Why a pause on AstraZeneca’s coronavirus vaccine trial isn’t entirely bad news | Canada News Media
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Why a pause on AstraZeneca’s coronavirus vaccine trial isn’t entirely bad news

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The world is waiting with bated breath for a coronavirus vaccine.

So when AstraZeneca, a frontrunner in Phase 3 of global trials, unexpectedly hit pause on its study due to a participant becoming ill, prospects for an early rollout dimmed.

While it might be disappointing, experts say it’s far from uncommon.

In fact, there’s some comfort to be found in the temporary hold, according to Craig Jenne, an associate professor in microbiology, immunology and infectious diseases at the University of Calgary.

“This is proof that the safety checks in place are robust and non-negotiable,” he said. “They didn’t wait for 10 patients to pause the study… We’re not willing to compromise safety to get a vaccine faster.”

AstraZeneca announced it would halt its trial Tuesday after a participant came down with a “potentially unexplained” illness. In a statement, the company said it would conduct an investigation and “review of safety data” to determine if the illness is a side effect of the vaccine or a coincidence.

The U.K.-based company began recruiting 30,000 people in the U.S. for its largest part of the study in late August. The vaccine is also being tested in thousands of people in Britain — as it’s being developed by Oxford University — as well as in Brazil and South Africa.

It’s been described by the World Health Organization as likely the world’s leading candidate and the most advanced in terms of development.

While the pause might be a setback, the researchers are ultimately being “very careful,” said Dr. Isaac Bogoch, an infectious disease specialist based out of Toronto General Hospital.

“This is exactly why you do Phase 3 clinical trials. You’re looking out for safety and efficacy,” he said. “There are certain things you can only find out if you give this drug or vaccine to thousands of thousands of people.”

AstraZeneca did not reveal any information about the possible side effect except to call it a “potentially unexplained illness.” However, a New York Times report citing an anonymous source “familiar with the situation” suggested that the participant in the U.K. trial was diagnosed with transverse myelitis — an inflammatory syndrome that affects the spinal cord and is often triggered by viral infections.

Bogoch emphasized that this is “still speculation” since the investigation has not been completed in full. The timing of the diagnosis, and whether it is linked to the AstraZeneca vaccine, remains unknown.

“It might be real. It might not be real. Let’s just wait until we hear from the people actually following this closely.”

AstraZeneca did not elaborate on how it will conduct the investigation, nor the procedural methods it undertook in the process of the third-stage study.

Jenne suspects the researchers and doctors will go through a litany of potential interactions and potential causes of the reaction of the patient, “keeping in mind that this may still be completely coincidental.”

“What exactly was the response? Is it attributable to the vaccine formulation? Was it something to do with the administration of the vaccine? How was it administered? Who administered it? Was there an underlying medical condition?” he said.

Alasdair Munro, a clinical researcher of pediatric infectious diseases in Britain who is working on the Oxford vaccine trials, provided a snapshot of what that investigation might look like in a human vaccine trial.

Munro said on Twitter that participants in Oxford studies have 24-hour-a-day access to a study doctor and complete “symptom diaries” following the vaccination. The researchers are alerted “if any serious symptoms are recorded,” which are followed up on and reviewed to see if they are related to the vaccine.

“Everything gets recorded,” he wrote, from mild to serious, and the unrelated. “If they took paracetamol for a headache, it gets recorded. Antihistamine for sneezing, gets recorded.”

The moment there are concerns a serious symptom “could” be related, “the studies stop until their dedicated safety monitoring team can collect and review all the relevant information to ensure they are happy the study is safe to continue,” he wrote.

“These reviews are extremely rigorous.”

Other vaccines on the table

Depending on what’s determined, the trial could very well go back to a second stage or even have the third stage “retooled,” Jenne said.

All parties involved in the trials also have to come to a cohesive conclusion and agree on whether it’s safe to continue, he added.

One report from the Financial Times claims AstraZeneca’s trials may resume as early as next week.

“One thing Canadians have to remember is that not all vaccines are going to be approved. That’s the whole reason we have a Phase 3,” Jenne continued.

More than 150 potential vaccines are being developed and tested globally to stop the COVID-19 pandemic, with 34 in human trials.

“This is also why Canada has invested in four different vaccine platforms. In the case one isn’t approved for whatever reason, we’re not relying on that. We have backup plans.”

Bogoch took it one step further. As pressure on researchers and pharmaceutical companies has grown, so, too, have concerns about fast-tracking trials.

The WHO has warned that “if you move too quickly to vaccinate… millions of people, you may miss certain adverse effects.”

“We hear these narratives. ‘We can’t rush this process,’ and ‘Is it going to be safe?’” Bogoch said.

“Well, here’s your safety mechanisms at work.”

— with files from the Associated Press and Reuters

 

Source: – Global News

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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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