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AstraZeneca Pauses Covid-19 Vaccine Trial for Safety Review

AstraZeneca Pauses Covid-19 Vaccine Trial for Safety Review

The pharmaceutical company AstraZeneca halted global trials of its coronavirus vaccine on Tuesday because of a serious and unexpected adverse reaction in a participant, the company said.

The trial’s halt, which was first reported by Stat News, will allow the British-Swedish company to conduct a safety review. How long the hold will last is unclear.

In a statement, the company described the halt as a “routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

In large trials like the ones AstraZeneca is overseeing, the company said, participants do sometimes become sick by chance, but such illnesses “must be independently reviewed to check this carefully.”

The company said it was “working to expedite the review of the single event to minimize any potential impact on the trial timeline” and that it was “committed to the safety of our participants and the highest standards of conduct in our trials.”

A person familiar with the situation, and who spoke on the condition of anonymity, said that the participant had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is unclear.

AstraZeneca’s vaccine, known as AZD1222, relies on a chimpanzee adenovirus that has been modified to carry coronavirus genes and deliver them into human cells. Although the adenovirus is generally thought to be harmless, the coronavirus components of the vaccine are intended to incite a protective immune response that would be roused again should the actual coronavirus try to infect a vaccinated individual.

Adenoviruses, however, can sometimes trigger their own immune responses, which could harm the patient without generating the intended form of protection.

AstraZeneca’s vaccine is currently in Phase 2/3 trials in England and India, and in Phase 3 trials in Brazil, South Africa and more than 60 sites in the United States. The company intended for its U.S. enrollment to reach 30,000.

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

Britain, seeing a sudden spike in new cases, will ban most gatherings of more than six people beginning next week, Prime Minister Boris Johnson is expected to announce on Wednesday.

“We need to act now to stop the virus spreading. So we are simplifying and strengthening the rules on social contact — making them easier to understand and for the police to enforce,” Mr. Johnson said in a statement on Tuesday.

The new measure, which will be subject to fines beginning at 100 pounds, will apply to both indoor and outdoor gatherings, including parks. It is not expected to apply to workplaces, weddings, funerals or team sports.

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

The current rules allow up to 30 people for certain types of gatherings, sowing confusion and making it difficult for officials to enforce.

In an interview with Sky News on Wednesday morning, Health Secretary Matt Hancock said that the new rules would not be implemented until Monday because people needed time to read them.

“Every single person in the country needs to know what they are so we can together keep a grip on the virus,” he said.

Mr. Hancok was asked by Sky News whether the decision by the pharmaceutical company AstraZeneca to halt global trials of its coronavirus vaccine would set back the vaccine development process.

“Not necessarily,” he said. “It depends on what they find when they do the investigation.”

There have been 41,586 deaths and at least 352,500 confirmed cases in the United Kingdom as of Wednesday morning, according to government data.

In other developments around the world:

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

  • India’s Health Ministry said on Tuesday that it planned to open classrooms for high school students on a voluntary basis, and only with their parents’ approval, starting from Sept. 21. The vast majority of schoolchildren will continue to study online. India has more than 4.3 million cases overall and reported nearly 90,000 new infections on Tuesday.

  • Ontario, Canada’s most populous province, said on Tuesday that it would take a four-week “pause” before it considers loosening restrictions or allowing further economic reopening. “Taking a pause in further reopening will help avoid broad-scale closures and shutdowns,” said Christine Elliott, Ontario’s health minister. Schools across the province began reopening on Tuesday. Ms. Elliott acknowledged that schools would most likely become vectors for the virus, and said that the province’s top priority was protecting them from transmission in the community. Ontario has reported more than 43,000 coronavirus cases, according to a Times database, including 852 in the past week.

  • Japan approved a plan to spend more than $6 billion from its emergency budget reserves on coronavirus vaccines. The chief cabinet secretary, Yoshihide Suga, told reporters that AstraZeneca had agreed to supply 120 million doses starting early next year, and that Pfizer would supply 120 million doses by the end of June. Mr. Suga said the government was also negotiating with Moderna for more than 40 million additional doses.

  • Amid a surge in new cases, Turkey is requiring masks to be worn in all public places, including offices, factories and open-air spaces such as parks and beaches. The country is also reinstating limits on public transportation after images of jam-packed minibuses began circulating on social media and fights over 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 in Jordan. UNHCR Jordan said that two Syrians in the Azraq camp had tested positive and were transferred to an isolation site near the Dead Sea, and that their contacts were being 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, with most living in cities, not inside camps.

  • Despite a steady decline in daily cases and deaths, Egypt surpassed the 100,000 mark for total known virus cases on Tuesday. The Arab world’s most populous country, with over 100 million people, Egypt endured a partial lockdown between March and June that included a nighttime curfew; the closure of airports, restaurants and cafes; and the suspension of prayers at all places of worship. But life on the streets has been returning to normal, with most of those restrictions lifted.

Nine drug companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.

The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” the companies said.

President Trump has repeatedly claimed that a vaccine could be available before Election Day, Nov. 3, heightening fears that his administration is politicizing the race by scientists to develop a vaccine and potentially undermining public trust in any vaccine approved.

“We’ll have the vaccine soon, maybe before a special date,” the president said on Monday. “You know what date I’m talking about.”

Three of the companies that signed the pledge are testing their candidate vaccines in late-stage clinical trials in the United States: Pfizer, Moderna and AstraZeneca. But only Pfizer has said that it could apply to the F.D.A. for emergency approval as early as 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 on Operation Warp Speed, the federal effort to quickly bring a vaccine to market, warned in an interview with National Public Radio that the chance of successful vaccine results by October was “very, very low.”

In the nine companies’ statement on Tuesday, they did not mention Mr. Trump, saying only that they have “a united commitment to uphold the integrity of the scientific process.”

The other six companies that signed the pledge were BioNTech, which is a development partner in Pfizer’s vaccine; GlaxoSmithKline; Johnson & Johnson; Merck; Novavax; and Sanofi. Plans for the pledge were first made public on Friday.

For millions of American schoolchildren, particularly in the Northeast, the Tuesday after Labor Day traditionally signals the end of summer vacation and a return to their classrooms. But this year, instead of boarding buses and lugging backpacks, most of those students are opening their laptops at home as schools commence the fall term virtually amid the pandemic.

Classes started Tuesday in some of the nation’s largest districts, including Chicago, Houston, Dallas and Baltimore, along with many suburbs of Washington, D.C. But almost all began the year remotely, with some still hoping to hold classes in-person several weeks from now.

In New York City, the nation’s largest district, teachers and staff members returned to schools on Tuesday, but the city’s 1.1 million students won’t arrive until Sept. 21 — 10 days later than initially planned. Mayor Bill de Blasio announced the shift a week ago after many educators said classrooms would not be ready to 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 now, resulting in a series of student quarantines and temporary shutdowns in some districts. Others seem to have reopened without major outbreaks — although reporting is uneven, making cases difficult to track.

While some educators spent the summer break seeking improved online instruction, concerns have grown over the academic impact of the pandemic, which has widened racial and economic achievement gaps. In Texas, more than 100,000 children never participated in remote learning assignments last spring, according to an analysis of state data by The Dallas Morning News, and 19,000 students dropped out of contact with teachers entirely.

Several large districts in Texas that opened remotely on Tuesday have said they plan to shift to some form of in-person instruction in the coming months, if case numbers allow.

For some districts, technical glitches are also hampering instruction. The Virginia Beach school district’s first day got off to a rocky start on Tuesday as an internet outage left students and parents unable to access online classes. “This outage is affecting schools up and down the East Coast,” the district announced in a Facebook post on Tuesday morning.

In other education news:

  • The graduate employees’ union at the University of Michigan began a four-day strike on Tuesday over concerns about the university’s reopening plans and lack of broad coronavirus testing on the Ann Arbor campus. The union’s demands include the right for graduate student instructors to work remotely, child care subsidies and rent freezes in campus housing.

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

  • In college football, the Sept. 12 season opener between Baylor and Louisiana Tech was postponed indefinitely. Louisiana Tech’s director of athletics, Tommy McClelland, cited a “significant increase” in Covid-19 cases after Hurricane Laura hit the state as a primary reason for the postponement of the game, which was to be played at the Baylor campus in neighboring Texas. Louisiana has reported over 5,000 cases in the past week, according to a Times database, and Louisiana Tech lies in a southwestern part of the state that was hit especially hard by the storm.

  • Bradley University in Peoria, Ill., said it was requiring all students to quarantine in their residence halls or off-campus housing for two weeks, starting Tuesday, after it confirmed nearly 50 positive cases on campus. All instruction would switch to remote, the university said. While in quarantine, students can leave their residences to pick up meals and spend time outside while masked. They are not allowed to have guests in their rooms or gather with others besides their roommates or housemates.

  • The opening of the public schools in Hartford, Conn., has been delayed by a virus — but not the coronavirus or any other biological virus. Rather, the school district’s computer servers fell victim to a computer virus in a ransomware attack.

  • With just under two weeks left until the start of in-person classes in New York City, a vast majority of classrooms in the nation’s largest school district passed ventilation inspections and will reopen as planned on Sept. 21, the mayor said Tuesday. The mayor also said that the city will open a child care program this month with 30,000 spots for homeless students and children of essential workers and teachers, and will add more spots throughout the fall. Children will attend child care on the days when they are learning remotely.

Some JPMorgan Chase employees and customers misused federal coronavirus aid money, according to an internal memo reviewed by The New York Times.

The memo, which was sent by the bank’s operating committee on Tuesday, said that officials had found “instances of customers misusing Paycheck Protection Program loans, unemployment benefits and other government programs.”

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

“We are doing all we can to identify those instances, and cooperate with law enforcement where appropriate,” they wrote.

Banks played a central role in distributing much of the $2.2 trillion in aid created by the federal government under the CARES Act to help Americans deal with the economic effects of the coronavirus. They were in charge of vetting businesses seeking aid money, and they also had a hand in distributing unemployment benefits that included an extra $600 a week in federal funds.

There was never a hope of keeping fraudsters away from the money entirely, and many lenders are scrutinizing customers’ activities. Some determined criminals created fake businesses to take advantage of the forgivable loans offered by the Paycheck Protection Program, while others got funds using stolen identities. JPMorgan, the country’s largest bank, handed out more than $29 billion in P.P.P. loans, the most by any lender.

It is not clear how widespread the misconduct among JPMorgan’s employees and customers had been or how it compared with other banks.

News of the memo was reported earlier by Bloomberg.

As senators returned to Washington on Tuesday, their leader, Mitch McConnell, Republican of Kentucky, announced that the Senate would vote to advance a scaled-back stimulus plan, which is expected to reinstate lapsed federal unemployment benefits at $300 per week — half their previous level — and allocate $105 billion for schools and funds for testing and the Postal Service, according to Republican aides familiar with the discussions.

The plan is an effort to intensify pressure on Democratic leaders, who want to fully restore the $600 unemployment benefits and have refused to consider any measure below $2.2 trillion.

“It does not contain every idea our party likes,” Mr. McConnell said in a statement. “I am confident Democrats will feel the same. Yet Republicans believe the many serious differences between our two parties should not stand in the way of agreeing where we can agree and making law that helps our nation.”

He added, “I will make sure every Senate Democrat who has said they’d like to reach an agreement gets the opportunity to walk the walk.”

The Republicans’ bill would carry a price tag of $500 billion to $700 billion, far less than the $3.4 trillion measure Democrats passed in the House and smaller than the $1 trillion measure Senate Republicans introduced in July. A procedural vote advancing the legislation could come as early as this week, Mr. McConnell said. Democrats are likely to block it.

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

“This emaciated bill is only intended to help vulnerable Republican senators by giving them a ‘check the box’ vote to maintain the appearance that they’re not held hostage by their extreme right-wing that doesn’t want to spend a nickel to help people,” the two Democrats said.

Some offenders caught without a mask were required to lie down in a coffin. Others were ordered to sit in the back of a hearse.

As Indonesia’s coronavirus caseload surges past 200,000, some officials are finding creative ways to drive home the message that wearing a mask is necessary 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 East Jakarta’s public order agency. “It’s our effort to convey the message to the people: the Covid-19 number is high and it causes death.”

But officials halted the practice after critics pointed out that onlookers were violating social distancing rules by crowding around to gawk and take photos.

Indonesia, the world’s fourth most populous country, passed 200,000 reported cases on Tuesday. New cases have been averaging more than 3,000 a day for two weeks, according to a New York Times database, and the death toll of 8,230 is the highest in East Asia.

Indonesia has one of the lowest rates of testing in the world, and its positivity rate is nearly 14 percent, slightly higher than Sweden’s and well above the 5 percent that the World Health Organization has given as a rough benchmark for relaxing social distancing measures. (A rising positivity rate can point to an uncontrolled outbreak; it can also indicate that not enough testing is occurring.)

Some independent experts suspect that Indonesia’s actual number of cases 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 that protecting public health is the nation’s highest priority.

“The key to our economy, for the economy to be good, is good health,” he said this week. “This means that our focus is still, number one, on health.”

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

Flouting the requirement to wear a mask in public in Jakarta is punishable by a fine of up to $67 for repeat offenders, a substantial sum for many residents.

In a South Jakarta neighborhood, local authorities recently drove a pickup truck through the streets carrying a coffin, flanked by people dressed as medical personnel. An officer called out over a loudspeaker that anyone caught without a mask would be required to spend five minutes inside.

In East Java Province’s Probolinggo Regency, an area hit hard by the virus, the authorities offered violators a choice of punishments, including sitting in a hearse next to a coffin, doing push-ups or cleaning streets, said Ugas Irwanto, the security coordinator for the regency’s Covid-19 task force.

So far, he said, about 75 people had been caught and punished. Some were too scared to sit in the hearse, he said, and chose to pick up a broom instead.

As the presidential campaign entered the post-Labor Day sprint to the finish line, President Trump returned to a familiar theme this week: minimizing the threat posed by the virus, sometimes in ways that contradict the advice of federal health authorities.

Mr. Trump took to Twitter on 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 hurt the economy prior to the most important election, perhaps, in our history.”

A day earlier he criticized a reporter for wearing a mask at a White House news conference, despite guidance from the Centers for Disease Control and Prevention that “everyone should wear a mask in public settings and when around people who don’t live in your household.”

And at an outdoor gathering on Tuesday in North Carolina with a large crowd, where many of his supporters did not wear masks, he accused Joseph R. Biden Jr., again, of “undermining scientists” with “anti-vaccine rhetoric” because he has raised questions about whether Mr. Trump was rushing a vaccine out to help his political chances in November.

It was part of a familiar pattern for Mr. Trump, who back in March began pushing for states to reopen by Easter, on April 12. (More than 160,000 people have died of the coronavirus in the United States since Easter, according to a New York Times database.) In mid-April Mr. Trump sided with protesters who were chafing at virus restrictions, calling to “LIBERATE” several states including Minnesota and Virginia, which both saw cases rise in subsequent weeks. And in June he held an in-person campaign rally in Tulsa, Okla., which local health officials said likely contributed to more cases there.

The outbreak in the United States is one of the worst in the world: it has the most reported total cases, more 6.3 million, and the most reported deaths, more than 189,000, according to a New York Times database. And it has lagged other wealthy nations when it has come to taming the virus.

U.S. Roundup

When many parts of the country were reeling from the virus in the spring, West Virginia was enviably quiet. It was the last of the 50 states to have a confirmed case, and its daily tallies of new cases remained low, topping 100 only once before July. But as summer comes to an end, the state’s fortunes have changed significantly for the worse.

Cases started climbing in July and, after a brief dip in late August, have been shooting upward since. 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, Gov. Jim Justice warned at a news briefing on Tuesday, West Virginia is now worse off than any other state in the country: the number of new infections that researchers estimate are arising from each single case, a measure of spread called Rt.

“We have told you a million times, we’re the oldest state, the most vulnerable state, the state with the most illnesses, the state with the most breathing problems,” Mr. Justice said, apparently referring to research that shows West Virginia’s population is at particularly high risk of serious illness. “We have also told you to wear your mask. And there are still some who are not wearing their mask.”

After reopening for in-person instruction last month, West Virginia University announced on Monday that nearly all classes at its Morgantown campus would move online for the next two and a half weeks, because the number of confirmed cases on campus has spiked upward. The university has suspended 29 students after reports surfaced of large fraternity parties 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 secondary schools are beginning this year with entirely remote learning.

Dr. Clay Marsh, the governor’s “coronavirus czar” and the vice president for 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 every place in the world,” he said in an interview.

The state has been aggressive in many ways, he said, closing its schools before New York State did, ordering universal testing at nursing homes in May and imposing a statewide mask mandate in early July.

But the virus chiseled away nonetheless: showing up in nursing homes, churches and prisons; traveling in with vacationers; and spreading quickly at newly reopened bars and restaurants.

Dr. Marsh said he was especially concerned about the foothold the virus appears to have gained in some coal-mining counties in the south of the state, where health care resources are fewer and conditions like black lung are prevalent. The sources of outbreaks in these smaller communities are less clear than in college towns, making them harder to combat.

“We have done well, but we are seeing the vagaries of Covid-19,” Dr. Marsh said. “I don’t think anybody escapes it.”

Elsewhere in the U.S.:

  • As part of a move by New York City to promote compliance with the state’s 14-day quarantine requirement for many travelers, the city’s sheriff, Joseph Fucito, said Tuesday that in late August his office began stopping buses before they arrived at the Port Authority Bus Terminal. Officials are boarding the buses and asking passengers to fill out the state’s required travel form with their contact information and quarantine plans. Under consideration was an expansion of the operation to buses that enter the city through places other than the Port Authority Bus Terminal, he said.

  • Gov. Andrew M. Cuomo of New York said Tuesday that travelers from Delaware, Maryland, Ohio and West Virginia are now required to quarantine for 14 days, joining a list of 30 other states as well as Guam. Puerto Rico and the U.S. Virgin Islands were removed in the weekly update.

  • Travelers to Connecticut and New Jersey will now also be subject to a 14-day quarantine if they are coming from those 35 places, though compliance is voluntary in New Jersey.

  • Demand for office space in New York City is slumping, putting its financial health and status as the world’s corporate headquarters at risk. Fewer than 10 percent of the city’s office workers had returned as of last month and just a quarter of major employers expect to bring their people back by the end of the year, according to a new survey. Only 54 percent of these companies say they will return by July 2021. Office work makes up the cornerstone of New York’s economy and property taxes from office buildings account for nearly 10 percent of the city’s total annual tax revenue.

  • Gov. Gavin Newsom of California announced that several counties, including Orange, Santa Clara and Santa Cruz, could now open indoors at reduced capacity a variety of long-shuttered businesses, including restaurants, gyms and places of worship. The governor on Tuesday gave an update on the state’s recently revamped opening process, which sorts California’s vast and diverse counties into tiers, tying the level of business restrictions to case numbers and positivity rates. The three counties were among those allowed to move from the most restrictive tier, in which most businesses are still barred from operating indoors.

In July, a veteran Tel Aviv hospital administrator, Dr. Ronni Gamzu, was anointed Israel’s virus czar. Acknowledging previous government mistakes, he enlisted the military to take responsibility for contact tracing and pleaded with Israelis to take the threat seriously and wear their masks.

He also vowed to restore the public’s trust, demanding accountability from municipal officials while replacing the central government’s zigzagging dictates with simple instructions that anyone should be able to understand and embrace.

Last week, Dr. Gamzu won cabinet approval for a traffic light-themed plan to impose strict lockdowns on “red” cities with the worst outbreaks, while easing restrictions in “green” ones where the virus was finding fewer victims. The goal was to avoid, or at least delay, another economically strangling nationwide lockdown.

By Sunday, however, Dr. Gamzu was looking more like a victim himself.

Ultra-Orthodox leaders who felt that their community was being stigmatized revolted against the traffic light plan and directed their ire at Dr. Gamzu’s most important backer, Prime Minister Benjamin Netanyahu.

And Mr. Netanyahu, under rare public pressure from one of his most vital constituencies, caved in on the targeted lockdown plan.

The upshot for Israel is a bleak prospect: The pandemic has mushroomed, with Israel’s number of new cases near the worst in the world on a per-capita basis. Yet the odds of stopping its march seem slim as the Jewish High Holy Days approach.

Ordinarily, the New Year, Yom Kippur and Sukkot are a festive and unifying time. Instead, there are fears that by Sept. 18, when the holidays begin, Israel will be either overrun by the pandemic or under a full lockdown.

Reporting was contributed by 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, Isabel Kershner, 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 and Karen Zraick.

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