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Pfizer seeking FDA approval of booster shot to protect against Delta variant – 680 News

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Pfizer-BioNTech says it will ask the Food and Drug Administration (FDA) to approve a booster dose, or a third shot, of its COVID-19 vaccine within the next month.

The drugmaker said on Thursday this step is based on evidence of greater risk of reinfection six months after two-dose treatment and due to the spread of the highly contagious Delta variant, now prevalent in several counties including Canada.

“While protection against severe disease remained high across the full 6 months, the observed decline in efficacy against symptomatic disease over time and the continued emergence of variants are key factors driving our belief that a booster dose will likely be necessary to maintain highest levels of protection,” Pfizer said in a statement.

Israel’s health ministry, a country that saw an increase in infections as a direct result of the Delta variant, said vaccine effectiveness in preventing both infection and symptomatic disease fell to 64 per cent in June.

Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet.

“Americans who have been fully vaccinated do not need a booster shot at this time,” the CDC and FDA said in the statement.

“We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses if and when the science demonstrates that they are needed.”

Speaking on Thursday, Pfizer Chief Scientific Officer Mikael Dolsten said while the Pfizer vaccine is highly effective against the Delta variant, after six months “there likely is the risk of reinfection as antibodies, as predicted, wane.”

Dolsten however did say that data from Israel and the U.K. suggests that even with decreasing or lower antibody levels, the vaccine remains around 95 per cent effective in protecting against severe disease.

“While we believe a third dose of BNT162b2 has the potential to preserve the highest levels protective efficacy against all currently known variants including Delta, we are remaining vigilant and are developing an updated version of the Pfizer-COVID-19 vaccine that uses a new construct based on the B.1.617.2 lineage, first identified in India and also known as the Delta variant,” Pfizer and BioNTech added.

The vaccine, developed with German partner BioNTech, showed 95 per cent efficacy in preventing symptomatic COVID-19 in clinical trials conducted within the last year.

Moderna CEO Stephane Bancel said in early May that a booster for his company’s vaccine would also likely be needed in the fight against transmissible variants.

Pfizer and Moderna vaccines have been widely distributed across Canada and its many provinces as the country’s vaccine rollout have greatly improved in recent months.

Canada’s top public health official says the country is “within reach” of fully vaccinating four out of every five eligible Canadians against COVID-19.

Dr. Theresa Tam says more than 40-million doses have been given so far, with 78 per cent of those 12 and older receiving at least one dose.

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TC Energy cuts cost estimate for Southeast Gateway pipeline project in Mexico

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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.

Companies in this story: (TSX:TRP)

The Canadian Press. All rights reserved.

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BCE reports Q3 loss on asset impairment charge, cuts revenue guidance

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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.

Companies in this story: (TSX:BCE)

The Canadian Press. All rights reserved.

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Canada Goose reports Q2 revenue down from year ago, trims full-year guidance

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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.

Companies in this story: (TSX:GOOS)

The Canadian Press. All rights reserved.

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