A phase 3 trial for Medicago with 30,000 volunteers is already underway in Canada, the United States and the United Kingdom, and will expand to Brazil this week.
The Phase 3 trial is the last step before Health Canada can decide whether or not to approve the vaccine, something Landry hopes can happen this summer.
If approved, the Medicago vaccine will likely be the first COVID-19 vaccine produced in Canada in any way. The bulk material will be manufactured primarily at Medicago’s facility in North Carolina, but the vials are filled and finished with the pandemic adjuvant GlaxoSmithKline in Canada.
An adjuvant is a substance used in vaccines to help the immune response.
A new manufacturing plant in Quebec that could manufacture most of the bulk materials in Canada is still under construction. Landry said the initial commissioning date of 2024 has been tentatively postponed by one year to 2023.
Canada signed an agreement in October to purchase 20 million doses of Medicago’s vaccine, with an option for another 56 million. But most Canadians will be vaccinated before Medicago is approved, leaving its role in Canada uncertain.
“We are discussing this situation with the Canadian government,” said Landry.
She said the most likely scenario was recalls. Canada could also donate the 20 million doses it bought to the global vaccine exchange alliance COVAX.
Landry said there were discussions about testing Medicago as a mixed vaccine for second doses, but acknowledged that there may not be time to complete it now.
Most Canadians should be fully immunized by the end of the summer.
Canada has authorized four vaccines to date and 45 percent of the population has received at least one dose. To date, approximately two-thirds have received Pfizer-BioNTech, one-fifth have received Moderna, and the remainder Oxford-AstraZeneca. Johnson & Johnson was approved in March but has yet to be used in Canada.
Medicago’s Phase 2 trial tested the particulate virus vaccine on approximately 900 volunteers in Canada and the United States.
A third of the group was made up of healthy adults between the ages of 18 and 64, a third were over 65 and the remaining third were adults with existing health conditions that could put them at greater risk if infected. by COVID-19.
Only results for healthy adults and the elderly are reported now, with results for those with existing health problems yet to come.
Overall side effects at the time of vaccination have been reported as mild and very short-lived.
The elderly did not see an immune response at a dose as robust as adults between 18 and 64, but both groups showed similar levels of antibodies after a second dose.
Medicago vaccine is a virus-like particulate vaccine, which develops a virus that looks like the SARS-COV-2 virus but does not contain its genetic material and therefore cannot multiply or make you sick.
Usually, particulate virus-like vaccines, such as those used against human papillomavirus or HPV, are grown in yeasts or bacteria. Medicago’s technology grows the particles in a plant that is a relative of the common tobacco plant.
This report by The Canadian Press was first published on May 18, 2021.
Mia Rabson, The Canadian Press