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Novavax, the little-known Maryland company that received a $1.6 billion deal from the federal government for its experimental coronavirus vaccine, announced encouraging results in two preliminary studies on Tuesday.
In one study, 56 volunteers produced a high level of antibodies against the virus without any dangerous side effects. In the other, researchers found that the vaccine strongly protected monkeys from coronavirus infections.
Although it’s not possible to directly compare the data from clinical trials of different coronavirus vaccines, John Moore, a virologist at Weill Cornell Medicine who was not involved in the studies, said the Novavax results were the most impressive he had seen so far.
“This is the first one I’m looking at and saying, ‘Yeah, I’d take that,’” Dr. Moore said.
Angela Rasmussen, a virologist at Columbia University who was not involved in the studies, called them “encouraging preliminary results,” but cautioned that it won’t be possible to say whether the vaccine is safe and effective until Novavax conducts a large-scale study — known as Phase III — comparing people who get vaccinated with people who get a placebo.
The company, which has never brought a vaccine to market in its 33-year history, has said that if its vaccine is shown to be effective, it can produce 100 million doses by the beginning of next year, or enough to give to 50 million people if administered in two doses. Under its deal with the federal government, the company will also receive money to undertake large-scale manufacturing of millions more doses if the vaccine is shown to work.
Novavax’s vaccine is one of more than two dozen products to have entered the first round of safety tests in people, known as Phase I trials. Five other coronavirus vaccines are already in Phase III trials, in which thousands of people are tested to see if a vaccine works.
An emergency order issued Monday by Gov. Larry Hogan of Maryland, which countermanded a Montgomery County Health Department directive regarding school closures, has highlighted a divide between public and private schools over reopening plans.
The county health department had instructed all private schools to start the year teaching remotely, as every public school district in the Washington area has already decided to do, including those in Montgomery County. Private schools would not be allowed to begin in-person classes until after Oct. 1, the order said.
But Mr. Hogan, a Republican, said on Monday that county health officers didn’t have the authority to stop private schools from reopening, noting in his statement that public school boards and superintendents have made individual decisions with the help of local health officials and saying that private institutions should be allowed to do the same.
“Private and parochial schools deserve the same opportunity and flexibility to make reopening decisions based on public health guidance,” Mr. Hogan said. “The blanket closure mandate imposed by Montgomery County was overly broad and inconsistent with the powers intended to be delegated to the county health officer.”
A similar dynamic is playing out in some other parts of the country, where public schools are opening remotely while private schools are planning in-person or various hybrid models.
Montgomery County, just outside the nation’s capital, is home to some of the nation’s most prestigious private schools, attended by the children of politicians, public officials and diplomats. They include St. Andrew’s Episcopal School, attended by Barron Trump, the president’s youngest child.
St. Andrew’s has not yet decided whether it will begin the school year with distance learning or a hybrid model. But some other private schools in Maryland, including Georgetown Preparatory, an all-male Jesuit school in North Bethesda, planned to let families choose between online or in-person classes, and would have had to alter those plans under the county order.
Other key education developments:
Students in Mexico will exclusively take classes broadcast on television or the radio when the school year begins later this month, in an effort to avoid further coronavirus outbreaks, the government announced on Monday. Schools will only reopen when authorities determine that new and active infections, which remain high across the nation, decline enough for a safe return to the classroom.
A rash of positive cases during the first week of school in some parts of the United States foreshadows a stop-and-start year in which students and staff members may have to bounce between instruction in the classroom and remotely at home because of infections and quarantines.
Israel reopened schools in May, and within days infections were reported at a Jerusalem high school. The virus rippled out to the students’ homes and then to other schools and neighborhoods, ultimately infecting hundreds of students, teachers and relatives. Other outbreaks forced hundreds of schools to close, and across the country, tens of thousands of students and teachers were quarantined. As countries consider back-to-school strategies for the fall, the outbreaks there illustrate the dangers of moving too precipitously.
The United Nations on Tuesday called for the world’s schools to make plans to reopen safely — but only after countries suppress transmission of the virus and control outbreaks.
“With the combined effect of the pandemic’s worldwide economic impact and the school closures, the learning crisis could turn into a generational catastrophe,” a U.N. policy brief from U.N. Secretary General António Guterres said.
The announcement argued that the adjustments made by schools worldwide to closing orders made in response to the coronavirus — providing lessons online, over radio, even on television in some places — highlighted inequalities among students and school districts and left many children behind, including those with disabilities.
“Parents, especially women, have been forced to assume heavy care burdens in the home,” the brief said.
In many countries around the world, including the United States, school districts planning to reopen are considering various measures, including holding classes in shifts or outdoors, mask wearing and so-called blended classes, in which students supplement in-person lessons with virtual ones.
NEW YORK ROUNDUP
New York City’s health commissioner, Dr. Oxiris Barbot, resigned on Tuesday in protest over her “deep disappointment” with Mayor Bill de Blasio’s handling of the coronavirus outbreak and subsequent efforts to keep the outbreak in check.
Her departure came after escalating tensions between City Hall and top Health Department officials, which began at the start of the city’s outbreak in March, burst into public view.
“I leave my post today with deep disappointment that during the most critical public health crisis in our lifetime, that the Health Department’s incomparable disease control expertise was not used to the degree it could have been,” she said in her resignation email sent to Mr. de Blasio, a copy of which was shared with The New York Times.
“Our experts are world renowned for their epidemiology, surveillance and response work. The city would be well served by having them at the strategic center of the response not in the background.”
Dr. Barbot’s resignation could renew questions about Mr. de Blasio’s handling of the response to the outbreak, which devastated the city in the spring, killing more than 20,000 residents, even as it has largely subsided in recent weeks. And it comes at a pivotal moment: Public schools are scheduled to partially open next month, which could be crucial for the city’s recovery, and fears are growing that the outbreak could surge again when the weather cools.
The mayor had been faulted by public health experts, including some within the Health Department, for not moving faster to close down schools and businesses in March, when New York emerged as an epicenter of the pandemic.
Public health officials have bristled at the mayor’s decision to strip the Health Department of its responsibility for contact tracing and give it instead to the public hospital system, known as Health + Hospitals. The Health Department has performed such tracing for decades; the public hospitals have not.
“It had been clear in recent days that it was time for a change,” Mr. de Blasio said in a hastily called news conference. “We need an atmosphere of unity. We need an atmosphere of common purpose.”
The mayor moved quickly to replace Dr. Barbot, immediately announcing the appointment of a new health commissioner, Dr. Dave A. Chokshi, a former senior leader at Health + Hospitals.
Elsewhere in the New York area:
In New York City, the 2020 holiday production of “Christmas Spectacular Starring the Radio City Rockettes” has been canceled because of the pandemic, Madison Square Garden Entertainment, which manages the show, announced on Tuesday. The Madison Square Garden Company plans to lay off 350 people, a spokeswoman said.
Negotiators on Tuesday are set to reconvene on Capitol Hill to continue hammering out differences over a coronavirus relief package, with top Trump administration officials scheduled to return for another meeting with congressional Democrats.
Treasury Secretary Steven Mnuchin and Mark Meadows, the White House chief of staff, will meet with Speaker Nancy Pelosi of California and Senator Chuck Schumer of New York, the minority leader. Mr. Mnuchin and Mr. Meadows will also join Senate Republicans for a closed-door policy lunch.
The Senate is scheduled to take a monthlong recess at the end of the week, but it is unclear if lawmakers will leave Washington without a deal. Tens of millions of Americans have lost crucial unemployment benefits as well as a federal moratorium on evictions, and economists warn that permanent damage could be wrought on the economy without action.
“I’ve never been a gambler,” said Senator Lisa Murkowski, Republican of Alaska, when asked about the prospect of a deal before the end of the week. “But if I were a gambler, I’d say we need to have some long days, long nights. Work hard.”
White House officials and Democratic leaders reported some progress over the weekend, but there are still substantial differences. Democrats are proposing a $3 trillion rescue plan that would include restoring $600-per-week jobless aid payments that expired on Friday and extending them through January, while Republicans are pushing a $1 trillion package that would reduce those payments substantially.
President Trump on Monday raised the idea of using an executive order to address the moratorium on evictions, while also hurling insults at Democratic leaders who were meeting with his top advisers in search of a compromise. But he has been notably absent from the negotiations themselves.
Mr. Trump accused Democrats of being focused on getting “bailout money” for states controlled by Democrats, and unconcerned with extending unemployment benefits.
Democrats have proposed providing more than $900 billion to strapped states and cities whose budgets have been decimated, but it is Republicans who have proposed slashing the jobless aid. Democrats have refused to do so, cementing the stalemate.
Fueling an already complicated impasse, outside advisers are also trying to get the president to bypass Congress and unilaterally impose a temporary payroll tax cut, an idea that Mr. Trump has championed but that his negotiators dropped amid opposition from both parties.
Congressional staff and lobbyists who are engaged in discussions said on Monday that the talks between administration officials and Ms. Pelosi and Mr. Schumer had essentially frozen negotiations between top Democrats and Republicans on key committees who would have to hammer out the details of any deal.
That could leave the parties little time to flesh out any compromises over additional aid to businesses or individuals, yielding a plan that mostly consists of re-upping existing aid programs like the Paycheck Protection Program and direct payments to individuals.
Isaias pounded a large swath of the Atlantic Coast on Tuesday, unleashing heavy rains and winds as fast as 70 miles per hour as the storm swept through the Carolinas and into the Northeast.
Shelters had prepared to deal with a dual threat from severe weather and the virus by screening for symptoms, socially distancing people and distributing protective gear. The storm has also closed testing centers from Florida to Maryland, which could complicate efforts to gauge virus transmission.
The storm weakened as it pushed north on Tuesday, but heavy winds knocked out power in areas of several states.
Governors of six states said on Tuesday that they were partnering to purchase millions of virus tests and expand their testing capability as many states continue to struggle to keep up with the demand for tests.
The governors of Louisiana, Maryland, Massachusetts, Michigan, Ohio and Virginia are negotiating a purchase of three million antigen tests — 500,000 per state — as part of the new compact, which was created by Gov. Larry Hogan of Maryland, a Republican and the outgoing chair of the National Governors Association.
Members of the compact hope that it will show companies that there is “significant demand” to create more tests, according to a statement from Mr. Hogan’s office, something made apparent by the long lines that continue to plague virus testing sites across the country. The governors — three Republicans and three Democrats — also hoped the compact would help states buy tests in a more “cost-effective manner.” More states and local governments may join the group.
Antigen tests can provide results in less than an hour, but scientists have said that they fear the tests will frequently miss infections. The governors are negotiating to purchase the three million tests from two medical companies — Becton, Dickinson & Company and the Quidel Corporation — whose tests could produce false negative results between 15 and 20 percent of the time. The companies were the first to receive emergency authorization from the Food and Drug Administration for their coronavirus antigen tests.
The Rockefeller Foundation, a philanthropic organization in New York, is also part of the compact between the governors and said it was ready to help find sources of funding for the testing operation.
“With severe shortages and delays in testing and the federal administration attempting to cut funding for testing, the states are banding together to acquire millions of faster tests to help save lives and slow the spread of Covid-19,” Mr. Hogan said in a statement.
A day before the United States surpassed 150,000 deaths from the coronavirus, Mr. Trump appeared resigned to the toll, saying in an interview, “It is what it is.”
“They are dying. That’s true,” Mr. Trump told Axios in an interview recorded on July 28 and released in its entirety on Monday. “It is what it is. But that doesn’t mean we aren’t doing everything we can. It’s under control as much as you can control it.”
The president’s critics say he could have done much more to keep the virus from spreading to the extent it has, including encouraging states to be more cautious in reopening instead of encouraging them.
The country’s death toll, currently nearly 156,000, is far from the total of “75, 80 to 100,000” deaths that Mr. Trump predicted in early May when he credited himself with preventing the toll from being worse.
Even after his predictions proved wrong, Mr. Trump has continued to credit himself for the United States not being even worse off.
“One person’s too much,” Mr. Trump told Axios. “And those people that really understand it, that really understand it, they said it’s an incredible job that we’ve done.”
The World Health Organization on Tuesday urged Russia to follow established guidelines for producing safe and effective vaccines, after Moscow announced that it would begin widespread vaccination of its population in October with a vaccine that had not yet been fully tested in clinical trials.
Amid a global race to develop the first effective coronavirus vaccine, experts have raised concerns about cutting corners in research and putting people at risk with an unsafe product. Last week Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States, warned Congress about programs like Russia’s that are not transparent.
“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone,” Dr. Fauci said at hearing.
Russia is moving ahead with several prototypes, its officials said, and at least one effort, developed by the Gamaleya Institute in Moscow, has reached advanced stages of testing. The vaccine candidate is similar to one developed by Oxford University and AstraZeneca, using modified viruses that typically cause mild colds in humans.
Russia said it will start so-called Phase III trials of the vaccine this month. In Phase III, trials test for effectiveness in humans, after testing in animals. It is the last stage before approval, allowing widespread use.
The candidate vaccine reportedly has been tested to some extent on soldiers, and the Russian defense ministry said those soldiers all had volunteered. The institute’s director said on Russian television that he himself had also tried the vaccine before it finished testing in monkeys.
The National Institutes of Health announced Tuesday the launch of a key second, phase of clinical trials for an antibody treatment to help patients early in the course of Covid-19.
The two studies, which are now recruiting patients, are testing drugs called monoclonal antibodies produced by Eli Lilly and its partner, Abcellera Biologics in Vancouver. Researchers hope to have results in October or November.
The process began in March, and has progressed at “record speed,” said Daniel Skovronsky, chief scientific officer at Eli Lilly. Two and a half months later, the company began safety tests in humans, “surely a record speed,” he said.
The first study, dubbed ACTIV 2, will start with 220 Covid-19 patients who are ill but not hospitalized. Half will receive the antibodies and half a placebo infusion. If there are signs the drug is helping, the trial will expand to a total of 2,000 patients with the hope that the drug reduces the duration of symptoms and speeds the time it takes for the virus to be undetectable in the patients’ upper respiratory tracts.
The second study, ACTIV 3, will begin with 300 patients who are hospitalized but not gravely ill who have had symptoms for 10 days or less, though patients with virus-caused organ damage are excluded. Half of the patients will receive a placebo infusion. If the drug appears helpful, the study will move on to 1,000 individuals.
The antibodies used in these trials were produced from serum from a Washington patient who was one of the first people to recover from Covid-19. Researchers at Abcellera selected this antibody from many in the patient’s blood because it was most effective at blocking the virus.
Without knowing if the drug will be beneficial, Eli Lilly is preparing to meet a goal of having 100,000 doses by the end of the year, Dr. Skovronsky said.
As these clinical trials progress, the researchers may add other treatments as well.
Australia’s second-largest city, Melbourne has imposed some of the toughest restrictions in the world as it grapples with a spiraling outbreak in a country that once thought it had the pandemic beat.
But as officials cast about for ways to break the chain of infections, the city has become a confounding matrix of hefty fines for disobedience, minor exceptions for everything from romantic partners to home building, and endless versions of the question: So, wait, can I ____?
Restaurant owners are wondering about food delivery after an 8 p.m. curfew began on Sunday. Teenagers are asking if their boyfriends and girlfriends count as essential partners. Can animal shelter volunteers walk dogs at night? Are house cleaners essential for those struggling with their mental health? Can the virus-tested exercise outside?
“This is such a weird, scary, bizarro time that we live in,” said Tessethia Von Tessle Roberts, 25, a student in Melbourne who admits to having hit a breaking point a few days ago, when her washing machine broke.
“Our health care workers are hustling around the clock to keep us alive,” she said. “Our politicians are as scared as we are, but they have to pretend like they have a better idea than we do of what’s going to happen next.”
Pandemic lockdowns, never easy, are getting ever more confusing and contentious as they evolve in the face of second and third rounds of outbreaks that have exhausted both officials and residents. With success against the virus as fleeting as the breeze, the new waves of restrictions feel to many like a bombing raid that just won’t end.
The pandemic has the nation’s caterers — roughly 12,000 individuals or companies with annual revenues of more than $60 billion — reeling. Many say they expect their business to be down between 80 and 90 percent this year.
Corporate cafeterias that they provide food and staff to remain closed. Events like graduation and anniversary parties, bar mitzvahs, charity dinners and weddings have been canceled or pushed into next year.
And the ones that took place were on a decidedly smaller scale. “We did one 50-person wedding,” said David Cingari of David’s Soundview Catering in Stamford, Conn. “It was a clambake in the backyard. That was supposed to be a 250-person wedding.”
On a recent Saturday, he was dashing about at a pop-up restaurant he opened in mid-June, serving lobster rolls, blackened mahi-mahi tacos and smashburgers alongside cocktails like the Painkiller to socially distanced diners.
He made about $600, far from the roughly $6,600 that a 210-person wedding (petite lobster rolls on toasted brioche, coconut shrimp with mango aioli) and a bar mitzvah party for 180 (torched s’mores and a chocolate fountain) planned for that day, pre-pandemic, would have brought in.
The collapse of the catering industry this year also directly affects bartenders, wait staff and others who typically work these events as part-time employees.
The industry — a collection of large corporations like Aramark and Compass Group and thousands of smaller companies owned by individuals — is not tracking how many caterers have permanently closed because of the pandemic, but they say it will happen.
And while caterers say they are taking a financial beating, many feel better situated than those in the restaurant business. Instead of paying often expensive rent in desirable locations like most restaurants, caterers typically pay less for large kitchens that can be off the beaten track.
In his first report to Congress since being appointed by Mr. Trump in June, Brian D. Miller, the inspector general overseeing the Treasury Department’s $500 billion pandemic recovery fund, said some individuals and companies have been able to draw from multiple pots of federal pandemic relief money at the same time, a practice he warned could lead to an increase in fraud and abuse.
Mr. Miller, a former White House lawyer, offered a broad overview of his responsibilities in his report on Tuesday and provided status updates on the lending programs that Treasury is managing as part of the $2.2 trillion law enacted in March.
Mr. Miller highlighted the fact that individuals and companies have been able to access government funds through multiple programs — what he called “multiple dipping” — as a potential problem. He noted that there is no bar against simultaneously utilizing the Paycheck Protection Program, which is designed to help small businesses maintain their payrolls; Federal Reserve lending facilities created to help large companies; and other relief funds such as the Payroll Support Program for airlines.
“Creating multiple programs resulting in multiple forms of financial support to a single individual or entity may well be sound policy,” he wrote. “But in such circumstances, the risk of fraud and abuse increases and questions arise.”
Mr. Miller urged Congress to consider whether such overlap among the funds was warranted and to clarify the legislation.
The report also suggested that bureaucratic delays at the Treasury Department had been hampering Mr. Miller’s ability to properly perform his job. He lamented a lengthy and cumbersome hiring process that has slowed his ability to investigate fraud, waste and abuse.
Color copies of the inaugural report could not even be produced, Mr. Miller said, because of the red tape required to obtain printers.
Counting for the 2020 census will end on Sept. 30, a month earlier than previously scheduled, the Census Bureau said in a statement on Monday.
The census is constitutionally required to count all residents of the United States every 10 years, but the 2020 effort has faltered amid the pandemic. In recent weeks, the Trump administration and Senate Republicans appeared to signal that they wanted the census finished well ahead of schedule.
Census data is enormously important. It is used to reapportion all 435 House seats and thousands of state and local districts, as well as to divvy up trillions of dollars in federal aid.
“Under this plan, the Census Bureau intends to meet a similar level of household responses as collected in prior censuses, including outreach to hard-to-count communities,” the Census Bureau said in its statement.
Critics said the move was pushed by the White House and motivated by partisanship.
“We’re dealing with a census that’s been really challenged by Covid-19,” said Vanita Gupta, a former head of the Justice Department’s civil rights division who is now the president of the Leadership Conference on Civil and Human Rights. “And in the middle of this pandemic, the administration has tried to sabotage the census for partisan gain, to move its anti-immigrant agenda and to silence communities of color.”
She added that rural communities could be badly hurt by an undercount.
On Monday night, the White House referred questions to the Commerce Department, which oversees the Census Bureau. It did not immediately respond to a request for comment.
Reporting was contributed by Livia Albeck-Ripka, Pam Belluck, Nicholas Bogel-Burroughs, Emma Bubola, Benedict Carey, Julia Carmel, Damien Cave, Emily Cochrane, Michael Gold, J. David Goodman, Maggie Haberman, Mike Ives, Juliana Kim, Isabel Kershner, Gina Kolata, Giulia McDonnell Nieto del Rio, Marc Stein, Eileen Sullivan, Jim Tankersley, Michael Wines, Will Wright and Karen Zraick.
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