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Pfizer COVID-19 vaccine candidate one step closer to approval – Canada News – Castanet.net

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One of the vaccines in Canada’s COVID-19 arsenal is another step closer to approval, after Pfizer reported more results from its clinical trials Wednesday.

The company said new test results show its coronavirus vaccine is 95 per cent effective, is safe and also protects older people most at risk of dying — the last data needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.

Pfizer and its German partner BioNTech just last week estimated the vaccine was more than 90 per cent effective after 94 infections had been counted in a study that included 44,000 people. With the new announcement, the company now has accumulated 170 infections in the study and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told The Associated Press.

The companies have not yet released detailed data on its study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters.

Pfizer said it is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

Pfizer applied to Health Canada for approval of the vaccine Oct. 9, and will submit the latest data to continue that process. Vaccines must be reviewed and authorized by the federal health department before they can be used in Canada. Health Canada is encouraging vaccine makers to submit for approval before their Phase 3 trials are done, so the approval process that normally takes up to a year can be finished faster.

Pfizer is also undergoing similar “rolling submissions” for approval with regulators in Europe and the United Kingdom.

AstraZeneca and Moderna have also submitted their vaccines for parallel review to Health Canada. All three are among the seven vaccine candidates Canada has contracts to buy on the understanding the doses will only be delivered if Health Canada green-lights the vaccine.

Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5 per cent effective after an interim analysis of its late-stage study.

Similar results from two vaccines both made with a brand-new technology — using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along — likely will add to experts’ reassurance about the novel approach.

The companies didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% of participants.

Canada has contracts to get 20 million doses from Pfizer, Moderna and AstraZeneca, with options to get up to 56 million more from Pfizer and 36 million more from Moderna. All three require would require an individual to get two doses of the vaccine, several weeks apart.

Canada has contracts for four other vaccines but none of those companies have yet requested approval from Health Canada.

The timeline for when the doses will actually come has always been murky. The federal government has been saying it is likely in the first quarter of 2021 but the specific timing depends on if and when they are approved.

Ontario Health Minister Christine Elliott said in Queen’s Park Wednesday that Canada was supposed to get four million doses of Pfizer’s vaccine, and two million of Moderna’s in the first three months of next year. She said Ontario is to get 40 per cent of those doses.

Federal Health Minister Patty Hajdu refused to confirm that however, saying on Parliament Hill that Ottawa would work out distribution to the provinces to make sure every Canadian gets access.

“There are a number of steps to go through before we actually get to the point of distribution,” Hajdu said.

Canada is trying to be ready to roll out the vaccine as soon as it gets approved, including buying millions of syringes, needles, bandages and the like, and most recently signing two contracts to buy freezers to store the vaccine. Pfizer’s vaccine has to be stored at -70 C, while Moderna’s requires temperatures of at least -20 C. Procurement Minister Anita Anand said Canada is going to buy 26 freezers that can be as cold as -80 C and 100 that can be up to -20 C.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

U.S. officials have said they hope to have about 20 million vaccine doses each from Moderna and Pfizer available for distribution in late December. The first shots are expected to be offered to vulnerable groups like medical and nursing home workers, and people with serious health conditions.

Canada’s National Advisory Committee on Immunization recommended similar priorities be made for the first doses of vaccine here.

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Roots sees room for expansion in activewear, reports $5.2M Q2 loss and sales drop

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TORONTO – Roots Corp. may have built its brand on all things comfy and cosy, but its CEO says activewear is now “really becoming a core part” of the brand.

The category, which at Roots spans leggings, tracksuits, sports bras and bike shorts, has seen such sustained double-digit growth that Meghan Roach plans to make it a key part of the business’ future.

“It’s an area … you will see us continue to expand upon,” she told analysts on a Friday call.

The Toronto-based retailer’s push into activewear has taken shape over many years and included several turns as the official designer and supplier of Team Canada’s Olympic uniform.

But consumers have had plenty of choice when it comes to workout gear and other apparel suited to their sporting needs. On top of the slew of athletic brands like Nike and Adidas, shoppers have also gravitated toward Lululemon Athletica Inc., Alo and Vuori, ramping up competition in the activewear category.

Roach feels Roots’ toehold in the category stems from the fit, feel and following its merchandise has cultivated.

“Our product really resonates with (shoppers) because you can wear it through multiple different use cases and occasions,” she said.

“We’ve been seeing customers come back again and again for some of these core products in our activewear collection.”

Her remarks came the same day as Roots revealed it lost $5.2 million in its latest quarter compared with a loss of $5.3 million in the same quarter last year.

The company said the second-quarter loss amounted to 13 cents per diluted share for the quarter ended Aug. 3, the same as a year earlier.

In presenting the results, Roach reminded analysts that the first half of the year is usually “seasonally small,” representing just 30 per cent of the company’s annual sales.

Sales for the second quarter totalled $47.7 million, down from $49.4 million in the same quarter last year.

The move lower came as direct-to-consumer sales amounted to $36.4 million, down from $37.1 million a year earlier, as comparable sales edged down 0.2 per cent.

The numbers reflect the fact that Roots continued to grapple with inventory challenges in the company’s Cooper fleece line that first cropped up in its previous quarter.

Roots recently began to use artificial intelligence to assist with daily inventory replenishments and said more tools helping with allocation will go live in the next quarter.

Beyond that time period, the company intends to keep exploring AI and renovate more of its stores.

It will also re-evaluate its design ranks.

Roots announced Friday that chief product officer Karuna Scheinfeld has stepped down.

Rather than fill the role, the company plans to hire senior level design talent with international experience in the outdoor and activewear sectors who will take on tasks previously done by the chief product officer.

This report by The Canadian Press was first published Sept. 13, 2024.

Companies in this story: (TSX:ROOT)

The Canadian Press. All rights reserved.

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Talks on today over HandyDART strike affecting vulnerable people in Metro Vancouver

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VANCOUVER – Mediated talks between the union representing HandyDART workers in Metro Vancouver and its employer, Transdev, are set to resume today as a strike that has stopped most services drags into a second week.

No timeline has been set for the length of the negotiations, but Joe McCann, president of the Amalgamated Transit Union Local 1724, says they are willing to stay there as long as it takes, even if talks drag on all night.

About 600 employees of the door-to-door transit service for people unable to navigate the conventional transit system have been on strike since last Tuesday, pausing service for all but essential medical trips.

Hundreds of drivers rallied outside TransLink’s head office earlier this week, calling for the transportation provider to intervene in the dispute with Transdev, which was contracted to oversee HandyDART service.

Transdev said earlier this week that it will provide a reply to the union’s latest proposal on Thursday.

A statement from the company said it “strongly believes” that their employees deserve fair wages, and that a fair contract “must balance the needs of their employees, clients and taxpayers.”

This report by The Canadian Press was first published Sept. 12, 2024.

The Canadian Press. All rights reserved.

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Transat AT reports $39.9M Q3 loss compared with $57.3M profit a year earlier

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MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.

The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.

The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.

Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.

On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.

Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.

This report by The Canadian Press was first published Sept. 12, 2024.

Companies in this story: (TSX:TRZ)

The Canadian Press. All rights reserved.

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