Exclusive: AstraZeneca COVID-19 vaccine trial in U.S. on hold until at least midweek – sources

By Julie Steenhuysen and Marisa Taylor

CHICAGO (Reuters) – AstraZeneca’s COVID-19 vaccine trial remains on hold in the United States pending a U.S. investigation into a serious side effect in Britain even as other trials of the vaccine resume, sources familiar with the details told Reuters.

AstraZeneca on Saturday said it had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

This was the first indication that the U.S. trial will remain on hold until the U.S. Food and Drug Administration and a safety panel investigate the case.

Enrollment in the company’s global trials of the vaccine, which it is developing with researchers at Oxford University, was put on pause on Sept. 6.

Sources told Reuters that enrollment of new patients and other trial procedures for the pivotal U.S. trial were being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.

Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had flagged AstraZeneca’s as the most promising. A prolonged delay in the U.S. trial could slow access to the vaccine in the United States.

The British adverse event involved a study patient thought to be suffering a rare spinal inflammatory disorder called transverse myelitis.

An AstraZeneca spokeswoman declined to comment on when the U.S. trial would resume. She said in an email the company “will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume.”

The status of the South African and Indian trials remains unknown, but the trial in Brazil has also restarted. The company has not commented on timing of resumption in other parts of the world besides Britain.

FDA did not immediately respond to a request for comment.

(Reporting by Julie Steenhuysen and Marisa Taylor; Editing by Peter Henderson and Cynthia Osterman)

Hospital ICUs lean on telemedicine amid U.S. COVID-19 crisis

By Chad Terhune

(Reuters) – As the coronavirus pandemic spreads deeper into America’s small towns and rural outposts, Dr. Tallulah Holmstrom has seen familiar faces fill her intensive-care unit in Camden, South Carolina.

A native of this hamlet of 7,000 people, Holmstrom saw its ICU threatened with closure in recent years as specialists departed for bigger cities. Now faraway doctors are helping treat the community’s COVID-19 patients, thanks to technology.

KershawHealth, the local hospital, installed cameras and other equipment for 24-hour monitoring by a company that employs doctors and nurses remotely. Sitting in cubicles in St. Louis, Houston and Honolulu, as well as other countries including Israel and India, these medical workers watch patients’ vital signs on computer screens and talk to local staff on two-way video about medications and treatments. KershawHealth employees can summon emergency help from these teleworkers by hitting a button on the wall.

Holmstrom said those changes, begun four years ago, have helped her hospital better handle the current crisis. While Camden and surrounding Kershaw County have seen more than 1,600 confirmed infections and 34 deaths, the technology has enabled many of the area’s COVID-19 patients to be hospitalized close to home.

“Now a patient can look up from their ICU bed here and they are seeing a friend’s daughter or son taking care of them or someone they go to church with,” said Holmstrom, chief medical officer at KershawHealth.

Camden is among a growing number of communities relying on this elaborate form of telemedicine to cope with an unrelenting COVID-19 case load and to manage unpredictable surges.

Well before the current crisis, vast stretches of rural America lacked easy access to advanced medical care. More than 130 rural hospitals have closed in the United States since 2010, including 18 last year, according to University of North Carolina researchers.

Rural areas tend to have higher rates of underlying health conditions such as diabetes and hypertension. Their populations often are older and poorer – making them more vulnerable to COVID-19.

Even if beds were available, qualified staff are hard to find. It’s estimated that 43 states, including South Carolina, face a shortage of highly trained ICU doctors, known as intensivists, according to researchers at George Washington University. These shortages may worsen with hospitalizations in many states predicted to peak this fall, when the coronavirus mixes with flu season, according to Patricia Pittman, director of the university’s Mullan Institute for Health Workforce Equity.

“No one is suggesting telemedicine is ideal, but it’s probably one of the least bad options,” she said. “It is definitely better than having no one and helicoptering people out.”

SCALING EXPERTISE

About a third of U.S. hospitals surveyed in 2017 said they had access to a formal program of telemedicine for critically ill patients. Studies have shown telemedicine can benefit ICU patients by promoting the best practices supported by medical evidence and by reducing complications. During the pandemic, doctors say, it has helped conserve personal protective equipment and reduce workers’ exposure to the virus.

There can be drawbacks, too, if physicians try to monitor too many people at once, which can lead to poor decisions or even medical errors. Tele-ICU generally requires physicians working remotely to hold a license in each state where people are hospitalized.

The Trump administration has eased rules on telehealth during the pandemic and expanded reimbursement by Medicare. Shares of telemedicine companies such as Teladoc Health Inc have soared as patients embraced online visits.

Sutter Health, a large hospital system in California, said it manages more than 300 ICU beds across 18 hospitals from offices in Sacramento and San Francisco.

Earlier this month at its Sacramento hub, Dr. Vanessa Walker checked in remotely on a patient who was taken off a ventilator earlier in the day at Sutter’s Roseville hospital about 25 miles away. Using a headset and camera, she clicked the patient’s name on her screen, which rang a doorbell to notify the patient that she was entering the room via video.

“Save your breath. You’re doing well otherwise,” she told the patient.

Walker, the medical director of Sutter’s electronic ICU for its hospitals in California’s Central Valley, had a wide array of information across six monitors at her desk. She could review medical records and see multiple scans of the patient’s lungs before and after treatment.

CAUTIONARY TALE

As use of this technology grows, patient-safety advocates warn hospitals not to cut corners. They say cameras and computers are no substitute for trained professionals at the bedside who can respond rapidly to life-threatening complications.

The Leapfrog Group, a nonprofit that monitors patient safety, recommends that a physician certified in critical care medicine perform an in-person review of each ICU patient daily before handing off monitoring to colleagues remotely. The group says remote doctors should lower their patient loads if they can’t respond within five minutes to requests from on-site staff and evaluate the patient.

Steve Burrows, a Los Angeles filmmaker, remains a skeptic.

He said his mother had complications during a hip operation in 2009 and suffered permanent brain damage in surgery and the ICU at a Wisconsin hospital.

In litigation, Burrows said, he learned that a doctor was remotely monitoring more than 150 ICU patients, and there was no physician in the ICU who could respond to his mother’s low blood pressure. He released an HBO documentary, “Bleed Out,” in 2018 about his mother’s case.

“Telemedicine is fantastic if it’s used properly,” he said in an interview. “But I think replacing doctors at the bedside with technology is insane.”

At trial, a jury found there was no negligence by the hospital. Advocate Aurora Health, the current hospital owner after a merger, said its electronic ICU “does not replace bedside caregivers. Instead, it serves as an additional set of eyes that provides an extra layer of safety.”

‘CONSTANT ATTENTION’

Advanced ICU Care, the St. Louis company serving Camden, works with more than 90 hospitals in 26 states. Overall, it has treated more than 1,300 COVID-19 patients.

“These patients need constant attention and continuous adjustments. That is a lot of what we do,” said Dr. Ram Srinivasan, the company’s chief medical officer.

South Carolina remains a hot spot for coronavirus infections with more than 126,000 cases and 2,877 confirmed deaths as of September 11.

The state’s first two cases of COVID-19 were announced the same day in early March and one was in Camden, a place so rural that signs remind people not to ride horses on the sidewalk.

Holmstrom, the chief medical officer at KershawHealth, got a call with the news while driving home that Friday, March 6. Within a matter of days, there were six people infected and four were hospitalized.

The Camden ICU was nearly full for weeks as the medical staff juggled COVID-19 patients alongside the normal flow of critically ill people. Hospitalizations eased around Memorial Day, Holmstrom said, only to surge again in July and much of August.

“When you’re a town this small and 32 people get sick in one day that’s a lot,” said Vic Carpenter, Kershaw County administrator.

Holmstrom, who was born in the hospital where she now works, has experienced highs and lows. A close friend who spent six weeks in the hospital is now back to full strength. Holmstrom arranged final video calls for others to say goodbye to their families.

KershawHealth is bracing for another surge this fall, when it once again will turn to remote doctors to back up busy hospital staff.

“It’s like someone constantly in the background overlooking everything with your care,” Holmstrom said.

(Reporting by Chad Terhune in Los Angeles; Additional reporting by Nathan Frandino in Sacramento; Editing by Marla Dickerson)

Appeals court finds Florida can require felons to pay fines before right to vote is restored

By Jarrett Renshaw

(Reuters) – A federal appeals court ruled on Friday that Florida can require felons to pay all fines, restitution and legal fees they face before they can regain their right to vote, reversing a lower court ruling that held the measure unconstitutional.

The ruling, by the U.S. 11th Circuit Court of Appeals, could influence the election outcome in November.

Florida is considered a must-win in President Donald’s Trump’s bid for re-election and disenfranchised felons account for a significant voting bloc in a state with a history of tight elections.

The dispute, which could ultimately head to U.S. Supreme Court, centers on whether the law is a way around a voter-approved 2018 measure that aimed to end the state’s lifetime prohibition on voting by ex-felons.

The Republican-controlled Florida legislature passed the law the following year, requiring all former felons to pay off outstanding court debts and legal fees to be eligible to vote.

Voting and civil rights groups sued the state’s Republican governor, Ron DeSantis, and state election officials over that requirement.

U.S. District Court Judge Robert Hinkle in May struck down most of the law as unconstitutional, describing it as a “pay to vote” scheme.

The appeals court, dominated by judges appointed by Trump, delayed the decision while it considered on appeal.

On Friday, a majority of the 11-judge panel found the defendants in the case failed to prove the measure violated the constitution, noting the country has a long history of placing restrictions on voting.

The decision was met with frustration by voting rights groups.

“Florida’s voters spoke loud and clear when nearly two-thirds of them supported rights restoration at the ballot box in 2018,” said Paul Smith, vice president at Campaign Legal Center. “Nobody should ever be denied their constitutional rights because they can’t afford to pay fines and fees.”

(Reporting By Jarrett Renshaw; Editing by Scott Malone and Steve Orlofsky)

U.S. CDC reports 191,353 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 6,381,013 cases of the new coronavirus, an increase of 37,451 cases from its previous count, and said that the number of deaths had risen by 1,091 to 191,353.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 p.m. ET on Sept. 10 versus its previous report a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Maju Samuel)

U.S. expects to identify Belarus sanctions targets in a few days

By Arshad Mohammed and Daphne Psaledakis

WASHINGTON (Reuters) – The United States signaled on Friday that it will soon punish individual Belarusians with sanctions for election fraud and a brutal crackdown on protests as Washington urged Russia to tell Belarusian President Alexander Lukashenko to step down.

Lukashenko denies rigging the country’s Aug. 9 election, which official results said he won by a landslide. He also has refused to talk to the opposition, accusing them of trying to wreck the former Soviet republic squeezed between NATO and Russia.

Speaking to reporters during a conference call, U.S. Deputy Secretary of State Stephen Biegun said Washington is coordinating sanctions with the European Union but made clear neither would wait for the other to impose penalties.

“We are looking at targeted sanctions aimed at the individuals who are most responsible for … the violence as well as the theft of the election,” Biegun said, adding wider sanctions might be considered later but Washington was loath to do anything that would hurt the broader population.

A senior U.S. State Department official told Reuters on Sept. 1 Washington was weighing sanctions on seven Belarusians.

Biegun said Lukashenko, who has been in power for 26 years and is to meet Russian President Vladimir Putin on Monday, is increasingly reliant on Moscow to maintain his rule, saying this could turn Belarusian public opinion against Russia.

“It risks turning the Belarusian people, who have no grievance with Russia, against Moscow,” he said, adding that he hoped the Kremlin would voice concern about the violence against protesters in Belarus and the abductions of opposition figures.

“A free and fair election will allow Belarusian people to select who will be the next president of Belarus,” he said. “Ultimately we hope the message from Moscow to Minsk is that the ruler needs to give way to the will of his people.”

(Reporting By Arshad Mohammed and Daphne Psaledakis; Editing by Chizu Nomiyama and David Gregorio)

Both Biden, Pence attend New York 9/11 memorial, Trump at Pennsylvania crash site

By Trevor Hunnicutt

NEW YORK (Reuters) – Democratic presidential candidate Joe Biden and Vice President Mike Pence, both masked, joined New York’s somber 19th anniversary of the Sept. 11 attacks, while President Donald Trump marked it at the Pennsylvania crash site of a hijacked jet.

Biden and Pence bumped elbows in greeting, one of the many ways the anniversary ceremony has been changed by the coronavirus pandemic, which has killed more than 191,000 people in the United States including 32,700 in New York state.

About 200 people including Governor Andrew Cuomo and U.S. Senator Chuck Schumer joined the New York ceremony, where family members read the names of the nearly 3,000 people killed when two hijacked jets slammed into the Twin Towers, with a third hitting the Pentagon and a fourth taken down in Shanksville, Pennsylvania, when its passengers rose up against the al Qaeda hijackers.

A similar memorial ceremony was being held at the Pentagon and in Shanksville, where people sat socially distanced on folding chairs near the site that Flight 93 went down.

“The only thing that stood between the enemy and a deadly strike at the heart of American democracy was the courage and resolve of 40 men and women – the amazing passengers and crew of Flight 93,” Trump told the crowd.

Biden is also due to visit Shanksville separately later in the day. Prior to boarding a plane from his Delaware home, Biden pledged not to make any news during the solemn day.

“I’m not going to talk about anything other than 9/11. We took all our advertising down. It’s a solemn day, and that’s how we’re going to keep it, okay?,” Biden said.

‘IT NEVER GOES AWAY’

The sun struggled to pierce hazy clouds in New York, a contrast with the 2001 morning of the attacks, which people present that day remember for its piercing, clear skies.

At the memorial site, Biden spoke to 90-year-old Maria Fisher, who lost her son in the 9/11 attacks. He told her he lost his son as well, and lamented, “It never goes away, does it?”

He handed her the rose he was holding.

Asked what today means for him, Biden replied, “It means I remember all my friends that I lost.”

The ruins of the shattered World Trade Center have since been replaced by a glittering $25 billion complex that includes three skyscrapers, a museum and the memorial with the goal that it would be again be an international hub of commerce.

But the pandemic has rendered it somewhat of a small ghost town, adding an eerie quality to the commemoration of the attack, with office workers staying home and tourists avoiding the memorial site.

The virus also altered the memorial event, with family members pre-recording the traditional reading of the names of the victims and the crowds at the site severely restricted.

Amanda Barreto, 27, of Teaneck, New Jersey, lost her godmother and aunt in the attacks. Biden came up to her and offered his condolences.

“He knows what it means to lose someone. He wanted me to stay strong,” Barreto said afterward. “And he’s so sorry for my loss.”

The Shanksville event was also closed to the public because of coronavirus concerns, the National Park Service said.

Flight 93, bound for San Francisco from Newark, New Jersey, never hit its intended target — the four hijackers were believed to be planning to crash it into either the U.S. Capitol or the White House — after passengers stormed the cockpit and attempted to regain control of the aircraft.

(Reporting by Trevor Hunnicutt in New York and Jeff Mason in Shanksville, Pennsylvania, additional reporting by John Whitesides, Joseph Ax and Jarrett Renshaw; Writing by James Oliphant; Editing by Scott Malone, Rosalba O’Brien and Diane Craft)

China imposes curbs on U.S. diplomats in response to U.S. move

BEIJING (Reuters) – China on Friday said it had imposed restrictions on staff at the U.S. Embassy and its consulates in mainland China and Hong Kong, responding to U.S. measures announced early this month.

China’s Foreign Ministry did not specify the measures, which it described as reciprocal.

Last week, Washington said it would require senior Chinese diplomats to get State Department approval before visiting university campuses or holding cultural events with more than 50 people outside mission grounds, which it had said were a response to China’s restrictions on American diplomats.

(Reporting by Lusha Zhang and Tony Munroe; Editing by Kevin Liffey)

Swiss add Paris, Vienna to list of areas for coronavirus quarantine

ZURICH (Reuters) – Switzerland has added the regions around Paris and Vienna to its list of areas with high COVID-19 infection rates requiring incoming travelers to enter quarantine for 10 days.

The government said it was adopting a regional approach for neighboring countries for the measures which will come into force on Sept. 14. As part of this, it named Ile de France and the Vienna region as areas with a raised risk of infection.

The government also put the Czech Republic and all of Spain on its list of entire countries with a quarantine requirement, which already includes the United States,  India and Brazil.

“It is not a good idea to go to high-risk areas,” Health Minister Alain Berset told a media conference, advising Swiss travelers to steer clear of places on the list.

Switzerland, which has had quarantine restrictions since July 6, said it was responding to a spike in infection numbers in the country.

Switzerland reported 528 new cases of the coronavirus on Friday, the highest daily rise in infections since early April.

As part of its new approach, the government said only regions of neighboring countries where the infection rate is above its limit of 60 cases per 100,000 people will be added to the list, rather then the entire country.

Border regions may be exempted from the list to take into account the close interaction with neighboring regions, it said.

Thousands of workers cross Switzerland’s borders with France, Germany and Italy daily to work in Geneva, Basel and the southern canton of Ticino.

(Reporting by John Revill; Editing by Michael Shields)

U.S. CDC reports 190,262 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) said on Thursday the number of deaths due to the new coronavirus had risen by 1,115 to 190,262 and reported 6,343,562 cases, an increase of 32,899 cases from its previous count.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 pm ET on Sept. 9 versus its previous report a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Trisha Roy in Bengaluru; Editing by Ramakrishnan M.)

Taiwan denounces large-scale Chinese drills near island

By Yimou Lee and Ben Blanchard

TAIPEI (Reuters) – Taiwan denounced China on Thursday over large-scale air and naval drills off its southwestern coast which it called a serious provocation and a threat to international air traffic.

It urged Beijing to rein in its armed forces.

China, which claims democratic Taiwan as its own, has stepped up military exercises near the island, in what Taipei views as intimidation to force it to accept Chinese rule.

Yeh Kuo-hui, from Taiwan’s defense ministry’s operations and planning department, told a hastily-arranged news conference that China’s intentions could not be predicted.

“We must make all preparations for war readiness,” Yeh said, following a news briefing from senior officers describing the Chinese activities over the last two days, and showing a map of Chinese movements.

The drills took place in Taiwan’s air defense identification zone, between mainland Taiwan and the Taiwan-controlled Pratas Islands, the ministry said. Taiwan says China sent advanced Su-30 and J-10 fighters to participate.

Taiwan Deputy Defense Minister Chang Che-ping said the drills threatened regional stability and endangered international aviation, he said.

“We once again say, do not underestimate the military’s determination to defend our home. We are confident and capable of defending the country,” Chang said.

Taiwan’s Foreign Ministry said the government had shared “information related to China’s threat to key friendly nations”, a likely reference to the United States, Taiwan’s main arms supplier and most important international backer.

China’s defense ministry did not respond to a request for comment. China has held numerous military exercises up and down its coast and near the island in recent weeks.

Taiwan has this week been carrying out live-fire weapons tests off its southeast and eastern coast.

Taiwan President Tsai Ing-wen has warned of a rising risk of accidental conflict, saying communication must be maintained to cut the risk of miscalculation.

(Reporting By Yimou Lee and Ben Blanchard; Editing by Michael Perry and Timothy Heritage)