Tag Archives: Pandemic

U.S. experts to review Biogen drug that could be first new Alzheimer’s treatment in decades

By Deena Beasley

(Reuters) – U.S. health experts this week will decide whether to recommend approval for Biogen Inc’s Alzheimer’s drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works.

In a field littered with unrelenting failure, Biogen believes in aducanumab it has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer’s. But its path to approval has been anything but smooth or assured.

Biogen abruptly ended clinical trials of aducanumab last year after an early look at trial results showed it was not effective. Last October, the company shocked many Alzheimer’s experts by reversing course, saying that a new analysis showed aducanumab could help patients with early-stage disease preserve their ability to function independently for longer. In July, Biogen filed for approval from the Food and Drug Administration.

Now the agency faces tremendous pressure to approve a treatment option for millions of Americans suffering from Alzheimer’s and the millions more expected to face it in coming years.

Patient advocates say the need for a new Alzheimer’s treatment that could help people remain independent is heightened by the coronavirus pandemic, which has killed more than 229,000 people in the United States, including tens of thousands of seniors in nursing homes.

“The pandemic came and it changed everything,” said Russ Paulsen, chief operating officer at patient advocacy group UsAgainstAlzheimer’s. “We need something to keep people out of nursing homes.”

A committee of outside advisers to the FDA will discuss aducanumab on Nov. 6. The agency’s final decision is expected by March. European health regulators have also accepted the drug for review.

Charles Flagg, a 79-year-old retired minister from Jamestown, Rhode Island, had been enrolled for years in a trial of aducanumab before it was stopped. He started receiving the drug again in August as part of a follow-up study, according to his wife Cynthia Flagg.

“He’s not 100 percent himself, but overall I’m not dealing with someone that needs to be led around or be in a care home,” Flagg said.

Aducanumab, an antibody designed to remove amyloid plaques from the brain – a strategy tried with many failed Alzheimer’s drugs – would reap billions of dollars in sales if approved.

Biogen, along with partner Eisai Co Ltd <4523.T>, is one of the last large drugmakers pursuing treatments for a disease that afflicts nearly 6 million Americans and millions more worldwide. Biogen estimates about 1.5 million people with early Alzheimer’s in the United States could be candidates for the drug.

‘CLINICALLY MEANINGFUL’

Late last year, Biogen said one of its two pivotal studies of aducanumab showed a statistically significant benefit at slowing cognitive and functional decline in patients with early Alzheimer’s. A second trial failed to achieve that goal, but did show a benefit for a subset of patients who were given a high dose for at least 10 months.

In March, it opened a follow-up long-term safety study to 2,400 people who had previously participated in trials of aducanumab, like Flagg.

Many Alzheimer’s researchers say Biogen should conduct a third large study to prove aducanumab works. They worry about its possible side-effects, such as brain-swelling, and the potential cost.

“Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes,” said Mayo Clinic neurologist Dr. David Knopman, who was recused from the expert panel because he helped conduct the trials.

Others believe the FDA could approve the drug without another trial.

Previous clinical studies had largely targeted patients in later stages of the disease, while many experts now believe attacking Alzheimer’s as early as possible may be the key to success. But there was a lack of clarity on how to assess a drug’s success when functional deficits are less pronounced.

In 2018, the FDA revised its standard of proof guidance for reviewing Alzheimer’s drugs by essentially combining what had been separate goals for cognition, or memory, and day-to-day function. The new guidance stressed the need for a drug to show “clinically meaningful” benefits, a term it has not clearly defined.

Alzheimer’s advocacy groups are pushing for a broad definition, saying it should include preserving the ability to perform daily activities such as shopping independently or remembering to turn off a stove.

“They have been trying to lower the bar and help any company to get a drug approved,” said Dr. Marwan Sabbagh, from the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “How much (improvement) do you need to be clinically meaningful? Naturally this is very subjective.”

The FDA did not immediately respond to a request for comment.

(Reporting by Deena Beasley; Editing by Caroline Humer and Bill Berkrot)

As Americans head to the polls, COVID-19’s long shadow looms

By Nick Brown and Ernest Scheyder

(Reuters) – For many Americans, this is the coronavirus election.

The pandemic has killed about 230,000 people in the country and destroyed millions of jobs, defining the last year of Donald Trump’s presidency and becoming a rallying cry for his Democratic opponent, Joe Biden.

Here are stories from a cross-section of Americans – voters and officials – for whom COVID-19 is the driving force in Tuesday’s election. Their stories underscore why the disease casts a long shadow over the 2020 U.S. presidential election.

SONIKA RANDEV, 36, NEW YORK, NEW YORK

Dr. Sonika Randev has had a dark year. In March, when she was a medical resident at New York’s Metropolitan Hospital, Randev contracted COVID-19, spending three weeks battling fever, brain fog, body aches, a loss of taste and smell and what she termed a “bone-chilling cold.”

Afterward, figuring she was immune to the coronavirus, Randev volunteered to care for the hospital’s sickest COVID patients, watching many die.

“My unit became an end-of-life unit,” she said. “We were basically waiting for patients to pass away or go to hospice.”

Melancholy quickly set in.

New York’s nightly ritual – in which people clapped and cheered for healthcare workers from their windows – stopped buoying Randev’s spirits. She found herself shutting her windows to the sound, which only reminded her of “the sea of misery” the city had become. When friends and colleagues took to drowning their sorrows, Randev found drinking only made her feel worse, so she stopped.

She felt powerless.

Now, as she gets back on her feet, she said she is trying to take some of that power back – by voting for Democratic candidate Joe Biden.

“Being able to go to the polls and finally exert some control just by casting a vote, I think that’s something powerful,” Randev said.

Recalling how doctors were forced to reuse the same masks and gowns for days, Randev said Trump should have done more to boost supply of protective gear. She also feels Trump unfairly left state governments to fight the pandemic on their own, then “turned around and criticized” those who imposed strict lockdowns.

In a statement to Reuters in October, a Trump campaign spokeswoman said the president has faced the pandemic “head on,” citing his restrictions on travel from China, adding that “he will not stop until we’ve beaten the coronavirus.”

But Randev does not believe Trump would do any better in a second term. “He is who he is,” she said. “He’s never going to change.”

CHRIS HOLLINS, 34, HOUSTON, TEXAS

It has been less than six months since Chris Hollins was thrust into the job of running elections in Harris County, Texas – the largest county in a historically conservative state that Biden has a chance of flipping.

Already, the new county clerk has battled Texas’ Republican governor and attorney general on voting rights access, underscoring the bitter battle for votes in the second-largest U.S. state.

Hollins launched drive-through voting and kept some early-voting locations open 24/7, largely for the convenience of the county’s large numbers of medical and oil industry workers, who often work odd hours.

A Republican state representative sued Hollins for the county’s use of drive-through voting in both the Texas Supreme Court, which rejected the suit on Sunday, and in federal court, where a judge on Monday ruled against it as well.

Hollins opposed the governor’s order limiting counties to one drop-off location for absentee ballots.

As a public appointee, Hollins cannot publicly endorse a candidate, though he is a Democrat.

Prodded partly by the COVID-19 pandemic, county commissioners boosted the election budget seven fold from 2016 levels to $27.7 million. Hollins used that money to triple the county’s early-voting locations to 120.

Plastic coverings that Hollins’ office bought for voters’ fingers – the county uses touchscreen voting terminals – have gone viral on social media, with some playfully describing them as “finger condoms.”

Hollins said his job is “to make sure every voter in Harris County has an opportunity to cast their ballots and can do so safely.”

He and the county have been largely been successful: By Oct. 29, more county voters had cast early ballots than in the entire 2016 election.

GLORIA “LEE” SNOVER, 52, BETHLEHEM TOWNSHIP, PENNSYLVANIA

Her father died of it. Her mother spent eight days in the ICU; her husband, 17 days. Five others in her family contracted it, including herself. For Lee Snover, COVID-19 was more than a news story. It was a family crisis.

Still, Snover goes to the polls more determined than ever to reelect Trump. The chair of the Republican Committee of Northampton County, Pennsylvania – a crucial swing district Trump won in 2016 – said that despite widespread criticism of the president’s handling of the disease, it never occurred to her to blame him for the pandemic that ravaged her family’s health and hamstrung its construction business.

Snover hit emotional rock-bottom the day of her father’s funeral in April, when, battling her own mild COVID diagnosis, she was forced to stay home. The same day, her husband entered the hospital with worsening symptoms. Her mother would soon join. The virus would ensnare eight family members total.

COVID has infected 5,700 Northampton residents and killed 315, according to Pennsylvania Department of Health data. That is 103 deaths per 100,000 residents, well above the U.S. average.

Snover opposes economic shutdowns, equating them to letting the virus win, even though doctors have said social distancing is the best way to beat COVID. “We see life as you gotta survive, you gotta win. We’re not victims. When something hits us, we beat it back and win,” she said.

With Trump behind in opinion polls, Snover says her last vote as a party official carries special weight.

“All this about women’s rights, and ‘Women are so mighty,’ but I look at them on Facebook and all they talk about is fear,” she said. “Putting my finger on that machine button and casting that ballot — that’s a victory against COVID.”

GARY SIMS, 52, RALEIGH, North Carolina

COVID-19 has caused Gary Sims to lose sleep, weight and time with his daughters – and he hasn’t even had the disease.

As director of elections for Wake County, North Carolina, Sims must stage a vote in the most populous county of a crucial battleground state, in the midst of a public health nightmare. The stress is eating him alive, he said.

From online poll worker training to mailing out hundreds of thousands of absentee ballots, “everything has been unprecedented,” Sims said.

He has had to reconfigure his agency’s 76,000-square-foot headquarters so that it can process five times its usual haul of mail ballots while keeping workers much farther apart than normal.

He has seen his two grown daughters just once this year, even though they live close by – for their own protection, he said, since he can’t work from home and is more exposed to the virus.

No stranger to pressure, the U.S. military veteran saw combat in two foreign conflicts. He worries political tensions could lead to confrontation, or that poll workers – many of whom are first-timers this year – could grow overwhelmed by the added burdens of enforcing social distancing and contending with a high turnout of partisan poll observers.

Sims’ blood pressure has spiked. Struggling to stomach solid foods, he’s subsisted mostly on protein shakes. He has lost 40 pounds (18 kg) in two months. “Did I need to lose the weight?” he said. “Yeah. Did I plan to lose it like that? No.”

As an official in charge of fair elections, Sims cannot reveal his own voting plans, but said he is an independent who votes with his daughters in mind.

“They’re getting their future started,” he said. “So my vote is for what’s best for them.”

ISRAEL SUAREZ, 76, FORT MYERS, FLORIDA

Israel Suarez nearly died after he contracted COVID-19 in August, but he did not let that stop him from voting.

Suarez spent 10 days in a Florida hospital and said he was convinced he was going to die. After the ordeal, the lifelong Republican and native of Puerto Rico voted early in October, an act he called a civic duty.

“The coronavirus shouldn’t stop anyone from exercising their moral and social responsibility to vote,” said Suarez, who founded the Nations Association Charities in Fort Myers, Florida, a nonprofit that runs youth groups and other community outreach programs.

Until now, Suarez has affiliated with Republican causes and politics. But this year, he’s supporting Biden.

“I’m so fed up with this man, Mr. Trump, because I almost died,” Suarez said. “I almost lost my life because of him.”

Suarez said Trump has divided and confused the country by failing to lead it successfully through the pandemic.

Suarez added that he persuaded his wife and daughter to vote for Biden, too. Biden “is a moral man,” Suarez said, “no matter what people think of him.”

(Reporting by Nick Brown and Ernest Scheyder; Editing by Ross Colvin and Cynthia Osterman)

With one day left, Trump and Biden search for last-minute support in key states

By Steve Holland and Trevor Hunnicutt

OPA-LOCKA, Fla./WILMINGTON, Del. (Reuters) – U.S. President Donald Trump hunts for support in four battleground states on Monday while Democratic rival Joe Biden focuses on Pennsylvania and Ohio during the final day of campaigning in their race for the White House.

The Republican Trump trails Biden in national opinion polls ahead of Tuesday’s Election Day. But the race in swing states is seen as close enough that Trump could still piece together the 270 votes needed to prevail in the state-by-state Electoral College that determines the winner.

Trump, aiming to avoid becoming the first incumbent president to lose re-election since fellow Republican George H.W. Bush in 1992, will hold five rallies on Monday in North Carolina, Pennsylvania, Wisconsin and Michigan.

He won those states in 2016 against Democrat Hillary Clinton, but polls show Biden is threatening to recapture all four for Democrats.

In a year that has seen much of American life upended by the coronavirus pandemic, early voting has surged to levels never before seen in U.S. elections. A record-setting 94 million early votes have been cast either in-person or by mail, according to the U.S. Elections Project, representing about 40% of all Americans who are legally eligible to vote.

Trump will wrap up his campaign in Grand Rapids, Michigan, the same place he concluded his 2016 presidential run with a post-midnight rally on Election Day.

Biden, running mate Kamala Harris and their spouses will spend most of Monday in Pennsylvania, splitting up to hit all four corners of a state that has become vital to the former vice president’s hopes.

Biden will rally union members and African-American voters in the Pittsburgh area before being joined for an evening drive-in rally in Pittsburgh by singer Lady Gaga.

He also will make a detour to bordering Ohio, spending time on his final campaign day in a state that was once considered a lock for Trump, who won it in 2016, but where polls now show a close contest.

Former President Barack Obama, whom Biden served as vice president for eight years, will hold a get-out-the-vote rally in Atlanta on Monday before closing out the campaign in the evening with a rally in Miami.

Biden has wrapped up the campaign on the offensive, traveling almost exclusively to states that Trump won in 2016 and criticizing the president’s response to the coronavirus pandemic, which has dominated the race.

Biden accuses Trump of giving up on fighting the pandemic, which has killed more than 230,000 Americans and cost millions of jobs. Polls show Americans trust Biden more than Trump to fight the virus.

During a frantic five-state swing on Sunday, Trump – who was impeached by the Democratic-led House of Representatives last December and acquitted by the Republican-controlled Senate in February – claimed he had momentum.

He promised an economic revival and imminent delivery of a vaccine to fight the pandemic.

Dr. Anthony Fauci, the top U.S. infectious diseases expert, has said the first doses of an effective coronavirus vaccine will likely become available to some high-risk Americans in late December or early January.

Trump, who has often disagreed with Fauci publicly, suggested early on Monday he might fire him as director of the National Institute of Allergy and Infectious Diseases after the election.

A ‘TERRIBLE THING’

Trump again questioned the integrity of the U.S. election, saying a vote count that stretched past Election Day would be a “terrible thing” and suggesting his lawyers might get involved.

Americans have already cast nearly 60 million mail-in ballots that could take days or weeks to be counted in some states – meaning a winner might not be declared in the hours after polls close on Tuesday night.

“I don’t think it’s fair that we have to wait for a long period of time after the election,” Trump told reporters. Some states, including battlegrounds Pennsylvania and Wisconsin, do not start processing mail-in votes until Election Day, slowing the process.

Trump has repeatedly said without evidence that mail-in votes are prone to fraud, although election experts say that is rare in U.S. elections. Mail voting is a long-standing feature of American elections, and about one in four ballots was cast that way in 2016.

Democrats have pushed mail-in voting as a safe way to cast a ballot in the coronavirus pandemic, while Trump and Republicans are counting on a big Election Day in-person turnout.

Both campaigns have created armies of lawyers in preparation for post-election litigation battles.

“We’re going in the night of – as soon as the election is over – we’re going in with our lawyers,” Trump told reporters without offering further explanation.

The attorneys general of Michigan and Pennsylvania, both Democrats, challenged Trump’s rhetoric on Twitter.

“The election ends when all the votes are counted. Not when the polls close,” Michigan Attorney General Dana Nessel wrote.

In a sign of how volatile the election could be, buildings for blocks around the White House were boarded up over the weekend. Federal authorities planned to extend the perimeter fencing around the White House to by several blocks, encompassing the same area fenced out during this summer’s protests against racism and police brutality, according to U.S. media.

To help ensure mail-in ballots are delivered in a timely fashion, a U.S. judge on Sunday ordered the U.S. Postal Service to remind senior managers they must follow its “extraordinary measures” policy and use its Express Mail Network to expedite ballots.

A federal judge in Texas on Monday will consider a Republican request to throw out about 127,000 votes already cast at drive-through voting sites in the Democratic-leaning Houston area.

The FBI, meanwhile, is investigating an incident in Texas when a pro-Trump convoy of vehicles surrounded a tour bus carrying Biden campaign staff. The caravan, which Trump praised, prompted the Biden campaign to cancel at least two of its Texas events, as Democrats accused the president of encouraging supporters to engage in acts of intimidation.

(Reporting by Steve Holland in Opa-Locka, Florida, and Trevor Hunnicutt in Wilmington, Delaware; Writing by John Whitesides; Editing by Scott Malone and Alistair Bell)

Trump or Biden’s big economic challenge: millions of struggling Americans

By Jonnelle Marte

(Reuters) – The winner of the race for the White House will face a generation of low-to-middle income Americans struggling to get back to work because of a health crisis not seen in more than 100 years.

Whether it’s President Donald Trump or Democratic challenger and former Vice President Joe Biden, the reality is grim: about half of the 22 million who lost their jobs during the pandemic are still out of work.

New hiring is slowing, dimming prospects for the low-wage workers hit hardest by job losses. Infections of the virus that killed more than 225,000 Americans are rising to new records. Hotels, transportation companies and food providers warn that more layoffs are coming, and the government aid that helped many pay the bills is long gone.

Securing a future for a vast, growing underclass “is the most important challenge America faces over the next few years, 10 years, 20 years,” said Gene Ludwig, a former comptroller of the currency under President Bill Clinton and author of “The Vanishing American Dream,” a book about the economic challenges facing lower and middle income Americans.

“We cannot sustain a democratic society that has these kinds of numbers of low and middle income people that aren’t able to have a hope for the American dream and live decently.”

Congressional Democrats and the Trump administration have been trying to negotiate a $2 trillion coronavirus aid bill, but many Senate Republicans object to the cost and question whether more stimulus is needed. A deal may not be reached until early 2021.

SAVINGS DRY UP

That’s going to be too late for some.

Direct cash payments and enhanced unemployment benefits established by the CARES Act, which added $600 a week to state unemployment benefits, lifted more Americans out of poverty in April even as unemployment soared, according to research by the Center on Poverty & Social Policy at Columbia University.

People receiving the enhanced benefits were able to spend more, build savings and pay off debt, according to an analysis by the JPMorgan Chase Institute.

But after the benefits expired at the end of July, poverty is once again on the rise – with the monthly poverty rate reaching 16.7% in September from 15% in February, according to the Columbia study. After a decade of decline, hunger is rising nationwide.

Lisandra Bonilla, 46, saved roughly a third of the enhanced unemployment benefits she received after she was furloughed in late March from her job at an employment agency in Kissimmee, Florida. “I had saved a lot because I didn’t know what was going to happen,” she said.

It was smart planning: in August her benefits were cut to $275 a week before taxes, the maximum in Florida, down from more than $800.

Bonilla returned to work part-time in late September, but now she is struggling to pay the bills on half her previous pay, and fears her savings will be gone by December.

If she isn’t hired full time soon, she needs to find another job.

“We’re trying to shovel ourselves out of the hole, but at the same time the hole is getting bigger,” said Wendy Edelberg, director of the Hamilton Project and senior fellow at the Brookings Institution.

Two factors are particularly worrying, she said. More than 420,000 small businesses shuttered between March and mid-summer, which is more than three times the typical pace, she estimates. And permanent layoffs are also on the rise, hitting 3.8 million in September from 1.3 million in February – similar to levels seen before the 2008 election.

THE LONGTERM UNEMPLOYMENT TRAP

Bishop Donald Harper has been on more than 50 job interviews since he was furloughed in March.

Harper, 55, a veteran chef, most recently oversaw five restaurants at an Orlando resort. But with occupancy still low, it’s not clear when he’ll get back to work.

Applications for jobs at super markets or in health care have also been fruitless.

“I can do anything and everything,” said Harper, who also serves as a bishop for a nondenominational church. He is struggling to pay for food and utilities on $275-a-week unemployment, and three months behind on his $1,900 a month rent.

“I don’t want to be homeless,” said Harper, who lives with two children ages 10 and 13. He has reached out to more than 20 groups seeking rental assistance, with no luck.

The United States has 2.4 million and growing “long-term” unemployed, officially defined as those who have been out of work for 27 weeks or more. Getting everyone back to work is crucial, but economists say these job seekers are at greater risk of dropping out of the labor market or taking lower paying jobs.

This week, the U.S. Commerce Department is expected to report that Gross Domestic Product surged in the third quarter, thanks in part to fiscal stimulus that kept U.S. workers afloat, but has mostly expired.

Now, people who are out of work or in low-wage jobs need rental support, direct cash payments and food assistance, as well as federal jobs projects and retraining programs, labor economists say.

If elected, Biden has pledged to raise the federal minimum wage, and roll out trillions of dollars in infrastructure and green energy programs. But he’ll need the votes in Congress to do it.

Trump has signaled support for more federal stimulus, but has offered fewer specifics on jobs.

Until help arrives, workers are struggling.

Rachel Alvarez, 44, a single mother of three in Naples, Florida, starts a new job this week as a server at a restaurant – her first time working since she lost her job in March.

Restaurant workers who depend on tips aren’t making much money, because business remains slow due to the coronavirus, she said. She hasn’t paid rent since June, and is still waiting to hear from the county government about a grant.

“I’m going to keep my head up, because if shit like this ever happens to my children I want them to keep their head up too,” said Alvarez.

(Reporting by Jonnelle Marte. Additional reporting by Andy Sullivan and Richard Cowan; Editing by Heather Timmons and Edward Tobin)

Strong retail sales boost optimism before U.S. election, but it may be short lived

By Jonnelle Marte

(Reuters) – In an ordinary presidential election, Friday’s retail sales report would have been a dream for an incumbent like Republican President Donald Trump. Headline sales topped expectations by a wide margin and spending was up from August in all but one of the major categories.

Still, this is no ordinary election. Despite the gains seen in September, spending in key sectors that suffered massive job losses during the pandemic, such as restaurants and clothing stores, remain deeply below last year’s levels.

The report from the Commerce Department offered a reminder that millions of Americans are still out of work, leaving them with less money to spend on dinners out or new outfits. Without a vaccine or effective treatment, many consumers also hesitate to head out to stores or restaurants where they may be exposed to the virus.

On the one hand, the retail report showed that overall retail spending is now above pre-pandemic levels. That is a sign that some people may have spent the $300 supplement the federal government temporarily added to unemployment benefits. Other people may have boosted spending after being called back to work.

If more people continue to see their finances improve, that could bode well for the economy and for the overall outlook people carry when they vote in the Nov. 3 election.

But some economists are also questioning whether the increase in spending seen in September will continue with virus infections rising, job growth stalling and government aid fading.

Enhanced unemployment benefits and direct cash payments distributed as part of the CARES Act made it possible for jobless Americans to boost spending and pad their savings. But much of those savings were spent in August after the supplement to unemployment benefits expired, according to a study released Friday by the JPMorgan Chase Institute.

The White House and Congress have yet to reach a deal on another package. Job growth is also slowing and the number of Americans filing new claims for jobless benefits reached a two-month high last week.

“The progress we’ve made, which has been better than expected, may be slowing,” said John Briggs, head of strategy for the Americas at NatWest Markets. “I don’t know how much it hurts Trump’s chances, but I don’t see how it can help him.”

(Reporting by Jonnelle Marte; Editing by Andrea Ricci)

New clashes in Nagorno-Karabakh; Pompeo says Turkey makes situation worse

By Nvard Hovhannisyan and Nailia Bagirova

YEREVAN/BAKU (Reuters) – Armenian and Azeri forces fought new clashes on Friday, defying hopes of ending nearly three weeks of fighting over the Nagorno-Karabakh enclave, and U.S. Secretary of State Mike Pompeo blamed Turkey for inflaming the situation by arming the Azeris.

The worst outbreak of violence in the South Caucasus since Armenia and Azerbaijan went to war over the enclave in the 1990s, the fighting risks creating a humanitarian disaster, especially if it draws in Russia and Turkey.

Nagorno-Karabakh is internationally recognized as part of Azerbaijan but populated and governed by ethnic Armenians.

Turkey has increased military exports six fold this year to its close ally Azerbaijan. Russia, is close to both sides but has a defense pact with Armenia. News agency RIA reported the Russian navy had started planned military exercises in the Caspian Sea.

(Graphic: Ethnic tensions in Nagorno-Karabakh, https://graphics.reuters.com/ARMENIA-AZERBAIJAN/xklpyqoddpg/armenia-azerbaijan-2020_ethnic.jpg)

There were further signs on Friday that a Russian-brokered ceasefire agreed last Saturday to allow the sides to swap detainees and the bodies of those killed had all but broken down.

Armenia and Azerbaijan each accused the other of launching attacks, and each said it had the upper hand.

Armenian defense ministry official Artsrun Hovhannisyan said Azerbaijan had conducted artillery bombardments of Nagorno-Karabakh from the north, “with total disregard for the humanitarian truce”. He added that Azeri forces had been repelled and had suffered significant losses.

Azerbaijan’s defense ministry said Nagorno-Karabakh forces had been forced to retreat and Azeri forces retained the advantage along the line of contact that divides the sides.

Reuters could not independently verify the reports.

Baku also accused Yerevan of a missile attack on Ordubad in Nakhchivan autonomous province, a region which belongs to Azerbaijan but is surrounded by Armenia and Iran. Armenia denied such an attack.

The Nagorno-Karabakh defense ministry reported 29 more military casualties, bringing to 633 the number of servicemen killed since fighting broke out on Sept. 27. Azerbaijan does not disclose military casualties. The Azeri prosecutor-general’s office said 47 civilians had been killed and 222 wounded.

U.S. CRITICISM OF TURKEY

The hostilities, close to pipelines in Azerbaijan that carry gas and oil to global markets, are stoking concern in Europe and the United States that Turkey and Russia, already at loggerheads over Syria and Libya, will be dragged in.

Pompeo said Turkey had worsened the conflict by providing resources to Azerbaijan. A diplomatic resolution was needed, rather than “third-party countries coming in to lend their firepower to what is already a powder keg of a situation,” he said in an interview with broadcaster WSB Atlanta.

Ankara accuses Armenia of illegally occupying Azeri territory. Armenia says Turkey has encouraged Azerbaijan to pursue a military solution to the conflict, putting Armenian civilians in danger.

Armenia’s foreign ministry said Foreign Minister Zohrab Mnatsakanyan had spoken by phone with United Nations Secretary-General António Guterres, asking the international community to “neutralize” Azeri actions which he said posed “an existential danger of the people of Nagorno-Karabakh”.

Meanwhile Iran tweeted that its foreign minister Mohammad Javad Zarif had offered the Azeri side Teheran’s help with the peace process.

ECONOMIC DAMAGE

The conflict between the two former Soviet republics threatens to further damage their economies, already hit by the COVID-19 pandemic and, in Azerbaijan’s case, weak oil prices.

With 43,280 COVID-19 cases, Azerbaijan said it would close secondary schools and shut the underground rail system in the capital Baku between Oct. 19 and Nov. 2.

Armenia said on Friday its caseload had risen to 61,460.

In projections drafted before fighting started, the World Bank predicted Armenia’s economy would shrink 6.3% this year, while expecting Azerbaijan to contract 4.2%.

(Additional reporting by Margarita Antidze in Tbilisi and Humeyra Pamuk in Washington; Writing by Sujata Rao; Editing by Timothy Heritage and Peter Graff)

Q&A: Where are we in the COVID-19 vaccine race?

By Carl O’Donnell

NEW YORK (Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

Who is furthest along?

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, U.S. biotech Moderna Inc and Britain-based AstraZeneca Plc in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials as early as October or November. Johnson & Johnson is a bit further behind.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. If the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial can also be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. Earlier this month, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines for the UK and the European Medicines Agency will review vaccines for European Union use.

When will regulators decide?

Regulators will review the vaccines after the companies have enough data to submit applications seeking an EUA or formal approval. Moderna’s first look at data is more likely to come next month. AstraZeneca could provide a look at late-stage data in November. Pfizer/BioNtech said it may have data as early as October, but that it would wait for safety data it expects in the third week of November to file with U.S. regulators.

Regulators for Europe and Canada are considering data on a rolling basis, as it becomes available. The UK and the United States both expect speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

Could these be the first approved coronavirus vaccines?

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics <6185.HK> and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia’s Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data at the end of October or early November. Russia has also given the vaccine to at least hundreds of “high-risk” members of the general population.

Is U.S. authorization up to President Trump?

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are intended to be given to hundreds of millions of healthy people. However, the U.S. Department of Health and Human Services (HHS) has the authority to override the FDA’s recommendation. President Donald Trump has complained about the new safety guidelines, which delay any vaccine availability until after the Nov. 3 presidential election at the earliest. The Trump administration can hire and fire HHS officials, opening the possibility of political pressure to approve a vaccine.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer, Bill Berkrot and Frances Kerry)

U.S. coronavirus cases surpass eight million as infections spike nationwide

By Anurag Maan and Shaina Ahluwalia

(Reuters) – U.S. cases of the novel coronavirus crossed 8 million on Thursday, rising by 1 million in less than a month, as another surge in cases hits the nation at the onset of cooler weather.

Since the pandemic started, over 217,000 people have died in the United States.

The United States reported 60,000 new infections on Wednesday, the highest since Aug. 14, with rising cases in every region, especially the Midwest.

Health experts have long warned that colder temperatures driving people inside could promote the spread of the virus. They have not pinpointed the reason for the rise but point to fatigue with COVID-19 precautions and students returning to schools and colleges.

According to a Reuters analysis, 25 states have so far set records for increases in new cases in October.

All Midwest and Northeast states have reported more cases in the past four weeks than in the prior four weeks, with the number of new cases doubling in states like Wisconsin, South Dakota and New Hampshire.

In the Midwest, daily new cases hit a record on Wednesday with over 22,000 new infections. The positive test rate tops 30% in South Dakota and 20% in Idaho and Wisconsin.

Ten states on Thursday reported record increases in new cases, including Wisconsin with 4,000 new cases. “Our numbers are high and they’re growing rapidly,” state Health Secretary-Designate Andrea Palm told a news conference.

“We have now surpassed 1,000 COVID-19 patients who are in the hospital. In some regions of our state, our ICU beds are 90% or more full. Over the course of the past six weeks, our average daily deaths have more than tripled,” Palm added.

California remains the state with the most total cases followed by Texas, Florida, New York and Georgia. Those five states account for over 40% of all reported COVID-19 cases in the nation.

With both cases and positive test rates rising in recent weeks, New York City has closed businesses and schools in neighborhood hot spots despite protests from a small contingent of Orthodox Jews.

In addition to rising cases, hospitals in several states are straining to handle an influx of patients.

In the Midwest, COVID-19 hospitalizations hit a record high for a tenth day in a row on Wednesday. Nationally, the United States reported nearly 37,000 hospitalizations, the highest since Aug. 28.

Wisconsin, which reported record hospitalization on Wednesday, has opened a field hospital outside of Milwaukee to handle COVID-19 patients.

(Reporting by Anurag Maan, Shaina Ahluwalia and Chaithra J in Bengaluru; Editing by Lisa Shumaker)

Catholics, Jews say New York coronavirus restrictions violate religious rights

By Peter Szekely

NEW YORK (Reuters) – New York Governor Andrew Cuomo’s recent measures to stem local outbreaks of the coronavirus have prompted demands from Catholics and Jews that courts void the restrictions because they limit religious freedom.

The Roman Catholic Diocese of New York of Brooklyn was set to hold hearing Thursday afternoon on a suit it filed in U.S. District Court in the borough on Oct. 8, while three Orthodox Jewish congregations filed suit on Thursday in U.S. District Court in Manhattan.

Both actions argue that the state’s restrictions on religious gatherings violate the U.S. Constitution’s First Amendment right to freedom of religion.

Cuomo issued an order on Oct. 6 that shut down non-essential businesses and restricted gatherings at religious institutions to as few as 10 people in certain targeted areas, including some Brooklyn neighborhoods, where infections have spiked.

Cuomo insisted that his infection-fighting measures were not intended to single out religious groups and were consistent with other steps he has taken to combat geographic “clusters,” which he has defined as “red zones,” where infections spread rapidly.

But he also blamed the Orthodox Jewish communities for causing some of the infection spread in their areas.

“They never complied with any of the close-down rules going back to March,” he said in a briefing on Thursday. “That’s why some find it shocking, because they didn’t follow many of the rules all along.”

In their complaint which is laced with historical references to persecution, the Orthodox congregations said Cuomo has outlawed “all but the most minimal communal religious worship.”

“For Jews, communal worship is an essential service for which untold thousands have risked and sacrificed their lives,” the congregations — Ohalei Shem D’Nitra, Yesheos Yakov and Netzach Yisroel — said in a 33-page complaint.

Brooklyn’s Roman Catholic diocese, meanwhile, was rebuffed on Friday in its request for a temporary court order to bar the restrictions from taking effect.

But the diocese said its case was still alive, with U.S. District Court Judge Nicholas Garaufis having set a hearing for 2 p.m. EDT (1800 GMT) Thursday for arguments on its request for a longer-lasting preliminary injunction against the restrictions in 28 areas of Brooklyn and Queens.

In its complaint the diocese said it has complied with the state’s restrictions since the pandemic erupted in March, and that the new targeted measures are overly broad, infringing not only on worship services but also on ceremonies such as weddings and funerals.

“By causing the cancellation or severe curtailment of such services, the order would impose irreparable harm on the Diocese of Brooklyn and those it serves,” said the 22-page complaint.

The state’s targeted measures have sparked protests and occasional violence in some predominantly Hasidic Jewish areas of Brooklyn’s Borough Park neighborhood. In that area, more than 8% of coronavirus tests came back positive last week.

(Reporting by Peter Szekely; Additional reporting by Gabriella Borter; Editing by Tom Brown)

Persistently high U.S. weekly jobless claims point to labor market scarring

By Lucia Mutikani

WASHINGTON (Reuters) – The number of Americans filing new claims for jobless benefits rose to a two-month high last week, stoking fears the COVID-19 pandemic was inflicting lasting damage to the labor market.

The weekly unemployment claims report from the Labor Department on Thursday, the most timely data on the economy’s health, also showed at least 25 million were on jobless benefits at the end of September. It reinforced views the economy’s recovery from the recession, which started in February, was slowing and in urgent need of another government rescue package.

The economic hardship wrought by the coronavirus crisis is a major hurdle to President Donald Trump’s chances of getting a second term in the White House when Americans go to the polls on Nov. 3. Former Vice President Joe Biden, the Democratic Party’s candidate, has blamed the Trump administration’s handling of the pandemic for the worst economic turmoil in at least 73 years.

“The increase in initial claims is disturbing,” said Chris Low, chief economist at FHN in New York. “It is difficult to see it and not think the recovery is vulnerable.”

Initial claims for state unemployment benefits increased 53,000 to a seasonally adjusted 898,000 for the week ended Oct. 10. Data for the prior week was revised to show 5,000 more applications received than previously reported.

Economists polled by Reuters had forecast 825,000 applications in the latest week. The surprise increase came even as California processed no claims. California, the most populous state in the nation, suspended the processing of new applications for two weeks in late September to combat fraud. It resumed accepting claims last Monday.

Unadjusted claims rose 76,670 to 885,885 last week. Economists prefer the unadjusted number given earlier difficulties adjusting the claims data for seasonal fluctuations because of the economic shock caused by the pandemic. Including a government-funded program for the self-employed, gig workers and others who do not qualify for the regular state unemployment programs, 1.3 million people filed claims last week.

Seven months into the pandemic in the United States, first-time claims remain well above their 665,000 peak during the 2007-09 Great Recession, though below a record 6.867 million in March. With new COVID-19 cases surging across the country and the White House and Congress struggling to agree on another rescue package for businesses and the unemployed, claims are likely to remain elevated.

Treasury Secretary Steven Mnuchin said on Thursday he would keep trying to reach a deal with House Speaker Nancy Pelosi, a Democrat, before next month’s election.

Stocks on Wall Street were lower. The dollar gained versus a basket of currencies. U.S. Treasury prices rose.

MILLIONS EXHAUST BENEFITS

About 3.8 million people had permanently lost their jobs in September, with another 2.4 million unemployed for more than six months. Economists fear those numbers could swell.

Though the claims report showed a decline in the number of people on unemployment rolls in early October, economists said that was because many people had exhausted their eligibility for benefits, which are limited to six months in most states.

The number of people receiving benefits after an initial week of aid declined 1.165 million to 10.018 million in the week ending Oct. 3.

About 2.8 million workers filed for extended unemployment benefits in the week ending Sept. 26, up 818,054 from the prior week. That was the largest weekly gain since the program’s launch last spring. These benefits are set to expire on Dec. 31.

Tens of thousands of airline workers have been furloughed. State and local government budgets have been crushed by the pandemic, leading to layoffs that are expected to escalate without help from the federal government.

“Risks to the labor market outlook are weighted heavily to the downside,” said Ryan Sweet, a senior economist at Moody’s Analytics in West Chester, Pennsylvania. “The increased spread of the virus across much of the country could result in an even larger pullback in business activity than expected.”

Though economic activity rebounded in the third quarter because of fiscal stimulus, the stubbornly high jobless claims suggest momentum ebbed heading into the fourth quarter.

Other reports on Thursday showed mixed fortunes for regional manufacturing in October. A survey from the New York Federal Reserve showed its business conditions index fell seven points to a reading of 10.5 this month. Companies reported continued gains in new orders and shipments, though unfilled orders maintained their decline. Factory employment rose modestly, but the average workweek increased significantly.

Separately, the Philadelphia Fed said its business conditions index jumped to a reading of 32.3 from 15.0 in September. Measures of new orders and shipments at factories in the region that covers eastern Pennsylvania, southern New Jersey and Delaware rose. A gauge of factory employment fell, but manufacturers increased hours for workers.

Third-quarter GDP growth estimates are topping a 32% annualized rate. The economy contracted at a 31.4% pace in the second quarter, the deepest decline since the government started keeping records in 1947. Growth estimates for the fourth quarter have been cut to as low as a 2.5% rate from above a 10% pace.

(Reporting by Lucia Mutikani; Editing by Chizu Nomiyama and Andrea Ricci)