The Food and Drug Administration on Sunday authorized the emergency use of blood plasma from people who have recovered from coronavirus infections for the treatment of patients hospitalized with Covid-19.
The decision, which was delayed after top federal scientists urged further study of the treatment, was praised by President Trump at a news conference in which he said plasma was “very effective,” even though no rigorous clinical trials have proven that it works.
The president’s endorsement notwithstanding, convalescent plasma, however promising, has not been proven to work in randomized clinical trials, considered the best way of determining whether a treatment is effective.
Although Mr. Trump said the new approval would “dramatically expand access” to the treatment, convalescent plasma cannot be easily scaled up into millions of doses like manufactured drugs, because it is derived from blood donations.
Still, many researchers have seen it as a potential bridge until a more effective treatment becomes available, or a vaccine.
On a call earlier in the day with reporters, the commissioner of the Food and Drug Administration, Dr. Stephen M. Hahn, said
that information from studies conducted this year showed that the treatment was safe and had the potential to be helpful. However, he added that the agency would continue working with researchers studying the treatment and update the authorization as appropriate.
But enrollment in randomized trials — at least 10 such studies have begun in the United States — have faltered, collectively enrolling only a few hundred people.
The agency’s decision Sunday was based mostly on an analysis of preliminary data. A previous authorization for the use of chloroquine and hydroxychloroquine was rescinded based on the findings of subsequent studies.
The authorization contains guidance for doctors on which patients should be considered. Dr. Peter Marks, the director of F.D.A.’s center for biologics, evaluation and research, said on the call that those who were treated “within three days of being diagnosed, with plasma that contained high levels of antibodies, as compared with lower levels of antibodies appeared to benefit more from this treatment than others. And those that seemed to benefit the most were those who were less than 80 years of age who were not on a respirator.”
The F.D.A.’s announcement had been expected to come sooner, but an intervention by top scientists, including Dr. Anthony S. Fauci, led to a delay that seemed to have angered President Trump. On the call, Dr. Hahn said that the decision to authorize the treatment was made “solely on the basis of the science and the data and on nothing else.”
During the Sunday news conference, however, Mr. Trump 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.”
Then, turning to Alex M. Azar II, the secretary of health and human services, Mr. Trump said there were people in “your larger department” who “can see things being held up and wouldn’t mind so much — that’s my opinion, my very strong opinion — and that’s for political reasons.”
Trump administration officials met with congressional leaders last month and told them they would probably give emergency approval to a coronavirus vaccine before the end of Phase 3 clinical trials in the United States, perhaps as early as late September, according to two people briefed on the discussion.
The move would be highly unusual and would most likely prompt concerns about whether the administration is cutting corners on approvals for political purposes.
The two-hour meeting involving Treasury Secretary Steven Mnuchin; the White House chief of staff, Mark Meadows; House Speaker Nancy Pelosi; and Senator Chuck Schumer, the Democratic leader, took place on the evening of July 30 in Ms. Pelosi’s conference room.
During the discussion, the people briefed on it said, Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate.
The projected timeline shows the administration’s hopes for a major victory against the pandemic before the election. It also suggests that officials have high expectations for the results of overseas drug trials, which began ahead of domestic ones.
Senior administration officials disputed the account, saying Mr. Meadows and Mr. Mnuchin were either being misrepresented or had been misunderstood on every major point.
The AstraZeneca-Oxford team is now conducting Phase 2 and Phase 3 trials in the United Kingdom, Brazil and South Africa. Researchers have said they expect results by September, at the earliest. Along with a number of other pharmaceutical companies, AstraZeneca has also begun large-scale trials in the United States, although it began enrolling volunteers only a few days ago.
The Food and Drug Administration typically requires clinical trials with American patients before approving vaccines for use in this country.
The administration officials’ comments at the meeting suggest that the White House is significantly more sanguine about the prospects for a speedy vaccine against a virus that has killed 176,000 Americans than its own scientific experts.
In an Aug. 13 briefing with reporters, Francis Collins, the director of the National Institutes of Health, said it “would be astounding” if the vaccine development progressed fast enough for the Food and Drug Administration to approve one by the end of next month. “Maybe November, December would be my best bet,” he said.
Dr. Anthony S. Fauci, the infectious disease expert who serves on the coronavirus task force, has said early next year is the most likely timing.
Mr. Trump has seen his political fortunes plummet over deep unhappiness among voters about how he and his administration have handled the pandemic, which his Democratic opponent, former Vice President Joseph R. Biden Jr., has made a central focus of his campaign.
A White House spokeswoman did not immediately respond to a request for comment.
One senior administration official who was briefed on the meeting said neither Mr. Meadows nor Mr. Mnuchin had suggested a vaccine could be approved as early as late September. The official was adamant that the administration would not approve a vaccine solely on the basis of foreign clinical trials.
A spokesman for Mr. Meadows disputed that he discussed AstraZeneca’s prospects. Neither did Mr. Mnuchin, according to the Treasury Department spokeswoman.
It was with great fanfare that President Vladimir V. Putin and other officials announced this month that a billion doses of a Russian vaccine for the coronavirus would soon be rolled out.
But if they imagined themselves taking bows now for saving the world, Russian health officials instead are finding themselves on the defensive.
“Some foreign colleagues, who must have felt certain competition and competitive edges of Russia’s product, have been trying to express opinions that we find totally groundless,” the minister of health, Mikhail Murashko, said at a news conference in Moscow.
Skeptics have noted that the vaccine, which the Russians call Sputnik V, has not been tested in the sort of late-stage, large, randomized control trials that are critical in establishing safety and effectiveness. By skipping such trials, Russia may be endangering people to score propaganda points, health experts warn.
“If we wanted to take the chance of hurting a lot of people or giving them something that doesn’t work, we could start doing this, you know, next week if we wanted to,” said Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases.
Aleksandr Gintsburg, the director of the Gamaleya Institute, the scientific body that designed the vaccine, said the pushback was merely “a fight for market share.”
The world’s major powers are racing to produce vaccines that, if successful and accepted by their own citizens and other countries, will bring not just prestige but geopolitical and economic benefits for the winner. The United States has poured billions of dollars into an effort called Operation Warp Speed.
Florida and Texas on Sunday became the second and third states to surpass 600,000 reported cases since the beginning of the pandemic, according to a New York Times database. The two states joined California, which crossed that threshold on Aug. 14
Texas, with more than 5,000 daily cases recorded during the past week, reached 600,099 cases Sunday.
Texas and Florida, which are the second and third most populous states behind California, experienced a surge of infections this summer after state officials eased lockdown measures.
New cases in all three states, however, have been decreasing in recent weeks, with Florida recording a 40 percent drop in its seven-day average compared to the average two weeks earlier. The decline in Texas has been less dramatic, with a 22 percent decrease during the same period. The caseload decrease in California was 7 percent.
Reported deaths, however, still remain high in all three states. Florida recorded 106 new deaths on Saturday, for a total of 10,324 since the beginning of the pandemic. Texas had 167 deaths, for a total of 11,650, and California counted at least 153 new deaths on Aug. 22, for a total of 12,141.
As bikers prepared to inundate the South Dakota city of Sturgis earlier this month, there were warnings that the motorcycle rally, a two-week event that attracts hundreds of thousands of people annually, could spur the spread of the coronavirus.
In the days since it ended last Sunday, there are troubling signs that it did.
On Tuesday, South Dakota health officials announced that a patron who spent five hours at One-Eyed Jack’s Saloon during the rally had since tested positive for the virus. On Thursday, they said an employee of a tattoo parlor who had worked five 16-hour shifts in five days had also tested positive. Then on Friday, the news arrived that another person who patronized three local saloons had also tested positive.
And public health officials in two neighboring states, Minnesota and Nebraska, attributed dozens of cases to the rally and warned people who had attended to monitor themselves for symptoms and get tested.
Even before the first bikers arrives for the rally, cases in South Dakota had slowly been trending upward.
At the beginning of July, the state was averaging 52 cases a day; by Saturday the average over the previous 7 days had reached 145, according to a New York Times database. And the state set a record Saturday with 251 new coronavirus cases.
Gov. Kristi Noem, a Republican, never issued a stay-at-home order and has refused to sign a statewide mask ordinance. She also hosted President Trump’s Independence Day rally at Mount Rushmore, a packed event without social distancing and with few masks.
Large gatherings have continued, and have even been encouraged by local officials throughout the state despite repeated incidents.
Attendees at the Sitting Bull Stampede Rodeo in Mobridge in July, a Big & Rich Concert in Sioux Falls at the beginning of August and now the Sturgis motorcycle rally have tested positive for the virus.
In a statement Sunday, the South Dakota Department of Health said “there have been less than 40 cases associated with the rally.”
In China, where the pandemic began, life is starting to look normal. Check out the pool party.
In Shanghai, restaurants and bars in many neighborhoods are teeming with crowds. In Beijing, thousands of students are heading back to campus for the fall semester. In Wuhan, where the coronavirus emerged eight months ago, water parks and night markets are packed elbow to elbow, buzzing as before.
While the United States and much of the rest of the world are still struggling to contain the virus, life in many parts of China has in recent weeks become strikingly normal. Cities have relaxed social distancing rules and mask mandates, and crowds are again filling tourist sites, movie theaters and gyms.
“It no longer feels like there is something too frightful or too life-threatening out there,” said Xiong Xiaoyan, who works at a paint manufacturer in the southern province of Guangdong.
Now, after months of travel restrictions and citywide testing drives, locally transmitted cases of the virus in China are near zero, according to official data. On Sunday, China reported no new locally transmitted cases for the seventh consecutive day. The 12 new infections it reported were all imported, bringing China’s total number of confirmed cases to 84,951, with at least 4,634 deaths.
China could still face a Covid-19 resurgence, experts warn, especially as the weather cools and people spend more time indoors.
“They still need to be cautious,” said David Hui, the director of the Stanley Ho Center for Emerging Infectious Diseases at the Chinese University of Hong Kong. “Mass gatherings and mass celebrations should not be encouraged.”
With Hurricane Marco and Tropical Storm Laura continuing to churn in the Caribbean this weekend, prompting warnings and watches for several countries, Gov. John Bel Edwards of Louisiana has urged residents to be mindful of the pandemic as they made their emergency preparations.
“Covid-19 does not become less of a threat because of tropical weather,” said Mr. Edwards, who advised people to include face masks and hand sanitizer in their emergency kits.
Still, the governor also announced that state virus testing sites would close on Monday and Tuesday.
The governor declared a state of emergency on Friday, and requested a federal emergency declaration from the White House on Saturday, as he warned that Marco and Laura were forecast to affect the state in quick sequence early this week.
Marco was aexpected to strengthen to bring dangerous storm surges to the Gulf Coast, and is on track to approach southeastern Louisiana on Monday.
On Sunday, Laura was lashing parts of the Dominican Republic and Haiti with heavy rains and “life-threatening” flash flooding, the center said. Laura’s center is forecast to move near or over Cuba as it crosses the southeastern Gulf of Mexico.
The storm is expected to produce three to six inches of rain in Puerto Rico and the U.S. Virgin Islands, with some areas getting as much as eight inches, the hurricane center said. Cuba is expected to receive similar rainfall amounts. The Dominican Republic and Haiti may get up to eight inches of rain, with as much as 12 inches across the southern areas.
Dennis Feltgen, a meteorologist with the National Hurricane Center, quashed public speculation that the storms would collide and form a single monster storm. “They cannot merge,” he said. “They actually repel each other because of the rotations.”
Inmates from state prisons have helped California fight fires for decades, playing a crucial role in containing the blazes striking the state with more frequency and ferocity in recent years.
This past week, though, hundreds of inmate firefighters were absent from the fire lines. They had already gone home, part of an early release program initiated by Gov. Gavin Newsom to protect them from the coronavirus.
That has highlighted the state’s dependence on prisoners in its firefighting force and complicated its battle against almost 600 fires, many of which continued burning across Northern California this weekend.
The virus has exposed countless examples of inequality across the United States, and the use of inmate firefighters shows how the pandemic’s consequences have reached deep into unexpected corners of society. In California, the presence of inmates has been the difference between having the resources to save homes from wildfires — or not.
To critics, the prison program is exploitative and should be replaced with proper public investment in firefighting. To others, it is an essential part of the state’s response to what has become an annual wildfire crisis.
Across the United States there have been 112,436 infections of inmates and correctional officers, and 825 have died, according to a New York Times database. In four of the six prisons that train incarcerated firefighters, there have been more than 200 infections each among inmates and staff members, according to the database.
The state’s main firefighting agency is pleading for more personnel, and Mr. Newsom has requested more firefighters from as far away as the East Coast and Australia.
After travelers reported wait times of up to 12 hours at Austria’s southern border with Slovenia overnight because of restrictions aimed at slowing the coronavirus, the Austrian authorities loosened the controls on Sunday morning.
An enormous traffic jam had formed as many Central and Western Europeans returned from vacations in the Balkans by car. Those in each vehicle, including people passing through Austria to other countries, were required by the Austrian health authorities to stop and fill out a registration form.
One vacationer from Bavaria, in southern Germany, told the German news media that he had arrived at the congested border at 5:30 p.m. on Saturday and then not been able to enter Austria until 7:30 a.m. on Sunday.
Caught off guard, the Slovenian and Austrian authorities did not provide assistance to stuck drivers, and the atmosphere during the wait grew tense and aggressive, according to Austrian media reports. Before the pandemic, the border was mostly open, with many drivers not even having to slow down when crossing the national border.
On Sunday morning, the governor of the Austrian state of Kärnten ordered border police officers to perform only spot checks at the crossing, which quickly reduced the wait time.
Austria reported 265 new coronavirus cases on Friday; Germany, to which many of the travelers caught up in the border delay were returning, recorded 2,034 new cases.
Nearly 40 percent of infections currently registered in Germany are thought to have been brought back by returning vacationers.
Restaurants in New York City, which were devastated by the pandemic shutdown in the spring, remain in crisis as a ban on indoor service continues, despite nearly 10,000 eateries having set up outdoor seating since July.
Though outdoor dining has been a hit with patrons and provided a tenuous lifeline, restaurant owners say they are operating at a fraction of regular seating capacity. Many remain open only because of the federal paycheck protection program, which supports payroll, and because they have not paid full rent in months.
Hanging in the balance is a vital New York City industry that before the pandemic employed more than 300,000 people, including recent immigrants, musicians, artists, writers and actors who help define the city as a cultural hub.
Last week, New York City restaurants were doing about 23 percent of last year’s volume in terms of people seated, according to data from Resy, the reservation app. The previous week it was 18 percent. In mid-July, it was 10 percent.
Gabriel Stulman said that Bar Sardine, one of his nine Manhattan restaurants, was doing 30 percent of normal business and that its landlord had refused to negotiate on rent. Without additional government relief, he predicted that many restaurants would close in the coming months if indoor dining remains barred.
“I don’t want to be dramatic, but this is apocalyptic for the industry,” he said. “If it’s not safe to open, I understand that — I’m a team player. But you got to do something about my rent, my payroll. You got to answer these questions.”
Ireland’s fragile governing coalition was in turmoil this weekend in the wake of a parliamentary golf club dinner that was held in violation of the country’s social distancing guidelines and resulted in several high-profile resignations.
The coalition parties’ leaders said they had agreed to recall Parliament early from its six-week summer recess to deal with the matter, and that Prime Minister Micheal Martin would make a formal request to the legislature on Monday.
The Golf Society event, held on Wednesday in a hotel in western Ireland, was attended by more than 80 guests, despite rules limiting most indoor gatherings to 50 people.
Among those in attendance was Phil Hogan, a longtime Irish lawmaker who is the European Union’s trade commissioner — a position that puts him at the forefront of the bloc’s Brexit negotiations with Britain, one of Ireland’s most significant trading partners.
Both Mr. Martin and the leader of Mr. Hogan’s party, Deputy Prime Minister Leo Varadkar, have urged the commissioner to “consider his position” after attending the Golf Society dinner.
The governing coalition, formed in June four months after a tight election, is the first time in Ireland’s history that its two main political parties have forged an alliance, having been staunch rivals since their formation after the country’s civil war nearly a century ago.
The Golf Society dinner has already led to the resignation of the agriculture minister, Dara Calleary, and the deputy chairman of Ireland’s Senate, Jerry Buttimer, both of whom were in attendance. Also present was a Supreme Court judge.
The head of Ireland’s state tourism agency also resigned last week after it was revealed that he had gone on vacation in Italy, despite a marketing campaign from his own agency urging people not to take trips abroad.
Ireland had reported nearly 28,000 coronavirus cases as of Sunday morning, and over 700 deaths.
Why antibody tests may not help you much.
Many tests are inaccurate, some look for the wrong antibodies, and even the right antibodies fade away, said experts at the Infectious Diseases Society of America, which issued the guidelines.
Because current tests cannot determine whether someone is immune, the society said, they “cannot inform decisions to discontinue physical distancing or lessen the use of personal protective equipment.”
With few exceptions, antibody testing should be used only for population surveys, not for diagnosing illness in individuals, the panel said.
Moreover, “if you live in a low-prevalence area, you have a much higher likelihood of getting a false-positive test, meaning you may think you are protected but you aren’t,” said Dr. Angela M. Caliendo, a testing expert at Brown University’s Alpert Medical School and a member of the society’s expert panel.
Despite the flaws of antibody tests, recent studies of patients who definitely were infected suggest that they have long-lasting immunity and that it is very unlikely that they will become reinfected.
That may be because white blood cells known as B and T cells, which are “primed” to recognize and attack the coronavirus, remain in circulation long after antibodies have faded away. B and T cells are not analyzed by common antibody tests.
Reporting was contributed by Nicholas Bogel-Burroughs, Derrick Bryson Taylor, Nicholas Fandos, Tess Felder, Sheri Fink, Thomas Fuller, Rebecca Griesbach, Maggie Haberman, Rebecca Halleck, Javier C. Hernández, Andrew Jacobs, Sharon LaFraniere, Sharon Otterman, Elisabetta Povoledo, Katie Rogers, Christopher F. Schuetze, Katie Thomas, Maura Turcotte, Albee Zhang and Karen Zraick.