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Trump says vaccine ready within weeks; Pfizer says some patients show side effects

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President Donald Trump reiterated his belief that a coronavirus vaccine may arrive before Election Day, even as top administration health officials have rebuffed such a timeline — and vaccine makers have vowed to wait for safety and efficacy data.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”In an interview with Fox &amp; Friends, Trump said a vaccine could be ready to distribute in as little as four to eight weeks, a highly condensed timeline for approval and distribution that many experts have questioned.” data-reactid=”18″>In an interview with Fox & Friends, Trump said a vaccine could be ready to distribute in as little as four to eight weeks, a highly condensed timeline for approval and distribution that many experts have questioned.

“We’re going to have a vaccine in a matter of weeks, it could be four weeks it could be eight weeks…will it be before the Election, it could be…we’ll start delivering it immediately upon getting it,” he said.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”The aggressive timetable has heightened the debate surrounding the deployment of a potential COVID-19 cure, which is perceived as crucial to restarting public life and ending the threat of lockdowns.” data-reactid=”20″>The aggressive timetable has heightened the debate surrounding the deployment of a potential COVID-19 cure, which is perceived as crucial to restarting public life and ending the threat of lockdowns.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”While not referencing a specific date or timeline, Trump’s own health officials, including U.S. Food and Drug Commissioner Stephen Hahn, have reiterated a commitment to safety in approving any drug. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases has said a vaccine by Election Day was unlikely, but at least theoretically possible.” data-reactid=”21″>While not referencing a specific date or timeline, Trump’s own health officials, including U.S. Food and Drug Commissioner Stephen Hahn, have reiterated a commitment to safety in approving any drug. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases has said a vaccine by Election Day was unlikely, but at least theoretically possible.

Since the FDA exists under the executive branch, and therefore under the White House— as does the U.S. Department of Health and Human Services (HHS)— it is possible for the White House to exert pressure, and there are provisions that give HHS Sec. Alex Azar the authority to push for an emergency authorization.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”But in an article Tuesday in the New England Journal of Medicine, Operation Warp Speed officials, including director Moncef Slaoui, indicated a focus on January 2021 for vaccine distribution and approval.” data-reactid=”23″>But in an article Tuesday in the New England Journal of Medicine, Operation Warp Speed officials, including director Moncef Slaoui, indicated a focus on January 2021 for vaccine distribution and approval.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Still, complications in human trials may emerge as a hurdle to rapidly deploying any inoculation— an expectation in the clinical trial process. On Tuesday, Pfizer (PFE) said some of its trial subjects displayed mild-to-moderate after-effects to either the company’s experimental coronavirus vaccine, or a placebo. The data showed that fatigue was the most common feeling, executives said on an investor call.” data-reactid=”24″>Still, complications in human trials may emerge as a hurdle to rapidly deploying any inoculation— an expectation in the clinical trial process. On Tuesday, Pfizer (PFE) said some of its trial subjects displayed mild-to-moderate after-effects to either the company’s experimental coronavirus vaccine, or a placebo. The data showed that fatigue was the most common feeling, executives said on an investor call.

Many southern states are seeing a week-over-week drop in cases. (Graphic: David Foster/Yahoo Finance)

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”The recent hiccup with AstraZeneca’s (AZN) clinical trials of Oxford University’s vaccine is another indicator of a possible delay — while U.K. Phase 3 trials have resumed, the U.S. remains on hold. The National Institutes of Health is concerned about the mysterious illness that put the U.K. trial on hold and says the company hasn’t been forthcoming with helpful information. The company has said it believes it can still have a vaccine approved by the end of the year.” data-reactid=”37″>The recent hiccup with AstraZeneca’s (AZN) clinical trials of Oxford University’s vaccine is another indicator of a possible delay — while U.K. Phase 3 trials have resumed, the U.S. remains on hold. The National Institutes of Health is concerned about the mysterious illness that put the U.K. trial on hold and says the company hasn’t been forthcoming with helpful information. The company has said it believes it can still have a vaccine approved by the end of the year.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Moderna (MRNA), a key frontrunner heavily funded by federal reesearch dollars, has also committed to the end of the year. Meanwhile, collaborators Pfizer and BioNTech (BNTX) have said they are on track to at least have results by the end of October — but not in time for an October 22 FDA meeting that will hash out details of approval and distribution of vaccines.” data-reactid=”38″>Moderna (MRNA), a key frontrunner heavily funded by federal reesearch dollars, has also committed to the end of the year. Meanwhile, collaborators Pfizer and BioNTech (BNTX) have said they are on track to at least have results by the end of October — but not in time for an October 22 FDA meeting that will hash out details of approval and distribution of vaccines.

But Pfizer also said that the FDA has indicated it will weigh an emergency use authorization based on a subset of the trial population. Though trials are upwards of 30,000 for Phase 3, and Pfizer has said it will expand to 44,000, the FDA is only requiring safety data for 6,000— 3,000 vaccinated and 3,000 placebo, executives said on the call.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Trump also referenced Johnson &amp; Johnson (JNJ), which is using a similar technology to AstraZeneca, and has not even entered late-stage trials yet for its candidate, though the company has said they will this month. In the wake of the AstraZeneca scare, some participants in a Phase 2 study in Spain have backed out.” data-reactid=”40″>Trump also referenced Johnson & Johnson (JNJ), which is using a similar technology to AstraZeneca, and has not even entered late-stage trials yet for its candidate, though the company has said they will this month. In the wake of the AstraZeneca scare, some participants in a Phase 2 study in Spain have backed out.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Meanwhile, other players are ramping up their output potential. Novavax (NVAX), which is in Phase 2 trials, announced Tuesday the company signed a deal with the Serum Institute of India for 1 billion doses. That pushes Novavax’s output to 2 billion doses by mid-2021.” data-reactid=”45″>Meanwhile, other players are ramping up their output potential. Novavax (NVAX), which is in Phase 2 trials, announced Tuesday the company signed a deal with the Serum Institute of India for 1 billion doses. That pushes Novavax’s output to 2 billion doses by mid-2021.

<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”The Serum Institute is the largest vaccine producer globally, and has been tapped by other companies, including AstraZeneca, to help with the global production of a Covid-19 vaccine. CEO Adar Poonawalla, recently told Financial Times that many vaccine companies have not ramped up quickly enough to meet the global demand, and it is likely the world won’t be fully supplied until 2024.” data-reactid=”46″>The Serum Institute is the largest vaccine producer globally, and has been tapped by other companies, including AstraZeneca, to help with the global production of a Covid-19 vaccine. CEO Adar Poonawalla, recently told Financial Times that many vaccine companies have not ramped up quickly enough to meet the global demand, and it is likely the world won’t be fully supplied until 2024.

 

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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.

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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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