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Pfizer reaches safety milestone for COVID vaccine, CEO says – BNN

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Pfizer Inc. Chief Executive Officer Albert Bourla said that a key safety milestone had been reached in the study of its COVID-19 vaccine, and the drugmaker is now preparing to seek an emergency-use authorization from U.S. regulators.

Speaking at a virtual conference hosted by the New York Times on Tuesday, Bourla said the company was preparing to submit its data to the U.S. Food and Drug Administration. Last week, Pfizer and its partner BioNTech SE reported that an interim analysis showed their experimental vaccine was more than 90 per cent effective in preventing symptomatic cases of COVID-19.

“We are preparing now for submissions,” Bourla said at the conference without specifying when it anticipated to file for an emergency use authorization.

Nonetheless, Bourla added, important questions about the vaccine still remain to be answered. “When it comes to how durable the protection could be, this is something we don’t know yet,” he said.

Bourla added that Pfizer would soon release more detailed efficacy results.

Pfizer shares were up 1.6 per cent at 3:22 p.m. in New York.

Safety Data

Pfizer and BioNTech had been working to accumulate two months of follow-up safety data on volunteers who had received the full two-dose regimen of their vaccine. The FDA requires the information for emergency clearance.

The safety data is one of the last hurdles needed before Pfizer and BioNTech can apply for emergency authorization. The New York-based drug giant will continue to monitor trial participants well after any authorization or approval in order to assure that safety concerns don’t crop up later, Bourla said.

Also See: Azar says Biden transition delay won’t hamper vaccination plan

The Pfizer-BioNTech vaccine is slightly ahead of one from Moderna Inc. in the race to the finish line. Moderna announced Monday that its own candidate was 94.5 per cent effective. Moderna expects to get the safety data it needs by the end of the month, allowing it to file for emergency clearance in the coming weeks.

Bourla said at the New York Times conference that Pfizer had not been overly specific when it reported “more than 90 per cent efficacy” because that number was likely to fluctuate as the trial gained more cases. The company will report out an additional number once it publishes fuller data, he said.

mRNA Platform

The drug industry executive spoke alongside Bill Gates and Heidi J. Larson, director of the Vaccine Confidence Project, in a discussion about vaccine development, distribution and uptake.

The most recent trial results are “a glorious confirmation of the power of the technology,” Bourla said, referring the the novel messenger RNA used in Pfizer and BioNTech’s vaccine.

Bourla’s tenure at Pfizer spans more than 27 years. He said at a later conference held Tuesday by the online media publication STAT that it was one of the best days of his life when he learned of the vaccine’s success.

“You’re relieved because the news that you’re expecting to hear will not only determine the future of the company, but the future of your world,” Bourla said. “I felt that I was living a dream.”

Tumult, Scrutiny

At other times throughout the pandemic, the company has faced political tumult and scrutiny, Bourla said.

The Pfizer chief rebutted concerns that he sought to report the effectiveness of the vaccine before Election Day, potentially influencing the outcome of the U.S. presidential vote.

“I did not have any political or any artificial timelines in my mind,” Bourla said. Instead, at the start of the company’s work on the vaccine, he set an October goal after his scientists said the product would only be ready by mid-2021.

He pushed for the earlier date, he said, to have a vaccine ready for a possible winter surge of infections.

“I said, ‘Go back and see how many people would die’” if there were a new spike in cases. But the October timeline became publicly conflated with President Donald Trump’s political ambitions.

Bourla said he didn’t take U.S. taxpayer dollars for the vaccine’s research and development in order to avoid politics that might be attached to the effort. “When you want to go from the middle of next year to the middle of October, you need to remove any bureaucracy,” he said. “And I knew this would become very political.”

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Roots sees room for expansion in activewear, reports $5.2M Q2 loss and sales drop

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TORONTO – Roots Corp. may have built its brand on all things comfy and cosy, but its CEO says activewear is now “really becoming a core part” of the brand.

The category, which at Roots spans leggings, tracksuits, sports bras and bike shorts, has seen such sustained double-digit growth that Meghan Roach plans to make it a key part of the business’ future.

“It’s an area … you will see us continue to expand upon,” she told analysts on a Friday call.

The Toronto-based retailer’s push into activewear has taken shape over many years and included several turns as the official designer and supplier of Team Canada’s Olympic uniform.

But consumers have had plenty of choice when it comes to workout gear and other apparel suited to their sporting needs. On top of the slew of athletic brands like Nike and Adidas, shoppers have also gravitated toward Lululemon Athletica Inc., Alo and Vuori, ramping up competition in the activewear category.

Roach feels Roots’ toehold in the category stems from the fit, feel and following its merchandise has cultivated.

“Our product really resonates with (shoppers) because you can wear it through multiple different use cases and occasions,” she said.

“We’ve been seeing customers come back again and again for some of these core products in our activewear collection.”

Her remarks came the same day as Roots revealed it lost $5.2 million in its latest quarter compared with a loss of $5.3 million in the same quarter last year.

The company said the second-quarter loss amounted to 13 cents per diluted share for the quarter ended Aug. 3, the same as a year earlier.

In presenting the results, Roach reminded analysts that the first half of the year is usually “seasonally small,” representing just 30 per cent of the company’s annual sales.

Sales for the second quarter totalled $47.7 million, down from $49.4 million in the same quarter last year.

The move lower came as direct-to-consumer sales amounted to $36.4 million, down from $37.1 million a year earlier, as comparable sales edged down 0.2 per cent.

The numbers reflect the fact that Roots continued to grapple with inventory challenges in the company’s Cooper fleece line that first cropped up in its previous quarter.

Roots recently began to use artificial intelligence to assist with daily inventory replenishments and said more tools helping with allocation will go live in the next quarter.

Beyond that time period, the company intends to keep exploring AI and renovate more of its stores.

It will also re-evaluate its design ranks.

Roots announced Friday that chief product officer Karuna Scheinfeld has stepped down.

Rather than fill the role, the company plans to hire senior level design talent with international experience in the outdoor and activewear sectors who will take on tasks previously done by the chief product officer.

This report by The Canadian Press was first published Sept. 13, 2024.

Companies in this story: (TSX:ROOT)

The Canadian Press. All rights reserved.

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Talks on today over HandyDART strike affecting vulnerable people in Metro Vancouver

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VANCOUVER – Mediated talks between the union representing HandyDART workers in Metro Vancouver and its employer, Transdev, are set to resume today as a strike that has stopped most services drags into a second week.

No timeline has been set for the length of the negotiations, but Joe McCann, president of the Amalgamated Transit Union Local 1724, says they are willing to stay there as long as it takes, even if talks drag on all night.

About 600 employees of the door-to-door transit service for people unable to navigate the conventional transit system have been on strike since last Tuesday, pausing service for all but essential medical trips.

Hundreds of drivers rallied outside TransLink’s head office earlier this week, calling for the transportation provider to intervene in the dispute with Transdev, which was contracted to oversee HandyDART service.

Transdev said earlier this week that it will provide a reply to the union’s latest proposal on Thursday.

A statement from the company said it “strongly believes” that their employees deserve fair wages, and that a fair contract “must balance the needs of their employees, clients and taxpayers.”

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

The Canadian Press. All rights reserved.

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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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