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

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

Credit…Marco Bello/Reuters

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.”

As global deaths approach one million, new hot spots continue to emerge.

Credit…Adnan Abidi/Reuters

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 morning, the global total stood at 993,600, 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 Britain, Spain and France.

Health experts offer tips for keeping the coronavirus at bay indoors.

Credit…Michael Ciaglo/Getty Images

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.”

Concern clouds relief as a reopening Colombia passes 800,000 infections.

Credit…Raul Arboleda/Agence France-Presse — Getty Images

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 to 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 Bogotá’s mayor, 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.”

THE NEW YORK TIMES /

SIENA COLLEGE POLL

Joseph R.

Biden Jr.

Donald

Trump

49%

41%

Based on a New York Times/Siena

College poll of 950 likely voters

from Sept. 22 to Sept. 24.

THE NEW YORK TIMES / SIENA COLLEGE POLL

Based on a New York Times/Siena College poll of

950 likely voters from Sept. 22 to Sept. 24.

Joseph R. Biden Jr.

Donald Trump

41%

49%

THE NEW YORK TIMES /

SIENA COLLEGE POLL

Based on a New York Times/Siena College poll

of 950 likely voters from Sept. 22 to Sept. 24.

Joseph R. Biden Jr.

Donald Trump

41%

49%

Trump’s handling of 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 might 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, might threaten.

‘The virus has not disappeared. The epidemic has picked up again’: France battles its second wave.

Credit…Michel Euler/Associated Press

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 French media on Sunday. “The virus has not disappeared. The epidemic has picked up again.”

The number of Covid-19 deaths has risen by 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.

French authorities have placed a number of French 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 sport 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, or 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.”

GLOBAL ROUNDUP

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

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Premier Dan Andrews of the Australian state of Victoria said Melbourne’s curfew would end at 5 a.m. on Monday, and outdoor gatherings with a limit of five people from no more than two households would be allowed.CreditCredit…Asanka Ratnayake/Getty Images

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.”

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, Israeli officials 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 was needed to contain a second wave of infections, the decision has sparked 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​.

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

Credit…Kirsten Luce for The New York Times

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, 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 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.

Sorry, kids. Snow days are probably over.

Credit…Stephen Speranza for The New York Times

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.”

The French Open, forced to move to autumn, debuts some useful added features.

Credit…Anne-Christine Poujoulat/Agence France-Presse — Getty Images

The official poster for the 2020 French Open, which began Sunday and runs through Oct. 11, shows a view of a sunlit clay court through a dense ring of green leaves.

That poster was commissioned long before the start of this year’s tournament was postponed from May to September because of the pandemic.

If it were being painted for the French Open’s new dates, falling leaves and chestnuts would be more appropriate.

This is not the first time a major tennis event has been played at the Roland Garros stadium in Paris in the autumn. But none of the others ended in mid-October, and none of them had to deal with the coronavirus, which 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.

A happier change is the new retractable roof over the main Philippe Chatrier Court, which will allow play to continue if the forecast of frequent rain for Week 1 turns out to be correct.

The Chatrier court and the 11 other courts at Roland Garros have also been equipped with lights for the first time, which will allow play to continue after dark.

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

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