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Moderna seeks Health Canada approval of COVID-19 vaccine for youngest children, announces new Montreal facility

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Ilana Diener holds her son, Hudson, 3, during an appointment for a Moderna COVID-19 vaccine trial in Commack, N.Y. on Nov. 30, 2021.EMMA H. TOBIN/The Associated Press

Moderna, Inc. has officially asked Health Canada to authorize its COVID-19 vaccine for children as young as six months old, making the company the first to seek Canadian approval to inoculate babies, toddlers and preschoolers against the pandemic virus.

Patricia Gauthier, Moderna’s Canadian general manager, told a news conference Friday that the company submitted its application to Health Canada Thursday night, not long after it filed for approval in the United States.

“We’re really proud to announce that we filed to Health Canada [Thursday] night our dossier to ask for the extension of the indication for a vaccine so that we could protect potentially infants as early as six months of age,” Ms. Gauthier told a Montreal audience at an event announcing plans for a Moderna vaccine plant in Quebec. “So it’s now in the hands of Health Canada.”

Many Canadian parents have been waiting eagerly to find out when the shot will be available to the youngest children. Right now, Health Canada has approved the Pfizer-BioNTech shot, sold under the brand name Comirnaty, for children as young as five, and Moderna’s shot, SpikeVax for children as young as six.

It’s too early to say how soon Health Canada will make a ruling on Moderna’s application. In the past, a few weeks to a few months have elapsed between vaccine-makers submitting their data on COVID-19 shots and the regulator granting approval.

News of Moderna’s application emerged on the same day the Massachusetts-based company fleshed out its plans for a manufacturing plant in the Montreal area that will eventually pump out shots for COVID-19 and other respiratory illnesses, along with future vaccines for whatever yet-to-emerge virus sparks the next pandemic.

On Friday, Moderna Chief Executive Officer Stéphane Bancel, Prime Minister Justin Trudeau, Quebec Premier François Legault and other politicians gathered at McGill University to announce the 10-year agreement, which also includes a Moderna commitment to spend an unspecified amount of money on scientific research in Canada.

“With this new Moderna facility Canada will now have more timely and more secure access to domestically-produced mRNA vaccines to respond in the event of future health emergencies, including future pandemics,” federal Health Minister Jean-Yves Duclos said.

Moderna and the federal government announced last August that they had signed a memorandum of understanding that would culminate in Moderna making Canada the site of its first manufacturing plant outside the United States, but the parties did not announce a location for the facility until Friday.

Moderna has since announced plans to build a plant in Australia on a similar timeline.

When the pandemic hit, Moderna was a startup with limited production capacity and no approved products. It contracted with other vaccine-makers, namely Switzerland’s Lonza, to pump out tens of millions of its mRNA shots, which alongside a similar vaccine made by Pfizer-BioNTech, helped curb the death toll of the pandemic.

Messenger RNA is a single-stranded molecule that transmits instructions for cells to manufacture proteins. In the case of the mRNA vaccines for COVID-19, the shots were encoded with a message telling cells to make the spike protein that studs SARS-CoV-2, coaxing the immune system to mount a defensive response it could repeat if the real virus showed up.

The shots were the first mRNA products to garner regulatory approval around the world.

“For the first time in the history of medicine, we have a molecule that is an information molecule and that changes everything,” Mr. Bancel, the Moderna CEO, said. “It is like going from Blockbuster to Netflix. It is a change of paradigm and we’re bringing this technology to Canada, which we’re very excited about.”

Moderna is now working on updated versions of its COVID-19 vaccine aimed at a broad range of variants, including the super-contagious Omicron, which has blunted the ability of vaccines to prevent mild infections. The mRNA vaccines still substantially reduce the risk of severe illness and death, especially in those who have received three or more doses.

Moderna has other prospective mRNA shots in its pipeline, including an mRNA flu shot scheduled to enter a phase three trial this fall, and an mRNA shot for respiratory syncytial virus, or RSV, for older adults that is already in phase three. RSV is a seasonal respiratory virus that is most dangerous to the very young and very old.

The “ultimate goal,” said Shehzad Iqbal, Moderna Canada’s medical director, is to create a single annual shot that would be effective against  multiple strains of COVID-19, influenza and RSV.

“We can create all these great vaccines, but if people don’t take them, it doesn’t help,” Dr. Iqbal said in an interview before Friday’s announcement. “If you can simplify the implementation side by combining them into one shot, then it just becomes a little bit easier to get better uptake.”

That goal is a tall order: There is currently no approved vaccine for RSV, while making a universal flu vaccine has bedevilled researchers for decades.

Along with producing vaccines against infectious respiratory diseases, the other purpose of the Moderna plant would be to supply Canada with emergency shots in the event of another pandemic.

By the time COVID-19 emerged, Canada had scant vaccine manufacturing capacity, leaving the country to rely on imported COVID-19 shots. The sector shrank over decades under multiple governments.

Canada did have a contract with the pharmaceutical giant GlaxoSmithKline to produce a pandemic flu vaccine at its plant in Quebec, but when the pandemic was caused by a coronavirus, not influenza, that contract was useless.

The mRNA platform, capable of being quickly recoded with the genetic sequence of a new virus, is more flexible than older ways of making vaccines.

The federal government has announced more than a billion dollars in investments in the biomanufacturing sector since the pandemic began, including $200-million for Resilience Biotechnology to expand its mRNA-making facility in Mississauga; $126-million for a National Research Council plant to make Novavax’s COVID-19 shot; and $415-million for Sanofi Pasteur to build a new flu vaccine facility in the Greater Toronto Area.

With files from Canadian Press

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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)

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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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