The ongoing Phase 3 clinical trial of Pfizer/BioNTech’s coronavirus vaccine confirms its protection lasts at least six months after the second dose, the companies said Thursday.
It’s the first look at how long protection for a coronavirus vaccine lasts, and while six months is a modest target, it’s longer than the 90 days of protection been the best estimate offered to date.
The vaccine remains more than 91% effective against disease with any symptoms for six months, the companies said. And it appeared to be fully effective against the worrying B.1.351 variant of the virus, which is the dominant strain circulating in South Africa and which researchers feared had evolved to evade the protection of vaccines, the companies said.
“The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA),” Pfizer and BioNTech said in a joint statement.
On Wednesday, the companies said a small trial of volunteers aged12 to 15 showed 100% efficacy in that age group.
“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in a statement. A BLA is an application for full approval. The vaccine currently has emergency use authorization, EUA, which falls short of full approval.
“The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”
The company has been studying the vaccine in more than 46,000 volunteers and has noted 927 cases of confirmed Covid-19.
“From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3%,” it said.
“Thirty-two cases of severe disease, as defined by the CDC, were observed in the placebo group versus none in the BNT162b2 vaccinated group, indicating that the vaccine was 100% efficacious in this analysis against severe disease by the CDC definition. Twenty-one cases, as defined by the FDA, were observed in the placebo group versus one case in the BNT162b2 vaccinated group, indicating 95.3% efficacy by the FDA definition.”
These definitions matter. The FDA’s definition of severe disease included a raised respiratory rate indicating respiratory distress; raised heart rate, an oxygen saturation level of 93% or lower; respiratory failure severe enough to need additional oxygen or ventilation; a blood pressure drop indicating shock; significant kidney, liver or neurological dysfunction, admission to an intensive care unit or death.
CDC’s definition includes a blood oxygen level of 94% or lower and an x-ray finding of lung infiltrates — an indication of pneumonia — of greater than 50%
The most common adverse events were pain at the injection site, fatigue and headache.
“In South Africa, where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%,” the company said.
“Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose.”
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.
