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Human clinical trials begin for Quebec-made COVID-19 vaccine candidate – Maple Ridge News

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

Dr. Bruce Clark, president and CEO of the biopharmaceutical company Medicago, cautions observers against holding unrealistic expectations that his product — or any of the numerous vaccines in development globally — will bring the pandemic to a screeching halt.

“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.”

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 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.

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.”

READ MORE: Would you take a COVID-19 vaccine? Poll suggests most Canadians say yes

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 effectiveness of the adjuvants and dosing by October, and then kick off a second, more targeted trial phase involving about 1,000 participants.

Clark says the third phase would involve about 15,000 to 20,000 subjects, and may be a global study, depending on circumstances of the pandemic.

If the vaccine is successful, 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 suggested 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 the 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.”

Cassandra Szklarski, The Canadian Press


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Alberta province halts AstraZeneca vaccine first shots due to supply issue

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Alberta has stopped administering first doses of the AstraZeneca COVID-19 vaccine because of limited supply, a government spokesman said on Tuesday.

Alberta Health spokesman Tom McMillan said the change was due to supply issues rather concerns about rare side-effects.

“This decision is based on the fact that we are receiving no known future shipments of AstraZeneca at this time but are receiving large quantities of mRNA vaccines,” McMillan said in an email, referring to messenger RNA vaccines from Moderna and Pfizer/BioNTech.

The shortage of AstraZeneca vaccines comes as the western oil-producing province of Alberta struggles with a surge in COVID-19 cases. Last week the provincial government introduced new restrictions to curb infections.

Alberta has administered approximately 255,000 first doses of the AstraZeneca vaccine. The remaining supply of about 8,400 doses will be used as second doses.

Last week, Alberta reported its first case of a patient dying from a blood clot condition after receiving the AstraZeneca vaccine. There have been three such deaths in Canada.

Despite the deaths linked to the AstraZeneca vaccine, Canada‘s health regulator has continued to support the use of the vaccine and highlighted its benefits.

Dozens of countries paused the use of the AstraZeneca vaccine this year after reports of rare, but serious, blood clots. Several of them have now resumed use either fully or with restrictions after health regulators said the benefits of the shot outweigh any risks.

The province is now receiving large and consistent shipments of Pfizer and Moderna vaccines, with more than 236,000 doses arriving this week.

(Reporting by Nia WilliamsEditing by Bill Berkrot and Nick Zieminski)

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BioNTech committed to deliver 1.8 billion doses of COVID-19 vaccine this year

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BioNTech SE said on Monday that its order backlog for delivery of COVID-19 vaccines this year together with partner Pfizer Inc had grown to 1.8 billion doses, underscoring its role as a major global supplier of immunization shots.

That was up from 1.4 billion doses announced in March.

Based on these delivery contracts, the company said it expects about 12.4 billion euros ($15.1 billion) in revenue from the vaccine this year, including sales, milestone payments from partners and a share of gross profit in the partners’ territories, up from a previous forecast of 9.8 billion euros.

More than 450 million doses of the two-shot vaccine known as Comirnaty were supplied globally as of May 6, 2021. By contrast, AstraZeneca, which has pledged to deliver up to 3 billion vaccine doses this year, said on April 30 it had supplied more than 300 million doses so far. That includes production from partners such as the Serum Institute of India.

BioNTech and Pfizer, which have been spared the type of production setbacks that have hobbled AstraZeneca and Johnson & Johnson , have repeatedly lifted projected delivery volumes amid a global scramble to speed vaccination campaigns.

Earlier on Monday, BioNTech unveiled plans to set up a new factory in Singapore to produce several hundred million doses of its mRNA vaccines per year from 2023.

BioNTech’s partner for China, Fosun Pharma , said on Sunday it would provide a factory with an annual capacity of up to 1 billion doses of the COVID-19 vaccine under a joint venture with BioNTech.

That followed a contract with the European Union for up to 1.8 billion doses of COVID-19 vaccines for 2021-2023, to cover booster shots, donations and reselling of doses.

BioNTech reported first-quarter total revenue of 2.05 billion euros, up from 27.7 million a year earlier, driven by vaccine sales, and including an estimated 1.75 billion euros from BioNTech’s share of gross profit from sales in Pfizer’s territories.

Quarterly net profit jumped to 1.13 billion euros, compared to a 53.4-million-euro loss in the year-earlier period.

The company said there was no evidence its current vaccine will need to be adapted to fight new virus variants, but added that it had developed strategies to address such variants should the need arise.

BioNTech reiterated that output capacity for the vaccine would reach 3 billion doses by the end of 2021, and more than 3 billion doses in 2022.

Pfizer last week said the pair was targeting production of as much as 4 billion doses of the shot next year, mostly for low- and middle-income countries.

($1 = 0.8222 euros)

(Reporting by Ludwig Burger; Editing by Thomas Escritt, Bernadette Baum and Bill Berkrot)

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Canada ready to discuss COVID-19 vaccine IP waiver, ‘not interfering or blocking’ -Trudeau

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covid-19 vaccines

Canada is ready to discuss an intellectual property rights (IP) waiver for COVID-19 vaccines and will not block one even though it stresses the importance of protecting patents, officials said on Friday.

U.S. President Joe Biden on Wednesday threw his support behind waiving IP rights for COVID-19 vaccines. Any such waiver would have to be negotiated through the World Trade Organization (WTO).

“We’ve been working with partners at the WTO to find a consensus-based solution and are ready to discuss proposals, in particular for COVID-19 vaccines,” Prime Minister Justin Trudeau told reporters.

Biden’s proposal angered pharmaceutical companies. Firms working on vaccines have reported sharp revenue and profit gains during the crisis.

Canadian International Trade Minister Mary Ng earlier said that Ottawa firmly believed in the importance of protecting IP.

“I can assure you Canada is not interfering or blocking. Canada is very much working to find a solution,” said Trudeau, who did not give details of the Canadian negotiating stance.

Ng said Ottawa recognized how much the pharmaceutical industry had done to innovate COVID-19 vaccines, adding that many barriers to access were unrelated to IP, such as supply-chain constraints.

Canada is trying to quell a third wave of the coronavirus pandemic that is pushing some healthcare systems to breaking points, particularly in the western provinces of Alberta and Manitoba.

Manitoba officials said they were postponing some non-urgent surgeries to open space for COVID-19 patients and planned to announce tougher public health restrictions as daily cases soared to a near-record high.

The U.S. state of Montana will offer vaccines to around 2,000 Alberta truckers who regularly cross the border, Alberta Premier Jason Kenney said.

Truckers will get vaccinated at a post being set up just south of the border, using Montana’s surplus Johnson & Johnson vaccines.

The scheme mirrors an agreement that Saskatchewan and Manitoba reached with North Dakota.

 

(Additional reporting by Nia Williams in Calgary and Rod Nickel in Winnipeg; Editing by David Goodman/Mark Heinrich, Grant McCool and Marguerita Choy)

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