Covid-19 Updates: White House Claims a ‘Therapeutic Breakthrough’ Is Coming



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 Britain, 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 the United States.

The administration officials’ comments at the meeting suggest that the White House is significantly more sanguine than its own scientific experts about the prospects for a speedy vaccine against a virus that has killed 176,000 Americans.

In an Aug. 13 briefing with reporters, Francis Collins, the director of the National Institutes of Health, said it “would be astounding” if 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.

President 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.

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 — has 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 the 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 Mr. 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.”

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 reported 110 new deaths on Sunday, for a total of 11,760, and California counted at least 164 new deaths over Saturday and Sunday, for a total of 12,152.

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.”

Many people feel trapped by the coronavirus pandemic. In Japan, some are distracting themselves by screaming inside closed caskets.

During 15-minute shows performed in Tokyo over the weekend, thrill seekers shrieked and trembled in glass caskets as they listened to ghost stories and the roar of chain saws. With nowhere to run, they were menaced by zombies, poked with rubber hands and splashed with water, all for less than $10 in admission.

The event was organized by Kowagarasetai, a horror event production company whose name means “Scare Squad.” But some customers said they actually left feeling more relaxed.

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.

About 160,000 people from the city’s bar and restaurant industry remain out of work, according to July federal employment data, and nearly 1,300 restaurants closed permanently between March and July.

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.”

In other New York developments:

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.

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, Tiffany May, Sharon Otterman, Elisabetta Povoledo, Katie Rogers, Christopher F. Schuetze, Katie Thomas, Maura Turcotte, Albee Zhang and Karen Zraick.



Sahred From Source link Health

Leave a Reply

Your email address will not be published. Required fields are marked *