Health Canada says it won’t require new clinical trial data from vaccine makers on booster shots being developed to target new variants of COVID-19.
Instead, the regulator will rely more heavily on lab tests of blood samples, which can show how many antibodies develop following vaccination. Those antibodies are a good indicator of how well the human body will fight off an infection.
The decision should help the regulator authorize the boosters for use in Canada much faster and is in line with the process used to approve new flu vaccines each year.
At least three variants of the virus that causes COVID-19 are circulating in Canada and are believed to spread more easily and possibly cause more serious illness. Having vaccines adjusted to target those new strains is a critical part of managing the COVID-19 pandemic.
But Health Canada’s chief medical adviser, Dr. Supriya Sharma, said there won’t be corners cut on safety in evaluating new boosters.
“They still need to demonstrate that the vaccine that comes out is still safe, effective and high quality,” she said in an interview with The Canadian Press earlier this week.
WATCH | Deputy chief public health officer on Health Canada approval of modified COVID-19 vaccines
Deputy Chief Public Health Officer Dr. Howard Njoo says Health Canada has developed guidance for modifying authorized COVID-19 vaccines in response to new variants. 0:58
New clinical trials would delay approval: Health Canada
Canada has authorized three vaccines, from Pfizer-BioNTech, Moderna and AstraZeneca-Oxford, and all are working on various boosters against variants.
The documents supporting Thursday’s decision note that demanding full clinical trials, as was the case for authorizing the original vaccines, would create a serious delay.
“This may also be problematic from a public health perspective since delay in updating a vaccine, where needed, bears the risk that the virus is evolving even further, potentially making a new vaccine version outdated at the time of approval again,” the document says.
Dr. Supriya Sharma, chief medical adviser at Health Canada, says the regulator won’t cut corners when it comes to determining if modified COVID-19 vaccines are safe and effective. (Sean Kilpatrick/The Canadian Press)
Coronaviruses don’t mutate as quickly as flu viruses but they do change as they spread among people. The more they spread, the more they change.
“So a virus is not going to mutate as much when it can’t replicate,” Sharma said.
The existing vaccines have shown reduced effectiveness against the variants of concern, though Sharma cautions the vaccines are still useful against the variants.
The vaccines Canada has authorized are performing well in countries like the United Kingdom and Israel, where the B.1.1.7 variant is now dominant. That variant is the most common of the three variants of concern in Canada so far; it accounts for more than 90 per cent of about 1,430 variant cases confirmed in this country to date.
Provinces screening for variants
Many provinces are now screening all confirmed cases of COVID-19 for the variants of concern, and as many as 10 per cent of all confirmed cases are fully sequenced to look for any mutations to the original virus.
The B.1.351 variant that first arose in South Africa is the most concerning to date in its potential to evade existing vaccines. As of Wednesday, there were 103 confirmed cases of it in Canada.
South Africa stopped using AstraZeneca’s vaccine altogether after lab tests suggested it wouldn’t be very effective against mild illness for B.1.351, which is dominant in that country.
That decision has contributed to growing concerns that AstraZeneca’s vaccine is less desirable. Sharma said it’s not that simple.
“Now, if you look at severe disease, or more severe cases, it actually looked like it was still quite protective,” she said.
“But in a country where that is your dominant circulating stream, and in a country where they had potentially had access to another vaccine shortly, they made the decision that maybe they weren’t going to go ahead with that.”
If B.1.351 becomes a dominant strain here, and current vaccines don’t show effectiveness against it, they’ll be pulled, Sharma said.
“We wouldn’t leave a vaccine on the market if we think that it wouldn’t be effective for the overall population.”
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.
