The first Canadian human trial of the coronavirus vaccine is underway. Here’s what it means


Canadian trials have just started for a possible coronavirus vaccine, but its Quebec manufacturer is already minimizing its potential impact.Dr. Bruce Clark, President and CEO of the biopharmaceutical company Medicago, has warned observers of unrealistic expectations that his product – or one of the many vaccines in development around the world – will end the pandemic.

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“Whatever vaccine we receive in this first round – unless it is a miracle – it will not be perfect,” said Clark, whose company began testing its proposed vaccine Monday in Quebec .

“He will have to undergo a development. It will probably take years to understand the right vaccine, the right approach. It is not a panacea.

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

Much is still known about COVID-19, Clark noted, including how it can manifest during flu season later this year.

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

Plant product to test on 180 people

The first phase of Medicago’s clinical trials will test an herbal product on 180 healthy men and women between the ages of 18 and 55.

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

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

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

Clark said that the herbal approach is much faster and offers more consistent results than the egg-based or cell-based methods.

While it takes five to six months to spread a virus in eggs, the herbal technique takes only five to six weeks, he said.

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

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Meanwhile, Clark said that viruses are prone to mutations when they adapt and develop in an egg, which could result in a vaccine that doesn’t exactly match the circulating virus. On the other hand, “a plant is a plant”, which makes production easily scalable.

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“A plant behaves like 100,000 plants,” he said.

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

He hopes to know the effectiveness of the adjuvants and the dosage by October, then launch a second, more targeted trial phase involving around 1,000 participants.

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

Border issues complicate supply chains

When will a COVID-19 vaccine be ready?

When will a COVID-19 vaccine be ready?

If the vaccine succeeds, Clark reported another uncertainty. Because the company’s commercial plant is located across the border in Durham, North Carolina, he said there was no guarantee of a Canadian supply.

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“” Guarantee “is a strong word,” said Clark. “Strange things are happening at the border in the context of a pandemic.”

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

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Clark suggested that similar barriers could have an impact on vaccine distribution, putting immediate pressure on Medicago to complete construction of a large-scale manufacturing plant in his home port of Quebec.

“We certainly need a facility in Canada,” said Clark.

“There is no guarantee of the ease of the two-way flow of materials if we have an effective vaccine. We must continue to focus on completing Canadian facilities in order to have national capacity. I think that is what concerns most countries. ”

By the end of 2023, the Quebec factory should be able to produce up to a billion doses of vaccine per year.

Until then, Medicago has said it plans to be able to make about 100 million doses by the end of 2021, assuming its trials are successful.

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Clark said countries must temper any nationalist agenda that might emerge with a viable vaccine and recognize that the fight against COVID-19 is global.

Meeting this demand would require multiple manufacturers, multiple channels of distribution, and a great deal of cooperation, he said, perhaps through the World Health Organization.

“There must be some capacity to share those around and to distribute, whether through an entity like WHO, or something equivalent,” he said.

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© 2020 The Canadian Press


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