed with early-stage Alzheimer's disease in 2015, Elizabeth Pan was devastated by the lack of options to slow his inevitable decline. But she was encouraged when she discovered the work of a UCLA neurologist, Dr. Dale Bredesen, who offered a comprehensive lifestyle management program to halt or even reverse cognitive decline in patients like her husband.

After decades of research, Bredesen had concluded that more than 36 drivers of Alzheimer's cumulatively contribute to the loss of mental acuity. They range from chronic conditions like heart disease and diabetes to vitamin and hormonal deficiencies, undiagnosed infections and even long-term exposures to toxic substances. Bredesen's impressive academic credentials lent legitimacy to his approach.

Pan paid $4,000 to a doctor trained in Bredesen's program for a consultation and a series of extensive laboratory tests, then was referred to another doctor, who devised a stringent regimen of dietary changes that entailed cutting out all sugars, eating a high-fat, low-carbohydrate diet and adhering to a complex regimen of meditation, vigorous daily exercise and about a dozen nutritional supplements each day (at about $200 a month). Pan said she had extensive mold remediation done in her home after the Bredesen doctors told her the substance could be hurting her husband's brain.

But two years passed, she said, and her husband, Wayne, was steadily declining. To make matters worse, he had lost more than 60 pounds because he didn't like the food on the diet. In April, he died.

"I imagine it works in some people and doesn't work in others," said Pan, who lives in Oakton, Virginia. "But there's no way to tell ahead of time if it will work for you."

Bredesen wrote the best-selling 2017 book "The End of Alzheimer's" and has promoted his ideas in talks to community groups around the country and in radio and TV appearances like "The Dr. Oz Show." He has also started his own company, Apollo Health, to market his program and train and provide referrals for practitioners.

Unlike other self-help regimens, Bredesen said, his program is an intensely personalized and scientific approach to counteract each individual's specific deficits by "optimizing the physical body and understanding the molecular drivers of the disease," he told KHN in a November phone interview. "The vast majority of people improve" as long as they adhere to the regimen.

Bredesen's peers acknowledge him as an expert on aging. A former postdoctoral fellow under Nobel laureate Stanley Prusiner at the University of California-San Francisco, Bredesen presided over a well-funded lab at UCLA for more than five years. He has been on the UCLA faculty since 1989 and also founded the Buck Institute for Research on Aging in Marin County. He has written or co-authored more than 200 papers.

But colleagues are critical of what they see as his commercial promotion of a largely unproven and costly regimen. They say he strays from long-established scientific norms by relying on anecdotal reports from patients, rather than providing evidence with rigorous research.

"He's an exceptional scientist," said George Perry, a neuroscientist at the University of Texas-San Antonio. "But monetizing this is a turnoff."

"I have seen desperate patients and family members clean out their bank accounts and believe this will help them with every ounce of their being," said Dr. Joanna Hellmuth, a neurologist in the Memory and Aging Center at UCSF. "They are clinging to hope."

Many of the lifestyle changes Bredesen promotes are known to be helpful. "The protocol itself is based on very low-quality data, and I worry that vulnerable patients and family members may not understand that," said Hellmuth. "He trained here" — at UCSF — "so he knows better."

The Bredesen package doesn't come cheap. He has built a network of practitioner-followers by training them in his protocol — at $1,800 a pop — in seminars sponsored by the Institute for Functional Medicine, which emphasizes alternative approaches to managing disease. Apollo Health also offers two-week training sessions for a $1,500 fee.

Once trained in his ReCODE Protocol, medical professionals charge patients upward of $300 for a consultation and as much as $10,500 for eight- to 15-month treatment packages. For the ReCODE protocol, aimed at people already suffering from early-stage Alzheimer's disease or mild cognitive decline, Apollo Health charges an initial $1,399 fee for a referral to a local practitioner that includes an assessment and extensive laboratory tests. Apollo then offers $75-per-month subscriptions that provide cognitive games and online support, and links to another company that offers dietary supplements for an additional $150 to $450 a month. Insurance generally covers little of these costs.

Apollo Health, founded in 1998 and headquartered in Burlingame, California, also offers a protocol geared toward those who have a family history of dementia or want to prevent cognitive decline.

Bredesen estimates that about 5,000 people have done the ReCODE program. The fees are a bargain, Bredesen said, if they slow decline enough to prevent someone from being placed in a nursing home, where yearly costs can climb past $100,000 annually.

Bredesen and his company are tapping into the desperation that has grown out of the failure of a decades-long scientific quest for effective Alzheimer's treatments. Much of the research money in the field has narrowly focused on amyloid — the barnacle-like gunk that collects outside nerve cells and interferes with the brain's signaling system — as the main culprits behind cognitive decline. Drugmakers have tried repeatedly, and thus far without much success, to invent a trillion-dollar anti-amyloid drug. There's been less emphasis in the field on the lifestyle choices that Bredesen stresses.

"Amyloids sucked up all the air in the room," said Dr. Lon Schneider, an Alzheimer's researcher and a professor of psychiatry and behavioral sciences at the Keck School of Medicine at USC.

Growing evidence shows lifestyle changes help delay the progress of the mind-robbing disease. An exhaustive Lancet report in August identified a long list of risk factors for dementia, including excessive drinking, exposure to air pollution, obesity, loss of hearing, smoking, depression, lack of exercise and social isolation. Controlling these factors — which can be done on the cheap — could delay or even prevent up to 40% of dementia cases, according to the report.

Bredesen's program involves all these practices, with personalized bells and whistles like intermittent fasting, meditation and supplements. Bredesen's scientific peers question whether data supports his micromanaged approach over plain-vanilla healthy living.

Bredesen has published three papers showing positive results in many patients following his approach, but critics say he has fallen short of proving his method's effectiveness.

The papers lack details on which protocol elements were followed, or the treatment duration, UCSF's Hellmuth said. Nor do they explain how cognitive tests were conducted or evaluated, so it's difficult to gauge whether improvements were due to the intervention, to chance variations in performance or an assortment of other variables, she said.

Bredesen shrugs off the criticism: "We want things to be in an open-access journal so everybody can read it. These are still peer-reviewed journals. So what's the problem?"

Another problem raised about Bredesen's enterprise is the lack of quality control, which he acknowledges. Apollo-trained "certified practitioners" can include everyone from nurses and dietitians to chiropractors and health coaches. Practitioners with varying degrees of training and competence can take his classes and hang out a shingle. That's a painful fact for some who buy the package.

"I had the impression these practitioners were certified, but I realize they all had just taken a two-week course," said a Virginia man who requested anonymity to protect his wife's privacy. He said that he had spent more than $15,000 on tests and treatments for his ailing spouse and that six months into the program, earlier this year, she had failed to improve.

Bredesen said he and his staff were reviewing "who's getting the best results and who's getting the worst results," and intended to cut poor performers out of the network. "We'll make it so that you can only see the people getting the best results," he said.

Colleagues say that to test whether Bredesen's method works it needs to be subjected to a placebo-controlled study, the gold standard of medical research, in which half the participants get the treatment while the other half don't.

In the absence of rigorous studies, said USC's Schneider, a co-author of the Lancet report, "saying you can 'end Alzheimer's now and this is how you do it' is overpromising and oversimplifying. And a lot of it is just common sense."

Bredesen no longer says his method can end Alzheimer's, despite the title of his book. Apollo Health's website still makes that claim, however.

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

Lies infected America in 2020. The very worst were not just damaging, but deadly. 

This article was published on Tuesday, December 16, 2020 in Kaiser Health News.

By Daniel Funke, Politifact and Katie Sanders, Politifact

A Florida taxi driver and his wife had seen enough conspiracy theories online to believe the virus was overblown, maybe even a hoax. So no masks for them. Then they got sick. She died. A college lecturer had trouble refilling her lupus drug after the president promoted it as a treatment for the new disease. A hospital nurse broke down when an ICU patient insisted his illness was nothing worse than the flu, oblivious to the silence in beds next door.   

Lies infected America in 2020. The very worst were not just damaging, but deadly. 

President Donald Trump fueled confusion and conspiracies from the earliest days of the coronavirus pandemic. He embraced theories that COVID-19 accounted for only a small fraction of the thousands upon thousands of deaths. He undermined public health guidance for wearing masks and cast Dr. Anthony Fauci as an unreliable flip-flopper. 

But the infodemic was not the work of a single person. 

Anonymous bad actors offered up junk science. Online skeptics made bogus accusations that hospitals padded their coronavirus case numbers to generate bonus payments. Influential TV and radio opinion hosts told millions of viewers that physical distancing was a joke and that states had all of the personal protective equipment they needed (when they didn’t).

It was a symphony of counter-narrative, and Trump was the conductor, if not the composer. The message: The threat to your health was overhyped to hurt the political fortunes of the president. 

Every year, PolitiFact editors review the year’s most inaccurate statements to elevate one as the Lie of the Year. The “award” goes to a statement, or a collection of claims, that prove to be of substantive consequence in undermining reality. 

It has become harder and harder to choose when cynical pundits and politicians don’t pay much of a price for saying things that aren’t true. For the past month, unproven claims of massive election fraud have tested democratic institutions and certainly qualify as historic and dangerously baldfaced. Fortunately, the constitutional foundations that undergird American democracy are holding. 

Meanwhile, the coronavirus has killed more than 300,000 in the United States, a crisis exacerbated by the reckless spread of falsehoods.

PolitiFact’s 2020 Lie of the Year: claims that deny, downplay or disinform about COVID-19. 

‘I Wanted to Always Play It Down’

On Feb. 7, Trump leveled with book author Bob Woodward about the dangers of the new virus that was spreading across the world, originating in central China. He told the legendary reporter that the virus was airborne, tricky and “more deadly than even your strenuous flus.”

Trump told the public something else. On Feb. 26, the president appeared with his coronavirus task force in the crowded White House briefing room. A reporter asked if he was telling healthy Americans not to change their behavior.

“Wash your hands, stay clean. You don’t have to necessarily grab every handrail unless you have to,” he said, the room chuckling. “I mean, view this the same as the flu.”

Three weeks later, March 19, he acknowledged to Woodward: “To be honest with you, I wanted to always play it down. I still like playing it down. Because I don’t want to create a panic.”

His acolytes in politics and the media were on the same page. Rush Limbaugh told his audience of about 15 million on Feb. 24 that the coronavirus was being weaponized against Trump when it was just “the common cold, folks.” That’s wrong — even in the early weeks, it was clear the virus had a higher fatality rate than the common cold, with worse potential side effects, too.

As the virus was spreading, so was the message to downplay it. 

“There are lots of sources of misinformation, and there are lots of elected officials besides Trump that have not taken the virus seriously or promoted misinformation,” said Brendan Nyhan, a government professor at Dartmouth College. “It’s not solely a Trump story — and it’s important to not take everyone else’s role out of the narrative.” 

Hijacking the Numbers 

In August, there was a growing movement on Twitter to question the disproportionately high U.S. COVID-19 death toll.  

The skeptics cited Centers for Disease Control and Prevention data to claim that only 6% of COVID-19 deaths could actually be attributed to the virus. On Aug. 24, BlazeTV host Steve Deace amplified it on Facebook.

“Here’s the percentage of people who died OF or FROM Covid with no underlying comorbidity,” he said to his 120,000 followers. “According to CDC, that is just 6% of the deaths WITH Covid so far.”

That misrepresented the reality of coronavirus deaths. The CDC had always said people with underlying health problems — comorbidities — were most vulnerable if they caught COVID-19. The report was noting that 6% died even without being at obvious risk. 

But for those skeptical of COVID-19, the narrative confirmed their beliefs. Facebook users copied and pasted language from influencers like Amiri King, who had 2.2 million Facebook followers before he was banned. The Gateway Pundit called it a “SHOCK REPORT.”

“I saw a statistic come out the other day, talking about only 6% of the people actually died from COVID, which is very interesting — that they died from other reasons,” Trump told Fox News host Laura Ingraham on Sept. 1.

Fauci, director of the National Institute of Allergy and Infectious Diseases, addressed the claim on “Good Morning America” the same day. 

“The point that the CDC was trying to make was that a certain percentage of them had nothing else but just COVID,” he said. “That does not mean that someone who has hypertension or diabetes who dies of COVID didn’t die of COVID-19 — they did.”

Trump retweeted the message from an account that sported the slogans and symbols of QAnon, a conspiracy movement that claims Democrats and Hollywood elites are members of an underground pedophilia ring. 

False information moved between social media, Trump and TV, creating its own feedback loop.

“It’s an echo effect of sorts, where Donald Trump is certainly looking for information that resonates with his audiences and that supports his political objectives. And his audiences are looking to be amplified, so they’re incentivized to get him their information,” said Kate Starbird, an associate professor and misinformation expert at the University of Washington.

Weakening the Armor: Misleading on Masks

At the start of the pandemic, the CDC told healthy people not to wear masks, saying they were needed for health care providers on the front lines. But on April 3 the agency changed its guidelines, saying every American should wear non-medical cloth masks in public.

Trump announced the CDC’s guidance, then gutted it.

“So it’s voluntary. You don’t have to do it. They suggested for a period of time, but this is voluntary,” Trump said at a press briefing. “I don’t think I’m going to be doing it.”

Rather than an advance in best practices on coronavirus prevention, face masks turned into a dividing line between Trump’s political calculations and his decision-making as president. Americans didn’t see Trump wearing a mask until a July visit to Walter Reed National Military Medical Center.

Meanwhile, disinformers flooded the internet with wild claims: Masks reduced oxygen. Masks trapped fungus. Masks trapped coronavirus. Masks just didn’t work.

In September, the CDC reported a correlation between people who went to bars and restaurants, where masks can’t consistently be worn, and positive COVID-19 test results. Bloggers and skeptical news outlets countered with a misleading report about masks.

On Oct. 13, the story landed on Fox News’ flagship show, “Tucker Carlson Tonight.” During the show, Carlson claimed “almost everyone — 85% — who got the coronavirus in July was wearing a mask.”

“So clearly [wearing a mask] doesn’t work the way they tell us it works,” Carlson said.

That’s wrong, and it misrepresented a small sample of people who tested positive. Public health officials and infectious disease experts have been consistent since April in saying that face masks are among the best ways to prevent the spread of COVID-19.

But two days later, Trump repeated the 85% stat during a rally and at a town hall with NBC’s Savannah Guthrie. 

“I tell people, wear masks,” he said at the town hall. “But just the other day, they came out with a statement that 85% of the people that wear masks catch it.”

The Assault on Hospitals 

On March 24, registered nurse Melissa Steiner worked her first shift in the new COVID-19 ICU of her southeastern Michigan hospital. After her 13-hour workday caring for two critically ill patients on ventilators, she posted a tearful video.

“Honestly, guys, it felt like I was working in a war zone,” Steiner said. “[I was] completely isolated from my team members, limited resources, limited supplies, limited responses from physicians because they’re just as overwhelmed.” 

“I’m already breaking, so for f—’s sake, people, please take this seriously. This is so bad.”

Steiner’s post was one of many emotional pleas offered by overwhelmed hospital workers last spring urging people to take the threat seriously. The denialists mounted a counteroffensive.

On March 28, Todd Starnes, a conservative radio host and commentator, tweeted a video from outside Brooklyn Hospital Center. There were few people or cars in sight.

“This is the ‘war zone’ outside the hospital in my Brooklyn neighborhood,” Starnes said sarcastically. The video racked up more than 1.5 million views.

Starnes’ video was one of the first examples of #FilmYourHospital, a conspiratorial social media trend that pushed back on the idea that hospitals had been strained by a rapid influx of coronavirus patients. 

Several internet personalities asked people to go out and shoot their own videos. The result: a series of user-generated clips taken outside hospitals, where the response to the pandemic was not easily seen. Over the course of a week, #FilmYourHospital videos were uploaded to YouTube and posted tens of thousands of times on Twitter and Facebook.

Nearly two weeks and more than 10,000 deaths later, Fox News featured a guest who opened a new misinformation assault on hospitals.

Dr. Scott Jensen, a Minnesota physician and Republican state senator, told Ingraham that, because hospitals were receiving more money for COVID-19 patients on Medicare — a result of a coronavirus stimulus bill — they were overcounting COVID-19 cases. He had no proof of fraud, but the cynical story took off. 

Trump used the false report on the campaign trail to continue to minimize the death toll. 

“Our doctors get more money if somebody dies from COVID,” Trump told supporters at a rally in Waterford, Michigan, on Oct. 30. “You know that, right? I mean, our doctors are very smart people. So what they do is they say, ‘I’m sorry, but, you know, everybody dies of COVID.’”  

The Real Fake News: The Plandemic

The most viral disinformation of the pandemic was styled to look as if it had the blessing of people Americans trust: scientists and doctors.

In a 26-minute video called “Plandemic: The Hidden Agenda Behind COVID-19,” a former scientist at the National Cancer Institute claimed the virus was manipulated in a lab, hydroxychloroquine is effective against coronaviruses, and face masks make people sick. 

Judy Mikovits’ conspiracies received more than 8 million views, partly credited to the online outrage machine — anti-vaccine activists, anti-lockdown groups and QAnon supporters — that push disinformation into the mainstream. The video was circulated in a coordinated effort to promote Mikovits’ book release.

Around the same time, a similar effort propelled another video of fact-averse doctors to millions of people in only a few hours. 

On July 27, Breitbart published a clip of a press conference hosted by a group called America’s Frontline Doctors in front of the U.S. Supreme Court. Looking authoritative in white lab coats, these doctors discouraged mask-wearing and falsely said there was already a cure in hydroxychloroquine, a drug used to treat rheumatoid arthritis and lupus.

Trump, who had been talking up the drug since March and claimed to be taking it himself as a preventive measure in May, retweeted clips of the event before Twitter removed them as misinformation about COVID-19. He defended the “very respected doctors” in a July 28 press conference. 

When Olga Lucia Torres, a lecturer at Columbia University, heard Trump touting the drug in March, she knew it didn’t bode well for her own prescription. Sure enough, the misinformation led to a run on hydroxychloroquine, creating a shortage for Americans like her who needed the drug for chronic conditions. 

A lupus patient, she went to her local pharmacy to request a 90-day supply of the medication. But she was told they were granting only partial refills. It took her three weeks to get her medication through the mail. 

“What about all the people who were silenced and just lost access to their staple medication because people ran to their doctors and begged to take it?” Torres said.

No Sickbed Conversion

On Sept. 26, Trump hosted a Rose Garden ceremony to announce his nominee to replace the late Ruth Bader Ginsburg on the U.S. Supreme Court. More than 150 people attended the event introducing Amy Coney Barrett. Few wore masks, and the chairs weren’t spaced out.

In the weeks afterward, more than two dozen people close to Trump and the White House became infected with COVID-19. Early on Oct. 2, Trump announced his positive test.

Those hoping the experience and Trump’s successful treatment at Walter Reed might inform his view of the coronavirus were disappointed. Trump snapped back into minimizing the threat during his first moments back at the White House. He yanked off his mask and recorded a video.

“Don’t let it dominate you. Don’t be afraid of it,” he said, describing experimental and mostly out-of-reach therapies he received. “You’re going to beat it.” 

In Trump’s telling, his hospitalization was not the product of poor judgment about large gatherings like the Rose Garden event, but the consequence of leading with bravery. Plus, now, he claimed, he had immunity to the virus.

On the morning after he returned from Walter Reed, Trump tweeted a seasonal flu death count of 100,000 lives and added that COVID-19 was “far less lethal” for most populations. More false claims at odds with data — the U.S. average for flu deaths over the past decade is 36,000, and experts said COVID-19 is more deadly for each age group over 30.

When Trump left the hospital, the U.S. death toll from COVID-19 was more than 200,000. Today it is more than 300,000. Meanwhile, this month the president has gone ahead with a series of indoor holiday parties. 

The Vaccine War 

The vaccine disinformation campaign started in the spring but is still underway.

In April, blogs and social media users falsely claimed Democrats and powerful figures like Bill Gates wanted to use microchips to track which Americans had been vaccinated for the coronavirus. Now, false claims are taking aim at vaccines developed by Pfizer and BioNTech and other companies.

• A blogger claimed Pfizer’s head of research said the coronavirus vaccine could cause female infertility. That’s false.
• An alternative health website wrote that the vaccine could cause an array of life-threatening side effects, and that the FDA knew about it. The list included all possible — not confirmed— side effects.
• Social media users speculated that the federal government would force Americans to receive the vaccine. Neither Trump nor President-elect Joe Biden has advocated for that, and the federal government doesn’t have the power to mandate vaccines, anyway.

As is often the case with disinformation, the strategy is to deliver it with a charade of certainty. 

“People are anxious and scared right now,” said Dr. Seema Yasmin, director of research and education programs at the Stanford Health Communication Initiative. “They’re looking for a whole picture.” 

Most polls have shown far from universal acceptance of vaccines, with only 50% to 70% of respondents willing to take the vaccine. Black and Hispanic Americans are even less likely to take it so far.

Meanwhile, the future course of the coronavirus in the U.S. depends on whether Americans take public health guidance to heart. The Institute for Health Metrics and Evaluation projected that, without mask mandates or a rapid vaccine rollout, the death toll could rise to more than 500,000 by April 2021.

“How can we come to terms with all that when people are living in separate informational realities?” Starbird said.

PolitiFact staff researcher Caryn Baird contributed to this report.

It will take months to approve use of the vaccines for middle- and high school-aged kids, and months more to test them in younger children.

This article was published on Tuesday, December 15, 2020 in Kaiser Health News.

By Arthur Allen

If clinical trials for COVID-19 vaccines aren't expanded soon to include children, it's unlikely that even kids in their teens will be vaccinated in time for the next school year.

The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people ages 16 and up. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.

It will take months to approve use of the vaccines for middle- and high school-aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.

Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they're split on how fast to move toward that, says Dr. James Campbell, professor of pediatrics at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health. Campbell and colleagues say it's a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.

Much of the debate centers on two issues: the degree of harm COVID-19 causes children, and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.

COVID-19's impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among people 19 and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.

Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Dr. Stanley Plotkin, professor emeritus of pediatrics at the University of Pennsylvania, told a federal panel. That's in line with the percentage who become gravely ill as result of infections like Haemophilus influenza type B, or Hib, for which doctors have vaccinated children since the 1980s, he pointed out.

Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, points out that "in a universe where COVID mainly affected children the way it's affecting them now, and we had potential vaccines, people would be clamoring for them."

The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.

"The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission," said Dr. Yvonne Maldonado, a professor of pediatrics at Stanford University who chairs the AAP's infectious disease committee. "If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren't a risk."

Other pediatricians worry that early pediatric trials could backfire. Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA's advisory committee on vaccines, is worried that whatever causes Multisystem Inflammatory Syndrome in Children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.

Meissner abstained from the committee's vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people 16 and older.

"I have trouble justifying it for children so unlikely to get the disease," he said during debate on the measure.

But panel member Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, said the 16-and-up authorization would speed the vaccine's testing in and approval for younger children. That is vital for the world's protection from COVID-19, he said, since in the United States and most places "most vaccines are delivered early in life."

While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Dr. Emily Erbelding, director of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases.

Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late last month, Pfizer had vaccinated approximately 100 children 12-15 years of age, said spokesperson Jerica Pitts.

Moderna has started enrolling 3,000 children 12 and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.

Similar stepdown approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.

Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who've received the Pfizer and Moderna vaccines, Campbell said.

But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year "will be closed even for our oldest children," said Dr. Evan Anderson, a pediatrics professor at Emory University. "Our younger children are almost certainly going into next school year without a vaccine option available for them."

In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can't be vaccinated, Erbelding said.

Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Plotkin said.

In the 1960s, Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella, or German measles, is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.

"We don't want to use children to protect everyone in the community," said Campbell. "But when you can protect both children and their community, that's important."

And while a coronavirus infection may not be bad for most children, missed school, absent friends and distanced families have caused them immense suffering, he said.

"It's a huge burden on a child to have their entire world flipped around," Campbell said. "If vaccinating could help to flip it back, we should begin testing to see if that's possible."

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

Arthur Allen: ArthurA@kff.org, @ArthurAllen202

A CDC advisory committee has recommended that top priority go to long-term care facilities and front-line healthcare workers.

This article was published on Monday, December 14, 2020 in Kaiser Health News.

By JoNel Aleccia

If there's such a thing as a date with destiny, it's marked on Dr. Taison Bell's calendar.

At noon Tuesday, Bell, a critical care physician, is scheduled to be one of the first healthcare workers at the University of Virginia Health System to roll up his sleeve for a shot to ward off the coronavirus.

"This is a long time coming," said Bell, 37, who signed up via hospital email last week. "The story of this crisis is that each week feels like a year. This is really the first time that there's genuine hope that we can turn the corner on this."

For now, that hope is limited to a chosen few. Bell provides direct care to some of the sickest COVID-19 patients at the UVA Health hospital in Charlottesville, Virginia. But he is among some 12,000 "patient-facing" workers at his hospital who could be eligible for about 3,000 early doses of vaccine, said Dr. Costi Sifri, director of hospital epidemiology.

"We're trying to come up with the highest-risk categories, those who really spend a significant amount of time taking care of patients," Sifri said. "It doesn't account for everybody."

Even as the federal Food and Drug Administration engaged in intense deliberations ahead of Friday's authorization of the Pfizer and BioNTech COVID vaccine, and days before the initial 6.4 million doses were to be released, hospitals across the country have been grappling with how to distribute the first scarce shots.

An advisory committee of the Centers for Disease Control and Prevention has recommended that top priority go to long-term care facilities and front-line healthcare workers, but the early allocation was always expected to fall far short of the need and require selective screening even among critical hospital workers.

Hospitals in general are advised to target the members of their workforce at highest risk, but the institutions are left on their own to decide exactly who that will be, Colin Milligan, a spokesperson for the American Hospital Association, said in an email.

"It is clear that the hospitals will not receive enough in the first weeks to vaccinate everyone on their staff, so decisions had to be made," Milligan wrote.

At Intermountain Healthcare in Salt Lake City, the first shots will go to staff members "with the highest risk of contact with COVID-positive patients or their waste," said Dr. Kristin Dascomb, medical director of infection prevention and employee health. Within that group, managers will determine which caregivers are first in line.

At UW Medicine in Seattle, which includes Harborview Medical Center, one early plan called for high-risk staff to be selected randomly to receive first doses, said Dr. Shireesha Dhanireddy, medical director of the infectious disease clinic. But the University of Washington hospital system expects to receive enough doses to vaccinate everyone in that high-risk tier within two weeks, so randomization isn't necessary — for now.

"We are allowing people to schedule themselves," Dhanireddy said, and encouraging staffers to be vaccinated near the end of their workweeks in case they have reactions to the new vaccine.

Trial results have shown the shots frequently produce side effects that, while not debilitating, could cause symptoms such as fever, muscle aches or fatigue that might keep someone home for a day or two.

"We want to make sure that not everybody has the vaccine on the same day so that if there are some side effects, we don't end up being short-staffed," said Sifri, of UVA Health, noting that guidelines call for no more than 25% of any unit to be vaccinated at once.

At UVA Health, once the initial 3,000 doses are distributed, the hospital plans to rely on what Sifri described as "a very strong honor code" to allow staff members to decide where they should be in line. They've been asked to consider professional factors, like the type of work they do, as well as personal risks, such as age or underlying conditions like diabetes.

"We're going to ask team members, using the honor code, to determine what their risk is for COVID and to determine whether they need to have an early vaccine sign-up time or a later vaccine sign-up time," he said.

That plan was chosen after healthcare staff members soundly rejected other options. For instance, few favored a proposal to allocate dosages via a lottery, like the chaotic birthday-based system depicted in the 2011 pandemic horror film "Contagion." "That was the biggest loser," he said.

Hospital officials also stressed they are trying to devise distribution plans that ensure vaccines are allocated equitably among healthcare workers, including the social, racial and ethnic groups that have been disproportionately harmed by COVID-19 infections. That requires thinking beyond front-line doctors and nurses.

At UVA Health, for example, one of the first groups invited to get shots will be 17 workers whose job is to clean rooms in the special pathogens unit where severe COVID cases are treated.

"We acknowledge that everybody is at risk for COVID, everybody is deserving of a vaccine," Sifri said.

In many cases, it will be clear who should go first. For instance, although Dhanireddy is an infectious disease doctor who consults on COVID cases, she is happy to wait to be vaccinated. "I wouldn't put myself in the first group at all," she said. "I think that we need to protect our staff that are really right there with them most of the day — and that's not me."

But hospitals must remain vigilant about relying on workers to prioritize their own access, Dhanireddy cautioned. "Sometimes, self-selection works more for self-advocacy," she said. "It's great that some individuals say they would defer to others, but sometimes that's not actually the case."

For some healthcare workers, not being first in line for vaccination is fine. Because the vaccine initially has been authorized only for emergency use, hospitals won't require employees to be inoculated as part of this first round. Between 70% and 75% of healthcare staff at UVA Health and Intermountain Health would accept a COVID vaccine, internal surveys showed. The rest are unsure — or unwilling.

"There are some that will be immediate acceptors and some who will want to watch and wait," Dascomb said.

Still, hospital officials say they're confident that those who want the vaccine won't have to wait long. Enough doses for roughly 21 million healthcare personnel should be available by early January, according to CDC officials.

Bell, the critical care doctor, said he's grateful to be among the first to receive the vaccine, especially after his parents, who live in Boston, both contracted COVID-19. He has posted about his upcoming appointment on Twitter and said he and other healthcare workers who are among the first in line should be public about the process.

"We'll serve as an example that this is a safe and effective vaccine," he said. "We're letting it go into our bodies. You should let it go into yours, too."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia