Cute Reacts Only: Watch Baby Koala’s Priceless Expressions as Another Tries to Climb Wall



https://cdn1.img.sputniknews.com/img/07e4/09/03/1080354520_57:0:1309:704_1200x675_80_0_0_a4ff0bd51dc85dd38c748d00a64a1309.jpg

Sputnik International

https://cdn2.img.sputniknews.com/i/logo.png

https://sputniknews.com/videoclub/202009031080356097-cute-reacts-only-watch-baby-koalas-priceless-expressions-as-another-tries-to-climb-wall/

Koalas are herbivorous marsupials which are native to Australia. These fuzzy guys love hanging out in trees and can sleep nearly all day.

This baby koala seems unconcerned about his mate struggling to climb a wall. With a confused expression, the adorable mammal almost puts his face into the camera and walks away, only to chill in a corner and enjoy the green surroundings.





Source link

Sources: TikTok sale talks have been complicated by China's new AI export restrictions, with parties unsure whether TikTok's algorithms can be included in sale (Wall Street Journal)




Wall Street Journal:

Sources: TikTok sale talks have been complicated by China’s new AI export restrictions, with parties unsure whether TikTok’s algorithms can be included in sale  —  Complexity of new Chinese export restrictions has reduced the chances of a sale occurring soon





Source link

In Steve Bannon Border Wall Case, Prosecutors Have ‘Voluminous’ Emails


Federal prosecutors have seized “voluminous” emails and other communications in their case against Stephen K. Bannon, the former adviser to President Trump who is charged with defrauding donors to a private group that promised to build a wall on the Mexican border, the government said on Monday.

Mr. Bannon and three other men have been accused of stealing hundreds of thousands of dollars in the scheme. The campaign, known as “We Build the Wall,” raised more than $25 million from private donors by promising to build portions of the wall, the president’s signature political initiative.

Prosecutors have said that while thousands of investors were led to believe all their donations would go toward the project, Mr. Bannon diverted over a million dollars and used some of it for personal expenses. He pleaded not guilty on Aug. 20 and declared as he left federal court in Manhattan, “This entire fiasco is to stop people who want to build the wall.”

The government outlined the materials it had seized during a virtual court hearing in Manhattan Monday that also highlighted the charged, election-year atmosphere surrounding the case.

Prosecutors had complained to the judge about Facebook posts by one of Mr. Bannon’s co-defendants, Brian Kolfage, a disabled Air Force veteran who founded the group and in recent days has proclaimed on the social network that the prosecution was “political,” a “witch hunt” and an effort to take “political prisoners.”

In the hearing on Monday, the judge, Analisa Torres of Federal District Court, set a trial date of May 24 for the four men, all of whom are charged with conspiracy to commit wire fraud and conspiracy to commit money laundering.

Mr. Kolfage, 38, and two other defendants, Andrew Badolato, 56, and Timothy Shea, 49, pleaded not guilty during the hearing. None of the defendants were physically in court. Because of the pandemic, they, the judge, the prosecutor and defense lawyers appeared remotely from different locations on video screens, with five images visible at a time.

According to the indictment, Mr. Bannon and Mr. Kolfage “repeatedly and falsely assured the public” that all the money raised would go to the project and Mr. Kolfage would “not take a penny in salary or compensation.”

But Mr. Kolfage secretly took more than $350,000 in donated funds and used them for home renovations, boat payments, a luxury car, a golf cart, jewelry, credit card debt and cosmetic surgery, the indictment charged.

Mr. Bannon, 66, received more than $1 million through a nonprofit he controlled and then used it to pay Mr. Kolfage and also to cover hundreds of thousands of dollars in personal expenses, the indictment said.

He was arrested early on the morning of Aug. 20 as he was on the deck of a 150-foot yacht off Westbrook, Conn. It belonged to the fugitive Chinese billionaire Guo Wengui, officials have said.

During the proceeding, Judge Torres asked the prosecutors when they would turn over the evidence and other materials they have gathered to the defense, so defense attorneys can prepare for trial.

One of the prosecutors, Alison G. Moe, characterized the material as “voluminous,” and told the judge that investigators obtained some of it as far back as January after executing search warrants for email and cloud storage accounts.

She said investigators executed more search warrants in July and August, seizing various devices that store emails — presumably phones, tablets or laptops — and searching several locations, which law enforcement officials said included the homes of the defendants.

Ms. Moe also said on Monday that Mr. Kolfage’s comments on social media had violated local rules governing the behavior of parties in federal court in New York. The prosecutors have said such posts could taint the potential jury pool.

In a letter to the judge last week, prosecutors had referenced “a steady stream” of “highly inflammatory” public statements that Mr. Kolfage had made since his arrest, including claims that the prosecution was an assault on the freedom of donors, made for “political reasons.”

Mr. Kolfage, an Air Force veteran from Miramar Beach, Fla., who lost both legs and an arm in a mortar attack in Iraq, initially created the wall project as a GoFundMe page in December 2018.

In one Facebook post cited by the government, Mr. Kolfage wrote that the U.S. attorney’s office in Manhattan “will ruin innocent people’s lives in order to have a war trophy pinned to the wall just before elections.”

Mr. Kolfage’s lawyer, Harvey A. Steinberg, argued in court that it was the prosecution that had made improper statements, not his client. He pointed out that one law-enforcement official had said in a news release that the indictment should serve as “a warning to other fraudsters that no one is above the law, not even a disabled war veteran.”

Mr. Steinberg added that the government reminded him of a bully “who picks on, if you will, the person who he perceives to be the weakest, and then when the weakest hits him back he runs to the teacher.”

Judge Torres warned that she expected the parties to abide by the local rules governing what may be said publicly without interfering with a fair trial. If necessary, she suggested, she would hold a hearing on the matter.

Juliana Kim contributed reporting.



Source link

Steve Bannon’s 3 co-defendants plead not guilty in ‘We Build the Wall’ fraud case


Bannon has called the charges “a political hit job.”

Former White House chief strategist Steve Bannon’s three co-defendants indicted in a conspiracy to commit wire fraud and money laundering in connection to a crowdfunding campaign to build a wall along the U.S.-Mexico border each pleaded not guilty on Monday.

Air Force veteran Brian Kolfage, 38, Andrew Badolato, 56, and Timothy Shea, 49, entered their pleas in U.S. federal court in New York during a hearing conducted via teleconference due to COVID-19 restrictions.

The three men, along with the 66-year-old Bannon, were charged with defrauding donors through the $25-million crowdfunding “We Build the Wall campaign” by allegedly making false representations to contributors.

Bannon pleaded not guilty earlier this month to allegedly using hundreds of thousands of dollars in donations made to the campaign to pay personal expenses.

Judge Annalisa Torres of the U.S. District Court for the Southern District of New York set a trial date of May 24, 2021.

“I’m going to be optimistic and hope that we have courtrooms available,” Torres said, noting the curtailing of in-person proceedings due to the COVID-19 pandemic.

Torres warned the defendants about statements they make outside of court that threaten “the court’s ability to conduct a fair trial.”

In court filings on Friday, federal prosecutors singled out Kolfage and asked Torres to warn him about his “steady stream of public statements via posts on his Facebook account” that could taint the jury pool.

Prosecutors said in court papers that Kolfage has repeatedly described the prosecution on social media as, among other things, “political,” a “witch hunt” and an assault on the freedom of every donor to the We Build the Wall campaign. Prosecutors say Kolfage has also claimed the case is an ‘”effort to take ‘political prisoners.'”

Kolfage’s attorney complained about the government’s filing and how prosecutors portrayed the indictment.

“Reminds me of a bully,” Kolfage’s defense attorney Harvey A. Steinberg said.

Bannon, who was President Donald Trump‘s former campaign CEO and later his chief strategist in the White House, has slammed the charges against him as “a political hit job” and “nonsense,” while vowing to fight the charges against him.

Prosecutors said Bannon and others defrauded hundreds of thousands of donors to the online campaign by falsely assuring them that the organizers were not taking a penny of donation money. Bannon had publicly stated, “we’re a volunteer organization.”

“Those representations were false,” the indictment said.

Bannon’s indictment makes him the sixth person associated with the top echelons of Trump’s 2016 presidential campaign to face federal charges — a list that includes Roger Stone, Michael Flynn, Rick Gates, Paul Manafort and Michael Cohen.

According to the indictment, Bannon took at least $1 million from the “We Build The Wall” campaign to secretly pay Kolfage, the group’s founder, and cover hundreds of thousands of dollars in personal expenses.

Bannon, Koflage, Badolato and Shea were each charged with one count of conspiracy to commit wire fraud and one count of conspiracy to commit money laundering. Each charge carries a maximum sentence of 20 years in prison, the Justice Department said.

The indictment states that all four defendants allegedly defrauded hundreds of thousands of donors in connection with the crowdfunding campaign.



Source link

China’s Xi calls for constructing ‘impregnable wall’ against separatism in Tibet


Beijing: Chinese President Xi Jinping has called for building a “new modern socialist” Tibet, constructing an “impregnable wall” against separatism in the sensitive Himalayan region and “sinicisation” of the Tibetan Buddhism, the official media reported on Saturday.

Xi, also the General Secretary of the ruling Communist Party of China (CPC), in his address to the seventh Central Symposium on Tibet Work, said that efforts must be made to build Tibet that is united, prosperous, culturally advanced, harmonious and beautiful, Xinhua news agency reported.

 

Underlining the need to fully implement the CPC’s policies on governing Tibet for a new era, Xi, in a comprehensive address on the Himalayan region, called for efforts to build a “new modern socialist” Tibet.

He told officials attending the two-day symposium that they should make efforts to “ensure national security and enduring peace and stability, steadily improve people’s lives, maintain a good environment, solidify border defence and ensure frontier security,” the report said.

Tibet, officially referred to as the Tibet Autonomous Region (TAR), remained deeply devoted to Buddhism where the Dalai Lama is revered as the spiritual head despite his self-exile to India since 1959 after China took control of the region in 1950. It also shares borders with India, Bhutan and Nepal.

 

President Xi said that the work in Tibet must insist on maintaining the unity of the motherland and strengthening national unity as the focus.

“It is necessary to strengthen the education and guidance of the masses, extensively mobilise the masses to participate in the struggle against separatism, and form an impregnable wall for maintaining stability,” he said.

While Beijing views the Dalai Lama as a separatist and “splittist” who seeks to split Tibet from China, the 1989 Nobel Peace Prize laureate says he only seeks greater rights for Tibetans, including religious freedom and autonomy.

 

The 14th Dalai Lama fled to India in 1959 following a crackdown on an uprising by the local population in Tibet. India granted him political asylum and the Tibetan government-in-exile is based on Dharamsala in Himachal Pradesh since then.

Xi also spoke of “sinicisation” of the Tibetan Buddhism.

“It is necessary to dig out, sort out and publicise the historical facts of the exchanges and integration of all ethnic groups in Tibet since ancient times, guide the people of all ethnic groups to see the direction and future of the nation, deeply realise that the Chinese nation is a community of destiny, and promote exchanges and integration of all ethnic groups,” Xi said.

 

‘Sinicisation’ broadly refers to bringing non-Chinese communities under the Chinese culture and political system being pursued by the CPC under the broad definition of socialism with Chinese characteristics.

Since 1959, Tibet has been witnessing periodic incidents of violence, unrest and protest against Beijing.

China asserts that Tibet has been its part since the 13th century and will remain so forever.

“It is necessary to actively guide the Tibetan Buddhism to adapt to the socialist society and promote the sinicisation of the Tibetan Buddhism,” Xi said.

 

He said that since the sixth symposium in 2015, Tibet has made comprehensive progress and historic achievements in its various undertakings.

He noted that Tibet has achieved sustained stability and rapid development, constituting a major contribution to the overall work of the CPC and the state.

Since the 18th CPC National Congress in 2012, when he took over power, policies on governing Tibet for a new era have taken shape, Xi said, stressing that the CPC leadership, the system of socialism with the Chinese characteristics and the system of regional ethnic autonomy must be upheld to carry out work related to Tibet.

 

Besides Xi, Premier Li Keqiang and other senior leaders of the CPC, official in-charge of the Tibet Autonomous Region, the party and government of various cities and provinces of Sichuan, Yunnan, Gansu and Qinghai provinces took part in the meeting which concluded here on Saturday.



Source link

Wall Street rallies on new Fed stance, COVID-19 test progress


Declines in market-leading momentum stocks capped the S&P’s gains and held the Nasdaq in the red.

Shares of Abbott Laboratories jumped 7.9 per cent after the company won US approval to market a cheap, portable, rapid COVID-19 antigen test, which could be a step toward containing the pandemic that sent the US economy spiralling into recession.

Economic recovery was forefront in Fed Chairman Jerome Powell’s remarks made as part of the Kansas City Fed’s virtual Jackson Hole symposium. In the speech Powell outlined the central bank’s aggressive new strategy to support the economy by lifting inflation and returning the economy to full employment.

“We’re going to have low interest rates as far as we can see and COVID is on the way out because of the inexpensive test that Abbot is introducing soon,” said Peter Tuz, president of Chase Investment Counsel in Charlottesville, Virginia. “It gives investors two reasons to be positive about equities.”

But with last week’s initial jobless claims stubbornly hovering above the 1 million mark, according to the Labor Department, a return to full employment currently appears to be a long haul.

In late trade, the Dow Jones is up 0.8 per cent, the S&P 500 has gained 0.3 per cent and the Nasdaq Composite has shed 0.2 per cent. The ASX is poised to edge lower, with futures at 5.35am AEST pointing to a drop of 10 points at the open.

Of the 11 major sectors in the S&P 500, financials enjoyed the biggest percentage gain while communications services , weighed down by Netflix and Facebook, lagged.

Shares of Walmart and Microsoft rose 5.3 per cent and 2.7 per cent, respectively after announcing a joint bid for TikTok’s US assets.

Luxury retailer Tiffany & Co advanced 1.9 per cent after reporting stronger-than-expected profit just days after delaying its $US16.2 billion ($22.3 billion) sale to France’s LVMH.

On the other end of the retail scale, discount stores Dollar General and Dollar Tree also beat quarterly profit expectations.

Boeing Co rose 1.4 per cent after the European Union Aviation Safety Agency announced plans to begin flight tests of its grounded 737 MAX plane.

Loading

Cosmetics maker Coty plunged 8.7 per cent after retail closures and weak demand led to a bigger-than-expected quarterly loss.

Advancing issues outnumbered declining ones on the NYSE by a 1.05-to-1 ratio; on Nasdaq, a 1.30-to-1 ratio favoured decliners.

The S&P 500 posted 37 new 52-week highs and no new lows; the Nasdaq Composite recorded 58 new highs and 20 new lows.

Reuters

Business Briefing

Start the day with major stories, exclusive coverage and expert opinion from our leading business journalists delivered to your inbox. Sign up for the Herald‘s here and The Age‘s here.

Market Recap

A concise wrap of the day on the markets, breaking business news and expert opinion delivered to your inbox each afternoon. Sign up for the Herald‘s here and The Age‘s here.

Most Viewed in Business

Loading



Source link

Wall Street rolls on with another record day


Salesforce.com, the cloud computing company and soon-to-be Dow component, saw its shares soar following its beat-and-raise earnings report.

“Your three highest sectors are all the mega-cap tech and tech-related stocks,” said Joseph Sroka, chief investment officer at NovaPoint in Atlanta. “So that notion of large-cap tech leading the market is in play today.”

“There’s this confidence that regardless of what happens with COVID, these companies have proven that they’re open for business.”

Supporting that thesis, Netflix shares had their best day in over three years. The stay-at-home favourite has surged about 67 per cent since the final closing bell of 2019.

Energy was the biggest percentage loser among S&P 500 sectors, as Hurricane Laura bore down on the Texas-Louisiana coastline, posing the largest threat to US energy assets since 2005’s Hurricane Katrina. The coming storm, now a Category 4, prompted crude producers and refiners to shut down their facilities.

Commercial air carrier stocks lost altitude even after the White House announced President Donald Trump was weighing an executive action to avoid massive layoffs in the sector.

The U.S. Federal Reserve is expected to unveil a new framework intended to soften the central bank’s inflation stance, which Chairman Jerome Powell is expected to address during his remarks on Thursday as part of the Kansas City Fed’s virtual Jackson Hole symposium.

Unofficially, the Dow Jones Industrial Average rose 0.3 per cent, the S&P 500 gained 1 per cent,and the Nasdaq Composite added 1.7 per cent. It sets up the ASX for gains this morning, with futures at 6am AEST pointing to a gain of 11 points, or 0.2 poer cent, at the open.

Communications services led the 11 major sectors in the S&P in percentage gains.

Second-quarter earnings season has wound down, with 483 of the companies in the S&P 500 having reported. Of those, 82.2 per cent have beaten consensus, according to Refinitiv data.

Loading

In aggregate, analysts now see earnings for the April to June quarter having dropped by 29.9 per cent year-on-year, according to Refinitiv.

Hewlett Packard ended the session higher after its full-year profit outlook beat expectations, while tax software firm Intuit advanced on a 17 per cent rise in quarterly revenue.

Apparel retailer Nordstrom tumbled in the wake of posting bigger-than-expected quarterly losses after being forced by mandated lockdowns to shutter its stores for much of the quarter.

Reuters

Business Briefing

Start the day with major stories, exclusive coverage and expert opinion from our leading business journalists delivered to your inbox. Sign up for the Herald‘s here and The Age‘s here.

Market Recap

A concise wrap of the day on the markets, breaking business news and expert opinion delivered to your inbox each afternoon. Sign up for the Herald‘s here and The Age‘s here.

Most Viewed in Business

Loading



Source link

Wall Street stocks stall at record high


Wall Street stocks lost momentum after hitting a new high following rises in Europe after data showed business sentiment improving in Germany and amid signs of progress on US-China trade talks.

The S&P 500 ticked up as much as 0.22 per cent in early dealings on Tuesday, enough to lift the index to a fresh all-time peak. The gauge, which has advanced almost 5 per cent in August, fell back to the unchanged line within less than an hour of the opening bell.

Investors also retreated from bonds while the euro firmed. This came after the US and China reaffirmed a commitment to their “phase one” trade talks, in a rare sign of co-operation following weeks of wrangling over issues such as the future of Chinese social media platform TikTok in the US.

German gross domestic product contracted 9.7 per cent in the second quarter, which was the height of the coronavirus pandemic in Europe, as private consumption, investments and exports collapsed. An earlier reading had, however, shown the economy shrinking by 10.1 per cent between April and June.

Meanwhile, a survey by Germany’s highly regarded Ifo Institute showed sentiment among business leaders in Europe’s biggest economy improved to its highest level since February. The research group’s business climate index rose to 92.6 for August, up from 90.4 in July.

The data boosted the euro, which rose 0.2 per cent against the dollar to purchase $1.1814. Germany’s Dax index was 0.3 per cent higher while France’s CAC 40 gained 0.5 per cent. The Europe Stoxx 600 rose 0.1 per cent.

The yield on the 10-year US Treasury rose 5 basis points (0.05 percentage points) to 0.699 per cent while gold lost 0.4 per cent to trade at $1,926 per troy ounce. Germany’s 10-year bond yield, which moves inversely to prices, rose 6bp to minus 0.39 per cent.

Monica Defend, head of global research at asset manager Amundi, said she was “really struggling with the idea that the S&P 500 will continue to climb”. She argued that while markets were pricing in a V-shaped recovery for the US economy, “we are expecting something less resilient”, after US jobless claims rose back above 1m last week.

She added, however, that she expected US inflation, which is traditionally negative for stocks and bonds, to remain low.

Investors are struggling with contradictory views on inflation, which has become harder for economists to forecast because of the pandemic.

Many are looking to the Jackson Hole meeting of central bank governors, which will be held on Thursday and Friday in a virtual format, for clues.

“We are hoping for more colour on inflation targeting from [Federal Reserve chairman] Jay Powell at Jackson Hole,” Ms Defend said.

The German GDP data were a “final glance in the rear-view mirror”, wrote Carsten Brzeski of ING, predicting a recovery in the July-to-September quarter because of a reduction in value added tax and summer domestic tourism. “The economy will have one of its best quarterly performances ever in the third quarter,” he said.

Shamik Dhar, chief economist at BNY Mellon, said that, while coronavirus cases were once again rising across Europe, hospitalisation and death rates did not appear to be heading back towards the levels seen in March and April.

“The course of the disease remains hugely uncertain and this latest spike may lead to more regional lockdowns,” he said. “But my essential view is that Germany will bounce back,” he added, in part because of pent-up consumer demand.

In London the FTSE 100, which has lost almost a fifth of its value during 2020 as fears over the economic impact of Covid-19 and Brexit mount, traded flat. Shares rose across Asia-Pacific for a second day, with MSCI’s benchmark up 0.4 per cent.

Brent crude, the international oil benchmark, added 0.5 per cent to $45.37 a barrel.



Source link

Wall Street closes at record highs on vaccine optimism


The blue-chip Dow, while leading Monday’s gains, remains nearly 4.2 per cent below its all-time high, and down 0.8 per cent year-to-date. The Nasdaq and the S&P have gained 26.8 per cent and 6.2 per cent, respectively, since the final closing bell of 2019.

Of note, the Dow Transports index, often considered a barometer of US economic health, handily outperformed the broader market.

“There’s been a broadening in this rally and the what’s reflected in the transports,” said Chuck Carlson, chief executive officer at Horizon Investment Services.

“(Higher) volume is accompanying this expanding breadth, and those are all bullish things.”

Markets worldwide were given a boost by new developments in the global race to battle the coronavirus, including an announcement from the Food and Drug Administration that it had given emergency authorisation for the use of plasma from recovered patients as a treatment option.

However, the World Health Organisation expressed scepticism about the treatment due to “low quality” data.

The Trump administration is considering fast-tracking an experimental COVID-19 vaccine being developed by AstraZeneca and Oxford University in hopes it could be deployed in the United States before Americans head to the polls in November.

“There’s an element of that news helping the ‘reopening trade,’ which is a euphemism of economically sensitive stocks performing better,” Carlson added.

The four-day Republican national convention got under way on Monday, with the party making the case for Trump’s re-election.

On Capitol Hill, Democrats and Republicans remained at loggerheads over funding levels and unemployment benefits.

Loading

Market participants will pay close attention to US Federal Reserve Chairman Jerome Powell’s remarks on monetary policy at this week’s Kansas City Fed Jackson Hole symposium, which is being held this year in a virtual format.

Energy and financials enjoyed the largest percentage gains.

Ahead of its 4-to-1 share split on Friday, Apple provided the biggest boost to the S&P 500 and the Nasdaq, its share price closing above $US500 days after becoming the first public US company to top $US2 trillion ($2.8 trillion) in market value. The stock gained 1.2 per cent.

Boeing gave the Dow its biggest lift, rising 6.4 per cent.

Advancing issues outnumbered declining ones on the NYSE by a 2.52-to-1 ratio; on Nasdaq, a 1.26-to-1 ratio favoured advancers.

The S&P 500 posted 45 new 52-week highs and no new lows; the Nasdaq Composite recorded 84 new highs and 36 new lows.

Volume on US exchanges was 8.94 billion shares, compared with the 9.53 billion average over the last 20 trading days.

Reuters

Business Briefing

Start the day with major stories, exclusive coverage and expert opinion from our leading business journalists delivered to your inbox. Sign up for the Herald‘s here and The Age‘s here.

Market Recap

A concise wrap of the day on the markets, breaking business news and expert opinion delivered to your inbox each afternoon. Sign up for the Herald‘s here and The Age‘s here.

Most Viewed in Business

Loading



Source link

Scientists to Wall Street: You don’t really understand how COVID vaccine tests work


Our mission to help you navigate the new normal is fueled by subscribers. To enjoy unlimited access to our journalism, subscribe today.

Earlier this month, shares in Novavax, a small biotechnology company, jumped 10% when its COVID-19 vaccine candidate showed promise in an early stage clinical trial.

Among the results that most excited investors were the high level of antibodies researchers had found in blood samples of those injected with the vaccine. Comparing the antibody counts—known as quantitative serum titers, or often simply “titers”—between vaccine candidates has become a parlor game of sorts for stock analysts, investors and venture capitalists seeking an early indication of which of the more than 165 vaccine candidates currently under development might prove most effective, and become the preferred inoculation for much of the world’s population.

In one bullish assessment, Evercore ISI analyst Josh Schimmer noted that Novavax’s antibody levels were “well above” what Novavax’s competitors had reported. J.P. Morgan analyst Eric Joseph wrote that “it’s not too far a stretch to conclude the [neutralizing antibody] activity of [Novavax’s vaccine candidate] looks best-in-class.”

Differences in reported neutralizing antibody titers also explains why, during the third week in July, when both Oxford University’s COVID-19 vaccine team and startup BioNTech both reported positive results from Phase 1 clinical trials of their respective vaccines, shares in AstraZeneca, which is working with Oxford, slumped while those of Pfizer, which is working with BioNTech, leapt: the titer figures were higher in the BioNTech research.

But scientists who study vaccines say there’s a major problem with such comparisons: they are, at this stage, completely invalid.

No “meaningful value”

Currently, it is impossible to make an apples-to-apples comparison of immune responses in blood tests between Covid-19 vaccine candidates. So far, each vaccine candidate has been tested using a different procedure—known as an assay— conducted in different labs. And it turns out that tests conducted this way produce wildly different results, even for the same vaccine.

“I don’t believe the neutralizing antibody numbers being reported right now have any meaningful value,” says John Moore, a professor of microbiology and immunology at Cornell University medical school who has written about the difficulties of comparing COVID-19 vaccine research results. “We don’t even know what a protective titer actually is: is a titer of 100 good or bad? We don’t know.”

Wayne Koff, the chief executive of the Human Vaccines Project, a nonprofit that is trying to speed the development of vaccines for numerous, says that most research teams working on Covid-19 vaccines are testing them on assays of their own choosing, often in their own labs. “This provides every opportunity of hyping a candidate and making it appear that one vaccine is better than another vaccine, when actually we don’t have the data to reach those conclusions,” he says.

Many research groups have been publishing comparisons of the antibody titers from the blood of people inoculated with their vaccine candidates to the antibody titers found in the blood of people who have recovered from Covid-19. The implication is that if the vaccine elicits a similar or higher antibody titer, and if people who’ve recovered from Covid-19 are immune from catching the disease again for some period of time, then the vaccine should also provide temporary immunity.

But even this analysis is flawed, Koff says. That’s because at the moment there is no standard panel of blood from recovered Covid-19 patients against which to assess the titers. The blood samples in some studies might have come from patients who were much more sick than in other studies and the level of antibody production can vary immensely between individuals depending on factors ranging from age to genetics.

A familiar problem

The problem of assay disagreement—that different tests produce different results—is well known among vaccine researchers. Moore and Koff, who both studied HIV/AIDS earlier in their careers, said that similar problems once plagued attempts to develop a vaccine for that disease. But, over the past decade, with encouragement and funding from the Gates Foundation, the field has agreed on a standard assay and designated just a few laboratories that are certified to carry out standardized testing for all vaccine candidates.

Some researchers want to replicate that system for COVID-19. Scientists at Oxford’s Jenner Institute, in publishing results of their Phase 1 human clinical trial, noted that they had tested blood samples on four different types of assay, and while the results correlated, the titers varied widely. In the paper, they called for a central lab to be set up to assess all Covid-19 vaccines.

Sarah Gilbert, one of the Oxford researchers, says a standardized assay and a central testing lab could accelerate getting multiple Covid-19 vaccines into production, something most analysts now think will be essential in order to distribute a vaccine to enough of the world’s population to end the pandemic. If one vaccine completed human safety-and-efficacy trials, and its neutralizing antibody titers were known, and a second vaccine showed the same or higher antibody titers on the same assay performed in the same lab, then this would be reasonable evidence that the second vaccine was also effective.

As a result, she says, the second vaccine might potentially be able to win regulatory approval without having to complete large scale Phase III testing. (The vaccine would still have to undergo human safety testing, of course.)  “You don’t want to have to do Phase III studies for every vaccine out there,” she says.

Operation Warp Speed

The U.S. government effort to accelerate development of an effective Covid-19 vaccine, known as Operation Warp Speed, has specified that all vaccines seeking a Food and Drug Administration license must be evaluated on the same neutralizing antibody assay in the same lab. That’s one of the reasons Operation Warp Speed’s findings will be so important to the global effort to find an effective vaccine.

John Mascola, the head of vaccine research for the National Institute of Allergies and Infectious Diseases, who has helped set up Operation Warp Speed, says that the project is currently in the process of creating and validating standardized assays. This includes designing strict procedures for how a lab should conduct the tests. He says this work should be completed “in the next few months, or sooner.” He says the lab designated by Operation Warp Speed for assessing vaccine candidates should also be named in the next few months.

He says the Operation Warp Speed is also hoping to eventually see a standardized panel of blood from recovered Covid-19 patients that can be used to compare the immune response the vaccines elicit to the immune response the actual virus creates, but that creating this panel was a lower priority and was being worked on in collaboration with the World Health Organization and European health agencies.  

The issue of standardized antiboday assays is further complicated by the fact that different types of assays may be needed. True neutralizing-antibody assays, which are the gold standard, use a live SARS-CoV-2 virus, which means they have to be conducted in a specialized lab with heightened safety and security protocols. In practice, this often means a government facility. In the U.K., the neutralizing-antibody testing is being carried out at the Centre for Applied Microbiology and Research, which is housed within the Defence Science and Technology Laboratory at Porton Down, near the town of Salisbury. Porton Down is also where the U.K. conducts much of its biological and chemical weapons research.

The protocols needed to handle a live virus, Gilbert says, makes true neutralizing-antibody assays slow to run. “It is never going to be a high throughput assay,” she says. To speed up testing and make assays available to more labs, the U.S. and other governments are also working to create a standardized “pseudovirus neutralizing assay.” This uses a harmless virus, usually a retrovirus, that is modified to produce the same external envelope of carbohydrates and proteins as the SARS-CoV-2 virus. If the antibodies a vaccine induces can neutralize this modified retrovirus, it is a reasonable guess—although not a guarantee—that they will also be able to knock out the coronavirus itself.

Blinding assays

Finally, there are what are known as “binding assays.” These simply test whether antibodies produced by a vaccine can latch on to the spike protein SARS-CoV-2 has on its surface. They do this by mixing the appropriate chemical proteins—unattached to any kind of virus—with the antibodies. Binding assays are considered less reliable indicators of a vaccine’s power than the two types of neutralizing-antibody assays, but they are simpler, cheaper and faster to perform.

Many of the same issues that bedevil comparing neutralizing antibody assays, apply equally to assays for T-cell responses. T-cells, which hunt down and neutralize infected cells and also signal the immune system to ramp up its response to a disease, are thought to be able to remember certain pathogens they’ve battled before. Many of the groups working on COVID-19 vaccines believe their inoculations will elicit a strong and long-lasting T-cell response that could confer immunity on those vaccinated, even if the antibodies prove short-lived.

But Mascola says efforts to create standardized T-cell assays are, if anything, even more fraught than creating standard antibody assays. That’s because, he says, T-cell assays require a more complex blood sample that preserves both the serum—or fluid part of blood—and the individual blood cells. These blood samples then have to be carefully frozen and unfrozen, creating a trickier protocol for standardization. Despite these difficulties, there are plans to create a standardized T-cell assay, Mascola says, but it is likely to take more time than the antibody assays.

Mascola also emphasizes that while the assay titers are important and might one day allow the short-circuiting of full Phase III clinical trials that Gilbert hopes for, the data that will determine which vaccines initially receive licenses from the FDA, and probably from most other government regulators around the globe, will be the efficacy results from large, Phase III human trials. Those trials track an inoculated group of individuals against a control group and compare how many people get COVID-19 in each.

It is only after some vaccines have proven themselves in Phase III trials that the antibody titers and T-cell numbers, performed on standardized assays, will provide a way to judge the strength of subsequent vaccine candidates against those already licensed, he says.

“There’s really no substitute for a Phase III trial,” he says.

More coronavirus coverage from Fortune:



Source link