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Feds announce plan to buy 7.9 million rapid COVID tests

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Public Services and Procurement Minister Anita Anand today announced a plan to buy roughly 7.9 million rapid point-of-care COVID-19 tests from U.S.-based Abbott Laboratories.

The purchase is meant to offer other testing options to Canadians at a time when the country’s testing apparatus is being severely strained, with coronavirus caseloads spiking in some regions.

To date, the vast majority of tests have been done at public health clinics, with samples then sent to laboratories for analysis — a process that can take days.

A point-of-care test could be administered by trained professionals in other settings. The molecular test Canada is looking to buy — the ID NOW — can produce results from a nasal swab in as little as 13 minutes.

While Canada has announced this purchase from a well-regarded U.S. firm, the test itself has not yet been approved by Health Canada for distribution.

Proactive purchasing

“As with many of our agreements for equipment, tests and vaccines, we have pursued an advanced purchase agreement to secure Canada’s access to these tests conditional on Health Canada’s regulatory approval,” Anand said.

“These rapid tests will aid in meeting the urgent demands from provinces and territories to test Canadians and reduce wait time for results, which is key to reducing the spread of the virus.”

The U.S. Food and Drug Administration (FDA) first issued an emergency use authorization (EUA) to Abbott for the ID NOW device in March.

Since then, some researchers have said the device has led to false positives in a small number of cases. The FDA re-issued a revised EUA on Sept. 18, saying that the test should be administered within the first seven days of the onset of symptoms.

Anand said that, beyond the Abbott deal, Canada will proactively purchase other rapid tests in bulk to supply the country.

With tens of thousands of tests being done each day, the demand is high.

The announcement comes as Health Canada bureaucrats in charge of regulating new testing devices are defending the government’s response to this point.

 

A lab technician dips a sample into the Abbott Laboratories ID Now testing machine at the Detroit Health Center in Detroit. Illinois-based Abbott Laboratories says its test delivers results within minutes. (Carlos Osorio/AP Photo)

 

Health experts — including Dr. David Naylor, the co-chair of the federal government’s COVID-19 task force — have for weeks been urging regulators to approve rapid testing to take the pressure off testing centres.

While other major Western countries such as the U.S. have authorized a number of point-of-care tests, Health Canada regulators have been slow to give the necessary approvals to deploy these devices.

Regulators approved Cepheid’s Xpert Xpress SARS-CoV-2 device in late March, a test that can be used in both lab and point of care settings.

The next approval for a point-of-care device — one that could be used in a doctor’s office or a walk-in clinic — only came last week.

On Sept. 23, Health Canada approved for use in Canada the Hyris bCube — a portable device that its Guelph, Ont.-based distributor says can be used “wherever people are — anytime, anywhere.”

The regulator hasn’t yet approved any antigen tests — a different form of testing that can be easily deployed to high-risk workplaces and schools to help identify positive COVID-19 cases.

In fact, Health Canada only posted guidance for antigen device manufacturers to its website today, seven months into the pandemic.

The antigen tests — which, depending on the device, use matter collected from a nasal or throat swab — don’t require the use of a lab to generate results.

While much faster, these tests are considered by some to be less accurate than the “gold standard” — the polymerase chain reaction (PCR) testing process currently in use across Canada.

 

U.S. President Donald Trump opens a box containing the ID NOW testing device during a coronavirus briefing at the White House in March. (Alex Brandon/AP Photo)

 

Antigen testing devices like Quidel Corporation’s Sofia 2 SARS, which received emergency authorization from the U.S. FDA in May, can produce results in less than 20 minutes. As of Tuesday, Quidel’s device was listed as “under review” by Health Canada.

Antigen tests have been used in thousands of U.S. long-term care homes for months.

Speaking to reporters on teleconference about Health Canada’s progress, Dr. Supriya Sharma, senior medical adviser to the department’s deputy minister, said she doesn’t think the authorization process has been slow to this point.

She said Canada’s regulatory regime is different from what’s in place in the U.S. and the department has been focused on approving lab-based PCR testing devices.

“I don’t think we’re slow. We’ve got staff working flat out,” she said. “There’s no file sitting on anyone’s desk not being looked at.”

Sharma said it’s difficult to state exactly when the Abbott test or an antigen test will be approved for use in Canada.

“Antigen testing is our number one priority and we are doing everything that we can to review these tests to ensure they are available to Canadians,” she said.

“We have increased the efficiency and we’re streamlining those review processes. We’re committed to getting a company a decision within 40 days,” she said, adding that the pre-pandemic process often would take months to complete.

She said regulators will not be rushed, citing the risk of approving a faulty test that tells people they’re clear of COVID-19 when they’re actually infected.

“A test that doesn’t meet this criteria could have devastating consequences for Canadians,” Sharma said.

When asked if the department was reluctant to approve new devices because of past missteps, Sharma conceded Health Canada’s early decision to authorize a device from Ottawa-based Spartan Bioscience — a test that later proved faulty — resulted in some “lessons learned” for regulators. In May, the National Microbiology Lab found problems with the test that made it unreliable.

While Canadian regulators have not yet given the green light, the World Health Organization (WHO) announced on Monday a plan to send 120 million COVID-19 antigen tests to low- and middle-income countries over the next six months to dramatically expand access to testing in places where PCR isn’t viable due to limited laboratory capacity.

The WHO touted these tests as “highly portable, reliable and easy to administer, making testing possible in near-person, decentralized healthcare settings.”

“High-quality rapid tests show us where the virus is hiding, which is key to quickly tracing and isolating contacts and breaking the chains of transmission,” Dr. Tedros Adhanom Ghebreyesus, the director general of the WHO, said in announcing the plan.

“The tests are a critical tool for governments as they look to reopen economies and ultimately save both lives and livelihoods.”

Asked about the WHO plan after a meeting with UN officials, Prime Minister Justin Trudeau told reporters Canada would rely on its own scientists to determine which devices should be used here at home.

 

 

Prime Minister Justin Trudeau appeared in a United Nations video conference on the COVID-19 crisis 0:47

“As much as we’d love to see those tests as quickly as possible, we’re not going to tell our scientists how to do their job and do that work. We are, however, ensuring that as soon as those approvals happen, we are ready to deliver these tests across the country,” he said.

Raywat Deonandan, an associate professor at the University of Ottawa and an expert in epidemiology, said that while antigen tests can be less sensitive than PCR tests, they can be useful for “reassurance” purposes.

“If someone needs a negative test to go back to work, we’ll use this,” Deonandan said in an interview.

“We need more creative tools on the table and this is one creative tool — again, with the caveat that it matters entirely how you use it, where you use it and by whom,” he said, adding that he believes antigen tests shouldn’t be a primary diagnostic tool.

While antigen tests can be less accurate, they’re also cheap to produce and easy to administer. That means they can be used multiple times to ensure a more accurate reading — not unlike a home pregnancy test.

“The advantage of these types of tests is that you can do them frequently,” said Ashleigh Tuite, an assistant professor at the University of Toronto and an infectious disease researcher.

“You could do it the day that you were going to visit the person who you cared about and it would basically tell you at that point in time, are you infectious? That’s incredibly powerful information.

“It just makes common sense — use every tool you have.”

Source:cbc.ca

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The latest news on COVID-19 developments in Canada – CityNews Toronto

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The latest news on COVID-19 developments in Canada (all times Eastern):

11:15 a.m.

Ontario is reporting 827 new cases of COVID-19 today, and four new deaths due to the virus.

Health Minister Christine Elliott says 355 cases are in Toronto, 169 in Peel Region, 89 in York Region and 58 in Ottawa.

The province has conducted 23,945 tests since the last daily report, with an additional 22,636 being processed.

In total, 312 people are hospitalized in Ontario due to COVID-19, including 75 in intensive care.

11:10 a.m.

Quebec is reporting 963 new cases of COVID-19 and 19 more deaths linked to the novel coronavirus.

The Health Department said today four of the deaths were reported in the past 24 hours, 14 date back to last week and one death was from an unknown date.

The number of patients in hospital declined by 16 to 527 while the number of intensive-care patients dropped by two to 91.

Quebec has reported a total of 101,885 COVID-19 cases and 6,172 deaths linked to the virus since the beginning of the pandemic.

10:55 a.m.

Nova Scotia is reporting one new case of COVID-19.

Health officials say the case is in the central health zone, which includes Halifax, and is related to travel outside the Atlantic region.

The province has six active cases of novel coronavirus.

In total, Nova Scotia has confirmed 1,102 cases, while 1,031 cases have been resolved and there have been 65 deaths.

This report by The Canadian Press was first published Oct. 27, 2020.

The Canadian Press

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Trudeau says pandemic 'sucks' as COVID-19 compliance slips and cases spike – CBC.ca

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Prime Minister Justin Trudeau said today he understands that Canadians are increasingly frustrated by “annoying” measures designed to curb the spread of COVID-19, but he’s urging people to stay the course as cases continue to climb in some parts of the country.

Canada is in the grips of a second pandemic wave. Some provinces — notably Alberta, B.C., Ontario, Manitoba and Quebec — are now seeing case counts larger than those reported in the spring, at the onset of the pandemic.

“This sucks, it really, really does,” Trudeau told a COVID-19 press briefing this morning. “It’s going to be a tough winter. It’s easy for us to want to throw up our hands … it’s frustrating to have to go through this situation.

“Nobody wanted 2020 to be this way, but we do get to control how bad it gets by all of us doing our part.”

Trudeau said Canadians must get this latest pandemic wave under control or risk putting their Christmas festivities in jeopardy.

“Unless we’re really, really careful, there may not be the kinds of family gatherings we want to have at Christmas,” he said.

After a summer lull, the death count in Canada has also started to climb. Hospitalizations and the number of people in intensive care units (ICUs) remain at manageable levels in most regions, despite the cresting caseload.

Some Toronto-area hospitals are nearing 100 per cent capacity as they grapple with both COVID-19 cases and other patients.

Data indicates that younger, healthier people — who are more likely to recover without medical intervention — are driving the COVID-19 spike during this round of the pandemic.

Dr. Howard Njoo, the deputy chief public health officer, said there’s no doubt that Canadians are tired of the restrictions that have upended their social and economic lives for the better part of eight months.

“What we’re seeing around the world is people are suffering from COVID fatigue,” Njoo said.

Another full lockdown is not necessary at this point, he said.

“We want to get back to as normal as possible, the functioning of society,” he said, adding Canada needs to find the “sweet spot” where new cases of COVID-19 don’t threaten to overwhelm the health care system.

Asked if governments bear any responsibility for conflicting messages from federal and provincial leaders and local public health officials about how Canadians should go about their daily lives during the pandemic, Trudeau said the situation on the ground in the provinces and territories varies greatly and does not demand national uniformity.

WATCH: Trudeau questioned about public confusion over pandemic messaging

Prime Minister Justin Trudeau spoke at the bi-weekly pandemic briefing in Ottawa on Tuesday. 2:34

Trudeau said Ottawa is not intent on plunging the country into another shutdown — and the country is better equipped to handle this wave than it was in March and April.

“We have a better understanding of COVID-19. We have better tools to deal with COVID-19 and we can be a little more targeted but, yeah, that means a little more complication in our messages,” Trudeau said.

“It’s frustrating to see friends at the other end of the country doing things you’d love to be able to do but you can’t.”

Trudeau said that when his six-year-old son Hadrien recently asked him if COVID-19 would with us “forever,” he assured him the pandemic  would end — but its impact will depend on Canadians doing their part in the short term by wearing masks wherever possible, keeping a two-metre distance from others and avoiding large social gatherings altogether.

“We need to do the right thing, we need to lean on each other, we need to use all the tools that we can,” he said.

Trudeau sounded a positive note today, too, saying that Canada has placed orders for tens of millions of possible vaccine candidates. He said pharmaceutical companies are developing promising treatments.

“Vaccines are on the horizon. Spring and summer will come and they will be better than this winter,” he said.

All told, the federal government has secured 358 million doses of COVID-19 vaccines — an insurance policy if some of the vaccines in development prove to be ineffective in clinical trials.

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Coronavirus: What's happening in Canada and around the world Tuesday – CBC.ca

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The latest:

People in British Columbia and Alberta’s two largest cities are facing tighter restrictions around some social gatherings after an uptick in COVID-19 cases.

Alberta’s Chief Medical Officer of Health Dr. Deena Hinshaw said Monday that while she has often spoken about the need to “balance between minimizing the risk of COVID-19 and minimizing the risk of harms of restrictions,” the province is now “losing the balance we have been seeking.”

The temporary measure, which caps attendance at 15 for events where people will be “mixing and mingling” like parties and baby showers, applies in the Calgary and Edmonton areas.

Alberta has reported a total of 25,733 cases since the pandemic began, with 4,477 of those listed as active cases. As of Sunday, health officials reported 118 people were being treated in Alberta hospitals, with 16 of those patients in ICU beds. 

Dr. Bonnie Henry, provincial health officer in British Columbia, also placed restrictions on gatherings on Monday, with a focus on events in people’s homes. Henry said gatherings are now limited to people in an immediate household, plus their so-called “safe six” guests.

WATCH | Dr. Bonnie Henry said mask-wearing is expected in public in B.C.:

B.C.’s provincial health officer says British Columbians must wear non-medical masks in public, but stopped short of making them mandatory. 2:13

“This is a bit of a sobering weekend for us,” she said after provincial health officials reported 817 new cases since Friday.

B.C. has reported a total of 13,371 COVID-19 cases since the pandemic began, with 2,325 of the cases considered active. The most recent information from health officials said 77 people were in hospital with 26 in intensive care.


What’s happening across Canada

As of 7 a.m. ET on Tuesday, Canada had 220,213 confirmed or presumptive coronavirus cases. Provinces and territories listed 184,303 of those as recovered or resolved. A CBC News tally of deaths based on provincial reports, regional health information and CBC’s reporting stood at 9,973.

Manitoba’s provincial public health officer also urged people to avoid gathering in large groups, saying many of the 100 new cases reported in the province on Monday linked back to social gatherings — including Thanksgiving.

Dr. Brent Roussin said if the province’s trajectory continues, health officials expect to have a total of more than 5,000 cases by the end of the week. The province had 4,349 cases as of Monday, with 2,117 considered active. There were 80 people in hospital, with 15 in intensive care.

WATCH | Manitoba frustrated by rise in COVID-19 cases:

As Manitoba sees a continued increase in COVID-19 cases, it’s seeing an unprecedented surge in its hospitals and ICUs. As pressure to close parts of the province mounts — officials are pointing fingers and doctors are bracing for the worst. 1:55

Roussin wasn’t the only Manitoba official with words of warning. Premier Brian Pallister expressed frustration on Monday at people with too many close contacts as cases increase.

“Grow up and stop going out there and giving people COVID,” the premier said. 

Saskatchewan reported 54 new COVID-19 cases on Monday, bringing the total number of reported cases in the province to 2,783, with 650 of those considered active cases.

In Ontario, a region west of Toronto is waiting for word on whether tougher measures will be imposed by the province as part of the effort to fight COVID-19. Dr. David Williams, the province’s chief medical officer, said while neither he nor Halton Region’s local medical officer are ready to make a decision on tighter measures for the area, they will be watching case counts and other metrics closely in the coming days.

Quebec Premier François Legault moved Monday to extend restrictions on people living in so-called red zones until Nov. 23, saying daily COVID-19 case numbers and deaths are still too high to allow an easing of limits in places like Montreal and Quebec City.

WATCH | How health authorities are trying to balance restrictions and COVID-19 caseloads:

Infectious disease physician Dr. Zain Chagla discusses how health officials try to balance restrictions and COVID-19 case loads when the data doesn’t show up for weeks after a decision is made. 1:35

In Atlantic Canada, New Brunswick reported three new cases on Monday, bringing the total number of active cases in the province to 60. Health officials in both Nova Scotia and Newfoundland reported one new case, while there were no new cases reported in Prince Edward Island.

There were two new cases reported in Yukon on Monday, and a mine in Nunavut reported that two workers who had been reported as presumptive cases were confirmed as positive for COVID-19. The workers were flown to their home province of Quebec and instructed to self-isolate.


What’s happening around the world

Several potential COVID-19 vaccines are seeing early results from Phase 3 trials, with AstraZeneca saying its has shown results in older and younger participants. Meanwhile, Moderna is so positive about its results it has applied to make its vaccine available earlier. 2:07

A case count maintained by Johns Hopkins University put the number of COVID-19 cases around the world at over 43.5 million as of Tuesday morning with over 29.2 million cases considered recovered. The Baltimore, Md.-based institution’s count of deaths stood at more than 1.1 million. 

In the Americas, the number of hospitalized COVID-19 patients in the United States is at a two-month high, straining health-care systems in some states.

The White House said on Tuesday it saw a potential deal on COVID-19 stimulus funding in “coming weeks,” casting doubt on whether a deal could be struck with Congress before the Nov. 3 election. A spokesperson for Democratic House Speaker Nancy Pelosi said Monday that she was hopeful an agreement could be reached ahead of the election, but noted that there were still major issues that needed to be addressed.

Amid the COVID-19 pandemic, people vote in the U.S. presidential election in the Jurassic Parking structure at Universal Studios Hollywood in Universal City, Calif., on Monday. (Mario Anzuoni/Reuters)

In the Asia-Pacific region, China reported the highest number of asymptomatic infections in nearly seven months. China detected 137 new asymptomatic coronavirus cases on Sunday in Kashgar in the northwestern region of Xinjiang after one person was found to have the virus the previous day — the first local new cases in 10 days in mainland China.

Hong Kong announced it would reopen public beaches and increase the number of people allowed to sit together in bars and restaurants starting Friday as the city continues to unwind strict COVID-19 rules put in place in July.

In India, authorities reported 36,470 newly confirmed coronavirus infections. That’s the lowest one-day tally in more than three months in a continuing downward trend. In its report Tuesday, the country’s health ministry also listed 488 new fatalities from COVID-19 in the previous 24 hours, raising the overall death toll to 119,502.

The case number reported Tuesday is the lowest since India had 35,065 newly confirmed infections on July 17. Last month, the country hit a peak of nearly 100,000 cases in a single day, but daily infections have been decreasing since then.

In Europe, many governments prepared on Tuesday to introduce new restrictions to try to curb a growing surge of coronavirus infections across the continent and provide economic balm to help businesses survive the pandemic. 

Italian police officers stand in front of a shattered Gucci store window during a protest of far-right activists against measures to curb the spread of COVID-19, in downtown Turin on Monday. (Marco Bertorello/AFP/Getty Images)

Hundreds of protesters took to the streets across Italy on Monday to vent their anger at the latest round of restrictions, including early closing for bars and restaurants, with demonstrations in some cities turning violent.

In neighbouring France, Interior Minister Gerald Darmanin warned the country to prepare for “difficult decisions” after some of the strictest restrictions currently in place anywhere in Europe have failed to halt the spread of the disease.

South Africa remained the hardest hit country in Africa, with more than 716,000 recorded COVID-19 cases and more than 19,000 deaths according to the Africa CDC.

People in Iran, the hardest-hit country in the Middle East, faced new daily records of infections and deaths. Authorities have ordered residents in Tehran to wear masks in public, and many public sector workers in the capital have been told to stay home every second day.

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