Health Canada has approved the Moderna COVID-19 vaccine for use in this country with the first doses expected to be delivered by Christmas.
Canada is now the second country in the world after the U.S. to approve the Moderna shot, the second coronavirus vaccine to get the green light in the country’s mass immunization effort. Two weeks ago, the federal health agency approved the Pfizer-BioNTech vaccine.
Health Canada has deemed the Moderna vaccine effective and safe for use on Canadians, which means deliveries of the first set of doses will begin imminently, weeks faster than the original timeline to receive shipments in January.
“Canada has an internationally recognized process of independent review, and I know that our best experts have upheld this highest standard,” Prime Minister Justin Trudeau said during a Wednesday afternoon news conference. “Now that Health Canada has approved the Moderna vaccine, we have the green light to start rolling it out across the country.”
Trudeau has said previously that Canada will receive up to 168,000 doses of the vaccine this month, with deliveries arriving between 24 and 48 hours after approval, as per the government’s contract with the U.S. biotech company.
“We know that this pandemic doesn’t start to end until we have vaccination of millions and millions of people which is why we’re continuing to ensure that everything is done safely and responsibly, to make those vaccines available as quickly as possible and we all look forward to things being much better in the spring,” Trudeau said.
Trudeau added that Canada is expected to have acquired 1.2 million doses of the two approved vaccines by the end of January, but Canada’s COVID-19 Immunity Task Force is still working with Pfizer and Moderna to confirm how many doses of each it will have by that timeframe.
“We have a number of planning assumptions for that, and moving forward in terms of both Moderna and Pfizer products, and we’re working actively to confirm those planning assumptions, turn them into facts as we move forward,” Maj.-Gen. Dany Fortin, the top military general in charge of Canada’s vaccine distribution, told reporters on Wednesday.
Fortin added that while the government expects more than a million doses by the end of January, he expects the rollout to really ramp up in the subsequent months.
“I anticipate a significant growth in quantities available in February (and) March,” he said. “I would be speculating as to what exactly that looks like, but as I indicated before, we have daily conversations with the manufacturers, and we will increase this frequency with Moderna as well.”
In total, Moderna has promised 40 million doses to Canada by the end of 2021.
“Today’s authorization is one more tool in our toolbox to bring COVID-19 under control,” Dr. Supriya Sharma, the chief medical advisor for Health Canada, said at a press conference in Ottawa on Wednesday.
It’s another crucial moment in the fight against the novel coronavirus as each vaccine candidate comes with its own unique set of advantages and barriers. The Pfizer-BioNTech vaccine, which is already in the arms of thousands of Canadians, needs to be kept at temperatures between -60 C and -80 C until injection, while the Moderna vaccine can be kept stable at just -20 C.
‘THE WORKHORSE VACCINE’
“The elephant is in the room that the Moderna vaccine is coming and probably the rollout of that vaccine is really going to change the landscape more than anything else,” Dr. Zain Chagla, an infectious disease specialist and associate professor at McMaster University, told CTVNews.ca during a phone interview on Wednesday.
“You don’t have to set up a clinic right beside where you have these ultra-cold fridges,” he said. Instead, health-care workers can administer the Moderna vaccine bedside in long-term care homes, he said. And the immunization task force can likely deliver the Moderna shots to small rural hospitals and remote northern regions that couldn’t facilitate the freezer requirements of the Pfizer product.
More Canadians are likely to get the Moderna vaccine than the Pfizer one, he added.
“This is the game-changer vaccine for sure,” he said. “For our long-term strategy for vaccinating all Canadians, the Moderna is probably going to be the workhorse vaccine. The Pfizer will probably be a vaccine in urban centres, in places where they’re able to set up the clinics that can do the Pfizer vaccine.”
WHO WILL GET IT AND WHEN?
Health Canada has approved the Moderna vaccine for use in Canadians aged 18 and older, but it will likely be many months before healthy adults who are not on the front lines get inoculated and still “several days” before the most vulnerable receive the shot, said Dr. Ronald St. John, the first Director-General of the Centre for Emergency Preparedness and Response at the Public Health Agency of Canada. While the Moderna shipments are coming this week, it’s just the first step in a logistical process, he told CTV News Channel.
“The plane arrives at the airport but then there’s a couple of steps, quite a few steps that have to take place from the airport to eventually end up in somebody’s arm,” he said. After Health Canada approved the Pfizer vaccine on Dec. 9, it took another four days for the first shipment to land in Canada on Dec. 13, and another day before the first health-care workers were immunized.
As with the Pfizer vaccine, the Canadian government’s immunization task force has outlined which Canadians will be at the front of the line for the Moderna shot, including health-care workers and vulnerable people in long-term care facilities.
To boost the immunization effort, the Canadian government has set up another 56 distribution sites (in addition to the 14 already operating) to administer doses to the prioritized groups.
“We’re going to grow the number of sites as we get more stability data and we’re able to further distribute down from those sites to additional sites,” Fortin said. “There’ll be a better spread.”
It is expected that the territories will receive more than the per capita percentage of Moderna vaccines since officials made the decision not to send the Pfizer shots to the North, where they lack the necessary ultra-cold storage capabilities. This time, the territories are well-equipped.
Last week, the Canadian Armed Forces delivered to the territories five freezers that can keep the Moderna doses stable at -20 C.
“With the unique situation in the North, the isolated communities, lack of access to let’s say tertiary health-care facilities and so on, the planning sort of assumption has been to really deliver enough vaccine to be able to cover 75 per cent of their population, so that we’re not making multiple trips to a small community,” said Dr. Howard Njoo, Canada’s deputy chief officer of public health.
“I think it’s really in a sense, get it all up there and then they can start vaccinating their populations as a whole.”
Fortin added shipments of the vaccine are expected to arrive in the territories beginning on Monday.
MODERNA VS. PFIZER
Both the Moderna and Pfizer shots are messenger RNA vaccines, which send a genetic code to cells to train them to develop an immune response to COVID-19. Early data suggests both are more than 90 per cent effective at fending off the virus, including strains that Health Canada said on Wednesday were “similar” to the new U.K. variant identified this month.
While the two products have much in common, one of the key differences is in their distribution plans. While Pfizer has been shipping its own vaccines with UPS, Canada will be in charge of getting the Moderna shipments across the country once they are delivered and have contracted Innomar Strategies and FedEx Express Canada to do the job. Earlier this month, officials confirmed that FedEx Express Canada and Innomar will be picking up Canada’s Moderna doses in Europe, where they have been kept on dry ice with temperature-monitoring devices. They will be flying them to a central location in Canada from where the allotments for each region will be distributed. The vaccines will be kept at Innomar distribution facilities across the country, including a 160,000-square-foot space in Ontario, all of which have controlled-temperature storage capabilities as low as -25 C, colder than required for the Moderna vaccine.
“Innomar will safely and securely store the vaccines in its storage facilities, which are equipped to store complex pharmaceutical products,” said a statement from Innomar on Wednesday. “Before the vaccines are shipped, teams will put the vaccine in packages that support the temperature requirements specified by the manufacturer.”
While some Canadians have expressed concern about the unprecedented speed with which COVID-19 vaccines have been approved, health experts continue to stress that corners were not cut and standards were not lowered. The latest Health Canada safety assessment began on Oct. 12, when Moderna submitted its candidate for evaluation and a number of steps before that were done in parallel, said Dr. Hassan Masri, an associate professor of medicine at the University of Saskatchewan.
“Canada has one of the highest most stringent requirements [for vaccine approval],” he told CTV News Channel on Wednesday. “Why this vaccine was approved more quickly and developed quicker is because all the phase one, phase two, phase three [steps] were happening simultaneously. All the red-taping and bureaucracy were eliminated, and there was a lot of funding for this.”
Health Canada officials stressed on Wednesday that the agency’s standards were maintained throughout the “rolling review” of the vaccine.
“Although this process was completed in a shorter time frame, Health Canada’s rigorous standards were upheld,” Dr. Sharma said in Ottawa on Wednesday. “Under an interim order, Health Canada allows vaccine manufacturers to submit data to us as it becomes available and for Health Canada experts to start the review process right away.”
Moderna has agreed to a set of terms and conditions on the vaccine’s approval that include continuing to provide Health Canada with information about the shot’s safety, effectiveness and quality.
While the new vaccine approval has been called a “game-changer” in Canada’s COVID-19 fight, the country is still in the midst of a worsening surge of coronavirus infections with many regions entering stricter lockdowns this month.
“While there is a light at the end of the tunnel, we know that there are still challenges ahead,” said Dr. Sharma. “We must all do our best to continue following public health guidelines this holiday season and in the new year.”
With files from CTV News Ottawa’s Rachel Aiello, CTVNews.ca Writer Ben Cousins and The Canadian Press
Why you might want to start wearing better masks — even outdoors – CBC.ca
The spread of more contagious coronavirus variants in Canada amid already high levels of COVID-19 makes it a critical time to think about the masks we wear.
Whether that means finding better quality masks, doubling up on masks, or wearing them in settings we wouldn’t normally think to, experts say it’s time we step up our game.
The variants first identified in South Africa and the U.K are spreading in Canada, in some cases with no known link to travel, and have already led to devastating outbreaks in long-term care homes.
But even as COVID-19 case numbers show early signs of slowing down in Canada, experts say it’s becoming more important than ever to lower our risk of exposure as much as possible to prevent variants from taking hold here.
“The floodwaters are receding right now, but it’s still very, very dangerous,” said Erin Bromage, a biology professor and immunologist at the University of Massachusetts, Dartmouth who studies infectious diseases.
“If [B117] does pop up as the dominant variant here, we are going to need to really up our game in regards to masks, in regards to … how many contacts we have in a day, because it definitely appears to have an upper hand.”
‘Time to step it up’ with masks
Canada currently recommends the use of three-layer non-medical masks with a filter layer to prevent the spread of the virus, but has not updated its recommendations since November, before the emergence of new variants.
Dr. Zain Chagla, an infectious diseases physician at St. Joseph’s Healthcare Hamilton, said that while three-layer non-medical masks are a good “minimum standard,” Canadians should opt for masks that offer better protection whenever possible.
WATCH: How does a three-layer mask protect you from COVID-19?
“When I go to the grocery store now, I wear my very best mask,” said Linsey Marr, one of the top aerosol scientists in the world and an expert on the airborne transmission of viruses at Virginia Tech. “Before I was wearing an OK mask that was comfortable and easy.”
She said a cloth mask can “easily filter out half of particles, maybe more, but we’re at the point where we need better performance.”
Bromage said he changed his approach to masks several months ago when COVID-19 cases started to spike in many parts of North America. That’s when he ditched common cloth masks for surgical masks, he said.
Bromage said Level 3 ASTM surgical masks, those that are used at dental clinics, for example, offer both a better level of protection and a better quality fit.
“The most important part is you’ve got to make sure your breath actually goes through the material,” he said.
“You really should see the mask expand and then collapse and expand and collapse with each breath that you take. That’s a good indication that what you’re breathing is actually going through the material.”
Double-masking and other tips
Bromage said a tight-fitting mask is more important than ever due to the emergence of variants, which is why it’s becoming more common to see people wearing two masks at the same time.
“It’s not that double-masking provides extra protection if the mask was fitting well,” he said. “Double-masking helps the mask that is closest to your skin fit more snugly, meaning more air goes through that mask.”
If you’re already wearing a high-quality mask that fits well, with air going through the material rather than out the sides, Bromage said there’s really no extra benefit in throwing an extra mask on top.
He recommends looking at yourself in the mirror before you go out to make sure your mask isn’t too loose fitting, which could put you at heightened risk of exposure in situations such as in-store shopping.
“I really want people to look at them and think, is all the air going through the material? And if it’s not, work out a way to do that,” he said. “And that may be putting a second mask on or finding a different mask that fits their face.”
Outdoors not without risk
Coronavirus variants can also change the level of risk we face in situations that are typically more safe, such as being outdoors.
“The risk is much lower outdoors than indoors, but with the new variants, we should be more careful outdoors as well as indoors,” said Marr.
“The times we need to be paying attention to it is if there are a lot of people around at a sporting event, or in a crowded park, or if you’re out walking or running and you’re passing by several people per minute, because all those little exposures can add up over time.”
Bromage said he gets concerned when he sees a group of people huddling together outdoors without moving around.
“The closer you are outdoors, the much more risky it is,” he said.
While not common, there have been cases of outdoor transmission of COVID-19 in Canada.
B.C. Provincial Health Officer Dr. Bonnie Henry told CBC News there have been several outdoor transmission events between spectators “clustering and talking with each other” during soccer games, and during wedding receptions where groups of people crowded together under tents.
“Again it comes down to being in close contact, without a mask, talking loudly or sharing food and drinks that makes it risky even outside,” Henry said.
She said B.C. has not seen transmission from brief outdoor encounters, waiting in line outside or at outdoor picnics where people maintain a reasonable distance and wear masks when close for short periods of time.
Chagla said standing six-feet apart while wearing masks is a responsible way to interact with others outdoors.
“There are ways to do things outdoors safely, even in the context of the variant,” said Chagla. “You don’t want outside to be a free pass, but you also want to use it for what it is, to let people see each other and have contact with humanity, too.”
Bromage said that while the risk of exposure outdoors is less than indoors, the risk of both is higher due to the emergence of coronavirus variants.
“It’s really time that people think about upping their game just in general,” he said.
“Because if we are going to get a new wave from this variant, and it’s already going to build off a very high level of infection that we already have, we need to do better to keep it out of our lives.”
Secret Nygard videos show former fashion mogul charged with sex trafficking travelling with teenage girl – CBC.ca
Hours of behind-the-scenes video shot by a whistleblower show former Canadian fashion mogul Peter Nygard, who is alleged to have abused women and girls for decades, screaming at his employees and approaching a 16-year-old girl at the London Olympics.
Nygard is in a Winnipeg court today, arguing to be released on bail from jail, where he has been held since his arrest last month.
Stephen Feralio was hired as Nygard’s personal videographer in 2011. He spent the next three years documenting Nygard.
“When I first was hired, Nygard told me that the reason why Jesus is so popular is because he had a good PR team. My job was to film literally everything,” Feralio told CBC News in an interview.
Feralio, who was based in Los Angeles when he worked for Nygard, came forward and shared the video with CBC as part of an investigation into Nygard by The Fifth Estate and the podcast, Evil By Design.
“If I don’t expose him, he’s going to get away with all the things that he’s been doing,” Feralio said.
Nygard was arrested in Winnipeg in December on an extradition warrant. U.S. authorities accuse him of racketeering, sex trafficking and sexual assault involving “dozens” of victims.
More than 80 women accuse Nygard of rape or sexual assault going back four decades. Fifty-seven are part of a separate class-action lawsuit launched in New York in February 2020.
Nygard denies the charges against him and says they are all lies as part of a conspiracy meant to destroy his reputation spearheaded by his former neighbour in the Bahamas, billionaire Louis Bacon.
Several videos shared with CBC document what Nygard called pamper parties. Every Sunday for years, Nygard would host parties in the Bahamas or Los Angeles. Young women and girls were invited for what Nygard said was a day involving fun on the beach, food and dancing.
According to the U.S. indictment, Nygard recruited victims at pamper parties.
“Nygard would just come down and choose a girl. Usually they would be drunk,” said Feralio, who filmed several of his pamper parties.
“He would be grabbing them, dancing with them. And then at the end of the night, he would give me the signal and that meant stop filming,” he said. “And he would go upstairs to the room sometimes with two or three or more girls.”
Feralio also travelled with Nygard, documenting life on his private Boeing 727 airplane.
“So life on the plane, there’s food and then there’s poker and then there is karaoke and then there is maybe a movie. And then there’s drinking and dancing. And, you know, Nygard had a bed on the plane, and so he would have sex with the girls up in the front of the plane.”
One day in 2012, Feralio said, he filmed a party on the plane that included a 17-year-old dancing along with several other young women.
“[They are] all dancing on the stripper pole on the plane,” said Feralio, pointing to the teen.
WATCH | Videographer shows a party on Nygard’s plane:
Feralio said the 17-year-old travelled with Nygard, becoming one of the women he referred to as his “girlfriends.”
According to the U.S. indictment, women and girls known as Nygard’s “girlfriends” were often victims of his alleged assaults.
“Nygard maintained control over his victims through threats, promises to grant or withhold modelling opportunities and other career advancement, granting and withholding financial support and other coercive means,” the indictment said.
Feralio documented many interactions between Nygard and his “girlfriends.”
“They were around when Nygard needed sex,” said Feralio.
“They would accompany Nygard to dinner. They would be parading in during the meetings. Nygard would call them the girlfriends.”
Entering a hotel suite
Another video shows Nygard and several women walking into a hotel suite in Las Vegas.
“[Nygard] motions to the room and he says: ‘This is where we sin. This is our sin bin,’ ” Feralio said.
At one point, Nygard appears to lose track of how many women are travelling with him.
“You’re all going to stay in this suite, it’s so big, so we’ve got…. You guys are with me. How many girls we got? Is there one missing?”
“No, no, you two in that room, we three here,” one woman replies.
“Oh, I thought we had one extra,” Nygard says.
WATCH | Videographer shows how Nygard lost track of how many women were travelling with him:
The U.S. indictment alleges Nygard had an elaborate and extensive system for recruiting young women and girls to victimize.
“To recruit victims, Peter Nygard … and others known and unknown used a network of trusted associates, ‘girlfriends’ and Nygard Group employees.”
One video shows Nygard meeting a young woman.
Feralio was filming when Nygard travelled to the Summer Olympics in London in 2012. In the video, Nygard and one of the women travelling with him can be seen approaching a 16-year-old athlete.
“Just to be here at the Olympics and to be running, good for you, and at 16 yet,” Nygard can be heard saying to the teenage girl, while he examines her Olympic credentials.
“Get her … number,” he says to the woman he is travelling with. “Her cell number or something. Two phone numbers. I don’t want to lose her now that I’ve found her.”
WATCH | Videographer shows how Nygard would approach young women:
Feralio said the video shows what he describes as a typical effort to recruit a young woman for Nygard.
“Part of what educates this … in the past, girls have said, ‘I found somebody else so that I don’t have to sleep with Nygard tonight.'”
Other videos show Nygard yelling at his employees.
“Some of these [videos] are kind of more difficult for me to watch,” Feralio said.
One video shows Nygard screaming at someone who appears to be a male employee or contractor in the Bahamas. Another shows Nygard yelling at his staff in an airport. Nygard can be heard saying: “You’re not following my law.”
WATCH | Videographer shows how Nygard would yell at employees:
“He screamed at us and he screamed at me a lot. It was a very stressful environment,” Feralio said.
Feralio’s videos became a hotly contested element in a bitter legal dispute between Nygard and Bacon.
The two neighbours had been feuding for years about the expansion of Nygard’s beaches. Nygard was dredging up the seabed that sits adjacent to both of their properties, causing environmental damage.
Feralio first approached people connected to Bacon in 2014, offering hundreds of hours of behind-the-scenes video in exchange for legal protection from lawsuits and living expenses.
Lawyers for Bacon filed a court action requesting access to the videos filmed by Feralio, hoping to use them as evidence in several lawsuits in the Bahamas.
Over the next five years, Nygard fought in court to keep Feralio’s video secret, arguing Feralio was his employee and Nygard owned the videos, not Feralio.
In 2019, Nygard abandoned that effort and now Feralio is sharing many of the videos with CBC.
“Nobody else in my world of Nygard has this evidence,” Feralio said.
Nygard has been in jail in Winnipeg since his arrest on Dec. 14. His lawyers argue he should be released on bail pending an extradition hearing because of his age and poor health and the risk of contracting COVID-19.
Watch full episodes of The Fifth Estate on CBC Gem, the CBC’s streaming service.
Pfizer will ship COVID-19 vaccine in fewer vials if Canada agrees to label change – CBC.ca
Pfizer and BioNTech will cut back on how many vials of COVID-19 vaccine they send Canada this year if the federal health regulator agrees to change the vaccine label to say every vial contains six doses instead of five.
Medical professionals in the United States were first to discover in December that they could get six doses from each vial by using smaller syringes or special ones that trap less vaccine around the needle after an injection.
Initially heralded as a way to stretch the precious vaccine even further, the company stepped in to note its contracts are for doses, not vials: If a recipient can get six doses instead of five, then Pfizer and BioNTech can ship fewer vials and still fulfil their contractual obligation.
Pfizer pushed the U.S. and Europe to change the label information on the number doses per vial and both did in early January. On Friday, Pfizer asked Canada to follow suit, and Health Canada’s vaccine regulatory team is now considering the request.
“The final decision on the label update will reside with Health Canada,” said Pfizer Canada spokeswoman Christina Antoniou.
Special syringes needed
If Canada agrees to the change, Canada’s 40 million doses of Pfizer-BioNTech’s vaccine will be shipped in about 6.7 million vials. Antoniou said if Canada does not, then the existing deliveries will continue based on five doses per vial, for a total of eight million vials.
“We will supply to Canada in line with our supply agreement and the label valid in the country,” she said.
Health Canada told medical professionals they could use sixth doses if they can get them from single vials, but advised against taking partial doses from multiple vials to make one dose due to the risk of cross-contamination.
WATCH | Ottawa offers assurances about COVID-19 vaccine supply:
There has been some success at doing this. Saskatchewan reports receiving 22,425 doses of Pfizer’s and 10,300 doses of Moderna’s vaccine, for a total of 32,725. But it has injected 34,080 doses. The government attributed that to being able to get more doses out each vial than expected.
But European health officials have complained that a shortage of the special syringes needed is making it hard to get six doses out of each vial.
Getting that extra dose requires the use of smaller syringes that allow less vaccine to go to waste with each injection. The best version is called a low-dead-volume syringe, which leaves less room for vaccine to get trapped in the needle and syringe after the plunger is pushed in all the way.
Those syringes are not as common as the three- and five-millilitre syringes mostly used in Canada’s vaccine campaign now, and the smaller ones have become the latest hot commodity of COVID-19.
Syringes on order
Public Services and Procurement Canada tendered contracts last year for 145 million syringes, 95 million of which are of the three- or five-millilitre variety.
There are 50 million one-millilitre syringes on order, including 37.5 million low-dead-volume versions.
The department wouldn’t say how many syringes of each type have arrived in Canada. A tender for one-millilitre syringes issued in October set a deadline for the first 15 million to be delivered at the end of this month and the rest by the end of March.
But whatever contract awarded has not been made public, including who the supplier is, how much it is worth, or when the supplies will be delivered.
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