Johnson & Johnson’s experimental one-shot COVID-19 vaccine generated a long-lasting immune response in an early safety study, providing a glimpse at how it will perform in the real world as the company inches closer to approaching U.S. regulators for clearance.
More than 90 per cent of participants made immune proteins, called neutralizing antibodies, within 29 days after receiving the shot, according to the report, and participants formed the antibodies within 57 days. The immune response lasted for the full 71 days of the trial.
“Looking at the antibodies, there should be good hope and good reason that the vaccine will work,” in the company’s late-stage clinical trial that’s soon to report results, J&J Chief Scientific Officer Paul Stoffels said Tuesday in an interview.
The one-shot vaccine generates more neutralizing antibodies than a single dose of other front-runner COVID-19 vaccine, all of which are two-shot regimens. But when compared with two shots of these rivals, the response to J&J’s single shot is in the same range, Stoffels said.
Interim results from the phase 1/2 trial of participants ages 18 and older were published Wednesday in the New England Journal of Medicine. The data expanded on more limited findings J&J first published in September.
J&J’s progress is being closely watched by top infectious disease experts because its vaccine has the potential to become the first that can protect people after just one shot, making mass-vaccination campaigns much easier. The company expects to get definitive efficacy data from a final-stage study by early next month, potentially leading to regulatory authorization by March.
Efficacy Ambitions
The U.S. has granted emergency-use authorizations to two vaccines, one developed by Pfizer Inc. and its partner BioNTech SE, and the other by Moderna Inc. Both employ a technology called messenger RNA that has never before been used in an approved product, and each showed more than 90 per cent efficacy against COVID-19 symptoms.
Those results were better than expected. U.S. government officials had earlier said any vaccine with greater than 50 per cent efficacy would be considered a success. Based on that guidance, J&J aimed for 60 per cent effectiveness, Stoffels said, but “we hoped and we planned for 70 per cent.”
Within weeks, J&J will learn how its vaccine performed in a late-stage trial of 45,000 volunteers. Stoffels now thinks it has the potential to be even higher than 70 per cent effective, based on the early-stage findings and other factors.
When the antibody response to J&J’s shot is compared to others that have been through final stage trials “there’s a good reason to believe we can get into very high levels of efficacy,” Stoffels said. “Will it be north of 90 per cent? I don’t know. The data will tell us.”
Moncef Slaoui, the chief scientific adviser to the U.S.’s Operation Warp Speed vaccine development and distribution effort, said Wednesday that he anticipates J&J’s one-shot vaccine will show 80 per cent to 85 per cent effectiveness against COVID-19. J&J and its government partners can’t see the data for the time being, a standard measure to prevent bias.
One-Dose Advantage
Experts have said that a single-shot vaccine offers advantages: ease of distribution and administration. Vaccines from Moderna Inc., AstraZeneca Plc, and the Pfizer Inc.-BioNTech SE partnership all require two shots, which means repeat shipping and clinic visits. While Pfizer-BioNTech’s shot must be frozen, J&J’s shot can be stored at refrigerator temperatures for three months.
“A single dose is going to be so much more effective in the world,” Stoffels said. “We are very confident that it works,” but another trial J&J is conducting of its vaccine plus a booster shot “will give us a backup.”
The study released Wednesday also found that a second dose of J&J’s shot, administered two months later, led to a three-fold increase in neutralizing antibodies. Stoffels said that’s positive news, as the drugmaker is still evaluating how long immunity from the single-shot will last, and whether higher antibody levels will be needed to combat new strains of the virus.
J&J kicked off the late-stage study of its two-dose vaccine regimen in November. Stoffels said the company is likely to finish enrolling the 30,000 participants before the end of first quarter, likely in March or April, and expects a data readout come summer.
Underlying Platform
The New Brunswick, New Jersey-based company’s vaccine candidate is made from a cold virus, called an adenovirus, that’s modified to make copies of the coronavirus’ spike protein, which the pathogen uses to enter cells.
Though the altered virus can’t replicate in humans, it induces an immune response that prepares the body for an actual COVID-19 infection. It was first developed with researchers at Harvard University who have spent years working on the adenovirus platform, which is also used in J&J’s Ebola vaccine, as well as its Zika, RSV, and HIV investigational vaccine candidates.
The NEJM report showed the vaccine was well-tolerated across all study participants. It also found that there was no difference in immunogencity between younger trial participants and the elderly, which is important given older populations are most vulnerable to the disease.
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.
