OTTAWA —
Health Canada has approved the Pfizer-BioNTech COVID-19 vaccine for use in this country, and the first doses could be administered as early as next week.
It’s a critical moment in Canada’s fight against the novel coronavirus, as it is the first vaccine to receive the green light.
“We expect vaccines to arrive maybe as early as Monday. It takes time to prepare the vaccine,” said Maj.-Gen. Dany Fortin, the top military general leading the rollout from the Public Health Agency of Canada, saying the first shots could be given by the middle of next week.
The approval comes alongside an update to the timeline for national mass vaccination effort. The plan is now to begin vaccinating the general population in April 2021, and have all Canadians immunized by the end of next year, with one of the several vaccines under consideration.
“This is a big deal,” said Prime Minister Justin Trudeau in the House of Commons Wednesday afternoon, thanking doctors, researchers and scientists who worked to approve the first COVID-19 vaccine. “We will see 30,000 vaccines begin to arrive next week, with many more on the horizon. But we are not through this yet, we’ve got a tough winter to get through and I know we’re going to be able to get through it together.”
“Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada,” said Health Canada in a statement, alongside a series of documents related to the decision, with the promise of more information about the clinical trial in the weeks ahead.
In a press conference, Health Canada’s chief medical adviser Dr. Supriya Sharma called the approval a “critical milestone in our fight against COVID-19 and in our efforts to provide every Canadian with access to a vaccine,” and said extensive work from a range of scientific experts went into issuing this approval.
“We concluded that there was strong evidence supporting that the benefits of the vaccine outweigh the risks,” Sharma said. “We know that even the best vaccines will only be effective if people trust them, and ultimately agree to receive them. An important part of building trust is openness and transparency, ensuring that people have as much information as possible, to help them make informed decisions for themselves and for those they care for,” she said.
Pfizer trials concluded that the vaccine was effective at preventing COVID-19 in 95 per cent of patients, one week after the second dose is given. In terms of the long-range immunity the vaccine may provide, that is still under evaluation.
The vaccine is an mRNA vaccine, which means it teaches cells how to make a protein that triggers an immune response, without using the live virus that causes COVID-19. Once that immune response is triggered, antibodies are produced, which protect people from being infected should the virus enter their system in the future.
In an interview with CTV National News Medical Correspondent Avis Favaro, Pfizer Canada’s Vaccines Medical Lead Dr. Jelena Vojicic said she is “very pleased” with Health Canada’s decision.
“This is certainly a historic moment for science, and for Canadians. And this is a result of a tremendous effort, starting with the international scientific community, and then going over the dedicated work of Pfizer and BioNTech employees, the clinical trial sites, the participants in the clinical trials, the volunteers,” Vojicic said.
“And of course, I need to acknowledge the tremendous work by Health Canada in quickly reviewing our file while maintaining really gold standards of review and keeping a vigilant eye on the data.”
The initial doses of the Pfizer vaccine are expected to arrive in Canada next week, and plans are already in place to have the shots ready to be administered at 14 delivery sites in major cities across Canada, within one or two days of shipments arriving.
SHIPPING DOSES ‘IMMINENTLY’
Vojicic said that Pfizer is prepared to ship to Canada and she is expecting that shipment will happen “imminently.” She anticipates most vaccines destined for Canada will be coming out of Belgium.
Fortin said he expects doses to be shipped by the end of the week, likely Friday.
By the end of December, Canada is set to receive up to 249,000 doses of this vaccine, or enough to vaccinate 124,500 people, given it requires two 0.3 ml shots into the muscle of the arm, 21 days apart. In total, the federal government has purchased 20 million doses of the vaccine, and has option to buy 56 million more.
From there, Fortin is expecting a “constant flow” of doses to arrive — up to four million Pfizer doses and possibly two million of the Moderna vaccine candidate which is next in line for approval, by the end of March 2021. Moderna’s candidate is now the most advanced in Canada’s regulatory process, but there isn’t a date or estimate yet for when it may be approved. That vaccine also requires cold storage but not as cold as Pfizer, meaning the logistical rollout of Moderna doses is expected to be less challenging.
That means that by the end of March, Canada is planning to have three million Canadians—or eight per cent of the population—immunized. From April and June, between 15 and 19 million Canadians will be immunized, which equates to between 40 and 50 per cent of the population. Then, between September and December the plan is to see all 38 million Canadians vaccinated. These latest projections are based on anticipated delivery schedules and are dependent on regulatory approvals of additional vaccines.
Prioritized groups will be the first to receive the vaccine, given the limited quantities to begin with. Among the earliest to receive these shots will be staff and residents in long-term care and other congregate senior living facilities and health-care workers with high exposure risks. Each province is able to modify the national recommendations for prioritization based on their regional situation. For example, Ontario has opted to use the first small batch in Toronto and Peel region, where the most severe lockdowns are in place due to weeks of surging case counts.
Reacting to Wednesday’s news, Ontario Premier Doug Ford said that “light at the end of the tunnel grows brighter.”
For now, the vaccine is being recommended for use in people 16 years of age or older, and further clinical trials are being run on children of all age groups, so it’s possible the Health Canada approval could be revised in the future to include children, if the data from these studies support it.
Because the vaccine needs to be stored at temperatures below -70 C, Pfizer will be delivering batches in special thermal shipping boxes it developed that can keep the vaccine stable for days.
“These thermal shippers are also equipped with GPS-enabled data loggers that records the temperature as well as the location of these shippers. So at any point of time, between the manufacturing site and the point of use, we will be able to track those shipments and prevent any unwanted temperature excursions,” said Vojicic, who added she doesn’t think the security of theses shipments will be an issue.
Before being injected, the vaccine is thawed, decanted, and mixed, but can only last a few hours at room temperature, so Pfizer is requesting the first doses be given on-site at these 14 medical facilities where there are ultra-cold freezers in place, to avoid as much wastage as possible from transporting the vials elsewhere. This means Canadians who live in the territories and other remote areas will likely be waiting until the Moderna vaccine is approved to be able to receive a COVID-19 vaccine.
CANADA THIRD IN WORLD
Canada is the third country in the world to approve the Pfizer-BioNTech vaccine.
Bahrain approved it first, followed by the United Kingdom, which began vaccinating its citizens with this vaccine on Tuesday, though their Medical and Healthcare Products Regulatory Agency is now warning that people who have a history of serious allergic reactions should not receive the vaccine as they investigate two instances of adverse reactions that occurred in health workers when they received the vaccine.
In general the side-effects reported during the clinical trials are similar to those of other vaccines, and are considered “mild or moderate.” They include pain at the site of injection, body chills, feeling tired and feeling feverish.
The United States Food and Drug Administration is set to give the Pfizer-BioNTech vaccine the green light to roll out to Americans this week.
For weeks, questions had been raised about Canada’s place in line for vaccines in comparison to other nations, given in part our inability to domestically produce initial vaccines. But Pfizer said Wednesday that “you can see from what’s happening today, that we’re definitely not at the back of the line. We’re actually at the front of the line in terms of the approvals of the vaccines, and the rollout of the vaccines.”
“I think we can be very content as to how Canada has done,” Vojicic said.
Asked how Canada was able to beat the U.S. FDA in deeming the vaccine safe, Sharma said jokingly “we’re just better.”
“We’re not in a race with any other regulator, we’re not trying to beat any other regulator, what we’re trying to do is beat this… virus and working against this virus,” she said.
“It just so happened we got the last piece of information late last night, people worked at it, they were up early this morning to get it ready… that’s why we’re announcing today,” Sharma said, adding that Canadian officials will be participating in the U.S. meeting happening over the next few days to discuss their approval of Pfizer.
Typically, the vaccine submission review process can usually take up to a year, but because of an emergency order, Health Canada has been able to expedite the authorization process. The agency began its regulatory review of the Pfizer vaccine in October, and has since been assessing rolling information as it comes in from the pharmaceutical company’s studies, rather than having to wait until the end of its work to begin reviewing the findings.
“Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place. Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified,” said Health Canada on Tuesday.
The pharmaceutical giant will also have to routinely provide additional quality, efficacy, and safety information. Pfizer has agreed to follow clinical trial participants for two years after their second dose, and will be releasing before March 31 a full risk management plan that covers the known and potential safety issues, plans for collection of additional safety and effectiveness information, and measures that will be put in place to minimize risks associated with the product.
Plans are being made for each province and territory to track who receives doses, and the federal government is considering an additional layer of national monitoring, both for overall immunization levels, and adverse reactions.
Pfizer was one of four vaccine candidates Health Canada has been evaluating, with assessment ongoing for the Moderna, AstraZeneca, and Johnson & Johnson vaccines. In total, Canada has signed contracts guaranteeing access to 194 million doses of potential COVID-19 vaccines with the option to purchase 220 million more, meaning if all trials pan out, we’d have access to 414 million doses.
Six of the seven vaccines require two doses, with the Johnson & Johnson vaccine candidate being the exception. For those that require two doses, all but the Moderna and Astra Zeneca require their doses to be given 21 days apart. Those two vaccines are to be administered 28 days apart.
COVID-19 vaccines will be offered to Canadians free of charge, and will not be mandatory.
“It’s an exceptional day for Canada. It’s one step along the road, it’s one tool in terms of our fight against COVID-19, along with all of the other measures,” said Sharma. “We have other vaccines that will be likely coming as well, but I think in a year where we haven’t had a lot of good news, this is a bit of good news. And I think we should take a moment to acknowledge that, and then we’re all going to get back to work.”
TAMPA, Fla. (AP) — The Tampa Bay Lightning selected Victor Hedman as the team captain on Wednesday as training camp opened, making the big defenseman the successor to Steven Stamkos.
Hedman, who is going into his 16th season with Tampa Bay, was considered the obvious choice to get the “C” after the Lightning did not re-sign Stamkos and their longtime captain left to join Nashville.
“Victor is a cornerstone player that is extremely well respected by his teammates, coaches and peers across the NHL,” general manager Julien BriseBois said. “Over the past 15 seasons, he has been a world-class representative for our organization both on and off the ice. Victor embodies what it means to be a member of the Tampa Bay Lightning and is more than ready for this exciting opportunity. We are looking forward to watching him flourish in his new role as we continue to work towards our goal of winning the Stanley Cup.”
The 33-year-old from Sweden was a key contributor in the Lightning hoisting the Cup back to back in 2020 and ’21, including playoff MVP honors on the first of those championship runs. Hedman also took home the Norris Trophy as the NHL’s top defenseman in 2018 and finished in the top three in voting five other seasons.
Ryan McDonagh, who was reacquired early in the offseason in a trade with the Predators, and MVP finalist Nikita Kucherov will serve as alternate captains with the Lightning moving on to the post-Stamkos era.
TORONTO – While Toronto FC is looking to improve its position on the pitch, general manager Jason Hernandez is trying to do the same off it.
That has been easier said than done this season.
Sending winger Jahkeele Marshall-Rutty to CF Montreal for up to $1.3 million (all dollar figures in U.S. funds) in general allocation money before the secondary transfer window closed in early August helped set the stage for future moves.
But there have been plenty of obstacles, which Hernandez has been working to clear.
“We feel a lot more confident going into this upcoming off-season that we did the one prior,” said Hernandez. “There’s a level of what I would say booby-traps that were uncovered when I first got the (GM) role at the end of last summer.”
The club is paying off departed forwards Adam Diomande and Ayo Akinola as well as a $500,000 payment due in 2024 to Belgium’s Anderlecht for Jamaican international defender Kemar Lawrence. That payment was part of the transfer fee for Lawrence, who joined TFC from Anderlecht in May 2021 and was traded to Minnesota United in March 2022.
Diomande was waived while Akinola’s contract was terminated by mutual agreement.
“That comes to an end in ’25, which is nice,” said Hernandez. “We had to suffer from a salary cap perspective this season. But those things coming off, the Jahkeele Marshall-Rutty money coming in, we’re going to be in a position to make some good additions, which is positive.”
While MLS clubs are allowed one contract buyout per year, Toronto had already used its on former captain Michel Bradley, who retired after last season. Bradley had previously restructured his contract, deferring money.
TFC’s only other move during the summer transfer window was the signing of free-agent defender Henry Wingo. Hernandez said the club knew going into the window that it was likely limited to the one acquisition “unless other business happened”
“We knew we had this bucket of money and we knew we were going to go get Henry,” said Hernandez.
While the sale of the highly touted Marshall-Rutty opened up other possibilities, it came on the eve of the transfer window closing. And the team did not like what it saw in the free-agent market.
“A lot of the opportunities we were presented in the free agency space felt more like a short-term, Band-Aid decision versus what actually the club probably needs.”
Hernandez was not willing to take in players who came with a “club-friendly” salary cap charge in 2024 and a much bigger number in 2025.
Instead, Toronto promoted forward Charlie Sharp and wingback Nate Edwards to the first team from TFC 2 ahead of last Friday’s roster freeze.
MLS teams are operating on a salary budget of $5.47 million this season, which covers up to 20 players on the senior roster (clubs can elect to spread that number across 18 players). But the league has several mechanisms that allow those funds to go further, including using allocation money (both general and targeted) to buy down salaries.
Designated players only count $683,750 — the maximum salary charge — against the cap no matter their actual pay. Toronto’s Lorenzo Insigne is actually earning $15.4 million with fellow Italian Federico Bernardeschi collecting $6.295 million and Canadian Richie Laryea $1.208 million.
Hernandez says Laryea’s contract can — and “very likely” will — be restructured so as to remove the designated player status.
There are benefits in going with just two designated players rather than three.
Teams that elect to go with two DPs can sign up to four players as part of the league’s “U22 Initiative.” The pluses of that structure include a reduced salary cap charge for the young players and up to an extra $2 million in general allocation money.
Hernandez says the club is currently pondering whether that is the way to go.
Captain Jonathan Osorio who is earning $836,370 this season, restructured his deal to allow the team to sign Laryea as a DP. In doing so, Osorio had his option year guaranteed so his contact runs through 2026.
Hernandez and coach John Herdman will have decisions to make come the end of the year.
The contracts of goalkeeper Greg Ranjitsingh ($94,200), defenders Kevin Long ($277,500), Shane O’Neill ($413,000) and Kobe Franklin ($100,520), midfielder Alonso Coello ($94,050) and Brandon Servania ($602,710), and forward Prince Owusu ($807,500) — all on the club’s senior roster — expire at the end of 2024 with club options to follow.
While there is more work to do, Hernandez believes TFC is on the right road.
Toronto, which finished last in the league at 4-20-10 in 2023, went into Wednesday’s game against visiting Columbus in a playoff position at eighth in the East at 11-15-3.
“By every metric, we are miles ahead of where we were at this point last year,” said Hernandez.
“That’s a low bar, so that’s not saying much,” he added.
But he believes TFC is “quite competitive” when it has all its players at its disposal.
“To get results in this final stretch, we’re going to need our prominent players to really show up and have big performances, and be supported by the rest of the cast.”
After Columbus, TFC plays at Colorado and Chicago and hosts the New York Red Bulls and Inter Miami. The club also travels to Vancouver for the Canadian Championship final.
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This report by The Canadian Press was first published Sept. 18, 2024
Mackenzie Hughes might just be what the International team needs as this year’s Presidents Cup.
Hughes, from Dundas, Ont., is one of three Canadians on the squad competing in the match-play event at Royal Montreal Golf Club next week.
His putting skills, cool demeanour under pressure, pre-existing connections with teammates and clubhouse leadership could help the team — made up of non-American players outside Europe — end a nine-tournament losing skid to the United States at the biennial event.
“I’ve had this one circled on the calendar for a few years now,” said Hughes on joining fellow Canadians Taylor Pendrith and Corey Conners as captain’s picks on the 12-player International team. “I pretty much knew that when it was announced the tournament would be in Canada and that Mike Weir was going to be the captain, you pretty much knew where that was going to go.
“To get that call from (Weir) is really special because he’s the guy that I looked up to, we all looked up to, as Canadian golfers.”
Pendrith and Conners are returning to the team after a disappointing 17 1/2 to 12 1/2 loss to the United States at Quail Hollow Club in Charlotte, N.C. in 2022.
Hughes was ranked 14th on the International team standings in 2022 and could have easily been included on that squad after Australia’s Cameron Smith and Chile’s Joaquin Niemann were ruled ineligible after jumping ship to the rival LIV Golf circuit.
However, captain Trevor Immelman of South Africa instead chose the lower ranked Christiaan Bezuidenhout (16th) of South Africa, Pendrith (18th), South Korea’s Kim Si-woo (20th) and Australia’s Cameron Davis (25th).
“I certainly wanted to be on that team but also I understood the picks,” said Hughes, who lives in Charlotte and plays at Quail Hollow regularly. “I think that like a lot of guys that don’t get picked you more so look back on your own play and I wish I had made that selection easier for them.
“I didn’t do myself any favours in the six weeks leading up to it and that’s a hard pill to swallow.”
It may have been a costly oversight on Immelman’s part, as finishing holes was an issue for the International team in 2022 and Hughes is one of the best putters on the PGA Tour. This season he’s third in shots gained around the green and fifth in shots gained from putting.
“It doesn’t mean that just because I was there it would have turned the tide, but I’d like to think maybe I could have helped,” said Hughes. “That’s why you play the matches. You have to get out there and do it.”
This year Hughes made it easier for Weir, the Canadian golf legend from Brights Grove, Ont., to choose him. Hughes is 51st in the FedEx Cup Fall standings and has made the cut seven tournaments in a row, including a tie for fourth at last week’s Procore Championship.
“Mac played very solidly all year. Really like his short game, an all-around short game,” said Weir on Sept. 3 after announcing his captain’s picks. “He’s one of the elite and best short game guys on the PGA Tour
“I also love Mac’s grit. So that was the reason I picked him.”
Hughes’s intangible qualities go beyond grit.
He, Pendrith and Conners will arrive at Royal Montreal as a unit within the International squad, having become close friends while playing on Kent State University’s men’s golf team before turning pro. They’re also part of a group of Canadians, including Nick Taylor and Adam Hadwin of Abbotsford, B.C., that regularly practice together before PGA Tour events.
“To have those guys with me is really icing on the cake, it’s very special,” said Hughes. “Opportunities like this don’t come around very often: to play this kind of team competition, which is already hard to do, but to play with some of your best friends, it almost seems scripted.”
An 11-year professional, Hughes has also been a member of the PGA Tour’s player advisory council the past two years and has been an outspoken advocate for making professional golf more accessible to fans.
Although Weir relied heavily on analytics to make his captain’s selections, Hughes’s character came up again and again when asked why he was named to the team.
“I just have a gut feeling with Mac that he has what it takes in these big moments,” said Weir. “They’re big pressure moments, and I have a feeling he’s going to do great in those moments.”
DP WORLD TOUR — Aaron Cockerill of Stony Mountain, Man., continues his chase for a spot in the Europe-based DP World Tour’s playoffs. The top 50 players on the Race to Dubai standings make the DP World Tour Championship and Cockerill moved eight spots up to 39th in the rankings after tying for ninth at last week’s Irish Open. He’ll be back at it on Thursday at the BMW PGA Championship at the Wentworth Club in Surrey, England.
KORN FERRY TOUR — Myles Creighton of Digby, N.S., is ranked 38th on the second-tier Korn Ferry Tour’s points list. He leads the Canadian contingent into this week’s Nationwide Children’s Hospital Championship. He’ll be joined at Ohio State University Golf Club — Scarlet Course in Columbus, Ohio by Edmonton’s Wil Bateman (53rd), Etienne Papineau (65th) of St-Jean-Sur-Richelieu, Que., and Sudarshan Yellamaraju (99th) of Mississauga, Ont.
CHAMPIONS TOUR — Calgary’s Stephen Ames is the lone Canadian at this week’s Pure Insurance Championship. He’s No. 2 on the senior circuit’s points list. The event will start Friday and be played at Pebble Beach Golf Links and Spyglass Hill Golf Course in Monterey, Calif.
LPGA TOUR — There are four Canadians in this week’s Kroger City Championship. Savannah Grewal (97th in the Race to CME Globe Rankings) of Mississauga, Ont., Hamilton’s Alena Sharp (115th), and Maude-Aimee Leblanc (142nd) of Sherbrooke, Que., will all tee it up at TPC River’s Bend in Maineville, Ohio.
EPSON TOUR — Vancouver’s Leah John is the low Canadian heading into the Murphy USA El Dorado Shootout. She’s 54th in the second-tier tour’s points list. She’ll be joined by Maddie Szeryk (118th) of London, Ont., and Brigitte Thibault (119th) of Rosemere, Que., at Mystic Creek Golf Club in El Dorado, Ark.
This report by The Canadian Press was first published Sept. 18, 2024.
