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AstraZeneca and Oxford halting a Covid-19 vaccine trial is good news

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One of the most promising Covid-19 vaccine candidates, being developed by AstraZeneca and Oxford University, had its Phase 3 trials put on hold after a patient experienced a serious adverse event. That certainly sounds like bad news for everybody eager to have a vaccine as soon as possible.

But hidden in this development is a kernel of good news, if you can call it that: This is exactly the kind of scientific rigor we want biopharma companies to practice — especially amid fears that the US approval of a Covid-19 vaccine could be compromised by politics.

The Oxford vaccine has been one of the most intriguing vaccines in development. As Bloomberg covered in its profile of the lead scientist, Oxford’s Sarah Gilbert, it is distinct from the other leading candidates because it does not need to be stored at nearly as cold a temperature. Others must be frozen to be transported; Oxford’s need only be chilled. That could be a serious advantage, considering the existing concerns about how easy it will be to widely distribute any Covid-19 vaccine.

AstraZeneca/Oxford Phase 3 trials got underway in the US in August, having already started in the United Kingdom, Brazil and South Africa. The company planned to enroll 30,000 Americans in its US trials. Phase 3 trials are the make-or-break moment for any new therapy, large-scale trials to determine whether a drug or vaccine has a meaningful effect and to monitor for any adverse effects in a much larger patient population than the earlier, smaller Phase 1 and Phase 2 trials.

STAT broke the news Tuesday evening that Oxford’s Phase 3 trial had been paused because of one patient’s medical complication. A follow-up story from STAT on Thursday conveyed the details of the patient’s case:

The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.

The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said.

The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan.

STAT also learned that an earlier stoppage in July resulting from another patient’s adverse event had turned out to be unrelated to the vaccine: the person was diagnosed with multiple sclerosis. It is a helpful reminder that a patient developing a medical condition while participating in a clinical trial doesn’t necessarily mean their diagnosis has any relation to the vaccine being investigated.

However, as Derek Lowe, who covers drug development for Science magazine, explained, there is some reason to worry about what this particular adverse event means for the viability of the Oxford vaccine.

The vaccine uses a live virus, adapted from a virus found in primates, to produce an immune response to Covid-19. The neurological complication experienced by the patient, transverse myelitis, has been associated in the past with an autoimmune response following viral infections. That link has not been conclusively proven, but it is part of the existing body of research.

“I think this is indeed an event to be taken seriously,” Lowe wrote, “and I think pausing the trial to take stock of what’s going on is entirely appropriate.”

That was the consensus of scientists and medical journalists after the Oxford news broke.

With the world desperate for a Covid-19 vaccine, nobody wants to see a clinical trial for a promising candidate slowed down. But such stoppages are not unusual — NIH Director Francis Collins told Congress on Wednesday that it was “not at all unprecedented” — and they represent sound scientific method.

“This type of pause normally happens when there is an unexpected severe adverse event,” Angela Rasmussen, a Columbia University virologist, wrote on Twitter about the news. “It may be unrelated to the vaccine, but the important part is that this is why we do trials before rolling out a vaccine to the general public.”

And that is really the point. We want a rigorous process to produce a viable vaccine because, as Vox’s Brian Resnick explained, many people are skeptical about whether the approval of a Covid-19 vaccine will be based on good science, given President Trump’s very public agitation for a vaccine to be approved as soon as possible. If too few people take a vaccine because of doubts about the process that produced it, then the pandemic isn’t going to end just because the FDA puts its stamp of approval on a vaccine.

Drug makers seem cognizant of that risk; Vox’s Umair Irfan covered the hopeful signs that companies won’t bow to political pressure by speeding up their clinical review. This stoppage is more evidence that they will actually live up to those principles.

As AstraZeneca CEO Pascal Soriot told investors, according to STAT: “A vaccine that nobody wants to take is not very useful.”

Everybody wants a vaccine as soon as possible. But science cannot be rushed. So strange as it may seem, the abundance of caution shown by AstraZeneca and Oxford after this adverse event is the kind of response we need to build and preserve public trust in a Covid-19 vaccine.

This story appears in VoxCare, a newsletter from Vox on the latest twists and turns in America’s health care debate. Sign up to get VoxCare in your inbox along with more health care stats and 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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