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The hunt for a vaccine: Canadian company begins human testing of COVID-19 candidate – CTV News

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TORONTO —
A Quebec City biopharmaceutical company began clinical trials on humans on Monday for a plant-derived COVID-19 vaccine.

Medicago is the first Canadian company to administer doses of a potential vaccine to volunteers, 180 men and women aged 18 to 55 who will receive two doses 21 days apart. The company expects to have safety and efficacy results for the two doses in October.

“(The) timeline is very aggressive and in fact we’re trying to do in 18 months what normally requires five to six years,” Nathalie Landry, executive vice-president of scientific and medical affairs at Medicago, told CTV News medical correspondent Avis Favaro.

“It’s a race. It is a race to find treatments to be able to vaccinate the population so we can get this COVID-19 under control.”

Unlike traditional vaccine development, Medicago does not use animal products or live viruses to create its products. The company says it uses “virus-like particles (VLPs) that mimic the shape and dimensions of a virus, which allows the body to recognize them and create an immune response in a non-infectious way.”

The company announced on March 12 that it had produced a VLP vaccine, 20 days after obtaining the SARS-CoV-2 gene that is responsible for COVID-19. It said in a news release at the time that it was collaborating with Laval University’s Infectious Disease Research Centre headed by Dr. Gary Kobinger, who helped develop a vaccine and treatment for Ebola.

Medicago says its clinical trial data in developing an influenza vaccine, which is now being reviewed for approval by Health Canada, along with its research into an H1N1 vaccine, shows that “VLPs have a multi-modal mechanism of action that is different from that of inactivated vaccines, activating both arms of the immune system – antibody and cell-mediated responses.”

Landry says its COVID-19 vaccine candidate stimulated a “very high neutralizing antibody response” in mice, along with activating the body’s T-cells, a major component of the immune system.

At least two other vaccine developers are expected to enter candidates into clinical trials in Canada soon.

According to Health Canada’s list of authorized clinical trials to investigate drug treatments and vaccines for the novel coronavirus, Medicago got approval to move forward with Phase 1 clinical trials July 9. 

Health Canada has authorized only two potential vaccines to go to clinical trials in this country so far. The other and the first, Ad5-nCoV that was developed by CanSino Biologics and Chinese government scientists, was to be tested in clinical trials conducted by the Canadian Center for Vaccinology (CCV) at Dalhousie University in Halifax.

Health Canada approval came through May 15 and clinical trials were to begin within weeks, but the CCV is now indicating they have been held up because the Chinese government has not approved sending the vaccine candidate to Canada. 

Edmonton-based biotechnology firm Entos Pharmaceuticals is working on a relatively new kind of treatment known as a DNA vaccine. Unlike other vaccines, which prompt a body to develop an immunity to a disease, DNA vaccines inject pieces of DNA code into cells, directly instructing them to produce an antibody that stops the virus.

Entos says it has developed two potential “pan-coronavirus” vaccines.

In a June 25 press release, company CEO John Lewis said preclinical results showed the company’s candidates “have the potential to be safe and highly potent vaccines that will provide protection against COVID-19 as well as future coronavirus threats.”

Lewis, a cancer researcher at the University of Alberta, confirmed to CTV News that Entos is on track to begin its clinical trials beginning with 70 to 75 volunteers in August. Entos has partnered with the CCV to carry out the human clinical trials and says it aims to develop a safe and effective vaccine for COVID-19 in one year.

Medicago is evaluating three dosage levels of the vaccine, both alone and in conjunction with two already-approved adjuvants.

“An adjuvant can be of particular importance in a pandemic situation as it may boost the immune response and reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and therefore contributing to protect the greatest number of people,” the company said in a news release.

Medicago, named after the Latin word for alfalfa, has its origins in a partnership between Agriculture Canada and Laval University. It was incorporated in 1999, went public in 2006, and was acquired by majority shareholder Mitsubishi Tanabe Pharmaceutical Corp. in 2013. It employs 450 people in Canada and the United States.

The Quebec government has invested $7 million in Medicago’s COVID-19 vaccine development and the company is also the recipient of funding through the Government of Canada’s $192-million COVID-19 research fund.

Landry says Medicago believes it is among the first 20 vaccines to move into clinical trial in the world, among an estimated 150 that are under development.

No one vaccine will provide a global solution to the pandemic, she says, because no manufacturer can produce enough to vaccinate the world’s population and no one formulation will protect everyone from infants to the elderly.

“We need multiple solutions to make sure that we can protect the population in general, with the most effective vaccine,” she said.

Another Canadian company, IMV, tells CTVNews that it plans to begin human tests later this month of a vaccine, called DPX-COVID-19, that officials say may work well in the elderly and those with immune disorders, two high-risk groups.

The tests will be conducted in healthy adults aged 18 to 84. Two dose levels of DPX-COVID-19 will be tested.

Andrew McArthur, an associate professor in biochemistry and biomedical sciences at McMaster University in Hamilton, Ont., says the Canadian pharmaceutical industry is contributing to “a shotgun approach” to finding answers to the pandemic.

He says the key is many different researchers trying many different solutions with the hope “a handful of them will light and do the job.”

“The more the merrier because it just increases our odds that we’ll get a viable vaccine.”

McArthur, who is lead on a lab that develops biological databases and undertakes genomic sequencing, says constant sequencing of the novel coronavirus shows it isn’t changing, meaning what researchers are working on for a vaccine is a “viable target” and improves the odds that it could work long term.

That makes it different from the influenza virus, which mutates rapidly, requiring a new vaccine each year.

Medicago says it expects to be able to manufacture 100 million doses of a COVID-19 vaccine by the end of 2021 in its facility in North Carolina, and another 10 million in a pilot facility in Quebec City. But when the company completes a new manufacturing centre in Quebec City in 2023, it anticipates annual manufacturing capacity of up to 1 billion doses.

Landry says the company is in discussions about distribution with several governments but nothing is official. She said the “expectation” is that if a deal is reached with the Canadian government that it would reserve doses for the Canadian population.

McArthur cautions there is a range of possible outcomes in the hunt for a vaccine. Scientists might be unsuccessful in developing one that effectively wards off COVID-19, but they might also zero in on one that is so effective it provides life-time immunity.

Or the reality could land somewhere in the middle: with a vaccine formulation that requires a booster every six months.

McArthur says all the global capacity in vaccine development that’s being built now is aimed at this pandemic, but will certainly help in the fight in the next one to come.

Canadian researchers are now “starting a massive national sequencing effort” to track every COVID-19 case, to figure out each genome and understand how it moved around, says McArthur. That is going to help prepare for and control future outbreaks of this virus and viruses yet to emerge. 

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TD posts big Q4 beat as provisions sink, wholesale profit triples – BNN

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Toronto-Dominion Bank closed out earnings season for Canada’s Big Six lenders on Thursday on the same note as its rivals: a big profit beat driven in part by spectacular growth in capital markets and far less cash set aside for loans that could go bad.

TD’s net income for the three months ending Oct. 31 totalled $5.1 billion, compared to $2.9 billion a year earlier, amid a $2.3-billion gain stemming from the stake it held in TD Ameritrade prior to the brokerage’s takeover by The Charles Schwab Corp.

On an adjusted basis, TD earned $1.60 per share in the fiscal fourth quarter. Analysts were expecting $1.27 in adjusted profit.

The bank booked $917 million in provisions for credit loss in the quarter, compared to $2.2 billion in the previous quarter and $3.2 billion in the fiscal second quarter.

“TD delivered solid results in the fourth quarter, capping off a year that demonstrated the strength of our business model and balance sheet, and the resilience of our people throughout the unprecedented COVID-19 pandemic,” said TD CEO Bharat Masrani in a release.

“While 2020 was not the year we expected it to be, we learned from the experience and demonstrated the speed and agility of our organization,” he added. “We will continue to adapt to the current environment to deliver for all of our stakeholders and support an inclusive and sustainable recovery.”

TD’s capital markets operations saw profit more than triple from a year earlier as net income reached $486 million in the final quarter of 2020.  The bank attributed the growth to higher revenue from trading activities as well as a jump in debt underwriting fees. The profit growth for the division stands in stark contrast to its condition less than two years ago when it posted a surprise loss in the first quarter of 2019.

The bank’s bread-and-butter retail operations in Canada were a pillar of strength in the fiscal fourth quarter as profit rose three per cent year-over-year to $1.8 billion.

TD’s operations south of the border struggled in the quarter, as profit from U.S. retail banking slid 41 per cent year-over-year to US$403 million. The decline came amid an uptick in provisions for credit losses and as income from fees and lending margins came under pressure.

Programming note: Don’t miss BNN Bloomberg’s conversation with TD CEO Bharat Masrani Friday, Dec. 4 at 2 p.m. ET / 11 a.m. PT.

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Gold price ignores better-than-expected U.S. weekly jobless claims data – Kitco NEWS

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(Kitco News) –    The gold market is holding on to strong gains for the third straight session even as fewer American workers apply for first time weekly unemployment benefits.

Thursday the U.S. Labor Department said that weekly jobless claims fell by 75,000 to 712,000, down from the previous week’s revised estimate of 787,000 claims.

The latest labor market data beat economists’ estimates as consensus forecasts called for initial claims to be round 775,000.

The gold market is seeing little reaction to the latest economic report as it continues to see strong technical buying after November’s dismal performance. February gold futures last traded at $1,841.50 an ounce, up 0.62% on the day.

After bouncing off critical support below $1,800, gold prices have rallied 3.5% in the first three days of December.

The four-week moving average for new claims – often viewed as a more reliable measure of the labor market since it flattens week-to-week volatility – fell to 739,500, down by 11,250 claims from the previous week.

Continuing jobless claims, which represent the number of people already receiving benefits, were at 5.52 million during the week ending Nov. 21, down by 569,000 from the previous week.

According to some economists, markets are taking the latest labor market data with a grain of salt as they wait for Friday’s nonfarm payrolls report for October. According to consensus forecasts, economists are expecting that 500,000 jobs were created in November.

However, downside risks for the labor market are growing after private payrolls processing company ADP reported, Wednesday, weaker than expected job growth last month.

ADP said that 307,000 jobs were created, well below consensus forecasts calling for gains of around 433,000 jobs.

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Stock market news live updates: Stocks hold near record levels after jobless claims top estimates – Yahoo Canada Finance

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The Canadian Press

Ho, ho – Whoa! Virus keeping most Santas at a distance

MIAMI — Brad Six becomes Santa Claus, pulling his black boots over his red pants in the office of a Miami outdoor supply company. It’s hot, so he forgoes the traditional heavy jacket for a lightweight vest and grabs his Santa hat.But before sliding it on, the gray-bearded 61-year-old dons a plastic face shield and then takes his chair positioned behind a plexiglass sheet.”Getting paid is nice, but to get your battery recharged and to really get something lasting out of it requires interacting with the kids — you don’t get a lot of that this year,” said Six, who first portrayed Santa 35 years ago.This is Santa Claus in the Coronavirus Age, where visits are conducted with layers of protection or online. Putting hundreds of kids daily onto Santa’s lap to talk into his face — that’s not happening for most. The physical attributes that make the perfect Santa align perfectly with those that make COVID-19 especially deadly.“Most of us tick all the boxes: We are old, we are overweight, we have diabetes and if we don’t have diabetes, we have heart disease,” said Stephen Arnold, the president of IBRBS, an association formerly known as the International Brotherhood of Real Bearded Santas.That has spurred creativity in Santa’s workshops. Santas conducting in-person visits are using some combination of masks, the outdoors, barriers and distance for safety. Others are doing virtual visits, where children chat with Santa online for prices typically ranging from $20 to $100, depending on the length and extras, such as whether customers want a recording. Some Santas are taking the season off.“Santa safety is our No. 1 concern” and negotiated into every contract, said Mitch Allen, president of HireSanta, one of the nation’s largest agencies. He said the pandemic initially dried up his business, but it bounced back, especially online.The average Santa makes $5,000 to $10,000 during a normal season, Allen said. That’s a welcome bonus for men often retired on a fixed income, but many Santas say revenue is down as corporate parties and other lucrative gigs evaporated.Jac Grimes, a Santa in Greensboro, North Carolina, gave up home visits, about a third of his business. He did it not just for his own health, but to prevent becoming a superspreader, fearing he’d pass the virus from one family to the next.At a farmers market he annually works, Grimes and his wife dress up as Santa and Mrs. Claus and sit in a parking lot where they to talk to people who remain inside their cars. Some homeowners associations are moving their annual Santa-visitation parties outdoors; Grimes will arrive in his red convertible to greet the crowds from afar.One of the hardest adjustments Santas have made is wearing masks that hide their painstakingly grown beards.“Santa performers are fairly vain people — if they are good,” Grimes said.The virus has many Santas and parents turning to virtual visits, which are booked through each Santa’s personal website or agencies like Allen’s. That often has Santas turning to their children and others for help mastering the computer skills needed.“It has been a challenge,” said Christopher Saunders, a Santa performer in Tool, Texas, a small town near Dallas.But Saunders and others say virtual sessions are a good if imperfect substitute for in-person visits. Parents fill out questionnaires, allowing performers to personalize their patter, and a side benefit is that the sessions aren’t rushed. Many Santa mall visits last no more than two minutes to keep the line moving.“You get a different energy,” Saunders said of the virtual visits. “You can see the child’s expressions, as pure as they are.”Jim Beidel, a Santa performer near Seattle, said knowing the children’s personal stories, such as their friends and school, helps Santas sell their Christmas magic.“It really enhances the engagement, the suspension of disbelief, especially among the older children,” he said.But even Santas with the best gigs are hurting. Howard Graham usually portrays Santa in the grand foyer of New York’s Radio City Music Hall during its Christmas show featuring the Rockettes. That’s gone, so he’s doing virtual visits and five days with a historic railroad in Pennsylvania. Still, he’s taking a financial and emotional hit.“I love what I do … bringing them (children) a little bit of smiles and hope,” said Graham, who has played Santa at Radio City for eight years. “I am going to do what I can not to change that.”That was also Six’s goal as he settled recently into Santa’s throne for a three-hour shift at Miami’s Bass Pro Shops.As families sat in front of the plexiglass for photos, Six tilted his head so his face shield didn’t reflect the camera’s flash. He cheerfully waved children around the plexiglass so they could tell him their wish list, keeping them 6 feet (1.8 metres) back. As he wished them a Merry Christmas, an elf swooped in with disinfectant, wiping the plexiglass and bench before the next group sat.Six said the arrangement is “a little easier physically on Santa’s back because he doesn’t have to pick anybody up, but it’s not as enjoyable because Santa doesn’t get the interaction he normally gets.”But for families, sitting with Santa, even if behind a shield, is a bit of normalcy in abnormal times.Paul and Sarah Morris and their children, 5-year-old Theo and Sophy, 4, were among the first to visit Six that night. An Air Force family visiting from Hawaii, the Morrises cajoled their children into hugging for their photo. “Stop wiggling,” Theo said, scolding his sister before each sibling told Santa their Christmas wish. Sophy wanted candy; Theo, a remote control Ford Mustang.“This is definitely different,” Sarah Morris said of the setup, “but the kids are excited and that’s what matters.”Terry Spencer, The Associated Press

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