Health

Covid-19 live updates: AstraZeneca pauses vaccine test for safety review

AstraZeneca stops a vaccine study to investigate a participant's disease.

Pharmaceutical company AstraZeneca on Tuesday canceled global trials of its coronavirus vaccine because of a serious and unexpected side effect from a participant.

The trial freeze, first reported by Stat News, enables the British-Swedish company to conduct a security review. How long the hold will last is unclear.

In a statement, the company described the stop as a "routine action to be taken if any of the studies have a potentially unexplained disease while it is being investigated to ensure we are maintaining the integrity of the studies".

In large studies like those monitored by AstraZeneca, participants sometimes get sick accidentally, but such illnesses need "to be independently screened to be checked carefully".

The company said it was working "to expedite the review of each event to minimize any potential impact on the study schedule" and was "committed to the safety of our participants and the highest standards of behavior in our studies."

A person familiar with the situation, who spoke on condition of anonymity, said the participant had taken part in a phase 2/3 study based in the UK. The person also said that one volunteer in the UK study was diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections. However, the timing of this diagnosis and whether it is directly related to AstraZeneca's vaccine is unclear.

AstraZeneca's vaccine, known as AZD1222, is based on a chimpanzee adenovirus that has been modified to carry coronavirus genes and deliver them to human cells. Although it is widely believed that the adenovirus is harmless, the coronavirus components of the vaccine are said to trigger a protective immune response that is re-triggered when the actual coronavirus tries to infect a vaccinated person.

However, adenoviruses can sometimes trigger their own immune responses that can harm the patient without creating the intended form of protection.

AstraZeneca's vaccine is currently in phase 2/3 trials in England and India, and phase 3 trials in Brazil, South Africa and more than 60 locations in the US. The company intended to enroll 30,000 US members.

AstraZeneca is one of three companies whose vaccines are in late-stage clinical trials in the United States.

Britain, which has seen a surge in new cases, will ban most gatherings of more than six people starting next week, Prime Minister Boris Johnson is expected to announce on Wednesday.

“We must act now to stop the virus from spreading. We are therefore simplifying and strengthening the rules for social contact – so that they are easier to understand and can be enforced by the police, "Johnson said in a statement on Tuesday.

The new measure, which will face fines of £ 100 or more, applies to both indoor and outdoor gatherings, including Parks. This is not expected to apply to jobs, weddings, funerals, and team sports.

A surge in cases this week and confusion over current rules led to the new measure, which is expected to take effect Monday. About 3,000 new cases were reported on both Sunday and Monday this week the highest daily numbers since May. Another 2,500 new cases were reported Tuesday.

The current rules allow up to 30 people for certain types of gatherings, which creates confusion and makes enforcement difficult for officials.

In other developments around the world:

  • On the Greek island of LesbosA fire forced thousands of migrants to flee a camp where they lived under coronavirus lockdown, The Associated Press reported early Wednesday, citing local authorities. The restrictions were imposed on Camp Moria last week after a 40-year-old asylum seeker tested positive for the virus.

  • IndiaThe Ministry of Health announced Tuesday that it plans to voluntarily open classrooms for students starting September 21, only with parental consent. The vast majority of students will continue to study online. India has a total of more than 4.3 million cases and reported nearly 90,000 new infections on Tuesday.

  • OntarioCanada's most populous province said Tuesday that it would take a four-week "hiatus" before considering easing restrictions or allowing further economic reopening. "Taking a break from further reopening can help avoid widespread closures and shutdowns," said Christine Elliott, Ontario Minister of Health. Schools across the province reopened Tuesday. Ms. Elliott admitted schools would most likely become carriers of the virus and said the province's top priority is to keep it safe from community transmission. Ontario has reported more than 43,000 coronavirus cases, including 852 in the past week, according to a Times database.

  • Japan approved a plan to spend more than $ 6 billion from its emergency budget reserves on coronavirus vaccines. Chief Cabinet Secretary Yoshihide Suga told reporters that AstraZeneca has agreed to ship 120 million cans from early next year and that Pfizer will ship 120 million cans by the end of June. Mr Suga said the government was also negotiating more than 40 million additional doses with Moderna.

  • In the midst of a surge in new cases, Turkey requires the wearing of masks in all public places, including offices, factories, and open spaces such as parks and beaches. The country is also reinstating public transport restrictions after pictures of packed minibuses were posted on social media and masks broke out between drivers and passengers.

  • The United Nations Refugee Agency announced the first confirmed cases of the virus among Syrians in refugee camps Jordan. UNHCR Jordan said two Syrians tested positive at the Azraq camp and were taken to an isolation location near the Dead Sea and that their contacts were tested and quarantined. The camp is home to more than 36,000 people, more than 60 percent of whom are children. There are more than 650,000 registered Syrian refugees in Jordan, most of whom live in cities rather than camps.

  • Despite a steady decline in daily cases and deaths Egypt exceeded the 100,000 mark for total known virus cases on Tuesday. Egypt, the most populous country in the Arab world with over 100 million inhabitants, experienced a partial lockdown between March and June that included a night curfew. the closure of airports, restaurants and cafes; and the suspension of prayers in all places of worship. But life on the streets has returned to normal, and most of these restrictions have been lifted.

Nine pharmaceutical companies jointly agreed on Tuesday to “stand with science” and not present a vaccine until it was thoroughly tested for safety and effectiveness.

The companies did not rule out applying for emergency approval for their vaccines, but promised that a potential coronavirus vaccine would be decided on the basis of "large, high-quality clinical trials" and that the companies would follow instructions from regulatory agencies such as the Food and Drug Administration consequences .

"We believe this promise will help build public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and ultimately approved," the companies said.

President Trump has repeatedly claimed that a vaccine could be available before Election Day, November 3, adding to fears that his administration is politicizing the race by scientists to develop a vaccine and possibly public trust in an approved vaccine undermines.

"We will have the vaccine soon, maybe before a special date," said the president on Monday. "You know what date I'm talking about."

Three of the companies that have signed the pledge are testing their vaccine candidates in late-stage clinical trials in the US: Pfizer, Moderna, and AstraZeneca. But only Pfizer said that for the F.D.A. for the emergency clearance back in October, while the other two have said they hope to have a vaccine by the end of the year.

Late last week, Moncef Slaoui, the top scientist at Operation Warp Speed, a federal attempt to get a vaccine to market quickly, warned in an interview with National Public Radio that the chance of successful vaccination results by October was "very, very slim" be. ”

In Tuesday's statement by the nine companies, they did not mention Mr. Trump, simply saying that they "have a shared commitment to uphold the integrity of the scientific process".

The other six companies that signed the pledge were BioNTech, a development partner for Pfizer's vaccine. GlaxoSmithKline; Johnson & Johnson; Merck; Novavax; and Sanofi. The plans for the pledge were first released on Friday.

For millions of American school children, especially in the Northeast, Tuesday after Labor Day traditionally means the end of the summer vacation and the return to their classrooms. But this year most of these students are opening their laptops at home rather than getting on buses and lugging backpacks as schools start the fall semester practically in the middle of the pandemic.

Classes began Tuesday in some of the country's largest counties, including Chicago, Houston, Dallas, and Baltimore, as well as many suburbs of Washington, DC. But almost all of them started the year remotely, and some were still hoping to be teaching in person in a few weeks' time.

In New York City, the largest borough in the country, teachers and staff returned to schools on Tuesday, but the city's 1.1 million students won't arrive until September 21, 10 days later than originally planned. Mayor Bill de Blasio announced the shift a week ago after many educators said the classrooms could not reopen this week.

In other parts of the country, including several states in the South and Midwest, schools have been open for more than a month, leading to a series of student quarantines and temporary closings in some districts. Others appear to have reopened with no major outbreaks – although reporting has been inconsistent, cases are difficult to follow up.

While some educators sought improved online teaching during the summer break, concerns have grown about the academic impact of the pandemic, which has widened the racial and economic performance gaps. In Texas, more than 100,000 children never took part in distance learning assignments last spring, according to an analysis of state data from the Dallas Morning News, and 19,000 students dropped out of contact with teachers entirely.

Several large districts in Texas, which opened remotely on Tuesday, announced that they would switch to some form of face-to-face teaching in the coming months, if case numbers permit.

In some districts, technical disruptions also hinder teaching. The first day of the Virginia Beach School District started rocky Tuesday as students and parents were unable to access online classes due to an internet outage. "This failure affects schools along the east coast," the district announced on Tuesday morning in a Facebook post.

In other education news:

  • The University Graduates Union at the University of Michigan A four-day strike began Tuesday over concerns about the university's reopening plans and the lack of comprehensive coronavirus testing on the Ann Arbor campus. The union’s demands include the right of PhD trainers to work remotely, childcare allowances and rental freezes in campus apartments.

  • Amid nationwide concerns about coronavirus clusters in sorority and fraternity houses University of Nebraska at Lincoln said Tuesday that it suspended several Greek chapters after photos and videos revealed they had hosted large parties where revelers did not wear face coverings or maintained social distancing.

  • In college football, the season opener is on September 12th between Baylor and Louisiana Tech has been postponed indefinitely. Louisiana Tech sports director Tommy McClelland cited a "significant increase" in Covid-19 cases after Hurricane Laura hit the state as the main reason behind the postponement of the game being played on the Baylor campus in neighboring Texas should. Louisiana has reported over 5,000 cases in the past week, according to a Times database, and Louisiana Tech is in a southwestern part of the state that was hit particularly hard by the storm.

  • Bradley University in Peoria, Illinois said all students must be quarantined in their dormitories or off campus for two weeks starting Tuesday after nearly 50 positive cases were confirmed on campus. All instructions would be switched to remote, the university said. During the quarantine, students can leave their homes to pick up meals and spend time outside, masked. They are not allowed to have guests in their rooms or to meet with anyone other than their flatmates or roommates.

  • The opening of the public schools in Hartford, Conn., was delayed by a virus – but not by the coronavirus or any other biological virus. Rather, the school district's computer servers became the victims of a computer virus in a ransomware attack.

  • Just under two weeks until the start of personal lessons in New York CityThe vast majority of classrooms in the country's largest school district have passed ventilation inspections and will reopen as scheduled on September 21, the mayor said Tuesday. The mayor also said the city will open a 30,000-seat childcare program this month for homeless students and children of key workers and teachers, and will add more spots later this fall. Children will attend childcare on the days when they study from a distance.

Some JPMorgan Chase employees and customers have misused federal coronavirus bailout funds, according to an internal memo from the New York Times.

The memo, sent Tuesday by the bank's operations committee, said officials had "found cases of customers abusing paycheck protection program loans, unemployment benefits and other government programs."

The committee, a group of senior executives that includes its executive director, Jamie Dimon, as well as its chief risk officer and general counsel, did not describe any specific misconduct by the staff, but said that in general some of the activities officials had found could be illegal.

"We are doing everything we can to identify these cases and, if necessary, cooperate with law enforcement agencies," they wrote.

Banks played a pivotal role in distributing much of the federal government's $ 2.2 trillion aid created under the CARES Act to help Americans cope with the economic impact of the coronavirus. They were responsible for screening companies seeking aid, and they were also involved in the distribution of unemployment benefits, which included an additional $ 600 per week in federal funds.

There was never any hope of completely keeping scammers away from the money and many lenders scrutinize customers' activities. Some determined criminals set up fake companies to take advantage of the futile loans offered by the paycheck protection program, while others were given money with stolen identities. JPMorgan, the country's largest bank, donated more than $ 29 billion to P.P.P. Loans, most from any lender.

It's not clear how widespread the misconduct has been among JPMorgan's employees and customers, or how it compares to other banks.

The news of the memo was previously reported by Bloomberg.

When the Senators returned to Washington on Tuesday, their chairman, Kentucky Republican Mitch McConnell, announced the Senate would vote to push a scaled-back stimulus plan that is expected to reinstate expired federal unemployment benefits at $ 300 a week – half According to Republican aides familiar with the discussions, $ 105 billion will be allocated to schools and funding for testing and the postal service.

The plan is an attempt to increase pressure on Democratic leaders who want to fully restore unemployment benefits to $ 600 and have refused to consider measures below $ 2.2 trillion.

"It doesn't contain every idea our party likes," McConnell said in a statement. “I am confident that the Democrats will feel the same way. Republicans believe, however, that the many profound differences between our two parties should not stand in the way of an agreement on where to come to an agreement and legislation that will benefit our nation. "

He added, "I will ensure that any Senate Democrat who has said they want to reach an agreement is given the opportunity to go the way."

The Republican bill would cost $ 500-700 billion, far less than the $ 3.4 trillion Democrats passed in the House of Representatives and less than the $ 1 trillion Republicans passed Senate in July. A procedural vote to advance the legislation could take place this week, McConnell said. Democrats will likely block it.

In a joint statement, spokeswoman Nancy Pelosi from California and Senator Chuck Schumer from New York, the minority leader, rejected the proposal, declaring it "laden with poison pills that Republicans know Democrats would never support".

"This emaciated bill is only meant to help vulnerable Republican senators by giving them a 'check the box' vote to create the impression that they are not being taken hostage by their far-right wing that refuses to spend nickel in order to help people, ”said the two Democrats.

Some of the perpetrators who were caught without a mask had to lie in a coffin. Others were ordered to sit in the back of a hearse.

With coronavirus numbers rising above 200,000 in Indonesia, some officials are finding creative ways to get home the message that wearing a mask is required to prevent new infections.

In East Jakarta, the authorities punished several people with time in a coffin.

"The coffin is a symbol to remind people not to underestimate the coronavirus," said Budhy Novian, head of the East Jakarta law enforcement agency. "We try to get the message across to people: The Covid-19 number is high and leads to death."

But officials halted the practice after critics pointed out viewers violating social distancing rules by pushing themselves to gawk and take photos.

Indonesia, fourth in the world most populous country, there were 200,000 reported cases as of Tuesday. According to a New York Times database, an average of more than 3,000 cases per day has occurred for the past two weeks, and the death toll is the highest in East Asia at 8,230.

Indonesia has one of the lowest testing rates in the world, and its positivity rate is close to 14 percent, slightly higher than Sweden's and well above the 5 percent the World Health Organization has cited as a rough benchmark for easing social distancing measures. (An increasing positivity rate can indicate an uncontrolled outbreak; it can also indicate that not enough tests are being done.)

Some independent experts suggest that the real number of cases in Indonesia is many times higher than 200,000.

President Joko Widodo, who first admitted withholding information about the virus to prevent panic and later said the public must learn to live with it, now says protecting public health is the country's top priority.

"The key to our economy, so that the economy is good, is good health," he said this week. "This means that our focus is still on health."

In Jakarta, the capital, officials erected a coffin-themed memorial last week to highlight the rising death toll and remind people to obey coronavirus protocols.

Failure to comply with the obligation to wear a mask in public in Jakarta is punishable by a fine of up to US $ 67 for repeat offenders, which is a substantial sum for many residents.

In a neighborhood in southern Jakarta, local authorities recently drove a pickup truck with a coffin through the streets, flanked by people disguised as medical staff. An officer shouted over a loudspeaker that anyone caught without a mask must spend five minutes inside.

In the Probolinggo reign of East Java Province, an area affected by the virus, authorities offered a choice of punishments for violators, including sitting in a hearse next to a coffin, push-ups or street cleaning, said Ugas Irwanto, the security coordinator for the Covid-19 Task Force of the Regency.

So far around 75 people have been caught and punished. Some were too scared to sit in the hearse, he said, using a broom instead.

Trump returns to a familiar topic: denouncing virus restrictions.

As the presidential campaign made the post-Labor Day sprint to the finish line, President Trump returned to a familiar topic this week: minimizing the threat from the virus, sometimes in ways that contradict the advice of federal health officials.

Mr Trump took to Twitter Tuesday morning to insist that "New York City must stop the shutdown now" and then to claim that virus restrictions in other states "were only being done to harm the economy before the major elections, perhaps , in our story. "

The day before he criticized a reporter for wearing a mask at a press conference at the White House, despite the fact that the Centers for Disease Control and Prevention stated that “everyone in public facilities and close to people who do not live in your household to wear a mask. ”

And at an outdoor meeting on Tuesday in North Carolina with a large crowd, at which many of his supporters were not wearing masks, he again accused Joseph R. Biden Jr. of undermining "scientists" with "rhetoric against vaccines" for having Questions raised whether Mr Trump threw out a vaccine to improve his political chances in November.

It was part of a familiar pattern for Mr Trump, who back in March urged states to reopen by Easter April 12. (According to a New, more than 160,000 people have died from the coronavirus in the U.S. since Easter, the York Times database.) In mid-April, Mr. Trump sided with protesters who poked fun at virus restrictions and called for multiple states , including Minnesota and Virginia, with both cases increasing in the weeks that followed. And in June he hosted a personal rally in Tulsa, Oklahoma, which local health officials say may have contributed to more cases there.

When the virus hit many parts of the country in the spring, West Virginia was enviable. It was the last of the 50 states to have a case confirmed, and the daily number of new cases remained low, reaching 100 only once before July. But by the end of summer, the state's fortunes deteriorated significantly.

The falls began climbing in July and have been shooting up since then after a brief slump in late August. The state announced more cases in the seven-day period ending Monday than in any other week of the pandemic.

And on one important front, Governor Jim Justice warned at a press conference on Tuesday that West Virginia was now worse off than any other state in the country: The number of new infections that researchers estimate comes from each individual case, a measure of spread called Rt .

"We have told you a million times, we are the oldest state, the most vulnerable state, the state with the most diseases, the state with the most respiratory problems," Justice said, apparently referring to research that shows West Virginia's population is exposed to a particularly high risk of serious illness. “We also told you to wear your mask. And there are still some who don't wear their masks. "

After reopening for in-person classes last month, West Virginia University announced Monday that almost all of the classes on its Morgantown campus will be online for the next two and a half weeks as the number of confirmed cases on campus has increased. The university suspended 29 students after reports surfaced of large fraternity celebrations held over the holiday weekend in violation of quarantine orders.

The surrounding county has one of the worst outbreaks in the state and is one of nine counties where elementary and high schools are starting completely distant learning this year.

Dr. Clay Marsh, the governor's "coronavirus tsar" and vice president of health sciences at W.V.U., said the surge was almost inevitable. "Covid found its way to West Virginia just like it found its way to anywhere in the world," he said in an interview.

The state has been aggressive in many ways, closing its schools outside New York State, ordering universal tests in nursing homes in May, and issuing a nationwide mask mandate in early July.

Even so, the virus has been chiseled: showing up in nursing homes, churches and prisons; Traveling with vacationers; and quickly spread in newly opened bars and restaurants.

Dr. Marsh said he was particularly concerned about the grip the virus appears to have in some coal mining areas in the south of the state, where health care resources are less and where black lung conditions are prevalent. The causes of outbreaks in these smaller communities are less clear than in university towns, making them more difficult to combat.

"We did well, but we're seeing the whims of Covid-19," said Dr. Marsh. "I don't think anyone can get away from it."

In July, a veteran hospital administrator from Tel Aviv, Dr. Ronni Gamzu, appointed the Israeli virus tsar. Acknowledging previous government errors, he hired the military to take responsibility for tracking contacts, and asked Israelis to take the threat seriously and wear their masks.

He also vowed to restore public confidence and demand accountability from community officials while replacing the zigzag dictation of central government with simple instructions that everyone should understand and accept.

Last week, Dr. Gamzu obtained cabinet approval for a traffic light plan to strictly lock down "red" cities with the worst outbreaks, while easing restrictions in "green" cities where the virus has found fewer victims. The aim was to avoid or at least delay another economically strangling nationwide lockdown.

On Sunday, Dr. Gamzu, however, looks more like a victim.

Ultra-Orthodox leaders who felt that their community was being stigmatized rebelled against the traffic light plan and turned their anger against Dr. Gatzus wichtigsten Unterstützer, Premierminister Benjamin Netanyahu.

Und Herr Netanyahu gab unter dem seltenen öffentlichen Druck eines seiner wichtigsten Wahlkreise dem gezielten Sperrplan nach.

Das Ergebnis für Israel ist eine trostlose Aussicht: Die Pandemie hat zugenommen, und die Zahl der Neuerkrankungen in Israel ist pro Kopf nahezu die schlimmste der Welt. Doch die Chancen, seinen Marsch zu stoppen, scheinen gering, wenn sich die jüdischen Hochheiligen Tage nähern.

Normalerweise sind das neue Jahr, Jom Kippur und Sukkot eine festliche und einheitliche Zeit. Stattdessen gibt es Befürchtungen, dass Israel bis zum 18. September, wenn die Feiertage beginnen, entweder von der Pandemie überrannt wird oder vollständig gesperrt ist.

Die Berichterstattung wurde von Keith Bradsher, Chris Buckley, Choe Sang-Hun, Emily Cochrane, Michael Cooper, Jill Cowan, Nicholas Fandos, Emily Flitter, Michael Gold, Veronique Greenwood, Jenny Gross, David M. Halbfinger, Mike Ives und Isabel Kershner verfasst. Sarah Kliff, Victor Mather, Jesse McKinley, Derek M. Norman, Richard C. Paddock, Nada Rashwan, Campbell Robertson, Margot Sanger-Katz, Anna Schaverien, Eliza Shapiro, Karan Deep Singh, Mitch Smith, Muktita Suhartono, Katie Thomas, Katherine J. Wu und Karen Zraick.

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