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Health Canada received more Johnson & Johnson data on same day as U.S. approval – CBC.ca

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4 years ago

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Health Canada on Saturday received additional data required to inform its decision on Johnson & Johnson’s COVID-19 vaccine — the same day the shot was approved in the United States.

“We were waiting on some manufacturing data, and that came in yesterday. So we’re starting to look at that,” Dr. Supriya Sharma, Health Canada’s chief medical adviser, said Sunday on Rosemary Barton Live.

“It’s really difficult to predict exactly when we might make a final decision because it really depends on that data. But we’re looking at … the next couple of weeks.”

The data received on Saturday is what health regulators need to ensure that “every dose of the vaccine that comes off the production lines meets quality standards,” Sharma wrote in an email to CBC News.

The approval timeline depends on that information, but it also depends on whether regulators need to discuss any questions that arise with the manufacturer. Work that happens in the final stages of review — including finalizing a risk-management plan for monitoring the vaccine after authorization — must also be completed.

The two-week approval target takes those steps into consideration but doesn’t account for unexpected issues that could crop up, Sharma said.

The government authorized the use of a third vaccine, the Oxford-AstraZeneca shot, on Friday.

WATCH | Johnson & Johnson vaccine approval could come in the next couple of weeks:

Health Canada’s chief medical adviser, Dr. Supriya Sharma, said the agency is waiting on manufacturer data to make a determination on Johnson & Johnson’s single-dose COVID-19 vaccine, but contingent on that data, approval could come in the next few weeks. 9:23

Single-dose shot makes for easier rollout

In a global trial, the Johnson & Johnson vaccine, which was cleared by the U.S. Food and Drug Administration (FDA) on Saturday, was found to be 66 per cent effective at staving off moderate to severe illness and was 85 per cent effective at preventing the most serious outcomes. 

Canada has ordered 10 million doses of the vaccine, with options for up to 28 million more. 

The best vaccine for an individual is [the] one that you can get.– Health Canada chief medical adviser Dr. Supriya Sharma

“In terms of the committee meeting that the FDA had, we had observers there as well, so all of that helps make for a more efficient review,” Sharma told CBC chief political correspondent Rosemary Barton.

While the vaccine was approved as a one-shot regimen, the company is also testing the efficacy of administering two doses of its product.

“If a vaccine is only only dose, then that makes it easier for administration. You don’t have to do the followup to record people and track them down to get the second dose,” Sharma told Barton. “So all of that helps, but what really helps the most is getting as many vaccines authorized and get that supply in as quickly as possible.”

Not a question of ‘good’ and ‘bad’ vaccines

Now that more vaccines are earning approvals, Sharma said a “narrative” has emerged where people assume one shot confers better protection than another.

Efficacy, she said, simply means determining whether “something does what it’s supposed to do.” As far as COVID-19 vaccines are concerned, that means comparing one group of people who receive the shot against another group of people who didn’t and contrasting the number of cases in both groups.

“When we look across all the vaccines, the major five that are under review and authorized, if you look at that subsection that matters most — severe disease, hospitalizations, dying of COVID-19 — all of these vaccines are equally protective,” Sharma explained.

The chief medical adviser cautioned against pitting one shot against another, something she said can only happen in a “head-to-head” trial, which would see two vaccines being tested together in the same trial.

“The best vaccine for an individual is [the] one that you can get. That’s pretty simple,” she said.

“For people who are sitting back and waiting for another vaccine, I would say the longer, and the more people, who do that, the more we’re all going to be sitting at home if we’re lucky to have a home.”

You can watch full episodes of Rosemary Barton Live on CBC Gem, the CBC’s streaming service. 

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Jays reliever Green and Canadian slugger O’Neill nominated for comeback player award

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5 hours ago

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October 21, 2024

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NEW YORK – Toronto Blue Jays reliever Chad Green and Canadian slugger Tyler O’Neill of the Boston Red Sox were named finalists for the Major League Baseball Players’ Association’s American League comeback player award on Monday.

Chicago White Sox left-hander Garrett Crochet was the other nominee.

New York Yankees outfielder Aaron Judge, Los Angeles Dodgers designated hitter Shohei Ohtani and Kansas City Royals shortstop Bobby Witt Jr. were named player of the year finalists.

The award winners, selected via player voting, will be named Saturday before Game 2 of the World Series.

Green, who missed most of the 2022 and ’23 seasons after undergoing Tommy John surgery, was a high-leverage option for the Blue Jays this past season and filled in at closer over the second half of the campaign.

The right-hander converted his first 16 save opportunities and finished the year with a 4-6 record, 17 saves and a 3.21 earned-run average over 53 appearances.

O’Neill, a native of Burnaby, B.C., also endured back-to-back injury-plagued seasons in ’22 and ’23.

After being traded to the Red Sox in the off-season, O’Neill set an MLB record by hitting a homer in his fifth straight Opening Day. He finished with 31 homers on the year and had an OPS of .847.

This report by The Canadian Press was first published Oct. 21, 2024.

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Duke’s Cooper Flagg makes preseason AP All-America team as ACC, Big 12, SEC each place 2 players

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6 hours ago

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October 21, 2024

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Alabama’s Mark Sears and North Carolina‘s RJ Davis looked into the possibility of leaving for the NBA before deciding to return for another college season.

Their decisions helped their teams earn top-10 rankings in the AP Top 25 and earned both players some preseason honors, too.

Sears was a near-unanimous selection for The Associated Press preseason All-America men’s basketball team released Monday, earning all but one vote from a 55-person national media panel. Davis was right behind him, nabbing 51 votes.

They were joined by Kansas big man Hunter Dickinson, Auburn forward Johni Broome, Arizona guard Caleb Love and Duke freshman Cooper Flagg. Love and Flagg tied for the final spot, creating a six-man team that includes only the ACC, Big 12 and SEC.

Alabama twin bill

Sears was a key cog in the Crimson Tide’s first trip to the Final Four a year ago, orchestrating one of college basketball’s highest-scoring teams.

The 6-foot-1 guard was named a second-team AP All-America after averaging 21.5 points, 4.2 rebounds and 4.0 assists. He was the first Division I player in 31 years to have 795 points, 150 rebounds, 145 assists and 95 three-pointers in a single season while breaking the Alabama single-season record with 26 games with at least 20 points.

Sears worked out for NBA scouts during the offseason before deciding to return to Alabama, earning the Crimson Tide a No. 2 ranking in the preseason AP Top 25.

“I saw the team that we had and I wanted to be a part of it, and bring home Alabama’s first national championship in basketball,” Sears said.

Across the state at rival Auburn, Broome made a quick decision about his future, announcing in April that he would be back for a fifth season.

The 6-10 forward was a third-team AP All-American last season after averaging 16.5 points and 8.5 rebounds while shooting nearly 55% from the floor. With an eye on an NBA future, Broome worked hard on his perimeter shooting during the offseason and his return earned Auburn a No. 11 preseason ranking.

“My main goal is a team goal, which is to win the national championship, to make it as far as I can in March Madness,” Broome said. “When a team shines, everyone shines individually.”

Along Tobacco Road

Like Sears, Davis has similar aspirations after opting to return for his fifth season at North Carolina.

The 6-foot guard was an AP All-American last season and the ACC player of the year after averaging 21.1 points, 3.6 rebounds and 3.5 assists on a team that reached the Sweet 16 of the NCAA Tournament. Davis enters this year within reach of former North Carolina big man Tyler Hansbrough’s all-time ACC scoring record.

“I know there’s more work to be done,” Davis said. “I know my jersey’s not going up until I leave. So there’s some more records to break and some more work to be done. I’m satisfied but I’m not satisfied, if that makes sense.”

Up the road at Duke, Flagg was the only underclassman on the preseason All-America team after arriving with tons of hype. The 6-9 swingman was the No. 1-rated high school recruit out of Newport, Maine and has been projected as the No. 1 overall pick in the NBA draft.

Flagg has the skills of a guard, but can also play inside and has worked hard on his perimeter shooting, giving him the potential to be one of college basketball’s most versatile players. He’s part of a stellar recruiting class that has No. 7 Duke eyeing a deep March run.

Big 12 duo

Dickinson was the biggest move in the transfer portal last spring after leaving Michigan for Kansas. The 7-2 center lived up to the billing, averaging 17.9 points and 10.9 rebounds while leading the Jayhawks back to the NCAA Tournament.

With Dickinson’s return and an influx of talented transfers, Kansas is ranked No. 1 going into the season that begins Nov. 4.

Love’s decision to return for a second season at No. 10 Arizona has ratcheted up expectations in the desert for the Big 12 rival of Kansas.

The athletic 6-4 guard had a high-scoring career at North Carolina and continued it after transferring to Arizona last season. He was the Pac-12 player of the year and a third-team All-American after averaging 18 points per game and making 92 3-pointers.

Love tested the NBA waters this summer before deciding to return.

“He’s had a very successful college career thus far,” Arizona coach Tommy Lloyd said. “He’s kind of this last generation of player that’s going to get better with this extra year, and so I just encourage him to take advantage of it.”

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Browns QB Deshaun Watson ruptured his Achilles tendon and is out for the season, AP source says

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6 hours ago

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October 21, 2024

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CLEVELAND (AP) — Browns quarterback Deshaun Watson will miss the rest of Cleveland‘s season after rupturing his right Achilles tendon on Sunday against Cincinnati, a person familiar with the situation told The Associated Press on Monday.

Watson was injured on a non-contact play in the second quarter of Cleveland’s 21-14 loss to the Bengals.

Watson will soon undergo surgery, said the person who spoke on condition of anonymity because the team has not announced the results of imaging tests taken on his leg.

It’s the second significant injury in two seasons for Watson, who broke the glenoid (socket) bone in his throwing shoulder last year.

The 29-year-old Watson went down without being touched on a draw play late in the first half. His right leg buckled and Watson collapsed to the turf. TV replays showed his calf rippling, consistent with an Achilles injury.

As he laid on the ground, there was cheering by some Cleveland fans, leading to some of Watson’s teammates criticizing that behavior during the team’s fifth straight loss.

The injury is yet another twist in Watson’s divisive stay with the Browns.

Cleveland traded three first-round draft picks to Houston and signed him to a fully guaranteed $230 million in 2022. The deal came amid Watson being accused by more than two dozen women of sexual assault and harassment during massage therapy sessions. He settled civil lawsuits in all but one of those cases.

Watson was suspended by the NFL for his first 11 games with the Browns and then made just six starts last season before hurting his shoulder.

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