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Human clinical trials begin for Quebec-made COVID-19 vaccine candidate – Humboldt Journal

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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.

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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.

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Manitoba extends state of emergency by 30 days – CTV News Winnipeg

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WINNIPEG —
The provincial government announced on Friday it would be extending Manitoba’s state of emergency by another 30 days.

The extension will take place on Sunday, December 6 at 4 p.m.

“Our province is constantly adapting to this evolving situation and taking the necessary steps to help flatten the curve and reduce the spread of COVID-19 in our communities and our health-care system,” said Infrastructure Minister Ron Schuler in a news release. “Manitobans need to work together to protect their families, friends and themselves.”

Manitoba first entered a state of emergency on March 20. Since then, the province has extended it eight times.

The news comes after Chief Provincial Public Health Office Dr. Brent Roussin announced another 320 new cases of COVID-19 and nine new deaths.

So far, 18,069 Manitobans have been infected with COVID-19—9,172 cases are considered active, leaving 8,535 people listed as recovered, although this figure could be higher due to a backlog in data entry.  

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B.C.'s top doctor says be festive but with your own household to avoid COVID-19 – Times Colonist

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VICTORIA — British Columbia’s top doctor and the health minister are urging the public to slow the spread of COVID-19 this weekend by limiting any festive gatherings to immediate households.

Dr. Bonnie Henry and Adrian Dix say 711 new infections have been recorded in the province and 11 more people have died, for a total of 492 fatalities.

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They say in a joint statement that B.C. is continuing to see a significant surge in community transmission so all public health orders must be followed as more than 36,000 people have tested positive for the virus.

Henry has said it’s important to remain vigilant in containing the virus for the next few months and that everyone in the province who wants to be vaccinated could be immunized by September.

Nearly 11,000 people who have been identified as being exposed to the virus are being monitored and 25,658 people who tested positive have recovered.

The latest public health orders have meant the cancellation of adult indoor and outdoor team sports, though children can continue participating in local games without spectators.

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

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Alberta's COVID-19 testing positivity rate hits 'grim milestone' at more than 10 per cent – CBC.ca

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On a day that Alberta reported 18,243 active cases of COVID-19 and 15 additional deaths, the province also reported a record high test positivity rate.

The positivity rate climbed to 10.5 per cent, a “grim milestone and one that should concern us all,” Dr. Deena Hinshaw, Alberta’s chief medical officer of health, told a news conference Friday.

With almost 17,200 people tested, and one of every 10 testing positive, the total number of new cases in Alberta reached 1,828.

To date 590 people have died in Alberta. As of Friday there were a record 533 people in hospital, including 99 in intensive care.

“We are heading into the first weekend of December,” Hinshaw said. “In a difficult year, I know this last month may be the toughest for many. This virus can spread quickly from one to many.

“In a month usually marked by festive gatherings, we feel the restrictions more keenly. But I want to stress the seriousness of the rising case numbers that we’re seeing and how crucial it is that we reduce the spread and bend the curve back down.”

Here is how the active cases break down among the regions:

  • Edmonton zone: 8,578 cases
  • Calgary zone: 6,666 cases
  • Central zone: 1,251 cases
  • North zone: 1,012 cases
  • South zone: 630 cases
  • Unknown: 106 cases

7 deaths at care home in Edmonton’s Chinatown

The 15 deaths reported Friday included seven people linked to an outbreak at the Edmonton Chinatown Care Centre: four men in their 90s, a woman in her 90s, a man in his 80s and a man in his 100s.

Other deaths reported Friday:

  • A woman in her 70s linked to the outbreak at Clifton Manor in Calgary.
  • A man in his 80s linked to the outbreak at Capital Care Lynnwood in Edmonton.
  • A man in his 70s from the Edmonton zone.
  • Two men in their 60s from the Edmonton zone.
  • A man in his 50s from the Edmonton zone.
  • A woman in her 70s from the Central zone.
  • A woman in her 90s from the Calgary zone.

Contact tracing getting help

Dr. Verna Yiu, president and CEO of Alberta Health Services, told the news conference AHS is working to bolster its troubled contact-tracing system.

“As case numbers have increased exponentially in the past six weeks it has become more and more difficult for our teams to keep up with demand,” Yiu said.

“We are rapidly increasing our response to the unprecedented volume of COVID-19 cases in the province.”

WATCH | Alberta to ramp up contact tracing efforts:

A desperate shortfall of COVID-19 contact tracers is one of the staffing challenges plaguing Alberta, says AHS president and CEO Dr. Verna Yiu. 1:29

The province has more than 900 contact tracers in Alberta and is on track to double that number by the end of the year, Yiu said.

“This means that we will have 36 contact tracers per 100,000 people, which will be on par or better compared to other provinces.” 

Bending the curve

Albertans are now one week into the latest round of restrictions aimed at bending the curve of COVID-19 cases in the province.

Last Friday, Premier Jason Kenney ordered junior and senior high schools to close, barred indoor social gatherings and capped capacity for businesses.

Next week Albertans will find out what impact those measures are having on the virus, which is spreading faster in Alberta than anywhere else in the country.

It was the second set of restrictions issued by the premier in November.

Three weeks ago, Kenney suspended indoor group fitness programs, team sports and group performance activities, and reduced operating hours for restaurants, bars and pubs in cities.  

But the curve didn’t bend and the virus has continued to surge since, setting records almost daily as it tightens its grip on the province.

The province’s contact-tracing system is struggling against demand. Alberta’s government continues to resist calls to adopt the federal contact-notification app or order a province-wide mask law.

It is also continuing to spurn calls by physicians for a two-week lockdown, or “circuit-breaker,” to drop the effective reproduction number and allow contact tracing to catch up. 

WATCH | Alberta requests field hospitals from Ottawa:

The Alberta government is in talks with Ottawa and the Canadian Red Cross for help in setting up field hospitals, as the number of COVID-19 patients continues to surge. 2:42

This week, the province acknowledged it is preparing for the worst. Alberta has asked the federal government for two field hospitals, and the Red Cross for two more. 

Alberta hospitals are preparing to double-bunk critically ill patients, revamp operating and recovery rooms and reassign staff to treat an expected surge of COVID-19 patients destined for intensive care units.  

AHS has asked hospitals in Calgary to begin rationing oxygen.

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