Covid Live Updates: F.D.A. Authorizes First Coronavirus Breath Test
“The test is about the size of a piece of carry-on luggage and can produce results in less than three minutes. South Korea plans to phase out most restrictions.
The Food and Drug Administration granted emergency use authorization to the first Covid-19 test that can detect the coronavirus in a breath sample, within a few minutes and with a high degree of accuracy, the agency said Thursday.
“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Jeff Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement.
The InspectIR Covid-19 Breathalyzer, which is about the size of a piece of carry-on luggage, can produce results in less than three minutes and can be used in doctor’s offices, hospitals and mobile testing sites by trained operators. A single machine can analyze about 160 samples per day.
Yvonne Maldonado, an infectious disease specialist at Stanford University School of Medicine who is working on another Breathalyzer test, said that having more options to test will only help the transition to the endemic phase of the pandemic.
“If you think back from the original P.C.R., those were pretty horrible,” Ms. Maldonado said. “They were very uncomfortable and seemed to last forever — the easier we can make it, the better off we are.”
The device was tested in a study made up of 2,409 individuals both with and without symptoms of the virus. In the study, the test identified 91 percent of positive samples correctly and 99 percent of negative samples correctly.
The Breathalyzer test uses a technique called gas chromatography gas mass-spectrometry, which separates and identifies chemical mixtures to detect five compounds associated with the coronavirus in exhaled breath. If a test comes back positive on the Breathalyzer, it should be confirmed with a molecular test, such as a P.C.R. lab test.
The F.D.A. warned that negative tests “should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with Covid-19” because they do not completely rule out an infection, and noted that the device “should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.”
InspectIR, the company that produces the breathalyzer, expects to be able to produce about 100 machines per week.
SEOUL — South Korea plans to phase out virtually all of its coronavirus restrictions, except for a mask mandate, starting next week, ending the curbs on business and social life that it has maintained in some form for two years.
As of Monday, restaurants and bars, which currently must close by midnight, will be allowed to operate 24 hours a day, Prime Minister Kim Boo-kyum said on Friday. Size restrictions will be removed for events like weddings and rallies, which have been capped at 299 attendees, and for private social gatherings, which have been limited to 10 people.
Starting April 25, Mr. Kim said, eating and drinking will again be allowed at movie theaters, indoor sports facilities and religious institutions. In addition, he said, many hospital beds that have been reserved for Covid patients will be returned to general use.
The Health Ministry also said on Friday that a seven-day isolation requirement for people who test positive for the coronavirus would end in late May, though isolation would still be recommended.
In two weeks, Mr. Kim said, the government will consider ending its outdoor mask mandate, given the “relatively low risk” of outdoor transmission. But the mask mandate for indoor public spaces will remain, he said.
“It’s inevitable that we’ll have to keep wearing a mask indoors for a long time,” Mr. Kim said.
South Korea first imposed coronavirus restrictions in March 2020, applying them to churches and some industries where the risk of infection was considered high. A wave of infections driven by the BA.2 Omicron subvariant has been ebbing in recent weeks; on Friday, the health ministry reported an average of 160,191 daily cases over the past seven days, down from 404,998 about a month ago.
Shanghai quarantine Leona Cheng
Line for water Leona Cheng
Food delivery Leona Cheng
Kids socializing Leona Cheng
Trying to sleep Leona Cheng
After Leona Cheng tested positive for the coronavirus late last month, she was told to pack her bags for a hospital stay. When the ambulance came to her apartment in central Shanghai to pick her up two days later, no one said otherwise.
So Ms. Cheng was surprised when the car pulled up not to a hospital but to a sprawling convention center. Inside, empty halls had been divided into living areas with thousands of makeshift beds. And on exhibition stall partitions, purple signs bore numbers demarcating quarantine zones.
Ms. Cheng, who stayed at the center for 13 days, was among the first of hundreds of thousands of Shanghai residents to be sent to government quarantine and isolation facilities, as the city deals with a surge in coronavirus cases for the first time in the pandemic. The facilities are a key part of China’s playbook of tracking, tracing and eliminating the virus, one that has been met with unusual public resistance in recent weeks.
Footage circulating on Chinese social media on Thursday showed members of one Shanghai community protesting the use of apartment buildings in their complex for isolating people who test positive for the virus. Police officers in white hazmat suits could be seen physically beating back angry residents, some of whom pleaded with them to stop.
China’s leaders have said that the country, unlike most of the rest of the world, cannot afford to live with the virus because it has a large and vulnerable aging population. But China’s zero-tolerance policy — in which anyone who tests positive is sent to a hospital or isolation facility, and close contacts are placed in quarantine hotels — is becoming both a logistical and political challenge as officials face more than 350,000 cases since the start of the current outbreak in March.
As of April 9, Shanghai had converted more than 100 public venues, including public schools and newly built high-rise office buildings, into temporary facilities called “fangcang,” or square cabin, hospitals. They are intended to house more than 160,000 people who have tested positive for the virus, officials said last week.
The protests on Thursday, at the Zhangjiang Nashi International apartment complex in Shanghai’s Pudong district, broke out after the developer notified 39 households that they would have to relocate because officials would turn nine buildings into isolation facilities, the developer said in a statement.
When Ms. Cheng first arrived at the exhibition center, it felt vast, cold and empty, she said in a phone interview. Ms. Cheng, who is a student in her early 20s, also wrote about her experience on Chinese social media.
The fluorescent lights were glaring but she tried to get some rest. She woke up the next morning to find her hall suddenly crammed with people.
There was no tap for running water and no showers, Ms. Cheng said, so each day she and others would crowd around several fresh water machines, waiting to fill up the pink plastic wash basins they had been given. The portable toilet stalls soon filled with so much human waste that Ms. Cheng said she stopped drinking water for several days so she wouldn’t have to use them as frequently.
Even if someone had figured out how to turn off the floodlights, Ms. Cheng said, it would still have been hard to sleep at night. That was when people would shout out their complaints and let off steam.
“Lots of people complained, and some people shouted out that it was too smelly to sleep,” she said.
Worried about upsetting her mother, Ms. Cheng didn’t tell her that she was in a fangcang. She said instead that she could not do video calls, giving her mother vague answers about daily life in quarantine. A woman sleeping in a nearby bed took a similar approach when speaking with her daughter. The two women shared a smile when they discovered they had the same secret.
Ms. Cheng said she struggled to come to terms with a quarantine system that reduced her to a number. If she wanted something, she had to find a nurse or doctor who was assigned to her zone. But the nurses and doctors were so busy that it was hard to get any help, she said.
Ms. Cheng said she had once admired the government’s goal of keeping the virus out of China. It meant that for more than two years, she could live a normal life, even as cities and countries around the world had to lock down.
Now, she’s not so sure.
“This time I feel it is out of control and it’s not worth controlling the cases because it is not so dangerous or deadly,” she said, referring to the highly contagious Omicron variant. “It’s not worth sacrificing so many resources and our freedom.”
Joy Dong and Li You contributed research.
A bill that would have required all California students to be vaccinated against the coronavirus, eliminating a personal belief exemption that has been used to circumvent similar mandates, was pulled by its legislative sponsor on Thursday.
Another mandate, by Gov. Gavin Newsom, will still take effect once a vaccine is formally approved for children. But unlike the governor’s mandate, the bill pulled by State Senator Richard Pan, a pediatrician, would have allowed only medical exemptions.
Dr. Pan, who spearheaded an earlier tightening of vaccine laws in California, had struggled to get support this year from fellow Democrats, who expressed concern about political backlash while coronavirus rates in the state are relatively low. They worried that anger from the state’s vocal anti-vaccine lobby could accelerate a concerning decline in student enrollment and complicate the party’s chances in the 2022 election.
Last month, a vaccine mandate for California employers was also shelved by its sponsor when Assemblywoman Buffy Wicks, a Democrat, cited falling case rates and opposition from organized labor.
Kevin Gordon, a longtime lobbyist for California school districts, said this week that school mandates for Covid inoculation “were in trouble,” because of legislative deadlines and the impending elections.
“There’s a sort of Covid mitigation fatigue,” Mr. Gordon said. “People are just sort of done with it now.”
Dr. Pan said in a statement that vaccination was “the cornerstone of safer schools and neighborhoods during Covid,” but that he had pulled the bill because child vaccination rates were low and the state needed to focus on improving access to vaccines.
Eighty percent of adults in California are fully vaccinated — which does not include a booster — against the coronavirus, but only 35 percent of children ages 5 to 11 have received shots. Seventy-two percent of children ages 12 to 17 are fully vaccinated.
“Until children’s access to Covid vaccination is greatly improved, I believe that a statewide policy to require Covid vaccination in schools is not the immediate priority,” he said.
The bill, S.B. 871, had not advanced since February.
The governor’s vaccine mandate for students will not take effect any earlier than July 2023, his office said on Thursday, because the Pfizer-BioNTech vaccine is still only approved for emergency use among children ages 5 to 11. The Food and Drug Administration has fully authorized that vaccine for people 12 and older.
Gov. Newsom’s mandate will require a coronavirus vaccine for students in seventh to 12th grades, and then for those in kindergarten to sixth grades, once one is fully authorized for all children in those groups.
Dr. Tomás J. Aragón, California’s public health officer, said in a statement about the delayed mandate that the state encouraged all people to be vaccinated.
“We continue to ensure that our response to the Covid-19 pandemic is driven by the best science and data available,” Dr. Aragón said. He added that “California is making informed decisions on how to further protect students and staff, to keep children safely in classrooms.”
When Gov. Newsom, who is running for re-election, announced the mandate that will add the coronavirus vaccine to a list of required school vaccines, state law required the inclusion of a personal belief exemption. It can be eliminated only by legislative action.
Shawn Hubler contributed reporting.
So many health professionals and patients have tested positive for the coronavirus in England that the situation has made it hard to address a backlog of more than six million people awaiting hospital treatment for other conditions, health leaders said on Thursday.
The issue of treatment backlogs is politically sensitive in Britain, where the government of Prime Minister Boris Johnson has promised to reduce them in the National Health Service.
The government has firmly backed its decision in February to lift coronavirus restrictions earlier than most other developed countries did. Britain recently stopped providing free coronavirus testing on demand.
As the restrictions were lifted, though, the highly transmissible Omicron subvariant known as BA. 2 was spreading through the country, and reports of new cases soared again. Britain’s Office of National Statistics estimated that almost 4.4 million people in England and Wales were infected in a single week in late March, and the percentage of test results that were coming back positive reached record highs.
These are days with a reporting anomaly.
The daily case counts have fallen from their March peaks, but even so, many scheduled hospital procedures are being canceled at the last minute because the patient or a staff member has tested positive, disrupting efforts to clear the hospital backlog, according to Dr. Tim Mitchell, vice president of the Royal College of Surgeons of England.
Dr. Chaand Nagpaul, council chair of the British Medical Association, said the government was “burying its head in the sand” over the problem.
“Unless this government acts now to bring down infection rates and address the staffing crisis with realistic proposals, the risk of harm to patients will only increase,” he said in a statement.
Overall, backlogs for health services at hospitals have increased this year, though some waiting lists have shortened, according to figures released on Thursday by the National Health Service.
During the winter, hospitals in England admitted 170,000 patients with Covid, and the service lost almost four million days of work because of Covid-related absences among its staff.
“That has meant more patients with Covid-19 in hospital beds, more staff off work with Covid-19 and more delayed discharges than anyone was expecting,” Chris Hopson, chief executive of N.H.S. Providers, an organization representing health care providers working under the National Health Service, said in a statement on Thursday. He said the figures showed “how much pressure the service is under.”
The government has promised to shorten wait times for elective treatment in hospitals to less than two years by July 2022 and less than one year by March 2025. The health service said on Thursday that it had made progress on those goals despite a record number of emergency calls over the winter.
The number of patients who had been waiting a year or longer for treatment fell by 12,000 people in February, to just under 300,000, and the number who had waited two years or more fell by more than 500, to 23,281, the service said.“
No comments:
Post a Comment