Health Canada approves first made-in-Canada COVID-19 vaccine

A Medicago employee is shown in the lab in this handout from the company. MEDICAGO/HO

By John Marchesan and The Canadian Press

Posted February 24, 2022 10:24 am.

Last Updated February 24, 2022 2:10 pm.

Health Canada has approved the first made-in-Canada COVID-19 vaccine and the world’s first plant-based vaccine for human use.

Covifenz was developed by Quebec-based biotech company Medicago, along with British-American pharmaceutical giant GlaxoSmithKline, and is permitted for use in adults aged 18 to 64.

Dr. Supriya Sharma, chief medical adviser at Health Canada, said Medicago is “currently gathering data on older individuals,” adding that the company’s clinical trials had limited participants over age 65 because many of them were already vaccinated when the studies took place.

Health Canada is recommending two doses of the vaccine be administered 21 days apart.

In clinical trials the vaccine was shown to be 71 per cent effective in protecting individuals against severe effects of COVID-19 while the company said the efficacy rate against the Delta variant increased to just over 75 per cent.

Clinical trials were conducted before the currently dominant Omicron variant of COVID-19 took hold, but Sharma said they did take place while other variants, including Alpha, Gamma, Lambda, Delta and Mu, were circulating.

The drugmaker says there were no serious adverse reactions reported in the vaccine group during the trial. Health Canada reports temporary side effects such as soreness, chills, mild fever and joint aches are possible for a few hours to a few days after receiving a dose.

Medicago says its vaccine does not contain any live viruses, egg proteins, preservatives, or human-derived materials. Instead, it used recombinant technology, involving the genetic sequence of a virus, with living plants as the host.

Sharma said the vaccine’s active ingredients consist of particles that “mimic the spike protein of the virus that causes COVID-19.”

That allows the body to recognize them and spark an immune response.

“The virus-like particles are grown in plants that are similar to tobacco plants, which can produce large amounts of the virus particles in a short period of time,” Sharma said Thursday in a virtual press briefing. “Once these particles are injected into the body, they trigger the immune system to produce antibodies against the virus.”

Sharma added that the virus-like particles mimic the natural structure of the virus without containing any of its genetic material – “which makes the person’s immune system able to recognize the particles without causing infection.”

Sharma said that while other vaccines, including jabs that protect against HPV and hepatitis B, use virus-like particles, Medicago’s COVID-19 shot is the first to use plant-based technology.

Dr. Marc Berthiaume, director of the bureau of medical sciences for Health Canada, said the Medicago vaccine is expected to be available by mid-May, though he added “the calendar and number of doses is still under discussion.”

Dr. Howard Njoo, Canada’s deputy chief public health officer, said Thursday that NACI’s preference has leaned towards the mRNA products in the past – “both from an effectiveness point of view but also because of the well-known safety profile.”

He said NACI is expected to provide guidance on the use of Medicago’s product within the next couple of weeks.

Medicago’s jab is the sixth COVID-19 vaccine authorized by Health Canada, following the mRNA shots from Pfizer-BioNTech and Moderna, the viral-vector vaccines from Oxford-AstraZeneca and Johnson & Johnson, and a protein-subunit jab from Novavax.

Novavax’s product was authorized by Health Canada last week, and the National Advisory Committee on Immunization described it in their Feb. 17 guidance as a “new option” for people who were unable or unwilling to receive an mRNA vaccine.