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Approval for Moderna's vaccine 'looks positive' but a few more documents still needed – CTV News

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The chief medical adviser at Health Canada says things are on track for her department to approve a second vaccine for COVID-19 very soon.

Dr. Supriya Sharma says things “look positive” for the vaccine from U.S. biotech firm Moderna but there are still some outstanding manufacturing documents needed before the decision can be made.

Ongoing reviews of two more vaccines are less certain, with AstraZeneca’s potentially needing more study before Health Canada is ready to make a decision, and the Johnson & Johnson vaccine candidate’s review still in the very early stages.

Health Canada approved the vaccine from Pfizer-BioNTech Dec. 9, and the first doses began arriving in Canada Sunday.

Health care workers in Toronto and long-term care residents in Montreal and Quebec City were the first to receive the vaccine Monday morning.

Long-term care workers from an Ottawa care home will be next, as that city rolls out its vaccination program this morning.

Health workers in Manitoba and Alberta are set to follow Wednesday and most other provinces intend to start vaccinating priority groups by the weekend.

The Pfizer-BioNTech vaccine has also been approved in several other countries including the United Kingdom, the United States, Bahrain and Saudi Arabia.

The U.S. Food and Drug Administration is to meet Dec. 17 to discuss Moderna’s application. Health Canada has been reviewing Moderna’s vaccine since October, and Sharma said the final clinical data was provided from the company Friday.

She said the review team spent the weekend poring over those documents, and now all that is left is data on the manufacturing plants. Those documents are expected by week’s end and then she’ll know better when the Moderna decision can be issued.

“It does look promising and it does look positive,” said Sharma.

It took only five days from the final delivery of manufacturing data for Pfizer’s vaccine to secure Health Canada approval but Sharma said Moderna’s facilities are not familiar to Health Canada. The manufacturing sites Pfizer is using have been reviewed by Health Canada before.

Sharma said that means there is more uncertainty about how long it might take to go over the data, though it’s possible the Moderna timeline could be similar to Pfizer’s.

Health Canada’s review team uses experts in a variety of areas, from toxicology and pharmacology to infectious diseases and manufacturing practices.

AstraZeneca was first to submit an application but its vaccine’s review was affected when the company realized some patients in the clinical trial had not been given full doses of the vaccine.

Sharma said because of that problem, Health Canada is still reviewing data to decide if it will ask the company to complete more studies. She said other international partners are undergoing the same process currently.

Johnson & Johnson only submitted its application two weeks ago for Canadian approval and the teams are conducting preliminary reviews now.

Pfizer and Moderna together are expected to deliver 60 million doses of vaccine to Canada by next fall, enough to vaccinate 30 million people.

Canada has procured doses of three other vaccines but none of their makers have yet applied for approval.

Procurement Minister Anita Anand said Monday she anticipates getting 30,000 Pfizer doses this week and a similar shipment next week. The federal government has said about 249,000 doses will arrive by the end of the month.

Both Pfizer’s and Moderna’s vaccines require two doses — 21 days apart for Pfizer and 28 days apart for Moderna. However Pfizer’s has much stricter cold-chain requirements that are restricting the places it can be delivered at the moment.

Moderna’s vaccine can survive in regular freezers and it will be prioritized for delivery to the territories, remote Indigenous communities and long-term care sites.

Sharma said with the Pfizer vaccine, a recipient’s immune system generates some protection after the first dose, with maximum immunity in place seven days after the second dose.

Enough doses are to start arriving in April for provinces to expand the vaccination program beyond the initial priority groups. Canada expects to be able to vaccinate every Canadian who wants an inoculation by the end of September 2021.

Authorities are still calling on Canadians to keep apart, wear face masks and practise careful hygiene to keep the virus that causes the illness from spreading.

This report by The Canadian Press was first published Dec. 15, 2020.

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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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