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Will Pfizer’s Vaccine Be Ready in October? Here’s Why That’s Unlikely.

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In media appearances and talks with investors, Pfizer’s chief executive nearly always mentions a word that is so politically perilous, most of his competitors shy away from it: October.

“Right now, our model — our best case — predicts that we will have an answer by the end of October,” the chief executive, Dr. Albert Bourla, told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive readout” by then, with an application for emergency authorization that could be filed “immediately.”

Dr. Bourla’s statements have put his company squarely in the sights of President Trump, who has made no secret of his desire for positive vaccine news to boost his chances on Election Day, Nov. 3. “We’re going to have a vaccine very soon. Maybe even before a very special date,” Mr. Trump said recently.

And yet by all other accounts, the idea that it will be ready in October is far-fetched. Even if the vaccine shows promising signs in clinical trials — still a big if — the company will not have collected enough data by then to say with any statistical confidence that it is safe and effective.

By repeating a date that flies in the face of most scientific predictions, Dr. Bourla is making a high-stakes gamble. If Pfizer puts out a vaccine before it has been thoroughly tested — something the company has pledged it will not do — it could pose a major threat to public safety. The perception matters, too: If Americans see the vaccine as having been rushed in order to placate Mr. Trump, many may refuse to get the shot.

But there is a significant upside, to the tune of billions of dollars, in being first to the U.S. market with a vaccine. And staying in the president’s good graces — particularly when he keeps talking about ways to lower drug prices — might not be a bad thing for a company that brought in nearly $40 billion in 2019 from sales of high-priced, brand-name drugs.

“There’s a huge financial advantage to being first out of the gate,” said Dr. Megan Ranney, an associate professor of emergency medicine and public health at Brown University. She was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.

And given the White House’s persistent efforts to interfere in the decisions of federal health agencies, some scientists fear a vaccine approval could come under similar pressure.

“What I worry about is that the politics or the financial gain may drive earlier release than is scientifically appropriate,” Dr. Ranney said.

Pfizer will not be anywhere near completion of its clinical trial by the end of October, according to a company spokeswoman. When Dr. Bourla referred to a “conclusive readout” next month, she said, he meant that it’s possible the outside board of experts monitoring the trial would have by that date found promising signs that the vaccine works.

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Pfizer’s trial blueprints allow the panel to look at the data after just 32 volunteers have become ill with Covid-19. Even if most of those cases were in the placebo group, regulators at the Food and Drug Administration would likely need data from more volunteers before making a decision on authorization, according to people familiar with the government’s vaccine approval process.

The F.D.A. has also told vaccine makers that they will need to track at least half of the patients’ safety data for two months before the agency will grant emergency access. That would push the earliest possible date into at least November.

In a statement, Pfizer said that it would continue to collect data on trial volunteers’ health for two years, and that it planned to submit two months of safety data to the agency “to help inform F.D.A.’s ultimate determination of authorization or approval.”

ImageDr. Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, has said it would be highly unlikely for a vaccine to be ready by October.
Credit…Samuel Corum for The New York Times

In public interviews, government health officials have refuted the October date. Both Dr. Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, the federal effort that has awarded billions of dollars to vaccine makers, and Dr. Anthony S. Fauci, the nation’s top infectious disease doctor, have said October was unlikely.

Pfizer’s leading competitors in the vaccine race, Moderna and AstraZeneca, have been more vague about timing, saying they expect something before the end of the year. In a recent interview, Moderna’s chief executive, Stéphane Bancel, said: “October is possible, because very few things in life are impossible.” The better word, he said, is “unlikely.”

“They will not get approved before the election,” said Ronny Gal, an analyst with the Wall Street firm Bernstein. “The timing just doesn’t work.”

One key to understanding how Pfizer vaulted to first place in the vaccine race is found in its trial blueprints, known as a protocol.

Even though Moderna and Pfizer began their trials on the same day, Pfizer’s is “built for speed,” as one Wall Street firm, SVB Leerink, described it.

Participants in Pfizer’s trial are given two doses of a vaccine 21 days apart, whereas those in Moderna’s wait 28 days in between. Pfizer begins looking for sick volunteers seven days after the second dose, whereas Moderna does so at 14 days. And Pfizer’s plan allows an outside review panel to look at early data after just 32 volunteers have become ill with Covid-19. Moderna’s plan doesn’t allow for a first peek until 53 cases.

Some experts have speculated that Pfizer’s volunteers happen to be in places where the virus is spreading quickly, making it more likely that they would have been exposed to the virus and put the vaccine to the test. While Moderna’s trial is being conducted only in the United States, Pfizer’s is international, with locations set up or planned in the United States, Brazil, Turkey and Argentina.

In Argentina, which has seen a surge of coronavirus infections since August, 33,000 volunteers quickly signed up for about 4,500 slots, said Dr. Fernando Polack, the head researcher of the Pfizer study that is being carried out at the Hospital Military Central in Buenos Aires.

“We have a lot of years of experience in these kinds of trials, and we’ve never seen these numbers before,” Dr. Polack said in an interview. He declined to comment on whether he was aware of any Covid-19 cases among volunteers.

Across all of its trial sites, Pfizer said, 24,000 volunteers have received the second dose of the vaccine, more than half of the 44,000 that are expected to enroll.

Credit…Marco Bello/Reuters

Despite Pfizer’s confident pronouncements, a win is not guaranteed. Around 15 percent of vaccines in late-stage trials do not make it to approval.

Dr. Mark Goldberger, an infectious disease expert at the Global Antibiotic Research and Development Partnership and a former F.D.A. official, noted that the agency has scheduled a meeting of outside experts to discuss experimental coronavirus vaccines on Oct. 22.

“It would take an enormous effort to get the data by then,” he said. “It’s within the realm of possibility, but there are things that could trip them up — a manufacturing issue, a safety issue, the efficacy is not as good as they expect.”

Taking first place in the vaccine race isn’t just about bragging rights, although the public-relations boost from developing a vaccine that could liberate the world from a deadly pandemic can’t be understated.

Mr. Gal, the Bernstein analyst, said that Pfizer could win a significant commercial edge by taking control of the early market for a coronavirus vaccine. Unlike Johnson & Johnson and AstraZeneca, which have said they will not profit from their products during the pandemic, Pfizer has made no such promises.

It also has not taken federal money to develop its vaccine, instead signing a $1.95 billion deal to sell the first 100 million doses of its vaccine to the U.S. government. Dr. Bourla has said that the company didn’t accept federal investment in its research and development so that the government wouldn’t be able to control the price of the vaccine later on.

“We didn’t take money so that we don’t have any restrictions,” Dr. Bourla said on Sept. 16 at an event organized by the investment bank J.P. Morgan. “Because I can imagine, if you take money, then you have to — a little bit to explain about your pricing.”

While smaller companies like Moderna have already benefited financially by rising share prices, Pfizer has not seen a similar stock bump. Mr. Gal has estimated the initial wave of vaccination as an $18 billion market. “So to the extent that they are able to capture any material amount of it, even for a company like Pfizer, it’s not a small thing,” he said.

Pfizer also has more at stake when it comes to doing business with the federal government. Moderna does not sell any approved products, but Pfizer has a broad portfolio of vaccines and drugs. The federal government is both a major customer — paying for treatments and vaccines through Medicare — and makes weighty decisions about everything from drug approvals to drug-pricing policy.

Even as Mr. Trump has urged the speedy approval of a vaccine, he has employed harsh rhetoric against the industry. Earlier this month, he issued an executive order aimed at lowering the cost of some drugs by tying them to prices in other countries. The measure was strongly opposed — and is likely to be challenged in court — by the drug industry.

Earlier this month, the president singled out Pfizer for special praise, describing it as a “great company,” and saying he had spoken to Dr. Bourla, who was a “great guy.”

Dr. Bourla, who has spent much of the past month giving interviews to media outlets and appearing on industry panels, has insisted the company’s accelerated timeline had nothing to do with politics. “We have politicians or journalists speaking about efficacy or safety about medicines which, of course, is not appropriate,” Dr. Bourla said at the company’s investor day on Sept. 15. “The scientists should be having these discussions.”

Ultimately, Pfizer’s strategy may be about managing the public’s expectations, said Brandon Barford, a partner at Beacon Policy Advisors, a research firm. Pfizer could now explain any delay past October by “saying, ‘We’re being extra cautious.’ And you get kudos for it.”

But if the opposite occurs, and Pfizer is seen to be pushing a vaccine before it is ready, the “potential fallout is enormous,” said Dr. Ranney, of Brown University. “We cannot afford to have a vaccine released for Covid-19 that is either unsafe or ineffective.”

Sharon LaFraniere, Daniel Politi, Noah Weiland and Katherine J. Wu contributed reporting.

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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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