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How the COVID-19 vaccines are being approved in Canada – CBC.ca

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The approval of a COVID-19 vaccine in Canada could potentially be days away with the initial supply to be limited to about three million Canadians, in the first three months of 2021. But what approval processes have the vaccines gone through? CBC explains:

Is the approval process for the COVID-19 vaccine different than for other vaccines?

Due to the immediate need for the COVID-19 vaccine, some flexibility has been introduced to the approval process. Typically, a vaccine manufacturer will do all their clinical trials, gather all their data, prepare a submission package and put that forward for approval, said John Greiss, a Toronto-based intellectual property lawyer with Norton Rose Fulbright, who advises companies in the life sciences sector that are regulated by Health Canada.

“Health Canada will comment on it or ask for additional information and it will go back and forth until they come to a decision, he said.

But with COVID-19, Health Canada has accepted what’s known as a “rolling submission.” 

“The new process allows for a company to start an application process, submit the information that they have available, as of that date and add new data and new information as it becomes available, Greiss said

Supriya Sharma, chief medical adviser to Health Canada, said this enables the organization to start reviewing the potential vaccine and will shorten the overall review process “while still maintaining those same standards for the safety and the efficacy.”

What’s included in the submission?

That really hasn’t changed, Greiss said. Vaccine manufacturers have to submit all of the scientific data that they have, which includes any kind of lab data that demonstrates how the vaccine works, any kind of clinical trial data that they have obtained, along with Phase 1 to Phase 3 clinical trial data.

WATCH | Vaccines are coming soon

Dr. Njoo tells reporters the federal government is expecting 6 million doses of first two vaccines to arrive in Canada after approvals within the first quarter of the new year. 1:35

They also have to submit information about the manufacturing process and standards and procedures that demonstrate they’re meeting good manufacturing processes in their facilities, Greiss said.

How is the vaccine reviewed?

One vaccine submission is hundreds of thousands of pages long and can take, on average around 2,000 person hours to review, Sharma said. For COVID-19, Health Canada is employing specialized teams of seven to 12 people who have experience in areas like toxicology, infectious diseases, clinical medicine, microbiology and epidemiology to review the vaccine.

“Each vaccine submission has its own team that’s dedicated to it. And they will go through all of that information,” she said.

Reviewers must confirm there are no significant safety concerns, determine that the vaccine is able to prompt an adequate immune response in vaccinated people and show that it can protect against disease, she said.

“We go through all of that to see if it actually meets our standards for safety, efficacy, quality,” Sharma said. 

“We need to make sure that the benefits of the vaccine outweigh the potential risks and that we know that it’s being made in at a licensed place that’s up to standards and up to code.”

Greiss said that during the review process, Health Canada officials might, for example, ask for further clarification about the clinical trial procedure, or how patients were recruited.

The approval process has been modified to accommodate the pressing need for the COVID-19 vaccine. (Dado Ruvic/Illustration/Reuters)

“Or if they see anomalies in the data, they’ll ask the company to justify or clarify that information,” he said. “So there is still that back and forth in terms of Health Canada sort of digesting and analyzing the data and the company having to provide answers for that before they get an approval.”

Are the vaccine manufacturing facilities inspected?

For manufacturing facilities around the world, not just for vaccines, but for medications as well, Health Canada has entered into mutual recognition agreements with other regulators, Sharma said.

“We actually have sent our inspectors over to their country,” she said. “They’ve sent inspectors over to our country. We make sure that our standards are the same, our processes are the same.”

Every facility that manufactures vaccines needs to have an inspection before it’s licensed. And there are ongoing inspections to make sure standards are maintained, she said.

What are they looking for in these facilities?

They’re looking at key factors, known as the four Ps, Sharma said. 

  • Product: What’s being made there.
  • Premises: There are very detailed specifications on the facilities themselves. For example, special flooring and ventilation systems have to be in place.
  • Process: All the processes that go into manufacturing the product.
  • People: The qualifications and training of the people that work there.

All of those things are really important in terms of making sure that standards are met, she said.

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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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