Results from a U.S. trial of AstraZeneca’s COVID-19 vaccine may have included “outdated information” and that could mean the company provided an incomplete view of efficacy data, U.S. federal health officials said early Tuesday.
AstraZeneca said in a statement that the data it released Monday included cases up to Feb. 17 — as the study rules specified — and that it was continuing to analyze cases that have occurred since then. The company said that a preliminary analysis of data that has continued to roll in was consistent with what it had already reported.
“We will immediately engage with the independent data safety monitoring board [DSMB],” AstraZeneca said. “We intend to issue results of the primary analysis within 48 hours.”
AstraZeneca reported Monday that its COVID-19 vaccine provided strong protection among adults of all ages in a long-anticipated U.S. study, a finding that some experts hoped would help rebuild public confidence in the shot around the world and move it a step closer to clearance in the U.S.
In the study of more than 30,000 people, the company reported that the vaccine was found to be 79 per cent effective at preventing symptomatic cases of COVID-19 — including in older adults.
There were no severe illnesses or hospitalizations among vaccinated volunteers, compared with five such cases in participants who received dummy shots — a small number, but consistent with findings from Britain and other countries that the vaccine protects against the worst of the disease.
WATCH Untangling the meaning and differences in efficacy rates:
Infectious disease specialist Dr. Sumon Chakrabarti explains what the different efficacy rates for the COVID-19 vaccines mean. 4:19
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of rare blood clots like those identified in Europe, a scare that led numerous countries to briefly suspend vaccinations last week.
Dr. Isaac Bogoch said it was the latest cloud for the company whose vaccine has been approved in dozens of countries, including Canada, but has faced questions over messaging over dose regimens in its trials, its efficacy with seniors, and, most recently, potential side effects for those who’ve suffered from blood clots.
“This is just a never ending series of public relations nightmares for a company that is producing a vaccine that is supposed to be the vaccine for planet Earth,” said Bogoch, an infectious disease physician in Toronto and member of Ontario’s COVID-19 Vaccine Distribution Task Force, in an interview with CBC News Network. “This is supposed to be used in many, many parts of the world including low- and middle-income countries,”
Bogoch said it was important to wait for further information from AstraZeneca, and that the next 48 hours would likely see clarifications from the British-Swedish pharmaceutical company and the U.S. regulators.
“Based on the snippets of information that we have now, and that we’ve seen in the past, this will probably end up being a very good vaccine,” he said.
‘An unforced error’
But just hours after the encouraging results were reported, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) issued an unusual statement.
The agency said the Data and Safety Monitoring Board (DSMB) “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the statement went on.
Dr. Anthony Fauci, U.S. President Joe Biden’s chief medical adviser, said the DMSB noticing a discrepancy in the data was an example of safeguards in the vaccine approval process being employed, but he characterized the correspondence to AstraZeneca as a “rather harsh note.”
“It really is unfortunate this happened,” Fauci said Tuesday morning on Good Morning America. “This is what you call an unforced error. The fact is, this is very likely a very good vaccine.”
Fauci, the director of NIAID, said he hoped the setback would not contribute to vaccine hesitancy.
AstraZeneca aims to file an application with the U.S. Food and Drug Administration (FDA) in the coming weeks, and the government’s outside advisers will then publicly debate the evidence.
Authorization and guidelines for use of the vaccine in the United States will be determined by the FDA and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
The FDA had set an efficacy threshold of 50 per cent for first-generation COVID-19 vaccines in order to consider authorizing them for use in a pandemic that has now killed over 520,000 Americans. But that was before coronavirus variants began to widely circulate throughout the world, including in the U.S., beginning late in 2020.
Variants first identified in the U.K. (B117), South Africa (B1351) and Brazil (P1) are concerning to health officials who say they could prove more resistant to the current vaccines.
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.
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.
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.
