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AstraZeneca COVID-19 vaccine study paused after one illness – CTV News

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Late-stage studies of AstraZeneca’s COVID-19 vaccine candidate are on temporary hold while the company investigates whether a recipient’s “potentially unexplained” illness is a side effect of the shot.

In a statement issued Tuesday evening, the company said its “standard review process triggered a pause to vaccination to allow review of safety data.”

AstraZeneca didn’t reveal any information about the possible side effect except to call it “a potentially unexplained illness.” The health news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom.

An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the U.S. and other countries. Late last month, AstraZeneca began recruiting 30,000 people in the U.S. for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.

Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany’s BioNTech. Those two vaccines work differently than AstraZeneca’s, and the studies already have recruited about two-thirds of the needed volunteers.

Temporary holds of large medical studies aren’t unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it’s possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.

“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the company statement said.

It’s likely the unexplained illness was serious enough to require hospitalization and not a mild side effect such as fever or muscle pain, said Deborah Fuller, a University of Washington researcher who is working on a different COVID-19 vaccine that has not yet started human testing.

“This is not something to be alarmed about,” Fuller said. Instead, it’s reassuring that the company is pausing the study to figure out what’s happening and carefully monitoring the health of study participants.

Dr. Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was “still optimistic” that an effective vaccine will be found in the coming months.

“But optimism isn’t evidence,” he wrote. “Let’s let science drive this process.”

Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the illness may be unrelated to the vaccine, “but the important part is that this is why we do trials before rolling out a vaccine to the general public.”

During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety.

The trials also assess effectiveness by tracking who gets sick and who doesn’t between patients getting the vaccine and those receiving a dummy shot.

The development came the same day that AstraZeneca and eight other drugmakers issued an unusual pledge, vowing to uphold the highest ethical and scientific standards in developing their vaccines.

The announcement follows worries that President Donald Trump will pressure the U.S. Food and Drug Administration to approve a vaccine before it’s proven to be safe and effective.

The U.S. has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective could be disastrous, derailing the effort to vaccinate millions of Americans.

Representatives for the FDA did not immediately respond to requests for comment Tuesday evening.

AstraZeneca’s U.S.-traded shares fell more than 6% in after-hours trading following reports of the trial being paused.

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Associated Press writers Matthew Perrone and Carla K. Johnson contributed to this report.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Japan’s SoftBank returns to profit after gains at Vision Fund and other investments

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TOKYO (AP) — Japanese technology group SoftBank swung back to profitability in the July-September quarter, boosted by positive results in its Vision Fund investments.

Tokyo-based SoftBank Group Corp. reported Tuesday a fiscal second quarter profit of nearly 1.18 trillion yen ($7.7 billion), compared with a 931 billion yen loss in the year-earlier period.

Quarterly sales edged up about 6% to nearly 1.77 trillion yen ($11.5 billion).

SoftBank credited income from royalties and licensing related to its holdings in Arm, a computer chip-designing company, whose business spans smartphones, data centers, networking equipment, automotive, consumer electronic devices, and AI applications.

The results were also helped by the absence of losses related to SoftBank’s investment in office-space sharing venture WeWork, which hit the previous fiscal year.

WeWork, which filed for Chapter 11 bankruptcy protection in 2023, emerged from Chapter 11 in June.

SoftBank has benefitted in recent months from rising share prices in some investment, such as U.S.-based e-commerce company Coupang, Chinese mobility provider DiDi Global and Bytedance, the Chinese developer of TikTok.

SoftBank’s financial results tend to swing wildly, partly because of its sprawling investment portfolio that includes search engine Yahoo, Chinese retailer Alibaba, and artificial intelligence company Nvidia.

SoftBank makes investments in a variety of companies that it groups together in a series of Vision Funds.

The company’s founder, Masayoshi Son, is a pioneer in technology investment in Japan. SoftBank Group does not give earnings forecasts.

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Yuri Kageyama is on X:

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Trump campaign promises unlikely to harm entrepreneurship: Shopify CFO

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Shopify Inc. executives brushed off concerns that incoming U.S. President Donald Trump will be a major detriment to many of the company’s merchants.

“There’s nothing in what we’ve heard from Trump, nor would there have been anything from (Democratic candidate) Kamala (Harris), which we think impacts the overall state of new business formation and entrepreneurship,” Shopify’s chief financial officer Jeff Hoffmeister told analysts on a call Tuesday.

“We still feel really good about all the merchants out there, all the entrepreneurs that want to start new businesses and that’s obviously not going to change with the administration.”

Hoffmeister’s comments come a week after Trump, a Republican businessman, trounced Harris in an election that will soon return him to the Oval Office.

On the campaign trail, he threatened to impose tariffs of 60 per cent on imports from China and roughly 10 per cent to 20 per cent on goods from all other countries.

If the president-elect makes good on the promise, many worry the cost of operating will soar for companies, including customers of Shopify, which sells e-commerce software to small businesses but also brands as big as Kylie Cosmetics and Victoria’s Secret.

These merchants may feel they have no choice but to pass on the increases to customers, perhaps sparking more inflation.

If Trump’s tariffs do come to fruition, Shopify’s president Harley Finkelstein pointed out China is “not a huge area” for Shopify.

However, “we can’t anticipate what every presidential administration is going to do,” he cautioned.

He likened the uncertainty facing the business community to the COVID-19 pandemic where Shopify had to help companies migrate online.

“Our job is no matter what comes the way of our merchants, we provide them with tools and service and support for them to navigate it really well,” he said.

Finkelstein was questioned about the forthcoming U.S. leadership change on a call meant to delve into Shopify’s latest earnings, which sent shares soaring 27 per cent to $158.63 shortly after Tuesday’s market open.

The Ottawa-based company, which keeps its books in U.S. dollars, reported US$828 million in net income for its third quarter, up from US$718 million in the same quarter last year, as its revenue rose 26 per cent.

Revenue for the period ended Sept. 30 totalled US$2.16 billion, up from US$1.71 billion a year earlier.

Subscription solutions revenue reached US$610 million, up from US$486 million in the same quarter last year.

Merchant solutions revenue amounted to US$1.55 billion, up from US$1.23 billion.

Shopify’s net income excluding the impact of equity investments totalled US$344 million for the quarter, up from US$173 million in the same quarter last year.

Daniel Chan, a TD Cowen analyst, said the results show Shopify has a leadership position in the e-commerce world and “a continued ability to gain market share.”

In its outlook for its fourth quarter of 2024, the company said it expects revenue to grow at a mid-to-high-twenties percentage rate on a year-over-year basis.

“Q4 guidance suggests Shopify will finish the year strong, with better-than-expected revenue growth and operating margin,” Chan pointed out in a note to investors.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:SHOP)

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RioCan cuts nearly 10 per cent staff in efficiency push as condo market slows

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TORONTO – RioCan Real Estate Investment Trust says it has cut almost 10 per cent of its staff as it deals with a slowdown in the condo market and overall pushes for greater efficiency.

The company says the cuts, which amount to around 60 employees based on its last annual filing, will mean about $9 million in restructuring charges and should translate to about $8 million in annualized cash savings.

The job cuts come as RioCan and others scale back condo development plans as the market softens, but chief executive Jonathan Gitlin says the reductions were from a companywide efficiency effort.

RioCan says it doesn’t plan to start any new construction of mixed-use properties this year and well into 2025 as it adjusts to the shifting market demand.

The company reported a net income of $96.9 million in the third quarter, up from a loss of $73.5 million last year, as it saw a $159 million boost from a favourable change in the fair value of investment properties.

RioCan reported what it says is a record-breaking 97.8 per cent occupancy rate in the quarter including retail committed occupancy of 98.6 per cent.

This report by The Canadian Press was first published Nov. 12, 2024.

Companies in this story: (TSX:REI.UN)

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