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Business

Vaxart shares plunge on weak antibody response to oral vaccine

An experimental coronavirus oral vaccine showed promising results in an early clinical trial of 35 healthy adults, Vaxart of South San Francisco said on Wednesday. Despite the results, Vaxart’s stock fell about 57%.

Vaxart scientists divided volunteers between the ages of 18 and 54 into three groups. The first group received two low doses of the vaccine – called VXA-CoV2-1 – 29 days apart, while the remaining groups received a single low or high dose.

The vaccine, contained in a small tablet, produced a type of T cell responsible for killing virus-infected cells in about 75% of the volunteers who received a single low or high dose. The reported reactions are higher than with the vaccines from Moderna and Pfizer.

However, neutralizing antibodies were not detected in volunteers after a single dose, Vaxart said. Researchers believe that the antibodies play an important role in the defense of cells against the virus. The company said it is currently testing second-dose antibody responses after antibodies were detected in two-dose volunteers’ nasal swab samples.

Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto, said the company’s shares could fall after the first dose due to the lack of neutralizing antibodies.

“The immune response is diverse,” he said, adding that one aspect of the immune response is to make antibodies, especially neutralizing antibodies. “While it is great to see that there seems to be a decent T-cell response, the lack of antibodies detected is problematic and can reduce the effectiveness of this vaccine.”

The company said no serious adverse events were reported in the Phase 1 study, with side effects generally being mild. Volunteers reported common side effects such as headache and fatigue, and there was a “slight increase” in the high-dose group of loose stool cases, the company said.

The data will be presented on Wednesday afternoon at the New York Academy of Sciences symposium.

“The most exciting thing about the [phase one data] is that we can get a very, very strong T-cell response even after one dose, “Sean Tucker, Vaxart’s chief scientific officer, told CNBC in a telephone interview, adding that T-cells do compared to antibodies fighting the virus is likely to be “underestimated”.

The biotech company said the vaccine has the potential to provide better protection against current and emerging strains of the virus than existing vaccines. Moderna, Johnson & Johnson and Novavax have announced in the past few days that their vaccines may be less effective against B.1.351, a highly contagious strain found in South Africa. US officials have raised concerns that Covid may continue to mutate and defy the protection of existing vaccines.

Vaxart’s vaccine contains DNA instructions for making the spike protein that allows the virus to enter human cells, as well as instructions for making the N protein, which is involved in other processes. Tucker said the inclusion of the N protein could cause the vaccine to retain its ability to work against emergent strains.

Many other vaccines under development chose spike protein as a “primary target,” he said. “But the problem with that [spike] Protein it definitely mutates more over time. We also added the N protein, which is highly conserved in the virus. “

According to Vaxart, the vaccine is the only oral tablet in the US that has been tested in humans. Similar technology is being used to develop vaccines against influenza and norovirus.

The company was investigated and investigated by the federal government late last year for allegedly exaggerating its involvement in Operation Warp Speed, former President Donald Trump’s vaccines and treatments program. A June press release said that “Vaxart’s Covid-19 vaccine has been selected for US government Operation Warp Speed,” which rocketed its stocks.

However, it found the company had received no federal government funding for vaccine doses and was only participating in preliminary U.S. studies to identify potential areas for possible Warp Speed ​​partnership and support, according to the New York Times.

Tucker told CNBC the company is in talks with the US and other governments to find possible ways to collaborate on its vaccine.

If Vaxart’s vaccine goes through other clinical trials and US approval, it could offer advantages over needle-based vaccines.

Dr. Paul Offit, a member of the FDA’s Advisory Committee on Vaccines and Allied Biological Products, said that an orally taken vaccine may be better accepted by the public who may be afraid of needles. Two US-approved Covid-19 vaccines – from Pfizer and Moderna – are injected into the arm and require two injections three to four weeks apart.

Vaxart said his vaccine is stable even at room temperature and does not require a freezer, which means it “can be stored and delivered to mass populations around the world”. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit. Moderna vaccine must be delivered between 13 and 5 degrees Fahrenheit.

Vaxart said the vaccine also doesn’t require any special medical training and can be taken at home. This will help comply with social distancing guidelines while relieving the burden on the health system.

The company said it was still critical whether it was single- or two-dose therapy.

A phase 2 study is expected “in the next few months,” Tucker said. In its “Fastest Accelerated Timeline,” the company expects Phase two and three studies to be completed by early 2022.

–CNBC’s Hugh Son contributed to this report.

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Entertainment

Dan + Shay’s Response to Fan’s “Tequila” Cowl on TikTok

If you’ve ever wondered how to get your celebrities to react to your Instagram DMs, here’s a strategy that might work: add a voice recording they just can’t resist. It definitely worked for TikToker Sharon Rowland, who after one too many drinks recorded a quick cover of Dan + Shay’s “Tequila” and announced the recording to the country duo. . . while still drunk.

Imagine her surprise when she woke up the next day to a response from her favorite musicians, even if it was just a simple “heart” and a few emojis. She may not have been the greatest singer of all time, but I have to say that the high note and whisper hit really different in the end and it seems like Dan + Shay thought the same thing.

But the exchange didn’t stop there. After Sharon shared their interaction on their TikTok Sunday, the video immediately went viral and once again caught the duo’s attention. Dan + Shay then filmed reactions to the clip of Sharon’s, um, loud singing, and honestly I can’t make up my mind which video is the funniest. In one clip, Dan tries hard to get in tune with her singing on his piano, while in another, Shay-lip is synchronized with the sound with a whole range of emotions. Prepare for a good belly laugh beforehand and watch Sharon’s original video with Dan + Shay’s answers.

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Business

Shopper focus is finest response to antitrust scrutiny

Alphabet and Google are facing multiple government antitrust cases, but the company believes continuing to serve consumers is a winning strategy.

David Paul Morris | Bloomberg | Getty Images

Alphabet and Google face increased government scrutiny, including an antitrust lawsuit filed in December, the third since October. It could take years to resolve the legal conflict with government regulators. According to Google’s head of marketing, an ongoing focus on the consumer is the best answer.

Google will continue to resonate with its users as the government scrutinizes big tech companies, said Lorraine Twohill, the company’s chief marketing officer, recently at CNBC’s CMO Exchange.

“We are by far the most helpful company in their lives and we must continue to do so,” Twohill said at the CNBC virtual event Thursday.

Twohill said user trust is a “core part” of Google’s DNA and consists of three components. This includes providing accurate and timely information as well as improving data protection and security measures to ensure user safety. Around 200 million users have already passed the platform’s privacy review, she said.

“If we continue to have a close relationship with our consumers and users by being helpful … that is the right answer for me right now,” said Twohill.

Then SVP speaks for global marketing at Google Lorraine Twohill on the stage of Creativity & Technology: Lorraine Twohill & David Droga in the discussion panel presented by Google during the Advertising Week 2015 AWXII on the Times Center Stage on September 30, 2015 in New York City.

Laura Cavanaugh | Getty Images

The government cases allege that the company used anti-competitive and exclusive contracts to ensure a continued monopoly on online search and to prevent competitors from accessing many of these sales search channels.

Earlier this month, the company called the case “a misleading attack” on the advertising technology business while addressing claims the company allegedly partnered with Facebook to set prices and minimize competition.

While government attorneys claim that the tech giant’s business practices are restricting consumers’ access to competing technologies, Google executives focus on the argument of delivering the services consumers want and improving them.

Google’s economic policy director Adam Cohen responded to the recent lawsuit in a blog post which the complaint read: “We shouldn’t have been working to improve searches and we should actually be less useful to you.”

Google isn’t the only big tech company under scrutiny. Facebook has gone through a number of government antitrust proceedings, including a lawsuit filed by the Federal Trade Commission last month and a number of attorneys general from 48 territories and states alleging the tech beast used its power to order Eliminate competitor threats when acquiring platforms like WhatsApp and Instagram.

Amazon could potentially face increased government scrutiny under the Biden administration, while Apple’s App Store has also been a focus for potential regulatory action.

With the world’s largest tech companies facing antitrust scrutiny – sometimes intertwined, as in the case of the billions of dollars that Google pays Apple to use as the default search engine for iPhones – it is important not to put them all together, according to Twohill.

“It’s important not to put all of the big technologies in one bucket. We’re all very different, we think and work very differently,” she said.

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Business

A Second Financial Disaster for Biden, however a Totally different First Response

Mr Biden has stressed that such aid will increase consumer spending, but he and his team are committed to redistributing the money in a more humane way: avoiding as many Americans as possible, in order to avoid the scar damage from homelessness, hunger and the virus itself to avoid .

The Biden team and its allies are confident that if successful, the economy will be prepared for a rapid recovery. Other policymakers and forecasters, including Federal Reserve chairman Jerome H. Powell, have predicted a rapid recovery once the virus is under control.

“The recovery from the great recession has been delayed for years because we have not acted to the extent of the problem,” said Heidi Shierholz, a former chief economist at the labor ministry who now works at the Liberal Economic Policy Institute. “This is a great break from past mistakes.”

The Biden Plan is not the exact plan many economists, including liberals like Mr. Furman, would have chosen. The direct controls that proved to be a successful political message in the Georgia runoff elections and put the Democrats in control of the Senate will reach millions of Americans who have not lost income during the pandemic and are most likely to put the money in savings.

And its price tag, along with the inclusion of provisions that Conservatives have long struggled against, such as raising the federal minimum wage to $ 15 an hour, means the package is unlikely to find much Republican support. Lawmakers are already warning that it is overspending and excessive on top of the $ 900 billion and $ 2.2 trillion packages passed in December and March.

Some conservative economists say the package is spending far more than is necessary to fill what is known as the “output gap,” which is essentially the value of the loss of performance in the economy due to the recession. They begin to warn that pouring too much fuel into the economy can lead to runaway inflation – the same argument that many made in 2009 that has been proven wrong.

“A package this size is not advisable,” said Michael R. Strain, an economist at the conservative American Enterprise Institute. “It would fill the output gap many times over.”

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World News

China response on delisting of Chinese language firms on New York Inventory Trade

A woman adjusts a Chinese flag near US flags.

Ng Han Guan | AFP | Getty Images

We’ll have to see if the Chinese government will retaliate against the US. But I think the actual things to be done won’t matter …

Ronald Wan

non-executive chairman at Partners Financial Holdings

When asked if more Chinese companies could be delisted, Brendan Ahern, chief investment officer of the investment firm KraneShares, said: “I don’t see any expansion of these three specific names just because it was really driven by this executive order.”

Speaking to CNBC’s Squawk Box Asia on Monday, he said the order could “reverse course” after President-elect Joe Biden was sworn in on Jan. 20.

He added that on the Chinese side, Beijing “wants the Biden government to really start the relationship over.”

Ronald Wan, non-executive chairman of Partners Financial Holdings, added that the measures Beijing is taking are unlikely to be “significant”.

“We’ll have to see if the Chinese government will retaliate against the US. But I think the actual actions won’t matter, which may restrict some type of US government-affiliated company, activity in China or Hong Kong. But I think the government is still welcoming US capital and funds to get into the Asian and Hong Kong markets, “he told CNBC’s Street Signs Asia on Monday.

Ahern said investors in the three US-listed stocks – China Telecom, China Mobile and China Unicom – will be able to convert them into their Hong Kong-listed stocks.

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Business

Google Denies Antitrust Claims in Early Response to U.S. Lawsuit

Google said Monday that it had not used its multi-billion dollar deals with other major technology firms to protect its position as the dominant online search engine. This was the company’s first formal rebuttal of Justice Department allegations that these deals violated antitrust laws.

The filing, a 42-page document, is a paragraph – and sometimes sentence – denial of claims by the government and a group of states that have joined their lawsuit. In the filing, Google says it “developed, continuously innovated and promoted” its search product as part of its mission to “organize the world’s information and make it universally accessible and useful”.

“People use Google Search because they choose, not because they’re forced to, or because they can’t just find alternative ways to search for information on the Internet,” the company said.

The filing is Google’s most significant to date in its antitrust battle with the Justice Department, but it will not be the last by a long way. The judge, Amit Mehta, said last week that the trial would not start until 2023.

Google has a growing number of legal disputes in the United States. Republican attorneys general in Texas and other states said in a lawsuit last week that Google broke the law to maintain and protect a monopoly on the technology that serves ads over the Internet.

A day later, a bipartisan group of states led by Colorado and Nebraska filed their own lawsuit focusing on the search business and expanded the Justice Department’s allegations in October. They asked to combine their case with the federal lawsuit.

The lawsuits are at the center of a growing legal backlash against the power of tech giants to act as gatekeepers for trade, communication and culture. The Federal Trade Commission and 40 attorneys general filed lawsuits against Facebook this month, saying they stamped out the competition by buying Instagram and WhatsApp, a lawsuit that the company could ultimately resolve if successful. Federal and state officials are also pursuing investigations against Amazon and Apple.

The Justice Department said in its lawsuit that Google had agreements with device manufacturers like Apple, Samsung, and LG to ensure that it was the default search engine on their phones. This pole position is powerful and prevents competing search products like DuckDuckGo from growing, prosecutors said. Eleven attorneys general signed the lawsuit when it was filed. Other states, including California, have asked to join the case.

The company claims that buying standard shelf space on mobile devices is no different from a consumer brand buying preferred shelf space in a grocery store. It is also argued that it is easy for Apple and Android smartphone users to switch from its search service to that of a competitor.

In its filing on Monday, Google admitted that some of the government’s claims were upheld: True, the company said that some dictionaries classify “Google” as a verb. It admitted that “it started in a garage in Menlo Park 22 years ago, creating an innovative way to search the internet. “

And it admitted that its parent company Alphabet is valued at around $ 1 trillion – but denied that such a claim could be made through Google itself.

A Justice Department spokeswoman did not immediately respond to a request for comment.

Categories
World News

U.Ok. Tackles Big Vaccine Rollout After Botched Covid Response

LONDON – In Bristol, a sports stadium is being converted into a makeshift clinic to carry out vaccinations, as is a racetrack outside London. Village houses, libraries, and parking lots across the country are also rapidly becoming makeshift vaccination centers, with the government seeking advice from military planners.

As the UK prepares to begin rolling out a coronavirus vaccine on Tuesday, it is facing the greatest logistical challenge the country’s healthcare system has ever faced: vaccinating tens of millions of people against coronavirus in just a few months. At the same time, law enforcement agencies are grappling with a number of potential security threats to the vaccination campaign.

Healthcare retirees are being sought for help while the National Health Service recruits tens of thousands of first aid workers and other workers to administer the shot as the vaccine becomes more and more available.

“I think all people who can help should put their hands up,” said Sarah Wollaston, who worked as a doctor before serving in Parliament until recently. She has just completed part of an online refresher course to qualify for the vaccine launch.

“Physically, it’s very easy to give someone a vaccine,” she said. “The challenge is the logistics.”

As industry experts and health officials grapple with this, law enforcement officers and cyber experts face an equally pressing challenge regarding the potential security threats associated with such a high-demand product.

“It’s the world’s most precious commodity right now,” said Lisa Forte, a former UK counterintelligence officer and partner at Red Goat, a cybersecurity company. “This will of course attract highly skilled cyber criminals, criminal groups and state actors.”

Europol warned that organized crime groups could crack down on trucks with vaccines against theft and kidnapping, and Interpol last week warned of a “rush of all kinds of criminal activity related to the COVID-19 vaccine,” which it calls “liquid gold” has designated. ”

From the factory to hospitals and other locations, the Pfizer vaccine – because it must be stored at around minus 70 degrees Celsius – is acutely susceptible to sabotage in addition to theft.

“With the vaccine, the two biggest risks are maintaining the cold chain and being intercepted by public or private actors,” said Sarah Rathke, an attorney at Squire Patton Boggs, who specializes in supply chain litigation.

“It is possibly the toughest supply chain challenge in recent history as there is not much time to prepare,” added Rathke.

Cyberattacks can reveal a wealth of information about the vaccines that can be exploited by state actors and criminal gangs, experts say.

Last week, IBM announced it had discovered a number of cyberattacks against companies involved in spreading coronavirus vaccines around the world in September. IBM said the attackers, whose identities could not be established, tried to learn how the vaccines were stored and dispensed.

“We targeted petrochemical companies because they are essential for making dry ice to store the vaccine,” said Claire Zaboeva, a senior cyber threat analyst at IBM’s Security X-Force.

Ms. Zaboeva added that state actors or even terrorist groups could try to disrupt supplies as nations compete to be the first to administer the vaccine. “Making a lot of vaccine doses spoiled and useless would be a pretty devastating attack,” she said.

While security agencies address these concerns, the UK health service will face the daunting problem of managing a mass vaccination program that reaches the population farther and faster than any other public health work in living memory.

A charity, St. John Ambulance, wants to train up to 30,000 vaccines and others in vaccination centers.

“Introducing a vaccine to tens of millions of people will be a monumental task as we seek to save lives and hopefully get back to our normal way of life,” said Ian Hudspeth, chairman of the Community Wellbeing Board for the Local Government, which represents local communities .

Success is hardly guaranteed as the UK achieved few logistical results during the Covid-19 crisis. In the early stages of the pandemic, hospitals chronically lacked basic protective equipment such as masks and gloves, putting some workers at risk of infection.

Since then, the government has made efforts to put in place a testing and tracing system, even though the much-criticized project was valued at around $ 16 billion.

Pfizer’s problems in sourcing raw materials alone could mean the number of vaccine doses promised for delivery to the UK this year may be cut by half to five million. And there is a potential bottleneck in the production of dry ice that is needed to package and ship the vaccine.

However, experts are cautiously optimistic that the vaccine rollout will go better than the government’s earlier efforts to fight the pandemic, as it is handled under the umbrella of the National Health Service, which has extensive experience organizing mass vaccinations such as annual flu shots .

“It won’t be without its problems because of its size and logistics – I would be amazed if nothing went wrong anywhere in six months,” said Helen Buckingham, director of strategy and operations at the Nuffield Trust, a health research institute.

However, the concept of mass vaccination is well known, she added, “and overall people go to great lengths to do this work.”

Vaccines are sold in three different places: hospitals; Medical practices and clinics; and temporary vaccination centers that are still in preparation, including transit sites, sports stadiums, and public buildings. General practitioners, who will shoulder much of the burden, can draw on their experience of delivering at least 15 million flu vaccinations each year.

However, the coronavirus vaccination will be different for several reasons. In addition to the vaccine against Pfizer and BioNTech, the UK is likely to get at least two more approved, one from Moderna and one from AstraZeneca and the University of Oxford. But when and where everyone will be available is unclear.

Martin Marshall, Chairman of the Council of the Royal College of General Practitioners, notes that the refrigeration requirements, especially for the Pfizer and Moderna vaccines, are a complication that doctors do not have to deal with flu shots. Both require a second injection after a few weeks, which can be an administrative nightmare.

“We’re pretty used to running large vaccination programs, but of course nobody has had to do one unless vaccinations are done in pre-filled syringes,” said Marshall.

According to experts, doctor’s offices and other makeshift clinics could come into play more if the AstraZeneca vaccine is approved. Not only does it cost a lot less, but it can also be stored with normal refrigeration.

Then there are concerns that the average Briton, let alone anti-vaccination campaigners, will be reluctant to take the Pfizer and Moderna vaccines, which are based on relatively untested technology.

Priority is given to those with the highest risk and the oldest Brits. Therefore, a system is also needed to call the right people for appointments at certain times and to do this again three weeks later for the second shot.

Early plans to vaccinate nursing home residents have been postponed because of the deceptively annoying question of how to dismantle Pfizer-supplied 975-dose batches and get them safely into those facilities. And it is unclear when – and in what quantities – other vaccines will be available.

All of this has to happen at a time when the health sector is in acute strain, its staff is overwhelmed after months of relentless pressure and during a winter season when people are generally more susceptible to disease.

Even so, Mr. Marshall is confident that the introduction of the vaccine can be successful.

“I think we can do this job if we work across the NHS and show some flexibility,” he said. “It plays with the strength of the NHS, a centralized, organized and managed system – and it also plays with our values.”