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Health Canada has final data needed from Moderna to make a decision on vaccine – CTV News

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OTTAWA —
Health Canada says it will “soon” be ready to announce if it can authorize a second COVID-19 vaccine after receiving final documents from U.S. biotech firm Moderna over the weekend.

Moderna’s new Canadian general manager — hired just three weeks ago to establish a Canadian office for the company — said Moderna’s team and Health Canada are in constant communication.

“Everybody worked really diligently all weekend,” Patricia Gauthier told The Canadian Press in an interview Monday.

She said the process is following the required course and “we’re hoping for a decision when Health Canada is ready.”

Eric Morrissette, a spokesman for Health Canada, said the documents are being reviewed as fast as possible.

The U.S. Food and Drug Administration issued an emergency authorization for the Moderna vaccine late last week, becoming the first country to approve it. The COVID-19 vaccine is also the first Moderna product ever authorized for use.

The company was established about a decade ago specifically to work on messenger RNA technology, or mRNA.

The final documents Health Canada needed included data on manufacturing. The Canadian doses of Moderna’s vaccine are being made in Switzerland and sent to Spain for the “fill and finish” process, where six doses will be filled into each vial and the vials packed into freezers for shipping.

As many as 110,000 doses can be transported on a single pallet. Moderna intends to start shipping its vaccine to Canada within 48 hours of approval, with as many as 168,000 doses anticipated before the end of December and two million by the end of March.

Health Canada initially contracted to buy 20 million doses from Moderna, but exercised an option to buy 20 million more earlier this month, for a total of 40 million.

Gauthier said that is enough to vaccinate two-thirds of the Canadian adult population, and that there are still 16 million doses remaining for Canada to potentially buy as part of the contract. Sources not authorized to speak on the matter tell The Canadian Press a decision on whether to buy those extra doses will likely be announced this week.

The Moderna vaccine is only recommended for use on adults over the age of 18. Gauthier said clinical trials on adolescents began earlier this month and the vaccine will be tested on younger children in 2021.

Health Canada approved a vaccine from Pfizer-BioNTech on Dec. 9 and vaccinations with that product began last week. It was about five days from the time the final documents were received until Pfizer got a green light, but Health Canada’s chief medical adviser Dr. Supriya Sharma has said Moderna’s production facilities are new to Health Canada and may take longer to review.

The vaccines from Pfizer and Moderna both use messenger RNA technology, which sends a genetic code to human cells to train them to create an immune response to COVID-19. Both drugmakers say the vaccines were more than 94 per cent effective at preventing infection.

But Pfizer’s technology requires the vaccine to be kept frozen between -60 C and -80 C until just before use, requiring complex shipping processes, dry ice and ultra-low-temperature freezers.

Moderna’s product can be kept stable at only -20 C and can be at room temperature for almost a month. The company said last week that where it is necessary, the vaccine can be shipped at temperatures between 2 C and 8 C.

It means Moderna’s vaccine can be more easily deployed wherever it is needed, including to the North, remote Indigenous communities and long-term care homes.

Moderna will be picked up by FedEx in Europe and shipped in freezers to Toronto, where logistics company Innomar Strategies will take possession of it.

Innomar president Guy Payette said the company will be the importer of record, run a quality assurance check on the vaccines, and then repackage the shipments into smaller amounts to be forwarded to provincial and territorial governments.

“We’re working on the assumption that it is imminent, and that we need to be ready when the vaccines get approved,” Payette told The Canadian Press.

Gauthier is now helping set up the Canadian division of Moderna, intending to hire a team of people whose first focus will be helping governments in Canada get the vaccine administered.

She says that includes efforts to communicate to Canadians the safety and effectiveness of the vaccine.

This report by The Canadian Press was first published Dec. 21, 2020.

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Alouettes receiver Philpot announces he’ll be out for the rest of season

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Montreal Alouettes wide receiver Tyson Philpot has announced he will be out for the rest of the CFL season.

The Delta, B.C., native posted the news on his Instagram page Thursday.

“To Be Continued. Shoutout my team, the fans of the CFL and the whole city of Montreal! I can’t wait to be back healthy and write this next chapter in 2025,” the statement read.

Philpot, 24, injured his foot in a 33-23 win over the Hamilton Tiger-Cats on Aug. 10 and was placed on the six-game injured list the next week.

The six-foot-one, 195-pound receiver had 58 receptions, 779 yards and five touchdowns in nine games for the league-leading Alouettes in his third season.

Philpot scored the game-winning touchdown in Montreal’s Grey Cup win last season to punctuate a six-reception, 63-yard performance.

This report by The Canadian Press was first published Sept. 12, 2024.

The Canadian Press. All rights reserved.



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Tua Tagovailoa sustains concussion after hitting head on turf in Dolphins’ loss to Bills

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MIAMI GARDENS, Fla. (AP) — Miami Dolphins quarterback Tua Tagovailoa sustained a concussion for the third time in his NFL career, leaving his team’s game Thursday night against Buffalo after running into defensive back Damar Hamlin and hitting the back of his head against the turf.

Tagovailoa remained down for about two minutes before getting to his feet and walking to the sideline after the play in the third quarter. He made his way to the tunnel not long afterward, looking into the stands before smiling and departing toward the locker room.

The Dolphins needed almost no time before announcing it was a concussion. The team said he had two during the 2022 season, and Tagovailoa was diagnosed with another concussion when he was a college player at Alabama.

Dolphins coach Mike McDaniel said Tagovailoa would get “proper procedural evaluation” and “appropriate care” on Friday.

“The furthest thing from my mind is, ‘What is the timeline?’ We just need to evaluate and just worry about my teammate, like the rest of the guys are,” McDaniel said. “We’ll get more information tomorrow and take it day by day from here.”

Some players saw Tagovailoa in the locker room after the game and said they were encouraged. Tagovailoa spoke with some players and then went home after the game, McDaniel said.

“I have a lot of love for Tua, built a great relationship with him,” said quarterback Skylar Thompson, who replaced Tagovailoa after the injury. “You care about the person more than the player and everybody in the organization would say the same thing. Just really praying for Tua and hopefully everything will come out all right.”

Tagovailoa signed a four-year, $212 million extension before this season — a deal that makes him one of the highest-paid players in the NFL — and was the NFL’s leading passer in Week 1 this season. Tagovailoa left with the Dolphins trailing 31-10, and that was the final score.

“If you know Tua outside of football, you can’t help but feel for him,” Bills quarterback Josh Allen said on Amazon following the game. “He’s a great football player but he’s an even greater human being. He’s one of the best humans on the planet. I’ve got a lot of love for him and I’m just praying for him and his family, hoping everything’s OK. But it’s tough, man. This game of football that we play, it’s got its highs and it’s got its lows — and this is one of the lows.”

Tagovailoa’s college years and first three NFL seasons were marred by injury, though he positioned himself for a big pay bump with an injury-free and productive 2023 as he led the Dolphins into the playoffs. He threw for 29 touchdowns and a league-best 4,624 yards last year.

When, or if, he can come back this season is anyone’s guess. Tagovailoa said in April 2023 that the concussions he had in the 2022 season left him contemplating his playing future. “I think I considered it for a time,” he said then, when asked if he considered stepping away from the game to protect himself.

McDaniel said it’s not his place to say if Tagovailoa should return to football. “He’ll be evaluated and we’ll have conversations and progress as appropriate,” McDaniel said.

Tagovailoa was hurt Thursday on a fourth-down keeper with about 4:30 left in the third. He went straight ahead into Hamlin and did not slide, leading with his right shoulder instead.

Hamlin was the player who suffered a cardiac arrest after making a tackle during a Monday night game in January 2023 at Cincinnati, causing the NFL to suspend a pivotal game that quickly lost significance in the aftermath of a scary scene that unfolded in front of a national television audience.

Tagovailoa wound up on his back, both his hands in the air and Bills players immediately pointed at him as if to suggest there was an injury. Dolphins center Aaron Brewer quickly did the same, waving to the sideline.

Tagovailoa appeared to be making a fist with his right hand as he lay on the ground. It was movement consistent with something that is referred to as the “fencing response,” which can be common after a traumatic brain injury.

Tagovailoa eventually got to his feet. McDaniel grabbed the side of his quarterback’s head and gave him a kiss on the cheek as Tagovailoa departed. Thompson came into the game to take Tagovailoa’s spot.

“I love Tua on and off the football field,” Bills edge Von Miller said. “I’m a huge fan of him. I can empathize and sympathize with him because I’ve been there. I wish him the best.”

Tagovailoa’s history with concussions — and how he has since worked to avoid them — is a huge part of the story of his career, and now comes to the forefront once again.

He had at least two concussions during the 2022 season. He was hurt in a Week 3 game against Buffalo and cleared concussion protocol, though he appeared disoriented on that play but returned to the game.

The NFL later changed its concussion protocol to mandate that if a player shows possible concussion symptoms — including a lack of balance or stability — he must sit out the rest of the game.

Less than a week later, in a Thursday night game at Cincinnati, Tagovailoa was concussed on a scary hit that briefly knocked him unconscious and led to him being taken off the field on a stretcher.

His second known concussion of that season came in a December game against Green Bay, and he didn’t play for the rest of the 2022 season. After that, Tagovailoa began studying ways where he may be able to fall more safely and protect himself against further injury — including studying jiu-jitsu.

“I’m not worried about anything that’s out of my hands,” McDaniel said. “I’m just worried about the human being.”

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Too much? Many Americans feel the need to limit their political news, AP-NORC/USAFacts poll finds

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NEW YORK (AP) — When her husband turns on the television to hear news about the upcoming presidential election, that’s often a signal for Lori Johnson Malveaux to leave the room.

It can get to be too much. Often, she’ll go to a TV in another room to watch a movie on the Hallmark Channel or BET. She craves something comforting and entertaining. And in that, she has company.

While about half of Americans say they are following political news “extremely” or “very” closely, about 6 in 10 say they need to limit how much information they consume about the government and politics to avoid feeling overloaded or fatigued, according to a new survey from the Associated Press-NORC Center for Public Affairs Research and USAFacts.

Make no mistake: Malveaux plans to vote. She always does. “I just get to the point where I don’t want to hear the rhetoric,” she said.

The 54-year-old Democrat said she’s most bothered when she hears people on the news telling her that something she saw with her own eyes — like the Jan. 6, 2021, attack on the U.S. Capitol — didn’t really happen.

“I feel like I’m being gaslit. That’s the way to put it,” she said.

Sometimes it feels like ‘a bombardment’

Caleb Pack, 23, a Republican from Ardmore, Oklahoma, who works in IT, tries to keep informed through the news feeds on his phone, which is stocked with a variety of sources, including CNN, Fox News, The Wall Street Journal and The Associated Press.

Yet sometimes, Pack says, it seems like a bombardment.

“It’s good to know what’s going on, but both sides are pulling a little bit extreme,” he said. “It just feels like it’s a conversation piece everywhere, and it’s hard to escape it.”

Media fatigue isn’t a new phenomenon. A Pew Research Center survey conducted in late 2019 found roughly two in three Americans felt worn out by the amount of news there is, about the same as in a poll taken in early 2018. During the 2016 presidential campaign, about 6 in 10 people felt overloaded by campaign news.

But it can be particularly acute with news related to politics. The AP-NORC/USAFacts poll found that half of Americans feel a need to limit their consumption of information related to crime or overseas conflicts, while only about 4 in 10 are limiting news about the economy and jobs.

It’s easy to understand, with television outlets like CNN, Fox News Channel and MSNBC full of political talk and a wide array of political news online, sometimes complicated by disinformation.

“There’s a glut of information,” said Richard Coffin, director of research and advocacy for USAFacts, “and people are having a hard time figuring out what is true or not.”

Women are more likely to feel they need to limit media

In the AP-NORC poll, about 6 in 10 men said they follow news about elections and politics at least “very” closely, compared to about half of women. For all types of news, not just politics, women are more likely than men to report the need to limit their media consumption, the survey found.

White adults are also more likely than Black or Hispanic adults to say they need to limit media consumption on politics, the poll found.

Kaleb Aravzo, 19, a Democrat, gets a baseline of news by listening to National Public Radio in the morning at home in Logan, Utah. Too much politics, particularly when he’s on social media sites like TikTok and Instagram, can trigger anxiety and depression.

“If it pops up on my page when I’m on social media,” he said, “I’ll just scroll past it.”

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Sanders reported from Washington. David Bauder writes about media for the AP. Follow him at http://x.com/dbauder.

The AP poll of 1,019 adults was conducted July 29-August 8, 2024, using a sample drawn from NORC’s probability-based AmeriSpeak Panel, which is designed to be representative of the U.S. population. The margin of sampling error for all respondents is plus or minus 4.0 percentage points.

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