The coronavirus tests kits are small and fast — they produce results in as a little as 15 minutes — and when they were first distributed to nursing homes around the country in August by the federal government, they were welcomed with open arms.
At last it seemed, there was a solution to the delays and equipment shortages that had stymied efforts to use laboratory-based tests to curb outbreaks.
But now Nevada has ordered its nursing facilities to immediately suspend the use of two of the rapid virus tests after their performance was found to be lacking, according to a directive issued by the state’s department of health.
The order was prompted by a spate of false-positive results, in which the tests mistakenly found that healthy people were infected. The state directed that use of the kits be discontinued “until the accuracy of the tests can be further evaluated,” the Nevada document said.
The rapid tests are manufactured by two companies: Quidel, and Becton, Dickinson and Company, Representatives for the companies defended their products and said they were conducting investigations into the reports of false positives in Nevada.
Lisa Sanders, director of media relations at LeadingAge, an association of nonprofit providers of aging services, said that several nursing homes in other states had been experiencing issues with BD and Quidel’s tests and reporting them to her organization and the American Health Care Association in recent weeks.
In submitting their applications to the Food and Drug Administration for emergency clearance, both BD and Quidel declared that their tests had no false positives.
But shortly after the tests were rolled out across the state this summer, nursing homes began to report that people who had been evaluated by both the rapid tests and a slower but highly reliable laboratory test, called P.C.R., were getting conflicting results. Among 39 positive antigen test results from both BD and Quidel, 23 were found by P.C.R. to be negative — an error rate of nearly 60 percent.
The results, which were collected from a dozen facilities where thousands of tests had been performed, prompted the state to pivot away from antigen tests like BD’s and Quintel’s to viral RNA tests such as P.C.R., according to the directive.
Susan Butler-Wu, a clinical microbiologist at the University of Southern California, said the findings in Nevada could be emblematic of a larger issue: the use of tests in ways for which they were not designed or validated.
Both BD’s and Quidel’s tests received F.D.A. clearance for use “within the first five days of the onset of symptoms.” The instructions that come with BD’s test have noted that “the performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals.”
Shannon Litz, a spokeswoman for Nevada’s department of health and human services, said in an email that the agency would be re-evaluating the tests’ performance before resuming their use.
President Trump returned to the Oval Office on Wednesday, even as a full picture of his health remained unclear and many of his aides were in quarantine amid a West Wing outbreak that continues to grow.
White House officials said he went in for an update on the stimulus talks that he called off Tuesday. And two people close to the White House said advisers were exploring a resumption of travel events for the president next week.
Despite the president’s insistence on returning to seeming normalcy, experts on the virus say he is entering a pivotal phase in the disease — seven to 10 days after the onset of symptoms — when some patients take a turn for the worse.
Underscoring the potential dangers, a White House memo instructed staff members to follow new safety protocols, among them some that Mr. Trump has previously dismissed. They include surgical masks and protective eye covers. Many health experts believe West Wing outbreak is a result of White House officials ignoring precautions recommended by public health experts.
Mr. Trump told the White House medical staff that he was feeling “great” and was symptom-free, according to a statement released Wednesday by his physician, Dr. Sean P. Conley. But Dr. Conley offered few further details about the president’s treatment, including whether he was still taking a steroid.
Dr. Conley’s statement said Mr. Trump has not needed supplemental oxygen since returning from the hospital. But the full picture of the his health remains murky. Doctors, for instance, have not shared results of the president’s chest X-rays or lung scans, crucial measures of the severity of his illness.
The president — trailing in the polls and just a month away from the election — is trying to project the image of a healthy leader, and not of a patient with Covid-19. He has said he plans to be at the next debate, on Oct. 15, when it is possible he could still be contagious. His opponent, former Vice President Joseph R. Biden Jr., says there should not be a debate if the president still has the virus.
Since leaving the hospital Monday evening, the president has returned to minimizing the seriousness of the pandemic — even as many states in the country are experiencing serious outbreaks.
Montana and Oklahoma, where hospitals are strained, set single-day case records on Tuesday, according to a Times database. And Alaska, Indiana, Minnesota, Montana, North Dakota, Utah and Wyoming reported more cases in the last week than they have during any seven-day period of the pandemic.
President Trump, releasing a direct-to-camera video of himself addressing the nation, said Wednesday that getting Covid-19 had been a “blessing” and claimed he would provide hundreds of thousands of doses of unapproved drugs to Americans free of charge.
“I think this was a blessing from God that I caught it,” Mr. Trump said in the nearly five-minute video, released after nearly two days of him being out of public view.
The coronavirus has killed more than one million people, including more than 211,000 Americans, but because of it, Mr. Trump said, he was treated with an experimental antibody cocktail, still in clinical trials, that is produced by Regeneron.
“I call that a cure,” said Mr. Trump, whose skin appeared darkened by makeup and who appeared to struggle to get air at times.
It is impossible to know if the treatment has cured the president or even if he has beaten the disease. Most people with Covid-19 eventually recover, and medical experts have also said that Mr. Trump is most likely still battling it.
And the Regeneron antibody cocktail is not the only drug that Mr. Trump was prescribed. He has also been taking the antiviral drug remdesivir, as well as the dexamethasone, a steroid.
But the president was unstinting in his endorsement.
“I feel great — I feel, like, perfect,” declared Mr. Trump, who has made broad claims about other unproven drugs in the past, some of them hotly debated.
The president has been desperate to announce some kind of definitive treatment, or a vaccine, ahead of the election, in which nearly all polls show him trailing former Vice President Joseph R. Biden Jr.
The president said that everyone should have access to the as-yet-approved drug for “free” and that he would make sure it was in every hospital as soon as possible. He did not provide any details, other than saying the military could help distribute the drug.
“Good luck,” Mr. Trump said, ending the video.
At the vice-presidential debate on Wednesday night, Senator Kamala Harris of California wasted no time in prosecuting the case against the Trump administration’s handling of the coronavirus crisis.
“The American people have witnessed what is the greatest failure of any presidential administration in the history of our country,” she said in her opening remarks on Wednesday.
Ms. Harris, in her debate debut as former Vice President Joseph R. Biden Jr.’s running mate, accused President Trump and Vice President Mike Pence of hiding the truth of the pandemic from the American people.
“They knew what was happening and they didn’t tell you,” she said. “They knew and they covered it up.”
Ms. Harris said a Biden administration would put in place a “national strategy” for contact tracing and coronavirus testing, which she said would be free for all Americans. Mr. Trump, she said, does not deserve any more chances to solve the problem.
“This administration has forfeited their right to re-election,” she said.
Mr. Pence, for his part, sought to highlight China’s role in the coronavirus pandemic, saying, “First and foremost, China is to blame for the coronavirus, and President Trump is not happy about it.”
As he has before, Mr. Pence praised Mr. Trump’s decision early in the pandemic to suspend travel from China, though he incorrectly characterized it as a ban on “all” travel from China. The virus ended up reaching the United States primarily through Europe.
The Chinese government’s failures in the early stages of the outbreak in Wuhan are well documented, but the Trump administration’s singular focus on those failures has often served to elide its own, equally well-documented failures, compared with efforts in other wealthy countries, in containing the virus once it arrived in the United States.
Ms. Harris noted that Mr. Trump had disbanded the Obama administration’s pandemic response team and had withdrawn American disease experts who were monitoring potential threats in China.
The coronavirus hung over Wednesday’s debate as it has hung over all of American life for months. There was no handshake. The candidates were seated 12 feet apart. Two plexiglass dividers stood between them, providing an illusion of protection that scientists said would not actually do anything against an airborne virus.
After President Trump was hospitalized for the coronavirus, Ms. Harris’s team had been pushing for stronger safety measures, including the plexiglass, in case Mr. Pence was infected. (He has tested negative, but tests are not always accurate until several days after exposure.) Aides to Mr. Pence had criticized the plans, but after negotiations, his staff accepted the placement of the dividers.
Boston is delaying the next step in its plan to reopen public school classrooms as the city’s rate of positive test results climbs.
The district, which serves 54,000 students, making it one of the nation’s 100 largest, began the year with remote learning on Sept. 21 and planned to allow students to return to classrooms in phases, with most students given the option to attend school in-person two days a week.
Last week, the city allowed a group of high-needs students, including some students with disabilities, students facing homelessness, and English language learners, to return to classrooms for the first time. Kindergarten students were expected to return as soon as Oct. 15, with older students moving into schools in waves over the following days.
But Mayor Marty Walsh had said that the city would only allow in-person to continue if the seven-day average positivity rate citywide remained under 4 percent. In recent days, as the city has experienced an increase in cases, the positivity rate has topped that threshold.
Mr. Walsh wrote on Twitter on Wednesday that the city would delay the return of kindergarten students, bringing them back no sooner than Oct. 22, and that it would continue to adjust its plans as needed based on new testing data.
The citywide positive rate puts us just over the 4% threshold that we established for moving forward with our phased-in, hybrid learning plan for @BostonSchools. So we believe it is prudent at this time to pause the school reopening plan.
— Mayor Marty Walsh (@marty_walsh) October 7, 2020
He said that, based on the guidance of public health experts and in consultation with state officials, the city had decided that the high-needs students who started in-person learning last week could continue to go to school.
“For many of these students, not being in school presents risk that cannot be mitigated the way that the risk of #COVID19 can be,” Mr. Walsh wrote.
New York City completed reopening schools on a hybrid model last week, but 100 public schools, and roughly 200 private schools, have already been closed in areas that have seen sharp upticks in cases. Most other big cities are holding off on in-person schooling for now, but thousands of smaller districts have reopened, especially in the South and the Midwest.
Massachusetts has seen a steady rise in coronavirus cases since early July, and some public health experts have urged Gov. Charlie Baker to roll back the state’s reopening process.
Global Roundup
More than 40 percent of patients hospitalized in intensive care units in the Paris region have Covid-19, the French authorities said this week, warning that local hospitals were coming under increasing strain from an influx of new cases.
Over 2,300 Covid-19 patients are hospitalized in Ile-de-France, the region that includes the French capital and that is the country’s most populated. Nearly 450 of them are in intensive care, and some hospitals have started to defer surgeries to make additional room.
Aurélien Rousseau, the head of the health authority for Ile-de-France, warned that Covid-19 patients could take up half of all intensive care units within the next 10 to 15 days if new restrictions put in place over the past week did not make an impact.
The new restrictions in Paris include the closure of all bars for at least two weeks. Gyms, dance halls and enclosed swimming pools are also closed to adults, and university classrooms and lecture halls can operate only at half capacity or below. Restaurants can remain open if they follow a strict health protocol.
Models from the Pasteur Institut, using data from Sept. 25, before any of the new restrictions were put in place, warned that the region’s intensive care units, at their current capacity, would be completely full with Covid-19 patients by November if nothing changed.
Mr. Rousseau stressed the need for residents to further reduce social interactions. “It is demanding, but it’s the condition to limit the number of infections and to protect the health system,” he said on Twitter.
France reported nearly 19,000 new daily cases on Wednesday, a record so far, as President Emmanuel Macron said that “we must go toward more restrictions” in regions where the epidemic was picking up speed, despite improvements in other areas.
“We are not in a normal time, and we won’t be for several months,” Mr. Macron told French television on Wednesday evening.
Mr. Macron did not detail how restrictions might be tightened, but the health minister is expected to announce any new measures at a news conference on Thursday evening.
Nearly 7,400 people are hospitalized because of Covid-19 around France, including 1,400 people in intensive care. That is a far cry from the peak in April, when hospitals around the country had more than 32,000 Covid-19 patients, but a worrying increase since late August, when that number was around 4,500.
Hospitals in other regions are also coming under increasing pressure from a rise in the number of infections, including the area around Marseille, in southern France, where restrictions had already been tightened last month, and in the northern Hauts-de-France region.
In other news around Europe:
-
Scotland will further tighten restrictions on its hospitality sector, closing pubs and canceling events around Glasgow, to avoid the likelihood of a second lockdown, the government said on Wednesday. Elsewhere in the country, pubs and restaurants will not be able to serve customers indoors after 6 p.m starting Friday. “We have a duty to balance all the different harms caused by the pandemic,” Nicola Sturgeon, the first minister, said, adding that without more restrictions, there was “a real risk the virus will run out of control by the end of this month.” Scotland reported over 1,000 new cases on Wednesday, with a dramatic spike in infections in those over the age of 70. The government will also provide £40 million in funding for businesses affected by the new measures.
-
State governors in Germany agreed Wednesday to restrict domestic travelers from renting rooms if they are coming from a virus hot spot. Those who live in areas where cases surpass 50 per 100,000 people in a week are discouraged from non-essential travel and will have to present a negative test result to book a room in a hotel or resort. The news came as Germans prepared for their traditional two-week October school break, during which many families travel, and amid a rise in cases. The health authorities registered 2,828 new infections across Germany on Tuesday, a figure not seen in the country since April. Bars and restaurants in Berlin must also close at 11 p.m. starting this weekend.
-
Members of the governments of Brussels and Wallonia, two out of three of Belgium’s regions, are in quarantine after two ministers tested positive for the virus. The news comes as Belgium implements rules limiting social interactions to three people outside of families in response to a rise in cases. The city of Brussels also announced on Wednesday that it would shut down all bars and cafes for a month.
With less than a month to go before Election Day, the pandemic-driven economic outlook is not a good one.
Job growth in the United States has stalled, layoffs are mounting, and there are no signs more financial help is coming anytime soon for families enduring hardships.
Households and businesses have gone two months without the enhanced unemployment benefits, low-interest loans and other programs that helped prop up the economy in the spring.
President Trump announced on Tuesday that he was cutting off stimulus negotiations until after the election. He later added confusion by urging Congress to act “IMMEDIATELY” to revive a lapsed loan program for small businesses and to approve funds for airlines and another round of stimulus checks.
But the only talks that seemed to be moving forward at all on Wednesday were on airlines. Speaker Nancy Pelosi of California and Steven Mnuchin, the Treasury secretary, spoke in the morning about the prospects of a stand-alone bill for airline relief.
Jerome H. Powell, the Federal Reserve chairman has argued that failing to provide enough support carried risks for the economy.
“Too little support would lead to a weak recovery, creating unnecessary hardship for households and businesses,” he said in a speech on Tuesday.
Already, many furloughs are turning into permanent job losses, and major companies like Disney and Allstate are embarking on new rounds of layoffs. The hotel industry is warning of thousands of closures, and tens of thousands of small businesses are weighing whether to close up shop for good. An estimated one of every seven small businesses in the United States had shut down permanently by the end of August — 850,000 in all — according to data from Womply, a marketing platform. The deeper those wounds, the longer the economy will take to heal.
After President Trump indicated that he might want to revive some stimulus measures, stocks on Wall Street rose on Wednesday, broadly erasing Tuesday’s losses. The bounce was just the latest in a series of head-spinning turns for the market.
The gridlock in Washington is a reversal from the spring, when lawmakers acted out of fear of an imminent economic collapse and approved trillions of dollars in aid to households and businesses. The effort was largely successful.
But most of the aid programs expired over the summer, and in recent weeks economic gains have faltered. Economists across the ideological spectrum agree that the loss of momentum is likely to get worse if more aid doesn’t arrive soon.
The California governor’s office wants people who dine in restaurants to put their masks back on their faces “in between bites.”
The recommendation appears to contradict advice from the World Health Organization, which warns mask wearers to avoid touching their masks as much as possible, and to wash their hands before and after touching it — hardly practical to do at a dining table between mouthfuls.
The tweet on the subject issued by the office of Gov. Gavin Newsom on Saturday also seemed to contradict itself. An accompanying graphic instructs diners to “minimize the number of times you take your mask off.” An illustration shows a diner wearing her mask while perusing a menu, maskless while taking a bite, and then wearing the mask again with an empty plate.
The unusual and confusing suggestion to take the mask on and off repeatedly throughout a meal attracted mockery online. “It’s confirmed, I live in the dumbest state,” one Twitter user responded.
As most states do in some form, California requires mask-wearing in public spaces. Many counties in the state restrict restaurants to outdoor seating only, or limit their indoor seating to 25 percent of capacity. The state has reported more than 840,000 cases of the virus so far, and more than 16,000 deaths, according to a New York Times database.
Experts have taken different approaches to mask-wearing while dining out. In an interview with “The Daily Show” last month, Dr. Anthony Fauci said he wears his mask around his neck while eating and drinking in public, and then places it over his face “while you’re waiting for the waiter” or during other lulls in the meal.
Orthodox Jewish and other religious leaders lashed out at Gov. Andrew M. Cuomo on Wednesday over new coronavirus restrictions on schools, businesses and houses of worship, as protests broke out in Brooklyn overnight, leading to scenes of chaos and the injury of at least one person.
The new restrictions, announced by Mr. Cuomo on Tuesday, are intended to combat worrisome outbreaks of the coronavirus in Brooklyn, Queens and New York City’s northern suburbs. The rules would shut down nonessential businesses and schools and impose tight restrictions on houses of worship, where attendance in the hardest-hit areas would be limited to 10 people. In other neighborhoods, attendance would be limited to 25 people.
On Wednesday, Mayor Bill de Blasio of New York City said that the restrictions in portions of Brooklyn and Queens, as outlined by the state, would go into effect on Thursday.
The rules — which will be put in place before an important Jewish holiday, Shemini Atzeret — seem to specifically target Orthodox synagogues that have become scenes of large gatherings of worshipers clustered together, with many not wearing face coverings.
The number of virus cases in the affected areas of Brooklyn and Queens has been rising for weeks, especially in Orthodox Jewish communities. Local leaders said that surge was driven by denialism, wishful thinking around herd immunity and misinformation.
Other religious leaders from communities affected by the new rules were also outraged. The Roman Catholic Diocese of Brooklyn, which has 1.5 million followers and 210 churches in Brooklyn and Queens, said it was taken by surprise by the governor’s announcement. Bishop Nicholas DiMarzio of Brooklyn condemned the new rules as “outrageous.”
Orthodox Jewish leaders, who also said they were not consulted before the governor announced the new restrictions, said they were “appalled” by the action. In a letter posted late Tuesday from four Orthodox Jewish lawmakers representing the affected areas said Mr. Cuomo “has chosen to pursue a scientifically and constitutionally questionable shutdown of our communities.”
Their frustration was reflected on the street, where video shared widely on social media showed hundreds of Hasidic men, most of them without masks, gathering after midnight and setting fires along 13th Avenue in the Borough Park neighborhood.
The crowd soon turned violent. One man can be heard yelling “Snitch!” in a video as the crowd beats a man the mob believed to be disloyal.
On Wednesday, Mr. Cuomo said that he sympathized with those who were upset with the restrictions. But, he added, “these limitations are better than going back to close down.”
“To the extent there are communities that are upset, that’s because they haven’t been following the original rules,” the governor said. “And that’s why the infection spread — because they weren’t following the rules. And the rules weren’t being enforced.”
At his own news conference, Mr. de Blasio said that the restrictions do not include the Crown Heights and Williamsburg neighborhoods of Brooklyn, two areas which have seen smaller increases in their virus positivity rates than areas subject to restrictions. He added that the city planned to continue monitoring those areas.
“I understand that there are people who disagree with this plan,” Mr. de Blasio said, noting the restrictions may be tough for different groups. “But it’s crucial that those who disagree still respect the fact that the state and city have made a decision for the health and safety of all.”
Statewide, the daily positivity rate was 1.25 percent, the governor said. He also reported that hospitalizations in the state had increased again, to 748, a rise he described as “seeing the hot spot clusters adding to hospitalization at over three times their population rate.”
The mayor reported the seven-day average rate of positive test results citywide was 1.74 percent.
Recruiting Black volunteers for coronavirus vaccine trials during a period of severe mistrust of the federal government and heightened awareness of racial injustice is a formidable task. So far, only about 3 percent of the people who have signed up nationally are Black.
Yet never has their inclusion in a medical study been more urgent. The economic and health impacts of the coronavirus are falling disproportionately hard on communities of color. It is essential, public health experts say, that research reflect diverse participation not only as a matter of social justice and sound practice but, when the vaccine becomes available, to help persuade Black, Latino and Native American people to actually get it.
Trials for vaccines developed by the drug companies Moderna and AstraZeneca are being conducted at local sites across the country, including the University of Pittsburgh. Academic researchers are turning to neighborhood leaders to attract more diverse pools of participants.
Rev. Paul Abernathy, 41, an Orthodox Christian priest and Iraq War veteran who is Black, has been sending his organization’s “community health deputies” into struggling neighborhoods, offering masks to young people hanging out on corners and picking up food and medicine for older people.
Now they’re recruiting for the vaccine trials, trying to counter deep skepticism built on present disparities as well as a long history of abuse.
“I won’t be used as a guinea pig for white people,” one tenant in a predominantly Black public housing complex declared after hearing their pitch.
To Father Paul, Covid-19 is one more deadly trauma in a litany that has shaken Black neighborhoods. People come to his organization seeking food, health care and clothes and wind up talking about stabbings, overdoses, robberies, fires, domestic violence.
“There is a great deal that is against us,” Father Paul said on a recent morning. “And we have to be honest about that. Our community needs more than what we have. But with a good spirit and a willing heart, miracles can happen.”
With reduced financial support from the British government, colleges and universities are pushing to stay open to retain tuition and room fees and placing students into severe lockdowns even as coronavirus infections rise in their dorms.
Students at Manchester Metropolitan University have taken to calling one of their residences H.M.P., for Her Majesty’s Prison, because of strict protocols that have left trash piled up in shared kitchens and students washing their clothes in bathroom sinks. Security guards stalked the gates, keeping anyone from leaving or entering.
Parties at the beginning of the school year led to the virus tearing though student suites, and the university largely left students on their own: It imposed such a draconian lockdown that students had to nurse roommates back to health, parents drove hours to deliver food and lawyers offered pro bono help.
The outbreaks have shone a harsh light on Britain’s decade-long campaign to turn higher education into a ruthless market. Cuts in state grants left schools dependent on tuition fees and room rents, leading them to jam more students onto campuses.
For Britain, where the Covid-19 death toll stands at 58,000, the highest in Europe, the pandemic has forced a reckoning with the government’s treatment of higher education, even as the country’s universities make crucial advances in the race for a vaccine.
“Students are money in the bank, and as long as we’re on campus they’ll worry about the consequences later,” said Aslan Warburton, a freshman at Manchester Metropolitan. “The financial side has taken priority over student well-being and the greater good.”
As President Trump returned from the hospital, still telling Americans not to be afraid of Covid-19, the coronavirus has exploded in North Dakota. In the past week, North Dakota reported more new cases per capita than any other state.
Hospitalizations for the virus have risen abruptly, forcing health care officials in some towns to send people to faraway hospitals, even across state lines to Montana and South Dakota.
Officials have huddled with hospital leaders in recent days to contemplate ways to free up more hospital beds even as they contend with broader turmoil over virus policy in a state that has seen resignations of three state health officers since the pandemic’s start.
The rise in cases and deaths — September was by far the deadliest month for North Dakota since the start of the pandemic — reflects a new phase of the virus in the United States. States in the Midwest and Great Plains, many of which had avoided large outbreaks in earlier months when coastal cities were hard hit, are seeing the brunt. And in rural portions of the hardest-hit states, medical resources are quickly stretched thin for residents who can live hours from large hospitals.
Still, partly because these outbreaks were slow in coming, public health officials say they have struggled to convince the public that the situation is urgent or that limits like mask rules make sense. North Dakota is one of fewer than 20 states with no statewide mask mandate and many counties have resisted restrictions. But as the state reaches a boiling point, health officials say they hope people now will start to take the virus more seriously.
“If there’s anything that should get our population’s attention, it’s this: how perilously close we are to the edge,” Vern Dosch, who leads contact tracing efforts for North Dakota, said last week.
The Italian government announced a new order making face masks mandatory around the country on Wednesday, including in outdoor areas when social distancing cannot be maintained, in an effort to stem a second wave of virus cases.
The decree, proposed by the Cabinet, was approved in Parliament on Wednesday despite opposition from right-wing lawmakers. Over 40 members of the body were themselves in quarantine this week, after three members tested positive for the virus.
The mask rule will also be extended to indoor private spaces, including offices. Children under the age of six and people practicing sports will be exempt.
Italy has reported 17,252 cases over the last seven days, far fewer than France, Britain, and Russia, among other countries. While the numbers remain far below the devastating first wave in the spring, the country has seen cases rise 58 percent over the last two weeks, raising concern among health experts.
The Food and Drug Administration released updated, stricter guidelines on Tuesday for coronavirus vaccine developers — a step that was blocked for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine could be authorized by Election Day.
The move, which was cleared by the Office of Management and Budget, appeared to be an abrupt reversal a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines.
The new recommendations, which do not carry the force of law, call for gathering comprehensive safety data in the final stage of clinical trials before an emergency authorization can be granted.
On Tuesday evening, President Trump showed his displeasure at the action of his own White House, and charged that the new guidelines were a conspiracy against his re-election prospects.
“New F.D.A. Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” he tweeted, tagging Dr. Stephen M. Hahn, the F.D.A. commissioner.
Since the start of the coronavirus pandemic, the F.D.A. has said that it has been seeking ways to accelerate the development of vaccines without sacrificing safety. In June, the agency released an initial set of guidelines to give vaccine developers a better idea of how the F.D.A. would decide if a vaccine were acceptable, either for an emergency use authorization or for a full license.
Four vaccines have reached the final stage of testing, known as a Phase 3 trial, in the United States. A fifth is expected to start this month. President Trump has repeatedly suggested that a vaccine would be ready by Election Day, if not before.
But with public confidence declining in opinion polls about what could be a rushed coronavirus vaccine, the F.D.A. submitted a new set of guidelines to the White House for approval on Sept. 21.
Among the recommendations, the agency advised vaccine makers to follow volunteers for a median of two months after the final dose. The F.D.A. also expected vaccine makers to document five cases of severe infection in people who received the placebo instead of the vaccine.
The White House objected that the guidelines would add more time before a vaccine could be authorized.
The F.D.A., however, continued to share parts of this guidance with vaccine developers in response to questions they submitted to the agency.
On Tuesday, the F.D.A. published the guidelines at the end of a document the F.D.A. prepared for the meeting on Oct. 22 of the Vaccines and Related Biological Products Advisory Committee. The committee will be discussing the development, authorization and licensing of Covid vaccines.
When shipments of federal food aid for needy families arrive at the San Diego Unified School District, workers open each box. The milk, eggs and other perishables go in refrigeration until they can be distributed. The letters signed by President Trump go in the recycling.
The boxes are part of the Department of Agriculture’s Coronavirus Food Assistance Program, which purchases food from local suppliers who have lost business because of the pandemic and distributes it free through food banks and school districts.
Beginning this month, the boxes started arriving with the presidential letters inside as well. In English and Spanish, they offer advice on coronavirus safety, including hand washing, staying home when sick, protecting older people and maintaining social distance.
But the district superintendent, Cindy Marten, says the letters are misleading — especially where they say that recipients should merely “consider” wearing a face covering when in public.
Ms. Marten noted that masks are mandatory in California. And her district, she said, has a large Hispanic population that has been hit disproportionately hard both by the virus and by unemployment from the economic shutdown.
“This is, for us, very important in terms of public health: to protect our local families from being misled on how to best safeguard themselves,” Ms. Marten said. “People now, more than ever, need clear messages from our leaders. And as the leader of the second-largest district, it’s important to me that we have clear messaging.”
Two-thirds of the district’s students receive some kind of food assistance through the schools. Since the start of the pandemic, Ms. Marten said, the district has distributed five million meals through its regular food program.
She said workers processed 850 of the Farmers to Families food boxes from the federal coronavirus aid program on Wednesday — and recycled the 850 letters.
Some food banks around the country have also been removing the letters, and have accused Mr. Trump of trying to use the food aid program for partisan political gain, The Washington Post reported.
Gov. Greg Abbott of Texas announced Wednesday that bars would be allowed to resume business next week in a limited capacity, pushing the state closer to a full reopening even as coronavirus cases and hospitalizations have been going up.
Bars in Texas were one of the last establishments to remain shuttered as Mr. Abbott steadily relaxed a number of restrictions and reopened other businesses, including retail shops, hair salons and restaurants.
The governor included a warning with his announcement.
“Opening bars does not mean that Covid-19 is no longer a threat, and most Texans are still susceptible to the virus,” Mr. Abbott said in a statement.
New cases, hospitalizations and deaths spiked in Texas after Mr. Abbott reopened the state in phases starting on May 1. By June he had paused the reopening and ordered bars to close again.
As the situation improved, Mr. Abbott eased restrictions on many businesses but kept the bar closure in place, frustrating bar owners and their supporters, many of whom organized demonstrations, Some bars reopened illegally to protest the shutdown and joined lawsuits against the Republican governor.
On Wednesday, Mr. Abbott said bars could reopen starting next Wednesday at up to 50-percent capacity. Dance floors must remain closed, tables will be limited to six people, and all patrons must wear masks when not seated at a table.
Bar reopenings may be limited, however, by Mr. Abbott’s decision to involve local officials in signing off on them.
Some bar owners are not enthusiastic about the governor’s order because they do not believe that some local officials will rush to allow them to reopen, said Greg Barrineau, who owns two bars in the San Antonio area and is a board member of the Texas Bar and Nightclub Alliance. Those officials, he said, worry that people can forget to social-distance when they drink.
“But we in the bar business are very good at controlling and managing people that drink,” Mr. Barrineau said. “That’s what we do every day that we’re open.”
Texas had led the nation in new cases in the past seven days, according to a New York Times database, with more than 30,000 cases.
Morgan Wallen, a country musician who was scheduled to perform on “Saturday Night Live” this weekend, won’t be appearing on the show after all, citing its coronavirus protocols.
Mr. Wallen made the announcement Wednesday in an Instagram post after he was seen in videos last weekend showing him celebrating in Tuscaloosa after a football victory by the University of Alabama.
In these clips, which appeared on TikTok and elsewhere, Mr. Wallen can be seen drinking shots, kissing fans and mingling in groups while not wearing a mask or following other social-distancing guidelines.
In the video he posted to Instagram on Wednesday, Mr. Wallen said that he was speaking from a hotel room in New York.
“I got a call from the show letting me know that I will no longer be able to play, and that’s because of Covid protocols, which I understand,” Wallen said. “I’m not positive for Covid, but my actions this past weekend were pretty shortsighted and they have obviously affected my long-term goals and my dreams. ”
“Saturday Night Live,” which is broadcast from NBC’s headquarters in Rockefeller Plaza, halted its live episodes in March amid the pandemic. The show’s longtime music coordinator Hal Willner died in April of complications consistent with the coronavirus.
The first time New Zealand thought it had eliminated the coronavirus from its isolated shores, a mysterious outbreak in its largest city shattered any sense of victory over a tenacious foe.
Now, after a second round of strict lockdown, the country believes — if a bit more tentatively this time — that it has effectively stamped out the virus once again.
On Wednesday, New Zealand moved to lift the last of its restrictions in Auckland after 10 days with no new cases linked to a cluster that first surfaced in August. The government will now allow unrestricted gatherings, and trips on public transit without social distancing or masks, in the city of 1.6 million people.
Prime Minister Jacinda Ardern, who is facing re-election next week, called the reopening a validation of the country’s “go hard, go early” response. The strategy is aimed at eradicating the virus with a swift science-based policy, one that trades weeks of lockdown and sacrifice for an emergence to full economic activity.
“Our team of five million, a little more battle-weary this time, did what national teams do so often. We put our heads down, and we got on with it,” Ms. Ardern told reporters in Christchurch on Monday as she announced that the restrictions would be loosened, referring to the total number of people in New Zealand.
“You only had to look around the world to see the alternative to our approach here in New Zealand,” she said, adding that there was a 95 percent probability that the country had eliminated local transmission of the virus.
Experts cautioned that New Zealand’s small population and isolation meant it was uniquely positioned to manage the disease. But its success presents a stark contrast to many other parts of the world as deaths from the pandemic have surpassed one million.
A bicycling craze has swept the United States during the pandemic, sending bike sales soaring and triggering a nationwide bicycle shortage.
In many cities, but perhaps most notably in New York, much of that growth has been driven by a surge in the number of women who took to bicycling after lockdown orders eliminated the main barrier that research has shown keeps them from cycling: streets that often feel perilous for cyclists.
In New York, there were an estimated 80 percent more cycling trips in July compared with the same month last year, with biking by women rising by 147 percent and increasing by 68 percent among men, according to data from Strava Metro, a mobility tracking application used by 68 million people globally.
But now traffic is rising again, and it remains unclear whether the momentum will continue. Cycling advocates say the city should build on what has happened during the outbreak and do more to create a transportation network that prioritizes cycling as a greener way to travel.
New York’s system of bike lanes is often disjointed and obstructed by cars, and lacks bike parking, which has discouraged cyclists.
Whether women remain on bikes will be a test for city officials who are under pressure to reduce space for cars to make more room for cyclists and pedestrians. Other cities face similar challenges in a country where biking has never come close to the levels seen in some European and Asian nations.
“There is no way we will get to high rates of cycling if we don’t solve the gender gap,” said Jennifer Dill, a professor of urban studies and planning at Portland State University. “The big question now is how this will change behavior in the long term.”
“This is a great opportunity if cities take advantage of it,” she added.
When an 80-year-old man at a bar near Buffalo, N.Y., noticed a fellow customer not wearing a face mask, he confronted him. The customer responded by swiftly pushing him to the ground, the police said. Five days later, the man was dead.
On Monday, the customer, Donald Lewinski, 65, of West Seneca, N.Y., was arrested and charged with criminally negligent homicide in the death of the 80-year-old, Rocco Sapienza. The case is believed to be one of the first of its kind in New York State.
Mr. Lewinski pleaded not guilty on Tuesday in court in Erie County. The charge carries up to four years in prison.
The encounter followed months of tension and often vitriolic confrontations across the United States over masks. Disputes have escalated to violence: Retail employees have broken up fistfights between customers, and in New York City dozens of transit workers have been attacked after trying to enforce the rules.
John J. Flynn, the Erie County district attorney, said he believed the confrontation between Mr. Sapienza and Mr. Lewinski — who apparently had exchanged terse words before the shove — was one of the first disputes over face coverings that had led to someone’s death in New York State. He said preliminary autopsy results showed that Mr. Sapienza died from blunt force trauma to the head.
“It’s beyond sad,” Mr. Flynn said. “These kinds of situations have continued to escalate, and this should cause everyone to pause and think twice now about how we as a society want to conduct ourselves during this pandemic.”
With coronavirus cases surging in Malaysia to their highest levels since the pandemic began, the prime minister, Muhyiddin Yassin, has placed himself in quarantine and acknowledged that a recent election campaign was one of the causes of the spike.
In an address to the nation on Wednesday, Mr. Muhyiddin stopped short of calling for a renewed lockdown. But casting himself as the nation’s “Abah,” or daddy, he said he would have to “use the rotan,” or cane, on those who violate mask and social-distancing rules. Caning miscreants is a well-known punishment in Malaysia.
The country of 32 million people, which by June had largely succeeded in containing the virus, reported 691 new cases on Tuesday and 432 the day before, its two highest daily totals. More than 10 percent of the country’s total number of cases have been reported in the past three days.
The prime minister went into quarantine on Monday after attending a cabinet meeting with his religious affairs minister, Zulkifli Mohamad Al-Bakri, who later tested positive for the virus. More than a dozen other cabinet members and top officials who attended the meeting also went into quarantine.
It was the second round of isolation for Mr. Muhyiddin, a cancer survivor, who went into quarantine in May after meeting with another official who later tested positive.
The Sept. 26 election in Sabah State, on Borneo Island, became the nexus for contagion as it drew people together for the campaign, including politicians and cabinet members allied with Mr. Muhyiddin who traveled to the state from Peninsular Malaysia.
Despite Sabah’s higher rate of infection, many of those returning to Peninsular Malaysia did not quarantine on their return. Some, including Mr. Zulkifli, traveled widely and met with numerous people in the days after.
“I admit the campaigning for Sabah elections is among the reasons for the recent spike of cases,” Mr. Muhyiddin said in a speech broadcast from his home.
Managing the coronavirus had been a bright spot for Mr. Muhyiddin, whose hold on power has been tenuous.
He was named prime minister in March by Malaysia’s king, Sultan Abdullah Sultan Ahmad Shah, without a vote from Parliament, and faces pressure from the opposition leader, Anwar Ibrahim, who claims to have the backing of a majority of Parliament.
Dr. William Foege, a legendary figure in public health circles who served both Democratic and Republican presidents, has written an extraordinary private letter to the director of the Centers for Disease Control and Prevention calling on him to expose the Trump administration’s mishandling of the coronavirus pandemic — even if it means getting fired.
In the Sept. 23 letter, obtained and published Tuesday evening by USA Today, Dr. Foege, who served as director of the C.D.C. under former Presidents Jimmy Carter and Ronald Reagan, called on the current director, Dr. Robert R. Redfield, to admit to the administration’s failures or risk presiding over the ruin of the public health agency’s reputation, and his own.
“Dear Bob, I start each day thinking about the terrible burden you bear,” he began, making clear that this was not the first conversation the two men have had about the administration’s response and Dr. Redfield’s role in it.
“As I have indicated to you before, resigning is a one-day story and you will be replaced,” Dr. Foege wrote, adding that if Dr. Redfield remained silent, the White House would simply “blame you for the disaster” and move on.
He suggested another course: “You could, upfront, acknowledge the tragedy of responding poorly, apologize for what has happened and your role in acquiescing, set a course for how C.D.C. would now lead the country if there was no political interference.”
“Don’t shy away from the fact this has been an unacceptable toll on our country,” he added. “It is a slaughter and not just a political dispute.”
Dr. Foege, 84, has worked in the field for more than half a century. He is credited with devising the strategy that led to the successful eradication of smallpox in the 1970s, and played a key role in improving immunization rates in developing countries in the 1980s. He told Dr. Redfield he needed to lift morale at the C.D.C. and restore the agency’s reputation.
“When they fire you,” he concluded, “this will be a multi-week story and you can hold your head high. That will take exceptional courage on your part. I can’t tell you what to do except to revisit your religious beliefs and ask yourself what is right.”
President Trump is fighting a virus that has afflicted hundreds of thousands of Americans, but almost nothing about his gold-plated treatment reflects the reality of regular patients.
Mr. Trump spent three days in his own private suite in the hospital. He arrived and left by helicopter. And he received multiple coronavirus tests, oxygen, steroids and an experimental antibody treatment available to a fraction of the population.
When he emerged from Walter Reed National Military Medical Center this week, he appeared on a balcony at the White House, tore off his mask, and proclaimed on Twitter that the public — often saddled with unexpected medical bills for less personalized treatment — should not “be afraid of Covid.”
For someone who isn’t president, the stay would have cost more than $100,000 in the American health system. And the biggest financial risks for people not enjoying blanket subsidized coverage paid by taxpayers would come not from the hospital stay but from ancillary services, including helicopter transit and repeated coronavirus testing.
Prudencio Matias Mendoza’s brother, Mariano, died from the coronavirus in late July, and in the past week, Mr. Matias Mendoza, 38, has been following Mr. Trump’s bout with the virus.
He supports some of the president’s policies. But he could not help but feel angry to see Mr. Trump and other officials ignoring social distancing and mask-wearing mandates.
“The president is not a god,” Mr. Matias Mendoza said. “Everyone has to do their part. This is a virus that comes to kill.”
A woman in Brooklyn was reminded of the $4,000 she was charged for medication for her father, who eventually died from the coronavirus, as she observed Mr. Trump’s treatment.
And one man in Texas said he understood why the president of the United States would have top-flight doctors, but could not help comparing the place where Mr. Trump was treated with the facility where his 87-year-old mother became sick and died.
Health economists are only starting to understand the full costs of coronavirus treatment; Many, but not all, health insurers have said they will not apply co-payments or deductibles to patients’ coronavirus hospital stays, which could help shield patients from large bills.
Uninsured patients, however, could be stuck with the entire hospital charge and not receive any discounts. While the Trump administration did set up a fund to cover coronavirus testing and treatment costs for the uninsured, The Times has reported that Americans without health insurance have received large bills for their hospital stays.
Mr. Trump so far seems to have benefited not only from power, money and access to first-class medical treatment, but also timing. He caught the virus seven months into the pandemic, after the country had built up supplies and doctors had honed their understanding of the disease.
One of his treatments, the steroid dexamethasone, was not used widely to treat patients at the beginning of the pandemic and was not adopted by some hospital officials in the United States until this summer.
In a memo titled “Precautions and POTUS Interactions” sent around the White House this week, staff members were warned about what to do when interacting with the president, including acquiring personal protective equipment from an “Isolation Cart.”
Staff members are to go to the Oval Office or the residence on the second floor, where the first family lives, only if they are requested to go and expected to be there. If staff members are not in close contact with President Trump, meaning they’re more than six feet away from him, only a “surgical mask” and hand sanitizer are required, according to the memo from the White House Management Office, which was reviewed by a New York Times reporter.
But within six feet, people must use sanitizer and “remove any outer garments,” according to the memo. “Ensure you are wearing the following Personal Protective Equipment (PPE). PPE is provided in the Isolation Cart” that’s located “in the foyer area of the second floor residence and the outer Oval Office,” the memo stated.
The memo listed the types of equipment, including, “Yellow gown,” “Surgical mask,” “Protective eye wear” and “Gloves.”
Upon exiting, people are instructed to remove gowns and gloves and put them in a trash receptacle next to the cart, clean the eye shields with wipes that are provided and save them for future use, and then wash hands or use sanitizer.
A senior vaccine scientist at the Department of Health and Human Services resigned from government service following a long battle with White House appointees over their interference in his efforts to fight the coronavirus pandemic.
Rick Bright served as chief of the department’s Biomedical Advanced Research and Development Authority until six months ago, when he was abruptly reassigned to a narrower job at the National Health Institute after raising concerns about “cronyism” and political interference in science.
Dr. Bright, who filed a whistle-blower complaint in May, filed a new addendum saying that officials at the N.I.H., where he worked after his demotion, rejected his idea for a national coronavirus testing strategy “because of political considerations.” He also accused them of ignoring his request to join the $10 billion effort to fast-track a coronavirus vaccine, known as Operation Warp Speed, and of sidelining him to the point where he had no work to do.
The addendum said Dr. Bright “remains very concerned” about the failure of the Trump administration to put forth a national plan to combat the pandemic and is troubled by the growing influence of Stanford’s Hoover Institution of Dr. Scott W. Atlas, a neuroradiologist without training in epidemiology or infectious diseases. Dr. Atlas’s aversion to mask wearing and his belief that “herd immunity” could stop Covid-19 have made him a favorite of President Trump.
“Dr. Bright was forced to leave his position at N.I.H. because he can no longer sit idly by and work for an administration that ignores scientific expertise, overrules public health guidance and disrespects career scientists, resulting in the sickness and death of hundreds of thousands of Americans,” Dr. Bright’s lawyers, Debra Katz and Lisa Banks, said in a statement.
On Tuesday evening, senior administration officials confirmed that Stephen Miller, Mr. Trump’s top speechwriter and a policy adviser, had tested positive for the coronavirus, joining a growing list of Mr. Trump’s close aides who have the virus.
“Over the last five days I have been working remotely and self-isolating, testing negative every day through yesterday,” Mr. Miller said in a statement. “Today, I tested positive for Covid-19 and am in quarantine.”
Mr. Miller is married to Katie Miller, Vice President Mike Pence’s communications director. A senior administration official said Ms. Miller, who contracted the virus this spring and returned to work in May, was tested Tuesday morning and was negative for any new infection.
On Tuesday, many White House offices were empty as officials stayed home to wait out the infectious period from an outbreak of the coronavirus within the building and among people who had been there.
President Trump was in the White House residence, convalescing, as a number of advisers and other officials stayed home, either because they had contracted the coronavirus or had been near people who did.
The White House communications and press shops were bereft of people. The White House press secretary, Kayleigh McEnany, announced on Monday that she had tested positive. Two other press office aides have also contracted the virus, and two more aides on Tuesday were said to have tested positive, people familiar with the results said.
The outbreak in the White House, which has extended to some lawmakers on Capitol Hill, has raised concerns in the city that surrounds it. Washington, D.C., which has managed to bring infection rates down in recent weeks through preventive laws and high rates of compliance, has almost no control over the federal government.
The city reported 105 new coronavirus cases on Tuesday, the highest number since June 3.
The gathering at the Rose Garden would have violated the city’s mandates limiting the size of gatherings and requiring masks. But because the White House is on federal property, it is exempt from such rules.
City officials said they would be closely monitoring infection trends for several days to see if the Capitol and White House cases affected the city’s overall infection rate.
In a bid to contain coronavirus clusters in parts of New York City and its northern suburbs, Gov. Andrew M. Cuomo on Tuesday announced new restrictions in those areas, including temporarily closing nonessential businesses and schools.
Starting as soon as Wednesday and no later than Friday, many stores, gyms, salons and other businesses will close in the hardest-hit places, where the rate of new cases has remained stubbornly high in the past week. Restaurants and bars would again be restricted to takeout and delivery only, as they were at the start of the pandemic.
Mass gatherings would be barred except at houses of worship, which would be limited to 25 percent capacity, with a 10-person maximum. And Mr. Cuomo, who on Monday closed schools in the city’s hot spots, said that schools in parts of Rockland and Orange Counties would also close.
In geographic areas around the clusters, less severe restrictions would be in place, including prohibiting indoor dining and closing businesses deemed “high-risk,” including gyms and personal care business.
The exact boundaries of all the new cluster zones began to emerge late Tuesday, with Mr. Cuomo posting on Twitter a map of the Brooklyn cluster zone, which appeared to include the neighborhoods of Bay Ridge, Borough Park, Midwood, Sheepshead Bay and Sunset Park, and maps for the other cluster zones. The restrictions will be in place for at least two weeks.
Today we establish clear limits for areas where we see high positivity: The Cluster Action Initiative.
Locations will be categorized either Red, Orange, or Yellow, based on proximity to the cluster.
The severity of the problem will determine the response. pic.twitter.com/707FYGHB0g
— Andrew Cuomo (@NYGovCuomo) October 6, 2020
The new measures marked a staggering setback in New York, once the center of the pandemic, where officials had seen months of declining or flat rates of positive test results after a devastating and deadly spring.
Officials have warned recently about clusters where the virus appeared to be spreading rapidly, including at colleges and universities.
In an effort to address hot spots in Brooklyn and Queens, Mr. Cuomo had already ordered all public and private schools in nine of the city’s ZIP codes to close as of Tuesday morning.
On Tuesday, Mr. de Blasio said that during testing at 35 schools in the nine ZIP codes, just two of 1,351 tests returned positive results between Sept. 25 and Oct. 5. But recent estimates of the spread of infections in city schools suggested that the city’s ambitious testing plans may be insufficient to catch outbreaks before they spread beyond a handful of students.
Officials in Orange County already closed all schools in Kiryas Joel, a predominantly ultra-Orthodox Jewish village located in a ZIP code seeing some of the highest seven-day average positivity rates in the state in recent days. Schools in other parts of that ZIP code were not ordered to close.
On Tuesday, the governor said 705 virus patients were hospitalized statewide, up from 636 the day before.
Mr. Cuomo also said that travelers from New Mexico are now required to quarantine for 14 days upon arrival, joining a long list of other states and territories.
Travelers to Connecticut and New Jersey are also now subject to a 14-day quarantine if they are coming from those same places, though compliance is voluntary in New Jersey and there is a testing alternative in Connecticut.
"current" - Google News
October 08, 2020 at 01:59AM
https://ift.tt/3nw0GwX
A former C.D.C. director wants the current one to expose the Trump administration’s failures. - The New York Times
"current" - Google News
https://ift.tt/3b2HZto
https://ift.tt/3c3RoCk
Bagikan Berita Ini
0 Response to "A former C.D.C. director wants the current one to expose the Trump administration’s failures. - The New York Times"
Post a Comment