Research, editing : Gan Yung Chyan, KUCINTA SETIA
Medicago's plant-based SARS-CoV-2 (novel coronavirus, covi) vaccine is now approved by Health Canada, which is giving Canadians the option of getting a homegrown shot against covi.
Regulators announced the decision to allow its use for adults 18 to 64 years of age on Thursday, making this the sixth vaccine approved in Canada, on the heels of Health Canada's approval of the Novavax shot on 17 February 2022.
In what the biopharmaceutical company calls a world first, the vaccine from Quebec City-based Medicago uses plant-derived, virus-like particles, which resemble covi, the cause of COVID-19 (covid, for short) but do not contain its genetic material.
Virus-like particles (VLPs) are a special type of protein subunit vaccines — vaccines where the protein is made outside the body and then used as a vaccine. With VLPs, the proteins self-assemble into particles that are intended to look like viruses to the human immune system.
Some vaccines on the market that use VLPs include vaccines for HPV (human papilloma virus) and Hepatitis B. (Emily Chung, CBC)
The shots also contain an adjuvant from British-American vaccine giant GlaxoSmithKline to help boost the immune response.
In December 2021, the companies reported high efficacy levels against infection as they geared up for regulatory approval.
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The plant-based covi vaccine Covifenz is 75% effective against Covi72, can be adapted as needed
Dubbed "Covifenz," the two-dose shot's overall efficacy rate against all covi variants studied was 71 per cent, with a higher efficacy rate of 75 per cent against COVID-19 infections of any severity from the Delta variant (Covi72), then dominant, according to data shared at the time in a press release.
The results followed a global, Phase 3, placebo-controlled study of the two-dose vaccine that was launched in March 2021. This was before the highly contagious Omicron family of subvariants, including BA.1 and BA.2, began circulating, though the company has said the vaccine can be adapted as needed.
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Covifenz produces antibodies that neutralizes Omicron
"While additional confirmatory data are needed, preliminary and exploratory data shows that Covifenz produces neutralizing antibodies against the Omicron variant," noted Health Canada in a statement.
The department has also placed terms and conditions on the authorization. Medicago must continue to provide information to Health Canada on the safety and efficacy of the vaccine, "including protection against current and emerging variants of concern as soon as it is available," the statement continued.
"We will, in the next several months, know how well our vaccine did against Omicron," the company's medical officer, Dr. Brian Ward, told CBC News, citing ongoing company trials, which also include a study on a booster dose that's slated to start within weeks.
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Canada buys 20 million doses of Covifenz
In October, Canada signed a deal to buy 20 million doses of Medicago's vaccine, with an option for 56 million more.
In a press release issued on 24 February 2022, the company stressed a commitment to providing its shots as soon as possible.
"The approval of our SARS-CoV-2 vaccine is a significant milestone for Canada in the fight against the pandemic. We appreciate Health Canada's timely review," said Takashi Nagao, the company's president and CEO, in the statement.
"We're also grateful for the Government of Canada's support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order."
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Canada will send doses of Covifenz abroad
Given this huge influx of vaccines, Canada's deputy chief public health officer Dr. Howard Njoo said some of those expected Medicago supplies will be part of Canada's ongoing efforts to send doses abroad.
"Canada is committed to the global effort to supply vaccines across the world," he said during a press conference.
Recommendations on the vaccine's use from the National Advisory Committee on Immunization are also expected in the weeks ahead, Njoo said.
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Covifenz not approved for adults above 65 years old
For now, the vaccine is only authorized for use in adults 18 to 64 years of age, based on the data that was reviewed by Health Canada.
"There was limited enrolment of participants older than 65 years of age in the clinical trials because a large proportion of older individuals were already vaccinated," the department said in its statement. "Medicago is currently gathering data in older individuals to support regulatory authorization for this age group."
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Plant-based technology could help future vaccine development
Dr. Isaac Bogoch, an infectious diseases specialist based in Toronto, told CBC News the vaccine's approval is good news, even though it comes after the majority of Canadians are already vaccinated with two or more doses.
"Is this going to have a major impact on us here in Canada? Probably not. But there might be some individuals who choose to get vaccinated with a non-mRNA product," he said, referring to the shots offered by Pfizer-BioNTech and Moderna.
What is most hopeful, Bogoch added, is how plant-based technology could help future vaccine development.
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Covifenz is developed by using tobacco plant species Nicotiana benthamiana
The process developed by Medicago uses the plant species Nicotiana benthamiana, a close relative of tobacco plants that is used for pharmaceutical development, largely because of the high number of viruses that can successfully infect it.
"This might be a pretty unique way to produce and scale vaccination," Bogoch said.
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