Covid-19 Live News: Moderna Patent, Vaccine Mandates and Boosters

ImageStudents wearing their school-required masks wait for their parents outside Lamar Elementary School in San Antonio, in August.
Credit…Matthew Busch for The New York Times

A federal judge ruled on Wednesday that Gov. Greg Abbott’s ban on mask mandates in Texas schools violates the rights of students with disabilities, clearing the path for districts in the state to issue their own rules for face coverings, a decision that could affect more than 5 million students.

The ruling comes after months of politicized disputes over measures at the state level opposing mask-wearing policies that had been intended to prevent the spread of Covid.

The lawsuit, which sought to overturn the mandate, was filed on behalf of several families of students with disabilities and the organization Disability Rights Texas.

They stated that the defendants — the state’s attorney general, Ken Paxton; the commissioner of the Texas Education Agency, Mike Morath; and the Texas Education Agency — had put students with disabilities at risk through their complete erasure of mask mandates.

The governor and some other state officials have maintained that protecting against the virus is a matter of personal responsibility.

Judge Lee Yeakel, who made the ruling in the suit filed in the United States District Court for the Western District of Texas, determined that the order from the governor violated the 1990 Americans With Disabilities Act because it put children with disabilities at risk.

The ruling also prohibits Mr. Paxton from enforcing the order by Mr. Abbott, who has repeatedly opposed Covid-related mandates.

“The spread of COVID-19 poses an even greater risk for children with special health needs,” Judge Yeakel said. “Children with certain underlying conditions who contract Covid-19 are more likely to experience severe acute biological effects and to require admission to a hospital and the hospital’s intensive-care unit.”

The State Supreme Court has repeatedly allowed the governor’s ban to remain in effect. But the impact of Wednesday’s federal ruling could ripple across the country in similar cases in other states.

Responding to the ruling in a statement, Mr. Paxton said that he disagreed, adding that his office was “considering all legal avenues to challenge this decision.”

Mr. Abbott’s office did not immediately respond to requests for comment on Wednesday night. Mr. Morath office also didn’t immediately respond.

The lawsuit was first filed in August, at the onset of the fall semester. Disability Rights Texas argued that school district leaders should make their own decisions about mask mandates. The school districts, the organization said, should be basing their decisions on the Covid transmission in their area and on the needs of their students.

The order from the governor, Judge Yeakel said, excluded “disabled children from participating in and denies them the benefits of public schools’ programs, services, and activities to which they are entitled.”

Several school districts had altered or undone their mask mandates since Mr. Abbott’s order.

Mr. Paxton sent letters to superintendents of school districts threatening them with “legal action by his office to enforce the governor’s order and protect the rule of law,” if they did not rescind their mask mandates, according to court documents. On Sept. 10, Mr. Paxton filed lawsuits against six school districts, the documents show.

The Justice Department signaled support for the lawsuit against the state in September, saying in a formal statement that “even if their local school districts offered them the option of virtual learning,” the ban still violated the rights of students with disabilities.

The statement showed a willingness by the federal government to intervene in states where governors and other policymakers have opposed mask mandates.

Credit…Bess Adler for The New York Times

The National Institutes of Health is prepared to aggressively defend its assertion that its scientists helped invent a crucial component of the Moderna coronavirus vaccine — including taking legal action if government lawyers deem it necessary, the agency’s director, Dr. Francis Collins, said Wednesday.

Moderna’s vaccine, which appears to provide the world’s best defense against Covid-19, grew out of four years of collaboration with research scientists at the N.I.H.’s Vaccine Research Center. The New York Times reported on Tuesday that the company has blocked three N.I.H. researchers from being named on a key patent application.

Much more than scientific recognition is at stake. If federal researchers were named as co-inventors in the patent, the government would have a nearly unfettered right to license the Moderna vaccine to other manufacturers, which could expand access to it in poorer nations and bring the government millions in revenue.

Dr. Collins declined to be interviewed. But speaking to Reuters in advance of a virtual health conference hosted by the news service, he made clear that the N.I.H., the government’s biomedical research agency, was not backing down.

“I think Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to people who played a major role in the development of the vaccine that they’re now making a fair amount of money off of,” he told Reuters. He added: “But we are not done. Clearly this is something that legal authorities are going to have to figure out.”

A spokeswoman for Dr. Collins, Renate Myles, stopped short of saying the dispute was headed to court.

“Dr. Collins simply stated that N.I.H. is not giving up on our claim that N.I.H. is a co-inventor on the mRNA technology use in the Moderna COVID-19 vaccine, but defers to legal authorities on how this might be resolved,” she said. By legal authorities, she said, Dr. Collins meant government lawyers.

The three government researchers that N.I.H. has been trying to get named alongside Moderna employees as co-inventors of the genetic sequence at the core of how the vaccine triggers an immune response.

As the virus began to spread in January 2020, scientists at N.I.H. and Moderna worked in parallel over a single weekend to zero in on the gene for the virus’s spike protein. Both teams independently identified the same gene.

Moderna has so far rebuffed the government’s efforts. In a July filing with the United States Patent and Trademark Office, Moderna said it had “reached the good-faith determination that these individuals did not co-invent” the component.

Moderna’s chief executive, Stéphane Bancel, said Wednesday the company was in confidential discussions with the N.I.H. and would communicate publicly if a resolution to the dispute is reached.

“What we just need to work out with the N.I.H. is who are the inventors. And there are very clear rules set out by the law about inventorship, and they are very important to protect the patent,” Mr. Bancel said at a virtual conference put on by Wired magazine.

Moderna has received $1.4 billion from the federal government to develop its vaccine and another $8.1 billion to provide the country with half a billion doses. It is also earning billions in profits from supply deals.

Biden administration officials have said they lack the legal authority to require the company to share its vaccine recipe and technical know-how with manufacturers who could produce it at a lower cost for poorer countries.

After Dr. Collins’s comments were reported, a Moderna spokeswoman, reiterated that the company has concluded that only Moderna scientists came up with the sequence that powers the vaccine.

Credit…Geoff Forester/The Concord Monitor, via Associated Press

Ten states filed a lawsuit on Wednesday seeking to block the Biden administration’s coronavirus vaccine mandate for health care workers, on the heels of a court decision that temporarily halted the broader U.S. requirement that workers of all large employers be vaccinated or undergo weekly testing.

The new suit, filed in U.S. District Court in eastern Missouri, claims the rule issued last week by the Centers for Medicare & Medicaid Services “threatens with job loss millions of health care workers who risked their lives in the early days of the Covid-19 pandemic to care for strangers and friends in their communities.”

The 10 states also argue the rule “threatens to exacerbate an alarming shortage of health care workers, particularly in rural communities, that has already reached a boiling point.” They say any further losses will only endanger patients, causing “devastating adverse effects on health care services.”

But the broader point echoes a separate lawsuit brought by many of the same Republican-led states against the private-employer mandate for those with 100 workers or more, contending that OSHA does not have the authority to dictate such policy.

In announcing the rule, the administration set a deadline of January for all 17 million health care workers to be fully vaccinated at health care facilities receiving government funding under the Medicare or Medicaid programs. Employees of hospitals and nursing homes, along with other medical sites, would not have the option of testing in lieu of immunization.

Federal officials said they could not comment on pending litigation. CMS did release a statement defending the mandates.

“There is no question that staff in any health care setting who remain unvaccinated pose both direct and indirect threats to patient safety and population health,” the agency said. “That is why it is imperative for health care providers to ensure their staff are vaccinated against COVID-19.”

But legal experts said the agency generally has the ability to establish rules governing the organizations it pays to deliver care. “C.M.S. has very broad authority to regulate Medicare-certified providers,” said Katrina A. Pagonis, a lawyer specializing in regulatory issues for Hooper, Lundy & Bookman.

The rule “is essentially a condition of participation” in federally funded programs, said Erin J. McLaughlin, a health care lawyer for Buchanan, Ingersoll & Rooney. The government invoked the Supremacy Clause in the Constitution to pre-empt state and local laws when issuing the rule.

President Biden’s call for mandates followed months of pandemic outbreaks as the Delta variant threatened regions of the country, some with low vaccination rates but also others with vulnerable populations like those in nursing homes that had just begun to recover from the devastating death toll of 2020.

Some public health experts have argued that breakthrough infections possibly caused by waning immunity six months or more after vaccination, especially among the elderly, was a factor in urging mandates for health care workers.

After a steady decline in infections earlier this year among nursing home staffs and residents, spikes in cases this past summer alarmed officials. Many nursing homes had large numbers of workers who remained unvaccinated even after Mr. Biden announced the plan to mandate immunizations.

Many medical societies came out in favor of strict mandates for health care workers, arguing these employees have a special obligation to keep their patients and colleagues safe. And many large, multistate hospital systems and large nursing home companies began requiring staff vaccination, although others lobbied against blanket requirements.

The administration said about 40 percent of all hospitals already require vaccinations. About 73 percent of nursing home workers are now vaccinated, according to federal data.

“It’s critical to us to make sure we’re ensuring the safety of residents living in nursing homes and other individuals in health care settings,” said Chiquita Brooks-LaSure, the administrator for Medicare, in an interview after the agency issued the new rule. Vaccinated staff members are less likely to get sick and spread Covid, she said.

Ms. Brooks-LaSure acknowledged providers’ concerns over losing workers who refuse to be vaccinated, but she said mandates often ease shortages because employees don’t become infected. “What we’re seeing on the ground is that they are not going to work because they are sick,” she said.

She also cited the experience in states that have issued requirements as evidence that vaccination rates will rise as a result of the government’s decision. Many large hospital systems and even city agencies that mandated the vaccine reported that only a small minority of employees were unwilling to be vaccinated.

But the 10 states — Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming — claim the federal government has overreached its authority to dictate what happens in their states. “This case illustrates why the police power over compulsory vaccination has always been the province of — and still properly belongs to — the states,” they argue in the lawsuit.

While some nursing homes and hospitals have expressed disappointment over the new rules, there is little expectation that large numbers would lose their government funding.

While Medicare has the authority to terminate providers that do not comply, Ms. Brooks-LaSure emphasized the agency’s approach will be to work with facilities. “Our focus is really on educating providers and getting people to be in compliance,” she said.

Credit…Bryan Anselm for The New York Times

Travelers from more than 30 countries previously banned by coronavirus restrictions poured into U.S. airports on Monday, the first day on which visitors coming from those countries, but travel from abroad still lagged far behind prepandemic levels.

This was the first time that airlines have required proof of vaccination for travelers boarding flights to the United States. Visitors also were required to show proof of a negative coronavirus test.

As photos of emotional reunions spread across social media on Monday, 206,990 international travelers arrived at U.S. airports, according to Customs and Border Protection. This is nearly 40,000 more travelers from abroad than the United States received on a typical day in 2020.

Visitors from England, Ireland, France, Brazil, China, India, Iran and 26 other previously restricted countries were welcomed in the change, which signaled a shift toward normality, an enormously significant development that buoyed hopes for hotels, restaurants, long-divided families and companies with overseas employees.

The overall number of incoming travelers, including U.S. citizens but not counting crew members, falls far short of a typical day in 2019, when 371,912 people, including air passengers and crew, flew into the United States. (Estimates for a typical day in 2021 are not yet available.)

On Monday the New York City area alone welcomed more than 37,800 people from abroad at Kennedy International Airport, the busiest in the country, and Newark Liberty International Airport, according to the border agency. Miami International Airport, the second-busiest in the country on Monday, received more than 21,000 travelers from abroad.

Numerous airlines are adding back flights to schedules they had slashed during the pandemic in the hope that travelers will take advantage of renewed access to United States. As of Monday, Air France had increased Paris-to-Kennedy flights to five a day from three. And British Airways said it had increased flights to New York to five a day from one daily flight. United Airlines said it was expecting to fly more than 30,000 passengers to the United States on Monday, about 10,000 more than on the previous Monday.

But overall, the total number of flights into the United States, 1,376, was not much different than the week before — up about 60 flights from the previous Monday, according to Cirium, an aviation data firm.

Numerous airlines and tourism analysts have expressed optimism that the real bump in travel to the United States from abroad will occur over the holidays.

Credit…Emily Elconin for The New York Times

The White House estimated on Wednesday that nearly a million young children have gotten Covid-19 shots since the Pfizer-BioNTech vaccine was cleared for 5- to 11-year-olds last week — a figure that President Biden’s top coronavirus adviser, Jeff Zients, described as a “good start.”

Because of a lag in reporting to the Centers for Disease Control and Prevention, which gathers vaccination data, the White House did its own analysis by collecting information from pharmacies and state and local health officials, Mr. Zients said. He said officials “estimate conservatively” that 900,000 children have had their first shot.

He said an additional 700,000 pediatric vaccination appointments have been scheduled at pharmacies across the nation.

“Our goal clearly is to vaccinate as many kids as possible,” Mr. Zients said at a White House briefing on the pandemic. “This is the very beginning of the program. The program is just getting up to full strength.”

The vaccine is now available to roughly 28 million children nationwide and so far, it has been difficult to gauge parent interest. In northwest Washington D.C., a relatively affluent area, there were long lines of parents and children waiting to be vaccinated over the weekend.

An elementary school in Virginia visited by Jill Biden, the first lady, earlier this week quickly filled 260 vaccine appointments. The school has 355 students.

And in New York City on Monday, officials were caught off-guard by the demand at certain schools, which far exceeded the interest last spring at school-based vaccine clinics for teenagers.

But elsewhere in the country, many parents are wary. A survey by the Kaiser Family Foundation, published last month before the F.D.A.’s authorization for younger children, found that 27 percent of parents said they would “definitely not” get their 5-to-11-year-olds vaccinated against the coronavirus. An additional 33 percent said they would “wait and see” how the vaccine was working before getting their children the shots.

The campaign to vaccinate young children does not resemble the campaign to vaccinate adults. There are no mass vaccination centers. The dose and the vials are smaller. The White House is recruiting pediatricians to get involved.

The campaign also differs in one other notable respect: The White House has not publicly set a goal for how many children it would like to see vaccinated and when.

Earlier this year, Mr. Biden set a goal of having 70 percent of all adults receive at least one Covid-19 shot by July 4. The White House did not meet that goal by that date, and when Mr. Zients was asked on Wednesday if the Biden administration had set a goal for children, he ducked the question.

“I want to emphasize again that we have plenty of supply for all 28 million kids ages 5 to 11,” Mr. Zients said in answer to the question, adding, “We’re off to a very strong start.”

Credit…Amir Cohen/Reuters

A panel of experts at Israel’s Health Ministry has approved giving the Pfizer-BioNTech vaccine to children ages 5 to 11, paving the way for the country to become one of the first after the United States to authorize the shot for children.

The decision requires the approval of the director general of the Health Ministry, Dr. Nachman Ash, before it takes effect.

All but two of the 75 Israeli experts backed the move in a vote on Wednesday evening. In a separate vote, 57 of the experts backed the vaccination of children who have already recovered from the virus.

In the United States, White House officials on Wednesday estimated that nearly a million children ages 5 to 11 have gotten shots since the Pfizer-BioNTech vaccine was cleared for use last week.

Under Prime Minister Benjamin Netanyahu, Israel was an early leader in administering the vaccine to its adult population, though its rate later fell behind that of other countries. Since taking office in June, Mr. Netanyahu’s successor, Naftali Bennett, has staked his reputation on rapid vaccine administration in a bid to avoid another nationwide lockdown.

Israel, Mr. Bennett has said, must learn to “live alongside the virus.”

In June, Mr. Bennett’s government became one of the first to vaccinate young people ages 12 to 15, and in July it authorized booster shots for people 60 and older, even before that approach was approved in the United States. Mr. Bennett allowed the rest of the population access to booster shots in August, again before most of the rest of the world.

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

The virus appears to be on the retreat at the moment in Israel. The country registered 147 serious cases on Wednesday, the lowest number since the end of July.

But its vaccine drive has been met with some resistance, particularly after participation in many public activities became conditional on the presentation of a vaccine passport. The Health Ministry, facing a backlash, canceled a live broadcast this week of a panel discussion about vaccinating children, and a senior health official was assigned a security detail after she received a series of threats.

Credit…Delil Souleiman/AFP — Getty Images

Secretary of State Antony J. Blinken said on Wednesday that the United States had negotiated a deal to ship additional doses of the Johnson & Johnson coronavirus vaccine overseas, to help people living in conflict zones.

Speaking at a meeting with his overseas counterparts, Mr. Blinken stressed the need to extend vaccine access to people living in areas unreachable by government-run programs. The latest initiative is being carried out via Covax, the global vaccine-sharing program; Mr. Blinken did not specify a number of doses.

“We need to ensure that people who cannot be reached by government vaccination campaigns aren’t left out of our efforts,” Mr. Blinken said. “They need to be protected, too.”

President Biden has pledged more than a billion vaccine doses to send abroad, but he has been under pressure to lean on pharmaceutical manufacturers, who have resisted sharing their technology with vaccine makers in lower-income countries.

Later on Wednesday, at the DealBook Online Summit, Mr. Blinken said that: “When it comes to distribution, with all the different actors involved — governments, companies, international organizations — we have fallen short of the mark.”

Worldwide, about 75 percent of shots that have gone into arms have been administered in high- and upper-middle-income countries, according to the Our World in Data project at the University of Oxford. Only 0.6 percent of doses have been administered in low-income countries.

During the meeting on Wednesday, Dr. Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, appeared to call on the United States and other high-income countries to do more to help scale up global vaccine distribution.

Dr. Tedros said that at least 550 million additional doses would be needed to reach the organization’s goal of vaccinating 40 percent of the population of every country by the end of the year.

“We ask those countries that have promised to donate vaccines to make good on those promises, as soon as possible,” he said.

Use of the Johnson & Johnson vaccine in the United States has not been as high as that of the Pfizer-BioNTech or Moderna vaccines. Johnson & Johnson doses have also been distributed abroad through the Covax program in an effort to bolster immunity in poorer countries, including many in Africa.

Many of those have been provided through a similar deal reached in May, under which Johnson & Johnson agreed to sell about 200 million doses to Covax at a discounted rate.

“In countries suffering from years of conflict — such as the Democratic Republic of Congo, South Sudan and Yemen — less than 2 percent of the population have been vaccinated against Covid-19,” Esperanza Martinez, the head of the Covid crisis management team for the International Committee of the Red Cross, said in a statement.

“This shocking inequality must be rectified,” she said. “The donation of these doses is a positive step in that direction.”

Mr. Blinken also announced the launch of a new online tracker that would compile global data on vaccination and ICU rates, drawing on assistance from the W.H.O.

He described the need to ramp up global vaccine distribution as the “current emergency,” acknowledging the ongoing challenges Covax has faced with delays and poor coordination.

“We’re eager for people in these difficult circumstances to get protection against Covid-19 as soon as possible,” he said. “We know the urgency of this fight.”

Credit…Waltraud Grubitzsch/DPA, via Associated Press

Germany’s state and federal politicians are scrambling to put new Covid rules in place as the country experiences record case numbers, and a top virologist has warned that the nation’s pandemic death toll could double if sufficient measures are not taken.

Nearly 40,000 new cases were registered in the country on Tuesday — the third time a daily record has been set within a week. And 236 people died of the disease in that 24-hour period.

“We have a real emergency situation,” Dr. Christian Drosten, the head of virology at Berlin’s Charité hospital, Germany’s most renowned research hospital, said on a podcast that aired on Tuesday.

Since the pandemic began, Germany has reported almost 97,000 Covid deaths. Dr. Drosten warned that a further 100,000 could result if no additional solutions were found, although the number of patients in intensive-care beds is now less than half of what it was during the peak in January.

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

Germany’s national government, which under Angela Merkel’s guidance was seen as a model in Europe on how to deal with the pandemic, is now struggling to keep control of the situation.

The three parties that are poised to succeed Ms. Merkel’s coalition government have proposed a set of Covid rules that will be discussed in Parliament on Thursday, although they will not be voted into law before next week and do not include the kind of strict rules that many experts have called for.

The incoming parties said last month that they would let a countrywide state of emergency, which allowed for national rules to be brought in, lapse at the end of November. Under the new law, free quick coronavirus tests for all — a costly initiative that was abandoned last month in the hopes of lifting the vaccination rate — would be reinstated.

The authorities in Bavaria, where cases have been risen 68 percent over the last two weeks, declared a state of emergency on Wednesday. Markus Söder, the Bavarian governor, last declared an emergency in December 2020. Several more states, including those that have been hardest hit, either have in place or plan to enact their own stricter regulations this week. Those rules would mandate vaccinations or documentation proving a past infection for people seeking to use certain services.

“We’re about to have 16 different regulations again, and that doesn’t per se lead to more acceptance,” said Jens Spahn, the acting national health minister.

Experts say that the recent surge in infections has resulted from the relatively low vaccination rate in some regions of Germany and the slow rollout of booster shots. About 67 percent of the country’s population is fully vaccinated.

Although a recent study suggested that 65 percent of unvaccinated people in the country did not plan to get a shot under any circumstance, lines at inoculation centers have been growing.

Two weeks ago, barely more than 200,000 vaccination doses were administered on some days, but on Tuesday, 312,000 shots were given in a single day, a daily total not seen since the summer.

Credit…Susan Montoya Bryan/Associated Press

Coronavirus cases are surging faster in New Mexico than in any other state, despite its relatively high vaccination rate, and some hospitals there are overwhelmed.

After a quiet spring and summer on the coronavirus front, the past couple of months have been difficult for the state as cases rose rapidly, plateaued and are now rising again.

New daily cases per person are up 48 percent over the past two weeks, compared with a 6 percent increase nationwide, according to a New York Times database. Neighboring Colorado, which is facing its own surge, activated crisis care standards on Tuesday; that allows the National Guard to support overwhelmed hospitals and allow medical facilities to move staff around.

New Mexico was an early leader in vaccinations, and 63 percent of its population is fully vaccinated, compared with the national average of 58 percent. It has kept its mask mandate going, although it is set to expire soon without another extension.

Source: State and local health agencies. Daily cases are the number of new cases reported each day. The seven-day average is the average of a day and the previous six days of data.

Experts aren’t warning of a catastrophic winter, with New Mexico nowhere near the peak caseloads it reached late last fall. But increasing hospitalizations are causing concern in a state with fewer beds per person than almost any other state.

New Mexico led the way in vaccinations in the United States in the spring, and health officials in the state have been tracking whether that means residents who haven’t gotten booster shots could now be more vulnerable to infections. Although over 70 percent of the state’s hospitalized Covid-19 patients are unvaccinated, early vaccinations could be a factor in the current surge, Dr. David R. Scrase, New Mexico’s health and human services secretary, said in an interview.

“We’re the first ones to vaccinate, we’re going to be the first one to experience the waning immunity,” he said.

In Farmington, in northwestern New Mexico, the San Juan Regional Medical Center instituted “crisis standards of care” last week, meaning that some patients may be denied health care services because of a shortage of resources. It also brought in additional health care workers to manage the rise in patients.

Laura Werbner, a spokeswoman for the facility, said that 88 patients there had been hospitalized with Covid-19 on Wednesday. That is not the most the hospital has cared for in one day — that was 100 patients on Dec. 30 — but the difference now is “that resources are stretched so thin,” she said.

Numbers provided by the hospital indicate that vaccinations were still protecting many patients who had received shots. From Oct. 1 to Nov. 2, it cared for 289 Covid patients, 81 percent of whom were not fully vaccinated.

“Right now, this is a disease of the unvaccinated,” Ms. Werbner said.

The reasons for the increase in cases around the state are complex.

Kathryn A. Hanley, a professor of biology at New Mexico State University whose laboratory is studying the coronavirus, said that “New Mexico has been terrific about implementing regulations, mask mandates and social distancing regulations, and people have been good about complying with the regulations.”

The problem, she said, is that the Delta variant hit as residents’ immunity began to wane.

Demographics are also at play. New Mexico has more children per household than many other states, which makes it vulnerable because many children remain unvaccinated, Dr. Hanley noted.

“A lot of the communities here are closely connected, with a lot of family visitation,” she said, and that makes for conditions that are conducive to the transmission of the virus.

Sarah Cahalan contributed research.

Credit…Ellume, via Associated Press

The Australian company Ellume has expanded a recall of its at-home coronavirus test because of concerns about a “higher-than-acceptable” rate of false positives, the U.S. Food and Drug Administration said on Tuesday.

The recall now includes roughly 2 million of the 3.5 million test kits that Ellume had shipped to the United States by last month, a substantial increase from the company’s earlier estimate that about 427,000 of those kits were potentially faulty.

It is not clear how many false positives the affected tests have yielded. The issue, which the company had previously traced to a problem with one of the raw materials used in its test kits, does not affect the reliability of negative results.

The F.D.A. categorized the recall, which was first announced last month, as Class I, the most serious type. Use of the tests could have “serious adverse health consequences,” the agency said. People who falsely test positive for the virus may receive unnecessary treatments for Covid-19 and experience delays in being diagnosed with and treated for “the actual cause of the person’s illness,” the agency noted.

“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” a company representative said. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”

Many of the affected test kits have already been used. Consumers can determine whether they have used or purchased one of the affected tests, and request a replacement, online.

Those who try to use one of the affected test kits will be notified in the app that the test has been recalled. “It really won’t be possible to use any of those tests now,” Dr. Sean Parsons, Ellume’s chief executive, said in an interview last month.

The company has put additional precautions in place to prevent the issue from recurring, he added.

“I’m very sorry that this has happened,” Dr. Parsons said. “We’re all about chasing accuracy, and to have these false positives is disappointing.”

Credit…Tingshu Wang/Reuters

Some places have come under criticism for their long quarantines, but few can compare to the northern Chinese city of Shenyang.

Travelers arriving there from overseas must spend 28 days in hotel quarantine, and during the hotel stay they are not allowed to open the door except to take in food deliveries. They are tested seven times for the coronavirus over that period. And once that hotel quarantine is over, they are expected to avoid going outside their home for another 28 days.

The latest restrictions, which have been in place for nearly a month, are a stark example of how seriously Chinese officials are taking the country’s “zero Covid” approach to the pandemic, nearly two years after the virus emerged in the Chinese city of Wuhan.

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

The restrictions come after China began locking down cities in mid-October to try to contain a fresh outbreak following a flurry of domestic travel during a nationwide holiday.

China on Wednesday reported 39 symptomatic Covid-19 cases and 25 asymptomatic ones. But Shenyang has not reported any Covid-19 cases since July 30. Dalian, another city in the same province, Liaoning, reported 32 cases on Wednesday.

While travelers from overseas face a four-week quarantine, those entering Shenyang from other parts of the country considered high risk are required to do 14 days in hotel quarantine and another 14 days of self-monitoring.

In Beijing, where a small outbreak in late October led the capital to lock down certain neighborhoods, the authorities shut down dozens of pharmacies that were caught selling cough medicine without requiring customers to register their identification. The authorities started requiring pharmacies to ask customers for their name, ID and contact information when buying cough medicine early in the pandemic.

China’s lockdowns and zero-Covid strategy appear to enjoy widespread support among the public as caseloads remain low, but there is occasional griping on social media.

A recent article about Shenyang’s restrictions had just one negative comment. One user, under the name JonasLambily, wrote, “A model of lazy governance.”

Credit…Andrew Rush/Pittsburgh Post-Gazette, via Associated Press

An order by Pennsylvania’s acting health secretary requiring masks in schools for grades K-12 was rejected on Wednesday by a state court, which sided with a Republican state senator and several parents who argued that the official had overstepped her authority.

The acting secretary, Alison Beam, had issued the order at the end of August, after a summer of raucous uproar in school board meetings across the state over whether districts were going to require masks.

A spokeswoman for the governor said that an appeal was being filed immediately to the Pennsylvania Supreme Court, leaving the school mask requirement in place for now.

Source: U.S. Department of Health and Human Services. The seven-day average is the average of a day and the previous six days of data. Currently hospitalized is the most recent number of patients with Covid-19 reported by hospitals in the state for the four days prior. Dips and spikes could be due to inconsistent reporting by hospitals. Hospitalization numbers early in the pandemic are undercounts due to incomplete reporting by hospitals to the federal government.

Ms. Beam’s order was in line with guidance from the Centers for Disease Control and Prevention, the national public health authority, which recommends that all students, teachers and staff members in K-12 schools wear masks, regardless of their vaccination status. Masks — even cloth ones — can limit the dispersal of airborne virus particles from an infected person and also keep some of the particles from reaching mask wearers.

But the ruling, by a 4-1 majority in Pennsylvania Commonwealth Court, emphasized that the judges were not taking a position on “the science or efficacy of mask-wearing, or the politics underlying the considerable controversy the subject continues to engender.”

Instead, the judges ruled that the acting secretary could not issue such an order without going through certain statutory rule-making procedures in the absence of a disaster emergency declared by the governor. In June, the Republican-controlled Pennsylvania Assembly voted to end the disaster emergency that Gov. Tom Wolf, a Democrat, had declared in March of 2020 for dealing with the Covid-19 pandemic.

On Monday, Mr. Wolf announced that school districts would be allowed to decide mask policy for themselves starting in January, effectively declaring an end date to the statewide order.

Credit…Jae C. Hong/Associated Press

Thousands of gyms, restaurants, movie theaters, shopping malls, salons and other indoor businesses in Los Angeles were required this week to start asking customers for proof that they had been fully vaccinated against Covid-19, under one of the nation’s strictest vaccination rules.

The law, which the City Council approved last month, allows people with medical conditions that preclude vaccination, or a sincerely held religious objection, to instead show proof of a negative coronavirus test taken within the preceding 72 hours.

Officials say that the law is meant to help revive a city that has been under varied levels of restriction for more than a year and a half, and that requiring almost everyone who enters an indoor public space to be vaccinated will help prevent a surge in cases as winter approaches.

“Our businesses can’t afford another shutdown,” Nury Martinez, the president of the Los Angeles City Council, said in a statement. “The goal of this mandate is to limit the transmission of the virus and save lives.”

Source: U.S. Department of Health and Human Services. The seven-day average is the average of a day and the previous six days of data. Currently hospitalized is the most recent number of patients with Covid-19 reported by hospitals in the state for the four days prior. Dips and spikes could be due to inconsistent reporting by hospitals. Hospitalization numbers early in the pandemic are undercounts due to incomplete reporting by hospitals to the federal government.

But some business owners said they were frustrated that they might be forced to turn away customers.

Kim Prince, who owns Hotville, a popular Nashville hot chicken restaurant in the city’s Crenshaw district, said the vaccine verification requirement for indoor diners was just one more thing she had to worry about, along with staffing challenges and skyrocketing prices of ingredients.

While she has encouraged neighbors to get vaccinated and the restaurant has a patio, she said the mandate could put her employees in the difficult position of explaining the restrictions to customers — some of whom may be arriving from out of town — for the first time.

“We become the villain. We become that target,” she said. “That’s not my role — I’m not a policymaker, I’m a business owner who loves working in my own neighborhood.”

It’s particularly difficult for historically marginalized neighborhoods like Crenshaw, where fewer people are vaccinated than in Los Angeles County overall.

Ms. Prince said she thought much of the problem could be solved if the city did a better job of communicating the restrictions so that restaurant workers aren’t required to explain them to hungry, unsuspecting customers.

Some residents viewed the restrictions not as a mere logistical burden but as an unfair encroachment. At a protest outside City Hall on Monday, The Los Angeles Times reported, thousands of demonstrators voiced anger with vaccine mandates more broadly, especially those for public employees.

Still, across much of Los Angeles, the mandate took effect with little incident. Many bars, restaurants and fitness studios were already asking patrons to submit proof of vaccination if they planned to spend time indoors. In many cases, they said they hoped to lure back customers who might otherwise feel uncomfortable.

Allie Tichenor, the owner of Pilates Punx in the Echo Park neighborhood, said that even before the mandate went into effect, clients had asked whether instructors were vaccinated. Some volunteered their own vaccination status, and no one questioned the studio’s mask policy.

So although she didn’t hear from the city about the new law until just before it went into effect, she quickly emailed clients asking them to send proof of vaccination.

“It helps the clients feel really safe,” she said. “I’m happy to err on the side of caution, and I’ve figured if somebody wants to push back, maybe this isn’t the studio for them.”

Credit…Ng Han Guan/Associated Press

Xiao Yu looked relieved when she walked out of the American Embassy in Beijing on Wednesday. Having passed her interview for a tourist visa, she can finally visit her friend in the United States. The last time they met was over 20 years ago when she was a bridesmaid at her friend’s wedding.

“I’m happy today,” said Ms. Xiao, who had arrived an hour before her appointment to beat the crowds. “It’s my first time applying for an American visa. There were not as many people here as I imagined.”

Before Covid, the street in front of the embassy in central Beijing drew some of the largest daily public crowds in the city as thousands waited in line for appointments to apply for visas.

On Tuesday, the United States resumed regular visa services in China, like in other parts of the world, for the first time since Feb. 3, 2020, after President Donald J. Trump blocked travel from China. And the lines have returned in Beijing and outside U.S. consulates in Guangzhou, Shanghai and Shenyang, though for now they are smaller than before.

Source: Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. The daily average is calculated with data that was reported in the last seven days.

That may reflect the political tensions between Washington and Beijing, but also the wariness of traveling to the United States, where the pandemic remains rampant compared with the relatively small outbreaks in China. Also, travelers returning to China face lengthy quarantines, deterring those who might leave.

The embassy declined to disclose how many applicants it had processed so far, but the website where people can schedule visa interviews showed that there were still slots open in Beijing next week.

Some, like Ms. Xiao, welcomed the chance to visit the United States again after so long, regardless of any safety concerns or logistical complications.

“Even if Americans are relatively free,” Ms. Xiao, 48, said on Wednesday, “I think they have beefed up their awareness” of the virus’s dangers.

She said she would stay in Indiana with her friend’s family, but also visit some college campuses to prepare for sending her son to study in the United States. She also wants to visit Times Square and the Statue of Liberty.

“I’m interested in the United States,” she said. “It’s also an American dream of a kind.”

Claire Fu contributed research.

Credit…Doug Mills/The New York Times

The Biden administration last week released the details of a sweeping measure requiring large companies to mandate coronavirus vaccinations by January or start weekly testing of their workers, expanding on a plan announced in September. The rule sorts employers into big and small right at triple digits, covering businesses with at least 100 workers.

That has left some companies weighing whether to keep head counts in the 90s as they grapple with people who remain resistant to vaccination and want assurances that the mandate will not apply to them.

The Labor Department said it had chosen the 100-person benchmark because it is confident that employers with at least that many workers have the administrative capacity to enforce the mandate. But most American employers — nearly six million of them — do not meet the 100-worker standard.

A federal appeals court temporarily blocked the rule on Saturday, in a sign of the legal wrangling that the measure will face.

In the meantime, many employers are scrambling to determine the rule’s legal requirements. The standard applies to part-time workers but not independent contractors. Remote employees and those who work exclusively outdoors do not have to comply with the requirements, but they are included in a company’s head count. And seasonal workers employed directly count toward the threshold as long as they are employed while the rule is in effect.



Early on, as this whole thing got politicized the mask, (right) instead of before, the mask word. I thought that should have been a quick and easy mandate. It’s a mask. It’s not the vaccine it’s a mask. No harm proven, and we only prove that it can be healthy. It’s a small inconvenience for a possible long term freedom, everybody, let’s pay the tithe, put one on. So we’re trying to figure this out as we go. The science is changing as we go. Now you’ve got vaccine mandates. Well, look here. We’re going to, one day, we’re going to see who was exaggerating because as this thing got politicized, both sides, both sides, you could feel them both start to exaggerate. One side of the left was trying to raise up every number and anyone that died with the common cold, they said, blame it on Covid, raise the numbers. The other side saying no, none of this would have happened. COVID is not getting anybody. Now, we’re nine weeks into college football in America. We just had Wimbledon. We just had the English Premier Cup over in England. Well, I was sitting there going, these are super spreader events. I can’t believe we’re doing it. Doomsday is coming. So far? (Right) 12 weeks later. Those don’t seem to be super spreader events. So now the question really does not even seem as much are you vaccinated? Because I think we’re living in a pandemic world for the rest of time now. I’ll make it more complicated. Kids. Senator Ted Cruz, your own state was giving Big Bird a hard time on this issue. I know, I know, I know, I know. So, so you see that. And you think what? Oh, look, Andrew. Here I am. I see that to his look. He just said. We can vaccinate kids. Are we going to? Do we need to trust? I want to trust in the science, Do I think that there’s any kind of scam or conspiracy theory? Hell, no, I don’t. No, I don’t think theres any kind of— we all got to get off that narrative. There’s not a conspiracy theory on the vaccines. These are scientists trying to do the right thing and then people say, yeah, but the big pharma is making the money they can. Fine, that’s, that’s as well, if that’s true. OK? It’s scary. Right now, I’m not vaccinating mine, I’ll tell you that. (You’re not?) I’m not vaccinating mine, I want to get, I’ve been vaccinated, my wife has been vaccinated. We have a high risk person in our household, my mother, who’s 90, and she’s immune compromised. So why? Why don’t you want your kids to be vaccinated? We run, we go slow on vaccinations anyway, even before COVID. Now, mind you, I’ve chosen, we’ve quarantined harder than any of our friends have and still are two years later. I don’t want to. Maybe I’m trying to keep it from my mom. OK, so we’ve been doing just a heavy amount of testing, when and everywhere we can. We even take the ones that take the ones with us out of the box where we can do them in our house, everywhere we can with anybody we come in contact with. Try to do things outdoors. I’m in a position, though, where I can do that, and I understand that not everyone can do that. (Right.) I don’t I can’t I couldn’t mandate having to vaccinate the younger kids, I still want to find out, I still want to find out more information, but I couldn’t mandate it for kids just yet. No.

Video player loading

The U.S. surgeon general has pushed back against comments by the actor and author Matthew McConaughey, who is contemplating a run for governor of Texas, about coronavirus vaccine mandates for children.

Speaking at the DealBook Online Summit on Tuesday, Mr. McConaughey said, “I couldn’t mandate having to vaccinate the younger kids. I still want to find out more information.”

Although the actor is vaccinated, as are his wife, mother and older child, his two youngest children are not, having become eligible for shots only recently.

He added that in his household, “We go slow on vaccinations, even before Covid.”

Mr. McConaughey said he trusted that scientists were trying “to do the right thing,” and he suggested that the conspiracy theory “narrative” about vaccines was problematic. “Do I think that there’s any kind of scam or conspiracy theory? No I don’t.”

He also criticized the exaggerated and polarized response to mask mandates. “Early on, this whole thing got politicized,” he said. “I thought that should’ve been a quick, easy mandate. It’s a mask, it’s not the vaccine.”

Masks, he said, are “a small inconvenience for possible long-term freedom.”

Mr. McConaughey later clarified that his comments about vaccine mandates were about children ages 5 to 11, not for children 12 and older, and that he planned to thoroughly consider information about immunizing children as it becomes available.

But Dr. Vivek Murthy, the surgeon general, later weighed in, telling CNN that the vaccines were effective and “remarkably safe” for children.

He also pointed out that the coronavirus posed a significant risk to younger people. Parents, Dr. Murthy told CNN, need to recognize that “Covid is not harmless in our children.”

“Many kids have died,” he said. “Sadly, hundreds of children — thousands — have been hospitalized, and as a dad of a child who has been hospitalized several years ago for another illness, I would never wish upon any parent they have a child that ends up in the hospital.”

Mr. McConaughey also told the DealBook summit that he was examining his “mind, heart and spirit” about the possibility of running for governor of Texas.

“I’m trying to study what politics is. What democracy is and can be. Where we got off track,” he said. “Are there ways to get back on track?”

Credit…Rick Scuteri/Associated Press

The N.F.L. has fined the Green Bay Packers $300,000 and two of its players, quarterback Aaron Rodgers and wide receiver Allen Lazard, $14,650 each for failing to follow the Covid-19 protocols agreed on by the league and players’ union.

The penalties come about a week after Rodgers tested positive for the coronavirus and his subsequent public statements espousing false and unfounded claims about the Covid-19 vaccines and treatments. Those comments were condemned by public health officials and by some fellow athletes, though the league’s decision focused on his compliance with the rules.

Rodgers and Lazard, who is also unvaccinated, were penalized for attending a Halloween party even though the Covid-19 protocols prohibit unvaccinated players from gathering outside the team facility in a group of more than three players.

Rodgers also did not wear a mask when speaking with reporters, another violation of the league’s rules.

The team, which was notified of the fines late Tuesday, was penalized far more than the players because it did not do more to police its players’ behavior. The fine against the Packers is one of the largest for Covid-19 protocol violations.

Credit…Alex Welsh for The New York Times

Potential organ donors are now routinely screened for coronavirus infections before their organs are removed, and the organs are generally considered safe for transplantation if the test is negative, even if the donor has recovered from Covid.

But there is no universally accepted set of recommendations regarding when organs can be safely recovered from virus-positive bodies and transplanted to patients in need.

Complicating the question is that people with long Covid, whose debilitating symptoms may persist for months, mostly do not test positive for the infection. Some researchers fear that the virus may be present nonetheless, hiding in so-called reservoirs within the body — including some of the very organs given to transplant patients.

The risk is that surgeons may “give the patient Covid, along with the organ,” said Dr. Zijian Chen, medical director of the Center for Post-Covid Care at the Mount Sinai Health System. “It’s a tough ethical question. If the patient assumes the risk, should we do it?”

Dr. David Klassen, chief medical officer at the United Network for Organ Sharing, which administers the nation’s organ procurement network, said decisions must be made on a “case by case” basis.

“Many people waiting for organs are deathly ill,” he said. “Their life span may be down to a few days. If they don’t get a transplant, they will not survive.”

Yet physicians with the American Society of Transplantation said they would not procure any organs from any patient who had shown signs of illness and had a positive test for the infection.

“If somebody has active Covid and they’re testing positive,” said Dr. Deepali Kumar, president-elect of the society, “we would not procure organs from that donor — none at all.”

Source link