Covid-19 Live Updates: Top White House Official Denies Pressuring F.D.A. on Vaccine Guidelines


A top Trump official dismisses a report that he pushed the F.D.A. to soften new vaccine guidelines.

The White House chief of staff, Mark Meadows, dismissed reports that he had pressured the Food and Drug Administration to soften new, stricter guidelines that the agency was preparing for the emergency authorization of coronavirus vaccines.

“Why would we do that?” he asked Margaret Brennan on the CBS program “Face the Nation” on Sunday.

Mr. Meadows said he was interested in the guidelines purely as a matter of quality control: “My challenge to the F.D.A. is just make sure it’s based on science and real numbers.”

The new guidelines under development would lay out more specific criteria for clinical trial data than the current guidelines, and would recommend that the data be vetted by a committee of independent experts before the F.D.A. authorizes any vaccine, according to several people familiar with a draft.

President Trump suggested on Wednesday that the new guidelines were a “political move,” and that the White House might not approve them.

The same day, Mr. Meadows called Stephen Hahn, the F.D.A. commissioner, and insisted that the agency provide detailed justification for the new guidance, according to a report in The Washington Post.

Ms. Brennan asked why the White House would insert itself into the F.D.A.’s process, raising concerns of political interference. “We want to make sure that it’s safe,” Mr. Meadows replied. “We’re trying to make sure that the guidance we give is not an inhibitor to getting things out fast,” but also “doesn’t detract from it.”

Ultimately, he added, the F.D.A. guidelines would make sure that everyone who gets the vaccine “can do that with some kind of assurance that the process is meted out properly.”

Mr. Meadows’s line of reasoning echoed that of Michael Caputo, the former spokesman for the Department of Health and Human Services, when he responded to reports two weeks ago that he and one of his aides had pressured the Centers for Disease Control and Prevention to alter its weekly disease assessments.

The aide “makes his position known, and his position isn’t popular with the career scientists sometimes,” Mr. Caputo told The Times on Sept. 12, a day before he made outlandish claims against C.D.C. scientists in an online video and a few days before going on medical leave. “That’s called science. Disagreement is science.”

Also on “Face the Nation,” Scott Gottlieb, who was commissioner of the F.D.A. from May 2017 to April 2019, said that the expected guidelines did not represent “a revision in the agency standards or any kind of higher bar” but rather “an articulation of the principles and standards that the F.D.A. has been using for a long time and frankly been communicating to the companies that are developing vaccines.”

Dr. Gottlieb, a physician now on the board of Pfizer, one of the companies racing to develop a coronavirus vaccine, said he believed that there was wide agreement that the guidelines, as discussed publicly, “were mostly in line with everyone’s expectations.”

He said he preferred to have the F.D.A. issue the guidance “because it would provide more transparency,” but regardless, “I think these are going to be the principles that govern that process.”

In Florida, a standoff between the state and Miami-Dade over when schools should reopen.

Florida’s education commissioner has demanded that the Miami-Dade school system abandon its plan to delay in-person education and open its doors to students by next Monday.

“I am writing today with grave concerns regarding the School Board of Miami-Dade County’s recent vote to revoke parents’ ability to choose brick-and-mortar schools for their children’s education,” Commissioner Richard Corcoran said in a letter sent over the weekend.

The letter, addressed to the schools superintendent, Alberto M. Carvalho, and the school board chairwoman, Perla Tabares Hantman, is the latest flare-up between state officials and local school districts during the pandemic.

Florida has been hit hard by the virus, but state officials eager to reopen the economy have pushed for in-person instruction. Some school districts have been reluctant to move too quickly.

Commissioner Corcoran’s letter followed a unanimous vote by the Miami-Dade school board to delay in-person instruction after a 29-hour virtual meeting at which hundreds of people weighed in during the public comment.

The plan approved by the board calls for a gradual start of in-person learning to begin Oct. 14. The full reopening was pushed back to Oct. 21, for any students wishing to attend in person.

Miami-Dade, the nation’s fourth-largest school system, has 345,000 students. They have already begun virtual learning, and there has been heated debate over when they should return to the classrooms.

Many teachers say it is unsafe, and when teachers unions sued Gov. Ron DeSantis and Commissioner Corcoran over the state’s attempt to force schools to open, a judge ruled in their favor.

On Sunday, the Miami-Dade teachers union president, Karla Hernandez-Mats, took issue with the state’s tactics.

“It seems that the fundamental essence of local control to allow communities to do what’s in the best interest of their citizens only applies if local leadership falls in line with Governor DeSantis and Commissioner Corcoran’s personal political agendas,” she said.

As the world moves toward another morbid threshold in the pandemic, a coronavirus death toll of one million, the countries where fatalities are increasing fastest remain spread out across the globe, with new hot spots constantly emerging.

The number of lives lost daily to the virus has been rising through most of August and September, reaching more than 5,000 in an average measured over seven days. As of Sunday evening, the global total stood at 995,600, according to a New York Times database.

On Saturday, India, the world’s second-most populous nation, continued to lead in daily virus-related deaths, with about 7,700 over the most recent seven-day period. The United States is second, with more than 5,000, Brazil third with more than 4,800, and Mexico fourth with nearly 3,000. Those four countries account for more than half of the world’s total deaths from the virus, according to the Times database.

New hot spots are also emerging in smaller countries like Israel, which led the world in new cases per capita over the past week.

The pandemic continues to wreak havoc in South America, where countries including Argentina, Colombia and Peru are recording thousands of new cases daily along with some of the highest numbers of deaths per capita in the world.

With seasons changing, some countries that were hit hard by the virus in the spring and summer are beginning to shed lockdown policies, raising fears of future surges. In Europe, second waves of infections have already hit Britain, Spain and France.

In places where the autumn chill is ushering people back into homes, classrooms and offices, health experts warn that the virus may resurge even in areas that so far have restrained its spread.

The virus poses a greater threat in crowded indoor spaces than it does outdoors. Southern U.S. states, for example, saw a spike in infections when the temperatures soared this summer, prompting people to remain inside with the air-conditioners humming.

“I’m a little concerned we’re going to see that shift to the northern latitudes as the weather gets cold,” said Linsey Marr of Virginia Tech in Blacksburg, who studies how viruses move through the air.

Unless you are living with an infected person — in which case the Centers for Disease Control and Prevention offers specific guidelines to follow — protecting yourself at home does not require extraordinary measures, Dr. Marr said. And when you venture elsewhere, wearing a face covering and washing your hands are still the best ways to protect yourself indoors.

Health experts offered several tips for dodging the virus indoors: Open the windows, buy an air filter — and forget the ultraviolet lights. Fear of the risk of transmission indoors has fueled a market for expensive devices that promise to scrub surfaces — and even the air — but most of those products are overkill and may even have unintended harmful consequences.

“Anything that sounds fancy and isn’t tried-and-true — those are all things to avoid,” said Delphine Farmer, an atmospheric chemist at Colorado State University in Fort Collins. “Soap and water work beautifully.”

Managers of larger buildings should encourage those who can to work from home and adopt strategies like adding air filters and disinfecting surfaces. Researchers at the Massachusetts Institute of Technology have created an app to determine how many people can safely congregate in a given space and for how long.

But regardless of these precautions, the optimal strategy is simply to wear a mask indoors, said Martin Bazant, a chemical engineer at M.I.T., adding, “That’s a much bigger effect than any of those strategies would provide.”

Colombia reached more than 800,000 cases this weekend, just as social life has begun to return to Bogotá, the capital and the heart of the health crisis.

The reopening of restaurants and other businesses has injected much-needed buoyancy into the economy and has lifted the collective mood, particularly in Bogotá. But concerns remain about the possibility of a new surge.

Colombia has been hit hard by the virus, though it has fared better than many of its neighbors.

One in 62 Colombians has tested positive for the virus, according to a Times database, compared with one in 40 in Peru and one in 44 in Brazil. Colombia has experienced about 50 deaths per 100,000 people, according to the database; Peru has had twice as many.

Colombia’s overall infection rate is close to that of Argentina, where about 1 in 63 people have been infected, and where cases topped 700,000 over the weekend.

Social life across much of Colombia has been almost completely shut down since late March. But in recent weeks the mayor of Bogotá’s, Claudia López, began allowing restaurants to offer indoor dining at reduced capacity and permitting long-shuttered businesses to renew operation.

The city’s markets and shops now bustle with mask-wearing residents, and a degree of normality has returned to the streets. The country’s airports, which closed in late March, have also begun to reopen.

Officials, however, say this appearance of normality hides a grimmer reality: The country continues to be a hot spot for new cases, at about 6,800 a day. On Sunday, the Colombian health ministry said its intensive care units were at 50 percent capacity.

“Keeping malls and other businesses open depends on citizens’ behavior,” the ministry of health said on Sunday. “Let’s practice social discipline and we’ll avoid contagion.”

Trump’s handling of the pandemic may cost him politically, polls show.

President Trump’s handling of the pandemic continues to be a major political liability, according to a national poll conducted by The New York Times and Siena College.

The poll found that 56 percent of voters said they disapproved of Mr. Trump’s approach to the virus, including half of white voters and the same proportion of men, groups that usually lean to the right. The poll has a margin of sampling error of 3.5 percentage points.

Two-thirds of voters said they would support a national mask mandate, while 63 percent said they would support new lockdowns if public health experts recommend them. Mr. Trump has often ridiculed mask wearing, and he has attacked state and local officials for imposing health-based restrictions on public activity.

Mr. Biden has taken an opposing set of positions that fall more in line with voters’ preferences. He endorsed a national mask mandate, acknowledging that a president may not have the power to impose one, and he has encouraged public officials to impose lockdowns as necessary.

Mr. Biden has also accused Mr. Trump of politicizing the coronavirus vaccine process. The president has repeatedly suggested that a vaccine will emerge before Election Day. But the poll shows that the president may not be making headway with voters by dangling the possibility of a hastily approved vaccine. Eighty-one percent said they would oppose distributing a vaccine before the completion of clinical trials.

The poll results also offered a warning for Republicans on the broader issue of health care. Fifty-seven percent of voters, including nearly two-thirds of independents, said they supported the Affordable Care Act, the Obama-era law that Mr. Trump’s administration is seeking to overturn even as the pandemic progresses.

Democrats are attempting to put Mr. Trump’s challenge to the popular law at the center of the fight over the Supreme Court seat left vacant by the death of Justice Ruth Bader Ginsburg, pairing it with Roe v. Wade as a measure his nominee, Judge Amy Coney Barrett, may threaten.

Infections are skyrocketing in France, with a daily average of more than 10,000 new cases over the past seven days, more than double the number at the height of the country’s first wave in the spring.

“We have been warning for several weeks now that we have not defeated the epidemic,” France’s health minister, Olivier Véran, told the French news media on Sunday. “The virus has not disappeared. The epidemic has picked up again.”

The number of Covid-19 deaths has risen 83 percent over the last 14 days, according to a New York Times database. Still, the death rate — averaging about 50 deaths per day in the last week — is far lower than it was in the spring, when the figure averaged more than 1,000 per day. Nonetheless, dozens of cities and regions across the country are preparing to enforce new restrictions on Monday, in an attempt to stem the rising tide of infections.

The French authorities have placed a number of cities, including Paris, Lyon and Bordeaux, on a “reinforced alert” level, which, starting on Monday, will restrict public gatherings to no more than 10 people. Bars will have to close early and enclosed sports establishments must shut down completely.

Meanwhile, hospitals are again under strain, with some 600 new Covid-19 hospitalizations each day since mid-September. Covid-19 patients now represent at least 10 percent of patients in intensive care across the country.

In recent months, France has ramped up its testing policy, with more than one million tests conducted per week, about five times more than in April. But French laboratories lack the capacity to keep up with the number of tests carried out, resulting in a backlog of tests that have hampered France’s strategy for preventing a second outbreak.

On Saturday, two Nobel Prize-winning economists suggested in Le Monde newspaper that France impose a national lockdown for most of December in order to allow families to gather safely for the end-of-year holidays and “save Christmas.”

Mr. Véran reacted by saying that a lockdown was not part of the government’s plans so far: “We do not rule out any option, but we do not plan for the lockdown option, we act to prevent it.”

U.S. airlines warn they will furlough tens of thousands of workers.

With the federal payroll support program stuck in the broader congressional stalemate over stimulus, U.S. airlines have warned that tens of thousands of their employees face being furloughed soon.

Additional aid for airlines is expected to be part of a new $2.4 trillion stimulus bill that Speaker Nancy Pelosi and other Democrats are developing in the House, the first sign of movement since the tortured negotiations between Democrats and the White House stalled in early August.

But the prospects for the bill to pass in time to forestall furloughs are unclear.

Airlines have been battered by the pandemic, as business travelers continue to work remotely and avoid unnecessary air travel. The airlines’ warnings of financial stress and the prospects of large numbers of layoffs stem from that reality, but they also serve as pressure on Congress and the Trump administration to strike a deal.

Doug Parker, the chief executive of American Airlines, suggested on Sunday that a new round of help was possible. “There is enormous bipartisan support for it,” he said on the CBS program “Face the Nation.” “We have Republicans, Democrats, the administration, all saying and knowing this is the right program, that it makes sense, that, indeed, it should be extended because airline employees provide critical infrastructure. And once we furlough those employees, it is really hard, for example, to get pilots back in training.”

U.S. passenger airlines received $25 billion to help pay workers under a March legislative package, with American Airlines alone receiving $5.8 billion.

On Friday, American Airlines said that it would take a $5.5 billion loan from the Treasury Department as part of funding made available to carriers through the government’s economic stimulus plan, and that it expected the loan to grow to $7.5 billion next month. United Airlines is expected to take out a similarly sized loan, though Southwest Airlines and Delta Air Lines declined the funding.

GLOBAL ROUNDUP

Melbourne further eases its lockdown as cases drop faster than expected.

Efforts to combat the virus in the Australian state of Victoria are “ahead of schedule,” Premier Dan Andrews said on Sunday, as he announced a further easing of restrictions after two months of a severe lockdown in Melbourne, the state capital.

The curfew in Melbourne, the country’s second-largest city, will be lifted starting at 5 a.m. Monday, said Mr. Andrews, who denied it was because of a looming legal challenge. Child care facilities will reopen, and outdoor public gatherings of up to five people from two different households will be allowed. Primary students will return to school starting Oct. 12.

Melbourne residents are still required to stay at home except for care or caregiving, essential shopping, exercise and work or education that cannot be done from home. Restaurants and cafes remain closed for dine-in service. Other rules have been tightened, with fines for unlawful indoor or outdoor gatherings of almost 5,000 Australian dollars, or about $3,500, and residents now required to wear fitted face masks rather than scarves or bandannas.

The rolling 14-day average of new cases in Melbourne — which was over 400 at the height of the city’s outbreak last month — is now 22.1, well below the target of 30 to 50 for taking this second step out of lockdown. If the decline in cases continues, Mr. Andrews said, all restrictions on leaving home could be lifted on Oct. 19, a week earlier than planned.

“It’s a remarkable thing — and an achievement that belongs to every single Victorian,” he said. “Because with grit and with guts and with heart, we are beating this thing. We are driving it down. We are winning.”

On Monday, Victoria reported five new cases, the lowest since mid-June.

In other global developments:

  • With positive coronavirus tests reaching new highs, the number of critically ill threatening to overload intensive care wards and hospitals reporting alarming numbers of younger patients, officials in Israel pleaded with the public on Sunday to heed lockdown measures heading into Yom Kippur, the holiest day on the Jewish calendar.

  • In Madrid, about 1,000 protesters took to the streets on Sunday to demand an end to a partial lockdown imposed by the regional government last Monday on about a million residents of specific neighborhoods, most of them in working-class suburbs. While the Madrid authorities have argued that the lockdown is needed to contain a second wave of infections, the decision has spurred protests and outrage among residents who consider it discriminatory. That viewpoint was bolstered on Friday when Spain’s health minister, Salvador Ila, said that Madrid should instead have introduced stricter restrictions across the whole capital region.

  • Britain could end up “caught in a cycle of epidemic waves” without further restrictions, a member of the government’s scientific advisory board has warned. The adviser, Jeremy Farrar, wrote in The Times of London that tightened measures announced by Prime Minister Boris Johnson this past week were a “fudge” and would “neither deliver an open economy nor save lives.” Mr. Farrar called for a ban on people from different households meeting indoors, and said another closure of restaurants, pubs, gyms, places of worship and nonessential shops should also be considered as the country tries to arrest a steep climb in infections.

  • South Korea on Sunday called for a joint investigation into the death of a South Korean official who was killed by North Korean troops who discovered him floating in North Korean waters. South Korea said that the official was trying to defect and that the troops shot him and set his body on fire on the unsubstantiated fear that he might be infected with the virus. The North disputes key parts of that account. “Since there are gaps in the findings by South and North Korea, we request a joint investigation so we can establish the truth as soon as possible,” said Suh Choo-suk, a deputy director of national security in South Korea​.

‘Voilà, I’m trying to hang in there.’ One French Open player feels fortunate just to be playing.

At a cold and drizzly opening day at the French Open, one player was relieved just to be in the tournament: Benoit Paire of France.

Paire, a flashy French shot maker with a hipster’s beard, was forced to withdraw from the United States Open last month after testing positive for the coronavirus. He had to isolate in his Long Island hotel room for 10 days before returning to Europe. Eleven other players and coaches had to quarantine in the same hotel because of close contact with him.

He tested positive again at an event in Hamburg, Germany, last week but was allowed to play by German health officials who deemed him less of a risk but still restricted him most of the day to his hotel room.

Paire then tested negative in Paris, permitting him to take the court on Sunday. He defeated Kwon Soon-woo of South Korea, 7-5, 6-4, 6-4.

Paire said his preparation for the French Open had been compromised and that he was frustrated that coronavirus protocols often varied between countries. “I feel if on tour it’s going to be one day you can play and another you cannot because of a test, it’s not very fair,” he said. “Physically I’m not at my best, of course. Mentally it’s tough, but voilà, I’m trying to hang in there.”

The delayed tournament begins as the coronavirus is on the rise again in France. The second wave forced organizers to scale back their grand plans for a nearly full house to a meager 1,000 spectators per day on the entire grounds of Roland Garros Stadium.

Philanthropy has shifted since the start of the pandemic and the death of George Floyd.

Charitable giving has increased this year and also gone in new directions, as donors big and small responded first to the pandemic and then to social justice causes after the killing of George Floyd in May.

Foundation Source, which advises smaller corporate and family foundations, recently surveyed its members and found that 39 percent of respondents had shifted their foundations’ missions in response to the events of this year, while 42 percent had increased their giving.

“We’ve seen a change in behavior,” said Stefanie Borsari, the national director of client services for Foundation Source. “Of the top reasons that people shifted their mission or focus,” she added, “the biggest was certainly Covid, but about a third of respondents also noted social justice concerns.”

A June report from Fidelity Charitable, the largest grant maker in the United States, said that grants to food assistance programs were up 667 percent nationally, but that donors had continued to give to their regular charities.

What smaller foundations and individual donors have often lacked, though, is information on which nonprofits in which communities would best use their donations. Two new philanthropic databases are aiming to fill that breach by highlighting nonprofits that are addressing social justice and pandemic issues.

The first, Give Blck, which went online Friday, aims to call attention to Black-founded nonprofits that have been little known or are too small to be highlighted by some of the leading philanthropic rating services. The second is an interactive map created by Vanguard Charitable, the mutual fund company’s donor-advised fund arm. It is set to be released next month.

For generations, snow days meant sleeping in, loafing in front of the TV with hot cocoa, and hours of sledding and snowball fights.

Now, they are likely to mean logging into a laptop for a Zoom lesson on long division.

As the weather cools and winter looms, many school leaders in snow-prone states are preparing teachers, parents and students to say goodbye to snow days. This month, New York City, the nation’s largest school system, canceled them for the year, citing the pandemic, which has forced districts everywhere to look for ways to make up lost days.

New York’s decision followed moves that other administrators have been making since last March, when schools were forced to transition to online learning and officials realized they could do the same during hazardous weather.

“We said, ‘Wow, this could really be a solution for us for snow days in the future,” said Robb Malay, a school superintendent who oversees seven districts in southern New Hampshire.

For many teachers, the end of the snow day looks inevitable, said Denis Anglim, 31, who teaches high school English and history in Philadelphia.

“For the sake of continuity of the curriculum, it’s a good thing,” he said. “But not in terms of hanging on to the nostalgia of waking up at 5 a.m. and looking at the ticker at the bottom of the television to see if your school will be closed.”

Reporting was contributed by Ellen Barry, William J. Broad, Alexander Burns, Damien Cave, Choe Sang-Hun, Christopher Clarey, Emily Cochrane, Maria Cramer, David M. Halbfinger, Jennifer Jett, Sapna Maheshwari, Apoorva Mandavilli, Jonathan Martin, Constant Méheut, Raphael Minder, Zach Montague, Anna Schaverien, Eileen Sullivan, Paul Sullivan, Lucy Tompkins and Julie Turkewitz.





First Published at www.nytimes.com on 2020-09-27 17:30:31

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