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Human clinical trials begin for Quebec-made COVID-19 vaccine candidate – Airdrie Today

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Canadian trials have just begun for a prospective COVID-19 vaccine but its Quebec-based manufacturer is already tempering expectations.

Bruce Clark, president and CEO of the biopharmaceutical company Medicago, cautions observers against holding unrealistic assumptions that his product — or any of the numerous vaccine hopefuls in development globally — can bring the pandemic to a screeching halt if proven viable.

Clark notes more than 120 companies are trying to come up with a COVID-19 vaccine, many of which have never been in the vaccine space before.

He doesn’t doubt that “something’s going to come out of this,” but he questions how effective it may be.

“Whatever vaccine we get in this first round — unless it’s a miracle — it’s not going to be perfect,” says Clark, whose company began trials for its proposed vaccine Monday in Quebec City.

“It’s going to have to undergo development, it’s going to take probably years to come up with an understanding of the right vaccine, the right approach. It’s not the panacea.

“To assume that we can have, in 18 months, the solution to a pandemic that comes around once in a generation, is naive.”

Canada’s deputy public health officer Dr. Howard Njoo expressed similar cautions Tuesday, while acknowledging the need to develop viable vaccines and therapies.

“Lots of different steps are still ahead of us before we might even anticipate that there might be a safe, effective vaccine that would be available for use in the general population,” said Njoo. 

So much is still unknown about COVID-19, notes Clark, including how it may manifest during the flu season later this year.

He suspects a more likely scenario is that a vaccine will offer only part of the solution, along with new therapeutics and ongoing public health interventions.

Medicago’s first phase of clinical trials will test the safety of a plant-based product on 180 healthy men and women, aged 18 to 55.

The randomized, partially blinded study uses technology that does not involve animal products or live viruses like traditional methods.

Clark notes that vaccine developers typically use chicken eggs to propagate a virus, but Medicago uses recombinant technology involving the genetic sequence of a virus, with living plants as the host.

The resulting virus-like particles mimic the shape and dimensions of a virus, which allows the body to recognize them and spark an immune response.

Clark says the plant-based approach is significantly faster and offers more consistent results than egg-based or cell-based methods.

It’s the same method Medicago has used for a proposed seasonal flu vaccine that Clark says is currently being reviewed by Health Canada. If approved, Clark says it would be the first plant-based vaccine in the world.

While it takes five to six months to propagate a virus in eggs, the plant-based technique requires just five to six weeks, he says.

“In a pandemic, something like COVID, if you’re able to cut that much time off development, you have a substantial impact on public health.”

Meanwhile, Clark says viruses are prone to mutations as they adapt and grow in an egg, which could result in a vaccine that doesn’t exactly match the circulating virus. In contrast, “a plant is a plant,” and that makes production easily scalable.

“One plant behaves like 100,000 plants,” he says.

The trial will evaluate three different dosages alone, or with one of two adjuvants provided by GlaxoSmithKline and Dynavax. An adjuvant can boost the effectiveness of a vaccine for a better immunological response, thereby reducing the required dose, Clark adds.

He hopes to know the safety of the product, as well as effectiveness of the adjuvants and dosing by October. Based on that, researchers would kick off a second, more targeted trial phase involving about 1,000 participants.

If that’s successful, Clark says a third phase would involve about 15,000 to 20,000 subjects, include older cohorts, and may be a global study, depending on circumstances of the pandemic by then.

If the vaccine proves effective, Clark points to another uncertainty.

Because the company’s commercial plant is across the border in Durham, N.C., he says there’s no guarantee of a Canadian supply.

“‘Guarantee’ is a strong word,” says Clark. “Strange things happen to borders in the context of a pandemic.”

Such border complications were made clear to Canadians in April when Prime Minister Justin Trudeau complained about problems with incomplete or non-existent deliveries of critical COVID-19 supplies. At the time, U.S. President Donald Trump ordered U.S. producers to prioritize the domestic market.

Clark suggests similar hurdles could impact vaccine distribution, putting immediate pressure on Medicago to complete construction of a large-scale manufacturing facility in its home base of Quebec City.

“Certainly, we need a facility in Canada,” Clark says.

“There’s no guarantee on the easy flow of materials back and forth across the border should we have a successful vaccine. We have to keep the focus on completing the Canadian facility so that we have domestic capacity. I think this is what most countries are concerned about.” 

By the end of 2023, the Quebec City plant is expected to be able to produce up to one billion doses of a COVID-19 vaccine annually.

Until then, Medicago says it expects to be able to make approximately 100 million doses by the end of 2021, assuming its trials are successful.

Clark says countries must temper any nationalist agendas that might emerge with a viable vaccine and acknowledge that the fight against COVID-19 is global.

Meeting that demand would require multiple manufacturers, multiple distribution routes, and lots of co-operation, he says, possibly through the World Health Organization.

“There has to be some ability to share those around and distribute, whether that’s through an entity like the WHO, or something equivalent.”

This report by The Canadian Press was first published July 14, 2020.

Cassandra Szklarski, The Canadian Press

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Alberta's central zone now has 1101 active COVID-19 cases – Stettler Independent

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The Government of Alberta reported 1,609 new COVID-19 cases on Sunday.

The province now has 15,692 active cases, to go along with 40,219 recovered cases, according to the latest statistics on the government’s website.

Alberta Health Services’ central zone has risen to 1,101 active cases, while the Edmonton zone has 7,230, Calgary has 5,756, the north zone has 857, the south zone has 642 and 223 cases are in an unknown area.

The provincial death toll has risen to 533, which is an increase of nine.

The City of Red Deer currently has 191 active cases, Red Deer County has 61, Sylvan Lake has 48, Lacombe County has 42, Clearwater County has 31, the City of Lacombe has 28, Olds has 21, Mountain View County has 15 and Stettler County has six.

Collectively, Ponoka County and Wetaskiwin County have 349.

“The next few weeks will be hard for all of us in light of the restrictions on social gatherings. I want to thank all of you for doing the right thing and making these sacrifices to help bend the curve,” Alberta’s chief medical officer of healthDr. Deena Hinshaw said on Twitter Sunday.

“While we may be physically separated from each other, I strongly encourage you to reach out to your friends and family and stay connected virtually. We are all in this together – so please reach out to a loved one if you need to.”

Provincially, 435 are in the hospital due to COVID-19 – 95 of those individuals have been admitted into an intensive care unit. In the central zone, 27 people have been hospitalized, five of whom are in intensive care.

In the past 24 hours, 23,282 tests were completed in the province, which brings the total number of tests to 2,234,470.

Hinshaw’s next live update is Monday.



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Red Deer up to 191 active COVID-19 cases – rdnewsnow.com

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Another nine deaths from COVID-19 were reported to bring Alberta’s total to 533.

Red Deer has 191 active cases of COVID-19 as of Sunday, an increase of 20. There have now been 334 recovered cases, an increase of three, as the total number of cases attributed to the city rose by 24 to 525.

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Red Deer County has 64 active cases as of Saturday, an increase of seven, while Sylvan Lake added four to sit with 48.

Lacombe County has 42 active cases, an increase of seven, while Lacombe has 28, also an increase of six.

Clearwater County (Rocky Mtn. House) added 10 more active cases for a total of 31.

Ponoka County added 12 active cases to sit with 250.

Mountain View County holds steady with 15 active cases, Olds added three for a total of 21, and Kneehill County added one for a total of 16. Starland County remains with four and the County of Stettler is up two for a total of six active cases.

There are now 1,101 active cases in the Central zone, an increase of 110, with 27 hospitalizations, including five in intensive care.

“The next few weeks will be hard for all of us in light of the restrictions on social gatherings. I want to thank all of you for doing the right thing and making these sacrifices to help bend the curve,” Dr. Deena Hinshaw, Alberta’s chief medical officer of health, Tweeted on Sunday.

“While we may be physically separated from each other, I strongly encourage you to reach out to your friends and family and stay connected virtually. We are all in this together – so please reach out to a loved one if you need to.”

Hinshaw is scheduled to share her next live update on Monday.

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Top doctor urges Canadians to limit gatherings as ‘deeply concerning’ outbreaks continue – Chemainus Valley Courier

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The country’s top doctor is asking Canadians to limit their contacts and gatherings as COVID-19 cases continue to surge in several provinces.

In a statement released Sunday (Nov. 29), chief medical officer Dr. Theresa Tam said there has been an average of 5,335 new cases daily over the past week, compared to 4,739 daily new cases from Nov. 13-19.

Canada’s active cases currently stand at 63,835, compared to 53,907 a week prior, while the positivity rate has increased from 6.6 per cent to 7.6 per cent. The number of patients in hospital with COVID-19 has increased to 2,111 from Nov. 20 to 26, up from 1,840 the week prior. The number of ICU patients treated daily jumped from 376 to 432 over the same time period, while average daily deaths increased by five to 76.

“More and larger outbreaks are occurring in long term care homes, congregate living settings and hospitals, and spreading in Indigenous communities and more remote areas of the country,” Tam said. “These developments are deeply concerning as they put countless Canadians at risk of life-threatening illness, cause serious disruptions to health services and present significant challenges for areas not adequately equipped to manage complex medical emergencies.”

Tam said that this time period was crucial, as the weather continues to get colder across the country and gathering indoors becomes more tempting.

“Avoid or limit time spent in the 3Cs – closed spaces, crowded places and close-contact settings and situations,” she said, as well as urging people to wear masks, stay home if they are sick and wash their hands frequently.

In total, Canada has reported 370,278 confirmed cases and 12,032 deaths due to COVID-19.

B.C. recorded a record-breaking 911 cases on Friday, the last day of a week that has proven to be its deadliest of the pandemic.

READ MORE: Canada extends COVID restrictions for non-U.S. travellers until Jan. 21 amid second wave


@katslepian

katya.slepian@bpdigital.ca

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