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FDA says kid-sized Pfizer vaccine doses appear highly effective, safe – CBC.ca

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U.S. health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children and caused no unexpected safety issues, as the country weighs beginning vaccinations in youngsters.

The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.

In their analysis, FDA scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized.

The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision.

U.S. children could begin vaccinations next month

If the FDA authorizes the shots, the Centers for Disease Control and Prevention will make additional recommendations on who should receive them the first week of November. Children could begin vaccinations early next month — with the first youngsters in line fully protected by Christmas.

Full-strength Pfizer shots already are recommended for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem infections from the extra-contagious delta variant and help keep kids in school.

WATCH | Pfizer releases clinical trial data for COVID-19 vaccine for children aged 5 to 11:

Pfizer releases clinical trial data for COVID-19 vaccine for children aged 5 to 11

13 hours ago

Pfizer publicly released data from its coronavirus vaccine trial appearing to show that it’s both safe and effective for children aged five to 11. But that data is now being reviewed by regulators, and parents want to carefully weigh the risks. 2:03

The FDA review affirmed results from Pfizer posted earlier in the day showing the two-dose shot was nearly 91 per cent effective at preventing symptomatic infection in young children. Researchers calculated the figure based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.

No new side effects

The FDA review found no new or unexpected side effects, which mostly consisted of sore arms, fever or achiness that teens experience.

However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects, including myocarditis, a type of heart inflammation that occasionally occurs after the second dose.

The agency used statistical modelling to try to predict how many hospitalizations and deaths from COVID-19 the vaccine would prevent versus the number of potential heart side effects it might cause. In four scenarios of the pandemic, the vaccine clearly prevented more hospitalizations than would be expected from the heart side effect. Only when virus cases were extremely low would the vaccine cause more hospitalizations than it would prevent. But overall, regulators concluded that the vaccine’s protective benefits “would clearly outweigh” its risks.

While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

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Canada Goose to get into eyewear through deal with Marchon

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TORONTO – Canada Goose Holdings Inc. says it has signed a deal that will result in the creation of its first eyewear collection.

The deal announced on Thursday by the Toronto-based luxury apparel company comes in the form of an exclusive, long-term global licensing agreement with Marchon Eyewear Inc.

The terms and value of the agreement were not disclosed, but Marchon produces eyewear for brands including Lacoste, Nike, Calvin Klein, Ferragamo, Longchamp and Zeiss.

Marchon plans to roll out both sunglasses and optical wear under the Canada Goose name next spring, starting in North America.

Canada Goose says the eyewear will be sold through optical retailers, department stores, Canada Goose shops and its website.

Canada Goose CEO Dani Reiss told The Canadian Press in August that he envisioned his company eventually expanding into eyewear and luggage.

This report by The Canadian Press was first published Sept. 19, 2024.

Companies in this story: (TSX:GOOS)

The Canadian Press. All rights reserved.

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A timeline of events in the bread price-fixing scandal

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Almost seven years since news broke of an alleged conspiracy to fix the price of packaged bread across Canada, the saga isn’t over: the Competition Bureau continues to investigate the companies that may have been involved, and two class-action lawsuits continue to work their way through the courts.

Here’s a timeline of key events in the bread price-fixing case.

Oct. 31, 2017: The Competition Bureau says it’s investigating allegations of bread price-fixing and that it was granted search warrants in the case. Several grocers confirm they are co-operating in the probe.

Dec. 19, 2017: Loblaw and George Weston say they participated in an “industry-wide price-fixing arrangement” to raise the price of packaged bread. The companies say they have been co-operating in the Competition Bureau’s investigation since March 2015, when they self-reported to the bureau upon discovering anti-competitive behaviour, and are receiving immunity from prosecution. They announce they are offering $25 gift cards to customers amid the ongoing investigation into alleged bread price-fixing.

Jan. 31, 2018: In court documents, the Competition Bureau says at least $1.50 was added to the price of a loaf of bread between about 2001 and 2016.

Dec. 20, 2019: A class-action lawsuit in a Quebec court against multiple grocers and food companies is certified against a number of companies allegedly involved in bread price-fixing, including Loblaw, George Weston, Metro, Sobeys, Walmart Canada, Canada Bread and Giant Tiger (which have all denied involvement, except for Loblaw and George Weston, which later settled with the plaintiffs).

Dec. 31, 2021: A class-action lawsuit in an Ontario court covering all Canadian residents except those in Quebec who bought packaged bread from a company named in the suit is certified against roughly the same group of companies.

June 21, 2023: Bakery giant Canada Bread Co. is fined $50 million after pleading guilty to four counts of price-fixing under the Competition Act as part of the Competition Bureau’s ongoing investigation.

Oct. 25 2023: Canada Bread files a statement of defence in the Ontario class action denying participating in the alleged conspiracy and saying any anti-competitive behaviour it participated in was at the direction and to the benefit of its then-majority owner Maple Leaf Foods, which is not a defendant in the case (neither is its current owner Grupo Bimbo). Maple Leaf calls Canada Bread’s accusations “baseless.”

Dec. 20, 2023: Metro files new documents in the Ontario class action accusing Loblaw and its parent company George Weston of conspiring to implicate it in the alleged scheme, denying involvement. Sobeys has made a similar claim. The two companies deny the allegations.

July 25, 2024: Loblaw and George Weston say they agreed to pay a combined $500 million to settle both the Ontario and Quebec class-action lawsuits. Loblaw’s share of the settlement includes a $96-million credit for the gift cards it gave out years earlier.

Sept. 12, 2024: Canada Bread files new documents in Ontario court as part of the class action, claiming Maple Leaf used it as a “shield” to avoid liability in the alleged scheme. Maple Leaf was a majority shareholder of Canada Bread until 2014, and the company claims it’s liable for any price-fixing activity. Maple Leaf refutes the claims.

This report by The Canadian Press was first published Sept. 19, 2024.

Companies in this story: (TSX:L, TSX:MFI, TSX:MRU, TSX:EMP.A, TSX:WN)

The Canadian Press. All rights reserved.

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TD CEO to retire next year, takes responsibility for money laundering failures

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TORONTO – TD Bank Group, which is mired in a money laundering scandal in the U.S., says chief executive Bharat Masrani will retire next year.

Masrani, who will retire officially on April 10, 2025, says the bank’s, “anti-money laundering challenges,” took place on his watch and he takes full responsibility.

The bank named Raymond Chun, TD’s group head, Canadian personal banking, as his successor.

As part of a transition plan, Chun will become chief operating officer on Nov. 1 before taking over the top job when Masrani steps down at the bank’s annual meeting next year.

TD also announced that Riaz Ahmed, group head, wholesale banking and president and CEO of TD Securities, will retire at the end of January 2025.

TD has taken billions in charges related to ongoing U.S. investigations into the failure of its anti-money laundering program.

This report by The Canadian Press was first published Sept. 19, 2024.

Companies in this story: (TSX:TD)

The Canadian Press. All rights reserved.

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