Covid-19 Live Updates: F.D.A. Blood Plasma Emergency Authorization Is Put on Hold

Here’s what you need to know:

Credit…Erin Schaff/The New York Times

Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.

The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.

Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.

But clinical trials have not proved whether plasma can help people fighting the coronavirus.

Several top health officials — led by Dr. Francis S. Collins, the director of the National Institutes of Health, and including Dr. Fauci, the government’s top infectious disease expert, and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.

The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and in animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has infused more than 66,000 people with Covid-19 thanks to financing from the federal government.

An F.D.A. spokeswoman declined to comment.

Plasma, the pale yellow liquid left over after blood is stripped of its red and white cells, has been the subject of months of intense enthusiasm from scientists, celebrities and Mr. Trump, part of the administration’s push for coronavirus treatments as a stopgap while pharmaceutical companies race to complete dozens of clinical trials for vaccines.

United States › On Aug. 18 14-day

New cases 43,226 -17%
New deaths 1,349 -3%

Where cases are highest per capita

Credit…Anna Moneymaker for The New York Times

Senate Republicans are circulating text of a narrow virus relief package that would spend less money, in fewer areas, than earlier offers, including reviving extra unemployment benefits at half the original rate.

The draft measure appears to be an effort to break through the political stalemate over providing another round of economic stimulus to Americans during the pandemic. And it comes at a time when rank-and-file lawmakers facing re-election from both parties have grown increasingly uneasy with the lack of congressional action.

The latest offer, however, is unlikely to alter the debate in Washington, where Democrats have repeatedly rejected previous Republican offers as insufficient, a theme likely to be raised Wednesday evening during the Democratic National Convention when House Speaker Nancy Pelosi, of California, is scheduled to speak.

Among the considerations in the new legislation is providing $105 billion for schools as students have begun returning to classes, and establishing liability protections — a longtime priority for Senate Majority Leader Mitch McConnell, of Kentucky — that Mr. Trump has dismissed as not essential.

But the proposal drops one of the few areas of bipartisan consensus from the original Republican plan and something Mr. Trump has said he wants to see: a second round of direct payments to low- and middle-income Americans.

It was not clear whether senators, currently scattered across the country until early September for the annual summer recess, will vote on the measure anytime soon.

Ms. Pelosi called House members back early from their summer recess to vote Saturday on legislation addressing changes to the Postal Service and providing $25 billion to the beleaguered agency, which will be critical to ensuring voters can cast their ballots by mail this November to avoid the risk of infection by voting in-person.

Dozens of House lawmakers have signed on to a letter to Ms. Pelosi and Representative Steny H. Hoyer of Maryland, the majority leader, asking for a second vote on Saturday, on legislation that would revive the full $600 weekly federal benefit and ensure an automatic continuation and adjustment based on the state of the economic and public health crises.

Lawmakers and aides are also discussing the possibility of using the looming lapse in annual government funding, which expires at the end of September, to jointly approve a short-term spending bill and relief package.

Top House Democrats called Wednesday for a congressional watchdog agency to investigate the way the Trump administration is collecting coronavirus information, saying they are concerned that abrupt shifts in hospital reporting requirements are generating flawed data and “undermine the nation’s COVID-19 response.”

The Democrats — Representative Frank Pallone Jr. of New Jersey, the chairman of the Energy and Commerce Committee, and two subcommittee chairwomen, Representatives Anna G. Eshoo of California and Diana DeGette of Colorado — made the request in a letter, not yet made public, sent Wednesday morning to the head of the Government Accountability Office, an independent and nonpartisan agency that works for Congress. A spokesman for the G.A.O. was not immediately available.

The lawmakers objected to a July order from the Department of Health and Human Services for hospitals to stop reporting to the Centers for Disease Control and Prevention, and instead send information on caseloads, deaths, bed capacity and other aspects of the response, to TeleTracking Technologies, a private vendor based in Pittsburgh. Experts say the switch has been burdensome for hospitals and have raised questions about the reliability of the data, but H.H.S. officials say the switch was necessary to streamline data collection and increase reporting.

The letter outlined three areas of inquiry: What “benefits or challenges” did the new reporting requirements have on the government’s response; how has the administration “monitored, tracked and aggregated data” through its various reporting systems; and “what was the timeline” that led to the decision to replace the C.D.C. system with the one run by TeleTracking?

“Not only have H.H.S.’s actions seemingly sidelined the nation’s top public health officials, but they have also reportedly led to unnecessary confusion, additional burden on critical Covid-19 response professionals, and the loss of timely and reliable data, all in the midst of the pandemic when people’s lives are at stake,” the lawmakers wrote.

Credit…Adriana Loureiro Fernandez for The New York Times

President Nicolás Maduro of Venezuela has tackled the virus much as he has any internal threat to his rule: by deploying his repressive security apparatus against it.

Officials in Venezuela’s government are denouncing people who may have come into contact with the coronavirus as “bioterrorists” and urging their neighbors to report them. The government is detaining and intimidating doctors and experts who question Mr. Maduro’s policies on the virus.

And it is corralling thousands of Venezuelans who are streaming home after losing jobs abroad, holding them in makeshift containment centers out of fear that they may be infected.

In commandeered hotels, disused schools and cordoned-off bus stations, the returning Venezuelans are forced into crowded rooms with limited food, water or masks and held under military guard for weeks or months for virus tests or treatment with unproven medications, according to interviews with the detainees, videos they have taken on their cellphones and government documents.

“They told us we’re contaminated, that we’re guilty of infecting the country,” said Javier Aristizabal, a nurse from the capital, Caracas, who said he spent 70 days in centers after he returned from Colombia in March.

In one major city, San Cristóbal, governing party activists are marking the homes of families suspected of having the virus with plaques and threatening them with detention, residents said. In another city, Maracaibo, the police are patrolling the streets in search of Venezuelans who re-entered the country without official approval. Local opposition politicians whose constituencies register an outbreak say they are threatened with prosecution.

“This is the only country in the world where having Covid is a crime,” said Sergio Hidalgo, a Venezuelan opposition activist who said he had come down with symptoms of the virus, only to find police officers at his door and government officials accusing him of infecting the community.

Credit…Octavio Jones for The New York Times

Local school officials in Florida, one of the hardest-hit states, are juggling a complex mix of political, parental and public health concerns over a reopening mandate that has led to confusion and confrontation with a Republican governor who has long been a proponent of local control.

Gov. Ron DeSantis has ordered all schools to offer in-person instruction by the end of the month, and has spent weeks promoting school openings, holding events with administrators, teachers and parents who say they are eager to go back to the classroom. The benefits of opening outweigh the health risks in most of the state, Mr. DeSantis says, and it is up to each district to decide how its reopening will work in practice.

“Just as the SEALs surmounted obstacles to bring Osama bin Laden to justice, so, too, would the Martin County school system find a way to provide parents with a meaningful choice of in-person instruction or continued distance learning — all in, all the time,” Mr. DeSantis said last week.

The state allowed just the three largest districts — in Miami-Dade, Broward and Palm Beach Counties, where the virus has been most entrenched — to remain online-only after Aug. 31. After 13 counties reopened their schools last week, at least three districts reported positive tests among students or teachers.

In Tampa, the Hillsborough County school board became convinced that reopening right away would lead to so much contagion that the schools would inevitably be forced to close again.

But when the school board changed its original reopening plan and elected to begin with four weeks of remote instruction, the state threatened to withhold $200 million in funding.

Addison Davis, the Hillsborough superintendent, drove from Tampa to Tallahassee, the state capital, to try to find a compromise, and eventually settled on a plan to offer remote instruction for one week and then open classroom doors on Aug. 31.

“I was beyond surprised — I was really shocked,” Karen Perez, a school board member in Hillsborough and a clinical social worker, said about the state’s power to effectively override the board’s vote. “Imagine what’s going to happen in those classrooms. They’re going to be petri dishes for Covid.”



Australia’s Prime Minister Announces Coronavirus Vaccine Deal

Prime Minister Scott Morrison of Australia signed a deal with the drugmaker AstraZeneca to manufacture a coronavirus vaccine and provide it free to 25 million Australians.

We’re here today to announce that we’ve signed a letter of intent with AstraZeneca which will enable Australia to access, should it be successful, the vaccine for Covid-19 here in Australia, manufactured here in Australia, distributed free to 25 million Australians, in the event that those trials prove successful. The next step in these arrangements is to see how those trials go, to complete the manufacturing agreements, and they are well advanced, and I feel very positive about those, and then to identify, as I said, other potential vaccine prospects that Australia can partner with. This particular vaccine, it’s an unproven technology so far, but the initial results are very positive in terms of both efficacy so the effectiveness of the vaccine will be trialled in larger groups of human trials over the coming months, but the efficacy in terms of developing antibodies against coronavirus has been shown to be true, as well as the safety in the Phase 1 and Phase 2 trials.

Video player loading

Prime Minister Scott Morrison of Australia signed a deal with the drugmaker AstraZeneca to manufacture a coronavirus vaccine and provide it free to 25 million Australians.CreditCredit…Pool photo by Nick Moir

The Australian government has signed a deal with the drugmaker AstraZeneca to secure a potential vaccine, and promised to offer it free to its 25 million citizens if clinical trials were successful.

The vaccine, a partnership between the British-Swedish drug maker and Oxford University, is in Phase III clinical trials. As of July, more than 10,000 participants in Britain, Brazil and South Africa had received doses.

“The Oxford vaccine is one of the most advanced and promising in the world, and under this deal we have secured early access for every Australian,” Prime Minister Scott Morrison said in a statement on Wednesday.

He added that the vaccine doses would be manufactured domestically for its citizens, and that his office was working to secure early access for countries in Southeast Asia and those in Australia’s “Pacific family.”

Australia has also signed a $17.9 million deal with the U.S. medical technology company Becton Dickinson to supply needles and syringes.

Mr. Morrison said that Australia had so far invested $185 million in coronavirus vaccines, but did not specify the value of the AstraZeneca deal. Local news reports have estimated that the country’s overall plan to acquire vaccines would be worth billions of dollars.

The partnership between Oxford and AstraZeneca is among the most closely watched coronavirus vaccine efforts in the world. It was also the first to enter Phase III trials, and several countries — including Britain and the United States — have already agreed to pay hundreds of millions of dollars for a total of two billion doses even before the vaccine’s efficacy has been proven.

On Wednesday, Mr. Morrison cautioned that there was “no guarantee that this, or any other, vaccine will be successful,” and that his government was casting its net wide to find a vaccine.

Australia has reported 23,773 cases and 438 deaths. A recent outbreak in Melbourne, the country’s second-largest city, led to a lockdown with some of the toughest restrictions in the world.

On Wednesday Apple became the first U.S. company to hit that valuation when its shares climbed in early trading. It was another milestone for the maker of iPhones, Mac computers and Apple Watches, cementing its title as the world’s most valuable public company and punctuating how the pandemic has been a bonanza for the tech giants.

As recently as mid-March, Apple’s value was under $1 trillion after the stock market plunged over fears of the coronavirus. On March 23, the stock market’s nadir this year, the Federal Reserve announced aggressive new measures to calm investors. Since then, the stock market — and particularly the stocks of Apple, Microsoft, Amazon, Alphabet and Facebook — largely soared, with the S&P 500 hitting a new high on Tuesday.

Credit…Ruth Fremson/The New York Times

Parents across the United States are facing the pandemic school year feeling overwhelmed, anxious and abandoned. With few good options for support, the vast majority have resigned themselves to going it alone, a new survey for The New York Times has found.

Just one in seven parents said their children would be returning to school full time this fall, and for most children, remote school requires hands-on help from an adult at home. Yet four in five parents said they would have no in-person help, whether from relatives, neighbors, nannies or tutors, according to the survey, administered by Morning Consult. And more than half of parents will be taking on this second, unpaid job at the same time they’re holding down paid work.

Raising children has always been a community endeavor, and suddenly the village that parents relied on is gone. It’s taking a toll on parents’ careers, families’ well-being and children’s education.

In families where both wage earners need to work outside the home, parents have obvious logistical challenges because they cannot be in two places at once. Three-fourths of these parents say they will be overseeing their children’s education, and nearly half will be handling primary child care, according to the survey, answered by a nationally representative group of 1,081 parents from Aug. 4 to 8.

Eighty percent of parents who are both working remotely during the pandemic will also be handling child care and education.

One-fifth of parents are considering hiring a private teacher or tutor to help with their children’s education while school is remote, according to the survey.

“All the choices stink,” said Kate Averett, a sociologist at the University at Albany in New York who has been interviewing parents nationwide since the spring. “There is a lot of stress, a lot of anxiety. Parents tell me about not being able to sleep because they’re so anxious, or tell me they’ve been crying a lot. There’s been a lot of actual crying during interviews.”

education roundup

Credit…Patrick Smith/Getty Images

Military discipline gives the nation’s service academies one advantage over civilian colleges: They can give students direct orders, and not just ask for compliance with safety precautions. But in many other ways, their traditions and long heritage creates complications, especially at the U.S. Naval Academy in Annapolis, Md.

When the midshipmen — the academy’s students — begin classes on Wednesday, not all of them will be seated in classrooms. And in what may be a first for the school, which was founded in 1845, not all will even be on campus — at least not right away.

Ordinarily, all midshipmen live in a single dormitory: Bancroft Hall, a sprawling building with eight wings. But this year, one wing has been set aside to quarantine students exposed to the virus and isolate those who contract it. (The nearest military hospital is 38 miles away.)

So the academy plans to house about 500 midshipmen off campus in the surrounding area — a major departure for a tightly guarded institution accustomed to curfews and strict discipline. The academy said it expected to bring the remainder of its midshipmen to Annapolis by mid-September.

The Naval Academy fills 338 acres, some of it reclaimed from the Severn River — a much tighter space than the U.S. Military Academy’s 16,000 acres at West Point, N.Y., and the Air Force Academy’s 18,000-plus acres in Colorado Springs, Colo.

With so much more space, the Army allowed all 4,400 cadets to be on campus when classes began Monday. Unlike Annapolis, West Point had several spare barracks available; two have been made ready to quarantine students if needed, and one has been converted to serve as an isolation ward. The Keller Army Community Hospital, with a 16-bed intensive care unit and a supply of ventilators, is on the post and can care for cadets who come down with Covid-19, according to Lt. Col. Christopher Ophardt, an Army spokesman.

Cmdr. Alana Garas, a Navy spokeswoman, said that, wherever they are, all 4,600 midshipmen will be taking classes offered in a “hybrid” fashion, combining in-person and online instruction.

The Air Force Academy, a much younger institution established in the 1950s, did not respond to queries about its pandemic precautions.

The Pentagon prohibits the academies from releasing the exact number of midshipmen and cadets who have contracted the coronavirus, but both Annapolis and West Point have reported an infection rate of less than two percent among students.

In other education news:

  • A week into the fall semester, the University of Notre Dame announced on Tuesday that it would move to online instruction for at least the next two weeks in an attempt to control a growing coronavirus outbreak. Michigan State University also shifted its reopening plans, telling students not to return for the start of classes in two weeks.


Credit…Eloisa Lopez/Reuters

The Philippines largely reopened for business on Wednesday, against the advice of some health experts.

The Philippines has nearly 170,000 confirmed coronavirus cases, including nearly 30,000 that were reported in the past week, according to a New York Times database. Its total caseload is the highest in Southeast Asia.

Under the rules that took effect on Wednesday, more industries were allowed to open, limited church services were allowed to resume, and restaurants welcomed dine-in customers. The rules apply in and around Manila, the capital, and several outlying provinces, a region that has been under various stages of lockdown since March.

“Almost all industries will reopen, except for those that attract mass gatherings” like amusement parks, said Harry Roque, a spokesman for President Rodrigo Duterte.

The easing of the lockdown was designed to revive a flagging economy that has taken a beating from the virus and that has officially slipped into recession in the second quarter. Mr. Duterte’s government has insisted that the majority of those infected in recent weeks have shown mild symptoms.

But health experts have warned that lifting lockdowns too quickly would lead to more cases and deaths. Nearly all of Manila’s hospitals are under severe strain.

“It’s really counterintuitive to reopen the economy amidst the steep rise of cases and the presence of fully loaded hospitals,” Dr. Anthony Leachon, a former adviser to Mr. Duterte’s government on the pandemic, said in an interview.

In other developments around the world:

  • South Korea reported 297 new infections on Wednesday, its highest daily rise since March. Kim Gang-lip, a senior health official, warned that new infections in and around Seoul, the capital, could lead to “massive nationwide transmission.” The country of about 51 million people has reported at least 16,000 confirmed infections during the pandemic, including at least 1,300 in the past week, according to a New York Times database.

  • The head of the organization responsible for approving vaccines in Germany expects the first doses of a coronavirus vaccine to be available in the country by the beginning of next year. Klaus Cichutek, the president of the Paul Ehrlich Institute, said the timing was contingent on whether “the data in the Phase 3 trials prove the efficacy and safety of vaccine products.” Germany recorded 1,510 new infections on Tuesday, according to a New York Times database, the country’s highest daily total since the beginning of May.

  • Pope Francis said on Wednesday that a coronavirus vaccine should be made universally available, especially to the poor. “How sad it would be if access to a Covid-19 vaccine were made available only to the rich,” the pope said during his weekly address, which since March has been broadcast from the apostolic library instead of being held in St. Peter’s Square. The pandemic, Francis said, was a crisis that could help improve the world by overcoming the “social injustice, lack of equal opportunity and marginalization of the poor.” He added, “We must come out better.”

  • Aiming to provide a better picture of how the virus is spreading across Britain, the government announced a rapid expansion of one of its testing programs. The program selects a random sample of the population, regardless of whether they are experiencing symptoms. The survey, which currently tests 28,000 people every two weeks in England, will be expanded to all parts of the United Kingdom, and a new target has been set of testing 150,000 people every two weeks by October. At least 41,000 people have died from the coronavirus in Britain, which has struggled in its efforts to track down those who have been exposed.

  • Nepal plans to reimpose a strict lockdown and curfew in the Kathmandu Valley for a week, the country’s news media reported. All movement except essential services will be restricted. Nepal has reported at least 4,300 cases in the past week, for a total of at least 28,000.

U.S. Roundup

New York City on Tuesday released more than 1.46 million coronavirus antibody test results, the largest number to date, providing more evidence of how the virus penetrated deeply into some lower-income communities while passing more lightly across affluent parts of the city.

In one ZIP code in Queens, more than 50 percent of people who had gotten tested were found to have antibodies, a strikingly high rate. But no ZIP code south of 96th Street in Manhattan had a positive rate of more than 20 percent.

Percent of people tested with Covid-19

antibodies in New York City, by ZIP code

Upper West Side

East Elmhurst


Borough Park

Percent of people tested with Covid-19 antibodies in New York City, by ZIP code


Source: N.Y.C. Department of Health

By Matthew Bloch

Across the city, more than 27 percent of those tested had positive antibody results. The borough with the highest rate was the Bronx, at 33 percent. Manhattan had the lowest rate, at 19 percent.

The data is likely to renew discussion about whether some neighborhoods or communities in New York City may be nearing herd immunity — the point at which enough people have immunity that the virus is no longer able to spread widely within a community.

Much remains unknown about the degree of protection against Covid-19 that antibodies may offer, or how long that protection may last. But the neighborhoods with more residents who were infected at the height of New York’s outbreak in March and April may be less likely to be among the hardest hit during a second wave.

On the other hand, neighborhoods in which few residents have been infected may find themselves more vulnerable in the event of a resurgence.

Some researchers have expressed hope that herd immunity for the virus may only require about half of the people in a given community to have immunity — while others have suggested a higher threshold, like 70 percent.

Elsewhere in the United States:

  • Former President Bill Clinton on Tuesday accused Mr. Trump of downplaying the virus crisis, and of collapsing under the pressure of a real management challenge. “At a time like this, the Oval Office should be a command center,” he said. “Instead, it’s a storm center. There’s only chaos. Just one thing never changes — his determination to deny responsibility and shift the blame. The buck never stops there.”

Reporting was contributed by Peter Baker, Alexander Burns, Choe Sang-Hun, Emily Cochrane, Nick Corasaniti, Sheri Fink, Katie Glueck, Joseph Goldstein, Jason Gutierrez, Isayen Herrera, John Ismay, Mike Ives, Jennifer Jett, Anatoly Kurmanaev, Sharon LaFraniere, Jonathan Martin, Jack Nicas, Claire Cain Miller, Adam Nagourney, Elisabetta Povoledo, Frances Robles, Anna Schaverien, Christopher F. Schuetze, Sheryl Gay Stolberg, Eileen Sullivan, Jim Tankersley, Sheyla Urdaneta, Noah Weiland and Elaine Yu.

View original article here Source

Related Posts