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The F.D.A. approves plasma treatment, as Trump claims the agency is undercutting him.
The Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.
Mr. Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the United States and left the nation lagging far behind most others in the effectiveness of its response.
At a news briefing, he described the treatment as “a powerful therapy” made possible “by marshaling the full power of the federal government.”
The decision will broaden use of a treatment that has already been administered to more than 70,000 patients. But the F.D.A. cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Mr. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.
Mr. Trump has portrayed his demands to cut red tape and speed approval of treatments and vaccines as a necessary response to a public health emergency.
But Sunday’s announcement came a day after he repeated his unfounded claim that the F.D.A. was deliberately holding up decision-making until after the election, this time citing a “deep state.” That accusation exacerbated concerns among some government scientists, outside experts and Democrats that the president’s political needs could undermine the integrity of the regulatory process, hurt public confidence in safety and introduce a different kind of public health risk.
No randomized trials of the sort researchers consider most robust have yet shown benefit from convalescent plasma. But the F.D.A. said the data it had so far, including more than a dozen published studies, showed that “it is reasonable to believe” that the treatment “may be effective in lessening the severity or shortening the length of Covid-19 illness in some hospitalized patients,” in particular those who receive it early.
White House officials have been urging speedy approval not just of Covid-19 treatments, but of vaccines. Their public statements that a safe and effective vaccine could be just around the corner have alarmed scientists who fear that White House pressure will result in premature approval timed to increase the president’s re-election chances.
In a July 30 meeting with Speaker Nancy Pelosi and Senator Chuck Schumer of New York, the Democratic minority leader, top administration officials suggested that emergency approval for a vaccine might be granted before Phase 3 trials in the United States are complete, perhaps as early as September, according to two people briefed on the discussion. Such a move would be highly unusual and most likely prompt more concern about whether the administration was pressuring the F.D.A. to approve drugs for political purposes.
Senior administration officials disputed the account of the meeting, saying Mark Meadows, the White House chief of staff, and Treasury Secretary Steven Mnuchin were either being misquoted or had been misunderstood on every major point.
In Russia, President Vladimir V. Putin announced this month that a billion doses of a vaccine for the new coronavirus would soon be rolled out, but Russian health officials have found themselves on the defensive because the vaccine has not been tested in late-stage, large, randomized control trials.
By skipping such trials, Russia is potentially endangering people to score propaganda points, health experts warn.
The layoffs are coming anyway.
A tsunami of job cuts is about to hit Europe as companies prepare to carry out sweeping downsizing plans to offset a collapse in business. Government-backed furlough programs that have helped keep about a third of Europe’s work force financially secure are set to unwind in the coming months.
As many as 59 million jobs are at risk of cuts in hours or pay, temporary furloughs or permanent layoffs, especially in industries like transportation and retail, according to a study by McKinsey & Company.
Governments are warning that millions will soon lose paychecks, and the European Central Bank last week said unemployment was likely to surge and stay high even when a recovery from the pandemic unfolds.
“Europe has been successful at dampening the initial effects of the crisis,” said John Hurley, senior research manager at Eurofound, the research arm of the European Union. “But in all likelihood, unemployment is going to come home to roost, especially when the generous furlough programs start to ease off.”
“There’s going to be a shakeout,” he added, “and it’s going to be fairly ugly.”
Compared with the United States, which lost more than 20 million jobs in April alone, the furlough programs in the European Union have prevented unemployment from going off the charts. Britain, Denmark, France and Germany are among the countries that have employed so-called short-work schemes, effectively nationalizing the paychecks of about 60 million private-sector employees.
But even before a recent resurgence of coronavirus cases, the pandemic’s economic damage was growing, and it now appears those expensive government programs postponed, rather than prevented, the pain for some workers. Some companies believe the disruption is the best time to move forward on long-contemplated downsizing.
Airbus, BP, Renault, Lufthansa, Air France, the Debenhams department store chain, Bank of Ireland, the retailer W.H. Smith and even McLaren Group, which includes the Formula One racing team, along with countless smaller businesses, are among those planning cuts that will sweep factory workers, retail employees, and high-paid white-collar workers into the ranks of the unemployed.
In other developments around the world:
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Prime Minister Jacinda Ardern on Monday extended a lockdown in Auckland, New Zealand’s largest city, until Sunday night. The restrictions had been set to expire on Wednesday, but Ms. Ardern said the extra time was necessary to ensure that a virus cluster in Auckland had been brought under control. Eight new confirmed or probable cases connected to the cluster were announced on Monday, bringing the total to 101. The prime minister also said masks were now mandatory on public transportation nationwide.
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The first volunteer was inoculated with a “made in Italy” vaccine on Monday at Spallanzani hospital in Rome, which specializes in infectious diseases. The vaccine is produced by ReiThera, a biotechnology company based near Rome but headquartered in Switzerland. Francesco Vaia, the medical director of the Spallanzani, said that, if all went well, the vaccine would be produced next spring.
After tests and temperature checks, 336 delegates representing 50 states, five territories and Washington, D.C., will gather in Charlotte, N.C., on Monday to officially renominate President Trump, the only in-person event of either political party’s quadrennial convention.
Under the state signs that typically dot a convention floor, representatives from each state and territory will have one minute to sing their praises for their home state and for the president in what will look like a fairly traditional convention roll call.
There will be some reminders of the coronavirus era. The microphone will be cleaned after every speaker. And masks will be required until the person representing his or her state steps up to the microphone, according to a person briefed on the protocols.
What may be lacking will be the electric feel of a typical convention floor. Just six representatives from each state and territory will be in the room, and they will be masked and seated at a distance from one another. The big highlight of the day is a speech by Mr. Trump himself, who will appear on every night of the convention. Vice President Mike Pence is also expected to fly in and address the delegates.
It will be a stark contrast to how the Democrats conducted their virtual roll call last week, featuring videos filmed across the country that highlighted local landmarks.
For 40 days, millions of people in the western Chinese city of Urumqi have been unable to leave their homes after the authorities put in place a sweeping lockdown to fight a resurgence of the coronavirus.
Now, with the outbreak seemingly under control but the restrictions still largely in place, many residents of Urumqi, the capital of the Xinjiang region, are lashing out at the government. They say they are being unnecessarily confined to their homes and denied access to critical services like health care.
“Is this a prison or cage?” one user wrote on Weibo, a popular social media site. “Is this prevention or suppression?”
The mounting anger poses a challenge for the ruling Communist Party, which is trying to hold up its handling of the epidemic as a model for the world. The party has long taken a harsh approach in Xinjiang, and in recent years has been widely criticized for leading a draconian crackdown on the region’s Muslim minority.
The lockdown in Urumqi, employing many of the same extreme measures used in Wuhan, began in mid-July as dozens of people fell ill with the virus. In recent weeks, locally transmitted cases have dwindled; there have been no such cases for eight days, officials say.
As anger mounted online, the authorities in Urumqi, a city of 3.5 million, on Monday said they would ease restrictions in some districts, allowing residents to leave their homes and walk inside their apartment complexes, according to Chinese news reports. Officials did not say when the full lockdown would be lifted.
After coronavirus cases surged in June and July, the number of new reported cases in the United States began to level off, then drop, though the infection rate remains one of the world’s highest.
Of the states that are driving the decrease, all have at least some local mask mandates. And most have paused or reversed statewide reopening policies, again closing bars, gyms and theaters.
Many of the states with the biggest decreases per million people also had some of the country’s worst outbreaks in July.
Experts said that the drop in reported cases could not be attributed to the recent drop in testing volume. They explained that decreased hospitalizations and a lower share of positive tests indicated that the spread had most likely slowed.
A July surge in Florida affected young people in particular. Statewide bar closures following earlier reopenings and local mask mandates are among the policies that have helped reverse the trend, said Mary Jo Trepka, chair of the Florida International University epidemiology department. And though Florida is doing better now, the state did surpass 600,000 cases on Sunday.
Arizona and Louisiana have also seen cases drop after taking mask mandates and other measures came into force.
Reporting was contributed by Liz Alderman, Maggie Astor, Sheri Fink, Claire Fu, Maggie Haberman, Javier C. Hernández, Annie Karni, Andrew E. Kramer, Sharon LaFraniere, Lauren Leatherby, Elisabetta Povoledo, Katie Thomas and Albee Zhang.