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Pfizer confirms possible November COVID vaccine application – BNN

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Pfizer Inc. said it could seek emergency-use authorization for its COVID-19 vaccine in the U.S. by late November if the shot is shown to be effective in a large late-stage trial, putting to rest any notion that a vaccine could be cleared for emergency use in the U.S. before Election Day.

Safety reviews will dictate the time line, with the U.S. Food and Drug Administration requiring that at least half the people in the study be watched for side effects for two months. That milestone should be achieved in the third week of November, Pfizer Chief Executive Officer Albert Bourla said in an open letter published Friday on the company’s website.

“Let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved,” Bourla wrote. An initial readout on whether the vaccine is effective could come later this month, depending on how quickly subjects in the trial — some of whom got a placebo shot — become infected with the virus.

Pfizer’s shares rose 3.2 per cent to US$37.73 at 1:40 p.m. in New York trading.

Although Bourla’s letter ends the idea that a vaccine could be cleared in the U.S. before Nov. 3 — a goal President Donald Trump has pushed for — the Pfizer timetable could give the president a partial victory. If Pfizer and its German partner BioNTech SE can say in late October that its inoculation protects people from the virus, that could let Trump claim his administration successfully pushed for a working vaccine before Nov. 3, regardless of whether the FDA has reviewed it.

‘Too Politicized’

“It’s a huge win. It’s a win for public safety,” said Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston. “We don’t want something that works, but we didn’t give patients a full and accurate assessment of the side effects that might be expected among some people.”

Faust was among a group of leading scientists who previously urged Pfizer to wait until at least late November before seeking emergency authorization.

Even mild or moderate side effects could undermine public trust in a vaccine if they weren’t initially understood or explained, something that waiting for two months of safety data makes significantly less likely, he said.

“I think what we effectively did was to point out the risk of ruin was higher if they rushed,” he said. “The worst possible scenario is people just stop trusting Pfizer and their astronomically large portfolio of products.”

‘Right Thing’

Howard Forman, director of the Yale School of Public Health’s health-care management program and another signer of the letter, also spoke approvingly of the decision by Pfizer. If Pfizer had pushed ahead with an October filing, “it was going to seem to be too politicized,” engendering skepticism among members of the public, he said.

Forman, who also signed the letter from the scientists, is participating in the Pfizer trial and received his second dose of the vaccine about a month ago.

“It sounds like they’re doing the right thing,” Forman said, noting that while he’s optimistic about the new November time line, the company still has to prove the vaccine is safe and works, including in different subgroups like the elderly.

The Pfizer partnership and Moderna Inc. are the two front-runners in testing COVID-19 vaccines in the U.S. Both are testing so-called messenger RNA vaccines, a new type of vaccine that turns the body’s own cells into tiny vaccine-making factories. The technology has never been used in an approved vaccine.

Vaccine Leaders

Moderna is only slightly behind Pfizer, and has said it could get preliminary efficacy data by late November. While both began late-stage trials at the end of July, Pfizer is in the lead due to the speed at which it enrolled its trial and quirks in how the vaccine is given. The two doses of the Pfizer vaccine are given three weeks apart compared with four weeks for the Moderna vaccine, shaving a week off the timetable. Moderna also slowed enrollment in its trial slightly to increase diversity among participants in the research.

U.S. trials of two other vaccines are on hold for safety checks, putting them significantly behind the two mRNA vaccines.

A U.S. trial of an AstraZeneca vaccine has been on hold since early September while regulators investigate a participant in the U.K. that experienced neurological issues, although large trials of the vaccine have resumed in the U.K., South Africa and Brazil. And a 60,000-patient trial of a Johnson & Johnson vaccine was paused this week due to an unexplained illness in a participant.

The Bourla letter released Friday confirmed a time line laid out by BioNTech CEO Ugur Sahin this week. The partners haven’t had to stop their late-stage study over safety concerns, Sahin said.

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Transat AT reports $39.9M Q3 loss compared with $57.3M profit a year earlier

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MONTREAL – Travel company Transat AT Inc. reported a loss in its latest quarter compared with a profit a year earlier as its revenue edged lower.

The parent company of Air Transat says it lost $39.9 million or $1.03 per diluted share in its quarter ended July 31.

The result compared with a profit of $57.3 million or $1.49 per diluted share a year earlier.

Revenue in what was the company’s third quarter totalled $736.2 million, down from $746.3 million in the same quarter last year.

On an adjusted basis, Transat says it lost $1.10 per share in its latest quarter compared with an adjusted profit of $1.10 per share a year earlier.

Transat chief executive Annick Guérard says demand for leisure travel remains healthy, as evidenced by higher traffic, but consumers are increasingly price conscious given the current economic uncertainty.

This report by The Canadian Press was first published Sept. 12, 2024.

Companies in this story: (TSX:TRZ)

The Canadian Press. All rights reserved.

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Dollarama keeping an eye on competitors as Loblaw launches new ultra-discount chain

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Dollarama Inc.’s food aisles may have expanded far beyond sweet treats or piles of gum by the checkout counter in recent years, but its chief executive maintains his company is “not in the grocery business,” even if it’s keeping an eye on the sector.

“It’s just one small part of our store,” Neil Rossy told analysts on a Wednesday call, where he was questioned about the company’s food merchandise and rivals playing in the same space.

“We will keep an eye on all retailers — like all retailers keep an eye on us — to make sure that we’re competitive and we understand what’s out there.”

Over the last decade and as consumers have more recently sought deals, Dollarama’s food merchandise has expanded to include bread and pantry staples like cereal, rice and pasta sold at prices on par or below supermarkets.

However, the competition in the discount segment of the market Dollarama operates in intensified recently when the country’s biggest grocery chain began piloting a new ultra-discount store.

The No Name stores being tested by Loblaw Cos. Ltd. in Windsor, St. Catharines and Brockville, Ont., are billed as 20 per cent cheaper than discount retail competitors including No Frills. The grocery giant is able to offer such cost savings by relying on a smaller store footprint, fewer chilled products and a hearty range of No Name merchandise.

Though Rossy brushed off notions that his company is a supermarket challenger, grocers aren’t off his radar.

“All retailers in Canada are realistic about the fact that everyone is everyone’s competition on any given item or category,” he said.

Rossy declined to reveal how much of the chain’s sales would overlap with Loblaw or the food category, arguing the vast variety of items Dollarama sells is its strength rather than its grocery products alone.

“What makes Dollarama Dollarama is a very wide assortment of different departments that somewhat represent the old five-and-dime local convenience store,” he said.

The breadth of Dollarama’s offerings helped carry the company to a second-quarter profit of $285.9 million, up from $245.8 million in the same quarter last year as its sales rose 7.4 per cent.

The retailer said Wednesday the profit amounted to $1.02 per diluted share for the 13-week period ended July 28, up from 86 cents per diluted share a year earlier.

The period the quarter covers includes the start of summer, when Rossy said the weather was “terrible.”

“The weather got slightly better towards the end of the summer and our sales certainly increased, but not enough to make up for the season’s horrible start,” he said.

Sales totalled $1.56 billion for the quarter, up from $1.46 billion in the same quarter last year.

Comparable store sales, a key metric for retailers, increased 4.7 per cent, while the average transaction was down2.2 per cent and traffic was up seven per cent, RBC analyst Irene Nattel pointed out.

She told investors in a note that the numbers reflect “solid demand as cautious consumers focus on core consumables and everyday essentials.”

Analysts have attributed such behaviour to interest rates that have been slow to drop and high prices of key consumer goods, which are weighing on household budgets.

To cope, many Canadians have spent more time seeking deals, trading down to more affordable brands and forgoing small luxuries they would treat themselves to in better economic times.

“When people feel squeezed, they tend to shy away from discretionary, focus on the basics,” Rossy said. “When people are feeling good about their wallet, they tend to be more lax about the basics and more willing to spend on discretionary.”

The current economic situation has drawn in not just the average Canadian looking to save a buck or two, but also wealthier consumers.

“When the entire economy is feeling slightly squeezed, we get more consumers who might not have to or want to shop at a Dollarama generally or who enjoy shopping at a Dollarama but have the luxury of not having to worry about the price in some other store that they happen to be standing in that has those goods,” Rossy said.

“Well, when times are tougher, they’ll consider the extra five minutes to go to the store next door.”

This report by The Canadian Press was first published Sept. 11, 2024.

Companies in this story: (TSX:DOL)

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U.S. regulator fines TD Bank US$28M for faulty consumer reports

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TORONTO – The U.S. Consumer Financial Protection Bureau has ordered TD Bank Group to pay US$28 million for repeatedly sharing inaccurate, negative information about its customers to consumer reporting companies.

The agency says TD has to pay US$7.76 million in total to tens of thousands of victims of its illegal actions, along with a US$20 million civil penalty.

It says TD shared information that contained systemic errors about credit card and bank deposit accounts to consumer reporting companies, which can include credit reports as well as screening reports for tenants and employees and other background checks.

CFPB director Rohit Chopra says in a statement that TD threatened the consumer reports of customers with fraudulent information then “barely lifted a finger to fix it,” and that regulators will need to “focus major attention” on TD Bank to change its course.

TD says in a statement it self-identified these issues and proactively worked to improve its practices, and that it is committed to delivering on its responsibilities to its customers.

The bank also faces scrutiny in the U.S. over its anti-money laundering program where it expects to pay more than US$3 billion in monetary penalties to resolve.

This report by The Canadian Press was first published Sept. 11, 2024.

Companies in this story: (TSX:TD)

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