Live Updates: F.D.A. Plans to Announce Emergency Use of Coronavirus Drug

The F.D.A. plans to announce the emergency use of a virus treatment after a trial showed shortened recovery time.

The F.D.A. plans to announce as early as Wednesday an emergency use authorization for remdesivir, an experimental antiviral drug that is being tested in treating patients with Covid-19, the disease caused by the coronavirus, according to a senior administration official.

Before the announcement President Trump and Dr. Anthony S. Fauci, the federal government’s leading infectious diseases scientist, on Wednesday hailed early trial results of the drug, holding out hope that it could help stem the rising death toll.

Meeting with reporters at the White House, Dr. Fauci cautioned that the results of the study overseen by his agency, the National Institute of Allergy and Infectious Disease, still need to be properly peer reviewed but expressed optimism that it could make a difference in speeding up the recovery of some patients infected with the virus.

Another study, conducted in China and published in the Lancet, questioned the value of the drug for treatment of severely ill patients but left open the possibility that it might be useful for others. The research was incomplete, however, because not enough participants could be enrolled.

Dr. Fauci said the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third. “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Dr. Fauci said. “This is very optimistic.”

Mr. Trump called that a good sign. “Certainly it’s a positive, it’s a very positive event,” he said.

In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Dr. Fauci’s institute, known as N.I.A.I.D. “We understand that the trial has met its primary endpoint and that N.I.A.I.D. will provide detailed information at an upcoming briefing.”

Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of Covid-19,” according to Gilead.

A representative for Gilead said in an email Wednesday that “as we have done since the beginning of the pandemic, we have been sharing information, transparently and as it becomes available, with the administration, other officials and the public.”

The spokesman, Ryan McKeel, said the company could not speculate on what actions the federal government would take. “However, we are continuing to discuss with them the growing body of evidence for remdesivir as a potential treatment for Covid-19, with the goal of making remdesivir more broadly available for patients in urgent need of treatment.”

Remdesivir has never been approved as a treatment for any disease. It was developed to fight Ebola, but results from a clinical trial in Africa were disappointing.

Expectations were fueled by anecdotal reports of Covid-19 patients who took remdesivir and recovered.

Two such reports were published in the prestigious New England Journal of Medicine, lending credibility to what researchers later said were uncertain results.

Without trials comparing the drug to a placebo, it has been impossible to know whether the drug made a difference or patients got better on their own with normal supportive care.

“This is not the outcome we hoped for,” he added.

America’s growth streak is over: The economy shrank 4.8 percent, and the worst is yet to come.

U.S. gross domestic product, the broadest measure of goods and services produced in the economy, fell at a 4.8 percent annual rate in the first quarter of the year, the Commerce Department said Wednesday. That is the first decline since 2014 and the worst quarterly contraction since 2008, when the country was in a deep recession.

“They’re going to be the worst in our lifetime,” Dan North, the chief economist for the credit insurance company Euler Hermes North America, said of the second-quarter figures. “They’re going to be the worst in the post-World War II era.”

Despite the grim report on Wednesday, Wall Street was set for a gain after a rally in global stocks. Futures for the S&P 500 got a lift after signs that a drug being tested as a possible treatment could be showing progress.

The Federal Reserve pledged on Wednesday to do what it can to insulate the economy as coronavirus lockdowns take a severe toll on economic growth, underlining that it will keep interest rates near zero until a recovery is well underway.

Stocks rallied on Wednesday, bolstered by indications that a drug being tested as a possible treatment could be showing progress, and as investors pinned their hopes on the gradual reopening of the world’s major economies.

The S&P 500 gained more than 2 percent, and major benchmarks in Europe were also higher.

The gains came despite data that showed the U.S. economy shrank by the most since 2008 in the first quarter of the year. Earnings reports from Volkswagen, Samsung, Airbus, Boeing and other giant businesses were also grim.

But investors have been shaking off bad news on the economy for weeks as they focus on progress on efforts to contain the coronavirus pandemic. A steady climb has lifted the S&P 500 by nearly 30 percent since its low on March 23.

The trading on Wednesday had all the hallmarks of a rally fueled by hopes of a return to normal, with shares of airlines and cruise operators — both industries that are dependent on the end of restrictions and the return of travelers — among the best-performing stocks in the S&P 500.

On Wednesday, West Texas Intermediate crude, the American benchmark, was up as much as 30 percent, to more than $16 a barrel. Brent crude, the international benchmark, was trading at a little over $23 a barrel, up about 14 percent.

Trump declared meatpacking plants “critical infrastructure,” but how they would stay open remains unclear.

Mr. Trump’s declaration on Tuesday that meatpacking plants were “critical infrastructure” that should be kept open during the pandemic sent a powerful signal that protecting the nation’s food supply was a federal priority.

But exactly how the executive order would keep plants running, even in the middle of outbreaks that have sickened thousands of workers and turned the facilities into hot spots, was unclear.

“This is more symbolism than substance,” said Steve Vladeck, a law professor at the University of Texas. “He’s opening the door for the executive branch to take some far more specific actions vis-à-vis the meat plants, but the order itself doesn’t do anything.”

While the order does not explicitly mandate that plants stay open, it could allow the Department of Agriculture to potentially force meat companies to fulfill orders from retailers, effectively keeping them in some capacity.

Lobbyists for the meat industry said the executive order, which invoked the Defense Production Act, was significant because it created federal guidelines for the steps plants needed to take to prevent the virus from spreading. Until now, meat plants have been forced to close based on a patchwork of regulations from local and state health departments. The meat industry has warned that closures could threaten the U.S. supply of beef, pork and other products.

“It’s now a partnership between federal agencies and state and local officials to ensure everything is done to keep workers safe,” said Julie Anna Potts, the chief executive of the North American Meat Institute, a trade group for beef, pork and turkey packers and producers.

Still, the order does not address some critical questions, such as whether the plants should test all their workers for the virus before reopening. Some plants have reopened without widespread testing.

A network of conservative leaders, donors and organizations has started a legal onslaught against state and local restrictions intended to slow the spread of the coronavirus. They are pushing to allow churches to hold services, businesses to reopen and people to be able to visit with family and friends.

The group has been emboldened in recent days by increasing signs of support from a powerful ally: the Justice Department.

Justice Department officials have spoken on conference calls with leaders of conservative groups, who have flagged individual cases as worthy of the department’s review. Some cabinet officials have signaled that they backed the effort by participating in private calls with conservative allies, according to multiple people involved with the calls.

Though the Justice Department has so far weighed in formally on only one case — a lawsuit by a Baptist church in Greenville, Miss. — the new directive reinforced the message that court challenges to state and local restrictions by Mr. Trump’s allies could get a favorable viewing, and potential support, from the administration.

Deaths have been mounting at a nursing home for veterans in western Massachusetts, where at least 68 residents have died after contracting the virus, making it one of the deadliest nursing home outbreaks in the country.

To date, 82 residents and 81 employees of the facility have tested positive for the virus.

Employees at the 247-bed, state-managed Holyoke Soldiers’ Home have described the facility as unprepared for the wave of virus cases that emerged in March, and said infected patients were left on crowded wards, exposing dozens of vulnerable veterans.

Lethal outbreaks of the virus have ravaged nursing homes across the nation. The virus is known to be more deadly to aging, immune-compromised people, and small, confined settings like nursing homes, where workers frequently move from one room to the next, are particularly vulnerable to spreading infection.

The outbreak in Holyoke became public at the end of March, after Alex Morse, the mayor of Holyoke, received an anonymous letter from a staff member, describing “horrific circumstances.” Within days, the facility’s superintendent had been placed on administrative leave, and the National Guard was deployed to assist with testing.

Since then, because military honors are unavailable, flags in the state have been lowered to half-staff, in memory of veterans lost in Holyoke and at a soldiers’ home in Chelsea.

A woman who gave birth on a ventilator dies of the virus while in prison.

A woman from South Dakota who gave birth while on a ventilator died in federal custody on Tuesday after contracting the virus.

Ms. Circle Bear was transferred on March 20 from a local jail in Winner City, S.D., to Federal Medical Center Carswell, a federal prison in Fort Worth, and immediately placed in quarantine. Just over a week later, on March 28, she was admitted to a hospital over concerns about her pregnancy and sent home the same day.

Ms. Circle Bear was readmitted on March 31 when she started experiencing a fever, dry cough and other possible symptoms of the coronavirus, and she was confirmed to have Covid-19 three days later, on April 4. By then she had already been placed on a ventilator and given birth to her son via Caesarean section.

Families Against Mandatory Minimums, a national criminal justice advocacy organization, has called for an investigation into Ms. Circle Bear’s death and questioned why she was imprisoned in the first place.

“Not every prison death is avoidable, but Andrea Circle Bear’s certainly seems to have been — she simply should not have been in a federal prison under these circumstances,” Kevin Ring, the group’s president, said in a statement. “Her death is a national disgrace, and I hope it is a wake-up call.”

Ms. Circle Bear is one of 30 inmates who is confirmed to have died from the virus while in custody, according to Bureau of Prison data.

Pelosi names Democrats to special coronavirus investigative committee.

Speaker Nancy Pelosi named six House Democrats on Wednesday to sit on a newly created select committee that will scrutinize the Trump administration’s response to the pandemic.

Among them are three senior Democrats who lead House committees: Representative Maxine Waters of California, the chairwoman of the Financial Services Committee; Representative Carolyn B. Maloney of New York, the chairwoman of the Oversight and Reform Committee; and Representative Nydia M. Velázquez of New York, the chairwoman of the Small Business Committee.

Ms. Pelosi also selected three more junior members based on their areas of expertise. Representative Bill Foster, Democrat of Illinois, is a former scientist. Representative Andy Kim of New Jersey is a former National Security Council staff member with extensive national security experience. And Representative Jamie Raskin of Maryland was a constitutional law professor before joining the House.

“We must make sure that the historic investment of taxpayer dollars made in the CARES Act is being used wisely and efficiently to help those in need, not be exploited by profiteers and price-gougers,” Ms. Pelosi said in a statement, referring to the $2.2 trillion stimulus measure.

The speaker had already announced that she would place Representative James Clyburn of South Carolina, the third-ranking Democrat and one of her top deputies, at the helm of the panel. It is expected to begin working in the weeks to come, and it will be given wide leeway to scrutinize all aspects of the federal response, from the fulfillment of the stimulus to the Trump administration’s struggle to ramp up virus testing.

Five slots on the committee are reserved for Republicans, who have yet to name their members.

As Pence defends his maskless visit to Mayo Clinic, some former patients also criticize the institution.

Vice President Mike Pence defended his decision Tuesday not to wear a face mask while touring a building at the renowned Mayo Clinic in Minnesota, saying he is regularly tested for the virus and was following the guidelines from the Centers for Disease Control and Prevention, even if he was violating the clinic’s own policy for visitors.

Kenneth Rinzler, an attorney who had open-heart surgery at the clinic in 2010, wrote in a letter to the president of the institution, that he was “beyond shocked” to see Mr. Pence inside the building without a mask “and violating every basic tenet of social distancing.”

Susie Watson, the wife of a former bone marrow transplant patient at the clinic, was equally alarmed and wrote to the Mayo Clinic asking why its administrators didn’t insist Mr. Pence wear a mask.

“It really makes us wonder about your judgment,” she wrote in an email that she shared with The Times. “Wearing a mask should not be voluntary at Mayo. This is seriously upsetting, not to mention a huge public relations mistake for all the nation to see.”

Ms. Watson also said she considered it “their error as much as Pence’s.”

A spokeswoman for the vice president did not respond to a request for comment on Wednesday. Mr. Pence defended his decision a day earlier and said, “As vice president of the United States, I’m tested for the coronavirus on a regular basis, and everyone who is around me is tested for the coronavirus.”

Randi Weingarten, the union’s president, said the plan offered “a stark contrast to the conflicting guidance, bluster and lies of the Trump administration.”

The union is asking for school buildings to remain closed until local cases have declined for 14 consecutive days with adequate testing. It says that when schools open, they should be prepared to screen for fevers, set up hand-washing stations at entry points, place individuals with suspected cases in isolation rooms and provide staff members with protective equipment.

The plan floats the possibility of voluntary summer programs, smaller class sizes of 12 to 15 students and schedules of partial days or weeks to maintain social distancing, with after-school programs for families that need more hours of child care.

The union is also asking for schools to halt formal evaluations of teachers’ work until more established procedures for both in-person and remote learning are in place.

On Twitter, the mayor “the Jewish community, and all communities” that violating social-distancing guidelines could lead to summonses or arrests. The police commissioner said that 12 summonses were issued, including four for refusal to disperse.

At his briefing on Wednesday, the mayor said the funeral was “by far the largest gathering in any community of New York City of any kind that I had heard of or seen directly or on video since the beginning of this crisis, and it’s just not allowable.”

Mr. de Blasio on Wednesday offered a limited apology, but he said he would not tolerate violations of social-distancing guidelines.

“If I see it in any other community, I’ll call that out equally,” he said. “If in my emotion I said something that in any way was hurtful, I’m sorry about that, that was not my intention. But I also want to be clear: I have no regrets about calling out this danger and saying I want to deal with it very, very aggressively.”

At his daily briefing, Gov. Andrew M. Cuomo of New York said that 330 more people had died, a third consecutive day at a flat rate, bringing the state’s official tally to 17,968. But the number of new hospital admissions for the virus increased slightly for the first time in 12 days.

New Jersey reported 329 new virus deaths — almost equal to New York’s, though it is more than twice as populous. The total number of deaths in New Jersey stands at 6,770.

Mr. Cuomo said he was issuing an order allowing elective surgeries to resume in 35 counties that had been affected less severely by the virus. New York City and the five counties closest to the city were not among them.

Top restaurateurs seek $120 billion in federal aid.

A group of prominent independent restaurant owners is asking Congress for a $120 billion stabilization fund to prevent thousands of restaurants across the country from closing after massive and protracted losses stemming from the pandemic.

“How do I make money if I have to bring back all my staff doing less volume and less sales?” Nina Compton, the owner of Compère Lapin in New Orleans, said during a conference call on Wednesday. “We need support, we need stabilization.”

Andrew Zimmern, the executive producer of the Travel Channel’s “Bizarre Foods” and a member of the coalition, said that only 20 percent of independent restaurants owners in cities that are shut down are certain they will be able to sustain their businesses.

“The severity of this crisis is extremely deep,” he said.

The Navy delays a decision on restoring the captain of the Theodore Roosevelt carrier and extends an investigation.

The acting secretary of the Navy on Wednesday ordered a wider investigation into the events aboard the aircraft carrier Theodore Roosevelt, apparently shelving for now a recommendation by the Navy’s top admiral to restore Capt. Brett E. Crozier to command the virus-stricken warship.

“I have unanswered questions that the preliminary inquiry has identified and that can only be answered by a deeper review,” the acting secretary, James E. McPherson, said in a statement.

Mr. McPherson said he was directing the chief of naval operations, Adm. Michael M. Gilday, to conduct a follow-on investigation, expanding a preliminary review that the Navy completed and presented to Defense Secretary Mark T. Esper last week.

Mr. McPherson’s announcement came just days after Admiral Gilday recommended giving Captain Crozier his job back. But Mr. Esper, who initially said he would leave the process largely in the hands of the military chain of command, delayed endorsing the findings last week until he said he could review the Navy’s investigation into the matter.

Mr. Kushner rejected the concerns of governors and public health experts who said that testing remained woefully inadequate to justify reopening the country after weeks of lockdown. While Mr. Trump’s administration committed this week to helping states be able to test at least 2 percent of their populations each month, experts said that is a fraction of what is needed to map out how far the virus has spread.

“We’ve done more tests than any other country in the world, so we’ve got to be doing a lot of things right,” Mr. Kushner said.

Mr. Kushner did not address why the president for weeks played down the virus, comparing it to the ordinary flu, predicting that cases would go down to zero and suggesting that the virus would “miraculously” go away. People close to the White House have said that Mr. Kushner agreed with Mr. Trump early on that the Democrats and media were hyping the virus to damage the president, although Mr. Kushner’s allies have insisted that the always took it seriously.

In his interview on Wednesday, Mr. Kushner said May “will be a transition month” as states began reopening. “I think you’ll see by June a lot of the country should be back to normal,” he said. “And the hope is that by July the country’s really rocking again.”

Follow updates on the pandemic from our team of international correspondents.

Sweden forged its own path while countries around it shut down, and Russia extended its lockdown despite having relatively few confirmed cases.

Reporting was contributed by Peter Baker, Ellen Barry, Alan Blinder, Nicholas Bogel-Burroughs, Audra D. S. Burch, Ben Casselman, Michael Cooper, Michael Corkery, Nicholas Fandos, Michael Gold, Dana Goldstein, Jenny Gross, Amy Harmon, Christine Hauser, Josh Katz, Gina Kolata, Lisa Lerer, Denise Lu, Rick Rojas, Margot Sanger-Katz, Marc Santora, Jennifer Steinhauer, Eileen Sullivan, Vanessa Swales, Linda Villarosa, Kenneth P. Vogel and Noah Weiland.

source: nytimes.com

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