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AstraZeneca to resume coronavirus vaccine trial after unexplained illness in U.K. – Global News

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Clinical trials testing a potential COVID-19 vaccine developed by AstraZeneca and the University of Oxford are set to resume after a six-day pause due to “potentially unexplained illness” in the United Kingdom.

An independent safety review was conducted Sept. 6 during what was referred to as a “routine action” to maintain the “integrity of the trials.” It concluded on Saturday.

In a release sent to Global News, Oxford University said the study vaccines had been administered to some 18,000 patients as part of the trial.

Read more:
AstraZeneca pauses COVID-19 vaccine trial after unexplained illness in U.K.

“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” the release said, adding they were unable to disclose the patient’s medical information due to “participant confidentiality.”

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On Thursday, a spokesperson for AstraZeneca said the brief pause was triggered after one woman developed “severe neurological symptoms” after taking the experimental COVID-19 vaccine.

AstraZeneca said the company’s “standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators.”

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“All routine follow-up appointments continued as normal during this period,” they said.






1:58
Coronavirus: WHO scientist calls AstraZeneca vaccine trial a ‘wake-up call’


Coronavirus: WHO scientist calls AstraZeneca vaccine trial a ‘wake-up call’

“We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”

On Thursday, Dr. Soumya Swaminathan, the World Health Organization’s chief scientist, urged against becoming “overly discouraged” by the halt in the Oxford and AstraZeneca vaccine trial.

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Instead, she said the pause should serve as a “wake-up call” to the global community to recognize the inevitable “ups and downs in clinical development.”

Read more:
Here’s when experts say Oxford University’s coronavirus vaccine could be ready

“This is normal procedure, this is good clinical practice because safety is the highest priority in any clinical trial,” she said. 

AstraZeneca is considered one of several pharmaceutical companies most likely to help produce the world’s first viable COVID-19 vaccine.

On Tuesday, executives from those companies made what they called an “historic pledge” to “uphold the integrity of the scientific process” amid rising concerns that drugmakers would skirt safety procedures in the face of political pressure from United States President Donald Trump to rush the vaccine.






1:09
Coronavirus: U.K. says pause on Oxford vaccine clinical trial ‘not unusual’


Coronavirus: U.K. says pause on Oxford vaccine clinical trial ‘not unusual’

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the pledge read.

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AstraZeneca, a British-Swedish multinational pharmaceutical and biopharmaceutical company, is collaborating with Oxford University to manufacture 2 billion doses of the COVID-19 vaccine.

Dr. Adrian Hill, director of the Jenner Institute at Oxford University said during a previous interview that high-risk groups could be vaccinated by December, but “certainly there’ll be a million doses around in September,” due to a manufacturing “scale-up.”

More to come.

© 2020 Global News, a division of Corus Entertainment Inc.

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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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