Drugmaker Pauses Covid-19 Vaccine Trial for Safety Review

The pharmaceutical firm AstraZeneca halted world trials of its coronavirus vaccine on Tuesday due to a critical and surprising hostile response in a participant, the corporate mentioned.

The trial’s halt, which was first reported by Stat News, will enable the British-Swedish firm to conduct a security assessment. How lengthy the maintain will final is unclear.

In an announcement, the corporate 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 massive trials like those AstraZeneca is overseeing, the corporate mentioned, individuals do typically turn out to be sick by likelihood, however such diseases “must be independently reviewed to check this carefully.”

The firm mentioned 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.”

An individual accustomed to the scenario, and who spoke on the situation of anonymity, mentioned that the participant had been enrolled in a Phase 2/three trial based mostly within the United Kingdom. The particular person additionally mentioned volunteer within the U.Ok. trial had been discovered to have transverse myelitis, an inflammatory syndrome that impacts the spinal twine and is commonly sparked by viral infections. However, the timing of this prognosis, and whether or not it was straight linked to AstraZeneca’s vaccine, is unclear.

AstraZeneca’s vaccine, generally known as AZD1222, depends on a chimpanzee adenovirus that has been modified to hold coronavirus genes and ship them into human cells. Although the adenovirus is mostly considered innocent, the coronavirus elements of the vaccine are supposed to incite a protecting immune response that may be roused once more ought to the precise coronavirus attempt to infect a vaccinated particular person.

Adenoviruses, nevertheless, can typically set off their very own immune responses, which might hurt the affected person with out producing the supposed type of safety.

AstraZeneca’s vaccine is presently in Phase 2/three trials in England and India, and in Phase three trials in Brazil, South Africa and greater than 60 websites within the United States. The firm supposed 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.

“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.

  • China’s biggest air show, originally planned for November in the southern city of Zhuhai, has been canceled because of the pandemic, its organizer said on Wednesday. The cancellation of the biennial China International Aviation and Aerospace Exhibition follows that of Britain’s Farnborough Airshow in July and comes amid a steep downturn in the industry.

  • 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. The Taj Mahal will also open for tourism on Sept. 21, with access restricted to 5,000 people per day. 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.

  • The director of the Tour de France tested positive and will quarantine for a week, the race reported on Tuesday. The director, Christian Prudhomme, had not been in direct contact with any riders, the race said, and no riders tested positive. The race started as usual on Tuesday morning. Four support staff members also tested positive. The race had said that teams would be ejected from the Tour if two members tested positive, but each of the four were from different teams. European news media reported that Mr. Prudhomme was asymptomatic. The Tour is entering its second week of three racing around France. Despite virus concerns, large crowds have turned up to watch.

  • 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.

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.

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.

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.

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.:

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.

As child care centers and schools reopen in the United States, parents are encountering another virus testing bottleneck: Few sites will test children. Even in large cities with dozens of test sites, parents are driving long distances and calling multiple centers to track down one accepting children.

The age policies at testing sites reflect a range of concerns, including differences in health insurance, medical privacy rules, holes in test approval, and fears of squirmy or shrieking children.

The limited testing hampers schools’ ability to quickly isolate and trace virus cases among students. It could also create a new burden on working parents, with some schools and child care centers requiring symptomatic children to test negative before rejoining class.

“There is no good reason not to do it in kids,” said Sean O’Leary, a Colorado pediatrician who sits on the American Academy of Pediatrics’ committee on infectious diseases. “It’s a matter of people not being comfortable with doing it.”

Many testing sites, including those run by cities and states, do not test any children, or they set age minimums that exclude young children. The age limits vary widely from place to place. Los Angeles offers public testing without any age minimum, while San Francisco, which initially saw only adults, recently began offering tests to children 13 and older. Dallas sets a cutoff at 5 years old.

Nir Menachemi, a professor of health policy and management at Indiana University, called the lack of child testing a blind spot that was interfering with school reopening plans and with efforts to understand how the virus was spreading.

“Having a blind spot makes you not able to respond from a public health perspective, either with the correct messaging or with the right policies to put into place to protect the people who are vulnerable,” he said.

Despite a steady decline in daily cases and deaths, Egypt surpassed the 100,000 mark for 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, although mask-wearing is still imposed. Flights resumed in July, and tourism has gradually been allowed back into some cities and attractions. Pressure has eased on the country’s underfunded health sector, with some hospitals that had been earmarked for quarantining virus patients returning to their normal operation.

Most school exams were canceled last semester, but the new school year is set to begin in October, with the introduction of online teaching along with classroom activities to relieve crowding in schools.

The pandemic had overwhelmed the country’s health system, which also suffers a shortage in manpower with an increasing number of doctors migrating in recent years for better career opportunities abroad.

Several doctors have been detained for publicly demanding better working conditions — such as supplying enough personal protective equipment — as hospitals were overflowing with patients.

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, Elaine Yu and Karen Zraick.

Source link Nytimes.com

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