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Novavax Enters Final Stage of Coronavirus Vaccine Trials

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The vaccine maker Novavax said Thursday that it would begin the final stages of testing its coronavirus vaccine in the United Kingdom and that another large trial was scheduled to begin next month in the United States.

It is the fifth late-stage trial from a company supported by Operation Warp Speed, the federal effort to speed a coronavirus vaccine to market, and one of 11 worldwide to reach this pivotal stage. Novavax, a Maryland company that has never brought a vaccine to market, reached a $1.6 billion deal with the federal government in July to develop and manufacture its experimental vaccine, which has shown robust results in early clinical trials.

The new study, known as a Phase 3 trial, is expected to enroll up to 10,000 people in the United Kingdom. Half of the volunteers will receive two doses of the experimental vaccine, 21 days apart, and the others will receive a placebo.

Although Novavax is months behind the front-runners in the vaccine race, independent experts are excited about its vaccine because its early studies delivered particularly promising results. Monkeys that were vaccinated got strong protection against the coronavirus. And in early safety trials, published early this month in The New England Journal of Medicine, volunteers produced strikingly high levels of antibodies against the virus.

It is not possible to make a precise comparison between early clinical studies of different vaccines, but John Moore, a virologist at Weill Cornell Medicine, said that the antibodies from Novavax were markedly higher than any other vaccine with published results. “You just can’t explain that away,” he said.

The Phase 3 trials will determine if Novavax can live up to that promise. Although the British trial is smaller than those of other leading vaccines, the vaccine’s potency means that it might deliver clear results well before the trial is over, said Natalie Dean, a biostatistician at the University of Florida. Researchers analyze clinical trial data at predetermined points during the study.

“That’s one of the reasons why we have those types of analyses — to catch a home run if something is working exceptionally well,” she said.

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Updated 2020-09-24T21:10:51.079Z

Paul Heath, professor of pediatric infectious diseases at St. George’s, University of London and the lead scientist of the trial, said that the team would make a special effort to recruit people who are at higher risk of getting sick.

“We will be reaching out to health and social care workers and others who are on the front line, and therefore are more likely to be exposed,” Dr. Heath said.

Novavax said that the trial would seek to enroll at least a quarter of its participants over the age of 65 and that it would prioritize groups that are most affected by Covid-19, including racial and ethnic minorities.

If the surge of Covid-19 continues in the United Kingdom, Dr. Heath said, the trial could determine if the vaccine is effective in several months. “Potentially early next year, we will have certainly seen sufficient numbers of cases for conclusions to be drawn,” he said.

Some vaccine experts said the Novavax candidate showed promise because it uses an older, more tried-and-true vaccine technology compared to companies like Moderna and Pfizer, which are testing vaccine platforms that have not yet been approved for use in people. Novavax’s vaccine uses coronavirus proteins to provoke an immune response, a method that is similar to already-approved vaccines for shingles and human papillomavirus.

“The Novavax vaccine strategy is a well-worn strategy,” said Dr. Paul A. Offit, a professor at the University of Pennsylvania who serves on the Food and Drug Administration advisory committee that will review coronavirus vaccines. “So, you know, we have experience doing this.”

Novavax has lined up a number of manufacturing partners to make the vaccine in huge amounts. In September, a deal with the Serum Institute of India, a major vaccine maker, led Novavax to predict it will be able to produce as many as two billion doses a year.

The vaccine can be stored at between 36 and 46 degrees Fahrenheit, which allows it to be distributed using what the company described as “standard vaccine channels.” Some of the newer vaccines, including those by Pfizer and Moderna, must be stored at subzero temperatures.

But Novavax has never successfully brought a vaccine to market. Its $1.6 billion deal with the federal government represented a huge vote of confidence in a company that has been around for decades but was financially struggling as recently as last year.

The U.K. trial will end when either 116 people develop symptoms of Covid-19, or when 63 people develop moderate to severe Covid-19. At that point, the researchers will “unblind” the results and compare how many of the infections were in the vaccinated group compared with the placebo group.

The trial’s goal is that the vaccine will be at least 60 percent more effective than a placebo.

The company also said it would soon publish its trial design, known as a protocol, following the lead of several other vaccine makers that did so after independent researchers called for more transparency.

Dr. Gregory M. Glenn, Novavax’s president for research and development, said in an interview on Thursday that the company was running a smaller safety trial in South Africa, in addition to the larger Phase 3 trials in the United Kingdom and the United States.

“There are so many things that are uncertain, we need to try to have three shots on goal,” he said. “So that the F.D.A., or anybody, could look at any one of these trials and say, you know, that’s evidence the vaccine is working.”

The company’s U.S. trial will be conducted in collaboration with the National Institutes of Health, and Dr. Glenn said that trial was expected to include 30,000 people and to begin in the middle of October. Johnson & Johnson announced this week that it was beginning a 60,000-person trial of its coronavirus vaccine.

Novavax’s U.K. trial will distinguish itself from competitors because up to 400 of the volunteers will also receive an approved flu shot. This kind of study can be valuable for doctors by determining whether it is safe to give patients two vaccines at the same time.

Dr. Heath said one possibility was that Covid-19 would surge every winter along with the flu. “A scenario where both vaccines can be given at the same time, and thereby minimize disease over the busy winter months, you know, is a good one to push for,” he said.

It also could give Novavax a competitive edge. If it becomes a regular shot that people need to take, some patients might like the convenience of scheduling both vaccines for the same day. Novavax has also developed a flu vaccine that succeeded in late-stage trials but has not been approved by the F.D.A.

“From a corporate standpoint, you can see it,” said Dr. David Bishai, a professor at the Johns Hopkins Bloomberg School of Public Health who studies the economics of vaccines. “This is something that will appeal to some members of the market.”

Dr. Glenn said that the company hoped to eventually combine its flu and coronavirus vaccines into one shot (although this would require more studies and a separate regulatory approval). “I think Covid is not going to go away,” he said.

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The Trump campaign celebrated a growth record that Democrats downplayed.

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The White House celebrated economic growth numbers for the third quarter released on Thursday, even as Joseph R. Biden Jr.’s presidential campaign sought to throw cold water on the report — the last major data release leading up to the Nov. 3 election — and warned that the economic recovery was losing steam.

The economy grew at a record pace last quarter, but the upswing was a partial bounce-back after an enormous decline and left the economy smaller than it was before the pandemic. The White House took no notice of those glum caveats.

“This record economic growth is absolute validation of President Trump’s policies, which create jobs and opportunities for Americans in every corner of the country,” Mr. Trump’s re-election campaign said in a statement, highlighting a rebound of 33.1 percent at an annualized rate. Mr. Trump heralded the data on Twitter, posting that he was “so glad” that the number had come out before Election Day.

The annualized rate that the White House emphasized extrapolates growth numbers as if the current pace held up for a year, and risks overstating big swings. Because the economy’s growth has been so volatile amid the pandemic, economists have urged focusing on quarterly numbers.

Those showed a 7.4 percent gain in the third quarter. That rebound, by far the biggest since reliable statistics began after World War II, still leaves the economy short of its pre-pandemic levels. The pace of recovery has also slowed, and now coronavirus cases are rising again across much of the United States, raising the prospect of further pullback.

“The recovery is stalling out, thanks to Trump’s refusal to have a serious plan to deal with Covid or to pass a new economic relief plan for workers, small businesses and communities,” Mr. Biden’s campaign said in a release ahead of Thursday’s report. The rebound was widely expected, and the campaign characterized it as “a partial return from a catastrophic hit.”

Economists have warned that the recovery could face serious roadblocks ahead. Temporary measures meant to shore up households and businesses — including unemployment insurance supplements and forgivable loans — have run dry. Swaths of the service sector remain shut down as the virus continues to spread, and job losses that were temporary are increasingly turning permanent.

“With coronavirus infections hitting a record high in recent days and any additional fiscal stimulus unlikely to arrive until, at the earliest, the start of next year, further progress will be much slower,” Paul Ashworth, chief United States economist at Capital Economics, wrote in a note following the report.

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Black and Hispanic workers, especially women, lag in the U.S. economic recovery.

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The surge in economic output in the third quarter set a record, but the recovery isn’t reaching everyone.

Economists have long warned that aggregate statistics like gross domestic product can obscure important differences beneath the surface. In the aftermath of the last recession, for example, G.D.P. returned to its previous level in early 2011, even as poverty rates remained high and the unemployment rate for Black Americans was above 15 percent.

Aggregate statistics could be even more misleading during the current crisis. The job losses in the initial months of the pandemic disproportionately struck low-wage service workers, many of them Black and Hispanic women. Service-sector jobs have been slow to return, while school closings are keeping many parents, especially mothers, from returning to work. Nearly half a million Hispanic women have left the labor force over the last three months.

“If we’re thinking that the economy is recovering completely and uniformly, that is simply not the case,” said Michelle Holder, an economist at John Jay College in New York. “This rebound is unevenly distributed along racial and gender lines.”

The G.D.P. report released Thursday doesn’t break down the data by race, sex or income. But other sources make the disparities clear. A pair of studies by researchers at the Urban Institute released this week found that Black and Hispanic adults were more likely to have lost jobs or income since March, and were twice as likely as white adults to experience food insecurity in September.

The financial impact of the pandemic hit many of the families that were least able to afford it, even as white-collar workers were largely spared, said Michael Karpman, an Urban Institute researcher and one of the studies’ authors.

“A lot of people who were already in a precarious position before the pandemic are now in worse shape, whereas people who were better off have generally been faring better financially,” he said.

Federal relief programs, such as expanded unemployment benefits, helped offset the damage for many families in the first months of the pandemic. But those programs have mostly ended, and talks to revive them have stalled in Washington. With virus cases surging in much of the country, Mr. Karpman warned, the economic toll could increase.

“There could be a lot more hardship coming up this winter if there’s not more relief from Congress, with the impact falling disproportionately on Black and Hispanic workers and their families,” he said.

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Ant Challenged Beijing and Prospered. Now It Toes the Line.

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As Jack Ma of Alibaba helped turn China into the world’s biggest e-commerce market over the past two decades, he was also vowing to pull off a more audacious transformation.

“If the banks don’t change, we’ll change the banks,” he said in 2008, decrying how hard it was for small businesses in China to borrow from government-run lenders.

“The financial industry needs disrupters,” he told People’s Daily, the official Communist Party newspaper, a few years later. His goal, he said, was to make banks and other state-owned enterprises “feel unwell.”

The scope of Mr. Ma’s success is becoming clearer. The vehicle for his financial-technology ambitions, an Alibaba spinoff called Ant Group, is preparing for the largest initial public offering on record. Ant is set to raise $34 billion by selling its shares to the public in Hong Kong and Shanghai, according to stock exchange documents released on Monday. After the listing, Ant would be worth around $310 billion, much more than many global banks.

The company is going public not as a scrappy upstart, but as a leviathan deeply dependent on the good will of the government Mr. Ma once relished prodding.

More than 730 million people use Ant’s Alipay app every month to pay for lunch, invest their savings and shop on credit. Yet Alipay’s size and importance have made it an inevitable target for China’s regulators, which have already brought its business to heel in certain areas.

These days, Ant talks mostly about creating partnerships with big banks, not disrupting or supplanting them. Several government-owned funds and institutions are Ant shareholders and stand to profit handsomely from the public offering.

The question now is how much higher Ant can fly without provoking the Chinese authorities into clipping its wings further.

Excitable investors see Ant as a buzzy internet innovator. The risk is that it becomes more like a heavily regulated “financial digital utility,” said Fraser Howie, the co-author of “Red Capitalism: The Fragile Financial Foundation of China’s Extraordinary Rise.”

“Utility stocks, as far as I remember, were not the ones to be seen as the most exciting,” Mr. Howie said.

Ant declined to comment, citing the quiet period demanded by regulators before its share sale.

The company has played give-and-take with Beijing for years. As smartphone payments became ubiquitous in China, Ant found itself managing huge piles of money in Alipay users’ virtual wallets. The central bank made it park those funds in special accounts where they would earn minimal interest.

After people piled into an easy-to-use investment fund inside Alipay, the government forced the fund to shed risk and lower returns. Regulators curbed a plan to use Alipay data as the basis for a credit-scoring system akin to Americans’ FICO scores.

China’s Supreme Court this summer capped interest rates for consumer loans, though it was unclear how the ceiling would apply to Ant. The central bank is preparing a new virtual currency that could compete against Alipay and another digital wallet, the messaging app WeChat, as an everyday payment tool.

Ant has learned ways of keeping the authorities on its side. Mr. Ma once boasted at the World Economic Forum in Davos, Switzerland, about never taking money from the Chinese government. Today, funds associated with China’s social security system, its sovereign wealth fund, a state-owned life insurance company and the national postal carrier hold stakes in Ant. The I.P.O. is likely to increase the value of their holdings considerably.

“That’s how the state gets its payoff,” Mr. Howie said. With Ant, he said, “the line between state-owned enterprise and private enterprise is highly, highly blurred.”

China, in less than two generations, went from having a state-planned financial system to being at the global vanguard of internet finance, with trillions of dollars in transactions being made on mobile devices each year. Alipay had a lot to do with it.

Alibaba created the service in the early 2000s to hold payments for online purchases in escrow. Its broader usefulness quickly became clear in a country that mostly missed out on the credit card era. Features were added and users piled in. It became impossible for regulators and banks not to see the app as a threat.

ImageAnt Group’s headquarters in Hangzhou, China.
Credit…Alex Plavevski/EPA, via Shutterstock

A big test came when Ant began making an offer to Alipay users: Park your money in a section of the app called Yu’ebao, which means “leftover treasure,” and we will pay you more than the low rates fixed by the government at banks.

People could invest as much or as little as they wanted, making them feel like they were putting their pocket change to use. Yu’ebao was a hit, becoming one of the world’s largest money market funds.

The banks were terrified. One commentator for a state broadcaster called the fund a “vampire” and a “parasite.”

Still, “all the main regulators remained unanimous in saying that this was a positive thing for the Chinese financial system,” said Martin Chorzempa, a research fellow at the Peterson Institute for International Economics in Washington.

“If you can’t actually reform the banks,” Mr. Chorzempa said, “you can inject more competition.”

But then came worries about shadowy, unregulated corners of finance and the dangers they posed to the wider economy. Today, Chinese regulators are tightening supervision of financial holding companies, Ant included. Beijing has kept close watch on the financial instruments that small lenders create out of their consumer loans and sell to investors. Such securities help Ant fund some of its lending. But they also amplify the blowup if too many of those loans aren’t repaid.

“Those kinds of derivative products are something the government is really concerned about,” said Tian X. Hou, founder of the research firm TH Data Capital. Given Ant’s size, she said, “the government should be concerned.”

The broader worry for China is about growing levels of household debt. Beijing wants to cultivate a consumer economy, but excessive borrowing could eventually weigh on people’s spending power. The names of two of Alipay’s popular credit functions, Huabei and Jiebei, are jaunty invitations to spend and borrow.

Huang Ling, 22, started using Huabei when she was in high school. At the time, she didn’t qualify for a credit card. With Huabei’s help, she bought a drone, a scooter, a laptop and more.

The credit line made her feel rich. It also made her realize that if she actually wanted to be rich, she had to get busy.

“Living beyond my means forced me to work harder,” Ms. Huang said.

First, she opened a clothing shop in her hometown, Nanchang, in southeastern China. Then she started an advertising company in the inland metropolis of Chongqing. When the business needed cash, she borrowed from Jiebei.

Online shopping became a way to soothe daily anxieties, and Ms. Huang sometimes racked up thousands of dollars in Huabei bills, which only made her even more anxious. When the pandemic slammed her business, she started falling behind on her payments. That cast her into a deep depression.

Finally, early this month, with her parents’ help, she paid off her debts and closed her Huabei and Jiebei accounts. She felt “elated,” she said.

China’s recent troubles with freewheeling online loan platforms have put the government under pressure to protect ordinary borrowers.

Ant is helped by the fact that its business lines up with many of the Chinese leadership’s priorities: encouraging entrepreneurship and financial inclusion, and expanding the middle class. This year, the company helped the eastern city of Hangzhou, where it is based, set up an early version of the government’s app-based system for dictating coronavirus quarantines.

Such coziness is bound to raise hackles overseas. In Washington, Chinese tech companies that are seen as close to the government are radioactive.

In January 2017, Eric Jing, then Ant’s chief executive, said the company aimed to be serving two billion users worldwide within a decade. Shortly after, Ant announced that it was acquiring the money transfer company MoneyGram to increase its U.S. footprint. By the following January, the deal was dead, thwarted by data security concerns.

More recently, top officials in the Trump administration have discussed whether to place Ant Group on the so-called entity list, which prohibits foreign companies from purchasing American products. Officials from the State Department have suggested that an interagency committee, which also includes officials from the departments of defense, commerce and energy, review Ant for the potential entity listing, according to three people familiar with the matter.

Ant does not talk much anymore about expanding in the United States.

Ana Swanson contributed reporting.

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