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Live updates: FDA approves first coronavirus test that delivers rapid results at home

The Washington Post logo The Washington Post 11/18/2020 Antonia Farzan
a large building: FDA officials announced Tuesday that they had granted emergency approval to the first rapid coronavirus test that can be performed entirely at home. © Jacquelyn Martin/AP FDA officials announced Tuesday that they had granted emergency approval to the first rapid coronavirus test that can be performed entirely at home.

The Food and Drug Administration has authorized the first rapid coronavirus test that can be taken at home and deliver results within minutes, potentially allowing people to skip long lines at testing sites as infections continue to surge nationwide.

The single-use test kit from Lucira Health, Inc. relies on nucleic acid amplification technology, which is considered more accurate than antigen tests. It will cost less than $50, according to the company’s website.

Here are some significant developments:

  • Sen. Charles E. Grassley (R-Iowa), who is 87 and third in line of succession to the presidency, revealed Tuesday that he has contracted the coronavirus.
  • President Trump said Tuesday that he had “reversed the ridiculous decision” to cancel a large annual event at Arlington National Cemetery over virus concerns.
  • The average daily number of patients dying of covid-19 in the United States has reached a level not seen since the outbreak surged during the summer. At least 247,000 fatalities and nearly 11.4 million infections have been reported nationwide since February.
  • Ohio Gov. Mike DeWine (R) announced a nightly curfew for businesses that will last at least three weeks. Similar restrictions were also announced in Los Angeles County, home to more than 10 million people.
  • The number of Americans willing to take a vaccine when one becomes available increased in the second half of October, according to a Gallup poll released Tuesday.

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3:36 AM: South Australia orders ‘circuit breaker’ lockdown after discovering cluster of 22 cases

a group of people standing in a room: People line up at a supermarket on Wednesday after the South Australian government announced a six-day lockdown. © Brenton Edwards/AFP/Getty Images People line up at a supermarket on Wednesday after the South Australian government announced a six-day lockdown.

South Australia ordered a strict, six-day “circuit breaker” lockdown on Wednesday in response to a cluster of 22 coronavirus infections.

Roughly 1.7 million people in the state are being told to stay home unless they are essential workers, or require medical care. Only one person from each household will be permitted to shop for groceries each day. Schools, stores and restaurants, including those offering takeout, must close by Thursday. Authorities said that the aggressive response was necessary to ensure that the virus doesn’t spread further while contact tracers are working to determine how many people may have been exposed.

“We know that these restrictions are going to be very punishing on the people of South Australia,” South Australian Premier Steven Marshall said Wednesday. “But we also know that we’re doing it for the right reasons to stop a far harsher lockdown which could come if we allow this virus to get away.”

Marshall emphasized that the state has “one chance” to prevent a much worse outbreak, like the one that took place in the neighboring state of Victoria over the summer. Both the South Australian cluster and the Victorian outbreak have been traced back to quarantine hotels, with infections spreading among workers and their family members.

South Australians had already started clearing supermarket shelves of toilet paper before the lockdown was announced, and officials insisted there was no need for panic-buying on Wednesday as large and frequently maskless crowds swarmed stores anyway.

“Supermarkets are going to be open beyond today,” South Australia police commissioner Grant Stevens pleaded, according to the Sydney Morning Herald. “There is no need for people to rush to supermarkets.”

By: Antonia Noori Farzan

3:06 AM: The pandemic isn’t going anywhere. Here’s how to organize your masks and other supplies.

Masks, hand sanitizer, thermometers and disinfectant wipes have become necessities in every household this year. When the coronavirus pandemic began in the spring, none of us could imagine that we would still need them in November. But here we are, and many of us are actually stocking up on supplies again as winter looms and virus cases continue to rise. If you haven’t yet developed a system to keep all of these supplies organized, it’s not too late to start.

The same principles that apply to all home-organizing projects also apply to coronavirus supplies: Designate a specific place to keep the items, so people know where to find what they need and so you can keep track of what you have. Put items where you use them and where they’re convenient to access. Buy only what you need and are going to use. And if you’re stocking up, don’t go overboard.

Read the full story

By: Nicole Anzia

2:36 AM: More than 900 Mayo Clinic staffers have contracted the coronavirus in the past two weeks

a sign on the side of a building: Rapid spread of the coronavirus in the Midwest is keeping roughly 1,500 employees at Mayo Clinic facilities out of work. © Bing Guan/Reuters Rapid spread of the coronavirus in the Midwest is keeping roughly 1,500 employees at Mayo Clinic facilities out of work.

More than 900 employees at the prestigious Mayo Clinic have tested positive for the coronavirus in the past two weeks as infections continue to surge across the Midwest, a top hospital official said Tuesday.

In about 93 percent of the instances where staffers have been exposed to the virus, that exposure has occurred outside of work, Amy Williams, the medical center’s dean of clinical practice, said at a Tuesday media briefing. “We’re really not seeing exposures from patients to staff, we are seeing it more in the community,” she said. “When we do see it at work, it’s when our staff are eating and their masks are off.”

Based in Rochester, Minn., the Mayo Clinic Health System also operates clinics in Wisconsin and Iowa in addition to Arizona and Florida. Across its facilities in the Midwest, roughly 1,500 employees are out of work either because they are infected or are caring for a family member who is sick, or are quarantined due to potential exposure, Williams said. She added that the 905 employees who tested positive in the past two weeks account for roughly a third of all cases that have been reported among staff since the pandemic began.

“Our staff are being infected mostly due to community spread, and this impacts our ability to care for patients,” she said.

Williams also said that the 32 intensive-care beds dedicated for coronavirus patients at the Rochester campus are full, and that the clinic is working on adding at least a dozen more in anticipation of hospitalizations continuing to rise. Minnesota’s seven-day average of new coronavirus cases set a record on Tuesday and has increased more than 40 percent from the previous week, according to data tracked by The Washington Post.

By: Antonia Noori Farzan

2:06 AM: Los Angeles County to enact curfew, other restrictions as cases mount

a view of a city: Drivers line up at a coronavirus testing site in a parking lot at Dodger Stadium in Los Angeles on Tuesday. © Dean Musgrove/AP Drivers line up at a coronavirus testing site in a parking lot at Dodger Stadium in Los Angeles on Tuesday.

Video: Tarrant County Health Officials Issue Public Health Warning (CBS Dallas)

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Los Angeles County, the most populous in the United States, will implement a host of new restrictions — including a curfew — in an attempt to slow rampant spread of the coronavirus, officials announced Tuesday evening.

Beginning Friday, restaurants, bars, breweries and wineries must close from 10 p.m. to 6 a.m., while all businesses allowed to operate indoors must limit their occupancy to 25 percent capacity. Outdoor dining will be limited to 50 percent capacity and personal care establishments — like salons, barbershops and tattoo parlors — must operate on an appointment-only basis. Outdoor gatherings are the only get-togethers allowed, and they must be limited to 15 people and three households.

The county is currently reporting nearly 2,900 new cases per day, according to its own five-day rolling average. If that number hits 4,500, or if hospitalizations increase from about 1,100 to more than 2,000, the county will enact another lockdown — keeping all but essential workers home for three weeks.

“Los Angeles County is at a critical moment to save lives and curb the spread of covid-19,” county public health director Barbara Ferrer said in a statement. “I urge our residents, businesses and community leaders to heed this warning and follow these heightened safeguards so that additional restrictions do not need to be imposed.”

The county’s announcement comes the day after Gov. Gavin Newsom announced California would be “pulling the emergency brake” and rolling back many of the state’s reopening steps as new infections spread there at record rates.

“The spread of covid-19, if left unchecked, could quickly overwhelm our health care system and lead to catastrophic outcomes,” Newsom said.

By: Reis Thebault

1:36 AM: Switzerland ICU units reach capacity as doctors suggest creating living wills

a group of stuffed animals sitting on top of a bed: Medical workers treat a coronavirus patient with in the intensive care unit of a hospital in Yverdon-les-Bains, Switzerland earlier this month. © Laurent Gillieron/AP Medical workers treat a coronavirus patient with in the intensive care unit of a hospital in Yverdon-les-Bains, Switzerland earlier this month.

Switzerland’s intensive care units reached full capacity on Tuesday, according to the Swiss Society of Intensive Care Medicine, which warned that people at high risk of developing severe complications might want to write a living will.

The country of roughly 8.5 million has 876 intensive care beds that are certified by the association, which is known as SGI. In a Tuesday statement, the organization said that all were “fully occupied.”

While delaying non-urgent procedures has helped to reduce the strain on hospitals, the influx of coronavirus patients with severe symptoms is pushing intensive care units to the limit, SGI said. The organization suggested that people who are especially vulnerable to the coronavirus should create an advance directive specifying if they want doctors to “take life-prolonging measures” in the case of a serious illness.

The number of coronavirus cases being reported in Switzerland multiplied dramatically last month as many European countries witnessed a second surge of infections. In late October, one top health official said that intensive care units could reach full capacity in 15 days. Authorities warned that people were not being as cautious to limit travel and activities as they were during the first wave in mid-March, and rushed to require masks and ban large public gatherings.

Though fewer new cases have been reported since those restrictions went into place, government health officials said Tuesday that the level of hospitalizations and fatalities was still troublingly high, according to Swiss media outlets.

By: Antonia Noori Farzan

1:06 AM: Belgium vowed to protect nursing homes from covid-19. Deaths there are still among the worst in the world.

a group of stuffed animals sitting on top of a bed: Staff at a nursing home in Landenne, Belgium, attend to a resident with covid-19. © Virginia Mayo/AP Staff at a nursing home in Landenne, Belgium, attend to a resident with covid-19.

One Belgian doctor described nursing homes in his country as a scene of “carnage” in the first wave of the coronavirus pandemic, with fatalities inside the institutions pushing Belgium to a worst-in-the-world death toll. Afterward, policymakers vowed to fortify the care homes to protect against a potential new surge.

Yet deep into a second wave, the virus is racing through nursing homes once more, and advocates say some of the same broad mistakes are cementing Belgium’s status as a country where reported coronavirus deaths per capita are off the charts.

Nursing home personnel lament that they are being sidelined again, while policymakers focus on protecting the hospital system from being overwhelmed. But as in the spring, more nursing home residents are dying than any other segment of society.

Read the full story

By: Michael Birnbaum

12:36 AM: A vial, a vaccine and hopes for slowing a pandemic — how a shot comes to be

Hundreds of ultracold freezers in a warehouse belonging to pharmaceutical giant Pfizer in Kalamazoo, Mich., will hold one of the most-anticipated vaccines in human history: a shot against the coronavirus. © AP/AP Hundreds of ultracold freezers in a warehouse belonging to pharmaceutical giant Pfizer in Kalamazoo, Mich., will hold one of the most-anticipated vaccines in human history: a shot against the coronavirus.

In a vast Pfizer warehouse in Kalamazoo, Mich., with hundreds of ultracold freezers standing sentry, the final leg of an unprecedented scientific, medical and industrial relay race is about to get underway.

The country appears to be on track to have two remarkably effective coronavirus vaccines available before year’s end — the one from Kalamazoo, made by Pfizer and its German partner BioNTech, and another from biotech company Moderna. Both are proving to be more than 90 percent effective in clinical trials so far.

But the next phase of this race will depend on the herculean task of producing these tiny vials of vaccine at a vast scale nearly overnight and distributing millions of doses without wasting any.

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By: Carolyn Y. Johnson

12:35 AM: Adopting mask mandates, some GOP governors give up the gospel of personal responsibility

Doug Burgum wearing a suit and tie: After months of resisting ordering the people of North Dakota to wear masks and limit the size of gatherings, North Dakota Gov. Doug Burgum's executive order Friday came as a surprise. (Mike McCleary/The Bismarck Tribune via AP, File) © Mike Mccleary/AP After months of resisting ordering the people of North Dakota to wear masks and limit the size of gatherings, North Dakota Gov. Doug Burgum's executive order Friday came as a surprise. (Mike McCleary/The Bismarck Tribune via AP, File)

A growing number of Republican governors, including some who had written off mask mandates as unenforceable or unacceptable to freedom-loving Americans, are now requiring people to cover their faces in public — a response to escalating coronavirus outbreaks overwhelming hospitals across the country.

After eight months of preaching personal responsibility in place of mandates, these governors have brought their states in line with much of the world by instituting the simple requirement backed by science but, in the United States, shot through with politics.

Read the full story

By: Isaac Stanley-Becker

12:34 AM: FDA authorizes first test users can take, get results at home

The Food and Drug Administration on Tuesday authorized the first rapid coronavirus test that users can take at home and get their results within minutes.

The “All-In-One” single-use test kit by Lucira Health, Inc. is the latest nasal-swab test to be granted emergency use authorization but marks a significant development in at-home testing as companies have raced toward getting an accurate, consumer-friendly diagnostic test to market. The molecular test works by looking for the virus’s genetic material in a self-collected sample swab, offering results in 30 minutes or less on a light-up display.

Since the agency updated guidelines in July specifying that an at-home test would need to be easy enough that a layperson could administer it, companies had ceased submitting applications for such products, the FDA told The Washington Post in late October.

The test by Lucira, which was developing an at-home influenza test kit before the pandemic, met the agency’s burden for ease of use. The test will cost less than $50, according to the company’s website.

With winter approaching and a surge of infections in most states, the test could offer people the flexibility of getting tested for the virus without waiting in long lines at labs, doctor’s offices and other testing locations.

The nucleic acid amplification technology is also considered more accurate than antigen tests, which detect proteins on the surface of the virus.

William Wan and Laurie McGinley contributed to this report.

By: Meryl Kornfield

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