. .
The FDA has authorized the test, which requires a prescription but is the first to be done entirely at home. France became the first country in Europe to exceed two million cases discovered.
The Food and Drug Administration on Tuesday gave an emergency green light for the first rapid test for coronavirus that can run from start to finish at home, paving a potential pathway for more widespread testing outside of healthcare settings..
The test, developed by California-based company Lucira Health, requires a prescription from a healthcare provider. People under the age of 14 cannot test themselves. But with a relatively simple nose swab, the test can return results in about half an hour, and the company expects it to cost $ 50 or less, according to the product’s website.. Doctors can also test patients, including children under the age of 14, and are likely to provide answers during a single visit to a care center or pharmacy, rather than directing a sample that is difficult to collect through the lab..
A few other tests have been approved by F. . Dr. a. To collect samples at home, which are then shipped to a laboratory for processing. But the Lucera test is the first test that eliminates the need for a mediator.
“Today’s delegation for a full home test is an important step toward F.. Dr. a. National Covid-19 Response, ”Jeff Shoren, Director of F. Dr. a. The Center for Devices and Radiation Health said in a statement. « Now, more Americans who may have Covid-19 will be able to take immediate action, based on their findings, to protect themselves and those around them..
People who have tested positive for the Coronavirus are expected to isolate themselves from others for 10 days from the day their symptoms began, or the day they test positive for the virus, according to guidelines issued by the Centers for Disease Control and Prevention.
Lab tests looking for the genetic material for coronavirus using a technique called polymerase chain reaction, or P. . C. R. , Is still considered the gold standard for virus detection. But the new home test relies on similar principles using a method called the loop amplification reaction, or LAMP. Like P. C. R. LAMP repeatedly copies genetic material until it reaches detectable levels, making it possible to recognize the virus even when it is only present at very low levels in the respiratory system.. While faster and less complex than P.. C. R. , LAMP is generally thought to be less accurate.
People taking the battery-powered test should slide a swab into each of their nostrils, dip it and flip it into a vial of chemicals. This vial is then attached to a test cartridge that handles the sample. Within half an hour, the test cartridge will light up as « positive » or « negative. ». Federal guidelines indicate that people taking the test should report the results to health care providers, who must then report to public health authorities to help track the spread of the virus..
Omai Garner, a clinical microbiologist and diagnostic expert in the UCLA Health System,
said a home test for the virus « was going to happen ». . “Hope it works well.
Dr.. However, Garner said the news should be taken with caution. In recent months, many experts have called for more widespread home testing as a way to help limit the spread of the virus. But others have raised concerns about the practical application of a strategy that will likely rely on tests that sacrifice a degree of accuracy for comfort and a reasonable price.. .
According to the product’s instructions, Lucira’s LAMP test was able to accurately detect 94 percent of the infections found by P. C. R. Based test. It also correctly identified 98 percent of uninfected healthy people.
Saskia Popescu, an infection prevention expert and epidemiologist at George Mason University, also warned that home testing, despite its remarkable progress, should not be considered a panacea. To help fill more gaps in Coronavirus diagnostics, Dr.. “We need more laboratory testing that is accessible and fast,” Popescu said.
One day after the California governor announced that the state was « pulling the emergency brakes » when reopening and reimposing sweeping restrictions, Los Angeles County took another step on Tuesday and announced a corporate curfew..
Starting Friday, restaurants, breweries, bars, wineries and non-essential retail establishments should close from 10 a.m.. M. To 6 a. M. A similar move is being considered statewide.
“This is a moment of a different kind, a new level of danger,” Mayor Eric Garcetti said Monday before the new measures were announced.. “If we don’t make these decisions now, there is really only one consequence: We will almost certainly have to shut things down again.. More people will get sick and die.
The moves in California came as state and local leaders across the United States try to slow down the Coronavirus, which has killed nearly 250,000 Americans and is now setting daily records for the number of people hospitalized due to illness. Wednesday morning that number reached 76,823, according to the Covid Tracking Project.
Dr.. Anthony S.. Fauci, the government’s chief infectious disease expert, said Tuesday that the nation needs a « unified approach », rather than a « disjointed » response for individual country, city by city.
This is not what happens. As happened in the spring, when the country failed to develop a coordinated national response, a set of measures are put in place to combat the virus. Public health experts say the lack of a national strategy has been the main reason for the world’s leading number of cases and deaths in the country.
Unlike spring, the virus is now spreading on a larger scale, taking a heavy toll on communities from coast to coast.. On Tuesday, more than 1,580 new deaths were reported nationwide, the highest in a single day since mid-May. Five states set one-day records of new deaths.
In the past two days, Ohio announced a night-time curfew, and Mississippi extended the mask’s mandate to seven more counties.. Iowa will issue its first statewide order, and Maryland will require all bars, restaurants and nightclubs to close by 10 a.m.. M. , And Pennsylvania will require anyone entering the state to be tested prior to arrival.
In Illinois, Governor. J. B. Pritzker said that starting Friday, the entire state will move to Level 3 under its mitigation plan, which limits the number of clients at many companies and limits private indoor gatherings to people in the same household, among other measures.. Casinos and indoor venues such as theaters and museums should be closed, and outdoor group activities will be restricted to 10 people.
In Maryland, the government. Larry Hogan announced that starting Friday, all bars, restaurants and nightclubs should close by 10 a.m.. M. Companies, foundations, and religious organizations will be limited to 50 percent of their capacity.
in Mississippi, where Gov is. Tate Reeves lifted mask mandate statewide in September, and new extensions in parts of the state meant masks were only required in 22 of the 82 counties..
The government. Mike DeWine of Ohio, a rare Republican leader for a red state who has consistently bucked President Trump’s opposition to strict restrictions, has announced that his state will be subject to a curfew beginning at 10 p.m.. . M. Up to 5 a. M. The three-week period begins on Thursday.
Ohio reported a daily average of more than 7,000 new cases last week, seven times what it was in early October and more than at any time since the pandemic began.. « These are astronomical numbers, » the governor said at a press conference on Tuesday, urging residents to wear masks and maintain strict social distancing until the vaccine is widely available.. .
Mr.. DeWine said all retail businesses should close during curfews and that residents should stay home unless they commute to work or are traveling for emergency purposes.. I call the rules « common sense. ».
Many states are considering imposing new restrictions on businesses and in some cases urging residents to stay home to stop the spread of the Coronavirus..
Even as France became the first country in Europe to exceed 2 million cases of coronavirus infection this week, authorities expressed optimism that weeks of restrictions on movement and social interactions began to slow the spread of the virus.
« Our collective efforts are starting to bear fruit, » Jerome Salomon, a senior health ministry official, said at a press conference on Tuesday.. .
However, French officials warned that the lockdown restrictions must remain in place for at least another several weeks. France recorded more than 45,000 new cases during the past 24 hours, bringing the country’s total cases to 2036,755.
The number of Covid-19 patients in hospitals has peaked at around 33,500 this week – slightly more than the first wave last spring – and the pressure on French hospitals is still « very strong, » Mr.. . Salomon said.
Last month, France became one of the first countries in Europe to return to a nationwide lockdown, albeit noticeably less draconian than measures introduced in the spring..
Public gatherings have been banned, restaurants, bars and cinemas are closed again, and movement outside the home has been restricted. But parks and schools remain open and a wide range of businesses are allowed to remain open.
French authorities are considering allowing small businesses and stores to reopen in the run-up to Christmas. Catholic worshipers have also protested in recent days, calling on the government to ease the ban on religious services.
Health Minister Olivier Ferrand told the BFM TV news channel Tuesday: « Your efforts are starting to bear fruit, you must definitely not stop them. ». . “Yes, it’s a long time, yes it’s difficult, but that’s the price to get back to normal life.
Senator Charles E.. Grassley, an 87-year-old Republican from Iowa, on Tuesday became the latest lawmaker to be affected and announced he had tested positive.. . His absence temporarily helped hamper confirmation of President Trump’s Federal Reserve candidate and shattered the master. . Grassley’s pride and happiness, the longest running streak in Senate history.
His diagnosis came the day after Representative Don Young from Alaska, also 87, revealed he was hospitalized over the weekend after what he described as a particularly brutal match with Covid-19.. The twin announcements by two men, their gender and age at the height of being killed by the virus, underscored the dangers lawmakers are operating under while Congress continues to confront them.. .
The marble and stone petri dish on Capitol Hill is a vivid microcosm of the national struggle to confront and contain the spread of the epidemic, as partisan bickering often frustrates health precautions already unevenly imposed. With effectively declaring themselves to be primary workers, lawmakers in the country – a group of elderly Americans whose jobs include weekly flights, ample intercom, and near-permanent gathering – are struggling once again to adapt their legislative and ceremonial measures to stem the spread of the virus, even as Raging in their ranks.
Starting Tuesday afternoon, Senator Rick Scott, Republican from Florida, and Mr.. Grassley was in quarantine as a result of potential exposure, which marked the master’s first time. Grassley had been absent from the vote since 1993. At home, mr. Young – who indicated on Monday that he is « alive, feeling better and on the road to recovery » after his exit – is among four lawmakers who tested positive for the virus last month..
More than 80 members of Congress have tested positive, isolated, or interacted with a person infected with the virus, according to GovTrack.
On Tuesday, the mr. Grassley and mr. Scott pauses to confirm Judy Shelton, Mr.. Fed candidate for Trump, after Republicans failed to get the support needed to advance to the final vote.
“There is that kind of manhood,“ Well, I’m not afraid of something Covid going on, ”said Senator Brian Schatz, a Democrat from Hawaii, who has one of the longest periods of mobility in Congress and instructed all of his staff to work remotely. « We have to run the government – it’s our duty. Our obligation is not to show that we are not afraid personally, because we have to pass legislation to address this crisis, and we are not good for anyone if we are sick or in quarantine..
Pharmaceutical company Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective and had no serious side effects – the first set of full results from a late-stage vaccine trial as Covid-19 cases spiked worldwide..
The company said the data showed the vaccine prevented the mild and severe forms of Covid-19. It was 94 percent effective in the elderly, who are more likely to contract severe Covid-19 and who do not respond strongly to some types of vaccines.. .
Pfizer, which developed the vaccine with its partner BioNTech, said the companies plan to apply to the Food and Drug Administration for emergency authorization « within days », raising hopes that an effective vaccine could soon become a reality..
The results of the experiment – less than a year after researchers began working on the vaccine – shattered all records of speed for vaccine development, a process that usually takes years..
If the letter F. . Dr. a. Authorizing the two-dose vaccine, Pfizer said it could have up to 50 million doses available by the end of the year, and up to 1. 3 billion by the end of next year.
However, only about half of its supplies will go to the United States this year, or enough for about 12. 5 million people – a slice of the US population of 330 million. Americans will get the vaccine for free, for less than a dollar. 95 billion deals reached by the federal government with Pfizer for 100 million doses.
Federal health officials said the first doses of vaccines will likely go to groups such as health care workers who are at high risk of exposure, as well as people most at risk of contracting the disease, such as the elderly.
The results are consistent with an early analysis published by Pfizer and BioNTech last week, which found the vaccine was more than 90% effective.. Then on Monday, the pharmaceutical company Moderna reported that its vaccine was 94. 5% effective in early analysis.
Dr.. Saad Omar, director of the Yale Institute for Global Health, said the results showing that vaccines protect people from severe disease were good news, because with such limited availability at the start, the first goal would not be to stop disease transmission, but to prevent people from becoming Very sick. He said, « This is very reassuring. ».
If the vaccine is licensed, attention will immediately shift to how it was distributed. The vaccine should be stored below 94 degrees Fahrenheit, which is colder than any other vaccine in development. Pfizer will ship the vaccine in special boxes of 1,000 to 5,000 doses stuffed with dry ice and equipped with GPS sensors..
The promising news that only one coronavirus vaccine was more than 90% effective in initial results has reinforced hopes that the end of the epidemic is imminent.. .
But even if vaccines are licensed soon by federal regulators – the companies that develop them say they expect progress soon – only a fraction of the American public will be able to get the vaccine by the end of the year.. Pfizer and Moderna estimated they would receive 45 million doses, or enough to immunize 22. 5 million Americans, by January.
Industry analysts and company executives are optimistic that hundreds of millions of doses will be taken by next spring.. But the companies – backed by billions of dollars in federal money – will have to overcome the hurdles they faced in the early days of making vaccines.. Moderna and Pfizer vaccines use new technology that has never been approved for widespread use. They are reaching millions for the first time. Other challenges include securing raw vaccine ingredients quickly and mastering the art of creating consistent, high-quality batches.
Operation Warp Speed - the federal effort to accelerate vaccine development – has been set as a target of 300 million doses this year, but it hasn’t achieved that much, reflecting how difficult and unpredictable the manufacturing process is..
Pfizer said this summer that it expects to produce 100 million doses by the end of the year, but has now said it can produce only half of that goal..
« The manufacture of a biological product is in some ways an art and a science, » said Prashant Yadav, who studies healthcare supply chains at the Center for Global Development in Washington.. .
In the spring, when European governments imposed strict lockdown orders that turned capitals into ghost towns and forced people to largely confine themselves to their homes, Sweden opted for a lighter touch..
The “Sweden model,” as it came to be known, has been the subject of controversy and study even as heated debate continues over the effectiveness of this approach.
But on Tuesday, in a few short words posted on social media, King Carl XVI Gustav seized an entirely different mood as the virus spread across Europe..
This week the government announced the toughest restrictions on the country since the coronavirus first surfaced and warned that there will be darker days ahead..
« It is a clear and sharp signal to every person in our country about what applies in the future, » Prime Minister Stefan Leuven said during a press conference on Monday.. . « Don’t go to the gym, don’t go to the library, don’t eat dinner outside, don’t party – cancel! »
With governments across Europe struggling to avoid sweeping national lockdown orders this time – but moving step by step in this direction with new restrictions imposed – Sweden is no longer the outgoing country.
Having previously adopted a ban on serving alcohol after 10 am. M. Advising against using public transportation, mr. Leuven announced a ban on public gatherings of more than eight people starting next week.
Although the number of Covid-19 deaths in Sweden is still small compared to those in some European countries such as Italy or Spain, it is more than 10 times higher than in Finland or Norway. During the past five days, Sweden recorded more than 15,000 new infections and Mr.. Leuven warned that « things will get worse.
However, despite taking more stringent anti-virus measures, the Swedish leader said the national lockdown was still off the table..
Children in the United States this year are walking to miss 9 million doses of vaccines against measles, polio and other highly contagious diseases, according to medical claims data – a disorder healthcare authorities have described as worrying and attributable to the coronavirus pandemic.. .
The data was released on Wednesday by the Blue Cross Blue Shield Association, one of the nation’s largest insurance companies, which said routine vaccinations for children were down by up to 26 percent, compared to 2019..
The results appeared less than two weeks after the World Health Organization and UNICEF warned that progress in vaccinating children against polio and measles had become threatened by the epidemic.. In an emergency call to action, the two organizations said the risk of measles and polio outbreaks was increasing.
Last week, the Centers for Disease Control and Prevention and W.. H. a. You mentioned that measles deaths worldwide rose to their highest level in 23 years in 2019 and were 50 percent higher than they were just three years ago..
Dr.. Megan Rani, an emergency physician at Brown University in Rhode Island who specializes in public health research, said that failure to maintain infant vaccination rates could compromise so-called herd immunity.. . The term denotes the point at which a disease stops spreading because nearly every member of the population has become immune to it.
“We know that once it drops below herd immunity, it provides a foothold for these deadly childhood diseases to raise their heads again in our communities,” Dr.. . Rani said in an interview.
Blue Cross Blue Shield said 40 percent of parents and legal guardians surveyed said their children had missed vaccinations because of the pandemic. The association said that most of the missed appointments occurred from March until May, at the start of the epidemic, and in August, which is the time when many children are vaccinated before school resumes.. .
South Australia will be subject to a six-day lockdown in an effort to contain the growing coronavirus outbreak. The group, which was traced to a traveler quarantined in a hotel, included 22 cases since Saturday.
It’s the first major outbreak in Australia since it appeared in Victoria state in June that has also been tracked in hotel quarantine.. Tight restrictions have been in place throughout Victoria for about four months.
Starting at midnight Wednesday, only one person per household in South Australia will be able to go out each day to access basic services: to buy groceries, access medical services, or caregiving purposes. Restaurants, cafes, bars and retail stores, as well as schools and universities will be closed. Outdoor sports and physical activities are prohibited, and masks will be mandatory.
The Prime Minister of South Australia, Stephen Marshall, said at a press conference: « This is about the temporary pause of South Australia so that we remain at the forefront of the virus. ». “Our concern is that if we didn’t have this circuit breaker, we wouldn’t stay ahead of the curve.
After the six-day lockdown, South Australia will face another eight days of fewer restrictions, the details of which have yet to be announced..
A national medical association said, on Tuesday, that Switzerland has reached its capacity in intensive care wards, and urged people particularly vulnerable to infection with the virus to consider writing a living will, while specifying whether they would like to have life support devices. All 876 adult intensive care beds, which have been certified by the Swiss Society of Intensive Care Medicine, are « currently completely full, » the association said in a statement.. .
British police say the coronavirus pandemic and subsequent social isolation have contributed to a « perfect storm » that leaves more young people vulnerable to extremism.
Neil Basu, Assistant Commissioner of the Metropolitan Police, said police have already seen a sharp increase in extremist material online, and with young people spending more time online in isolation without the protective effect of schools and support networks, they are increasingly at risk..
“In my opinion, this is a complete storm, a storm that we cannot predict and may feel its effects for many years to come,” Mr.. Basu said in a statement issued by the police on Wednesday.
The comments come after a series of attacks in France and this month’s shooting in Vienna, all linked to Islamic extremists.. The terrorist threat in Britain has been raised to its highest level – severe – in the aftermath of the violence, which means that the authorities suspect an attack, even if there is no specific threat..
Mr.. Basu also noted that the police are witnessing more youths being attracted to terrorist activities. He pointed out that in 2019, 12 children under the age of 18 years – including some children up to the age of 14 – were arrested for terrorism crimes.. .
“This is a relatively new and disturbing trend in the United States. K. Because just a few years ago, we did not see anyone with this young man among our social businesses.. Basu said.
The information was released when authorities introduced a new website, called ACT, that encourages family and friends to communicate if they fear that someone they know is at risk of radicalization.
She wrote « I Will Always Love You » and « Julien » the same day and created a theme park around her. She has put on unforgettable performances on screen as an amazing hairdresser and secretary who got bullied. She even helped create “Buffy the Vampire Slayer.”.
Now, Dolly Parton fans are taking credit for saving the world from the Coronavirus. It’s an exaggerated claim, tongue-in-cheek, for sure. But for the legions of fans, Mrs.. Barton’s donation this spring to Vanderbilt University Medical Center, which has worked with pharmaceutical company Moderna to develop a vaccine against the Coronavirus, was another example of how the singer’s generosity and philanthropy made her one of the world’s most beloved artists..
In April, Mrs.. Parton announced that she donated $ 1 million to Vanderbilt after her friend, Dr.. Nagy Abumurad, a professor of surgery at the University of Nashville, told her about the work researchers are doing to create a vaccine. .
Her contribution, which became known as the Dolly Parton Covid-19 Research Fund, helped pay for the first part of the vaccine research, led by Dr.. . Mark Denison, Professor of Pathology, Microbiology and Immunology at Vanderbilt. The federal government ultimately invested $ 1 billion in creating and testing the vaccine, but Dr.. Denison said she was the mrs. Parton’s funds, which funded the first « critical » stages of the research.
« Her money helped us develop the test that we used first to show that Moderna was giving people a good immune response that might protect them, » Dr.. . Denison said on Tuesday.
On Monday, after Moderna announced that early trials of the vaccine showed 94. The effectiveness rate is 5%, the reaction of the fans was enthusiastic.
Author Liz Linz said on Twitter: « Shakespeare may have written King Lear during the plague, but Dolly Parton funded a vaccine for the Covid virus, and released a Christmas album and a Christmas song. ». .
Food and Drug Administration, Coronavirus, Emergency Use Permission
World News – US – Live Updates for Covid-19: Coronavirus test at home wins emergency approval, as it stresses States restrictions
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Ref: https://www.nytimes.com