Taking too long? Close loading screen.
Connect with us

Business

Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial

Published

on

The biotech company Moderna released a 135-page document on Thursday that spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined.

The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.

Those timelines mesh with the cautionary estimates from many researchers, and stand in sharp contrast to President Trump’s predictions that a vaccine will become widely available before the end of this year.

Scientists have been calling on vaccine makers to share their study plans, known as protocols, so that outside experts can evaluate them. Until now, none of the nine companies that are testing vaccines in late-stage clinical trials have done so.

Moderna, AstraZeneca and Pfizer, which is collaborating with the German company BioNTech, are among the front-runners in the global race to produce a vaccine to fight the pandemic.

AstraZeneca’s trial stopped temporarily because of serious illness in a participant. It has resumed in Britain, but not in the United States.

Pfizer said on Saturday that it planned to expand its trial to 44,000 participants from 30,000, but that it still expected to have efficacy results by the end of October.

Both Moderna and Pfizer/BioNTech use genetic material from the virus, known as mRNA, to prompt cells in the body to make a fragment of the virus that will train the immune system to fight off an infection.

Dr. Tal Zaks, Moderna’s chief medical officer, said that his firm was the first of the coronavirus vaccine makers to release its protocol, and that pharmaceutical companies were usually reluctant to do so, for competitive reasons.

“I’m proud of doing that,” he said in an interview. “I don’t think there’s much there that we’re disclosing that hasn’t already been spoken to, but let the public be the judge of that.”

Cognizant of public wariness and skepticism about vaccines, Dr. Zaks said Moderna consulted an outside ethics expert who advised the company that the only way to win trust was to be “transparent to the point of discomfort.”

He also sought to address researchers’ complaints about the lack of disclosure.

“If what you want to do is see the protocol — here,” Dr. Zaks said.

The action might encourage other vaccine makers to do the same, Dr. Stéphane Bancel, Moderna’s chief executive, said in an interview.

Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego, gave the company “big kudos” for sharing the information, but said that he was disappointed by some of the details. For example, the company intends to include in its data people who developed relatively mild cases of Covid-19. Dr. Topol said more compelling evidence of the vaccine’s effectiveness would be produced if the company counted only moderate to severe cases.

In addition, the protocol allows for the possibility of stopping the trial early after a relatively small number of cases. Stopping early could lead to an exaggerated perception of the vaccine’s efficacy, and could also miss safety problems that could turn out to be significant later if the vaccine is given to millions and millions of people.

“Take the time, the extra weeks,” Dr. Topol said. “No shortcuts. Nobody will regret it. I’ve been doing clinical trials for decades. I don’t know if there’s ever been a more important one than this one. I’d like to see it done right, and not stopped early.”

Moderna’s protocol release coincided with a call Thursday morning with investors to discuss the company’s coronavirus work, research on other vaccines and its plans to begin developing flu vaccines.

The company’s coronavirus vaccine, developed in collaboration with scientists from the National Institutes of Health, was the first to be tested in humans. The Phase 3 study now underway has enrolled more than 25,000 of its intended 30,000 volunteers, and Dr. Zaks said the enrollment should be complete in the next few weeks.

About 28 percent of the participants are Black, Latino or from other populations that have been particularly hard hit by the disease. A diverse enrollment has been considered essential to make sure that the findings apply to people from as many backgrounds as possible.

Half the participants receive the vaccine, and half a placebo shot consisting of salt water, with neither the volunteers nor the doctors treating them knowing who gets which. Two shots are needed, four weeks apart. Then the participants are monitored to see if they develop symptoms of Covid-19 and test positive for the virus.

Side effects of the vaccine are also tracked, with participants recording symptoms in electronic diaries, taking their own temperatures, making clinic visits and receiving periodic phone calls to assess their condition. In earlier studies the vaccine has caused transient reactions like a sore arm, fever, chills, muscle and joint pain, fatigue and headaches.

To determine the vaccine’s efficacy, Covid-19 cases are counted only if they occur two weeks after the second shot. Some patients are already two weeks beyond the second shot, but Dr. Zaks said he did not know if any trial participants had contracted the disease yet.

A total of 151 cases — spread between the vaccine and placebo groups — would be enough to determine whether the vaccine is 60 percent effective. The Food and Drug Administration has set the bar at 50 percent.

But if the vaccine turns out to be highly effective, with a statistically significant difference emerging between the two groups with fewer than 151 cases, efficacy could be proved sooner, Dr. Zaks said.

The numbers will be watched by a panel of independent experts picked by the National Institutes of Health. The same group will also monitor several other trials.

The panel, called a data-safety monitoring board, will perform its first analysis of the efficacy data once 53 cases have occurred.

Mr. Bancel said the company would report publicly on the results of this so-called interim analysis, and the next one, when they are conducted.

The safety board can also put the trial on hold if there is evidence that a participant may have been harmed, as occurred recently in AstraZeneca’s vaccine study.

Dr. Zaks and Mr. Bancel said that the first analysis would probably not take place before November. In theory, the vaccine could be found effective at that point, though the odds of demonstrating 60 percent effectiveness at the first analysis are not high, Dr. Zaks said.

If the data are not conclusive, the panel will look again after there have been a total of 106 cases. If there is still no answer, the next and final analysis will occur after 151 people contract Covid.

How long it takes to reach any of those case counts depends on the trajectory of the pandemic and how likely participants are to be exposed to the virus.

It will probably take five months from the study start — when the first participant received the first shot — to reach 53 cases, eight months to reach 106 and 10 months to reach 151, the protocol states. Those estimates depend on certain assumptions being correct, including that in a six-month period, the incidence of Covid in the placebo group will be 0.75 percent.

The study began in late July, which would suggest that the first interim analysis may not occur until late December, and the final one in late May.

Regardless of whether the vaccine is effective or not, the participants’ health will be monitored for two years after the second shot, the protocol states.

Moderna and other companies have already begun making their vaccines “at risk,” meaning financial risk, because if the trials find that the products do not work, they will have to be thrown away. Both Moderna and Pfizer have projected that millions of doses will be ready early in 2021. But the world population is 7 billion, and everyone will need two doses.

“In the first half of next year, at least maybe until Labor Day next year, I anticipate that the world is going to be massively supply-constrained, meaning not enough vaccine to vaccinate everybody,” Mr. Bancel said.

Source

Continue Reading
Advertisement
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Business

The Trump campaign celebrated a growth record that Democrats downplayed.

Published

on

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.

Source

Continue Reading

Business

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

Published

on

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.

Source

Continue Reading

Business

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

Published

on

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.

Source

Continue Reading

Trending