Tag Archives: COVID-19

EU urged to review remdesivir supply deal after COVID trial results

By Francesco Guarascio

BRUSSELS (Reuters) – The European Union should renegotiate a 1 billion euro ($1.17 billion) contract it sealed last week with Gilead for a six-month supply of the COVID-19 drug remdesivir after it showed poor results in a large trial, experts said on Friday.

In a blow to one of the few drugs being used to treat people with COVID-19, the Solidarity Trial conducted by the World Health Organization showed on Friday that remdesivir appeared to have little or no effect on mortality or length of hospital stays among patients with the respiratory disease.

The trial results were disclosed a week after the EU’s executive Commission announced its largest contract to date with Gilead for the supply of 500,000 courses of the antiviral drug at a price of 2,070 euro per treatment, which Gilead said was the standard for wealthy nations.

The Commission “needs to present the reasons behind the rush to conclude the latest contract with Gilead and move to review it in light of the Solidarity Trial findings,” said Yannis Natsis, who represents patients’ organizations on the board of the European Medicines Agency (EMA), the EU drug regulator.

The EU announced on Oct. 8 that it had signed the supply contract with the U.S. company on behalf of its 27 member states and 10 partner countries, including Britain.

Gilead had known about the results of Solidarity since Oct. 6, the WHO said, citing disclosure rules under the Solidarity Trial.

Gilead told Reuters it had received in late September an “heavily redacted manuscript” from the WHO which contained different information from the final document published on Friday.

“TIME IS OF THE ESSENCE”

The Commission’s decision was made after EU countries warned of shortages of remdesivir in their hospitals amid a new surge of COVID-19 infections across Europe.

The contract does not oblige countries to buy remdesivir, although it ties them to the agreed price.

Gilead did not comment on whether remdesivir’s price for wealthy countries could change after the WHO trial, and the company questioned its results.

“As time is of the essence – we are in a situation of a public health emergency – we have to not only invest up-front in vaccine development but also in access to therapeutics,” a spokesman for the European Commission said.

He added the EMA would look into the Solidarity results and data available from other studies on COVID treatments “to see if any changes are needed to the way these medicines are used”.

But the spokesman did not comment on whether the EU was aware of the Solidarity results before it signed the contract with Gilead. He also did not reply to questions on whether the price agreed with Gilead could be renegotiated.

“The EU should revisit the prices to be paid for Remdesivir. Why pay 1 billion euros for a drug with no effects on survival?” said Andrew Hill, a senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

He said generic versions of the drug manufactured in India were sold at 200 euros per course.

(Reporting by Francesco Guarascio @fraguarascio; additional reporting by John Miller; Editing by Gareth Jones)

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)

NIH tests therapies to help cut hospital stays for COVID-19 patients

(Reuters) – The U.S. National Institutes of Health (NIH) has started a late-stage trial to evaluate if immune-modulating therapies from three drugmakers can help reduce the need for ventilators for COVID-19 patients and shorten their hospital stay.

The NIH said on Friday it has selected three agents for the study – Johnson & Johnson unit Janssen Research’s Remicade, Bristol Myers Squibb’s Orencia and Abbvie Inc’s experimental drug cenicriviroc.

The study will enroll up to 2,100 hospitalized adults with moderate to severe COVID-19 symptoms in the United States and Latin America.

Immune-modulating therapies are medications that alter the way the immune system works. Severe infections are believed to be triggered by an over-reaction of the immune system, known as a “cytokine storm,” and drugs that suppress certain elements of the immune system can play a role in arresting a rapid escalation of symptoms.

This can lead to acute respiratory distress syndrome and multiple organ failure, among other life-threatening complications.

The NIH said its clinical trial – ACTIV-1 Immune Modulators (IM) – will last six months, and the agency will study if the therapeutics can restore balance by modulating that immune response.

All patients will be given Gilead Sciences Inc’s antiviral drug remdesivir – the current standard of care – and also be randomly assigned to receive a placebo or one of the immune modulators as an add-on treatment, the NIH said in a statement.

Remdesivir was one of the drugs used to treat U.S. President Donald Trump’s coronavirus infection, and has been shown in previous studies to have cut time to recovery, though the European Union is investigating it for possible kidney injury.

(Reporting by Vishwadha Chander in Bengaluru, Editing by Sherry Jacob-Phillips)

Pfizer says earliest COVID-19 vaccine application to U.S. regulators would be after election

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the U.S. election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000 person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall.

The president’s rush to a vaccine has also raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

U.S. health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalized a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its time line raise the possibility of U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s U.S. trial has been on hold since September.

After the FDA announced the two-month requirement on Oct. 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov. 3., Trump called the move a ‘political hit job.’

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1% in premarket trading, while BioNTech’s U.S-listed shares were up 4% before the opening bell. Moderna was unchanged and U.S. futures were higher.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey, Patricia Weiss in Frankfurt; writing by Caroline Humer in New York; Editing by Patrick Graham, Saumyadeb Chakrabarty and Steve Orlofsky)

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)

In U.S. Midwest states, new COVID-19 infections rise to record highs

By Lisa Shumaker and Maria Caspani

CHICAGO (Reuters) – Wisconsin and other states in the U.S. Midwest are battling a surge in COVID-19 cases, with new infections and hospitalizations rising to record levels in an ominous sign of a nationwide resurgence as temperatures get colder.

More than 22,000 new cases of the novel coronavirus were reported on Wednesday across the Midwest, compared with a previous record of more than 20,000 on Oct. 9. Hospitalizations in those states reached a record high for a 10th day in a row as some hospitals began feeling the strain.

More than 86% of the beds in Wisconsin’s intensive care units were in use as of Wednesday, and a field hospital opened in a Milwaukee suburb in case medical facilities become overwhelmed.

Neat rows of makeshift cubicles enclosing beds and medical supplies occupied the fairgrounds in West Allis, which has been the home of the Wisconsin State Fair since the late 1800s.

Dr. Paul Casey, the medical director of the emergency department at Bellin Hospital in Green Bay, Wisconsin said entire wards full of COVID-19 patients were stretching resources “to the limit.”

“It’s going to get worse,” he told CNN on Thursday. “We predict it will peak mid-Novemeber.”

More than 1,000 people were hospitalized for COVID-19 in Wisconsin on Wednesday, the state’s health department said, and health authorities recorded an almost 25% spike in coronavirus hospitalizations in the past seven days compared to the previous week.

Other Midwestern states were also setting grim records.

Since the start of October, North Dakota and South Dakota have reported more new COVID-19 cases per capita than all but one country in the world, Andorra.

These states are reporting three times as many new cases per capita this month than the United Kingdom, Spain or France, according to a Reuters analysis.

“It’s quite concerning,” Dr. Anthony Fauci, the nation’s top infectious disease expert, said in an interview with ABC television on Thursday. “We really got to double down on the fundamental public health measures that we talk about every single day because they can make a difference.”

Fauci also warned about the risks of holding crowded rallies as President Donald Trump returned to the campaign trail after recovering from the coronavirus.

Trump, making a push in the weeks before the Nov. 3 presidential election after being hospitalized with COVID-19, has continued to minimize the threat to public health posed by the virus that has killed more than 216,000 Americans.

New York, once the U.S. epicenter of the virus, is now dealing with a spike in infections in several “clusters.” Governor Andrew Cuomo said he expected flare-ups to continue for at least a year.

“The way of the world going forward is going to be that the virus will constantly flare up in certain locations,” Cuomo told reporters on Wednesday. “The art form is going to be identify these small sites where it flares up and be able to stop it before it spreads.”

(Reporting by Lisa Shumaker in Chicago and Maria Caspani in New York; Additional reporting by Gabriella Borter in New York; Editing by David Gregorio)

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)

Nagorno-Karabakh ceasefire hopes sink as death toll rises

By Nailia Bagirova and Nvard Hovhannisyan

BAKU/YEREVAN (Reuters) – Hopes of a humanitarian ceasefire ending fighting over Nagorno-Karabakh sank further on Thursday as the death toll mounted and Armenia and Azerbaijan accused each other of launching new attacks.

Armenia accused Turkey of blocking flights carrying emergency aid from using its airspace, and Azerbaijan’s president warned of “new victims and new bloodshed” from fighting over the mountain enclave that broke out on Sept. 27.

Azeri President Ilham Aliyev demanded that Armenia “halt attempts to capture liberated territories back” and said his country would take all regions of Nagorno-Karabakh if Armenia “acts negatively.”

Last Saturday’s ceasefire, aimed at letting the sides swap detainees and bodies of those killed in the clashes, has had little impact on the fighting around Nagorno-Karabakh, a mountain territory internationally recognized as part of Azerbaijan but populated and governed by ethnic Armenians.

In the deadliest flare-up since a 1990s war killed about 30,000 people, 604 Nagorno-Karabakh defense personnel have been killed, ethnic Armenian authorities say.

On Thursday, three Azeri civilians were killed and three were wounded during a funeral in Azerbaijan’s Terter region when an artillery shell fell on a cemetery, presidential aid Hikmet Hajiyev said on Twitter.

That would add to Azeri estimates provided on Wednesday that 43 civilians had so far been killed. Baku does not disclose military casualties. The prosecutor’s office said earlier on Thursday that two civilians had been wounded in shelling of the Aghdam area.

The Armenian prosecutor-general’s office said Azeri drones had killed two soldiers in the Vardenis region of Armenia on Wednesday, raising the Armenian military death toll to five. The servicemen were not involved in military action, it said.

A tweet from Nagorno-Karabakh’s ombudsman accused Azerbaijan of using heavy rockets to target civilian infrastructure in the town of Stepanakert.

Reuters could not independently verify the reports.

HUMANITARIAN CONCERNS

International organizations, including the International Committee of the Red Cross, have warned that the conflict, coming on top of the COVID-19 pandemic, could leave tens of thousands of people in need of aid over coming months.

Zareh Sinanyan, Armenian High Commissioner for Diaspora Affairs, said the delivery of 100 tonnes of aid from the United States was being delayed as Turkey had prohibited Armenia-bound humanitarian aid flights over its airspace.

Armenia’s civil aviation committee was told on Wednesday the Qatar Airways flight from Los Angeles was cancelled but gave no reasons, said the committee’s head, Tatevik Revazyan.

“We have grounds to claim that Turkey closed the air route deliberately,” Revazyan told Reuters, adding alternative routes over Russia or Georgia were being sought.

Turkey’s foreign ministry, which handles airspace issues, was not immediately available to comment.

Aside from humanitarian concerns, fears are growing of Russia and Turkey being sucked in. Turkey’s military exports to its ally Azerbaijan have risen six-fold this year, data shows, and Armenia has a defense pact with Russia.

In a phone call on Wednesday with Turkish President Tayyip Erdogan, Russian leader Vladimir Putin expressed concerns about the participation of Middle East fighters in the conflict, though Turkey and Azerbaijan deny the presence of such fighters.

The fighting is also close to Azeri pipelines which carry natural gas and oil to international markets. Aliyev accused Armenia on Wednesday of trying to attack the pipelines, a charge that Armenia denied.

(Additional reporting by Margarita Antidze in Tbilisi and Jonathan Spicer in Ankara; Writing by Sujata Rao; Editing by Timothy Heritage)

Split screen: Trump and Biden to headline dueling town halls

By Joseph Ax

(Reuters) – U.S. President Donald Trump and Democratic challenger Joe Biden will hold dueling prime-time town halls on Thursday instead of their second presidential debate, which was canceled after Trump declined to take part in a virtual matchup.

With less than three weeks to go until the Nov. 3 vote, the Republican president is searching for ways to change the dynamics of a race in which Biden has a double-digit advantage in some national polls.

Nearly 15 million Americans, a record for this date, have cast ballots, according to the U.S. Elections Project at the University of Florida, as voters seek to avoid in-person lines on Election Day because of concerns about the novel coronavirus.

North Carolina, a highly competitive state, began more than two weeks of in-person early voting on Thursday. Local news reports showed long lines of voters eager to cast ballots, and Trump was due to hold an afternoon rally in Greenville in the eastern part of the state.

Trump’s campaign is counting on a surge of last-minute votes. But Reuters/Ipsos polling conducted between Oct. 9 and Oct. 13 shows there are far fewer undecided likely voters this year – around 8% – and they are just as likely to pick Biden as they are Trump.

Four years ago at this stage of the campaign, more than twice as many people were similarly wavering between Trump and his Democratic opponent, Hillary Clinton.

The Reuters/Ipsos polling shows Biden holding a 10 percentage-point lead nationally, with a tighter margin in the battleground states that will help decide the election.

Both candidates have been visiting those states this week, with Trump holding rallies in Florida, Pennsylvania and Iowa and Biden traveling to Ohio and Florida.

Trump has pulled into a statistical tie with Biden in Florida, a key battleground, with 47% support versus Biden’s 49%, and a credibility interval of 4 points, a Reuters/Ipsos opinion poll showed.

Thursday’s town halls, in which each candidate will field questions from voters, will take place at 8 p.m. EDT (0000 GMT), with Trump on NBC from Miami and Biden on ABC from Philadelphia.

Trump pulled out of the scheduled debate when the commission in charge of organizing the event said it would be held virtually after the president contracted the coronavirus. A final debate is still scheduled for Oct. 22 in Nashville, Tennessee.

On Thursday, the Biden campaign said two people involved in the campaign had tested positive for COVID-19, including one on the staff of U.S. Senator Kamala Harris, Biden’s running mate.

Although neither Biden nor Harris was in close contact with the people, the campaign said it was cancelling Harris’ travel until after Sunday, “in line with our campaign’s commitment to the highest levels of precaution.”

Trump has returned to the campaign trail after spending several days being treated for the virus in a military hospital.

NBC said on Wednesday that Clifford Lane, clinical director at the National Institutes of Health, and the government’s top infectious disease specialist, Anthony Fauci, had concluded “with a high degree of confidence” that Trump was no longer “shedding infectious virus.”

The election could be the most closely contested in recent memory due to a deeply divided electorate and the possibility that Trump will challenge widely used mail-in ballots, claiming without evidence they are fraudulent.

(Reporting by Trevor Hunnicutt and Chris Kahn in New York and Doina Chiacu and James Oliphant in Washington; Writing by Joseph Ax and Sonya Hepinstall; Editing by Colleen Jenkins and Matthew Lewis)