In this March 20, 2020, file photo, Dr. Rhonda Flores looks at protein samples at one of the labs developing a COVID-19 vaccine, in Rockville, Md.
ANDREW CABALLERO-REYNOLDS/AFP/Getty Images
The United States plans a massive testing effort involving more than 100,000 volunteers and a half dozen or so of the most promising vaccine candidates in an effort to deliver a safe and effective one by the end of 2020, scientists leading the program told Reuters.
The project will compress what is typically 10 years of vaccine development and testing into a matter of months, testimony to the urgency to halt a pandemic that has infected more than 5 million people, killed over 335,000 and battered economies worldwide.
To get there, leading vaccine makers have agreed to share data and lend the use of their clinical trial networks to competitors should their own candidate fail, the scientists said.
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Candidates that demonstrate safety in small early studies will be tested in huge trials of 20,000 to 30,000 subjects for each vaccine, slated to start in July.
Between 100,000 and 150,000 people may be enrolled in the studies, said Dr. Larry Corey, a vaccine expert at Fred Hutchinson Cancer Center in Seattle, who is helping design the trials.
“If you don’t see a safety problem, you just keep going,” Dr. Francis Collins, director of the National Institutes of Health (NIH), told Reuters. The vaccine effort is part of a public-private partnership called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) announced last month.
The effort fits into the research and development arm of “Operation Warp Speed,” the White House program announced last week to accelerate coronavirus vaccine development.
Vaccines, which are intended for use in healthy people, are typically tested in successive steps, starting with trials in animals.
Human testing begins with a small safety trial in healthy volunteers, followed by a larger study to find the right dose and get an early read on efficacy. The final stage consists of large-scale testing in thousands of people. Only then would a vaccine developer commit to manufacturing millions of doses.
In the era of coronavirus, many of those steps will overlap, particularly the midstage and late-stage trials, Collins and Corey said.
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The approach has its risks, as certain safety issues may only appear in large-scale trials. Americans are concerned about the speed of the vaccine effort, a Reuters/Ipsos poll showed.
A highly effective vaccine could be tested in as little as six months if there is a big difference in benefit between the vaccine and placebo groups, Corey said. For a modestly effective vaccine, trials could take nine to 12 months.
The U.S. government has committed billions of dollars to help manufacturers produce doses of vaccines that may never prove successful.
THE SHORTLIST
To get the quickest answer, vaccines will be tested in health care workers and communities where the virus is still spreading to show whether they reduced new cases of COVID-19.
Washington, D.C, which has not reached the peak of its outbreak, is one likely test site. Trials may be conducted abroad, including in Africa, where the virus has just started to spread, Collins said.
The government plans to tap its own trial networks, including the Department of Veterans Affairs’ 100 health care facilities, for potential study volunteers, while drugmakers will recruit from their clinical research networks.
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A Moderna Inc vaccine, developed in partnership with the NIH, will be the first to the enter large-scale testing in July, and may be joined by a vaccine from Britain’s Oxford University and AstraZeneca Plc, Collins said.
The U.S. government said on Thursday it would spend $1.2-billion to secure 300 million doses of the Oxford vaccine.
“What we might try to do is run those two side by side, but with a control arm” that would also include 10,000 healthy individuals who got a dummy vaccine, Collins said.
Moderna’s candidate is already proceeding to midstage human trials. Vaccines by Johnson & Johnson, Sanofi and Merck & Co are a month or two behind the front-runners and “may get added over the course of the summer” following early-stage human trials, Collins said.
Merck has not made any specific announcements on its vaccine program and declined to comment.
Collins would not name other candidates on the U.S. shortlist of 14, but said they will need to finish early safety testing by this summer to make it into the bigger trials.
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Trials will need to assess if the vaccines cause disease enhancement – a potentially dangerous side effect in which the vaccine makes the disease worse in some individuals instead of preventing it. Disease enhancement has been seen in animal studies of vaccines developed to fight a close cousin of the virus that causes COVID-19.
“If there is enhancement, that’s a big stop sign for everything,” said Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases at NIH.
“If all the cards fall into the right place and all the stars are aligned, you definitely could get a vaccine by December or January,” Fauci said.
The United States called on the World Health Organisation on Friday to begin working immediately on investigating the source of the novel coronavirus, as well as its handling of the response to the pandemic.Reuters
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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.
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)
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.
