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.
“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.”
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.”
“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.
“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.”
CALGARY – TC Energy Corp. has lowered the estimated cost of its Southeast Gateway pipeline project in Mexico.
It says it now expects the project to cost between US$3.9 billion and US$4.1 billion compared with its original estimate of US$4.5 billion.
The change came as the company reported a third-quarter profit attributable to common shareholders of C$1.46 billion or $1.40 per share compared with a loss of C$197 million or 19 cents per share in the same quarter last year.
Revenue for the quarter ended Sept. 30 totalled C$4.08 billion, up from C$3.94 billion in the third quarter of 2023.
TC Energy says its comparable earnings for its latest quarter amounted to C$1.03 per share compared with C$1.00 per share a year earlier.
The average analyst estimate had been for a profit of 95 cents per share, according to LSEG Data & Analytics.
This report by The Canadian Press was first published Nov. 7, 2024.
BCE Inc. reported a loss in its latest quarter as it recorded $2.11 billion in asset impairment charges, mainly related to Bell Media’s TV and radio properties.
The company says its net loss attributable to common shareholders amounted to $1.24 billion or $1.36 per share for the quarter ended Sept. 30 compared with a profit of $640 million or 70 cents per share a year earlier.
On an adjusted basis, BCE says it earned 75 cents per share in its latest quarter compared with an adjusted profit of 81 cents per share in the same quarter last year.
“Bell’s results for the third quarter demonstrate that we are disciplined in our pursuit of profitable growth in an intensely competitive environment,” BCE chief executive Mirko Bibic said in a statement.
“Our focus this quarter, and throughout 2024, has been to attract higher-margin subscribers and reduce costs to help offset short-term revenue impacts from sustained competitive pricing pressures, slow economic growth and a media advertising market that is in transition.”
Operating revenue for the quarter totalled $5.97 billion, down from $6.08 billion in its third quarter of 2023.
BCE also said it now expects its revenue for 2024 to fall about 1.5 per cent compared with earlier guidance for an increase of zero to four per cent.
The company says the change comes as it faces lower-than-anticipated wireless product revenue and sustained pressure on wireless prices.
BCE added 33,111 net postpaid mobile phone subscribers, down 76.8 per cent from the same period last year, which was the company’s second-best performance on the metric since 2010.
It says the drop was driven by higher customer churn — a measure of subscribers who cancelled their service — amid greater competitive activity and promotional offer intensity. BCE’s monthly churn rate for the category was 1.28 per cent, up from 1.1 per cent during its previous third quarter.
The company also saw 11.6 per cent fewer gross subscriber activations “due to more targeted promotional offers and mobile device discounting compared to last year.”
Bell’s wireless mobile phone average revenue per user was $58.26, down 3.4 per cent from $60.28 in the third quarter of the prior year.
This report by The Canadian Press was first published Nov. 7, 2024.
TORONTO – Canada Goose Holdings Inc. trimmed its financial guidance as it reported its second-quarter revenue fell compared with a year ago.
The luxury clothing company says revenue for the quarter ended Sept. 29 totalled $267.8 million, down from $281.1 million in the same quarter last year.
Net income attributable to shareholders amounted to $5.4 million or six cents per diluted share, up from $3.9 million or four cents per diluted share a year earlier.
On an adjusted basis, Canada Goose says it earned five cents per diluted share in its latest quarter compared with an adjusted profit of 16 cents per diluted share a year earlier.
In its outlook, Canada Goose says it now expects total revenue for its full financial year to show a low-single-digit percentage decrease to low-single-digit percentage increase compared with earlier guidance for a low-single-digit increase.
It also says it now expects its adjusted net income per diluted share to show a mid-single-digit percentage increase compared with earlier guidance for a percentage increase in the mid-teens.
This report by The Canadian Press was first published Nov. 7, 2024.