Reports of AEFIs made directly to vaccine manufacturers are sent to Health Canada. But despite this, Medicago hasn’t lost sight of its goal: a vaccine. The Canadian government made procurement deals in August, when the vaccine's viability was relatively unknown, seems to be a risk that seems to now be paying off according to Moderna’s chairman. The company’s name, Medicago, was Latin for the plant they were using at the time: alfalfa. Anand said they’re doing everything they can to get more doses. In the late 2000s, PMI had a mandate to “explore adjacent technologies that could lead to new lines of profitable business” and a robust R&D division that knew the potential of the plant. To make good on that promise, Canada says it … In 2005, then-CEO Andy Sheldon, who had much experience with pandemic development, started the shift to influenza vaccine development. Dr. Alan Bernstein says that with new variants of the novel coronavirus emerging, Canadians might need multiple vaccines for several years. A made-in-Canada vaccine to protect against COVID-19 began human clinical trials Tuesday in Toronto, says the biotechnology company that developed the vaccine. While Medicago’s vaccine may not be first out of the gate, its technology is still far quicker than traditional ones, like influenza and MMR, which are cultured in chicken eggs — a cumbersome process that can take up to six months. “The quantities that we expect to receive remains to be confirmed by the manufacturer so at this time, I can’t really tell you what the quantity will be, but we do not expect to receive 249,000 doses at this time.”. Indeed, today, as recent reports have emphasized, there is no independent Canadian vaccine production capacity, at least none able to manufacture a COVID-19 vaccine … Medicago built a facility in Durham, North Carolina after getting U.S. funding for pandemic preparedness in 2010. “They were loans. It said PMI was seeking offers from investors who might be “better suited to help Medicago on the next phase of its journey.”. However, sometimes situations can cause a delay in getting vaccines to those who need it, but this is unusual. “And so they’re trying to figure out, when do they write the big cheques for the facility when they don’t really have a commitment from the Canadian government as to how it’s going to play in their strategy,” Clark said. It requires resources from the supplier and given the scarcity of resources, suppliers emphasized locations that had existing capacity and would be able to manufacture quickly.”. For years, Medicago warned that Canada needed to prepare itself for a pandemic and lobbied government officials for funding to build a domestic manufacturing site for a vaccine. While it’s possible the company may emerge as the new wunderkind of the Canadian biotech sector, it wasn’t without adversity. OTTAWA – Procurement Minister Anita Anand said she tried to entice all of the COVID-19 vaccine manufacturers to make their product here at home, but Canada didn’t have the facilities they needed. In Connaught’s history the Canadian government had called upon it to provide assistance in urgent situations of national health. Mother's Day Flash Sale: Get $100 Off HelloFresh Including Free Shipping! Plants key for Canada’s COVID-19 vaccine contender, Plants key for Canada’s COVID-19 vaccine contender – Jan 11, 2021. Seven months later, the federal government signed an agreement worth up to $173 million to accelerate Medicago’s vaccine development, secure doses, and complete the manufacturing plant. Canada may not have a vaccine in production yet but it does have a long-term strategy in the works — to develop a made-in-Canada vaccine and the vaccine independence that comes with it. In March, the federal government announced it would fund Medicago’s COVID-19 vaccine efforts. It’s called Nicotiana benthamiana, a relative of the tobacco plant, native to Australia, and it is a key to biopharmaceutical company Medicago’s COVID-19 vaccine. AstraZeneca vaccine: how to fix supply issues. But its expectation was that when it came, it would be an influenza strain, like the 2009 H1N1 swine flu pandemic, and not a coronavirus. 1st Canadian human trial for coronavirus vaccine is underway. A made-in-Alberta COVID-19 vaccine is taking a major step forward on the path to Health Canada approval with the imminent start of a Phase 1 clinical trial. Medicago’s commercial-grade production plant on the north-east side of Quebec City is expected to be complete in late 2023, early 2024. When trying to attend WHO meetings, Medicago found it difficult to get a formal invitation. Notably, last November, the medical journal The Lancet, which had published Medicago’s influenza study only a month earlier, decided not to publish the Quebec company’s phase one COVID-19 results over concerns about who was supporting the research. Medicago uses the leaves of Nicotiana Benthamiana, a cousin of the tobacco plant, to produce its vaccine. The Canadian vaccine producers are likely to engineer their vaccines to better protect, for instance, children, pregnant women and Canadians exposed to the COVID-19 variants. These were not free gifts,” Sheldon said. “The U.K. certainly pivoted, and was able to do manufacturing domestically but they were starting from a much higher base.”. It's off-label usage, in many ways," he said. Not only did Medicago hit its target of making 10 million doses a month, the once fledgling biotech startup now had a production plant. Microsoft and partners may be compensated if you purchase something through recommended links in this article. GSK declined to comment on PMI’s potential exit and whether it was spurred by its recent partnership with Medicago. Click to share quote on Twitter: "We are not publishing tobacco science.". Here’s what Canada can learn, Canadian company to collaborate on potential coronavirus vaccine with GSK, Canada’s pharmacies ‘ready and willing’ to join coronavirus vaccination effort, Canada investigating timing of second coronavirus vaccine dose, Tam says. Medicago would be using GSK’s adjuvant in its COVID-19 vaccine to amplify its effectiveness. “If they had made the decision two years ago when we were in discussions with them, we’d have a facility by now,” Clark said. … I’m afraid the editorial meeting concluded that we should follow the guidelines and not publish research supported by the tobacco industry.”. Maj.-Gen. Dany Fortin, who is overseeing the distribution, said they don’t know yet how large the shipment will be, but it won’t be a full shipment. That’s because Medicago’s Quebec City manufacturing site is still under construction and won’t be ready until the end of 2023, possibly 2024. Canada is expecting just 70,000 doses of COVID vaccine next week from Pfizer, before the company has promised a ramp up to more than 300,000 doses per week in the last half of the month. Despite signalling its intent to look for a more suitable partner, the impact of Medicago’s association with PMI endures. Health Canada, the Public Health Agency of Canada (PHAC), the provinces and territories, and manufacturers continue to closely monitor the safety of COVID-19 vaccines. Click to share quote on Twitter: "I'm not just optimistic, I'm confident that it will work," said Dr. Brian Ward, medical officer at Medicago. Today, the pace of construction at Medicago’s new production plant on the north-east side of Quebec City plant mirrors the urgency in its labs. In a March 23 statement, Pfizer said its phase 3 clinical trial study was "designed to evaluate the vaccine's safety and efficacy following a 2-dose schedule, separated by 21 days. A Medicago employee works on the company’s COVID-19 vaccine candidate. Read more: In phase one of its clinical trials, 100 per cent of people who received its COVID-19 vaccine developed significant antibody responses with no severe adverse effects. Read more: With the U.S. plant operational, the money started to come in Canada. But it wasn’t until Medicago shifted to Nicotiana benthamiana, a cousin of the tobacco plant, that it attracted an investor that would accelerate its growth as well as lead to some of its greatest controversy: tobacco giant Phillip Morris International (PMI). “It is extremely disappointing. Once injected with the genetic material for the spike protein, the plant forms what’s called “virus-like particles” or VLPs. “They were our major lifeline, an economic lifeline for the start of the company,” Dr. Ward said. The federal government is the single largest purchaser of vaccines, according to Canada’s procurement department—meaning that drug companies looking to sell to the Canadian … © 2021 Global News, a division of Corus Entertainment Inc. Canadian vaccine maker pioneers new technology using plants, The leading Canadian vaccine maker, Quebec-based Medicago, is using a breakthrough approach with plants to create its COVID-19 vaccine – Jan 11, 2021. “It’s not pie in the sky. But the money Medicago needed to build a manufacturing site didn’t arrive. Fires and floods: How Fort McMurray is addressing risk of disaster 5 years after massive wildfire, 5 years after ‘The Beast’ ignited, investigation into Fort McMurray wildfire ‘remains open and active’, Fort McMurray residents preach resilience 5 years after wildfire swept through community, Canadian company sees positive results in early coronavirus vaccine tests, 1st Canadian human trial for coronavirus vaccine is underway. The Canadian government has agreed to buy 76 million doses of Medicago’s vaccine. “There was a small group at PMI … that were producing proteins in the tobacco plant,” recalls Nathalie Landry, executive vice president of scientific and medical affairs at Medicago. Then in December, the company replaced its president and CEO. Canada lost a world-class vaccine-making facility and the … … It’s difficult for Medicago to be associated with WHO.”, The WHO has a detailed framework about who it will partner with, stating it “does not engage with the tobacco industry or with non‑State actors that represent the interests of the tobacco industry.” However, a spokesperson for the WHO said “Medicago has been treated the same as all other influenza vaccine manufacturers and they have been in various WHO meetings.”, Read more: “It’s good that the Canadian government is now supporting a Canadian company, since the U.S. government supported the Canadian company first,” Dr. Halperin of the Canadian Centre for Vaccinology said. “The reality is it took COVID to get a decision made,” Clark said. The garage was double-wide, in a house still under construction, overlooking the St Lawrence River. Neither he nor Vézina remain with the company. “We were using a different plant that is in the same family … but it’s not the one used to produce cigarettes.”. Canadian cGMP vaccine manufacturers who benefit from our bioprocessing expertise will be well positioned to supply both domestic and global markets. “The plant is basically acting as a factory to produce the spike protein,” said Dr. Scott Halperin, director of the Canadian Centre for Vaccinology in Halifax. The federal government would not answer questions about whether Medicago’s association with PMI impacted its earlier decisions whether or not to fund Medicago. COVID-19 vaccine maker Canada signed a contract with last summer was asked if they could make the doses in Canada and all of them concluded they … With the sale, the Canadian government lost an important capability. Canadian Prime Minister Justin Trudeau is sticking to his promise: Every Canadian who wants a vaccine will get one by September. Medicago says its production facility in Quebec city won’t be ready until late 2023 or early 2024. “The pressure is high, and I think everybody in the company is tired,” Dr. Ward said. In July, it announced plans to distance itself from a significant shareholder, Philip Morris International, which owns about one-third of the company — a controversial association with Big Tobacco that has been the source of roadblocks and criticism. While Mitsubishi Tanabe Pharma declined to comment on the change in leadership, Medicago’s Nathalie Landry said that while Clark was “instrumental in leading Medicago to where we are today … Takashi is qualified to lead Medicago through this business model change.”. Phase two clinical trials are currently wrapping up and phase three is expected to begin later this month. A year later, PMI invested $16 million in Medicago to become a 49.8 per cent shareholder of the company. “The human who gets that sees that as, ‘Oh, that looks like a virus,’” Dr. Halperin explains. 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", Coronavirus: Health Canada says some clinical questions remain on outstanding vaccine approvals, Coronavirus: Health Canada says some clinical questions remain on outstanding vaccine approvals – Jan 8, 2021. Simon Kennedy, a deputy minister in the industry department, said the U.K. was simply much further ahead when the pandemic began. “That point of view, saying that it’s impossible to occur, is simply untrue, based on what we’re being told from the vaccine manufacturers themselves,” she said. “We are hopeful that in the next influenza season we will have a licensed influenza vaccine for the world,” Dr. Ward said. She said opposition politicians who were suggesting Canada would never meet that target need to tone down the rhetoric and deal with facts. Canada investigating timing of second coronavirus vaccine dose, Tam says. It will involve 30,000 people in 11 countries — including Canada — and will ultimately determine if the vaccine protects people from COVID-19. The benefits of vaccines authorized in Canada continue to outweigh the risks. Nothing.". Click to share quote on Twitter: "They were loans. “We manage to always get the notification and invitation. CAEFISS . It’s discouraging and it’s unnecessary,” said Bruce Clark, Medicago’s CEO and president from 2017 until December 2020. It’s called Nicotiana benthamiana, a relative of the tobacco plant, native to Australia, and it is a key to biopharmaceutical company Medicago’s COVID-19 vaccine. The call for domestic manufacturing comes as imports of vaccines to Canada have dwindled considerably. A greenhouse, the size of 10 football fields will soon grow thousands of plants which could satisfy far more than the Canadian demand. “The reality is that standing up new manufacturing of a vaccine requires expertise. “I think what comes to mind is the classic Canadian dilemma,” said Bruce Clark, the CEO from 2017 to 2020. Canada contributed $440 million to the facility, with half of that money designated to purchase vaccines for Canada and half designated to buy vaccines for developing countries. Here’s what Canada can learn. Read more: Medicago is the leading Canadian-based contender to produce a vaccine, with an agreement to provide the federal government with 76 million doses if approved for use. “Did Canada seek this right?”. The Lancet said it does not comment on individual cases and would not explain why it had accepted Medicago’s influenza study earlier this fall and not its subsequent COVID-19 research. “You have capability that’s sound and proven, but it has to go somewhere else in the world to get validated, typically south of the border, and then the Canadians say, ‘Oh it’s pretty good, maybe we should use it.’”. The Vaccine and Infectious Disease Organization―International Vaccine Centre (VIDO-InterVac) at the University of Saskatchewan has been operating for decades, working on … Israel is leading the world in COVID-19 vaccine rollout. Canada’s pharmacies ‘ready and willing’ to join coronavirus vaccination effort. “Manufacturers concluded that bio-manufacturing capacity in this country, at the time of contracting last August and September, was too limited to justify the investment of capital and expertise to start manufacturing in Canada,” she said. “It’s not a virus that can infect you because it’s just a plant capsule surrounding the spike protein, but because the immune system is tricked into seeing it as a viral particle, it responds very well.”. Several MPs asked why the government hadn’t done more to increase Canada’s domestic manufacturing capability in the last year, particularly when compared to efforts in the United Kingdom. It wasn’t until the pandemic struck that the money and a purpose came together. Read more: So when Sheldon realized PMI representatives were attending the same biotech conference he was in Vancouver in 2007, he quickly brokered a meeting. Here’s what that means. But Medicago didn’t get what it needed from the federal government until after the COVID-19 crisis struck. “You can anticipate that having a big pharma working with a tobacco company could be a challenge,” Landry said. Canada is one of a few wealthy countries to draw from COVAX so far and also has a side agreement with AstraZeneca for 20 million doses. Only 10 per cent will actually be “made in Canada” the first year, coming from its pilot plant on the west side of Quebec City. These were not free gifts," Sheldon said. None of the seven deals Canada has signed for vaccines includes significant homegrown production. Click to share quote on Twitter: "DARPA had money and they had a program," Sheldon said. Click to share quote on Twitter: "Their involvement was actually probably critical for the survival of the company. Phase 3 clinical trials are set to begin next month. It involves a new technology that’s rapid and nimble, and a vaccine that can be stored at normal fridge temperatures, of 2 C to 8 C, unlike the two other vaccines currently in circulation, which each require frozen or ultra-cold frozen storage. Last July, Medicago announced a new partnership with another major pharmaceutical company, GlaxoSmithKline — one of the leading makers of smoking cessation products, with brands like Nicorette and the NicoDerm patch. “In addition to these AstraZeneca doses under our bilateral agreement, we are scouring the globe for additional doses of AstraZeneca that we can bring into the country as soon as possible,” she said. The vision and follow-through for a production plant came in the U.S, from DARPA, an R&D agency of the defence department. “DARPA had money and they had a program,” Sheldon said. “I’m not just optimistic, I’m confident that it will work,” said Dr. Brian Ward, medical officer at Medicago. Coronavirus: Trudeau announces $214M investment for made-in-Canada vaccine development, Coronavirus: Trudeau announces $214M investment for made-in-Canada vaccine development – Oct 23, 2020. In 2009, under the Obama administration, DARPA launched the Blue Angel project as a response to the deadly swine flu that year to show that if another pandemic were to hit, it could respond rapidly with a vaccine. In the most recent chapter of its corporate makeover, in early December, Medicago parted ways with Clark, a former PMI VP, and replaced him with Takashi Nagao, former chairman of the Medicago board and Mitsubishi Pharma Tanabe executive. “Countries like Mexico, Australia, Japan, South Korea, India, and others have done so and are producing AstraZeneca vaccines domestically,” he said. On Thursday, Maj.-Gen. Dany Fortin, who is overseeing the vaccine rollout in Canada, said 403,650 doses of the vaccine arrived last week from pharmaceutical firm … But if and when Medicago gets the green light from Health Canada to start shipping its COVID-19 vaccine later this year, the bulk of its doses will initially come from the U.S., not Canada. "He has ignored the manufacturers of the vaccines when he stretched the dosing cycle to such an extreme limit. By the next year, he said there were “frequent meetings” with the federal government, in an effort to secure funds to scale up. The vaccine requires two doses, 21 days apart, and if approved by Health Canada, could be in the arms of Canadians by the second half of this year. Based in part on task force advice, the Canadian government locked down agreements for seven different vaccine candidates, including one Canadian-made option from a … The use of VLP technology has already proven an effective platform, most notably with HPV vaccines, Gardasil and Cervarix — but developing VLPs in plants for use in a commercial vaccine has never been done. 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