Pfizer applied for emergency use authorization of its coronavirus vaccine with United States regulators Friday, days after the company said it finished its final round of human trials — with promising results.
Pfizer and its partner company, BioNTech, said the final data shows its vaccine is 95 per cent effective against the virus, with no serious safety concerns. But, the full results of its trial have not been released and must be peer-reviewed by independents scientists.
Even though the data is not available, the vaccine has been submitted to the U.S. Food and Drug Administration (FDA) for emergency use approval.
If it gets the green light, this does not mean the vaccine has full approval; the vaccine is only deemed “investigational” and can be given to people while studies are ongoing, according to the FDA.
Story continues below advertisement
This means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, the FDA said.
1:28 Pfizer says coronavirus vaccine is 95 per cent effective
Pfizer says coronavirus vaccine is 95 per cent effective
What about in Canada?
In Canada, Health Canada is in charge of reviewing and approving Pfizer’s coronavirus vaccine.
Pfizer applied to Health Canada for approval of the vaccine on Oct. 9, according to the department’s website.
Speaking at a media conference Friday, Minister of Health Patty Hajdu said Health Canada has a “rolling review” process for the vaccine. Meaning, Pfizer submits data to the department as it becomes available.
The rolling review process allows Health Canada to review the data right away as it continues to come in. This is in order to accelerate the process, according to the department.
“The rolling review process is because the situation is urgent so that as soon as the data is available it can be quickly reviewed,” Kerry Bowman, a professor of bioethics and global health at the University of Toronto, said. “But there is no way they are cutting corners on this. They are looking at all the evidence section by section. I find it very encouraging.”
He said so far Health Canada is still reviewing Pfizer’s Phase 3 trials, but there is a chance more information about the data will come in December.
“They are balancing safety and trying to keep things going as quickly as possible,” he said.
Does Canada have an ’emergency authorization’?
Health Canada does not have an emergency use authorization like the FDA. However, it has a review process that is comparable.
The interim order allows “expedited authorization” for the importation, sale and advertising of drugs used in relation to coronavirus.
Story continues below advertisement
So, instead of a company, like Pfizer, providing substantial evidence of the safety and effectiveness of a new drug — as usually required by federal law — the interim order says an applicant can submit the information as it becomes available, allowing for the “rolling review” process.
This allows for a faster approval process during a health crisis.
“This new rolling review process under the IO (interim order) involves reviewing all the necessary data to support authorization in the context of the pandemic and urgent public health needs, and can shorten the time it takes for a new drug to be authorized once all of the necessary data are available,” Health Canada told Global News in an email.
Once a company submits new data, Health Canada said it starts the review “immediately.”
Under the interim order, a coronavirus drug is approved by Canada’s ministry of health once evidence shows the benefits outweigh the risks.
1:23 Coronavirus: Trudeau won’t confirm date of receiving Moderna and Pfizer vaccines
Coronavirus: Trudeau won’t confirm date of receiving Moderna and Pfizer vaccines
In order to be approved, the vaccine goes through a rigorous review process in Canada, despite the expedited timeline, Dr. Supriya Sharma, the federal department’s chief medical advisor, previously told Global News.
Story continues below advertisement
Under Canada’s system, three federal scientific teams review a vaccine prior to approving or rejecting it. Sharma explained that one team looks at pre-trial research on animals, a second team reviews human clinical trials, and a third team reviews the manufacturing process.
Sharma also said that the department’s review of potential COVID-19 vaccines will be “the same as with any other vaccine.” So if the department determines a vaccine candidate doesn’t meet the standards, Health Canada will not approve it, she said.
Following the authorization of any vaccine submission, Health Canada said it will also publish the evidence it reviewed in making its decision for transparency purposes.
How Canada’s vaccine approval differs from the U.S.
Health Canada said the requirements for vaccine approval under its interim order are similar to the FDA’s emergency use authorization — but there are some differences.
One important difference is that the FDA has been reviewing aspects of Pfizer’s data that Health Canada hasn’t seen yet.
Because Pfizer’s vaccine clinical trials took place in the U.S., Health Canada said U.S. regulators were able to review data such as the “quality” and “manufacturing” details, for several months.
“These trials were not carried out in Canada, therefore Health Canada will only have access to key data once they are filed under the IO,” the department said.
But Health Canada said it has been in “continuous contact” with Pfizer on the progress of their studies and filing plans.
Both the FDA and Health Canada have set up systems that safely allow ways to dramatically speed up the process for COVID-19 vaccines. This is because the normal approval process of a new vaccine can take about a decade.
3:32 Canada’s plan for a COVID-19 vaccine rollout
Canada’s plan for a COVID-19 vaccine rollout
An exact timeline of vaccine approval is still unclear in Canada, but last week Prime Minister Justin Trudeau said he hopes to have the vaccine available in early 2021.
If the vaccine is approved, Canada has an advance-purchase agreement for 20 million doses. The vaccine requires two doses.
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.
