Johnson & Johnson has begun dosing up to 60,000 volunteers in a study of its COVID-19 vaccine, marking the first big U.S. trial of an inoculation that may work after just one shot.
J&J became the fourth vaccine maker to move its candidate into late-stage human studies in the U.S. If enrollment goes as expected, the trial could yield results as soon as year-end, allowing the company to seek emergency authorization early next year, should it prove effective, according to Chief Scientific Officer Paul Stoffels.
“A single dose could be a very efficient tool to combat the pandemic as it is faster acting,” he said Wednesday in an interview. Animal models and early human studies showed that one shot of its vaccine generated a strong immune response in just 15 days, he said.
The final-stage study will pit the vaccine against a placebo injection, with a goal of showing whether it reduces cases of moderate to severe COVID-19, “the most important part of the disease to prevent,” Stoffels said. J&J is also looking at whether the shot curbs the virus’s spread.
The company’s shares rose as much as 2.3 per cent in New York.
The New Brunswick, New Jersey-based company published detailed trial plans on Wednesday. Frontrunners Pfizer Inc., Moderna Inc. and AstraZeneca Plc have already done the same in a broader transparency push.
“It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a statement. J&J’s vaccine “may be especially useful in controlling the pandemic if shown to be protective after a single dose.”
The study is nearly two months behind those of Moderna, working with NIAID, and Pfizer, partnered with BioNTech SE, whose final-stage trials started in late July. Pfizer has said it could get efficacy results by the end of October. Those vaccines use two-dose regimens.
J&J’s vaccine could offer an advantage in distribution over those inoculations, which require vaccination sites to ensure recipients return for their second dose. The company also said its vaccine can be stored at refrigerator temperatures for three months, far longer than the Pfizer vaccine that requires deep freezing for long-term storage.
“In countries where there is less health-care infrastructure, it can be much better used at a very large scale,” Stoffels told Bloomberg. “Single dose, easy to use in the field are the main characteristics that make it different.”
Years in the Making
The J&J product is made from a cold virus, called an adenovirus, that’s modified to make copies of the coronavirus’s spike protein, which the pathogen uses to enter cells. The altered virus can’t replicate in humans, but it induces an immune response that prepares the body for an actual COVID-19 infection. The vaccine was developed with researchers at Harvard University who have spent years working on the adenovirus vaccine platform, which is also used in J&J’s Ebola vaccine.
The health-care behemoth is running the study in conjunction with NIAID and the Biomedical Advanced Research and Development Authority at sites in the U.S., Brazil, Mexico, South Africa and other countries. It will include significant representation among those over the age of 60, as well as minorities at disproportionate risk of becoming infected, including Black, Hispanic, American Indian and Alaskan Native peoples, according to a statement.
J&J has also agreed to collaborate with the U.K. on a separate phase 3 clinical trial that will test a two-dose regimen of the vaccine in multiple countries, with two months between each dose, according to Stoffels. That booster could be critical to providing long-term protection, he said.
Trial Protocol
The decision to begin the final-stage trial was based on data from an earlier human study that showed a single shot was safe and stimulated a strong immune response, Stoffels said.
Like other final-stage vaccine trials, J&J’s study is monitored by an independent board of doctors and statisticians who wait for a certain number of coronavirus cases to accumulate before looking at the data.
The trial aims to accumulate 154 cases for a final analysis. If the vaccine turns out to be more than 90% effective, the study could produce results after just 20 cases, Stoffels said. He said that scenario is unlikely, though.
J&J’s trial appears to have stringent criteria for declaring early success that prevent a readout based on very short-term results in patients with relatively moderate symptoms. Based on discussions with U.S. regulators, the data won’t undergo its first analysis until at least half of participants have been vaccinated for two months or more.
The study will also have to accrue at least 5 severe cases for an early readout. And to be considered a success, the absolute number of severe cases needs to be half of that in the placebo group, along with other benchmarks, according to documents posted on J&J’s website.
Still, the study will take less time to complete than it would with two doses. Scientists will start counting cases just 15 days after patients get their inoculations or placebo shots.
Despite accelerated timelines, Operation Warp Speed won’t cut corners in confirming vaccine safety or efficacy, National Institutes of Health director Francis Collins said on the Tuesday media call. “That absolutely will not be allowed to happen,” he said.
Stoffels said J&J will continue to clinch new manufacturing partnerships to meet its 1 billion dose production goal for 2021. The company has already kick-started at-risk manufacturing in hopes the shot will prove successful in the clinic.
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.
