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Health Canada approves Moderna COVID-19 vaccine – CBC.ca

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Health Canada has approved Moderna’s COVID-19 vaccine for use in this country, clearing the way for thousands of doses to arrive by month’s end.

The federal department announced the approval on Wednesday after completing a review of the company’s clinical trial data.

“The data provided supports favourably the efficacy of the Moderna COVID-19 Vaccine as well as its safety,” Health Canada said in a notice authorizing use of the vaccine for people over the age of 18.

“There were no important safety issues identified and no life-threatening adverse events (AEs) or deaths related to the vaccine.”

This is the second COVID-19 vaccine to be approved by Health Canada.

The department approved Pfizer-BioNTech’s vaccine on Dec. 9, and it’s already being administered in parts of the country to people in high-priority groups, including health-care workers as well as long-term care workers and residents.

The Moderna approval means vaccinations can now begin in northern, remote and Indigenous communities, which lack the health care infrastructure to safely store the Pfizer-BioNTech vaccine at ultra-low temperatures.

The storage requirements of the Moderna vaccine are less onerous than those required for Pfizer-BioNTech’s vaccine. 

Last week, Prime Minister Justin Trudeau said Canada would receive up to 168,000 doses of the Moderna vaccine before the end of December, and that deliveries would begin within 48 hours of Health Canada’s authorization.

Trudeau is expected to address the approval at a news conference today at 1 p.m. Shortly after, government officials and public health officials will provide details on plans to distribute the vaccine. CBC News will carry those events live.

Moderna vaccine requires 2 doses

The Moderna Phase 3 trial involved over 30,000 individuals in the U.S., half of whom received the vaccine while the other half received a placebo. 

The vaccine was found to be 94.1 per cent effective in participants with no prior COVID-19 infection, Health Canada said, and 86.5 per cent effective in people over the age of 65. 

The data showed the vaccine’s effectiveness and safety was consistent across age, sex and ethnicity.

During the trial, 30 people in the placebo group experienced severe cases of COVID-19, compared to none from the vaccine group, Health Canada said.

Health Canada warned people shouldn’t take the vaccine if they are allergic to any of its ingredients, or if they currently have symptoms of COVID-19.

Like the Pfizer-BioNTech vaccine, Massachusetts-based Moderna’s shot requires two doses to achieve maximum immunity.

It uses mRNA technology — a new vaccine technology that directs cells to produce proteins that trigger an immune response to prevent or fight the virus that causes COVID-19.

The two doses should be taken one month apart.

In August, Canada placed an order for 20 million doses of the Moderna product.

Earlier this month, Procurement Minister Anita Anand announced the government would exercise its contractual option for 20 million more shots in 2021. Canada could still buy up to another 16 million doses.

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Why you might want to start wearing better masks — even outdoors – CBC.ca

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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. 

The variant discovered in the U.K., known as B117, is estimated to be at least 56 per cent more transmissible and potentially more deadly than the original coronavirus strain.

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.

Those include surgical masks, which are a step below N95 or KN95 masks. They come in three different filtration levels determined by the American Society for Testing and Materials (ASTM).

WATCH: How does a three-layer mask protect you from COVID-19?

Doctors answer viewer questions about COVID-19 including why three-layer masks are now being recommended to protect against the virus. 5:22

“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.  

U.S. President Joe Biden seen wearing two masks in this file photo as he arrives in Fort Lauderdale, Fla., on Oct. 13, 2020. Immunologist Erin Bromage says 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 ‘double-masking.’ (AFP via Getty Images)

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. 

Places such as San Francisco and New Brunswick have mandated outdoor mask use, and Toronto and Ottawa recently announced they now require face masks for outdoor activities such as skating.

“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.”

Coronavirus variants can also change the level of risk we face in situations that are typically more safe, such as being outdoors. (Evan Mitsui/CBC)

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.  

An outdoor 40-person barbecue at a park in Ottawa this summer led to 105 people being exposed and two testing positive, while a “heated conversation” in B.C. caused an infection. 

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.” 

Places such as San Francisco and New Brunswick have mandated outdoor mask use and Toronto and Ottawa recently announced they require face masks for outdoor activities such as skating. (Andrew Lee/CBC)

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.”

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Secret Nygard videos show former fashion mogul charged with sex trafficking travelling with teenage girl – CBC.ca

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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.   

Feralio reviews video he filmed of Nygard as his personal videographer. (Stephen Feralio)

                                

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.

Feralio was hired as Nygard’s personal videographer in 2011 and spent three years documenting Nygard’s life. (Submitted by Stephen Feralio)

“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:

Videographer Stephen Feralio travelled with Nygard, documenting life on his private 727 airplane. One day in 2012, Feralio said, he filmed a party on the plane that included a 17-year-old girl dancing and drinking alcohol along with several other young women. 0:23

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:

A video captured by Stephen Feralio shows Nygard and several women walking into a hotel suite in Las Vegas. At one point, Nygard appears to lose track of how many women are travelling with him. 0:32

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:

Stephen Feralio was filming when Nygard travelled to the 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. Feralio said the video shows what he describes as a typical effort to recruit a young woman for Nygard. 0:34

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:

Stephen Feralio’s videos show 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.’ 0:23

“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.

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Pfizer will ship COVID-19 vaccine in fewer vials if Canada agrees to label change – CBC.ca

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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:

Prime Minister Justin Trudeau is trying to reassure Canadians about the COVID-19 vaccine supply after the European Union raised the possibility of imposing export controls on vaccines leaving the EU. Canada’s Pfizer-BioNTech shots are made in Belgium. 1:44

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.

If Canada agrees to the change but can’t get the six doses out of every single vial, its goal to vaccinate 20 million people with Pfizer’s 40 million doses will be impossible to meet. 

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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