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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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Telus prioritizing ‘most important customers,’ avoiding ‘unprofitable’ offers: CFO

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Telus Corp. says it is avoiding offering “unprofitable” discounts as fierce competition in the Canadian telecommunications sector shows no sign of slowing down.

The company said Friday it had fewer net new customers during its third quarter compared with the same time last year, as it copes with increasingly “aggressive marketing and promotional pricing” that is prompting more customers to switch providers.

Telus said it added 347,000 net new customers, down around 14.5 per cent compared with last year. The figure includes 130,000 mobile phone subscribers and 34,000 internet customers, down 30,000 and 3,000, respectively, year-over-year.

The company reported its mobile phone churn rate — a metric measuring subscribers who cancelled their services — was 1.09 per cent in the third quarter, up from 1.03 per cent in the third quarter of 2023. That included a postpaid mobile phone churn rate of 0.90 per cent in its latest quarter.

Telus said its focus is on customer retention through its “industry-leading service and network quality, along with successful promotions and bundled offerings.”

“The customers we have are the most important customers we can get,” said chief financial officer Doug French in an interview.

“We’ve, again, just continued to focus on what matters most to our customers, from a product and customer service perspective, while not loading unprofitable customers.”

Meanwhile, Telus reported its net income attributable to common shares more than doubled during its third quarter.

The telecommunications company said it earned $280 million, up 105.9 per cent from the same three-month period in 2023. Earnings per diluted share for the quarter ended Sept. 30 was 19 cents compared with nine cents a year earlier.

It reported adjusted net income was $413 million, up 10.7 per cent year-over-year from $373 million in the same quarter last year. Operating revenue and other income for the quarter was $5.1 billion, up 1.8 per cent from the previous year.

Mobile phone average revenue per user was $58.85 in the third quarter, a decrease of $2.09 or 3.4 per cent from a year ago. Telus said the drop was attributable to customers signing up for base rate plans with lower prices, along with a decline in overage and roaming revenues.

It said customers are increasingly adopting unlimited data and Canada-U.S. plans which provide higher and more stable ARPU on a monthly basis.

“In a tough operating environment and relative to peers, we view Q3 results that were in line to slightly better than forecast as the best of the bunch,” said RBC analyst Drew McReynolds in a note.

Scotiabank analyst Maher Yaghi added that “the telecom industry in Canada remains very challenging for all players, however, Telus has been able to face these pressures” and still deliver growth.

The Big 3 telecom providers — which also include Rogers Communications Inc. and BCE Inc. — have frequently stressed that the market has grown more competitive in recent years, especially after the closing of Quebecor Inc.’s purchase of Freedom Mobile in April 2023.

Hailed as a fourth national carrier, Quebecor has invested in enhancements to Freedom’s network while offering more affordable plans as part of a set of commitments it was mandated by Ottawa to agree to.

The cost of telephone services in September was down eight per cent compared with a year earlier, according to Statistics Canada’s most recent inflation report last month.

“I think competition has been and continues to be, I’d say, quite intense in Canada, and we’ve obviously had to just manage our business the way we see fit,” said French.

Asked how long that environment could last, he said that’s out of Telus’ hands.

“What I can control, though, is how we go to market and how we lead with our products,” he said.

“I think the conditions within the market will have to adjust accordingly over time. We’ve continued to focus on digitization, continued to bring our cost structure down to compete, irrespective of the price and the current market conditions.”

Still, Canada’s telecom regulator continues to warn providers about customers facing more charges on their cellphone and internet bills.

On Tuesday, CRTC vice-president of consumer, analytics and strategy Scott Hutton called on providers to ensure they clearly inform their customers of charges such as early cancellation fees.

That followed statements from the regulator in recent weeks cautioning against rising international roaming fees and “surprise” price increases being found on their bills.

Hutton said the CRTC plans to launch public consultations in the coming weeks that will focus “on ensuring that information is clear and consistent, making it easier to compare offers and switch services or providers.”

“The CRTC is concerned with recent trends, which suggest that Canadians may not be benefiting from the full protections of our codes,” he said.

“We will continue to monitor developments and will take further action if our codes are not being followed.”

French said any initiative to boost transparency is a step in the right direction.

“I can’t say we are perfect across the board, but what I can say is we are absolutely taking it under consideration and trying to be the best at communicating with our customers,” he said.

“I think everyone looking in the mirror would say there’s room for improvement.”

This report by The Canadian Press was first published Nov. 8, 2024.

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TC Energy cuts cost estimate for Southeast Gateway pipeline project in Mexico

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CALGARY – TC Energy Corp. has lowered the estimated cost of its Southeast Gateway pipeline project in Mexico.

It says it now expects the project to cost between US$3.9 billion and US$4.1 billion compared with its original estimate of US$4.5 billion.

The change came as the company reported a third-quarter profit attributable to common shareholders of C$1.46 billion or $1.40 per share compared with a loss of C$197 million or 19 cents per share in the same quarter last year.

Revenue for the quarter ended Sept. 30 totalled C$4.08 billion, up from C$3.94 billion in the third quarter of 2023.

TC Energy says its comparable earnings for its latest quarter amounted to C$1.03 per share compared with C$1.00 per share a year earlier.

The average analyst estimate had been for a profit of 95 cents per share, according to LSEG Data & Analytics.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:TRP)

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BCE reports Q3 loss on asset impairment charge, cuts revenue guidance

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BCE Inc. reported a loss in its latest quarter as it recorded $2.11 billion in asset impairment charges, mainly related to Bell Media’s TV and radio properties.

The company says its net loss attributable to common shareholders amounted to $1.24 billion or $1.36 per share for the quarter ended Sept. 30 compared with a profit of $640 million or 70 cents per share a year earlier.

On an adjusted basis, BCE says it earned 75 cents per share in its latest quarter compared with an adjusted profit of 81 cents per share in the same quarter last year.

“Bell’s results for the third quarter demonstrate that we are disciplined in our pursuit of profitable growth in an intensely competitive environment,” BCE chief executive Mirko Bibic said in a statement.

“Our focus this quarter, and throughout 2024, has been to attract higher-margin subscribers and reduce costs to help offset short-term revenue impacts from sustained competitive pricing pressures, slow economic growth and a media advertising market that is in transition.”

Operating revenue for the quarter totalled $5.97 billion, down from $6.08 billion in its third quarter of 2023.

BCE also said it now expects its revenue for 2024 to fall about 1.5 per cent compared with earlier guidance for an increase of zero to four per cent.

The company says the change comes as it faces lower-than-anticipated wireless product revenue and sustained pressure on wireless prices.

BCE added 33,111 net postpaid mobile phone subscribers, down 76.8 per cent from the same period last year, which was the company’s second-best performance on the metric since 2010.

It says the drop was driven by higher customer churn — a measure of subscribers who cancelled their service — amid greater competitive activity and promotional offer intensity. BCE’s monthly churn rate for the category was 1.28 per cent, up from 1.1 per cent during its previous third quarter.

The company also saw 11.6 per cent fewer gross subscriber activations “due to more targeted promotional offers and mobile device discounting compared to last year.”

Bell’s wireless mobile phone average revenue per user was $58.26, down 3.4 per cent from $60.28 in the third quarter of the prior year.

This report by The Canadian Press was first published Nov. 7, 2024.

Companies in this story: (TSX:BCE)

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