WASHINGTON — U.S. health officials have allowed emergency use of the first antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.

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On Monday, the Food and Drug Administration cleared emergency use of bamlanivimab, the first antibody drug to help the immune system fight COVID-19. Courtesy of Eli Lilly via AP

The Food and Drug Administration on Monday cleared the experimental drug, bamlanivimab, from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. It’s a one-time treatment given through an IV.

The therapy is still undergoing additional testing to establish its safety and effectiveness. It is similar to a treatment President Trump received after contracting the virus last month.

Lilly’s studies of the antibody drug are continuing. Early results suggest it may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. A study of it in hospitalized patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.

The government previously reached an agreement to buy and supply much of the early production of Lilly’s drug.

Only one drug – Gilead Sciences’ remdesivir – has full FDA approval for treating COVID-19. Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalized patients.

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Virus relief package uncertain in post-election Congress

WASHINGTON — Congress began a lame-duck session Monday facing uncertain odds for a new COVID-19 relief bill, with the split decision in the election empowering both President-elect Joe Biden and Senate Majority Leader Mitch McConnell while eroding the hardline negotiating posture of House Speaker Nancy Pelosi.

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Senate Majority Leader Mitch McConnell of Kentucky walks back to his office on Capitol Hill in Washington on Monday. Susan Walsh/Associated Press

The outlook for legislation was also clouded by President Trump’s refusal to concede his defeat in the election. He was the chief GOP force pushing for the legislation this fall — at least when he thought it could assist his reelection — but his posture now is at best uncertain.

Having held their own in the election, Republicans controlling the Senate are poised to assert more influence. Republicans largely deferred to Trump’s team during more than three months of long and frustrating negotiations when the White House appeared willing to accept a package of up to $2 trillion, even as they called for a smaller, more targeted bill.

“I’m glad that Sen. McConnell has determined that he’ll be the chief negotiator for our side of the building,” said Sen. Roy Blunt, R-Mo., who added that Pelosi “certainly should be more motivated to get a deal than maybe she was before the election.”

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The renewed legislative maneuvering comes at pivotal moment in the pandemic, with surging COVID-19 caseloads across the country putting new strain on hospitals and raising fears of an economic slowdown. Biden on Monday quickly established an coronavirus advisory board and implored Americans to wear masks, saying action is needed to avoid a “dark winter.”

Biden also made clear he does not want to wait until January to get a relief package done.

“Although we are not in office yet, I’m just laying out what we expect to do and hope can be done, some of it, between now and the time we’re sworn in,” Biden said. “There’s a need for bold action to fight this pandemic. We’re still facing a very dark winter.”

Biden’s victory in the election puts him in the driver’s seat over Pelosi, whose ambitious pre-election demands for the virus package were rooted in assumptions of a sweeping Democratic victory that would expand her majority. Instead, the party suffered an unexpected loss of seats.

Now, the California Democrat may have to settle for a lot less than the $2 trillion-plus package the House passed before the election. That measure is loaded with Democratic agenda items like rental assistance and aid to state and local governments.

Apart from virus aid, lawmakers face a Dec. 11 deadline to prevent a partial government shutdown. At minimum, they must pass a stopgap spending measure to fund operations into the Biden administration.

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McConnell says he wants the pass COVID relief in the lame-duck session, but he says any COVID relief must be targeted to a few areas like aid for businesses that have been especially slammed by the pandemic, funding for schools struggling with the virus, and help for the jobless. McConnell’s other priorities for the session include a $1.4 trillion catchall spending bill, annual passage of the defense authorization bill, and one final round of Trump’s judicial nominees.

U.S. surpasses 10 million coronavirus cases

The United States surpassed 10 million coronavirus cases on Monday, just 10 days after hitting 9 million.

The average number of daily new infections has exceeded 100,000, and public health experts warn the country is entering the pandemic’s worst phase yet.

Utah Republican Gov. Gary R. Herbert declared a state of emergency and issued a statewide mask mandate late Sunday, after months of resisting such an order.

Missouri’s largest county offered a dire warning to its 1 million residents on Monday: New restrictions will be necessary unless the coronavirus surge is brought under control.

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St. Louis County already requires face coverings and has imposed other restrictions, but Democratic Executive Sam Page said at a news conference that with cases rising again and hospitals filling quickly, more drastic measures could be announced next week.

“No one wants to shut down our economy and no one wants more restrictions,” Page said. “We understand how harmful that will be. But we can’t stand by as this virus continues to rage in our community.”

Missouri is among dozens of states seeing a big increase in COVID-19 cases and hospitalizations. After reaching new records in cases several times last week, culminating with a high of 4,559 on Saturday, the state health department reported better numbers Monday — 3,244 new cases and no new deaths.

It’s too early to tell if that was a one-day blip or the start of a trend.

State data showed Missouri’s positivity rate at 19.5 percent — nearly four times the benchmark suggested by the World Health Organization. Missouri has now reported 212,441 confirmed cases and 3,153 deaths since the start of the pandemic.

On Sunday, Dr. Alex Garza of the St. Louis Metropolitan Pandemic Task Force cited a “frightening” amount of virus in the St. Louis area, and he warned that hospitals are increasingly overwhelmed. Average daily hospitalizations and admissions have more than doubled over the past month at St. Louis-area hospitals.

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Israel to offer coronavirus testing at airport

TEL AVIV, Israel — Israel will soon offer coronavirus testing at its main international airport, something authorities hope will speed the revival of air travel.

Passengers at Ben Gurion International Airport will be able to pay around $13 for a test and get results within 14 hours, with faster testing methods on offer in the coming weeks. Authorities say labs at the airport will be able to process 20,000 tests per day. Passengers can register starting Thursday and the testing booths open Sunday.

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Gloves hang from a booth at a new on-site COVID-19 testing facility at Tel Aviv International Airport in Israel, Monday, Nov. 9. AP Photo/Maya Alleruzzo

Visiting the facility on Monday, Prime Minister Benjamin Netanyahu said it can “help us get back to a better, quicker and more efficient aviation routine,” adding that “we want to renew Israel’s link to the world.”

Israel is gradually emerging from its second nationwide lockdown since the pandemic began. The country has reported nearly 320,000 cases, including 2,674 deaths.

An earlier lockdown last spring largely succeeded in containing the outbreak, but cases surged over the summer after authorities reopened too quickly. At one point, Israel, with a population of just 9 million, had one of the world’s worst outbreaks on a per capita basis.

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Authorities plan to gradually ease restrictions over several weeks following the second lockdown, which began in mid-September and was partially lifted last month.

Biden hails Pfizer ‘breakthrough,’ announces task force

U.S. President-elect Joe Biden has hailed as a “breakthrough” Pfizer’s announcement that its vaccine data suggests the shots may be 90% effective at preventing COVID-19.

Biden on Monday congratulated those involved in giving the country “such cause for hope.”

But at the same time, Biden noted that the end of the battle against COVID-19 is still months away.

He said even if a vaccine is approved by the end of this month and some Americans are vaccinated later this year, it’ll be many more months before there’s widespread vaccination across the country.

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Biden cited a warning by the head of the U.S. Centers for Disease Control and Prevention that for the foreseeable future, a mask remains a more potent weapon against the virus than the vaccine.

“Today’s news doesn’t change this urgent reality,” Biden said, adding that Americans will have to rely on masking, distancing, social tracing, hand washing and other measures to keep themselves safe well into next year.

He said the U.S. is still losing over 1,000 people a day from COVID-19 and will continue to get worse unless progress is made on mask-wearing and other actions.

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Belgian officials say surge has hit peak

BRUSSELS — Belgian health authorities are confident a renewed surge of hospital admissions related to COVID-19 has peaked in the hard-hit country.

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Virologist Yves Van Laethem told a news conference on Monday that about 400 people were hospitalized due to coronavirus complications on Sunday, compared with 879 on Nov. 3.

Some 6,948 patients are currently being treated in Belgian hospitals following a COVID-19-infection. It’s about 500 less than on Nov. 3.

To break the chain of contamination, Belgium has returned to partial lockdown measures including closing nonessential shops, bars and restaurants, as well as extending the autumn school vacation.

Van Laethem said the measures seem to have had an impact, as the number of patients in intensive care is also tending to stabilize. There were fears last month that Belgium would reach its maximum capacity for COVID-19 patients in intensive care by mid-November.

Germany sees cases leveling off

BERLIN — Germany’s health minister says the increase in new coronavirus infections appears to be levelling off in the country but it’s too early to talk about a reversal of the trend.

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Germany is one week into a four-week partial shutdown that’s meant to help prevent the health system from being overwhelmed. Restaurants, bars, sports and leisure facilities have been closed and new contact restrictions introduced, though schools and shops remain open.

New infections have continued to increase, reaching a new one-day record of 23,399 on Saturday. The country’s national disease control center on Monday reported 13,363 cases in the previous 24 hours, up from 12,097 a week earlier. Figures are typically lower on Sundays and Mondays because fewer tests are conducted over the weekend.

Health Minister Jens Spahn said Monday “we are seeing that the momentum is flattening, that we have less strong increases. But of course that is not the aim: we don’t want less strong increases, we have to get the figures down.”

Germany, which has 83 million people, has recorded 671,868 coronavirus cases since the pandemic started. Another 63 deaths were reported Monday, bringing the total to 11,352.

Italy’s new concern is number of specialists

ROME — Doctors warn that while Italy for now has enough ICU beds for COVID-19 patients, it won’t have enough specialists to care for them all if the numbers of new infections keep rapidly rising.

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Filippo Anelli, who is president of the national association of doctors, told state TV on Monday that hospitals have reached “critical levels” and cited the growing lines of ambulances parked by hospitals with patients inside waiting for bed space.

Recently in Naples, nurses started checking on ailing persons sitting in their cars as they waited to access emergency rooms. Anelli said while Italy now has a total of 11,000 ICU beds, after 5,000 of them are filled, there won’t be a sufficient number of anesthesiologists to care for the patients occupying them.

As of Sunday, 2,749 ICU beds were filled nationwide. Doctors and other health experts have been pressing the Italian government to lock down the entire country, like it was this spring.

Regional representatives and health ministry experts were conferring on Monday to see which other regions need to be declared “red zones.”

Russia hits new record in coronavirus infections

MOSCOW — Russia on Monday reported a record number of new coronavirus infections but a daily death toll well below the highest toll.

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The national coronavirus task force said 21,798 new cases were recorded, more than 1,000 more than the previous daily tally. It said there were 256 new deaths; the highest daily death toll is 389, recorded on Nov. 4.

Overall, Russia has tallied about 1,796,000 infections and 30,793 deaths but officials say there is no need for another national lockdown.

UN health agency vows accountability in pandemic

GENEVA — The World Health Organization’s chief says his agency is committed to “continuous accountability” as an independent panel evaluating WHO’s management of the global response to the coronavirus pandemic gets ready to brief the organization’s countries this week.

In a speech Monday, WHO chief Tedros Adhanom Ghebreyesus said WHO welcomes “any and all efforts to strengthen the organization,” months after the organization bowed to demands from member countries to start an independent probe evaluating the COVID-19 response.

Tedros also pleaded for more money for the organization, saying there was a “shocking” imbalance between WHO’s annual budget and the expectations countries have of it.

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He said WHO’s budget is equivalent to the amount the globe spends on tobacco products in a single day.

Tedros thanked donors for the $1.6 billion they have provided to WHO’s COVID-19 strategy.

Coronavirus hits milestone 50 million cases

BOSTON — The coronavirus has hit another sobering milestone: more than 50 million cases.

Johns Hopkins University’s coronavirus tracker tallied more than 50.3 million reported cases of coronavirus infection as of Sunday. More than 1.2 million people have died from COVID-19, according to its count.

The U.S., with about 4% of the world’s population, represents almost a fifth of all reported cases.

The country has had more than 9.9 million cases and more than 237,000 deaths from the virus since the pandemic started, according to Johns Hopkins University’s data.

Coronavirus cases and deaths also continue to soar in the U.S., as they are in many countries.


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