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Filing Suit for ‘Wrongful Life’

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Filing Suit for ‘Wrongful Life’

More Americans are writing end-of-life instructions as the pandemic renders such decisions less abstract. But are medical providers listening?

When Elaine Greenberg’s husband, Gerald, was diagnosed with early-onset Alzheimer’s, his specific advance directive — comfort measures only — went unheeded at the hospital where he was treated.
When Elaine Greenberg’s husband, Gerald, was diagnosed with early-onset Alzheimer’s, his specific advance directive — comfort measures only — went unheeded at the hospital where he was treated.Credit…Jackie Molloy for The New York Times

  • Jan. 22, 2021, 10:31 a.m. ET

Gerald and Elaine Greenberg married in 1976, as dental students. They practiced on Long Island and in Manhattan and raised two sons. Then in 2010, she noticed that her husband, the math whiz, was having trouble calculating tips in restaurants. “He just didn’t seem as sharp,” she said.

The devastating diagnosis from a neurologist: early-onset Alzheimer’s disease.

“We knew what could be ahead for him,” Elaine Greenberg said. “He didn’t want to lie there with tubes and diapers. That’s not how he wanted to end his life.”

Together, they called a lawyer and drew up advance directives in 2011. “We gave it a lot of thought,” she said. His directive was very specific: If he became terminally ill, permanently unconscious or seriously and irreversibly brain damaged, he wanted comfort measures only. No cardiac resuscitation or mechanical respiration. No tube feeding. No antibiotics.

Gerald Greenberg died in 2016 at Montefiore New Rochelle Hospital in Westchester County — and a recent lawsuit brought by his widow charges that when he was unresponsive and near death from sepsis, the hospital and an attending physician there failed to follow his directive.

The suit alleges that they also disregarded a New York State MOLST — medical orders for life-sustaining treatment — form and his spouse’s explicit instructions to a doctor who called to seek her guidance.

Medical records show that her husband received antibiotics and other unwanted treatments and tests. The suit charges that he survived for about a month in the unresponsive state that he had sought to avoid. (A Montefiore spokesman said the hospital could not comment, given ongoing litigation.)

“They made the end of his life horrible and painful and humiliating,” Dr. Greenberg said. “What’s the sense of having a living will if it’s not honored?”

Lawsuits charging negligence or malpractice by hospitals and doctors typically claim that they have failed to save patients’ lives. More recently, though, some families have sued if providers failed to heed patients’ documented wishes and prevented death from occurring.

“In the past, people have said, ‘How have we harmed you if we kept you alive?’” said Thaddeus Pope, a professor at the Mitchell Hamline School of Law in St. Paul, Minn., who follows end-of-life legal cases. “Now, courts have said this is a compensable injury.”

The campaign to persuade people to document end-of-life instructions goes back decades, but it remains an uphill battle. A 2017 analysis of 150 studies, involving nearly 800,000 Americans, found that among those over 65, only 45.6 percent had completed an advance directive, including barely half of nursing home residents.

But recent evidence suggests that those proportions have climbed during the coronavirus pandemic. The crisis has made such questions less abstract and the need to honor documents more urgent.

Dr. Greenberg with Gerald Greenberg and their first grandchild in 2016.
Dr. Greenberg with Gerald Greenberg and their first grandchild in 2016.Credit…via Elaine Greenberg

Patients themselves may bear some responsibility for mix-ups. Advance directives go astray, get locked in desk drawers, become so outdated that designated decision makers have died. Or they use language like “no heroic measures,” so vague that “it’s hard for doctors to comply with,” Mr. Pope said.

The state MOLST or POLST (portable orders for life-sustaining treatment) forms strive to make the decisions concrete by providing detailed documentation of patients’ wishes and functioning as physicians’ orders. Studies in Oregon and West Virginia have demonstrated the forms’ effectiveness, but as several of these cases show, that is not universal.

Sometimes — nobody has tracked how often — institutions overlook the documents in patients’ charts or ignore conversations with health care proxies. Doctors who doubt that a patient actually prefers to die may override the instructions.

“Their attitude is, ‘Nobody was hurt,’” said Gerald Grunsfield, the lawyer representing Dr. Greenberg. “But there was physical hurt, emotional hurt, a lot of hurt.”

In an interview four years ago, Mr. Pope noted that nobody at that point had received compensation from any “wrongful life” suit. Since then, several plaintiffs have received hefty payments, and courts have weighed in as well.

In Georgia, Jacqueline Alicea won a $1 million settlement from Doctors Hospital of Augusta and a surgeon there (from their insurers, more accurately). They had placed her 91-year-old grandmother on a ventilator, disregarding both Ms. Alicea’s instructions as her grandmother’s health care proxy and her grandmother’s advance directive. That meant Ms. Alicea had to eventually order that life support be removed, a wrenching decision.

Settlement amounts often remain confidential, but “we wanted this settlement to be shouted from the mountaintops,” her lawyer, Harry Revell, said. “We wanted it to have a deterrent effect on health care providers who think this isn’t important.”

The Alicea case, already being cited in other lawsuits, may have an impact because after the trial court denied a motion to dismiss it, the state’s Court of Appeals and its Supreme Court both ruled that the suit could proceed. The parties settled on the eve of a trial in 2017.

In Montana, a jury delivered what is believed to be the first verdict in a wrongful life case, awarding $209,000 in medical costs and $200,000 for “mental and physical pain and suffering” to the estate of Rodney Knoepfle in 2019.

Debilitated by many illnesses, Mr. Knoepfle had a do-not-resuscitate order and a POLST form in his records at St. Peter’s Health, Helena’s largest hospital. “He’d suffered more pain than anyone should in a lifetime and was comfortable with going, if it was his time to go,” said Ben Snipes, one of his lawyers.

But a medical team resuscitated Mr. Knoepfle — twice. Tethered to an oxygen tank, he lived another two years before dying at age 69. “The last few months, he was almost incoherent with pain, living in a hospital bed, getting morphine crushed into his pudding,” Mr. Snipes said.

Beatrice Weisman, 83, had been hospitalized after a stroke in 2013 when doctors at Maryland General Hospital found her turning blue and resuscitated her, an action that her advance directive and MOLST form specifically prohibited.

The Weisman family sued and in 2017 received a “satisfactory” sum through mediation, said Robert Schulte, their lawyer. He could not divulge the amount but said it had helped pay for seven years of round-the-clock care, until Ms. Weisman died last October.

The Greenbergs on their wedding day in 1976.Credit…Jackie Molloy for The New York Times

A California case developed differently. Dick Magney had opted for palliative care, and his doctors were complying, until someone reported potential neglect to Humboldt County’s adult protective services agency. The county filed a petition to take over his health care, removing his wife as his decision maker, and ordered that Mr. Magney receive antibiotics he had earlier refused. At one point, the county won temporary conservatorship.

“It just led to him suffering longer,” said Allison Jackson, the lawyer representing Mr. Magney’s wife. Mr. Magney died in 2015.

A state appellate court ruled that the petition to remove Mr. Magney’s wife had been fraudulent. She eventually won more than $200,000 in reimbursement for lawyers’ fees and pursued a federal civil rights complaint, leading to a $1 million settlement from the county. Two lawyers representing the county now face disciplinary charges from the California state bar.

Such awards and rulings, and news coverage, have led more families to seek legal remedies and have encouraged lawyers to take such cases, said Mr. Pope, who is a consultant to the Montana lawyers and a testifying expert witness in the upcoming California disciplinary hearings.

Now similar suits are pending in Georgia, Maryland and New Jersey, in addition to two malpractice cases that Mr. Grunsfeld has brought against Montefiore in New York.

Lawyers for Montefiore have moved to dismiss the Greenberg suit; even if the court allows it to go forward, resolution could take years. But Dr. Greenberg and her sons are in it for the long haul, she said.

During the month her husband survived, after his directive would have permitted him to die, he lay unconscious, diapered, in restraints and moaning in pain, she recalled.

“He tried to make choices, and his choices weren’t respected,” Dr. Greenberg said. “I don’t want anyone else to go through what we went through.”

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Amid One Pandemic, Students Train for the Next

Amid One Pandemic, Students Train for the Next

Researchers have banded together to find safe, virtual ways to teach the principles of microbiology and epidemiology.

Teresa Bautista, a student at the High School for Environmental Studies in Manhattan, collecting goose dropping samples at Van Cortlandt Park in the Bronx.
Teresa Bautista, a student at the High School for Environmental Studies in Manhattan, collecting goose dropping samples at Van Cortlandt Park in the Bronx.Credit…Christine Marizzi/BioBus
Katherine J. Wu

  • Jan. 21, 2021, 5:00 a.m. ET

On a crisp afternoon in November, Teresa Bautista ventured into Van Cortlandt Park in the Bronx, N.Y., on the lookout for feces. It didn’t take long for Ms. Bautista, 17 — and, to her chagrin, her white Puma shoes — to hit some serious pay dirt.

Speckled all across the park’s grass was the greenish glint of goose droppings, which Ms. Bautista eagerly swabbed and swirled into a tubeful of chemicals. “This was my first time digging into poop,” she said. “It was really fun.”

Ms. Bautista was after more than just bird excrement. Teeming within it, she hoped, were swarms of infectious viruses ready to spill their genetic secrets and, perhaps, help young scientists like her stop future pandemics.

Over the next few months, Ms. Bautista and four other New York area high school students will continue to gather samples from the city’s birds as a part of the Virus Hunters program, hosted by the nonprofit science outreach organization BioBus. Their goal is to catalog the flu viruses that often lurk in urban fowl, some of which might have the potential to someday hop into humans.

The surveillance program, which was developed in partnership with virologists at the Icahn School of Medicine at Mount Sinai, is one of several outreach efforts that have emerged in recent years to equip young scientists with hands-on experience in outbreak preparedness — a quest that has only gained urgency since the new coronavirus started its tear across the globe.

For many months to come, Covid-19 will continue to shutter schools and thwart attempts to gather. The changes have forced educators and researchers to change their teaching tactics. But several groups have met the challenge head on, not merely weathering the pandemic’s inconveniences but transforming them into opportunities for scientific growth.

In Cambridge, Mass., a team of computational biologists designed an outbreak simulation that eerily portended the stealthy spread of the coronavirus and is now fighting the spread of Covid-19 in real-time. In Tucson, Ariz., an immunologist has led an effort to include young, underrepresented scientists in microbiology research, even while the pandemic rages on.

And in New York, where Ms. Bautista is nurturing her love for virology, the effects of these efforts are already starting to take shape. That foraging trip to Van Cortlandt Park, she said, wasn’t just her first experience sampling feces: “It was the first time I actually felt like a scientist.”

Viruses of a feather

The Virus Hunters program was borne of a collaboration among BioBus, a wildlife rehabilitation center called the Wild Bird Fund and a group of researchers led by the Mount Sinai virologist Florian Krammer. Flu viruses are fairly cosmopolitan pathogens that are capable of jumping into a wide range of animals, including birds, and changing their genetic material along the way. Only some of these viruses pose a possible threat to people, Dr. Krammer said. But which ones? Researchers won’t know unless they check.

“There is very little information on influenza circulating in birds in New York City,” Dr. Krammer said. “I wanted to know what’s in my backyard.”

Florian Krammer of the Icahn School of Medicine at Mount Sinai.
Florian Krammer of the Icahn School of Medicine at Mount Sinai.Credit…Brittainy Newman/The New York Times

The project was awarded funding in early 2020, said Christine Marizzi, the chief scientist at BioBus. Weeks later, the coronavirus began to pummel the nation, and the team was forced to shift their plans. But Dr. Marizzi, who has long specialized in community-based research, was undeterred. For the remainder of the school year, the team will train its virus hunters through a mix of virtual lessons, distanced and masked lab work, and sample collection in the field.

It is a welcome distraction for Ms. Bautista, who, like many other students, had to switch to remote learning at her high school in the spring. “When the pandemic hit, I felt really helpless,” she said. “I felt like I couldn’t do anything. So this program is really special to me.”

School of outbreak

A thousand miles south, the students of Sarasota Military Academy Prep, a charter school in Sarasota, Fla., have also had to make some drastic changes since the coronavirus made landfall in the United States. But a select few of them may have entered 2020 a bit more prepared than the rest, because they had experienced a nearly identical epidemic just weeks before.

These were the graduates of Operation Outbreak, a researcher-designed outreach program that has, for the past several years, simulated an annual viral epidemic on the school’s campus. Led by Todd Brown, Sarasota Military Academy Prep’s community outreach director, the program began as a low-tech endeavor that used stickers to mimic the spread of a viral disease. With guidance from a team of researchers led by Pardis Sabeti, a computational biologist at Harvard University, the program quickly morphed into a smartphone app that could ping a virtual virus from student to student with a Bluetooth signal.

Sarasota’s most recent iteration of Operation Outbreak was uncanny in its prescience. Held in December 2019, just weeks before the new coronavirus began its rampage across the globe, the simulation centered on a viral pathogen that moved both swiftly and silently among people, causing spates of flulike symptoms.

The students in each simulation, partitioned into roles in government, public health, medicine, the military and the media, had to scramble to adapt and work together.

Bradford Walker, a junior at the academy, said he felt “really confident” going into the simulation as an eighth grader in 2017. “I was like, ‘We’ll get this together, no problem.’”

But the moment the campus’s outbreak began, “everything became a mess,” Mr. Walker said. Panic ensued; protests flared up; Nerf-gun shots were fired. Media personnel stalked and pestered Mr. Walker, who was acting as a government official. “It was very reminiscent of real life,” he said.

Students with the Sarasota Military Academy Prep “rescued” an ill student to triage as part of the school’s Operation Outbreak program.Credit…Becky Morris

Surrounded by a real pandemic, Mr. Walker often thinks back to his Operation Outbreak days. The program gave him an inkling of what a true viral outbreak might bring, he said. But he’s been unnerved by how wholly unprepared the world was for the coronavirus.

“The coronavirus is a wake-up call,” he said. “We have to be ready for this kind of stuff.”

Operation Outbreak was slated to run several in-person courses in 2020, until an actual pandemic intervened. But Dr. Sabeti and her colleagues have been building online tools, curriculums and games that can bring the lessons of their program to anyone who wants them.

After some careful finagling, the team was also able to engineer a handful of in-person outbreak simulations at college and high school campuses, using an updated version of their smartphone app. One simulation, run over Halloween weekend at Colorado Mesa University, followed a group of more than 350 students as they mingled during their normal routines. Unsurprisingly, an increase in interactions fueled the spread of the fictional virus — the same dynamic that was causing outbreaks of Covid-19 on campus that same semester.

The Operation Outbreak app has since grown more sophisticated. As part of the simulations, users can now toggle their epidemics to include diagnostic tests, masks, vaccines and other public health tools that curb and monitor the spread of infection. Eventually, schools and other organizations might be able to use the simulations as guides as they prepare to reopen for business.

“Beyond being an education tool, it’s a tool to get real-world data,” Dr. Sabeti said. “It’s an exercise in preparing public health teams.”

Expanding science’s reach

Isabel Francisco, left, a doctor of veterinary medcine at the Icahn School of Medicine at Mount Sinai, with Shatoni Bailey, a student at Central Park East High School, participating in BioBus’s virus hunters program.Credit…Christine Marizzi/BioBus

In Arizona, the microbiologist Michael D.L. Johnson has also taken advantage of the pivot to virtual learning prompted by the pandemic. Last summer, he led an effort to enroll 250 students from underrepresented backgrounds in the National Summer Undergraduate Research Program, or NSURP, matching them to more than 150 mentors with expertise in microbiology.

All the projects were remote. But, Dr. Johnson said, that obstacle likely also created opportunities for students who might otherwise have been excluded from science because of geographical or socioeconomic restrictions. And mentors who had old data sets lying around, or heavily computational projects that needed an extra pair of hands, found themselves partnered with eager new collaborators.

“The pandemic has made us adapt,” Dr. Johnson said. “We’re learning that there are some better ways of doing this.”

Some NSURP students even had the opportunity to better understand the coronavirus that had upended their summers. Emy Armanus, now a freshman at the University of California, Irvine, was paired with Suhana Chattopadhyay, an environmental health researcher at the University of Maryland School of Public Health, and spent the summer investigating how the use of nicotine products can worsen cases of Covid-19.

“It definitely made me more knowledgeable about the pandemic,” said Ms. Armanus, who is interested in pursuing a career in medicine. “This program was a great way to discover myself.”

The pandemic has altered just about every aspect of daily life. But Dr. Marizzi of BioBus said students should still feel empowered to engage in scientific discourse — something that sorely needs a new generation of diverse and enthusiastic voices.

For Ms. Bautista, the budding virologist in New York, the Virus Hunters program is bound to leave a lasting impression. Already, she has learned the basics of how viruses infiltrate hosts and how to coax intact genetic material out of cells — and, of course, to never again wear white shoes on a field survey.

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Emerging Coronavirus Variants May Pose Challenges to Vaccines

Emerging Coronavirus Variants May Pose Challenges to Vaccines

Laboratory studies of mutations circulating in South Africa suggest they may dodge some of the body’s immune responses.

Health workers tended to a Covid-19 patient at Greenacres Hospital in Port Elizabeth, South Africa, in November.
Health workers tended to a Covid-19 patient at Greenacres Hospital in Port Elizabeth, South Africa, in November.Credit…Samantha Reinders for The New York Times
Apoorva Mandavilli

  • Jan. 20, 2021, 6:37 p.m. ET

The steady drumbeat of reports about new variants of the coronavirus — first in Britain, then in South Africa, Brazil and the United States — have brought a new worry: Will vaccines protect against these altered versions of the virus?

The answer so far is yes, several experts said in interviews. But two small new studies, posted online Tuesday night, suggest that some variants may pose unexpected challenges to the immune system, even in those who have been vaccinated — a development that most scientists had not anticipated seeing for months, even years.

The findings result from laboratory experiments with blood samples from groups of patients, not observations of the virus spreading in the real world. The studies have not yet been peer-reviewed.

But experts who reviewed the papers agreed that the findings raised two disturbing possibilities. People who had survived mild infections with the coronavirus may still be vulnerable to infection with a new variant; and more worryingly, the vaccines may be less effective against the variants.

Existing vaccines will still prevent serious illness, and people should continue getting them, said Dr. Michel Nussenzweig, an immunologist at Rockefeller University in New York, who led one of the studies: “If your goal is to keep people out of the hospital, then this is going to work just fine.”

But the vaccines may not prevent people from becoming mildly or asymptomatically infected with the variants, he said. “They may not even know that they were infected,” Dr. Nussenzweig added. If the infected can still transmit the virus to others who are not immunized, it will continue to claim lives.

The vaccines work by stimulating the body to produce antibodies against the coronavirus. Scientists had expected that over time, the virus may gain mutations that allow it to evade these antibodies — so-called escape mutations. Some studies had even predicted which mutations would be most advantageous to the virus.

But scientists had hoped that the new vaccines would remain effective for years, on the theory that the coronavirus would be slow to develop new defenses against them. Now some researchers fear the unchecked spread has given the virus nearly unfettered opportunities to reinvent itself, and may have hastened the appearance of escape mutations.

The studies published on Tuesday night show that the variant identified in South Africa is less susceptible to the antibodies created by natural infection and by vaccines made by Pfizer-BioNTech and Moderna.

Vaccinations of nurses, doctors and health professionals in São Paulo, Brazil, this week.
Vaccinations of nurses, doctors and health professionals in São Paulo, Brazil, this week.Credit…Victor Moriyama for The New York Times

Neither the South African variant nor a similar mutant virus in Brazil has yet been detected in the United States. (The more contagious variant that has blazed through Britain does not contain these mutations and seems to be susceptible to vaccines.)

Fears that the vaccines would be powerless against new variants intensified at a scientific conference held online on Saturday, when South African scientists reported that in laboratory tests, serum samples from 21 of a group of 44 Covid-19 survivors did not destroy the variant circulating in that country.

The samples that were successful against the variant were taken from patients who had been hospitalized. These patients had higher blood levels of so-called neutralizing antibodies — the subset of antibodies needed to disarm the virus and prevent infection — than those who were only mildly ill.

The results “strongly, strongly suggest that several mutations that we see in the South Africa variant are going to have a significant effect on the sensitivity of that virus to neutralization,” said Penny Moore, a virologist at the National Institute for Communicable Diseases in South Africa who led the study.

The second study brought better tidings, at least about vaccines.

In that study, Dr. Nussenzweig and his colleagues tested samples from 14 people who had received the Moderna vaccine and six people who had received the Pfizer-BioNTech vaccine.


Covid-19 Vaccines ›


Answers to Your Vaccine Questions

While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.

Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.

Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while they’re not experiencing any cough or other symptoms. Researchers will be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.

The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection won’t be any different from ones you’ve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. It’s possible that people may need to plan to take a day off work or school after the second shot. While these experiences aren’t pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.

No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

The researchers saw a slight decrease in antibody activity directed against engineered viruses with three of the key mutations in the variant identified in South Africa. That result was significant “because it’s seen in just about every individual tested,” Dr. Nussenzweig said. Still, it “is not something that we should be horribly freaked out about.”

In most people, infection with the coronavirus leads to a strong immune response; the vaccines seem to induce an even more powerful response. Two doses of the vaccines from Pfizer and Moderna, at least, produce neutralizing antibodies at levels that are higher than those acquired through natural infection.

Even if antibody effectiveness were reduced tenfold, the vaccines would still be quite effective against the virus, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.

In Liverpool, England, people lined up to receive a coronavirus test at a recreational tennis center last year.Credit…Mary Turner for The New York Times

And while neutralizing antibodies are essential for preventing infection, the vaccines — and natural infection — also lead to production of thousands of other types of antibodies, not to mention various immune cells that retain a memory of the virus and can be roused to action when the body encounters it again.

Even when confronted with variants, those other components of the immune system may be enough to prevent serious illness, said Florian Krammer, an immunologist at the Icahn School of Medicine at Mount Sinai in New York. In clinical trials, the vaccines protected people from illness after just one dose, when the levels of neutralizing antibodies were low or undetectable, he noted.

Vaccine trials being conducted in South Africa by Novavax and Johnson & Johnson will provide more real-world data on how the vaccines perform against the new variant there. Those results are expected within the next few weeks.

All viruses mutate, and it’s no surprise that some of those mutations sidestep the body’s immune defenses, experts said. Each new host affords a virus fresh opportunities to amass and test mutations by slightly scrambling the sequence of RNA letters in its genetic code.

“The beauty, the elegance, the evolution and the magnificence of a virus is that every single time it infects a person, it’s exploring that sequence space,” said Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh.

Some mutations don’t improve on the original, and fade away. Others add to the pathogen’s power, by making it more contagious — like the variant first identified in Britain — more fit, or less susceptible to immunity.

The mutations in the variant circulating in South Africa, called B.1.351, have independently emerged more than once, and all together, suggesting that they work in concert to benefit the virus.

A field hospital for treating Covid-19 patients outside Port Elizabeth, South Africa, in November. Credit…Samantha Reinders for The New York Times

The key mutation, called E484K, and two of its companions alter the shape of a part of the virus that is crucial for immune recognition, making it difficult for antibodies to attach themselves to the virus. The trio popped up in several lab studies that tried to predict which mutations would be advantageous to the virus.

“I think we need to monitor mutations closely and look out for things like that that could be becoming dominant in certain parts of the world,” said Akiko Iwasaki, an immunologist at Yale University.

Britain detected the more contagious variant circulating there because it sequences more virus samples than any other nation. The United States lags far behind: It has sequenced about 71,000 samples so far, a tiny proportion of the millions infected in the country. But the Centers for Disease Control and Prevention plans to work with state and local public health labs to sequence as many as 6,000 samples per week, agency scientists said Friday.

It will be important to limit travel — and the import of variants — from other countries until a majority of the population is immunized, said John Moore, a virologist at Weill Cornell Medicine in New York.

“Even if they are already here, the more often they are reintroduced, the more likely there could be a super-spreader event,” Dr. Moore said. (President Joseph R. Biden Jr. plans to sustain existing travel restrictions on anyone who has recently traveled to Europe and Brazil.)

The mRNA technology on which the Pfizer and Moderna vaccines rely can be altered in a matter of weeks, and far more easily than the process used to produce flu vaccines. But it would be wise to prepare for this eventuality now and think through not just the technical aspects of updating the vaccines, but the testing, approval and rollout of those vaccines, experts said.

Still, the best path forward is to prevent the emergence of new mutations and variants altogether, they said.

“Imagine having to do catch-up like this all the time — it’s not something desirable,” Dr. Iwasaki said. “If we can just stop the spread as soon as possible, while the vaccine is very effective, that’s the best way.”

Could a Small Test Screen People for Covid-19?

Could a Smell Test Screen People for Covid?

A new modeling study hints that odor-based screens could quash outbreaks. But some experts are skeptical it would work in the real world.

A health worker in Altos de San Lorenzo, a neighborhood outside Buenos Aires, Argentina, administered a smell test last year.
A health worker in Altos de San Lorenzo, a neighborhood outside Buenos Aires, Argentina, administered a smell test last year.Credit…Alejandro Pagni/Agence France-Presse — Getty Images
Katherine J. Wu

  • Jan. 19, 2021, 5:49 p.m. ET

In a perfect world, the entrance to every office, restaurant and school would offer a coronavirus test — one with absolute accuracy, and able to instantly determine who was virus-free and safe to admit and who, positively infected, should be turned away.

That reality does not exist. But as the nation struggles to regain a semblance of normal life amid the uncontrolled spread of the virus, some scientists think that a quick test consisting of little more than a stinky strip of paper might at least get us close.

The test does not look for the virus itself, nor can it diagnose disease. Rather, it screens for one of Covid-19’s trademark signs: the loss of the sense of smell. Since last spring, many researchers have come to recognize the symptom, which is also known as anosmia, as one of the best indicators of an ongoing coronavirus infection, capable of identifying even people who don’t otherwise feel sick.

A smell test cannot flag people who contract the coronavirus and never develop any symptoms at all. But in a study that has not yet been published in a scientific journal, a mathematical model showed that sniff-based tests, if administered sufficiently widely and frequently, might detect enough cases to substantially drive transmission down.

Daniel Larremore, an epidemiologist at the University of Colorado, Boulder, and the study’s lead author, stressed that his team’s work was still purely theoretical. Although some smell tests are already in use in clinical and research settings, the products tend to be expensive and laborious to use and are not widely available. And in the context of the pandemic, there is not yet real-world data to support the effectiveness of smell tests as a frequent screen for the coronavirus. Given the many testing woes that have stymied pandemic control efforts so far, some experts have been doubtful that smell tests could be distributed widely enough, or made sufficiently cheat-proof, to reduce the spread of infection.

“I have been intimately involved in pushing to get loss of smell recognized as a symptom of Covid from the beginning,” said Dr. Claire Hopkins, an ear, nose and throat surgeon at Guy’s and St. Thomas’ Hospitals in the United Kingdom and an author of a recent commentary on the subject in The Lancet. “But I just don’t see any value as a screening test.”

A reliable smell test offers many potential benefits. It could catch far more cases than fever checks, which have largely flopped as screening tools for Covid-19. Studies have found that about 50 to 90 percent of people who test positive for the coronavirus experience some degree of measurable smell loss, a result of the virus wreaking havoc when it invades cells in the airway.

“It’s really like a function of the virus being in the nose at this exact moment,” said Danielle Reed, the associate director of the Monell Chemical Senses Center in Philadelphia. “It complements so much of the information you get from other tests.” Last month, Dr. Reed and her colleagues at Monell posted a study, which has not yet been published in a scientific journal, describing a rapid smell test that might be able to screen for Covid-19.

In contrast, only a minority of people with Covid-19 end up spiking a temperature. Fevers also tend to be fleeting, while anosmia can linger for many days.

A coronavirus testing site in Los Angeles. Smell tests, unlike P.C.R. and antigen tests, would not diagnose the disease nor look for the virus directly.
A coronavirus testing site in Los Angeles. Smell tests, unlike P.C.R. and antigen tests, would not diagnose the disease nor look for the virus directly.Credit…Kendrick Brinson for The New York Times

A smell test could also come with an appealingly low price tag, perhaps as low as 50 cents per card, said Derek Toomre, a cell biologist at Yale University and an author on Dr. Larremore’s paper. Dr. Toomre hopes that his version will fit the bill. The test, the U-Smell-It test, is a small smorgasbord of scratch-and-sniff scents arrayed on paper cards. People taking the test pick away at wells of smells, inhale and punch their guess into a smartphone app, shooting to correctly guess at least three of the five odors. Different cards contain different combinations of scents, so there is no answer key to memorize.

He estimated that the test could be taken in less than a minute. It is also a manufacturer’s dream, he said: A single printer “could produce 50 million of these tests per day.” Numbers like that, he argued, could make an enormous dent in a country hampered by widespread lack of access to tests that look directly for pieces of the coronavirus.

In their study, Dr. Larremore, Dr. Toomre and their collaborator Roy Parker, a biochemist at the University of Colorado, Boulder, modeled such a scenario using computational tools. Administered daily or almost daily, a smell screen that caught at least 50 percent of new infections was able to quash outbreaks nearly as well as a more accurate, slower laboratory test given just once a week.

Such tests, Dr. Larremore said, could work as a point-of-entry screen on college campuses or in offices, perhaps in combination with a rapid virus test. There might even be a place for them in the home, if researchers can find a way to minimize misuse.

“I think this is spot on,” said Dr. Carol Yan, an ear, nose and throat specialist at the University of California, San Diego. “Testing people repeatedly is going to be a valuable portion of this.”

Dr. Toomre is now seeking an emergency use authorization for the U-Smell-It from the Food and Drug Administration, and has partnered with a number of groups in Europe and elsewhere to trial the test under real-world conditions.

Translating theory into practice, however, will come with many challenges. Smell tests that can reliably identify people who have the coronavirus, while excluding people who are sick with something else, are not yet widely available. (Dr. Hopkins pointed to a couple of smell tests, developed before the pandemic, that cost about $30 each and remain in limited supply.) Should they ever be rolled out in bulk, they would inevitably miss some infected people and, unlike tests that look for the actual virus, could never diagnose disease on their own.

And smell loss, like fever, is not exclusive to Covid-19. Other infections can blunt a person’s sense of smell. So can allergies, nasal congestion from the common cold, or simply the process of aging. About 80 percent of people over the age of 75 have some degree of smell loss. Some people are born anosmic.

Moreover, in many cases of Covid-19, smell loss can linger long after the virus is gone and people are no longer contagious — a complication that could land some people in a post-Covid purgatory if they are forced to rely on smell screens to resume activity, Dr. Yan said.

There are also many ways to design a smell-based screen. Odors linked to foods that are popular in some countries but not others, such as bubble gum or licorice, might skew test results for some individuals. People who have grown up in highly urban areas might not readily recognize scents from nature, like pine or fresh-cut grass.

Smell also is not a binary sense, strictly on or off. Dr. Reed advocated a step in which test takers rate the intensity of a test’s odors — an acknowledgment that the coronavirus can drastically reduce the sense of smell but not eliminate it.

But the more complicated the test, the more difficult it would be to manufacture and deploy speedily. And no test, even a perfectly designed one, would function with 100 percent accuracy.

Dr. Ameet Kini, a pathologist at Loyola University Medical Center, pointed out that smell tests would also not be free of the problems associated with other types of tests, such as poor compliance or a refusal to isolate.

Smell screens are “probably better than nothing,” Dr. Kini said. “But no test is going to stop the pandemic in its tracks unless it’s combined with other measures.”

Could a Smell Test Screen People for Covid?

Could a Smell Test Screen People for Covid?

A new modeling study hints that odor-based screens could quash outbreaks. But some experts are skeptical it would work in the real world.

A health worker in Altos de San Lorenzo, a neighborhood outside Buenos Aires, Argentina, administered a smell test last year.
A health worker in Altos de San Lorenzo, a neighborhood outside Buenos Aires, Argentina, administered a smell test last year.Credit…Alejandro Pagni/Agence France-Presse — Getty Images
Katherine J. Wu

  • Jan. 19, 2021, 5:49 p.m. ET

In a perfect world, the entrance to every office, restaurant and school would offer a coronavirus test — one with absolute accuracy, and able to instantly determine who was virus-free and safe to admit and who, positively infected, should be turned away.

That reality does not exist. But as the nation struggles to regain a semblance of normal life amid the uncontrolled spread of the virus, some scientists think that a quick test consisting of little more than a stinky strip of paper might at least get us close.

The test does not look for the virus itself, nor can it diagnose disease. Rather, it screens for one of Covid-19’s trademark signs: the loss of the sense of smell. Since last spring, many researchers have come to recognize the symptom, which is also known as anosmia, as one of the best indicators of an ongoing coronavirus infection, capable of identifying even people who don’t otherwise feel sick.

A smell test cannot flag people who contract the coronavirus and never develop any symptoms at all. But in a study that has not yet been published in a scientific journal, a mathematical model showed that sniff-based tests, if administered sufficiently widely and frequently, might detect enough cases to substantially drive transmission down.

Daniel Larremore, an epidemiologist at the University of Colorado, Boulder, and the study’s lead author, stressed that his team’s work was still purely theoretical. Although some smell tests are already in use in clinical and research settings, the products tend to be expensive and laborious to use and are not widely available. And in the context of the pandemic, there is not yet real-world data to support the effectiveness of smell tests as a frequent screen for the coronavirus. Given the many testing woes that have stymied pandemic control efforts so far, some experts have been doubtful that smell tests could be distributed widely enough, or made sufficiently cheat-proof, to reduce the spread of infection.

“I have been intimately involved in pushing to get loss of smell recognized as a symptom of Covid from the beginning,” said Dr. Claire Hopkins, an ear, nose and throat surgeon at Guy’s and St. Thomas’ Hospitals in the United Kingdom and an author of a recent commentary on the subject in The Lancet. “But I just don’t see any value as a screening test.”

A reliable smell test offers many potential benefits. It could catch far more cases than fever checks, which have largely flopped as screening tools for Covid-19. Studies have found that about 50 to 90 percent of people who test positive for the coronavirus experience some degree of measurable smell loss, a result of the virus wreaking havoc when it invades cells in the airway.

“It’s really like a function of the virus being in the nose at this exact moment,” said Danielle Reed, the associate director of the Monell Chemical Senses Center in Philadelphia. “It complements so much of the information you get from other tests.” Last month, Dr. Reed and her colleagues at Monell posted a study, which has not yet been published in a scientific journal, describing a rapid smell test that might be able to screen for Covid-19.

In contrast, only a minority of people with Covid-19 end up spiking a temperature. Fevers also tend to be fleeting, while anosmia can linger for many days.

A coronavirus testing site in Los Angeles. Smell tests, unlike P.C.R. and antigen tests, would not diagnose the disease nor look for the virus directly.
A coronavirus testing site in Los Angeles. Smell tests, unlike P.C.R. and antigen tests, would not diagnose the disease nor look for the virus directly.Credit…Kendrick Brinson for The New York Times

A smell test could also come with an appealingly low price tag, perhaps as low as 50 cents per card, said Derek Toomre, a cell biologist at Yale University and an author on Dr. Larremore’s paper. Dr. Toomre hopes that his version will fit the bill. The test, the U-Smell-It test, is a small smorgasbord of scratch-and-sniff scents arrayed on paper cards. People taking the test pick away at wells of smells, inhale and punch their guess into a smartphone app, shooting to correctly guess at least three of the five odors. Different cards contain different combinations of scents, so there is no answer key to memorize.

He estimated that the test could be taken in less than a minute. It is also a manufacturer’s dream, he said: A single printer “could produce 50 million of these tests per day.” Numbers like that, he argued, could make an enormous dent in a country hampered by widespread lack of access to tests that look directly for pieces of the coronavirus.

In their study, Dr. Larremore, Dr. Toomre and their collaborator Roy Parker, a biochemist at the University of Colorado, Boulder, modeled such a scenario using computational tools. Administered daily or almost daily, a smell screen that caught at least 50 percent of new infections was able to quash outbreaks nearly as well as a more accurate, slower laboratory test given just once a week.

Such tests, Dr. Larremore said, could work as a point-of-entry screen on college campuses or in offices, perhaps in combination with a rapid virus test. There might even be a place for them in the home, if researchers can find a way to minimize misuse.

“I think this is spot on,” said Dr. Carol Yan, an ear, nose and throat specialist at the University of California, San Diego. “Testing people repeatedly is going to be a valuable portion of this.”

Dr. Toomre is now seeking an emergency use authorization for the U-Smell-It from the Food and Drug Administration, and has partnered with a number of groups in Europe and elsewhere to trial the test under real-world conditions.

Translating theory into practice, however, will come with many challenges. Smell tests that can reliably identify people who have the coronavirus, while excluding people who are sick with something else, are not yet widely available. (Dr. Hopkins pointed to a couple of smell tests, developed before the pandemic, that cost about $30 each and remain in limited supply.) Should they ever be rolled out in bulk, they would inevitably miss some infected people and, unlike tests that look for the actual virus, could never diagnose disease on their own.

And smell loss, like fever, is not exclusive to Covid-19. Other infections can blunt a person’s sense of smell. So can allergies, nasal congestion from the common cold, or simply the process of aging. About 80 percent of people over the age of 75 have some degree of smell loss. Some people are born anosmic.

Moreover, in many cases of Covid-19, smell loss can linger long after the virus is gone and people are no longer contagious — a complication that could land some people in a post-Covid purgatory if they are forced to rely on smell screens to resume activity, Dr. Yan said.

There are also many ways to design a smell-based screen. Odors linked to foods that are popular in some countries but not others, such as bubble gum or licorice, might skew test results for some individuals. People who have grown up in highly urban areas might not readily recognize scents from nature, like pine or fresh-cut grass.

Smell also is not a binary sense, strictly on or off. Dr. Reed advocated a step in which test takers rate the intensity of a test’s odors — an acknowledgment that the coronavirus can drastically reduce the sense of smell but not eliminate it.

But the more complicated the test, the more difficult it would be to manufacture and deploy speedily. And no test, even a perfectly designed one, would function with 100 percent accuracy.

Dr. Ameet Kini, a pathologist at Loyola University Medical Center, pointed out that smell tests would also not be free of the problems associated with other types of tests, such as poor compliance or a refusal to isolate.

Smell screens are “probably better than nothing,” Dr. Kini said. “But no test is going to stop the pandemic in its tracks unless it’s combined with other measures.”

How to (Literally) Drive the Coronavirus Away

How to (Literally) Drive the Coronavirus Away

What’s the transmission risk inside a car? An airflow study offers some insight for passengers and drivers alike.

Although cars don’t carry enough people to host a traditional superspreader event, they are small, sealed spaces that can still carry the risk of Covid-19 transmission.
Although cars don’t carry enough people to host a traditional superspreader event, they are small, sealed spaces that can still carry the risk of Covid-19 transmission.Credit…Matt Rourke/Associated Press

  • Jan. 16, 2021, 5:00 a.m. ET

Over the past year, as the health authorities have tried to curb the Covid-19 pandemic, researchers have trained their scientific attention on a variety of potentially risky environments: places where large groups of people gather and the novel coronavirus has ample opportunity to spread. They have swabbed surfaces on cruise ships, tracked case numbers in gyms, sampled ventilation units in hospitals, mapped seating arrangements in restaurants and modeled boarding procedures in airplanes.

They have paid less attention to another everyday environment: the car. A typical car, of course, does not carry nearly enough people to host a traditional super-spreader event. But cars come with risks of their own; they are small, tightly sealed spaces that make social distancing impossible and trap the tiny, airborne particles, or aerosols, that can transmit the coronavirus.

“Even if you’re wearing a face covering, you still get tiny aerosols that are released every time you breathe,” said Varghese Mathai, a physicist at the University of Massachusetts, Amherst. “And if it’s a confined cabin, then you keep releasing these tiny particles, and they naturally would build up over time.”

In a new study, Dr. Mathai and three colleagues at Brown University — Asimanshu Das, Jeffrey Bailey and Kenneth Breuer — used computer simulations to map how virus-laden airborne particles might flow through the inside of a car. Their results, published in early January in Science Advances, suggest that opening certain windows can create air currents that could help keep both riders and drivers safe from infectious diseases like Covid-19.

To conduct the study, the research team employed what are known as computational fluid dynamic simulations. Engineers commonly use these kinds of computer simulations, which model how gases or liquids move, to create racecars with lower drag, for instance, or airplanes with better lift.

The team simulated a car loosely based on a Toyota Prius driving at 50 miles per hour, with two occupants: a driver in the front left seat and a single passenger in the back right, a seating arrangement that is common in taxis and ride shares and that maximizes social distancing. In their initial analysis, the researchers found that the way the air flows around the outside of the moving car creates a pressure gradient inside the car, with the air pressure in the front slightly lower than the air pressure in the back. As a result, air circulating inside the cabin tends to flow from the back of the car to the front.

A diagram showing air circulation in a car with the front right and rear left windows open. A pressure gradient causes the air to generally flow from back to front in the car.
A diagram showing air circulation in a car with the front right and rear left windows open. A pressure gradient causes the air to generally flow from back to front in the car.Credit…Mathai et al., Science Advances 2021

Next, they modeled the interior air flow — and the movement of simulated aerosols — when different combinations of windows were open or closed. (The air-conditioning was on in all scenarios.) Unsurprisingly, they found that the ventilation rate was lowest when all four windows were closed. In this scenario, roughly 8 to 10 percent of aerosols exhaled by one of the car’s occupants could reach the other person, the simulation suggested. When all the windows were completely open, on the other hand, ventilation rates soared, and the influx of fresh air flushed many of the airborne particles out of the car; just 0.2 to 2 percent of the simulated aerosols traveled between driver and passenger.

The results jibe with public health guidelines that recommend opening windows to reduce the spread of the novel coronavirus in enclosed spaces. “It’s essentially bringing the outdoors inside, and we know that the risk outdoors is very low,” said Joseph Allen, a ventilation expert at the Harvard T.H. Chan School of Public Health. In an op-ed last year, he highlighted the danger that cars could pose for coronavirus transmission, and the potential benefits of opening the windows. “When you have that much turnover of air, the residence time, or how much time the aerosols stay inside the cabin, is very short,” Dr. Allen said

Because it’s not always practical to have all the windows wide open, especially in the depths of winter, Dr. Mathai and his colleagues also modeled several other options. They found that while the most intuitive-seeming solution — having the driver and the passenger each roll down their own windows — was better than keeping all the windows closed, an even better strategy was to open the windows that are opposite each occupant. That configuration allows fresh air to flow in through the back left window and out through the front right window and helps create a barrier between the driver and the passenger.

“It’s like an air curtain,” Dr. Mathai said. “It flushes out all the air that’s released by the passenger, and it also creates a strong wind region in between the driver and the passenger.”

Richard Corsi, an air quality expert at Portland State University, praised the new study. “It’s pretty sophisticated, what they did,” he said, although he cautioned that changing the number of passengers in the car or the driving speed could affect the results.

Dr. Corsi, a co-author of the op-ed with Dr. Allen last year, has since developed his own model of the inhalation of coronavirus aerosols in various situations. His results, which have not yet been published, suggest that a 20-minute car ride with someone who is emitting infectious coronavirus particles can be much riskier than sharing a classroom or a restaurant with that person for more than an hour.

“The focus has been on superspreader events” because they involve a lot of people, he said. “But I think what sometimes people miss is that superspreader events are started by somebody who’s infected who comes to that event, and we don’t speak often enough about where that person got infected.”

In a follow-up study, which has not yet been published, Dr. Mathai found that opening the windows halfway seemed to provide about the same benefit as opening them fully, while cracking them just one-quarter of the way open was less effective.

Dr. Mathai said that the general findings would most likely hold for many four-door, five-seat cars, not just the Prius. “For minivans and pickups, I would still say that opening all windows or opening at least two windows can be beneficial,” he said. “Beyond that, I would be extrapolating too much.”

Ride-sharing companies should be encouraging this research, Dr. Mathai said. He sent a copy of his study to Uber and Lyft, he said, but has not received a response.

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What Does a More Contagious Virus Mean for Schools?

What Does a More Contagious Virus Mean for Schools?

The coronavirus variant discovered in Britain is more easily spread among children, as it is among adults. Current safeguards should protect schools, experts said, but only if strictly enforced.

Children in Knutsford, England, returning to school this month following a Christmas break.
Children in Knutsford, England, returning to school this month following a Christmas break.Credit…Martin Rickett/PAMPC, via Associated Press
Apoorva Mandavilli

  • Jan. 14, 2021, 3:46 p.m. ET

It wasn’t until last fall that many parents started to breathe easier, as it became clear that elementary schools, at least, were not cesspools of infection with the coronavirus. But the alarming news of a more contagious version of the virus, first identified in Britain, revived those concerns.

Initial reports were tinged with worry that children might be just as susceptible as adults, fueling speculation that schools might need to pre-emptively close to limit the variant’s spread. But recent research from Public Health England may put those fears to rest.

Based on detailed contact-tracing of about 20,000 people infected with the new variant — including nearly 3,000 children under 10 — the report showed that young children were about half as likely as adults to transmit the variant to others. That was true of the previous iteration of the virus, as well.

“There was a lot of speculation at the beginning suggesting that children spread this variant more,” said Muge Cevik, an infectious disease expert at the University of St. Andrews in Scotland and a scientific adviser to the British government. “That’s really not the case.”

But the variant does spread more easily among children, just as it does among adults. The report estimated that the new variant is about 30 percent to 50 percent more contagious than its predecessors — less than the 70 percent researchers had initially estimated, but high enough that the variant is expected to pummel the United States and other countries, as it did Britain.

Prime Minister Boris Johnson of Britain had promised last year to do all he could to keep schools open. But he changed course in the face of soaring infections and buckling hospital systems, and ordered schools and colleges to move to remote learning. Other European countries put a premium on opening schools in September and have worked to keep them open, though the variant already has forced some to close.

In the United States, the mutant virus has been spotted only in a handful of states but is expected to spread swiftly, becoming the predominant source of infections by March. If community prevalence rises to unmanageable levels — a likely proposition, given the surge in most states — even elementary schools may be forced to close.

But that should be a last resort, after closures of indoor restaurants, bars, bowling alleys and malls, several experts said.

“I still say exactly what many people have said for the past few months — that schools should be the last thing to close,” said Helen Jenkins, an infectious disease expert at Boston University. Keeping schools open carries some risk, but “I think it can be reduced substantially with all the mitigations in place,” she said.

Reports of the new variant first surfaced in early December, and some researchers initially suggested that unlike with previous versions of the virus, children might be just as susceptible to the new variant as adults.

Researchers at P.H.E. looked at how efficiently people of various ages transmitted the variant to others. They found that children under 10 were roughly half as likely as adults to spread the variant.

Adolescents and teenagers between ages 10 and 19 were more likely than younger children to spread the variant, but not as likely as adults. (The range for the older group in the study is too broad to be useful for drawing conclusions, Dr. Cevik said. Biologically, a 10-year-old is very different from a 19-year-old.)

Over all, though, the variant was more contagious in each age group than previous versions of the virus. The mutant virus will result in more infections in children unless schools shore up their precautions, experts said.

“The variant is not necessarily affecting children particularly, but we know that it’s adding on more transmissibility to all age groups,” Dr. Cevik said. “We need to find ways to return these kids back to school as soon as possible; we need to use this time period to prepare.”

A schoolyard in Dortmund, Germany, this month. Fears of the new variant prompted Chancellor Angel Merkel to order schools closed.
A schoolyard in Dortmund, Germany, this month. Fears of the new variant prompted Chancellor Angel Merkel to order schools closed.Credit…Ina Fassbender/Agence France-Presse — Getty Images

In Germany, Chancellor Angela Merkel had vowed that schools would be the last thing to close during the second lockdown that began in November. Schools went to great lengths to keep in-person classes in session, requiring children to wear masks and opening windows to ensure better ventilation even as temperatures plummeted.

But fear of the variant’s spread prompted Ms. Merkel to keep schools closed following the holiday break at least through the end of January.

In France, where the new variant has not resulted in a surge of infections so far, schools reopened earlier this month after the winter break. France was not dealing with a particularly difficult epidemic, and health protocols put in place last September limited transmission in schools, Jean-Michel Blanquer, France’s education minister, has said.

The Italian government, too, has allowed not just elementary schools to open but also high schools, albeit at half capacity. Still, local leaders have implemented tighter restrictions, with some high schools slated to stay closed until the end of the month.

In the United States, the variant has only been spotted in a handful of states, and still accounts for less than 0.5 percent of infections. Schools remain open in New York City and many other parts of the country, but some have had to shut down because of rising virus infections in the community.

“Obviously, we don’t want to get to a point where it seems like we closed schools too late,” said Dr. Uché Blackstock, an urgent care physician in Brooklyn and founder of Advancing Health Equity, a health care advocacy group. “But at the same time, I think that we should try to keep our young children in school for as long as possible for in-person learning.”

It’s been clear for months what measures are necessary, Dr. Blackstock and other experts said: requiring masks for all children and staff; ensuring adequate ventilation in schools, even if just by opening windows or teaching outdoors; maintaining distance between students, perhaps by adopting hybrid schedules; and hand hygiene.

The new variant, while more contagious, is still thwarted by these measures. But only a few schools in Britain implemented them.

“When we look at what’s happened in the U.K. and think about this new variant, and we see all the case numbers going up, we have to remember it in the context of schools being open with virtually no modification at all,” Dr. Jenkins said. “I would like to see a real-life example of that kind of country or state or location, which has managed to control things in schools.”

There are some examples within the United States.

Erin Bromage, an immunologist at the University of Massachusetts Dartmouth, advised the governor of Rhode Island, as well as schools in southern Massachusetts, on preventive measures needed to turn back the coronavirus. The schools that closely adhered to the guidelines have not seen many infections, even when the virus was circulating at high levels in the community, Dr. Bromage said.

“When the system is designed correctly and we’re bringing children into school, they are as safe, if not safer, than they would be in a hybrid or remote system,” he said.

The school Dr. Bromage’s children attend took additional precautions. For example, administrators closed the school a few days before Thanksgiving to lower the risk at family gatherings, and operated remotely the week following the holiday.

Officials tested the nearly 300 students and staff at the end of that week, found only two cases, and decided to reopen.

“That gave us the confidence that our population was not representative of what we were seeing in the wider community,” he said. “We were using data to determine coming back together.”

The tests cost $61 per child, but schools that cannot afford it could consider testing only teachers, he added, because the data suggest the virus is “more likely to move from teacher to teacher than it is from student to teacher.”

In New York City, students and teachers are randomly tested, and have so far shown remarkably low rates of transmission within schools.

Dr. Blackstock has two children at an elementary school in Brooklyn, and said her son has not been tested all year. Even if the new variant brings a spike in cases, the city’s policy of closing a school if it has two unrelated infections is “too conservative,” she said.

If the number of cases skyrockets and the schools shut down more often, “then I would probably say, ‘This doesn’t feel right, let’s keep them home,’” she said. “But they’re going to be in school as long as I can possibly keep them.”

Emma Bubola contributed reporting from Milan, Melissa Eddy from Berlin, Constant Méheut from Paris and Benjamin Mueller from London.

One Mask Is Good. Would Two Would Be Better?

One Mask Is Good. Would Two Would Be Better?

Health experts double down on their advice for slowing the spread of the coronavirus.

A double-mask wearer in New York City in April.
A double-mask wearer in New York City in April.Credit…Kena Betancur/Getty Images
Katherine J. Wu

  • Jan. 12, 2021, 12:51 p.m. ET

Football coaches do it. President-elects do it. Even science-savvy senators do it. As cases of the coronavirus continue to surge on a global scale, some of the nation’s most prominent people have begun to double up on masks — a move that researchers say is increasingly being backed up by data.

Double-masking isn’t necessary for everyone. But for people with thin or flimsy face coverings, “if you combine multiple layers, you start achieving pretty high efficiencies” of blocking viruses from exiting and entering the airway, said Linsey Marr, an expert in virus transmission at Virginia Tech and an author on a recent commentary laying out the science behind mask-wearing.

Of course, there’s a trade-off: At some point, “we run the risk of making it too hard to breathe,” she said. But there is plenty of breathing room before mask-wearing approaches that extreme.

A year into the Covid-19 pandemic, the world looks very different. More than 90 million confirmed coronavirus infections have been documented worldwide, leaving millions dead and countless others with lingering symptoms, amid ongoing economic hardships and shuttered schools and businesses. New variants of the virus have emerged, carrying genetic changes that appear to enhance their ability to spread from person to person.

And while several vaccines have now cleared regulatory hurdles, the rollout of injections has been sputtering and slow — and there is not yet definitive evidence to show that shots will have a substantial impact on how fast, and from whom, the virus will spread.

Through all that change, researchers have held the line on masks. “Americans will not need to be wearing masks forever,” said Dr. Monica Gandhi, an infectious disease physician at the University of California, San Francisco, and an author on the new commentary. But for now, they will need to stay on, delivering protection both to mask-wearers and to the people around them.

The arguments for masking span several fields of science, including epidemiology and physics. A bevy of observational studies have suggested that widespread mask-wearing can curb infections and deaths on an impressive scale, in settings as small as hair salons and at the level of entire countries. One study, which tracked state policies mandating face coverings in public, found that known Covid cases waxed and waned in near-lockstep with mask-wearing rules. Another, which followed coronavirus infections among health care workers in Boston, noted a drastic drop in the number of positive test results after masks became a universal fixture among staff. And a study in Beijing found that face masks were 79 percent effective at blocking transmission from infected people to their close contacts.

Recent work by researchers like Dr. Marr is now pinning down the basis of these links on a microscopic scale. The science, she said, is fairly intuitive: Respiratory viruses like the coronavirus, which move between people in blobs of spittle and spray, need a clear conduit to enter the airway, which is crowded with the types of cells the viruses infect. Masks that cloak the nose and mouth inhibit that invasion.

The point is not to make a mask airtight, Dr. Marr said. Instead, the fibers that comprise masks create a haphazard obstacle course through which air — and any infectious cargo — must navigate.

“The air has to follow this tortuous path,” Dr. Marr said. “The big things it’s carrying are not going to be able to follow those twists and turns.”

Experiments testing the extent to which masks can waylay inbound and outbound spray have shown that even fairly basic materials, like cloth coverings and surgical masks, can be at least 50 percent effective in either direction.

Several studies have reaffirmed the notion that masks seem to be better at guarding people around the mask-wearer than mask-wearers themselves. “That’s because you’re stopping it right at the source,” Dr. Marr said. But, motivated by recent research, the Centers for Disease Control and Prevention has noted that there are big benefits for those who don masks as well.

Masks awaiting disinfecting at the Battelle N95 decontamination site in Somerville, Mass.
Masks awaiting disinfecting at the Battelle N95 decontamination site in Somerville, Mass.Credit…Michael Dwyer/Associated Press

The best masks remain N95s, which are designed with ultrahigh filtration efficiency. But they remain in short supply for health workers, who need them to safely treat patients.

Layering two less specialized masks on top of each other can provide comparable protection. Dr. Marr recommended wearing face-hugging cloth masks over surgical masks, which tend to be made with more filter-friendly materials but fit more loosely. An alternative is to wear a cloth mask with a pocket that can be stuffed with filter material, like the kind found in vacuum bags.

But wearing more than two masks, or layering up on masks that are already very good at filtering, will quickly bring diminishing returns and make it much harder to breathe normally.

Other tweaks can enhance a mask’s fit, such as ties that secure the fabric around the back of the head, instead of relying on ear loops that allow masks to hang and gape. Nose bridges, which can help the top of a mask to fit more snugly, offer a protective boost as well.

Achieving superb fit and filtration “is really simple,” Dr. Gandhi said. “It doesn’t need to involve anything fancy.”

No mask is perfect, and wearing one does not obviate other public health measures like physical distancing and good hygiene. “We have to be honest that the best response is one that requires multiple interventions,” said Jennifer Nuzzo, a public health expert at Johns Hopkins University.

Mask-wearing remains uncommon in some parts of the country, in part because of politicization of the practice. But experts noted that model behavior by the nation’s leaders might help to turn the tide. In December, President-elect Joseph R. Biden Jr. implored Americans to wear masks for his first 100 days in office, and said he would make doing so a requirement in federal buildings and on planes, trains and buses that cross state lines.

A large review on the evidence behind masking, published this month in the journal PNAS, concluded that masks are a key tool for reducing community transmission, and is “most effective at reducing spread of the virus when compliance is high.”

Part of the messaging might also require more empathy, open communication and vocal acknowledgment that “people don’t enjoy wearing masks,” Dr. Nuzzo said. Without more patience and compassion, simply doubling down on restrictions to “fix” poor compliance will backfire: “No policy is going to work if no one is going to adhere.”

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A Colonoscopy Alternative Comes Home

A Colonoscopy Alternative Comes Home

An at-home test for colon cancer is as reliable as the traditional screening, health experts say, and more agreeable.

Credit…Karlotta Freier

  • Jan. 11, 2021, 1:40 p.m. ET

Most Americans who are due for a colon cancer screening will receive a postcard or a call — or prompting during a doctor’s visit — to remind them that it’s time to schedule a colonoscopy.

But at big health care systems like Kaiser Permanente or the federal Veterans Health Administration, the process has changed. Patients who should be screened regularly (age 50 to 75) and who are of average risk, get a letter telling them about a home test kit arriving by mail.

It’s a FIT, which stands for fecal immunochemical test. The small cardboard mailer contains equipment and instructions for taking a stool sample and returning the test to a lab, to detect microscopic amounts of blood. A week or so later, the results show up on an online patient portal.

Five to 6 percent of patients will have a positive test and need to schedule a follow-up colonoscopy. But the great majority are finished with colon cancer screening for the year — no uncomfortable prep, no need to skip work or find someone to drive them home after anesthesia, no colonoscopy.

Last spring, when the coronavirus pandemic closed many medical facilities and postponed nonemergency procedures, this approach suddenly looked even more desirable.

“We know that from March to May, colon cancer screenings fell by about 90 percent,” said Dr. Rachel Issaka, a gastroenterologist at the University of Washington and the Fred Hutchinson Cancer Research Center. Although testing has resumed, she said, “we’re still not back to where we were.”

Yet colon cancer represents the third-highest cause of cancer deaths, after lung cancer and, tied for second place, breast and prostate cancer. Unlike those, colon cancer can be prevented with early detection.

With many older adults trying to avoid hospitals and surgical centers, even as their risk of colon cancer rises with age, an at-home test provides an alternative to colonoscopy — one that is both safer, with a lower risk of complications and Covid-19 exposure, and does as good a job.

“If your doctor tells you a colonoscopy is better, that’s not accurate,” said Dr. Alex Krist, chairman of the U.S. Preventive Services Task Force, an independent expert panel that reviews evidence and issues recommendations. “The data show the tests are equally effective at saving lives.”

The Task Force is updating its guidelines for colon cancer screening and this year will likely recommend lowering the age at which it should begin, to 45. But the recommendations on the upper end will remain unchanged: Based on strong evidence, adults up to age 75 should be screened regularly.

Beyond that age, the disadvantages begin to mount. The Task Force says the benefit of screening 76- to 85-year-olds is small, and that the decision should be an individual one, reached in consultation with a doctor.

Colon cancer develops slowly, explained Dr. James Goodwin, a geriatrician and researcher at the University of Texas Medical Branch in Galveston. Patients at older ages, who typically contend with several other diseases, may not live long enough to benefit. “You cause more harm than good,” Dr. Goodwin said.

The advice to stop screening isn’t always popular with patients. “People don’t like to hear about not living very long,” he said. But with colonoscopy, he noted, “you go through an unpleasant experience — or an unpleasant experience followed by an unpleasant diagnosis and unpleasant treatment — for something that, if you’d never known about it, wouldn’t cause you harm.”

Even if a test eventually finds colon cancer, surgery plus chemotherapy, the standard treatment, could itself endanger a frail older person. “I would be heavily biased against anyone getting a screening, of any sort, over age 80,” Dr. Goodwin said.

Although Americans still rely mostly on colonoscopy, his research has shown that for many older people, that test is overused, either because of the patients’ ages or because they are tested too frequently.

Yet screening is simultaneously underused. In 2018, according to the Centers for Disease Control and Prevention, only about 70 percent of adults were up-to-date on colorectal cancer testing. About one-fifth of those 65 to 75 had not been screened as recommended. Among those 50 to 65, where lack of Medicare or other insurance probably contributed, only about 63 percent were appropriately screened.

The Task Force has found several kinds of screening tests effective, but the ones used most for people at average risk are colonoscopy, at a recommended 10-year interval, or FIT annually.

A newer entry, an at-home test sold under the brand name Cologuard that detects blood and cancer biomarkers in stool, may be used every three years, but a study found it to be less effective than most other methods and far more expensive than FIT.

When screening is recommended, how does FIT stack up against colonoscopy?

Higher-risk patients — including those who have had colon cancer or parents or siblings with colon cancer, those with inflammatory bowel disorders like Crohn’s disease, and those who have had abnormal previous tests, including multiple or large polyps — should seek out a colonoscopy, often on an accelerated schedule. The procedure involves inserting a viewing instrument through the anus to directly visualize an anesthetized patient’s colon.

A colonoscopy offers one distinct advantage: if the gastroenterologist spots polyps, growths that over time could become cancerous (although most don’t), these can be removed immediately. “You’re preventing cancer, snipping out the things that could lead to cancer,” Dr. Goodwin said. After a negative colonoscopy, patients don’t need another for a decade.

But the procedure’s complications increase with age, although they remain low; the most serious, a perforated colon, requires hospitalization. Cleaning out the bowel on the day before the procedure, in preparation, is disruptive and disagreeable, and Dr. Goodwin notes that older patients sometimes experience cycles of diarrhea and constipation for weeks afterward.

Rural residents may find traveling to a facility difficult. The use of anesthesia means that every patient needs someone to drive or escort them home afterward. The prospect of spending two to four hours in a facility, even one using rigorous safety measures, will cause some older adults to postpone testing because of Covid-19 fears.

The FIT, which is far more widely used in other countries, avoids many of those difficulties. A marked improvement over earlier at-home stool tests, it requires a sample from one day instead of samples from three, and imposes no food or drug restrictions. A positive result still calls for a colonoscopy, but the great majority of patients avoid that outcome.

Why do so many Americans still undergo colonoscopies, then? “There’s a large financial incentive for people who do colonoscopies to do colonoscopies,” Dr. Goodwin said, so patients may not hear much about the alternatives.

“Many of my own patients are surprised to learn that there’s another way,” said Dr. Krist, also a family physician at Virginia Commonwealth University. “As they age, they want less invasive methods” and may be happy to switch.

Wider adoption of FIT could also save patients and insurers, notably Medicare, a boatload. The home test, which is available through several manufacturers, generally costs less than $20; a colonoscopy can easily exceed $1,000.

Moreover, with personalized messages to patients and follow-up reminders to return the kit, FIT use can result in more people being screened. That could prove important when the Preventive Services Task Force lowers the recommended age to 45, which would add 22 million Americans to the list of people advised to undergo colon cancer screening. Their needs, plus a backlog of patients who postponed tests during the pandemic, could swamp gastroenterology practices.

“If a provider doesn’t bring up” the possibility of an at-home test, Dr. Issaka said, “patients should feel empowered to ask about it.” Colon cancer screenings, of any type, “are considered non-urgent,” she said. “But they’re not optional.”

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One 18-Hour Flight, Four Coronavirus Infections

One 18-Hour Flight, Four Coronavirus Infections

An outbreak aboard a September flight from Qatar to New Zealand offers researchers, and airlines, an opportunity to study in-transit contagion.

A masked passenger on a flight out of Kansas City, Mo., last year. The study of a largely empty flight last fall suggests that airlines will need to further tighten precautions on flights.
A masked passenger on a flight out of Kansas City, Mo., last year. The study of a largely empty flight last fall suggests that airlines will need to further tighten precautions on flights.Credit…Charlie Riedel/Associated Press
Benedict Carey

  • Jan. 7, 2021, 5:50 p.m. ET

The millions of airline passengers who traveled over the holidays experienced firsthand the unsettling uncertainties that come with flying during a pandemic. The anxious glances. The awkward semi-distancing. The haphazard mask etiquette, and the absence of regular service.

In an effort to reassure, the airlines have updated and adjusted their requirements for travelers, with patchwork results. Some airlines work to maintain social distance, both at the gate and at boarding; others are less vigilant. Mask-wearing is dependent on passenger compliance, and not predictable; nor, increasingly, is flight capacity, which can range from 20 percent to nearly full.

Given the variables, infectious disease specialists have had a hard time determining the risks of flying. But a study published on Wednesday provides some clarity.

After an 18-hour flight from Dubai landed in Auckland, New Zealand, in September, local health authorities discovered evidence of an outbreak that most likely occurred during the trip. Using seat maps and genetic analysis, the new study determined that one passenger initiated a chain of infection that spread to four others en route.

Previous research on apparent in-flight outbreaks focused on flights that occurred last spring, when few travelers wore masks, planes were running near capacity and the value of preventive measures was not broadly understood. The new report, of a largely empty flight in the fall, details what can happen even when airlines and passengers are aware and more cautious about the risks.

The findings deliver a clear warning to both airlines and passengers, experts said.

“The key message here is that you have to have multiple layers of prevention — requiring testing before boarding, social distancing on the flight, and masks,” said Dr. Abraar Karan, an internal medicine physician at Brigham and Women’s Hospital and Harvard Medical School who was not part of the study team. “Those things all went wrong in different ways on this flight, and if they’d just tested properly, this wouldn’t have happened.”

The new infections were detected after the plane landed in New Zealand; the country requires incoming travelers to quarantine for 14 days before entering the community. The analysis, led by researchers at the New Zealand Ministry of Health, found that seven of the 86 passengers on board tested positive during their quarantine and that at least four were newly infected on the flight. The aircraft, a Boeing 777-300ER, with a capacity of nearly 400 passengers, was only one-quarter full.

A diagram from the study shows the seating arrangement of the seven passengers who tested positive. The open circles represent passengers who tested negative for the coronavirus after the flight. All other seats shown remained empty.
A diagram from the study shows the seating arrangement of the seven passengers who tested positive. The open circles represent passengers who tested negative for the coronavirus after the flight. All other seats shown remained empty.Credit…Centers for Disease Control and Prevention

These seven passengers came from five countries, and they were seated within four rows of one another for the 18-hour duration of the flight. Two acknowledged that they did not wear masks, and the airline did not require mask-wearing in the lobby before boarding. Nor did it require preflight testing, although five of the seven passengers who later tested positive had taken a test, and received a negative result, in the days before boarding.

The versions of the coronavirus that all seven carried were virtually identical genetically — strongly suggesting that one person among them initiated the outbreak. That person, whom the report calls Passenger A, had in fact tested negative four or five days before boarding, the researchers found.

“Four or five days is a long time,” Dr. Kamar said. “You should be asking for results of rapid tests done hours before the flight, ideally.”

Even restrictive “Covid-free” flights, international bookings that require a negative result to board, give people a day or two before departure to get a test.

The findings are not definitive, cautioned the authors, led by Dr. Tara Swadi, an adviser with New Zealand’s Health Ministry. But results “underscore the value of considering all international passengers arriving in New Zealand as being potentially infected, even if pre-departure testing was undertaken, social distancing and spacing were followed, and personal protective equipment was used in-flight,” the researchers concluded.

Previous studies of infection risk during air travel did not clearly quantify the risk, and onboard air filtration systems are thought to reduce the infection risk among passengers even when a flight includes one or more infected people. But at least two recent reports strongly suggest that in-flight outbreaks are a risk: one of a flight from Boston to Hong Kong in March; the other of a flight from London to Hanoi, Vietnam, also in March.

On the Hong Kong flight, the analysis suggested that two passengers who boarded in Boston infected two flight attendants. On the Hanoi flight, researchers found that 12 of 16 people who later tested positive were sitting in business class, and that proximity to the infectious person strongly predicted infection risk.

Airline policies vary widely, depending on the flight and the carrier. During the first months of the pandemic, most U.S. airlines had a policy of blocking off seats, or allowing passengers to reschedule if a flight was near 70 percent full. But by the holidays those policies were largely phased out, said Scott Mayerowitz, executive editor at The Points Guy, a website that covers the industry.

All carriers have a mask policy, for passengers and crew — although passengers are not always compliant.

“Even before the pandemic, passengers weren’t always the best at following rules on airplanes,” Mr. Mayerowitz said. “Something about air travel brings out the worse in people, whether it’s fighting over reclined seats, or overhead bin space, or wearing a mask properly.”

Temperature checks are uncommon and are less than reliable as an indicator of infectiousness. And coronavirus tests are not needed for boarding, at least on domestic flights. Some international flights are “Covid tested”: to fly from New York to Rome on Alitalia, for example, passengers must have received a negative test result within 48 hours of boarding. They are tested again on arrival in Rome.

Dr. Kamar said that, unless all preventive measures are in place, there will be some risk of infection on almost any flight.

“It is surprising and not surprising, on an 18-hour flight, that an outbreak would occur,” Dr. Kamar said. “It’s more than likely that more than just those two people took off their mask at some point,” and every such lapse increases the likelihood of spread.

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A Riot Amid a Pandemic: Did the Virus, Too, Storm the Capitol?

A Riot Amid a Pandemic: Did the Virus, Too, Storm the Capitol?

Some scientists fear that the mayhem on Capitol Hill may have led to a so-called super-spreading event.

The rally on the National Mall before a mob entered the Capitol on Wednesday.
The rally on the National Mall before a mob entered the Capitol on Wednesday.Credit…Pete Marovich for The New York Times
Apoorva Mandavilli

  • Jan. 7, 2021, 3:29 p.m. ET

The mob that stormed the Capitol yesterday did not just threaten the heart of American democracy. To scientists who watched dismayed as the scenes unfolded on television, the throngs of unmasked intruders who wandered through hallways and into private offices may also have transformed the riot into a super-spreader event.

The coronavirus thrives indoors, particularly in crowded spaces, lingering in the air in tiny particles called aerosols. If even a few extremists were infected — likely, given the current rates of spread and the crowd size — then the virus would have had the ideal opportunity to find new victims, experts said.

“It has all the elements of what we warn people about,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. “People yelling and screaming, chanting, exerting themselves — all of those things provide opportunity for the virus to spread, and this virus takes those opportunities.”

President Trump has downplayed the pandemic almost since its beginning, and many of his supporters who entered the Capitol yesterday did not appear to be wearing masks or making any effort at social distancing. Under similar conditions, gatherings held in such close quarters have led to fast-spreading clusters of infection.

But transmission of the virus has always been difficult to track. There is little effective contact tracing in the United States, and many in the crowd at the Capitol arrived from communities far from Washington.

The Black Lives Matter protests in the summer raised similar concerns. But most were held outdoors, and greater numbers of participants seemed to be masked. Research afterward suggested these were not super-spreading events.

Attendees of the rally preceding the rush to the Capitol on Wednesday also stood outdoors close together for hours, but “I’m less worried about what was happening outdoors,” Dr. Rimoin said. “The risk increases exponentially indoors.”

Rioters in the National Statuary Hall in the Capitol on Wednesday.
Rioters in the National Statuary Hall in the Capitol on Wednesday.Credit…Anna Moneymaker for The New York Times

Hundreds of rioters shouting in crowded rooms and hallways for extended periods of time can infect dozens of people at once, she and other experts said.

Three distinct groups — Capitol Police, rioters and members of Congress — “were spending time indoors, without social distancing, for long periods of time,” said Dr. Joshua Barocas, an infectious diseases physician at Boston University. The melee likely was a super-spreader event, he added, “especially given the backdrop of the highly transmissible variants that are circulating.”

Dr. Barocas was referring to a highly contagious new variant of the coronavirus, first identified in Britain. It has been spotted in several U.S. states but may well have spread everywhere in the country, making events like the Capitol riot even more risky, he said.

The idea that members of Congress may have been exposed, amid an already difficult transfer of power, particularly disturbed some scientists. “I am worried not only that it could it could lead to super spreading, but also super spreading to people who are elected officials,” said Dr. Tom Ingelsby, director of the Center for Health Security at Johns Hopkins University.

And infected members of Congress and law enforcement could have spread the virus to one another as they sheltered from the violence, he noted.

Rep. Jake LaTurner, Republican of Kansas, announced on Twitter early Thursday morning that he had tested positive for the virus. Mr. LaTurner was cloistered in the chamber with other members of Congress for much of the day.

At least a dozen of the 400 or so lawmakers and staff who were huddling in one committee room refused to wear masks even after being offered one, or wore them improperly below their chins, said Representative Susan Wild, Democrat of Pennsylvania.

They gathered in a committee room that quickly became crowded, making social distancing impossible, she said. Some of the lawmakers were unmasked, and several were shouting: “Tensions were high, and people were yelling at each other.”

“I just started getting really kind of angry, thinking about the holidays just passed, and how so many people did not spend time with their immediate families for fear of spreading,” she added, referring to her unmasked colleagues.

Representative Debbie Dingell, Democrat of Michigan, said the environment made her so nervous she sat on the floor at one point, hoping to duck whatever virus might be floating about. She has asked experts whether the lawmakers present should now quarantine, she said. She was wearing two masks, as she often does.

“I get that they think they have their individual freedoms,” she said of Republican lawmakers who eschewed masks. “It’s a rule for a reason. It’s to protect the common good.”

Electoral College votes were returned to a joint session of Congress late Wednesday.Credit…Erin Schaff/The New York Times

The risk for members of Congress will depend greatly on ventilation in the room where they sheltered, said Joseph Allen, an expert on buildings quality at the Harvard T.H. Chan School of Public Health in Boston.

“If there is a well-designed secure facility, then it would have great ventilation and filtration,” Dr. Allen said. “If it’s a place where they were just hunkered down wherever they could go that was safe, and it was not a place that was designed like that, then we don’t really know.”

It’s natural in a heart-pounding crisis to disregard risks that seem intangible or theoretical, he and other scientists noted.

“You cannot keep distance if you’re trying to leave a very intense and dangerous situation,” said Seema Lakdawala, an expert in respiratory virus transmission at the University of Pittsburgh. “You’re weighing the risk of your life over the risk of getting a virus at that moment.”

Members of Congress returned to continue the electoral count after the rioters were cleared from the Capitol. Some legislators took off their masks before giving a speech, Dr. Barocas noted, at precisely the time they needed to wear them. Talking at a high volume can expel vast quantities of aerosols, propelling them through an enclosed space.

Scientists have documented infectious aerosols suspended in air nearly 20 feet from an infected person. And a recent study from South Korea found that two people had become infected after spending just five minutes in a restaurant, 15 feet away from an infected patron.

Many Americans breathed sighs of relief as rioters departed the Capitol. Some experts feared that rioters heading back home could set off new chains of infection, perhaps impossible to track.

“We might get an inkling into how bad it might be because of the federal employees,” Dr. Barocas said. But “I don’t think that we’re going to know the extent of this super-spreader event.”

Even as the mob stormed the Capitol on Wednesday, the pandemic marked a grim milestone: The virus claimed nearly 4,000 lives, the highest daily toll thus far. The numbers are expected to keep rising.

The president has “created a culture in which people think it’s a hoax, and these basic control measures are being flouted repeatedly everywhere,” Dr. Allen said.

Some Covid Survivors Haunted by Loss of Smell and Taste

Some Covid Survivors Haunted by Loss of Smell and Taste

As the coronavirus claims more victims, a once-rare diagnosis is receiving new attention from scientists, who fear it may affect nutrition and mental health.

Katherine Hansen used to be able to recreate a restaurant recipe just from tasting a dish. “I’m like someone who loses their eyesight as an adult,” she said.
Katherine Hansen used to be able to recreate a restaurant recipe just from tasting a dish. “I’m like someone who loses their eyesight as an adult,” she said.Credit…Jovelle Tamayo for The New York Times
Roni Caryn Rabin

  • Jan. 2, 2021, 10:26 a.m. ET

Until March, when everything started tasting like cardboard, Katherine Hansen had such a keen sense of smell that she could recreate almost any restaurant dish at home without the recipe, just by recalling the scents and flavors.

Then the coronavirus arrived. One of Ms. Hansen’s first symptoms was a loss of smell, and then of taste. Ms. Hansen still cannot taste food, and says she can’t even tolerate chewing it. Now she lives mostly on soups and shakes.

“I’m like someone who loses their eyesight as an adult,” said Ms. Hansen, a realtor who lives outside Seattle. “They know what something should look like. I know what it should taste like, but I can’t get there.”

A diminished sense of smell, called anosmia, has emerged as one of the telltale symptoms of Covid-19, the illness caused by the coronavirus. It is the first symptom for some patients, and sometimes the only one. Often accompanied by an inability to taste, anosmia occurs abruptly and dramatically in these patients, almost as if a switch had been flipped.

Most regain their senses of smell and taste after they recover, usually within weeks. But in a minority of patients like Ms. Hansen, the loss persists, and doctors cannot say when or if the senses will return.

Scientists know little about how the virus causes persistent anosmia or how to cure it. But cases are piling up as the coronavirus sweeps across the world, and some experts fear that the pandemic may leave huge numbers of people with a permanent loss of smell and taste. The prospect has set off an urgent scramble among researchers to learn more about why patients are losing these essential senses, and how to help them.

“Many people have been doing olfactory research for decades and getting little attention,” said Dr. Dolores Malaspina, professor of psychiatry, neuroscience, genetics and genomics at Icahn School of Medicine at Mount Sinai in New York. “Covid is just turning that field upside down.”

Smell is intimately tied to both taste and appetite, and anosmia often robs people of the pleasure of eating. But the sudden absence also may have a profound impact on mood and quality of life.

Studies have linked anosmia to social isolation and anhedonia, an inability to feel pleasure, as well as a strange sense of detachment and isolation. Memories and emotions are intricately tied to smell, and the olfactory system plays an important though largely unrecognized role in emotional well-being, said Dr. Sandeep Robert Datta, an associate professor of neurobiology at Harvard Medical School.

“You think of it as an aesthetic bonus sense,” Dr. Datta said. “But when someone is denied their sense of smell, it changes the way they perceive the environment and their place in the environment. People’s sense of well-being declines. It can be really jarring and disconcerting.”

Many sufferers describe the loss as extremely upsetting, even debilitating, all the more so because it is invisible to others.

“Smell is not something we pay a lot of attention to until it’s gone,” said Pamela Dalton, who studies smell’s link to cognition and emotion at the Monell Chemical Senses Center in Philadelphia. “Then people notice it, and it is pretty distressing. Nothing is quite the same.”

British scientists studied the experiences of 9,000 Covid-19 patients who joined a Facebook support group set up by the charity group AbScent between March 24 and September 30. Many members said they had not only lost pleasure in eating, but also in socializing. The loss had weakened their bonds with other people, affecting intimate relationships and leaving them feeling isolated, even detached from reality.

“I feel alien from myself,” one participant wrote. “It’s also kind of a loneliness in the world. Like a part of me is missing, as I can no longer smell and experience the emotions of everyday basic living.”

Another said, “I feel discombobulated — like I don’t exist. I can’t smell my house and feel at home. I can’t smell fresh air or grass when I go out. I can’t smell the rain.”

Loss of smell is a risk factor for anxiety and depression, so the implications of widespread anosmia deeply trouble mental health experts. Dr. Malaspina and other researchers have found that olfactory dysfunction often precedes social deficits in schizophrenia, and social withdrawal even in healthy individuals.

“From a public health perspective, this is really important,” Dr. Datta said. “If you think worldwide about the number of people with Covid, even if only 10 percent have a more prolonged smell loss, we’re talking about potentially millions of people.”

The most immediate effects may be nutritional. People with anosmia may continue to perceive basic tastes — salty, sour, sweet, bitter and umami. But taste buds are relatively crude preceptors. Smell adds complexity to the perception of flavor via hundreds of odor receptors signaling the brain.

Many people who can’t smell will lose their appetites, putting them at risk of nutritional deficits and unintended weight loss. Kara VanGuilder, who lives in Brookline, Mass., said she has lost 20 pounds since March, when her sense of smell vanished.

“I call it the Covid diet,” said Ms. VanGuilder, 26, who works in medical administration. “There no point in indulging in brownies if I can’t really taste the brownie.”

But while she jokes about it, she added, the loss has been distressing: “For a few months, every day almost, I would cry at the end of the day.”

Michele Miller developed anosmia following a bout with Covid-19 in March. She did not smell the gas from the oven filling up her kitchen.
Michele Miller developed anosmia following a bout with Covid-19 in March. She did not smell the gas from the oven filling up her kitchen.Credit…Joshua Bright for The New York Times

Smells also serve as a primal alarm system alerting humans to dangers in our environment, like fires or gas leaks. A diminished sense of smell in old age is one reason older individuals are more prone to accidents, like fires caused by leaving burning food on the stove.

Michele Miller, of Bayside, N.Y., was infected with the coronavirus in March and hasn’t smelled anything since then. Recently, her husband and daughter rushed her out of their house, saying the kitchen was filling with gas.

She had no idea. “It’s one thing not to smell and taste, but this is survival,” Ms. Miller said.

Humans constantly scan their environments for smells that signal changes and potential harms, though the process is not always conscious, said Dr. Dalton, of the Monell Chemical Senses Center.

Smell alerts the brain to the mundane, like dirty clothes, and the risky, like spoiled food. Without this form of detection, “people get anxious about things,” Dr. Dalton said.

Even worse, some Covid-19 survivors are tormented by phantom odors that are unpleasant and often noxious, like the smells of burning plastic, ammonia or feces, a distortion called parosmia.

Eric Reynolds, a 51-year-old probation officer in Santa Maria, Calif., lost his sense of smell when he contracted Covid-19 in April. Now, he said, he often perceives foul odors that he knows don’t exist. Diet drinks taste like dirt; soap and laundry detergent smell like stagnant water or ammonia.

“I can’t do dishes, it makes me gag,” Mr. Reynolds said. He’s also haunted by phantom smells of corn chips and a scent he calls “old lady perfume smell.”

It’s not unusual for patients like him to develop food aversions related to their distorted perceptions, said Dr. Evan R. Reiter, medical director of the smell and taste center at Virginia Commonwealth University, who has been tracking the recovery of some 2,000 Covid-19 patients who lost their sense of smell.

One of his patients is recovering, but “now that it’s coming back, she’s saying that everything or virtually everything that she eats will give her a gasoline taste or smell,” Dr. Reiter said.

The derangement of smell may be part of the recovery process, as receptors in the nose struggle to reawaken, sending signals to the brain that misfire or are misread, Dr. Reiter said.

After loss of smell, “different populations or subtypes of receptors may be impacted to different degrees, so the signals your brain is used to getting when you eat steak will be distorted and may trick your brain into thinking you’re eating dog poop or something else that’s not palatable.”

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Patients desperate for answers and treatment have tried therapies like smell training: sniffing essential oils or sachets with a variety of odors — such as lavender, eucalyptus, cinnamon and chocolate — several times a day in an effort to coax back the sense of smell. A recent study of 153 patients in Germany found the training could be moderately helpful in those who had lower olfactory functioning and in those with parosmia.

Dr. Alfred Iloreta, an otolaryngologist at Mount Sinai Hospital in New York, has begun a clinical trial to see whether taking fish oil helps restore the sense of smell. The omega-3 fatty acids found in fish oil may protect nerve cells from further damage or help regenerate nerve growth, he suggested.

“If you have no smell or taste, you have a hard time eating anything, and that’s a massive quality of life issue,” Dr. Iloreta said. “My patients, and the people I know who have lost their smell, are completely wrecked by it.”

Mr. Reynolds feels the loss most acutely when he goes to the beach near his home to walk. He no longer smells the ocean or salt air.

“My mind knows what it smells like,” he said. “And when I get there, it’s not there.”

How Does the Coronavirus Variant Spread? Here’s What Scientists Know

How Does the Coronavirus Variant Spread? Here’s What Scientists Know

Contagiousness is the hallmark of the mutated virus surfacing in the U.S. and more than a dozen other countries.

The first infection with the new variant in the United States was traced to a National Guardsman who was working at the Good Samaritan Society, an assisted living facility in Simla, Calif.
The first infection with the new variant in the United States was traced to a National Guardsman who was working at the Good Samaritan Society, an assisted living facility in Simla, Calif.Credit…Matthew Staver for The New York Times
Apoorva Mandavilli

  • Dec. 31, 2020, 3:37 p.m. ET

A more contagious form of the coronavirus has begun circulating in the United States.

In Britain, where it was first identified, the new variant became the predominant form of the coronavirus in just three months, accelerating that nation’s surge and filling its hospitals. It may do the same in the United States, exacerbating an unrelenting rise in deaths and overwhelming the already strained health care system, experts warned.

A variant that spreads more easily also means that people will need to religiously adhere to precautions like social distancing, mask-wearing, hand hygiene and improved ventilation — unwelcome news to many Americans already chafing against restrictions.

“The bottom line is that anything we do to reduce transmission will reduce transmission of any variants, including this one,” said Angela Rasmussen, a virologist affiliated with Georgetown University. But “it may mean that the more targeted measures that are not like a full lockdown won’t be as effective.”

What does it mean for this variant to be more transmissible? What makes this variant more contagious than previous iterations of the virus? And why should we worry about a variant that spreads more easily but does not seem to make anyone sicker?

We asked experts to weigh in on the evolving research into this new version of the coronavirus.

The new variant seems to spread more easily between people.

Many variants of the coronavirus have cropped up since the pandemic began. But all evidence so far suggests that the new mutant, called B.1.1.7, is more transmissible than previous forms. It first surfaced in September in Britain, but already accounts for more than 60 percent of new cases in London and neighboring areas.

The new variant seems to infect more people than earlier versions of the coronavirus, even when the environments are the same. It’s not clear what gives the variant this advantage, although there are indications that it may infect cells more efficiently.

It’s also difficult to say exactly how much more transmissible the new variant may be, because scientists have not yet done the kind of lab experiments that are required. Most of the conclusions have been drawn from epidemiological observations, and “there’s so many possible biases in all the available data,” cautioned Muge Cevik, an infectious disease expert at the University of St. Andrews in Scotland and a scientific adviser to the British government.

Scientists initially estimated that the new variant was 70 percent more transmissible, but a recent modeling study pegged that number at 56 percent. Once researchers sift through all the data, it’s possible that the variant will turn out to be just 10 to 20 percent more transmissible, said Trevor Bedford, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.

Even so, Dr. Bedford said, it is likely to catch on rapidly and become the predominant form in the United States by March. Scientists like Dr. Bedford are tracking all the known variants closely to detect any further changes that might alter their behavior.

Apart from greater transmissibility, the variant behaves like earlier versions.

The new mutant virus may spread more easily, but in every other way it seems little different than its predecessors.

So far, at least, the variant does not seem to make people any sicker or lead to more deaths. Still, there is cause for concern: A variant that is more transmissible will increase the death toll simply because it will spread faster and infect more people.

“In that sense, it’s just a numbers game,” Dr. Rasmussen said. The effect will be amplified “in places like the U.S. and the U.K., where the health care system is really at its breaking point.”

The routes of transmission — by large and small droplets, and tiny aerosolized particles adrift in crowded indoor spaces — have not changed. That means masks, limiting time with others and improving ventilation in indoor spaces will all help contain the variant’s spread, as these measures do with other variants of the virus.

“By minimizing your exposure to any virus, you’re going to reduce your risk of getting infected, and that’s going to reduce transmission over all,” Dr. Rasmussen said.

A drive-through Covid testing site at Dodger Stadium in Los Angeles on Wednesday.
A drive-through Covid testing site at Dodger Stadium in Los Angeles on Wednesday.Credit…Mario Tama/Getty Images

Infection with the new variant may increase the amount of virus in the body.

Some preliminary evidence from Britain suggests that people infected with the new variant tend to carry greater amounts of the virus in their noses and throats than those infected with previous versions.

“We’re talking in the range between 10-fold greater and 10,000-fold greater,” said Michael Kidd, a clinical virologist at Public Health England and a clinical adviser to the British government who has studied the phenomenon.

There are other explanations for the finding — Dr. Kidd and his colleagues did not have access to information about when in their illness people were tested, for example, which could affect their so-called viral loads.

Still, the finding does offer one possible explanation for why the new variant spreads more easily. The more virus that infected people harbor in their noses and throats, the more they expel into the air and onto surfaces when they breathe, talk, sing, cough or sneeze.

As a result, situations that expose people to the virus carry a greater chance of seeding new infections. Some new data indicate that people infected with the new variant spread the virus to more of their contacts.

With previous versions of the virus, contact tracing suggested that about 10 percent of people who have close contact with an infected person — within six feet for at least 15 minutes — inhaled enough virus to become infected.

“With the variant, we might expect 15 percent of those,” Dr. Bedford said. “Currently risky activities become more risky.”

Scientists are still learning how the mutations have changed the virus.

The variant has 23 mutations, compared with the version that erupted in Wuhan, China, a year ago. But 17 of those mutations appeared suddenly, after the virus diverged from its most recent ancestor.

Each infected person is a crucible, offering opportunities for the virus to mutate as it multiplies. With more than 83 million people infected worldwide, the coronavirus is amassing mutations faster than scientists expected at the start of the pandemic.

The vast majority of mutations provide no advantage to the virus and die out. But mutations that improve the virus’ fitness or transmissibility have a greater chance to catch on.

At least one of the 17 new mutations in the variant contributes to its greater contagiousness. The mechanism is not yet known. Some data suggest that the new variant may bind more tightly to a protein on the surface of human cells, allowing it to more readily infect them.

It’s possible that the variant blooms in an infected person’s nose and throat, but not in the lungs, for example — which may explain why patients spread it more easily but do not develop illnesses more severe than those caused by earlier versions of the virus. Some influenza viruses behave similarly, experts noted.

“We need to look at this evidence as preliminary and accumulating,” Dr. Cevik said of the growing data on the new variant.

Still, the research so far suggests an urgent need to cut down on transmission of the variant, she added: “We need to be much more careful over all, and look at the gaps in our mitigation measures.”

Don’t Let the Pandemic Stop Your Shots

the new old age

Don’t Let the Pandemic Stop Your Shots

Even as older adults await the coronavirus vaccine, many are skipping the standard ones. That’s not wise, health experts say.

Credit…Chris Lyons

  • Dec. 28, 2020, 12:12 p.m. ET

Peggy Stein, 68, a retired teacher in Berkeley, Calif., skipped a flu shot this year. Her reasoning: “How could I get the flu if I’m being so incredibly careful because of Covid?”

Karen Freeman, 74, keeps meaning to be vaccinated against shingles, but hasn’t done so. A retired college administrator in St. Louis, she quipped that “denial has worked well for me these many years.”

Sheila Blais, who lives on a farm in West Hebron, N.Y., has never received any adult vaccine. She also has never contracted the flu. “I’m such an introvert I barely leave the farm, so where’s my exposure?” said Ms. Blais, 66, a fiber artist. “If it’s not broke, don’t fix it.”

While older adults await vaccination against Covid-19, public health officials also worry about their forgoing, forgetting, fearing or simply not knowing about those other vaccines — the ones recommended for adults as we age and our immune systems weaken.

“There’s a lot of room for improvement,” said Dr. Ram Koppaka, associate director for adult immunization at the Centers for Disease Control and Prevention.

Every year, campaigns urge older adults to protect themselves against preventable infectious diseases. After all, influenza alone has killed 12,000 to 61,000 Americans annually over the past decade, most of them 65 or older, and has sent 140,000 to 810,000 people a year to hospitals.

The coronavirus pandemic has introduced another imperative. Those hospitals are filling fast with Covid-19 patients; in many places they are already swamped, their staffs overworked and exhausted.

“Knowing how stressed the health care system is, prevention is key,” said Dr. Nadine Rouphael, a vaccine researcher and infectious disease specialist at Emory University. “When we have record numbers of deaths, why would you go to a hospital for a vaccine-preventable illness?”

Yet the nation has long done a better job of vaccinating its children than its elders. The most recent statistics, from 2017, show that about one-third of adults over 65 had not received a flu shot within the past year. About 30 percent had not received the pneumococcus vaccine.

The proportion receiving the shingles vaccine, a fairly recent addition to the list, has inched up, but by 2018 only 34.5 percent of people over 60 had been vaccinated.

Moreover, Dr. Koppaka pointed out: “When you look deeper, there are longstanding, deep, significant differences in the proportion of Black and Hispanic adults getting vaccines compared to their white counterparts. It’s really unacceptable.”

Close to 40 percent of non-Hispanic whites had been vaccinated against shingles, for instance, compared with fewer than 20 percent of Blacks and Hispanics.

One might expect a group who can recall polio fears and outbreaks of whooping cough to be less hesitant to get vaccinated than younger cohorts. “You’ll probably have a different concept of vaccination from someone who never experienced what a serious viral illness can do,” Dr. Koppaka said.

When it comes to the Covid-19 vaccine, for instance, only 15 percent of those over 65 say they would definitely or probably not get it, compared with 36 percent of those 30 to 49, a Kaiser Family Foundation tracking poll showed earlier this month. (Ms. Stein, Ms. Blais and Ms. Freeman all said they would happily accept the Covid vaccine.)

But for other diseases, vaccination rates lag. Given that older people are more vulnerable to severe illness from them, why the gaps in coverage?

Internists and other doctors for adults don’t promote vaccines nearly as effectively as pediatricians do, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University. Older patients, who often see a variety of doctors, may also have trouble keeping track of when they got which shot.

Experts fear that vaccination rates may have fallen further during the pandemic, as they have among children, if older people wary of going to doctors’ offices or pharmacies skipped shots.

Financial and bureaucratic obstacles also thwart vaccination efforts. Medicare Part B covers three vaccines completely: influenza, pneumococcus and, when indicated, hepatitis B.

The Tdap and shingles vaccines, however, are covered under Part D, which can complicate reimbursement for doctors; the vaccines are easier to obtain in pharmacies. Not all Medicare recipients buy Part D, and for those who do, coverage varies by plan and can include deductibles and co-pays.

Still, older adults can gain access to most recommended vaccines for no or low cost, through doctors’ offices, pharmacies, supermarkets and local health departments. For everyone’s benefit, they should.

Here’s what the C.D.C. recommends:

Influenza An annual shot in the fall — and it’s still not too late, because flu season peaks from late January into February. Depending on which strain is circulating, the vaccine (ask for the stronger versions for seniors) prevents 40 to 50 percent of cases; it also reduces illness severity for those infected.

Thus far this year, flu activity has remained extraordinarily low, perhaps because of social distancing and masks or because closed schools kept children from spreading it. Manufacturers shipped a record number of doses, so maybe more people got vaccinated. In any case, fears of a flu/Covid “twindemic” have not yet been realized.

Nevertheless, infectious disease experts urge older adults (and everyone over six months old) to get flu shots now. “Flu is fickle,” Dr. Schaffner said. “It could take off like a rocket in January.”

Tetanus, diphtheria, pertussis. A booster of TD vaccine every 10 years, to prevent tetanus and diphtheria. If you’ve never had the Tdap vaccine — which adds prevention against pertussis — that’s the one you want. Although pertussis, better known as whooping cough, occasionally shows up in adults, newborns are particularly at risk. Pregnant women will ask expectant grandparents to get a Tdap shot. Because it is covered under Part D, a pharmacy is the best bet.

Pneumococcus. “It’s a pneumonia vaccine, but it also prevents the most serious consequences of pneumonia, including meningitis and bloodstream infections,” Dr. Koppaka said.

People over 65 should get the polysaccharide formula — brand name Pneumovax — but there are certain circumstances, such as immune-compromising conditions, to discuss with a health care provider.

Those over 65 may choose, again in consultation with a provider, to also get the conjugate pneumococcal vaccine (brand name Prevnar), which provides some additional protection. If so, C.D.C. guidelines specify which vaccine to take when.

Shingles. Social distancing won’t ward off this disease; anyone who had chickenpox, which is just about every senior, still carries the virus.

“If you live to be 80, you stand a 35 to 50 percent chance of having an episode,” Dr. Schaffner said. “And the older you are when you get it, the more apt you are to get the most serious complication” — lingering nerve pain called post-herpetic neuralgia.

The C.D.C. recommends Shingrix, the highly effective shingles vaccine the F.D.A. approved in 2017, for everyone over 50. The previous shingles vaccine has been discontinued. Get Shingrix even if you had the earlier vaccine, Zostavax, and even if you’ve had shingles — it can recur.

The two required shots, given two to six months apart, can total $300 out of pocket. But Medicare Part D beneficiaries will pay an average of $50 for the pair, said a spokesman for the manufacturer GlaxoSmithKline, and people with private insurance even less.

Hepatitis A and hepatitis B. These aren’t age-related; the vaccines are recommended for people with certain health conditions, including chronic liver disease and H.I.V. infection, or for travelers to countries where the diseases are widespread.

The hepatitis B vaccine is also recommended, at a provider’s discretion, for diabetics over 60 who haven’t been previously vaccinated. Talk to a health care professional about your risks.

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Small Number of Covid Patients Develop Severe Psychotic Symptoms

Small Number of Covid Patients Develop Severe Psychotic Symptoms

Most had no history of mental illness and became psychotic weeks after contracting the virus. Cases are expected to remain rare but are being reported worldwide.

Dr. Hisam Goueli treated several psychotic patients who had never had mental health issues before, including a woman who told him she kept visualizing her children being murdered. “It was like she was experiencing a movie,” he said.
Dr. Hisam Goueli treated several psychotic patients who had never had mental health issues before, including a woman who told him she kept visualizing her children being murdered. “It was like she was experiencing a movie,” he said.Credit…Jovelle Tamayo for The New York Times
Pam Belluck

  • Dec. 28, 2020, 12:03 p.m. ET

Almost immediately, Dr. Hisam Goueli could tell that the patient who came to his psychiatric hospital on Long Island this summer was unusual.

The patient, a 42-year-old physical therapist and mother of four young children, had never had psychiatric symptoms or any family history of mental illness. Yet there she was, sitting at a table in a beige-walled room at South Oaks Hospital in Amityville, N.Y., sobbing and saying that she kept seeing her children, ages 2 to 10, being gruesomely murdered and that she herself had crafted plans to kill them.

“It was like she was experiencing a movie, like ‘Kill Bill,’” Dr. Goueli, a psychiatrist, said.

The patient described one of her children being run over by a truck and another decapitated. “It’s a horrifying thing that here’s this well-accomplished woman and she’s like ‘I love my kids, and I don’t know why I feel this way that I want to decapitate them,’” he said.

The only notable thing about her medical history was that the woman, who declined to be interviewed but allowed Dr. Goueli to describe her case, had become infected with the coronavirus in the spring. She had experienced only mild physical symptoms from the virus, but, months later, she heard a voice that first told her to kill herself and then told her to kill her children.

At South Oaks, which has an inpatient psychiatric treatment program for Covid-19 patients, Dr. Goueli was unsure whether the coronavirus was connected to the woman’s psychological symptoms. “Maybe this is Covid-related, maybe it’s not,” he recalled thinking.

“But then,” he said, “we saw a second case, a third case and a fourth case, and we’re like ‘There’s something happening.’”

Indeed, doctors are reporting similar cases across the country and around the world. A small number of Covid patients who had never experienced mental health problems are developing severe psychotic symptoms weeks after contracting the coronavirus.

In interviews and scientific articles, doctors described:

A 36-year-old nursing home employee in North Carolina who became so paranoid that she believed her three children would be kidnapped and, to save them, tried to pass them through a fast-food restaurant’s drive-through window.

A 30-year-old construction worker in New York City who became so delusional that he imagined his cousin was going to murder him, and, to protect himself, he tried to strangle his cousin in bed.

A 55-year-old woman in Britain had hallucinations of monkeys and a lion and became convinced a family member had been replaced by an impostor.

Beyond individual reports, a British study of neurological or psychiatric complications in 153 patients hospitalized with Covid-19 found that 10 people had “new-onset psychosis.” Another study identified 10 such patients in one hospital in Spain. And in Covid-related social media groups, medical professionals discuss seeing patients with similar symptoms in the Midwest, Great Plains and elsewhere.

“My guess is any place that is seeing Covid is probably seeing this,” said Dr. Colin Smith at Duke University Medical Center in Durham, who helped treat the North Carolina woman. He and other doctors said their patients were too fragile to be asked whether they wanted to be interviewed for this article, but some, including the North Carolina woman, agreed to have their cases described in scientific papers.

Medical experts say they expect that such extreme psychiatric dysfunction will affect only a small proportion of patients. But the cases are considered examples of another way the Covid-19 disease process can affect mental health and brain function.

Although the coronavirus was initially thought primarily to cause respiratory distress, there is now ample evidence of many other symptoms, including neurological, cognitive and psychological effects, that could emerge even in patients who didn’t develop serious lung, heart or circulatory problems. Such symptoms can be just as debilitating to a person’s ability to function and work, and it’s often unclear how long they will last or how to treat them.

Experts increasingly believe brain-related effects may be linked to the body’s immune system response to the coronavirus and possibly to vascular problems or surges of inflammation caused by the disease process.

“Some of the neurotoxins that are reactions to immune activation can go to the brain, through the blood-brain barrier, and can induce this damage,” said Dr. Vilma Gabbay, a co-director of the Psychiatry Research Institute at Montefiore Einstein in the Bronx.

Brain scans, spinal fluid analyses and other tests didn’t find any brain infection, said Dr. Gabbay, whose hospital has treated two patients with post-Covid psychosis: a 49-year-old man who heard voices and believed he was the devil and a 34-year-old woman who began carrying a knife, disrobing in front of strangers and putting hand sanitizer in her food.

Physically, most of these patients didn’t get very sick from Covid-19, reports indicate. The patients that Dr. Goueli treated experienced no respiratory problems, but they did have subtle neurological symptoms like hand tingling, vertigo, headaches or diminished smell. Then, two weeks to several months later, he said, they “develop this profound psychosis, which is really dangerous and scary to all of the people around them.”

Also striking is that most patients have been in their 30s, 40s and 50s. “It’s very rare for you to develop this type of psychosis in this age range,” Dr. Goueli said, since such symptoms more typically accompany schizophrenia in young people or dementia in older patients. And some patients — like the physical therapist who took herself to the hospital — understood something was wrong, while usually “people with psychosis don’t have an insight that they’ve lost touch with reality.”

Some post-Covid patients who developed psychosis needed weeks of hospitalization in which doctors tried different medications before finding one that helped.

Dr. Robert Yolken, a neurovirology expert at Johns Hopkins University School of Medicine in Baltimore, said that although people might recover physically from Covid-19, in some cases their immune systems, might be unable to shut down or might remain engaged because of “delayed clearance of a small amount of virus.”

Persistent immune activation is also a leading explanation for brain fog and memory problems bedeviling many Covid survivors, and Emily Severance, a schizophrenia expert at Johns Hopkins, said post-Covid cognitive and psychiatric effects might result from “something similar happening in the brain.”

It may hinge on which brain region the immune response affects, Dr. Yolken said, adding, “some people have neurological symptoms, some people psychiatric and many people have a combination.”

From left, Drs. Jonathan Komisar, Brian Kincaid and Colin Smith of Duke University Medical Center, who treated a woman whose sudden psychosis made her paranoid that her children were about to be kidnapped and that cellphones were tracking her.
From left, Drs. Jonathan Komisar, Brian Kincaid and Colin Smith of Duke University Medical Center, who treated a woman whose sudden psychosis made her paranoid that her children were about to be kidnapped and that cellphones were tracking her.Credit…Jeremy M. Lange for The New York Times

Experts don’t know whether genetic makeup or perhaps an undetected predisposition for psychiatric illness put some people at greater risk. Dr. Brian Kincaid, medical director of psychiatric emergency department services at Duke, said the North Carolina woman once had a skin reaction to another virus, which might suggest her immune system responds zealously to viral infections.

Sporadic cases of post-infectious psychosis and mania have occurred with other viruses, including the 1918 flu and the coronaviruses SARS and MERS.

“We think that it’s not unique to Covid,” said Dr. Jonathan Alpert, chairman of psychiatry and behavioral sciences at Albert Einstein College of Medicine, who co-wrote the report on the Montefiore patients. He said studying these cases might help to increase doctors’ understanding of psychosis.

The symptoms have ranged widely, some surprisingly severe for a first psychotic episode, experts said. Dr. Goueli said a 46-year-old pharmacy technician, whose family brought her in after she became fearful that evil spirits had invaded her home, “cried literally for four days” in the hospital.

He said the 30-year-old construction worker, brought to the hospital by the police, became “extremely violent,” dismantling a hospital radiator and using its parts and his shoes to try to break out of a window. He also swung a chair at hospital staff.

How long the psychosis lasted and patients’ response to treatment has varied. The woman in Britain — whose symptoms included paranoia about the color red and terror that nurses were devils who would harm her and a family member — took about 40 days to recover, according to a case report.

The 49-year-old man treated at Montefiore was discharged after several weeks’ hospitalization, but “he was still struggling two months out” and required readmission, Dr. Gabbay said.

The North Carolina woman, who was convinced that cellphones were tracking her and that her partner would steal her pandemic stimulus money, didn’t improve with the first medication, said Dr. Jonathan Komisar at Duke, who said doctors initially thought her symptoms reflected bipolar disorder. “When we began to realize that maybe this isn’t going resolve immediately,” he said, she was given an antipsychotic, risperidone and discharged in a week.

The physical therapist who planned to murder her children had more difficulty. “Every day, she was getting worse,” Dr. Goueli said. “We tried probably eight different medicines,” including antidepressants, antipsychotics and lithium. “She was so ill that we were considering electroconvulsive therapy for her because nothing was working.”

About two weeks into her hospitalization, she couldn’t remember what her 2-year-old looked like. Calls with family were heartbreaking because “‘You could hear one in the background saying ‘When is Mom coming home?’” Dr. Goueli said. “That brought her a lot of shame because she was like, ‘I can’t be around my kids and here they are loving me.’”

Ultimately, risperidone proved effective and after four weeks, she returned home to her family, “95 percent perfect,” he said.

“We don’t know what the natural course of this is,” Dr. Goueli said. “Does this eventually go away? Do people get better? How long does that normally take? And are you then more prone to have other psychiatric issues as a result? There are just so many unanswered questions.”

Coronavirus Variant Is Indeed More Transmissible, New Study Suggests

Coronavirus Variant Is Indeed More Transmissible, New Study Suggests

Researchers warn that the British variant is so contagious that new control measures, including closing down schools and universities, may be necessary.

A gazebo outside a bar in the West End of London on Dec. 15. The city entered Tier 3 restrictions the next day.
A gazebo outside a bar in the West End of London on Dec. 15. The city entered Tier 3 restrictions the next day.Credit…Andrew Testa for The New York Times
  • Dec. 23, 2020, 10:22 p.m. ET

A team of British scientists released a worrying study on Wednesday of the new coronavirus variant sweeping the United Kingdom. They warned that the variant is so contagious that new control measures, including closing down schools and universities, might be necessary. Even that may not be enough, they noted, saying, “It may be necessary to greatly accelerate vaccine rollout.”

The study, released by the Center for Mathematical Modeling of Infectious Diseases at the London School of Hygiene and Tropical Medicine, has not yet undergone review by a scientific journal. The study compares a series of models as predictors of data on infections, hospitalizations and other variables; other researchers are studying the variant in laboratory experiments to determine if it is biologically distinct.

The study found no evidence that the variant was more deadly than others. But the researchers estimated that it was 56 percent more contagious. On Monday, the British government released an initial estimate of 70 percent.

Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health who was not involved in the study, said that it presented a compelling explanation of the past and potential future of the variant.

“The overall message of it is solid and consistent with what we’ve been seeing from other sources of information,” he said in an interview. “Does this matter? Yes. Is there evidence for increased transmission? Yes. Is that going to impact the next few months? Yes. Those are all, I think, pretty solid.”

A New Variant

A series of tiny mutations found in many British samples of the coronavirus may help the virus spread more easily. The coronavirus variant is known as B.1.1.7.

Spikes used to latch onto and enter human cells

Spike

protein

gene

CORONAVIRUS

CORONAVIRUS

GENOME

ORF1a

protein

ORF1b

protein

Spike

protein

E

M

N

Change in

RNA sequence

MUTATIONS

that led to the

B.1.1.7 variant

X

(deletion)

X

Change in

amino acid

X

Spikes used to latch onto and enter human cells

CORONAVIRUS

Spike

protein

gene

Change in

RNA sequence

Change in

amino acid

CORONAVIRUS

GENOME

N protein

M protein

E protein

Spike protein

MUTATIONS

that led to the

B.1.1.7 variant

ORF1b protein

(deletion)

ORF1a protein

By Jonathan Corum | Source: Andrew Rambaut et al., Covid-19 Genomics Consortium U.K.

The variant, which came to the attention of British researchers earlier this month, has been rapidly spreading in London and eastern England. It carries a set of 23 mutations, some of which may make it more contagious.

The authors of the study found more evidence that the variant does indeed spread more rapidly than others. For example, they ruled out the possibility that it was becoming more common because outbreaks had started in places where people were more likely to come into contact with each other. Data recorded by Google, indicating the movements of individual cellphone users over time, showed no such difference.

The researchers built different mathematical models and tested each one as an explanation for the variant’s spread. They analyzed which model of the spread best predicted the number of new cases that actually were confirmed, as well as hospitalization and deaths.

The team then projected what the new variant would do over the next six months and built models that factored in different levels of restrictions. Without a more substantial vaccine rollout, they warned, “cases, hospitalizations, I.C.U. admissions and deaths in 2021 may exceed those in 2020.”

Closing schools until February could buy Britain some time, the researchers found, but lifting those extra restrictions would then cause a major rebound of cases.

Because of the higher transmission rate, the country will need a much higher percentage of the population to get vaccinated to reach herd immunity. To reduce the peak burden on I.C.U.s, the researchers found, vaccination would need to jump to two million people per week from the current pace of 200,000.

“You need to be able to get whatever barriers to transmission you can out there as soon as possible,” Dr. Hanage said.

The researchers warned that their model was based, like any model, on a set of assumptions, some of which may turn out to be wrong. For instance, the rate at which infected people die from Covid-19 may continue to drop as doctors improve at caring for hospitalized patients. Uncertainties remain as to whether the new variant is more contagious in children, and if so, by how much.

Still, they wrote, “there is an urgent need to consider what new approaches may be required to sufficiently reduce the ongoing transmission of SARS-CoV-2.”

Alessandro Vespignani, director of the Network Science Institute at Northeastern University in Boston, who was not involved in the study, said of the new estimates, “Unfortunately, this is another twist in the plot.”

“While we were all rejoicing for the vaccine,” he added, “here is the possibility of a change of epidemiological context that makes our next few months much more complex and more perilous to navigate. Evidence is accumulating that the variant is more transmissible, and this implies that it will likely require an even greater effort to keep spreading under control.”

Dr. Hanage cautioned that the model had some shortcomings. The researchers assumed that all people younger than 20 had a 50 percent chance of spreading the disease. Although that might be true for younger children, Dr. Hanage said, it is not for teenagers. “That’s the weakest part of their model,” he said.

Nonetheless, he said, the study provided an important glimpse into the country’s possible futures. “It’s not a forecast, it’s not a prediction, it’s not saying this will happen,” he said. “It is saying that if you don’t take it seriously, this is the kind of thing that could very easily happen.”

Benjamin Mueller contributed reporting.

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Frontline Workers and People Over 74 Should Get Shots Next, CDC Panel Says

Frontline Workers and People Over 74 Should Get Shots Next, CDC Panel Says

The recommendation was a compromise aimed at getting the coronavirus vaccine to the most vulnerable of two high-risk groups.

Director of nursing education Loraine Hopkins Pepe, left, administers the Pfizer BioNTech COVID-19 vaccine to Dr. Richard Fine, head of anesthesiology, at Einstein Medical Center in Philadelphia, PA.
Director of nursing education Loraine Hopkins Pepe, left, administers the Pfizer BioNTech COVID-19 vaccine to Dr. Richard Fine, head of anesthesiology, at Einstein Medical Center in Philadelphia, PA.Credit…Hannah Yoon for The New York Times
  • Dec. 20, 2020, 3:40 p.m. ET

Striking a compromise between two high-risk population groups, a panel advising the Centers for Disease Control and Prevention voted Sunday to recommend that people 75 and older be next in line to receive the coronavirus vaccine in the United States, along with about 30 million “frontline essential workers,” including emergency responders, teachers and grocery store employees.

The debate about who should receive the vaccine in these early months has grown increasingly urgent as the daily tally of cases has swelled to numbers unimaginable even a month ago. The country has already begun vaccinating health care workers, and on Monday, CVS and Walgreens were to begin a mass vaccination campaign at the nation’s nursing homes and long-term care facilities. This week roughly six million doses of the newly authorized Moderna vaccine are to start arriving at more than 3,700 locations around the country, including many smaller and rural hospitals.

The panel of doctors and public health experts had previously indicated it would recommend a much broader group of Americans defined as essential workers — about 87 million people with jobs designated by a division of the Department of Homeland Security as critical to keeping society functioning — as the next priority population and that elderly people who live independently should come later.

But in hours of discussion on Sunday, the committee members concluded that given the limited initial supply of vaccine and the higher Covid-19 death rate among elderly Americans, it made more sense to allow the oldest among them to go next along with workers at the highest risk of exposure to the virus.

Groups of essential workers, such as construction and food service workers, the committee said, would be eligible for the next wave. Members did clarify that local organizations had great flexibility to make those determinations.

“I feel very strongly we do need to have that balance of saving lives and keeping our infrastructure in place,” said Dr. Helen Talbot, a member of the panel and infectious-disease specialist at Vanderbilt University.

Together, the two groups the committee voted to prioritize on Sunday number about 51 million people; federal health officials have estimated that there should be enough vaccine supply to inoculate all of them before the end of February.

Still, as the first week of vaccinations in the U.S. came to a close, frustrations were flaring about the pace of distribution. Some 128,000 shots had been given in the as of Friday, according to a New York Times database tracking vaccinations — a total that was just slightly more than half the number of new cases reported across the country that same day.

This weekend Gen. Gustave F. Perna, who heads the Trump administration’s distribution effort, apologized for more than a dozen states learning at the last minute that they would receive fewer doses next week of the vaccine manufactured by Pfizer than they had expected. Tensions were also broiling in some states over local decisions regarding which health care workers should get their shots immediately and which should wait.

The director of the C.D.C., Dr. Robert Redfield, will review the panel’s recommendation and decide, likely by Monday, whether to embrace it as the agency’s official guidance to states. The panel, the Advisory Committee on Immunization Practices, emphasized that its recommendations were nonbinding and that every state would be able to fine-tune or adjust them to serve the unique needs of its population.

The 13-to-1 vote came as frustrations flared about the pace of vaccine distribution. Some 128,000 shots have been given in the first five days of the vaccine United States, according to a New York Times database tracking vaccinations — just slightly more than half the number of new cases reported across the country on Friday alone. This weekend, Gen. Gustave F. Perna, who heads the Trump administration’s distribution effort, apologized for at least 14 states learning at the last minute that they would receive fewer doses of the vaccine manufactured by Pfizer next week than they had expected. Tensions were also flaring in some states over local decisions regarding which health care workers should get their shots immediately, and which should wait.

In addition to teachers, firefighters and police, a subgroup of the committee suggested that “frontline essential workers” should include school support staff; day care, corrections personnel, public transit, grocery store and postal workers; and those in working in food production and manufacturing. But the group’s official recommendation is not that specific.

Originally, the committee had signaled last month that they had been inclined to let 87 million essential workers receive vaccines ahead of adults 65 and older. Many had expressed their alarm that essential workers, who are often low-wage people of color, were being hit disproportionately hard by the virus and additionally were disadvantaged because of their lesser access to good health care.

general population.”

Hearing Aids Could Use Some Help

the new old age

Hearing Aids Could Use Some Help

The vital medical devices could be inexpensive and available over the counter. But efforts have stalled under the F.D.A.

Credit…
Isabel Seliger

  • Dec. 14, 2020, 11:56 a.m. ET

By now, we were supposed to be swiftly approaching the day when we could walk into a CVS or Walgreens, a Best Buy or Walmart, and walk out with a pair of quality, affordable hearing aids approved by the Food and Drug Administration.

Hearing aids, a widely needed but dauntingly expensive investment, cost on average $4,700 a pair. (Most people need two.) So in 2017, Congress passed legislation allowing the devices to be sold directly to consumers, without a prescription from an audiologist. The next step was for the F.D.A. to issue draft regulations to establish safety and effectiveness benchmarks for these over-the-counter devices.

Its deadline: August 2020. A public comment period would follow, and then — right about now — the agency would be preparing its final rule, to take effect in May 2021. So by next summer, people with what is known as “perceived mild to moderate hearing loss” might need to spend only one-quarter of today’s price or less, maybe far less. And then we could have turned down the TV volume and stopped making dinner reservations for 5:30 p.m., when restaurants are mostly empty and conversations are still audible.

“These regulations are going to help a lot of people,” said Dr. Vinay Rathi, an otolaryngologist at Massachusetts Eye and Ear. “There could be great potential for innovation.”

So, where are the new rules? This long-sought alternative to the current state of hearing aid services has been delayed, perhaps one more victim of the pandemic.

Of course, the agency has other crucial matters to address just now. Although the office charged with hearing aid regulations is not the one assessing Covid-19 vaccines, an F.D.A. spokesman said via email that it was dealing with “an unprecedented volume of emergency use authorizations” for diagnostics, ventilators and personal protective equipment.

Nevertheless, “issuing the proposed rule remains a priority and we are working expeditiously to do so,” the spokesman added, providing no timetable for when that might happen.

It’s a major undertaking. The F.D.A. has never established such requirements for hearing aids, because ever since it last issued regulations, in 1977, only state-licensed providers have been allowed to prescribe and sell them — and have been presumed able to safeguard wearers. Providers and manufacturers have also kept prices high by combining testing, fitting and sales into one costly package, a practice the new law was designed to disrupt.

No other country has regulated over-the-counter hearing aids, according to Dr. Frank Lin, an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University. “We’ll be the first,” he said. “There are no performance requirements. There’s no precedent.”

But, Dr. Rathi said, “it’s not like the F.D.A. put everything else on hold.” He pointed to an array of regulations issued last month by the agency, including guidance on cross-labeling oncology medications and rules on impurities in animal drugs. “They’re still going about a lot of their regular business.”

Recently he and a colleague wrote an editorial in The New England Journal of Medicine that questioned the delay, under a pointed title, “Deafening Silence from the F.D.A.”

Senator Elizabeth Warren, Democrat of Massachusetts and Senator Chuck Grassley, Republican of Iowa, who were among the sponsors of the bipartisan 2017 law, wrote to the F.D.A. commissioner last month urging action. They noted that “despite the pandemic, hearing loss continues to be a problem for millions of Americans.” In fact, masks and distancing create greater hearing difficulties.

One-quarter of Americans in their 60s and nearly two-thirds of those over 70 have hearing loss. Its damaging consequences can include social isolation, an increased risk of falls and much higher rates of dementia.

Yet a recent analysis of federal data shows that despite modest increases, in 2018 only about 18.5 percent of Medicare beneficiaries over 70 owned and used hearing aids.

Usage was lower among women than men and far lower among Black beneficiaries than white ones; the proportion of low-income seniors using hearing aids actually declined to 10.8 percent in 2018 from 12.4 percent in 2011.

Stigma explains some of that aversion. Hearing aids can feel like “constant reminders of aging,” said Kevin Franck, director of audiology at Massachusetts Eye and Ear and an author of the New England Journal editorial. “We have people who come in who want to hide them.”

The inconvenience of multiple visits to an audiologist or technician for testing, fitting and adjustment probably also plays a role.

But expense constitutes a formidable barrier. Traditional Medicare covers testing but not hardware or other services. (It does cover cochlear implants, for those whose hearing loss grows too severe for hearing aids.) Many Medicare Advantage plans provide some hearing coverage, but beneficiaries still wind up paying 79 percent of the cost out of pocket.

“It’s the No. 1 question we get,” said Barbara Kelley, executive director of the Hearing Loss Association of America. “‘I can’t afford hearing aids and Medicare doesn’t cover them. What do I do?’”

Advocates plan to keep lobbying Congress for Medicare coverage for hearing services and aids, included in the expansive bill H.R.3 that passed the House of Representatives last year but never came to a Senate vote.

In the meantime, over-the-counter devices retailing for several hundred dollars could make hearing aids broadly more affordable, for people or — one day, perhaps — for Medicare.

They could also solve another consumer problem, Dr. Lin added. Manufacturers can legally sell PSAPs — personal sound-amplification products that resemble hearing aids — as long as they don’t advertise them as a remedy for hearing loss. Their quality varies drastically.

The Hopkins team has been testing whether trained community health workers could help low-income seniors improve their hearing. (A pilot study indicates they can.) Their research protocol uses an effective PSAP from Sound World Solutions that retails for about $700 a pair.

But, Dr. Lin said, “most of what you see out there — ‘$50 miracle device!’ — is complete garbage. People can’t tell which to trust.”

Once federal requirements are set for over-the-counter hearing aids, however, manufacturers of quality PSAPs can apply for approval. “All the other PSAPs will go by the wayside,” Dr. Lin said. If their labels say they’re not approved by the F.D.A., “nobody will buy them, and they shouldn’t.”

Eyeing a vast and underserved market, consumer electronics companies (said to include Apple and Samsung) are standing by, along with start-ups. “There’s a lot of venture capital funding for hearing technology, once the barriers come down,” Dr. Rathi said.

Bose acted early, receiving F.D.A. clearance in 2018 for its Hearphone, which the buyer could tune with a smartphone app. But without the new rule, state restrictions would have prevented national sales, so Bose didn’t market it.

The company is working on a new over-the-counter product, however. “We’re cautiously optimistic that 2021 will be the year,” said Brian Maguire, director of the Bose Hear group.

Once the F.D.A. acts and companies and retailers ramp up, expect new products and advertisements to pop up in stores and online. “We’ll have a bit of a Wild West period,” Ms. Kelley said. “People are going to be confused. They’re going to need a lot of information.”

At that point, audiologists will no longer serve as exclusive gatekeepers to hearing aids. But they can still render important services: testing, education and counseling, adjusting devices — even if clients bought them elsewhere.

“Wearing something comfortably in your ear all day, day after day, is a challenge,” Dr. Franck said. “You want it customized. If you hear echoes or feedback, audiologists know a lot about those issues.”

But the country has only about 18,000 audiologists, Ms. Kelley pointed out. Particularly in rural areas, people with hearing loss might need to drive hours to find one.

But a supermarket? A big box store? A pharmacy? A website? Almost everyone can get to one of those.

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Fears of a ‘Twindemic’ Recede as Flu Lies Low

Fears of a ‘Twindemic’ Recede as Flu Lies Low

Despite early worries, flu patients are not competing with Covid-19 patients for ventilators, and the threat of dueling outbreaks may be waning.

A free flu shot administered at Comerica Park in Detroit, Mich., last month.
A free flu shot administered at Comerica Park in Detroit, Mich., last month.Credit…Seth Herald/Agence France-Presse — Getty Images
Donald G. McNeil Jr.

  • Dec. 13, 2020, 5:00 a.m. ET

Despite the horrifying surge of Covid-19 cases and deaths in the United States right now, one bit of good news is emerging this winter: It looks unlikely that the country will endure a “twindemic” of both flu and the coronavirus at the same time.

That comes as a profound relief to public health officials who predicted as far back as April that thousands of flu victims with pneumonia could pour into hospitals this winter, competing with equally desperate Covid-19 pneumonia victims for scarce ventilators.

“Overall flu activity is low, and lower than we usually see at this time of year,” said Dr. Daniel B. Jernigan, director of the influenza division of the Centers for Disease Control and Prevention. “I don’t think we can definitively say there will be no twindemic; I’ve been working with flu for a long time, and I’ve been burned. But flu is atypically low.”

Since September, the C.D.C. “FluView” — its weekly report on influenza surveillance — has shown all 50 states in shades of green and chartreuse, indicating “minimal” or “low” flu activity. Normally by December, at least some states are painted in oranges and reds for “moderate” and “high.”

(For one puzzling week in November, Iowa stood out in dark burgundy, indicating “very high” flu levels. But that turned out to be a reporting error, Dr. Jernigan said.)

Of 232,452 swabs from across the country that have been tested for flu, only 496, or 0.2 percent, have come up positive.

That has buoyed the spirits of flu experts.

Dr. William Schaffner, medical director for the National Foundation for Infectious Diseases, which promotes flu shots, said he was recently on a telephone discussion with other preventive medicine specialists. “Everybody was in quiet awe about how low flu is,” he said. “Somebody said: ‘Shh, don’t talk about it. The virus will hear us.’”

Flu numbers are likely to remain low for many more weeks, predicted Kinsa Health, a company that uses cellphone-connected thermometers and historical databases to forecast flu trends.

“Going forward, we don’t expect influenza-like illness to go high,” said Inder Singh, Kinsa’s founder and chief executive. “It looks like the twindemic isn’t going to happen.”

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By The New York Times | Source: Kinsa

A combination of factors is responsible for the remarkably quiet flu season, experts said.

In the Southern Hemisphere, where winter stretches from June through August, widespread mask-wearing, rigorous lockdowns and other precautions against Covid-19 transmission drove flu down to record-low levels. Southern Hemisphere countries help “reseed” influenza viruses in the Northern Hemisphere each year, Dr. Jernigan said.

Also, to keep Covid-19 out, New Zealand and Australia have closed their borders either to all noncitizens or to Americans, so there has been very little air traffic from those Southern Hemisphere countries.

In the United States, the cancellation of large indoor gatherings, closings of schools and use of masks to prevent coronavirus transmission have also driven down levels of all respiratory diseases, including influenza.

In addition, Dr. Jernigan said, a “phenomenal number” of flu shots were manufactured and shipped to pharmacies, hospitals and doctors’ office in August, a month earlier than usual.

As of late November, 188 million doses had been shipped; the old record was 175 million doses shipped last year. Spot shortages were quickly reported in some cities, so experts assumed that large numbers of Americans took them.

However, there is not yet enough data to confirm that assumption. According to a preliminary tally released Dec. 9, about 70 million adults had received the shots through pharmacies or doctors’ offices as of mid-November, compared with 58 million last year.

Although that appears to be a substantial increase, the C.D.C. does not know how many Americans who normally get their flu shots at work were unable to do so this year because of stay-at-home orders, said Dr. Ram Koppaka, the agency’s associate director for adult immunization. There was a big increase in flu shots delivered by pharmacies, and that may represent people who normally would have received the shots at work.

“The best we can say is that it appears that we are now about where we were last year,” Dr. Koppaka said.

Given that vaccines were available early, he added: “I’m disappointed that it’s not better than it is. We need to keep telling people that it’s not too late to get a flu shot.”

Normally, about 80 percent of all adults who get flu shots have had them by the end of November. But about nine million doses of vaccines that were meant for uninsured adults, and which the federal government purchased this year out of fear of a “twindemic,” are still being delivered, Dr. Koppaka said.

The finally tally of how many shots were taken will not be available until summer, after the flu season is over, he said.

Nonetheless, even the preliminary data showed disturbing trends in two important target groups: pregnant women and children. Only 54 percent of pregnant women have received flu vaccine this year, compared with 58 percent by this time last year. And, although about 48 percent of all children got flu shots both last year and this year, the percentage of Black children who got them dropped substantially this year, by 11 percentage points.

Dr. Koppaka said he could not yet account for those drops in coverage. Pregnant women might have been afraid to go to doctors or pharmacies for fear of getting Covid-19, and many Black children might have been missed because public schools that offer vaccines were closed — but that was just speculation, he emphasized.

Although Dr. Koppaka strongly encouraged unvaccinated Americans to get flu shots, the threat of a two-headed pandemic monster appears to be fading.

Because of the coronavirus pandemic, the C.D.C. is not currently posting forecasts on its FluSight page, where it predicts the future course of the flu season.

Kinsa Health, by contrast, is predicting that flu will stay at historic lows through February, when the season typically peaks. The company has a record of accurately predicting flu seasons several weeks ahead of the C.D.C.

C.D.C. surveillance data is based on weekly reports from doctors’ offices and hospitals noting the percentage of patient visits that are for flu symptoms. Because there are delays in reporting, sometimes for weeks, there is a lag between the time a flu arrives in a county and the agency’s confirmation that it is there.

Also, people who catch flu but never see a doctor are not captured in the C.D.C.’s surveillance net. People avoid doctors for many reasons, including a lack of insurance or because, this year, they are afraid of catching the coronavirus.

Kinsa receives about 100,000 readings each day from about two million thermometers connected to smartphones; the company claims it can detect local fever spikes down to the ZIP code level.

Both Covid-19 and flu can drive up the number of reported fevers, but flu outbreaks can be distinguished from Covid ones, Mr. Singh said.

The company has access to decades of historical flu data from 600 cities across the country, and there are patterns to how flu typically spreads in each city based on climate and population density, said Samuel D. Chamberlain, the company’s chief data scientist.

Also, because everyone is susceptible to the new coronavirus, Covid fevers surge and spread much faster across ZIP codes than do those caused by colds and flu, Mr. Singh said.

Moreover, users are asked to enter all their symptoms in the Kinsa app. Loss of smell and taste is a common Covid-19 symptom. Making things even simpler, the app asks users if they have had a positive coronavirus or flu test.

Currently, flu is at less than half its typical level for early December, Mr. Singh said. By February, when cases typically shoot to a sharp peak, its numbers should be down to about one-quarter of a typical seasonal apex, he predicted.

“In theory, the flu virus could be taking a year off,” said Dr. Arthur Reingold, head of epidemiology at the School of Public Health of the University of California, Berkeley.

He recently asked a friend who was treating Covid-19 cases at the University of California, San Francisco, hospital how many flu cases she had seen this year.

“The answer was zero,” he said. “That’s a relief, and certainly a relief to my friends who do clinical work.”

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Pregnant and Breastfeeding Women May Opt to Receive the Vaccine

Pregnant and Breastfeeding Women May Opt to Receive the Vaccine

Although no coronavirus vaccine has been studied in these women, many scientists believe the benefits will outweigh any potential risks.

With vaccines in short supply, the F.D.A.’s decision most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States.
With vaccines in short supply, the F.D.A.’s decision most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States.Credit…Callaghan O’Hare/Reuters
Apoorva Mandavilli

  • Dec. 11, 2020, 11:14 p.m. ET

In its emergency authorization of the Pfizer-BioNTech vaccine on Friday night, the Food and Drug Administration took an unexpected step, leaving open the possibility that pregnant and breastfeeding women may opt for immunization against the coronavirus.

The agency authorized the vaccine for anyone 16 and older, and asked Pfizer to file regular reports on the safety of the vaccine, including its use in pregnant women.

There had been no guarantee that the agency would take this route. The vaccine was not tested in pregnant women or in those who were breastfeeding. Regulators in the United Kingdom recommended against these women receiving the shots even while acknowledging that the evidence so far “raises no concerns for safety in pregnancy.”

The Centers for Disease Control and Prevention has not yet endorsed the vaccine for pregnant women, but an advisory committee to the agency is expected to meet this weekend to make further recommendations.

Some experts said the virus itself poses greater risks to pregnant women than the new vaccine, and noted that vaccines have been given to pregnant women for decades and have been overwhelmingly safe.

“This is a really huge step forward in recognizing women’s autonomy to make decisions about their own health care,” said Dr. Emily Miller, an obstetrician at Northwestern University and a member of the Covid-19 task force of the Society for Maternal and Fetal Medicine.

With the first doses of the vaccine reserved for health care workers and residents of long-term care facilities, the F.D.A.’s authorization most immediately affects the estimated 330,000 pregnant and breastfeeding health care workers in the United States.

“I am incredibly supportive of the F.D.A.’s decision to leave the door open to Covid vaccination for pregnant and lactating workers,” said Ruth Faden, a bioethicist at Johns Hopkins University in Baltimore.

Some health care workers are at high risk of Covid-19, either because their jobs bring them into intense contact with the virus — for example, cleaning the rooms of sick patients — or because they live in low-income and multigenerational homes, Dr. Faden said.

“We have to be able to give women the opportunity to think through this for themselves with whoever it is providing obstetrical care to them,” she said.

Health care organizations should also help their employees weigh the risks, and accommodate women who do not feel comfortable working on the front lines, she added.

None of the vaccine clinical trials have so far included pregnant or lactating women, nor even women who are planning to get pregnant; some trials are expected to begin in January.

Still, the American College of Obstetrics and Gynecology, the S.M.F.M. and other organizations have been calling on the F.D.A. to allow pregnant and lactating people access to the vaccine.

At a meeting on Thursday to review Pfizer’s data for an emergency use authorization, Dr. Doran Fink, the F.D.A.’s deputy director for vaccine development, signaled that the agency was open to the idea.

“We really have no data to speak to risks specific to the pregnant women or the fetus, but also no data that would warrant a contraindication to use in pregnancy at this time,” Dr. Fink said. “Under the E.U.A., they would be then free to make their own decision in conjunction with their health care provider.”

The E.U.A. did not endorse the vaccine for pregnant or breastfeeding women, other than to note that Pfizer should collect long-term data on how the vaccine performs in pregnant women.

Since the 1960s, pregnant women have been urged to receive vaccines against influenza and other diseases. These women are generally cautioned against live vaccines, which contain weakened pathogens.

Even so, the benefits of live vaccines outweigh the risks in some situations, said Dr. Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of A.C.O.G.’s committee on Covid vaccines.

“We have a long track record of giving pregnant women vaccinations, and nearly all vaccinations are very safe,” Dr. Jamieson said.

Dr. Jamieson said she was “disappointed that F.D.A. was not more explicit” but encouraged that “there is no explicit contraindication regarding pregnancy, which is good.”

Health care providers should be prepared to counsel pregnant patients on the decision to be immunized, based on the patients’ potential exposures and underlying conditions like diabetes and obesity, Dr. Jamieson added.

“A woman who can stay home, who doesn’t have any other children and no one in the household is working, is very different than an essential worker who needs to go out every day and be around other people,” she said.

Women who are contemplating pregnancy should get both vaccine doses before trying to get pregnant, she added.

In the initial rollout, it will be mostly pregnant health care workers who must weigh the benefits and possible risks. By the time the vaccine is available to pregnant essential workers or to women in the general population, there should be a lot more data available, the experts said.

“The big question we don’t know quite yet is if it actually crosses the placenta,” said Dr. Geeta Swamy, an obstetrician at Duke University in Durham, N.C., and a member of A.C.O.G.’s Covid vaccine group, referring to the vaccine. “To be honest, what would be the most reassuring would be to see some of the animal data.”

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So-called D.A.R.T. — developmental and reproductive toxicity — studies are conducted in animals to assess a vaccine’s possible effects on a fetus. These data are typically required for licensing a vaccine, but not for an E.U.A.

Animal studies would ideally have been conducted as soon as safety data on the vaccines were available and before companies started large trials, Dr. Faden, the bioethicist, said. But at the F.D.A. meeting on Thursday, officials at Pfizer hinted that the animal data would be available by the end of the year.

(Moderna did not respond to queries about its timeline for animal studies, and it was unclear whether AstraZeneca and Johnson & Johnson had begun theirs.)

“The vaccines that are behind — if they haven’t started their D.A.R.T. studies, they should start them yesterday,” Dr. Faden said.

The experts were particularly enthusiastic about the prospect that breastfeeding women might get the vaccine. “The biologic plausibility to there being some risk of harm to an infant from breastfeeding is extremely, extremely low,” Dr. Swamy said.

In the time it would take an antigen — the essential ingredient in the new vaccine — injected into a woman’s arm to travel through her bloodstream and into breast milk, the antigen would disintegrate.

“There’s not a good reason even to think that vaccinating children is unsafe,” Dr. Swamy added. “To be honest, the reason we don’t have pediatric studies yet is because they’re trying to figure out the right dosage.”

Some women breastfeed for years and, particularly in low- and middle-income countries, not being able to do so may have devastating consequences for babies, experts said.

“I would applaud the fact that the F.D.A. has recognized that in the absence of data and meaning in either direction, decisions should be made between patients and their providers,” Dr. Swamy said. “We’re talking about women who are adult individuals, right?”

The Swiss Cheese Model of Pandemic Defense

The Swiss Cheese Model of Pandemic Defense

It’s not edible, but it can save lives. The virologist Ian Mackay explains how.

The multilayered “Swiss cheese” model was devised in the 1990s to improve industrial safety. Ian Mackay, a virologist at the University of Queensland, recently adapted it for the coronavirus pandemic. “It’s important to use more slices to prevent those volatile holes from aligning and letting virus through,” he said.
The multilayered “Swiss cheese” model was devised in the 1990s to improve industrial safety. Ian Mackay, a virologist at the University of Queensland, recently adapted it for the coronavirus pandemic. “It’s important to use more slices to prevent those volatile holes from aligning and letting virus through,” he said.Credit…Ian M. Mackay

By

  • Dec. 5, 2020, 5:00 a.m. ET

Lately, in the ongoing conversation about how to defeat the coronavirus, experts have made reference to the “Swiss cheese model” of pandemic defense.

The metaphor is easy enough to grasp: Multiple layers of protection, imagined as cheese slices, block the spread of the new coronavirus, SARS-CoV-2, the virus that causes Covid-19. No one layer is perfect; each has holes, and when the holes align, the risk of infection increases. But several layers combined — social distancing, plus masks, plus hand-washing, plus testing and tracing, plus ventilation, plus government messaging — significantly reduce the overall risk. Vaccination will add one more protective layer.

“Pretty soon you’ve created an impenetrable barrier, and you really can quench the transmission of the virus,” said Dr. Julie Gerberding, executive vice president and chief patient officer at Merck, who recently referenced the Swiss cheese model when speaking at a virtual gala fund-raiser for MoMath, the National Museum of Mathematics in Manhattan.

“But it requires all of those things, not just one of those things,” she added. “I think that’s what our population is having trouble getting their head around. We want to believe that there is going to come this magic day when suddenly 300 million doses of vaccine will be available and we can go back to work and things will return to normal. That is absolutely not going to happen fast.”

Rather, Dr. Gerberding said in a follow-up email, expect to see “a gradual improvement in protection, first among the highest need groups, and then more gradually among the rest of us.” Until vaccines are widely available and taken, she said, “we will need to continue masks and other common-sense measures to protect ourselves and others.”

In October, Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health, retweeted an infographic rendering of the Swiss cheese model, noting that it included “things that are personal *and* collective responsibility — note the ‘misinformation mouse’ busy eating new holes for the virus to pass through.”

“One of the first principles of pandemic response is, or ought to be, clear and consistent messaging from trusted sources,” Dr. Hanage said in an email. “Unfortunately the independence of established authorities like the C.D.C. has been called into question, and trust needs to be rebuilt as a matter of urgency.” A catchy infographic is a powerful message, he said, but ultimately requires higher-level support.

The Swiss cheese concept originated with James T. Reason, a cognitive psychologist, now a professor emeritus at the University of Manchester, England, in his 1990 book, “Human Error.” A succession of disasters — including the Challenger shuttle explosion, Bhopal and Chernobyl — motivated the concept, and it became known as the “Swiss cheese model of accidents,” with the holes in the cheese slices representing errors that accumulate and lead to adverse events.

The model has been widely used by safety analysts in various industries, including medicine and aviation, for many years. (Dr. Reason did not devise the “Swiss cheese” label; that is attributed to Rob Lee, an Australian air-safety expert, in the 1990s.) The model became famous, but it was not accepted uncritically; Dr. Reason himself noted that it had limitations and was intended as a generic tool or guide. In 2004, at a workshop addressing an aviation accident two years earlier near Überlingen, Germany, he delivered a talk with the title, “Überlingen: Is Swiss cheese past its sell-by date?”

In 2006, a review of the model, published by the Eurocontrol Experimental Center, recounted that Dr. Reason, while writing the book chapter “Latent errors and system disasters,” in which an early version of the model appears, was guided by two notions: “the biological or medical metaphor of pathogens, and the central role played by defenses, barriers, controls and safeguards (analogous to the body’s autoimmune system).”

The cheese metaphor now pairs fairly well with the coronavirus pandemic. Ian M. Mackay, a virologist at the University of Queensland, in Brisbane, Australia, saw a smaller version on Twitter, but thought that it could do with more slices, more information. He created, with collaborators, the “Swiss Cheese Respiratory Pandemic Defense” and engaged his Twitter community, asking for feedback and putting the visualization through many iterations. “Community engagement is very high!” he said. Now circulating widely, the infographic has been translated into more than two dozen languages.

Dr. Mackay, a creator of the “Swiss Cheese Respiratory Pandemic Defense.”
Dr. Mackay, a creator of the “Swiss Cheese Respiratory Pandemic Defense.”Credit…Faye Sakura for The New York Times

“This multilayered approach to reducing risk is used in many industries, especially those where failure could be catastrophic,” Dr. Mackay said, via email. “Death is catastrophic to families, and for loved ones, so I thought Professor Reason’s approach fit in very well during the circulation of a brand-new, occasionally hidden, sometimes severe and occasionally deadly respiratory virus.”

The following is an edited version of a recent email conversation with Dr. Mackay.

Q. What does the Swiss cheese model show?

A. The real power of this infographic — and James Reason’s approach to account for human fallibility — is that it’s not really about any single layer of protection or the order of them, but about the additive success of using multiple layers, or cheese slices. Each slice has holes or failings, and those holes can change in number and size and location, depending on how we behave in response to each intervention.

Take masks as one example of a layer. Any mask will reduce the risk that you will unknowingly infect those around you, or that you will inhale enough virus to become infected. But it will be less effective at protecting you and others if it doesn’t fit well, if you wear it below your nose, if it’s only a single piece of cloth, if the cloth is a loose weave, if it has an unfiltered valve, if you don’t dispose of it properly, if you don’t wash it, or if you don’t sanitize your hands after you touch it. Each of these are examples of a hole. And that’s in just one layer.

To be as safe as possible, and to keep those around you safe, it’s important to use more slices to prevent those volatile holes from aligning and letting virus through.

Q. What have we learned since March?

A. Distance is the most effective intervention; the virus doesn’t have legs, so if you are physically distant from people, you avoid direct contact and droplets. Then you have to consider inside spaces, which are especially in play during winter or in hotter countries during summer: the bus, the gym, the office, the bar or the restaurant. That’s because we know SARS-CoV-2 can remain infectious in aerosols (small floaty droplets) and we know that aerosol spread explains Covid-19 superspreading events. Try not to be in those spaces with others, but if you have to be, minimize your time there (work from home if you can) and wear a mask. Don’t go grocery shopping as often. Hold off on going out, parties, gatherings. You can do these things later.

We don’t talk about eye coverings much, but we should, because we don’t know enough about the role of eyes in transmission. We do know that eyes are a window to the upper respiratory tract.

Q. Where does the “misinformation mouse” fit in?

A. The misinformation mouse can erode any of those layers. People who are uncertain about an intervention may be swayed by a loud and confident-sounding voice proclaiming that a particular layer is ineffective. Usually, that voice is not an expert on the subject at all. When you look to the experts — usually to your local public health authorities or the World Health Organization — you’ll find reliable information.

An effect doesn’t have to be perfect to reduce your risk and the risk to those around you. We need to remember that we’re all part of a society, and if we each do our part, we can keep each other safer, which pays off for us as well.

Another example: We look both ways for oncoming traffic before crossing a road. This reduces our risk of being hit by a car but doesn’t reduce it to zero. A speeding car could still come out of nowhere. But if we also cross with the lights, and keep looking as we walk, and don’t stare at our phone, we drastically reduce our risk of being hit.

We’re already used to doing that. When we listen to the loud nonexperts who have no experience in protecting our health and safety, we are inviting them to have an impact in our lives. That’s not a risk we should take. We just need to get used to these new risk-reduction steps for today’s new risk — a respiratory virus pandemic, instead of a car.

Q. What is our individual responsibility?

A. We each need to do our part: stay apart from others, wear a mask when we can’t, think about our surroundings, for example. But we can also expect our leadership to be working to create the circumstances for us to be safe — like regulations about the air exchange inside public spaces, creating quarantine and isolation premises, communicating specifically with us (not just at us), limiting border travel, pushing us to keep getting our health checks, and providing mental health or financial support for those who suffer or can’t get paid while in a lockdown.

Q. How can we make the model stick?

A. We each use these approaches in everyday life. But for the pandemic, this all feels new and like a lot of extra work. Because everything is new. In the end, though, we’re just forming new habits. Like navigating our latest phone’s operating system or learning how to play that new console game I got for my birthday. It might take some time to get across it all, but it’s worthwhile. In working together to reduce the risk of infection, we can save lives and improve health.

And as a bonus, the multilayered risk reduction approach can even decrease the number of times we get the flu or a bad chest cold. Also, sometimes slices sit under a mandate — it’s important we also abide by those rules and do what the experts think we should. They’re looking out for our health.

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‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand

April Abbott, director of microbiology at Deaconess Hospital in Evansville, Ind., a mother of three who keeps a bed in her office for when her duties keep her overnight. “There is always more work to be done than the hours to do it in,” she said.
April Abbott, director of microbiology at Deaconess Hospital in Evansville, Ind., a mother of three who keeps a bed in her office for when her duties keep her overnight. “There is always more work to be done than the hours to do it in,” she said.Credit…Kaiti Sullivan for The New York Times

‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand

Laboratory technologists have been working nonstop to help the nation diagnose an ever-growing number of coronavirus cases.

April Abbott, director of microbiology at Deaconess Hospital in Evansville, Ind., a mother of three who keeps a bed in her office for when her duties keep her overnight. “There is always more work to be done than the hours to do it in,” she said.Credit…Kaiti Sullivan for The New York Times

Katherine J. Wu

By

  • Dec. 3, 2020, 5:00 a.m. ET

In March, April Abbott dragged a hospital bed into her office at Deaconess Hospital in Evansville, Ind. In the nine months since, she has slept in it a half-dozen times while working overnight in her clinical microbiology laboratory, where a team of some 40 scientists toils around the clock running coronavirus tests.

These all-night stints in the lab pull Dr. Abbott, the director of microbiology at Deaconess, away from her husband and three children, the oldest of whom is 8. A couple of times a week, she heads home for dinner, then drives back to work after the kids have gone to bed. She is at the lab when machines break. She is there to vet testing protocols for the lab. She is there when new testing sites open, flooding the lab with more samples to process.

“I do it because there is always more work to be done than the hours to do it in,” she said.

Nearly a year into a pandemic that has claimed more than 272,000 American lives, some 192 million tests for the coronavirus have been processed nationwide. Millions more will be needed to detect and contain the virus in the months ahead. Behind these staggering figures are thousands of scientists who have been working nonstop to identify the coronavirus in the people it infects.

Across the nation, testing teams are grappling with burnout, repetitive-stress injuries and an overwhelming sense of doom. As supply chains sputter and laboratories rush to keep pace with diagnostic demand, experts warn that the most severe shortage stymieing America’s capacity to test is not one that can be solved by a wider production line or a more efficient machine. It is a dearth of human power: the dwindling ranks in a field that much of the public does not know even exists.

When shortages arise, “there’s workarounds for almost everything else,” said Karissa Culbreath, the medical director and infectious disease division chief at TriCore Reference Laboratories in New Mexico. “But people are irreplaceable.”

In the absence of trained workers to process and analyze the nation’s tests, America’s diagnostic infrastructure will not merely wrinkle and slow, experts said. It will collapse.

“Doctors and nurses are very visible, but we work behind the scenes,” said Marissa Larson, a medical laboratory scientist supervisor at the University of Kansas Health System. “And we are underwater.”

‘I don’t even know where to start’

Darcy Velasquez, a medical technologist at Children’s Hospital Colorado in Aurora, begins her shifts at 5:30 a.m. with a refrigerator of up to 500 tubes, trying to clear a backlog before another shipment arrives at 8 a.m.
Darcy Velasquez, a medical technologist at Children’s Hospital Colorado in Aurora, begins her shifts at 5:30 a.m. with a refrigerator of up to 500 tubes, trying to clear a backlog before another shipment arrives at 8 a.m.Credit…Matthew Staver for The New York Times

The gold standard in coronavirus diagnostics hinges on a decades-old laboratory method called polymerase chain reaction, or P.C.R. The method is a signal amplifier: It can copy genetic material, including fragments of the genome of the coronavirus, over and over until it reaches detectable levels, making the virus discoverable even when it is extremely scarce in the body. P.C.R. is the metric against which all new testing techniques are compared; in the diagnostic landscape, few can match its ability to root out infection.

But such accuracy comes at a cost. Even highly automated forms of P.C.R. require people to handle tubes, babysit machines and scrutinize ambiguous results.

P.C.R.-based coronavirus tests also deal in DNA, the molecular language in which the human genome is written. The coronavirus, however, stores its genetic information in a close cousin called RNA, which must first be carefully extracted from virus particles, then converted to its more testable counterpart before diagnostics can proceed.

When laboratories are well stocked, P.C.R. diagnostics can run from start to finish in just a few hours. But since the spring, laboratories around the country have been hamstrung by severe, often unpredictable shortages of chemicals and plasticware needed for these protocols.

And caseloads have skyrocketed; America’s testing capacity has increased since March, but it has been vastly overtaken by the demand for tests.

“The spring pales in comparison to what we are experiencing now,” said Dr. Culbreath, of TriCore, which has run more than 600,000 coronavirus tests.

Amid the pandemonium, labs must still work through their queues for other infectious disease tests, including for sexually transmitted infections. “Labs are trying to maintain our standard of operation with everything else, with a pandemic on top of it,” Dr. Culbreath said.

Darcy Velasquez, a medical technologist at Children’s Hospital Colorado in Aurora, where cases continue to surge, is fighting to keep pace with some of her institution’s highest sample volumes yet. Her shifts in the lab begin at 5:30 a.m., sometimes to a double-door refrigerator already brimming with 500 tubes, each containing a fresh patient swab and a small volume of liquid — more than a full day’s work for one person.

Ms. Velasquez typically spends the first couple hours of her day frantically trying to clear as much of the backlog as she can before another batch arrives around 8 a.m., when the local clinic opens.

As much as an hour of that time might be spent simply de-swabbing samples: manually unscrewing and rescrewing caps and plucking out swabs, all without contaminating one sample with the contents of another.

“Sometimes you walk into these refrigerators full of specimens and you think, ‘I don’t even know where to start,’” Ms. Velasquez said.

Taylor Smith, a virologist and technologist for the Georgia Department of Public Health, with her dog, Spunk.Credit…Johnathon Kelso for The New York Times

At Georgia’s state public health laboratory, direct handling of patient samples must be done with extra safeguards to minimize the chances of exposing personnel to infectious virus. Taylor Smith, a virologist and technologist at the lab, spends a large fraction of her workday in a full-body gown, sleeve covers, two pairs of gloves, an N95 respirator and goggles.

Simply donning it all is exhausting. And although Ms. Smith has long been deft with lab instruments, the work always feels high-stakes, she said: “You’re constantly thinking about how to not contaminate yourself.”

To keep their experiments running, lab workers must be proficient mechanics. The instruments needed for diagnostic tests were not built to run continuously for months on end. But as more facilities transition to 24/7 testing, malfunctions and breakdowns have become more common, requiring people to fix them.

Tyler Murray, a clinical laboratory scientist at the University of Texas Medical Branch in Galveston, spends his days listening for telltale alarms — a sign that one of his instruments has failed or is low on chemical ingredients.

“I make sure I talk nicely to them,” Mr. Murray said of the lab’s machines, which he decorates with gleaming gold stars when they perform at their best. “I say, ‘Hey bud, you worked hard this week, I’m proud of you.’”

But morale is low among the humans. After 10-hour shifts at U.T.M.B., Mr. Murray heads home and lies on the floor beside his two cats, Arya and Cleo. “The fatigue builds,” he said. “You can’t help but feel it.”

Tyler Murray, a clinical laboratory scientist at the University of Texas Medical Branch in Galveston, with Cleo, one of his two cats.Credit…Go Nakamura for The New York Times

The invisible work force

The monotonous motions that lab workers engage in daily take a physical and mental toll. Technologists are nursing repetitive-use injuries, a result of hours of maneuvering tubes and pipettes, which take up and dispense liquids with the press of a plunger. Workers must also be vigilant sanitizers, pausing regularly to swap out soiled gloves, clear their workspaces of plastic debris and scour surfaces with harsh chemicals that leave their clothes freckled with stains.

“We’re accustomed to holding things up in the background,” said Natalie Williams-Bouyer, the director of the division of clinical microbiology at the University of Texas Medical Branch in Galveston. “We enjoy doing it because we know we’re helping people.”

But the enduring anonymity of testing labs has begun to splinter some spirits. Elizabeth Stoeppler, a senior medical technologist in the molecular microbiology lab at the University of North Carolina’s School of Medicine, said that an old volleyball injury, which inflamed a tendon in her elbow years ago, had flared up after months of long stints in the lab. A few of her co-workers are wrestling with carpal tunnel syndrome.

The strain has begun to affect Ms. Stoeppler outside of the lab. She bolts awake at 3 a.m., panicked about the previous day’s work. She recently started a prescription medication to improve her chances of getting a full night’s sleep.

“There’s signs everywhere that say, ‘Heroes work here,’” she said of her hospital. She loves her job, she added. “But nobody sees us. We’re just in the basement, or in the back.”

On a good day in a diagnostics lab, the phone might ring only a few times, with messages from clinicians inquiring about samples. But when “things are going poorly, it just rings off the hook,” said Rachael Liesman, the director of clinical microbiology at the University of Kansas Health System, where she frequently clocks 15-hour shifts.

To keep the lab on track, Dr. Liesman has put in some hours running tests herself — a task that is not a part of her normal job description. “It’s very strange to have your director on the bench,” said Ms. Larson, a supervisor in the lab. “When you see that, some flare guns should be going up.”

Marissa Larson, left, a medical laboratory scientist supervisor at the University of Kansas Health System, and Rachael Liesman, its director of clinical microbiology.Credit…Barrett Emke for The New York Times

In mid-November, Dr. Liesman’s lab suffered a three-day stretch during which a supply of chemicals nearly ran dry on a Friday, then a pair of machines failed on Saturday and Sunday.

“We were basically drowning in specimens” by Monday, she said. “I was paged by three different providers while brushing my teeth.”

Morale in the labs has flagged as the country continues to shatter records for caseloads, hospitalizations and deaths. The nation’s testing experts know these statistics better than anyone: They count the numbers themselves, sample by sample. But they are also easy targets of criticism and complaint.

“There is always this undercurrent of, it’s never good enough,” said Dr. Abbott, of Deaconess Hospital in Indiana. “It’s devastating. We’re working as hard as we can.”

Chelsa Ashley, a medical laboratory scientist at Deaconess, aches to be home with her three children, to whom she is a single mother, after 13-hour shifts in the lab. Once there, she struggles to leave her work behind.

“There’s that panicked feeling that I should have stayed to take care of our community samples,” she said. “There’s guilt, when you walk away.”

In the past few months, Ms. Ashley’s children, who are 18, 13 and 10, have had to become substantially more self-sufficient. Shaylan, her youngest, rouses herself from bed at 5:50 a.m. every day to spend a few moments with her mother before she heads off to work.

“Even if it’s only 10 minutes, it’s 10 minutes that we talk,” Ms. Ashley said. “That is one thing that has not changed.”

‘A dying breed’

For some, the tidal wave of stress brought on by the pandemic has proved untenable. Since March, scientists have trickled out of laboratories, leaving chasms of expertise in a field that for years has struggled to recruit fresh talent.

Joanne Bartkus, the former director of the Minnesota Department of Public Health Laboratory, retired from her position in May after a dozen years on the job. She pinned one of the pandemic’s crucial inflection points to March 6, the day President Trump publicly remarked that “anybody that wants a test can get a test.”

“That was when the poop hit the fan,” Dr. Bartkus said. Within about a week, her team went from receiving fewer than a dozen coronavirus testing samples each day to being inundated with roughly 1,000 daily specimens.

It was unlike anything Dr. Bartkus had seen in her years at the institution. In 2009, the year of the H1N1 flu pandemic, Minnesota’s public health laboratory tested about 6,000 patient samples. This spring, it broke that record in a couple of weeks.

Dr. Bartkus, who is 65, had already planned to retire before the year was up. By the time April came, she had hastened her timeline to May: “It didn’t take me long before I said, ‘OK, I’m done with this.’”

In interviews, several scientists noted that they were struggling to fill vacancies in their labs, some that were left open by overwhelmed technologists who had recently quit their jobs. While the need for such workers has grown in recent years, the number of training programs that build these skill sets has dropped.

“Medical technologists are a dying breed,” Ms. Stoeppler, of the University of North Carolina, said.

Natalie Williams-Bouyer, the director of the division of clinical microbiology at the University of Texas Medical Branch in Galveston. “I hope people can see us now,” she said.Credit…Go Nakamura for The New York Times

In Indiana, Dr. Abbott, of Deaconess Hospital, said her team had already performed more than 100,000 tests for the coronavirus. But the most chaotic months are most likely still ahead.

For the first time in nine years, Dr. Abbott is doing hands-on work in the lab to help her staff cope with rising demand. She has yet to take more than a day off at a time since the pandemic’s start, but insists that she can soldier on: “This is out of the sheer will of not wanting to be beaten by this pandemic.”

In the mini-refrigerator in her office, next to rotating bags of salad greens and a small cavalry of Diet Cokes, sits an unopened bottle of champagne that she purchased in March, intending to uncork it upon reaching a worthy testing milestone. Nothing has yet felt like enough.

“I can’t tell you what will feel like a reason to celebrate at this point,” Dr. Abbott said. “Ask me after the next 100,000 tests.”

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C.D.C. Officials Shorten Recommended Quarantine Periods

C.D.C. Officials Shorten Recommended Quarantine Periods

The agency also urged Americans to stay home during the coming holidays, and to get tested if they do travel.

Signage on California’s Highway 99 advised people to stay home to avoid Covid-19 last month.
Signage on California’s Highway 99 advised people to stay home to avoid Covid-19 last month.Credit…Peter Dasilva/EPA, via Shutterstock
Roni Caryn Rabin

By

  • Dec. 2, 2020, 5:03 p.m. ET

Federal health officials on Wednesday effectively shortened quarantine periods for those who may have been exposed to the coronavirus, hoping to improve compliance among Americans and reduce the economic and psychological toll of long periods of seclusion.

Citing the spiraling number of infections nationwide, officials at the Centers for Disease Control and Prevention also urged Americans again to avoid travel over the holiday season.

“The C.D.C. recommends the best way to protect yourself and others is to postpone travel and stay home,” Dr. Henry Walke, who oversees day-to-day management of pandemic response at the agency, said at a news briefing.

People who choose to travel over the holiday season despite the warnings should consider getting tested for coronavirus infection one to three days before their trip, and again three to five days after return, Dr. Walke and other officials said.

It is the first time the agency has urged testing for domestic travelers; until now, testing was recommended only for Americans traveling internationally. Dr. Walke noted that testing before and after travel “does not eliminate all risk.”

Travelers returning home should keep nonessential activities to a minimum for at least seven days if they are getting tested, and for 10 days if they are not getting tested. (Many states already require travelers to self-quarantine after arrival, though the rules vary from state to state.)

Federal health officials also offered two new ways to shorten quarantine periods. Those without symptoms may end quarantine after seven days if they are tested for the virus and receive a negative result, or after 10 days without a negative test.

P.C.R. or rapid tests are both acceptable, the officials said, and should be taken within 48 hours of the end of the quarantine period. People should continue to watch for symptoms for 14 days.

(Quarantine refers to people who are well but may become ill; isolation refers to those known to be ill.)

Until now, the C.D.C. has recommended a 14-day quarantine period following potential exposure, and Dr. Walke stressed that the full two weeks is still considered ideal and the surest way to curb transmissions.

While a shortened quarantine period may be more palatable to Americans, officials acknowledged that the new guidance might lead to some infections being missed.

“We can safely reduce the length of quarantine, but accepting that there is a small residual risk that a person who is leaving quarantine early could transmit to someone else if they became infected,” said Dr. John Brooks, the chief medical officer for the Covid-19 response at the C.D.C.

Some patients may not develop symptoms until two weeks after exposure, and even longer in a very small fraction of cases. Infected individuals may pass the virus to others before they develop symptoms; recent studies show they are most infectious two days before symptoms begin, and for about five days afterward.

The new recommendations do not have the force of law. Federal officials share them with state and county public health agencies, who make their own determinations based on local conditions and needs.

The agency’s warnings against holiday travel echoed those issued just a week before Thanksgiving. Millions of Americans hit the road nonetheless to spend the holiday with friends and family, though the number of travelers was lower than in a typical year.

“Cases are rising, hospitalizations are increasing, deaths are increasing,” Dr. Walke said. “We need to try to bend the curve, stop this exponential increase.”

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Dr. Cindy Friedman, chief of the travelers health branch at the C.D.C., said the agency was reiterating the message further in advance of the Christmas holiday to provide more time for people to plan ahead, “think about the safest option for them and their families” and make “tough choices.”

“We know it’s a hard decision, and people need time to prepare and have discussions with family and friends and to make these decisions,” Dr. Friedman added. Even a small percentage of infected travelers could “translate into hundreds of thousands of additional infections.”

Hospitals are already overwhelmed in many regions, as cases have been rising rapidly, with the country adding over a million new infections during a recent one-week period, according to data maintained by The New York Times.

Daily deaths have been exceeding 2,000 for the first time since early May, and close to 100,000 Americans are already hospitalized.

“We are at the point now, even before Christmas, that there may not be room at your hospital, because we don’t have enough health care workers to take care of you,” said Michael Osterholm, a member of President-elect Joseph R. Biden Jr.’s Covid-19 advisory board, who also urged Americans to stay home.