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.
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.
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.”
Even a state as spread out as Montana can be vulnerable to a spike in cases.
The coronavirus is surging in one of the most rural states in the country, Montana, whose population is so scattered that Billings is the only city in the state that can claim more than 100,000 residents.
Daily reports of new cases in the state have more than doubled in the last two weeks to an average of 250 a day, according to a New York Times database — shattering records and raising concerns that the state’s hospitals could become overwhelmed.
Other states in the Mountain West and northern Great Plains are also experiencing surges, including Wyoming, Utah and North Dakota.
The impact of the coronavirus in Montana had been relatively mild until recently. While coastal cities like Seattle and New York were experiencing major outbreaks in April and May, Montana’s case curve had an almost imperceptible bump.
Now, Montana is reporting three times as many cases a day as King County, Wash., which includes Seattle and has twice Montana’s population. Almost half the state’s total 171 deaths from Covid-19 have come in the past month, and hospitalizations are up sharply.
Some of the surge can be attributed to outbreaks in prisons and nursing homes, settings that have been proven vulnerable in rural and urban states alike. But state experts also point to the recent reopening of schools and universities and the beginning of sports practice.
Cases among school-age children have increased by more than 90 percent since the first week of September, Stacey Anderson, the state’s lead epidemiologist, told reporters on Tuesday.
Montana is home to seven Indian reservations, which have fought to keep the virus out but are now seeing worrying increases in cases. The Blackfeet Nation, which closed its border with Glacier National Park over the summer to keep tourists who might be carrying the virus from driving through, imposed two-week quarantines on two of its towns last week because of upticks in cases.
State officials pleaded with residents to help spare Montana from the heavy toll the virus has taken in denser, more populous states like Texas or Florida, by obeying the state’s mask mandate and social distancing guidelines.
“We have a unique opportunity here in Montana, by our location and by learning from others around us,” said Greg Holzman, the state medical officer. “We don’t have to have those outcomes here.”
Vermont’s population is exploding, and its small towns are struggling to keep up.
In towns like Winhall, which had a year-round population of 769 before the pandemic, that is not the problem anymore.
Instead, officials are hard-pressed to keep up with the burst of growth.
Elizabeth Grant, the town clerk, reckons that the town’s population topped 10,000 over the summer. When school reopened this month, the number of enrolled students had increased by 54, a jump of more than 25 percent, so the costs to taxpayers will exceed projections by half a million dollars.
The post office ran out of available P.O. boxes in mid-June. Electricians and plumbers are booked until Christmas. Complaints about bears have quadrupled.
Real estate agents in town knew something was up in late April, when Gov. Phil Scott began cautiously reopening businesses.
Since then, the number of available single-family homes in Winhall and Stratton, the adjacent ski resort, has dropped to 29 from 129, its lowest level since 2003, according to Tim Apps, a realtor with the Vermont Sales Group.
Now the question is whether the newcomers will stay, since many of their companies allowed remote working only on a temporary basis.
Officials will have a better sense of how many people have moved into the state in a few weeks, after gathering figures on school enrollment, which had been steadily declining in Vermont for a decade. They expect an increase of 2 to 5 percent statewide, and as much as 15 percent in some towns, said Michael S. Pieciak, commissioner at the state Department of Financial Regulation.
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.
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.
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.
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 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, Damien Cave, Choe Sang-Hun, Christopher Clarey, Maria Cramer, David M. Halbfinger, Jennifer Jett, Apoorva Mandavilli, Constant Méheut, Raphael Minder, Zach Montague, Anna Schaverien, Eileen Sullivan, Paul Sullivan and Lucy Tompkins.
