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Spartan Bioscience says Health Canada approves rapid COVID-19 test – CBC.ca

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Ottawa-based company Spartan Bioscience has received Health Canada approval for its made-in-Canada rapid COVID-19 test, authorizing the sale of the device. 

“Spartan’s test is the first truly mobile, rapid PCR test for COVID-19 for the Canadian market,” a news release from the company states. “The Spartan COVID-19 system offers the speed and ease of use of a rapid test, while using the technology of lab-based COVID-19 testing solutions.”

Health Canada originally provided regulatory approval for the company’s device in April 2020 — with the federal government ordering 40,000 tests monthly. At the time, the portable test was being called a “game changer” by health officials because it could deliver on-location results within 60 minutes.

The federal agency restricted the device to research use in May, however, after finding problems with the test that made it unreliable. Approval was granted on Friday after the company conducted clinical trials based on a new device design, Health Canada spokesperson Natalie Mohamed told CBC News in an email.

“The Spartan Bioscience test is a point-of-care molecular test,”  Mohamed wrote. “This new device meets Health Canada’s requirements for safety and effectiveness.”

WATCH | Health Canada approves Canadian-made rapid COVID-19 testing system:

Canada’s health authority approved Spartan Bioscience’s rapid COVID-19 testing system. 3:12

New swab, upgrades to chemistry kit

Dr. James Spiegelman, a co-founder of the company who also practises internal medicine at Humber River Regional Hospital in Toronto, said the problems stemmed from the efficacy of the swabs used to collect tissue samples, not the machine itself.

Spartan originally used a proprietary cheek swab that it developed for other DNA diagnostics, he said, but it became clear that the swab wasn’t collecting enough genetic material to produce consistent, reliable results.

The company now uses standard nasopharyngeal swabs to collect tissue from the nose.

“We found that that provides the best sample for increased sensitivity of the test,” Spiegelman said.

Spiegelman said the company also made improvements to the sample processing kit so that it no longer needs to be shipped and stored at frozen temperatures but can be stored at room temperature. 

With the Spartan test, a trained health-care professional swabs the nose of the person being tested, places the swab into a processing kit that generates a chain reaction and then puts that kit into the cube-shaped device, which takes about 50 minutes to analyze and produce results. 

Spiegelman said the test could be used to provide quick and accurate COVID-19 diagnostics everywhere from hospitals and workplaces to pharmacies and remote communities. 

“I think [Spartan’s rapid test] will really help alleviate and give us a tool in our toolbox to reduce the spread of COVID-19,” he said.

Rapid tests already in use across Canada 

Rapid diagnostic tests are already in use in many settings across Canada to test for COVID-19, including in homeless shelters, long-term care homes and remote communities. Prime Minister Justin Trudeau said on Tuesday that the federal government had distributed more than 14 million to the provinces and territories. 

“Hopefully we see these integrated into work environments, especially work environments where we know they’re at greater risk for outbreaks,” said infectious disease specialist Dr. Isaac Bogoch, who is also a member of the Ontario COVID-19 vaccine task force.

“I think you could think about certainly integrating them into certain schools or certain school settings, rural, remote, underserviced locations. There’s a lot of places where rapid tests would be extremely helpful.”

Spartan Bioscience CEO Roger Eacock said the company currently has the manufacturing capacity to produce 60,000 of the tests per week, but the company plans to ramp that up to 200,000 per week in the future. 

Eacock said the company already has deals with the federal government and several provinces, as well as some airlines and resource companies, and that shipments are expected to begin in the coming week.

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How a bridge to Canada got the axe from American lawmakers – CBC.ca

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Funding for this bridge between upstate New York and the Ottawa-Montreal region, seen here in March 2020, was included in a major U.S. pandemic-relief bill. Then it was chopped. (Christine Muschi/Reuters)

This story is part of Watching Washington, a regular dispatch from CBC News correspondents reporting on U.S. politics and developments that affect Canadians. 

What’s new

As American lawmakers inched toward approving a bill with an eye-watering 13-digit price tag, it was apparently a bridge to Canada that proved a bridge too far.

Funds to upkeep an existing cross-border bridge from Massena, N.Y., to Cornwall, Ont., were included in, and have now been stripped out of, a $1.9 trillion US pandemic-relief bill that Congress could pass any day.

Less than one-millionth of the bill’s overall price tag had originally been set to fund operations of the half-century-old Seaway International Bridge, jointly run by the Canadian and U.S. governments.

The original version of the bill that passed the U.S. House of Representatives guaranteed $1.5 million for several months’ funding of the span, which connects upstate New York with the Ottawa-Montreal area through Cornwall, Ont.

“It’s a vital, necessary access point between our two countries,” Steven O’Shaughnessy, the town supervisor of Massena.

That funding is gone in the latest version of the bill, which could be advanced into law any day by the U.S. Senate.

If adopted, the bill would become the first major piece of legislation passed during Joe Biden’s presidency and would fund a vast array of causes, from reducing child poverty to expanding access to health care to sending out $1,400 relief cheques to Americans.

What’s the backstory

Critics called it a ‘bridge to nowhere’ and accused top Senate Democrat Chuck Schumer, a New Yorker, of pork-barrel politics. But New York Republicans wanted the bridge funding, too. (Leah Millis/Reuters)

So how did one of the most expensive pieces of legislation in American history, which will affect tens of millions of lives, stumble over a bridge that ends near the Cornwall BBQ in southeastern Ontario?

As fate would have it, that bridge became a symbolic talking point for critics of the bill.  

Republicans pointed to it as an example of how myriad items unrelated to the pandemic are being crammed into a supposed rescue package.

“We have millions upon millions of dollars for this lovely bridge to get from New York into Canada,” Iowa Senator Joni Ernst said earlier this week, inflating the price of the bridge upkeep. “And, folks, how is that helping us fight COVID?

“This is supposed to be a COVID recovery package. And somehow I don’t see my Iowa taxpayers benefiting from those porky pricey projects.”

Never mind that funding for the bridge has previously been supported by New York lawmakers from both parties, including Senate Leader Chuck Schumer and the area’s House lawmaker, Elise Stefanik.

It became Exhibit A of the idea that this 630-page bill, which would also allot billions of dollars to expanding health coverage and decreasing child poverty, is about more than COVID.

It was derided on Fox News, in its news coverage and by its hosts, as a “bridge to nowhere.”    

But it’s more complicated than that. 

The bridge, which has seen toll revenues drop during the pandemic, sits in the district of New York Republican lawmaker Elise Stefanik. She has previously supported additional funding for the bridge but voted against the stimulus bill that included $1.5 million US for upkeep of the span. ( Republican National Convention/Handout via REUTERS)

Democrats have argued that most of this bill’s items are, indeed, connected to COVID-19 — including that bridge funding.

The pandemic has caused a spectacular drop in cross-border traffic, with a 70 per cent plunge in toll fees collected at the bridge since last year, said a U.S. official with the binational Great Lakes St. Lawrence Seaway Development Corp.

So why not just fund the bridge in a transportation bill instead of a pandemic-relief bill?

Blame the joys of the American legislative process. 

A generation of partisan gridlock has resulted in fewer bills becoming law. So majority parties have tended to rely more often on a legislative shortcut, a process called reconciliation, which allows a bill to pass with just 51 Senate votes instead of 60.

The catch with that process is it can only be used once a year, on a budget bill. Which is how you wind up with all sorts of unrelated items crammed together in what is colloquially referred to in Washington as a Christmas tree bill.

In the end, under this particular tree, there was nothing left for Cornwall and Massena.

What’s next

Democrats pulled that item, and some other items, out of the Senate bill to help silence the naysayers and ease its adoption.

The bridge is now funded through the end of this month thanks to $2.5 million delivered from the Canadian government last year. 

But the U.S. official said the cash originally in the bill would have supplied funding from next month to September. Without it, the official said, there could be an impact on its services and its essential workers.

The bridge itself is in decent physical shape after millions of dollars in renovations over the last decade.

Bernadette Clement, mayor of Cornwall, said she hopes it stays that way because it not only connects families and friends and the regional economy but also supports international trade, with hundreds of commercial trucks using it each day.

The Seaway International Bridge joins Cornwall, Ont., and Massena, N.Y. It is a regional link between Canadian and American communities and also a commercial trade link that sees hundreds of trucks per day. (CP)

“It is extremely important to our national economies,” Clement said. “The maintenance of those bridges — it’s critical for us.”

When asked what happens after this month, a Canadian government spokesperson said the bridge’s critical needs will be met — but did not immediately say whether it might require an additional cash injection from Ottawa.

It wouldn’t be the first time political gridlock in the U.S. left Canada with the bill for a cross-border bridge. 

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How a bridge to Canada got the axe from American lawmakers – CBC.ca

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Funding for this bridge between upstate New York and the Ottawa-Montreal region, seen here in March 2020, was included in a major U.S. pandemic-relief bill. Then it was chopped. (Christine Muschi/Reuters)

This story is part of Watching Washington, a regular dispatch from CBC News correspondents reporting on U.S. politics and developments that affect Canadians. 

What’s new

As American lawmakers inched toward approving a bill with an eye-watering 13-digit price tag, it was apparently a bridge to Canada that proved a bridge too far.

Funds to upkeep an existing cross-border bridge from Massena, N.Y., to Cornwall, Ont., were included in, and have now been stripped out of, a $1.9 trillion US pandemic-relief bill that Congress could pass any day.

Less than one-millionth of the bill’s overall price tag had originally been set to fund operations of the half-century-old Seaway International Bridge, jointly run by the Canadian and U.S. governments.

The original version of the bill that passed the U.S. House of Representatives guaranteed $1.5 million for several months’ funding of the span, which connects upstate New York with the Ottawa-Montreal area through Cornwall, Ont.

“It’s a vital, necessary access point between our two countries,” Steven O’Shaughnessy, the town supervisor of Massena.

That funding is gone in the latest version of the bill, which could be advanced into law any day by the U.S. Senate.

If adopted, the bill would become the first major piece of legislation passed during Joe Biden’s presidency and would fund a vast array of causes, from reducing child poverty to expanding access to health care to sending out $1,400 relief cheques to Americans.

What’s the backstory

Critics called it a ‘bridge to nowhere’ and accused top Senate Democrat Chuck Schumer, a New Yorker, of pork-barrel politics. But New York Republicans wanted the bridge funding, too. (Leah Millis/Reuters)

So how did one of the most expensive pieces of legislation in American history, which will affect tens of millions of lives, stumble over a bridge that ends near the Cornwall BBQ in southeastern Ontario?

As fate would have it, that bridge became a symbolic talking point for critics of the bill.  

Republicans pointed to it as an example of how myriad items unrelated to the pandemic are being crammed into a supposed rescue package.

“We have millions upon millions of dollars for this lovely bridge to get from New York into Canada,” Iowa Senator Joni Ernst said earlier this week, inflating the price of the bridge upkeep. “And, folks, how is that helping us fight COVID?

“This is supposed to be a COVID recovery package. And somehow I don’t see my Iowa taxpayers benefiting from those porky pricey projects.”

Never mind that funding for the bridge has previously been supported by New York lawmakers from both parties, including Senate Leader Chuck Schumer and the area’s House lawmaker, Elise Stefanik.

It became Exhibit A of the idea that this 630-page bill, which would also allot billions of dollars to expanding health coverage and decreasing child poverty, is about more than COVID.

It was derided on Fox News, in its news coverage and by its hosts, as a “bridge to nowhere.”    

But it’s more complicated than that. 

The bridge, which has seen toll revenues drop during the pandemic, sits in the district of New York Republican lawmaker Elise Stefanik. She has previously supported additional funding for the bridge but voted against the stimulus bill that included $1.5 million US for upkeep of the span. ( Republican National Convention/Handout via REUTERS)

Democrats have argued that most of this bill’s items are, indeed, connected to COVID-19 — including that bridge funding.

The pandemic has caused a spectacular drop in cross-border traffic, with a 70 per cent plunge in toll fees collected at the bridge since last year, said a U.S. official with the binational Great Lakes St. Lawrence Seaway Development Corp.

So why not just fund the bridge in a transportation bill instead of a pandemic-relief bill?

Blame the joys of the American legislative process. 

A generation of partisan gridlock has resulted in fewer bills becoming law. So majority parties have tended to rely more often on a legislative shortcut, a process called reconciliation, which allows a bill to pass with just 51 Senate votes instead of 60.

The catch with that process is it can only be used once a year, on a budget bill. Which is how you wind up with all sorts of unrelated items crammed together in what is colloquially referred to in Washington as a Christmas tree bill.

In the end, under this particular tree, there was nothing left for Cornwall and Massena.

What’s next

Democrats pulled that item, and some other items, out of the Senate bill to help silence the naysayers and ease its adoption.

The bridge is now funded through the end of this month thanks to $2.5 million delivered from the Canadian government last year. 

But the U.S. official said the cash originally in the bill would have supplied funding from next month to September. Without it, the official said, there could be an impact on its services and its essential workers.

The bridge itself is in decent physical shape after millions of dollars in renovations over the last decade.

Bernadette Clement, mayor of Cornwall, said she hopes it stays that way because it not only connects families and friends and the regional economy but also supports international trade, with hundreds of commercial trucks using it each day.

The Seaway International Bridge joins Cornwall, Ont., and Massena, N.Y. It is a regional link between Canadian and American communities and also a commercial trade link that sees hundreds of trucks per day. (CP)

“It is extremely important to our national economies,” Clement said. “The maintenance of those bridges — it’s critical for us.”

When asked what happens after this month, a Canadian government spokesperson said the bridge’s critical needs will be met — but did not immediately say whether it might require an additional cash injection from Ottawa.

It wouldn’t be the first time political gridlock in the U.S. left Canada with the bill for a cross-border bridge. 

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Health Canada 'days away' from decision on Johnson & Johnson vaccine – CTV News

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OTTAWA —
Canada is on the cusp of authorizing a fourth vaccine for COVID-19, raising the possibility that every Canadian adult will be offered at least one dose before Canada Day.

Dr. Supriya Sharma, the chief medical adviser at Health Canada, said Thursday the review of Johnson and Johnson’s vaccine “is going very well.”

“It’s progressing, and we’re expecting to have that completed and a decision in the next few days,” Sharma said at a virtual news conference from Ottawa.

Johnson and Johnson, which was authorized in the United States last weekend, would join Pfizer-BioNTech, Moderna and Oxford-AstraZeneca on Canada’s list of approved vaccines. Pfizer and Moderna have been in use since December, with more than 1.5 million Canadians now vaccinated with at least one dose.

Canada’s deputy chief public health officer Dr. Howard Njoo said that with new vaccines being approved and moves by provinces to delay second doses, more Canadians will be vaccinated at a faster rate.

All provinces have indicated they will accept a recommendation made Wednesday by the National Advisory Committee on Immunization to delay second doses of vaccine by up to four months.

The new guidelines say the science shows a first dose is so effective that delaying the second dose so everyone can get a first dose more quickly, is better both for individual protection and to establish herd immunity in Canada.

Canada had been expecting enough doses of approved vaccines to vaccinate every adult with two doses by the end of September, based on Pfizer, Moderna and AstraZeneca all requiring two doses given 21 or 28 days apart.

Canada is in line to get 26 million more doses of Pfizer and Moderna, and at least 3.5 million of AstraZeneca by the end of June. Those deliveries alone would be enough to offer a first dose to every Canadian over 16 years of age by Canada Day.

No vaccines are approved for use on children under the age of 16 yet.

Another 20 million doses of AstraZeneca and 10 million from Johnson and Johnson are to arrive by September, but it’s not yet clear how many will arrive by June.

Another 55 million doses expected from Pfizer and Moderna between July and September would more than cover the necessary second doses.

The national advisory panel’s recommendation to delay doses is the latest adjustment to vaccine guidelines that some fear may make Canadians hesitant to trust the vaccines.

“We’re very concerned about that,” said Sharma. “We want to make sure that people have confidence in the decisions that are being made about vaccines.”

She said experts are basing vaccine decisions on evidence as it is presented. With more data coming almost daily about the vaccines, including how they’re faring as millions of doses are administered around the world, new and changing guidance is not surprising.

“The responsible thing to do is to make sure that we get all that information and incorporate that into our decision-making,” she said.

“So definitely, the messaging would be simpler if we had one set of data and we had one message, and it never changed. But that’s not what science does.”

This report by The Canadian Press was first published March 4, 2020.

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