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Coronavirus: Johnson & Johnson's one-shot COVID-19 vaccine gets Health Canada approval – CTV News

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OTTAWA —
The first one-shot COVID-19 vaccine from Johnson & Johnson has been authorized by Health Canada, making it the fourth vaccine that can be administered to Canadians.

Health Canada is now the first major regulator to have approved four different COVID-19 vaccines for use, said chief medical adviser at Health Canada Dr. Supriya Sharma during a briefing announcing the approval.

The authorization follows “an independent and thorough scientific review for safety, efficacy, and quality,” Sharma said.

Canada can now use the Pfizer-BioNTech, Moderna, AstraZeneca, and Johnson & Johnson vaccines in its ongoing mass vaccination campaign, largely viewed as a key pillar in overcoming the nearly year-long pandemic.

Canada’s federal health agency has been assessing the viral vector Johnson & Johnson shot since Nov. 30, and like the AstraZeneca vaccine given the green light last Friday, it will be logistically easier to administer as it can be shipped at temperatures between two- to eight-degrees Celsius and stored in those refrigerated conditions for at least three months.

Vials of the Johnson & Johnson vaccine can be kept for three hours at room temperature once the seal has been punctured, while it can stay stable if unopened for up to 12 hours.

“This is a game changer,” physician Dr. Lisa Salamon said in an interview on CTV News Channel. “Family doctors can give it to their patients; it can be given in pharmacies, public health units.”

Overall, in clinical trials involving approximately 43,000 participants, the single dose of the Johnson & Johnson vaccine was shown to be 66 per cent effective in preventing moderate to severe COVID-19, two weeks after vaccination.

As with other vaccines, Sharma said common side effects include pain and tenderness at the injection site, headache, muscle pain, fever, and chills. The majority of adverse reactions reported during the clinical trials were mild to moderate in severity, and resolved within a few days.

The Johnson & Johnson vaccine has been approved for use in adults 18 years of age and older, and with nearly 20 per cent of the participants in clinical trials being 65 years of age and older, no difference in safety or efficacy was seen compared to the younger age groups.

Health Canada has also approved a clinical trial for the vaccine in children ages 12 to 17 that’s yet to recruit patients, while trials are underway with the other vaccines but do not have Canadian sites.

There is an also on ongoing study considering a second shot of the Johnson & Johnson vaccine, which federal health officials say they’ll keep an eye on.

Sharma said that the Johnson & Johnson shot has shown to provide “acceptable levels” of protection against the B.1.351 variant first discovered in South Africa and against the P.1 variant first identified in Brazil.

Seeking to clarify concerns around whether certain approved vaccines are superior given their higher efficacy rates, Sharma said that any of the Health Canada authorized shots will “greatly” reduce the change of contracting COVID-19.

“The efficacy rate does not mean that following vaccination with a vaccine with 66 per cent efficacy, that you will have a 34 per cent chance of contracting COVID-19,” Sharma said.

“It’s not just about getting COVID-19, what’s really important is whether any of the vaccines will prevent you from being hospitalized, or dying of COVID-19,” she said, noting that all the vaccines approved so far are effective at preventing severe illness or death.

WHEN WILL IT ARRIVE?

The federal government has secured access to up to 38 million doses of the Johnson & Johnson vaccine, with a deal in place for at least 10 million doses and the option to purchase 28 million more.

During a briefing on Canada’s vaccine rollout on Thursday, director general for vaccines at Public Services and Procurement Canada Joelle Paquette told reporters that the 10 million doses are expected by the end of September.

It’s unclear how quickly the initial delivery of these doses could arrive in Canada, but with the addition of this vaccine to Canada’s COVID-19 inoculations arsenal it’s likely this country’s overall immunization timeline can be accelerated.

MORE DATA COMING

Regulatory approval deeming the Johnson & Johnson shot safe and effective for use in Canada comes on the heels of the United States approving the vaccine candidate from pharmaceutical company Jannsen last weekend, while other medical regulators such as the European Medicines Agency, continue their examination of the vaccine.

The vaccine was authorized with terms and conditions, including requiring the manufacturer to continue provide information to Health Canada on the safety, efficacy and quality of the vaccine.

With the authorization, Health Canada released a series of documents that detail the consumer information, the regulatory decision summary, as well as more data about the adverse events reported.

The agency says additional detailed information will be published in the coming weeks.

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 and has been able to assess rolling information as it comes in, rather than having to wait until the end of its work to begin reviewing the findings.

There is still a fifth vaccine still under review by Health Canada, the Novavax vaccine. Health officials said Friday there is “a fair amount” of information outstanding and Health Canada’s decision to authorize or not could be months away.

More coming.

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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.”

___

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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