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COVID in kids under 5: When will vaccines be approved? – CTV News

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Even as Canadians contend with a sixth wave of COVID-19 infections, children under the age of five remain the only age group in Canada without access to vaccines designed to protect against the virus.

As of April 27, Health Canada has not received applications from any vaccine manufacturers requesting authorization of a COVID-19 vaccine for children under the age of five. However, Moderna says it is currently working on a submission to Health Canada for approval.

The lack of vaccines, combined with high levels of community transmission, may leave some parents concerned about their youngest children being exposed to infection.

Dr. Martha Fulford is an infectious disease expert and chief of medicine at the McMaster University Medical Centre in Hamilton, Ont. She said that until a vaccine has been proven to provide the youngest children with significant protective benefits, there’s no reason to rush the process.

“You can’t vaccinate a zero to four-year-old until you have a vaccine that actually does something for the child, and where the benefit has been shown to outweigh any potential risk,” Fulford told CTVNews.ca in a phone interview on April 25. “Eventually, I think we’ll have one, but it shouldn’t be rushed.”

Pfizer Inc. and BioNTech SE are currently in the process of manufacturing a vaccine for children under the age of five, while Moderna Inc. is working on developing its own version of this vaccine for children under the age of six. Early data published so far is limited to press releases shared by the pharmaceutical companies.

In Pfizer-BioNTech’s case, an ongoing clinical study is evaluating the efficacy of vaccines for children between six months and four years of age. After two doses, the company saw that the vaccine did not meet its criteria for immunogenicity, said Dr. Dina Kulik, a pediatric emergency doctor based in Toronto. This means the vaccine was unable to elicit an effective antibody response among those involved in the study, she said. What the company has decided to do instead is extend its trial to include a third dose. Pfizer is expected to release this data in May, before it is evaluated by the United States Food and Drug Administration.

“It wasn’t approved because it wasn’t effective, quite frankly,” Kulik told CTVNews.ca on April 21 in a phone interview. “It didn’t do what it’s meant to do, so why would we give any vaccine … if you’re not going to see benefit?”

While it may have been disappointing to see that two doses of the vaccine were not as effective among children under the age of five as they initially were in adolescents or adults, it’s typical for vaccine products manufactured for children to face delays and enter the market later than products created for adults, said Dr. Jesse Papenburg, a pediatric infectious disease specialist at the Montreal Children’s Hospital.

“We’ve all been so accustomed to such rapid success in terms of the randomized control trial data showing tremendous efficacy for adults so quickly,” he told CTVNews.ca in a phone interview on April 26. “It’s really not unusual for vaccine development for children [to] take longer in terms of having those studies and really trying to find the lowest dose possible that elicits a protective immune response.”

Data released by Moderna is based on a study involving children from six months to five years of age, with results separated between two age groups – those who are six months and one year old, and those between the ages of two and five. Results show that two doses of the vaccine had an efficacy of 43.7 and 37.5 per cent across both groups, respectively. The company recently submitted an application to the U.S. FDA for authorization of its vaccine.

Both pharmaceutical companies are expected to submit their applications to the FDA for approval before submitting to Health Canada, Papenburg said, though it’s likely Canada could see these requests for authorization within days or weeks of being filed in the U.S. The goal of this review is to determine that the products work and are safe to use, he said.

“These companies prioritize the U.S. market because FDA approval does carry some weight internationally,” he said. “I would expect Health Canada to receive submissions, if not by the end of May, then by sometime in June … based on the information that the FDA has provided with their anticipated timelines.”

However, looking at the data that’s currently available on efficacy of these vaccines, Fulford said she isn’t entirely convinced that they will offer a strong benefit to children under five. More data is needed to assess how much these vaccines will decrease the burden of COVID-19 among children in this age group, and how safe they will be before doctors are able to make recommendations on their use, she said.

“To me, there’s just more questions than answers at this point,” said Fulford. “You have to have a really compelling case that there’s going to be a significant benefit to doing this.”

‘HIGHER BAR’ FOR VACCINE EFFICACY IN CHILDREN

According to Fulford, the bar for developing and approving vaccines for children is much different than it is for adults. This stems from evidence that children tend to be at lower risk of bad outcomes from COVID-19 infection, she said. Studies have shown that the risk of severe illness from contracting the virus increases with age.

“Kids have a much higher bar in terms of effectiveness of vaccines … and you have to be darn sure you’ve discussed the adverse outcomes,” she said. “When you have the lowest-risk group of people for [severe] outcomes from the disease, you have to have the highest safety bar.”

Papenburg echoed this sentiment, adding that the goal is for manufacturers to produce vaccines with the smallest dosage possible.

“The idea of using the lowest possible dose really stems, in part, from a desire to have as safe a product as possible, considering that the disease we’re preventing in pediatrics is less deadly than it is in adults,” Papenburg said. “We do hold vaccines to a little bit of a higher standard when it comes to safety in children.”

In the pediatric patients she’s seeing at the moment, Kulik said common symptoms such as fever, sore throat, fatigue and body aches continue to surface. But with the Omicron BA.2 sub-variant in particular, she said she’s also noticing less respiratory distress and more vomiting and diarrhea, as well as rashes often mistaken for hand, foot and mouth disease.

“This particular strain seems to be causing more discomfort from what I’m seeing professionally,” she said. “It’s uncomfortable, but it’s not causing severe illness … By and large, kids are doing well but they do feel very crummy.”

The fifth wave likely saw the largest number of hospitalizations among children under the age of five in Canada, Papenburg said. As Canadians continue to navigate a sixth wave, hospitalizations among this age group continue to be reported, but not in such large quantities, he said.

According to data collected by Public Health Ontario as of April 25, the number of children aged zero to four who were hospitalized over the two weeks prior was 47 out of a total population of about 723,000. As of April 26, Quebec health authorities reported just seven hospitalization among children within the same age group. These figures are quite low compared to hospital admission rates for some of Canada’s older populations, Fulford said.

As a result, it’s crucial to determine a clear goal for vaccines in children, Fulford said. Based on the vaccine program that has been rolled out in Canada so far, the goal has largely been to prevent severe outcomes as a result of COVID-19 infection, she said. But when dealing with an age group that is already at lower risk of these outcomes, particularly when compared to older populations, this means it is important to also weigh the risks and benefits associated with getting vaccinated for each individual child, Fulford said. This includes taking into consideration existing comorbidities such as obesity or diabetes, which tend to result in higher risk of developing severe outcomes as a result of infection.

“The kids who are at risk kind of know who they are,” she said. “They’re the kids who were at risk before being infected with COVID-19.”

WHAT CAN BE DONE TO MITIGATE RISK IN KIDS?

In addition to awaiting COVID-19 vaccine approval for children ages four and below, it remains to be seen what the guidance will be surrounding its use, Fulford said.

“Approving something is not the same as saying, ‘Everybody should get it now,’” she said.

Once approved, immunization advisory committees are expected to put vaccine efficacy results into broader context, factoring in the disease burden facing the population, as well as relevant risk-benefit analyses to produce recommendations on the use of these vaccines.

“Is it possible that both [vaccines] will be recommended with the same strength, or would there be preferential recommendation for one product over another?” Papenburg said. “That’s what [the National Advisory Committee on Immunization] will look at, in the framework of equity ethics, acceptability and feasibility.”

Another important question that remains to be answered is what the potential benefit of COVID-19 vaccination would be in young children who have already been infected, Fulford said. One study conducted during the Alpha and Delta waves in England shows that reinfection rates appear to be lower among children than adults, for example, but more recent data on the topic remains limited. In the United States, recent data from the Centers for Disease Control and Prevention show that nearly three quarters of children across the country have previously been infected with COVID-19.

Omicron continues to be the predominant variant in circulation in Canada. While Omicron infections appear to be milder in children, they are not trivial, Papenburg said. If a high number of children become infected with the virus, this also increases the chances that a greater proportion of these children could develop severe outcomes after infection, said Kulik.

Children attending school or daycare are especially at risk of contracting the disease due to high levels of interaction with others, often in settings where mask mandates are not in effect, she said.

“The vast majority of kids and adults do well with COVID, [with] a pretty mild, flu-like illness,” she said. “But if you have enough people that get COVID, you’re going to have enough people that get very sick with COVID, kids included. It’s really just a numbers game.”

While no vaccines are currently available for children under the age of five in Canada, efforts can still be taken to limit the chances of these children contracting COVID-19, Papenburg said. This includes limiting social contact with others, and for those aged two and older, wearing a mask indoors if possible, especially when physical distancing is not an option. Mitigating risk also involves avoiding crowded spaces, close contact and poor air circulation, Fulford said.

“Everything that we’ve told people they can do to help reduce risks [of contracting COVID-19], these things are still applicable today,” said Papenburg.

Fulford also encourages parents with young children to assess the potential risk and benefits of going forward with any activity when it comes to developing a COVID-19 infection. There may be circumstances where risks exist, such as when a child attends school or participates in extra curricular activities with other children, but any associated benefits might outweigh those risks, she said.

“Risk-benefit isn’t COVID versus no COVID – it’s total harm minimization in every aspect of what might affect a child’s life,” Fulford said. “It’s a balancing act for every family.”

——-

What questions do you have about Omicron?

With the emergence of a new COVID-19 variant of concern, labelled Omicron, CTVNews.ca wants to hear from Canadians with any questions.

Tell us what you’d like to know when it comes to the Omicron COVID-19 variant.

To submit your question, email us at dotcom@bellmedia.ca with your name, location and question. Your comments may be used in a CTVNews.ca story.

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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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