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How the COVID-19 vaccines are being approved in Canada – CBC.ca

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The approval of a COVID-19 vaccine in Canada could potentially be days away with the initial supply to be limited to about three million Canadians, in the first three months of 2021. But what approval processes have the vaccines gone through? CBC explains:

Is the approval process for the COVID-19 vaccine different than for other vaccines?

Due to the immediate need for the COVID-19 vaccine, some flexibility has been introduced to the approval process. Typically, a vaccine manufacturer will do all their clinical trials, gather all their data, prepare a submission package and put that forward for approval, said John Greiss, a Toronto-based intellectual property lawyer with Norton Rose Fulbright, who advises companies in the life sciences sector that are regulated by Health Canada.

“Health Canada will comment on it or ask for additional information and it will go back and forth until they come to a decision, he said.

But with COVID-19, Health Canada has accepted what’s known as a “rolling submission.” 

“The new process allows for a company to start an application process, submit the information that they have available, as of that date and add new data and new information as it becomes available, Greiss said

Supriya Sharma, chief medical adviser to Health Canada, said this enables the organization to start reviewing the potential vaccine and will shorten the overall review process “while still maintaining those same standards for the safety and the efficacy.”

What’s included in the submission?

That really hasn’t changed, Greiss said. Vaccine manufacturers have to submit all of the scientific data that they have, which includes any kind of lab data that demonstrates how the vaccine works, any kind of clinical trial data that they have obtained, along with Phase 1 to Phase 3 clinical trial data.

WATCH | Vaccines are coming soon

Dr. Njoo tells reporters the federal government is expecting 6 million doses of first two vaccines to arrive in Canada after approvals within the first quarter of the new year. 1:35

They also have to submit information about the manufacturing process and standards and procedures that demonstrate they’re meeting good manufacturing processes in their facilities, Greiss said.

How is the vaccine reviewed?

One vaccine submission is hundreds of thousands of pages long and can take, on average around 2,000 person hours to review, Sharma said. For COVID-19, Health Canada is employing specialized teams of seven to 12 people who have experience in areas like toxicology, infectious diseases, clinical medicine, microbiology and epidemiology to review the vaccine.

“Each vaccine submission has its own team that’s dedicated to it. And they will go through all of that information,” she said.

Reviewers must confirm there are no significant safety concerns, determine that the vaccine is able to prompt an adequate immune response in vaccinated people and show that it can protect against disease, she said.

“We go through all of that to see if it actually meets our standards for safety, efficacy, quality,” Sharma said. 

“We need to make sure that the benefits of the vaccine outweigh the potential risks and that we know that it’s being made in at a licensed place that’s up to standards and up to code.”

Greiss said that during the review process, Health Canada officials might, for example, ask for further clarification about the clinical trial procedure, or how patients were recruited.

The approval process has been modified to accommodate the pressing need for the COVID-19 vaccine. (Dado Ruvic/Illustration/Reuters)

“Or if they see anomalies in the data, they’ll ask the company to justify or clarify that information,” he said. “So there is still that back and forth in terms of Health Canada sort of digesting and analyzing the data and the company having to provide answers for that before they get an approval.”

Are the vaccine manufacturing facilities inspected?

For manufacturing facilities around the world, not just for vaccines, but for medications as well, Health Canada has entered into mutual recognition agreements with other regulators, Sharma said.

“We actually have sent our inspectors over to their country,” she said. “They’ve sent inspectors over to our country. We make sure that our standards are the same, our processes are the same.”

Every facility that manufactures vaccines needs to have an inspection before it’s licensed. And there are ongoing inspections to make sure standards are maintained, she said.

What are they looking for in these facilities?

They’re looking at key factors, known as the four Ps, Sharma said. 

  • Product: What’s being made there.
  • Premises: There are very detailed specifications on the facilities themselves. For example, special flooring and ventilation systems have to be in place.
  • Process: All the processes that go into manufacturing the product.
  • People: The qualifications and training of the people that work there.

All of those things are really important in terms of making sure that standards are met, she said.

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Whitehead becomes 1st CHL player to verbally commit to playing NCAA hockey

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Braxton Whitehead said Friday he has verbally committed to Arizona State, making him the first member of a Canadian Hockey League team to attempt to play the sport at the Division I U.S. college level since a lawsuit was filed challenging the NCAA’s longstanding ban on players it deems to be professionals.

Whitehead posted on social media he plans to play for the Sun Devils beginning in the 2025-26 season.

An Arizona State spokesperson said the school could not comment on verbal commitments, citing NCAA rules. A message left with the CHL was not immediately returned.

A class-action lawsuit filed Aug. 13 in U.S. District Court in Buffalo, New York, could change the landscape for players from the CHL’s Western Hockey League, Ontario Hockey League and Quebec Maritimes Junior Hockey League. NCAA bylaws consider them professional leagues and bar players from there from the college ranks.

Online court records show the NCAA has not made any response to the lawsuit since it was filed.

“We’re pleased that Arizona State has made this decision, and we’re hopeful that our case will result in many other Division I programs following suit and the NCAA eliminating its ban on CHL players,” Stephen Lagos, one of the lawyers who launched the lawsuit, told The Associated Press in an email.

The lawsuit was filed on behalf of Riley Masterson, of Fort Erie, Ontario, who lost his college eligibility two years ago when, at 16, he appeared in two exhibition games for the OHL’s Windsor Spitfires. And it lists 10 Division 1 hockey programs, which were selected to show they follow the NCAA’s bylaws in barring current or former CHL players.

CHL players receive a stipend of no more than $600 per month for living expenses, which is not considered as income for tax purposes. College players receive scholarships and now can earn money through endorsements and other use of their name, image and likeness (NIL).

The implications of the lawsuit could be far-reaching. If successful, the case could increase competition for college-age talent between North America’s two top producers of NHL draft-eligible players.

“I think that everyone involved in our coaches association is aware of some of the transformational changes that are occurring in collegiate athletics,” Forrest Karr, executive director of American Hockey Coaches Association and Minnesota-Duluth athletic director said last month. “And we are trying to be proactive and trying to learn what we can about those changes.

Karr was not immediately available for comment on Friday.

Earlier this year, Karr established two committees — one each overseeing men’s and women’s hockey — to respond to various questions on eligibility submitted to the group by the NCAA. The men’s committee was scheduled to go over its responses two weeks ago.

Former Minnesota coach and Central Collegiate Hockey Association commissioner Don Lucia said at the time that the lawsuit provides the opportunity for stakeholders to look at the situation.

“I don’t know if it would be necessarily settled through the courts or changes at the NCAA level, but I think the time is certainly fast approaching where some decisions will be made in the near future of what the eligibility will look like for a player that plays in the CHL and NCAA,” Lucia said.

Whitehead, a 20-year-old forward from Alaska who has developed into a point-a-game player, said he plans to play again this season with the Regina Pats of the Western Hockey League.

“The WHL has given me an incredible opportunity to develop as a player, and I couldn’t be more excited,” Whitehead posted on Instagram.

His addition is the latest boon for Arizona State hockey, a program that has blossomed in the desert far from traditional places like Massachusetts, Minnesota and Michigan since entering Division I in 2015. It has already produced NHL talent, including Seattle goaltender Joey Daccord and Josh Doan, the son of longtime Coyotes captain Shane Doan, who now plays for Utah after that team moved from the Phoenix area to Salt Lake City.

___

AP college sports:

The Canadian Press. All rights reserved.



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Calgary Flames sign forward Jakob Pelletier to one-year contract

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CALGARY – The Calgary Flames signed winger Jakob Pelletier to a one-year, two-way contract on Friday.

The contract has an average annual value of US$800,000.

Pelletier, a 23-year-old from Quebec City, split last season with the Flames and American Hockey League’s Calgary Wranglers.

He produced one goal and two assists in 13 games with the Flames.

Calgary drafted the five-foot-nine, 170-pound forward in the first round, 26th overall, of the 2019 NHL draft.

Pelletier has four goals and six assists in 37 career NHL games.

This report by The Canadian Press was first published Sept. 13, 2024.

The Canadian Press. All rights reserved.



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Kingston mayor’s call to close care hub after fatal assault ‘misguided’: legal clinic

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A community legal clinic in Kingston, Ont., is denouncing the mayor’s calls to clear an encampment and close a supervised consumption site in the city following a series of alleged assaults that left two people dead and one seriously injured.

Kingston police said they were called to an encampment near a safe injection site on Thursday morning, where they allege a 47-year-old male suspect wielded an edged or blunt weapon and attacked three people. Police said he was arrested after officers negotiated with him for several hours.

The suspect is now facing two counts of second-degree murder and one count of attempted murder.

In a social media post, Kingston Mayor Bryan Paterson said he was “absolutely horrified” by the situation.

“We need to clear the encampment, close this safe injection site and the (Integrated Care Hub) until we can find a better way to support our most vulnerable residents,” he wrote.

The Kingston Community Legal Clinic called Paterson’s comments “premature and misguided” on Friday, arguing that such moves could lead to a rise in overdoses, fewer shelter beds and more homelessness.

In a phone interview, Paterson said the encampment was built around the Integrated Care Hub and safe injection site about three years ago. He said the encampment has created a “dangerous situation” in the area and has frequently been the site of fires, assaults and other public safety concerns.

“We have to find a way to be able to provide the services that people need, being empathetic and compassionate to those struggling with homelessness and mental health and addictions issues,” said Paterson, noting that the safe injection site and Integrated Care Hub are not operated by the city.

“But we cannot turn a blind eye to the very real public safety issues.”

When asked how encampment residents and people who use the services would be supported if the sites were closed, Paterson said the city would work with community partners to “find the best way forward” and introduce short-term and long-term changes.

Keeping the status quo “would be a terrible failure,” he argued.

John Done, executive director of the Kingston Community Legal Clinic, criticized the mayor’s comments and said many of the people residing in the encampment may be particularly vulnerable to overdoses and death. The safe injection site and Integrated Care Hub saves lives, he said.

Taking away those services, he said, would be “irresponsible.”

Done said the legal clinic represented several residents of the encampment when the City of Kingston made a court application last summer to clear the encampment. The court found such an injunction would be unconstitutional, he said.

Done added there’s “no reason” to attach blame while the investigation into Thursday’s attacks is ongoing. The two people who died have been identified as 38-year-old Taylor Wilkinson and 41-year-old John Hood.

“There isn’t going to be a quick, easy solution for the fact of homelessness, drug addictions in Kingston,” Done said. “So I would ask the mayor to do what he’s trained to do, which is to simply pause until we have more information.”

The concern surrounding the safe injection site in Kingston follows a recent shift in Ontario’s approach to the overdose crisis.

Last month, the province announced that it would close 10 supervised consumption sites because they’re too close to schools and daycares, and prohibit any new ones from opening as it moves to an abstinence-based treatment model.

This report by The Canadian Press was first published Sept. 13, 2024.

The Canadian Press. All rights reserved.



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