Medicago’s vaccine is fast approaching Health Canada approval. It is the first of its kind in the nationally produced COVID-19 vaccine.
The ongoing review process authorized by Health Canada ensures that data from the third stage clinical trial of the vaccine candidate is transmitted to Canadian regulatory authorities.
Nicholas Petit, vice president of commercial operations at Medicago, explains that in normal times, outside of an epidemic, Health Canada is waiting for a finalized file before launching an analysis.
“In an epidemic, the goal is to ensure the safety and effectiveness of the vaccine, but also to expedite its availability to Canadians. With ongoing review, Medico will not wait until the case is finalized to submit the available data,” he said.
Vaccines in the fall
However, Health Canada will not decide whether to authorize the COVID-19 vaccine applicant until all data is available in support of a risk-benefit decision based on safety, efficacy and quality.
This is the first time Health Canada has accepted a request for ongoing review for the COVID-19 vaccine. For Medicago, this represents an “important first milestone”.
Mr Petit said the data transmission process had already begun. Last March, Medicago began the third phase of its clinical trial.
“The goal is to finalize the third phase by the end of spring. Then we will collect and analyze data and prepare the latest submissions to Health Canada. Today we are confident that we will be able to deliver the vaccines in the third quarter. [à l’automne] Following Health Canada certification, ”Mr. Petit added.
The third phase of the study consisted of 30,000 subjects recruited from ten countries, some of whom were not well developed in terms of vaccine publicity.
“Recruitment is going as planned. For now, we are on schedule, ”he said.
The coronavirus-like cell vaccine candidate is paired with GSK’s pandemic aide. The vaccine is given in two doses, injected over a period of 21 days.
Medicago estimates that factories in the technology park in Durham, North Carolina and Quebec will be able to produce up to 80 million doses per year from 2021.
With a large-scale manufacturing facility in Quebec by 2024, Medicago will have the capacity to produce one billion doses of COVID-19 vaccines a year.
Last October, Medicago received funding from Ottawa to produce 76 million doses of the COVID-19 vaccine.
How it works Their vaccine?
- Medicogo vaccine is made from the plant Nicotiana Benthamiana
- Medicago’s technology uses virus-like cells (PPVs) that mimic the shape and dimensions of a virus, allowing the body to detect and create them Immune response in a non-infectious way
- Five steps of Vaccine production Synthesis, infiltration, incubation, harvesting and purification
- Finally Phase III Clinical Trial : Spring 2021
- Second Phase Results Announcement: In early May 2021
- Vaccine distribution begins: 3E Quarter 2021
- Large-scale vaccine production begins in Quebec: 2024
- New Quebec Plant Cost: 245 m $
- Founded in 1999
- Headquarters: Quebec
- Employees: More than 450 people
- Medicago is currently focusing on vaccines Coronavirus (COVID-19 / SRAS-CoV-2) Yet Influenza, And initiated the early development of vaccines against Rotavirus Yet Norovirus