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A look at how Canada approved 5 COVID-19 vaccines in under a year – Global News

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In the last four years, Health Canada has approved more than 1,500 new or updated pharmaceuticals.

Ten of them are vaccines.

Five of those are for COVID-19.

Dr. Supriya Sharma, the chief medical adviser at Health Canada helping oversee the review process, has never seen anything like the speed with which the COVID-19 vaccines got approved.

Read more:
A look at how much the government spends on tracking, studying viruses like COVID-19

“I mean, unprecedented is the one word that we’ve been overusing, but there’s nothing even close to comparable to this,” she said in an interview.

The five non-COVID vaccines approved, four for influenza and one for shingles, took an average of 397 days from the day the company applied for approval in Canada, until that approval was granted.

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The average time for COVID-19 vaccines? 82 days.

That includes 61 days for Pfizer-BioNTech, 72 days for Moderna, 95 days for Johnson & Johnson, 148 days for Oxford-AstraZeneca and 34 days for Covishield, the AstraZeneca vaccine produced by the Serum Institute of India.

Covishield is a slight outlier because Health Canada mostly just needed to review the manufacturing process, as the vaccine is the same formula as the AstraZeneca doses made elsewhere. Sharma likens it to the same recipe made in a different kitchen, but the kitchen still needs to be up to snuff.


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Americans race to get vaccinated as COVID-19 surges


Americans race to get vaccinated as COVID-19 surges

A sixth vaccine from Novavax is still under review, with the results from its big clinical trial not expected until next month. It has been under review by Health Canada for 58 days at this point.

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The speed has raised fears among Canadians that everything moved too quickly. Many medical experts worry it is contributing to hesitancy to get the vaccines.

But Sharma says speed did not come at the expense of safety.

“That’s the only priority, the only thought, is what’s best for Canadians,” she said. “There’s no other motivation anywhere.”

Lack of research funds can slow down new drug development, but in this case, as lockdowns shuttered economies worldwide and death tolls mounted, countries poured billions of dollars into getting a vaccine to get us out of the pandemic.

Most of the successful vaccines for COVID-19 so far use existing vaccine technology that was adjusted for the SARS-CoV-2 virus that causes COVID-19.

Read more:
One year into COVID-19, a look at when and where the next pandemic could emerge

They start with lab studies to check for safety on animals and see how the vaccine works in a lab setting on blood samples and on samples of the virus.

Then it is tested on a very small number of humans to look for any glaring safety concerns. Then they test it on a slightly larger number of people — usually fewer than 100 — to look for safety and the development of antibodies.

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If that goes well, the trial is expanded to thousands of volunteers, some of whom get the vaccine and some of whom don’t. Then they wait to see how many in each group get infected.

Phase 3 trials usually take between one and four years. For the vaccines approved in Canada so far, phase three trials took about three months.

Sharma said the time a trial takes depends on finding enough patients to participate, and then having enough of their trial participants get sick to know how well the vaccine is or isn’t working.

Fortunately and unfortunately, COVID-19 was spreading so rampantly in so many places, getting enough people exposed did not take very long.

Canada has seen very few vaccines tested here so far, mainly because our infection rates weren’t high enough.

While the drug makers were busy getting the trials going, Health Canada was getting ready for their submissions. Sharma said discussions about COVID-19 vaccines began in earnest with international bodies in mid-January 2020, before Canada had even had a single confirmed case.

“I think we knew that … we had a virus that was going to be transmissible, that could be causing significant respiratory disease, and that there would be an interest in therapies and vaccines definitely, very early on,” said Sharma.

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Over 200 Queen’s University students volunteer to distribute COVID-19 vaccine


Over 200 Queen’s University students volunteer to distribute COVID-19 vaccine

It was determined quickly that this virus was so new there was no existing vaccine that could be adjusted quickly, as had happened with the H1N1 pandemic in 2009.

By March, Health Canada had started putting teams in place to review new therapies and vaccines for COVID-19 as soon as they were ready.

Each team was made up of 12 to 15 people, with varying specialties. There was some overlap between the teams but not a lot because many vaccines were being reviewed at the same time.

The experts on the file included infectious disease specialists, pharmacologists, biostatisticians, and epidemiologists.

Separate from that were teams of people looking at manufacturing facilities. Approving a vaccine isn’t just about making sure the clinical data shows it to be safe and effective, but also about making sure the place it is to be made follows the required safety standards.

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They needed an emergency order from Health Minister Patty Hajdu to do a rolling review. Normally drug makers can’t apply until they have every piece of data ready but with a rolling review Health Canada scientists can start reviewing the data as it becomes available.

Read more:
Where is Canada now in its rollout of the COVID-19 vaccine?

Hajdu granted that on Sept. 16.

Then the vaccine submissions began pouring in — AstraZeneca applied Oct. 1, Pfizer Oct. 9, Moderna on Oct. 12, and J&J on Nov. 30. The Covishield application came Jan. 23 and Novavax submitted on Jan. 29.

Sharma says the teams were working 15 to 18 hours a day, seven days a week, reviewing data, asking the companies questions, requesting more information or new analyses.

Sometimes they were doing it in the middle of the night. Collaborations with international partners in very different time zones, meant 2 a.m. or 4 a.m. video conference calls were not unusual.

When Pfizer and Moderna were reviewed, it was entirely based on clinical trail and pre-market data because the vaccines hadn’t been approved anywhere else. Canada was the third in the world to authorize Pfizer on Dec. 14th, and second to approve Moderna Dec. 23.

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By the time Health Canada authorized AstraZeneca — a review process complicated by some mistakes during the clinical trial in dosing and the number of seniors among its volunteer patients — it was also able to pull data from real-world use of the vaccine in the United Kingdom.


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Report: COVID-19 variants heighten risk of hospitalization and death


Report: COVID-19 variants heighten risk of hospitalization and death

The regulatory work doesn’t end when the authorization is announced. The post-market surveillance data is still non-stop. The recent blood clot concern with the AstraZeneca vaccine took a lot of time, but just monitoring the data submitted by the vaccine makers on adverse events overall is still critical.

To date, the adverse event reports in Canada have not been different than what was seen in clinical trials.

Companies also adjust their submissions requiring further review. Pfizer has so far asked for two changes, one to the number of doses per vial and another for the temperature at which the vaccine has to be kept.

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If anything changes on safety, or if the efficacy seen in a clinical trial doesn’t play out in the real world, Sharma says Canada will not hesitate to make adjustments. But those decisions will be made by Canadian experts, said Sharma, the same ones who have been on the files all along.

“It’s important that if anything comes up, we have people that have reviewed it, have gone through every piece of paper, the 2,000 hours, the hundreds of thousands of pages, and that if anything comes up, it’s like they’ve got a really strong science base, and they can put that stuff in context and we can make decisions really quickly.”

© 2021 The Canadian Press

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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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