Health Canada begins rolling review of first Canadian COVID-19 vaccine
Health Canada has begun a rolling review of the first Canadian-based COVID-19 vaccine candidate.
Medicago, a biopharmaceutical company headquartered in Quebec City, announced on April 23 that Health Canada had accepted its submission for a rolling review of its vaccine.
The company’s COVID-19 vaccine uses “virus-like-particles,” a technology that mimics the structure of the coronavirus but doesn’t actually contain any genetic material from it, making it non-infectious.
It also contains an adjuvant from pharmaceutical company GlaxoSmithKline, which helps create a “stronger and longer-lasting” immunity than the vaccine would alone.
Medicago’s COVID-19 vaccine requires two doses which are administered 21 days apart.
The company has begun a Phase 3 clinical trial of its vaccine, which will enroll up to 30,000 individuals in up to 10 countries, including Canada, the US, the UK, and Brazil.
The trial will initially focus on healthy individuals between the ages of 18 and 65, followed by those over the age of 65 with comorbidities.
Once the “efficacy and safety endpoint” of the trial has been reached, the last portion of the company’s rolling submission to Health Canada will be filed.
- See also:
Under an interim order issued in September 2020, Medicago can submit information to Health Canada as it becomes available, rather than at the completion of all studies, to accelerate the review process.
However, Health Canada will not authorize any vaccine to be considered under a rolling review until it has received the “complete evidence” required to support its benefit-risk assessment, including the safety, efficacy, and quality of the vaccine.
“We are grateful to Health Canada and look forward to continuing to work with them as they move forward with review,” said Carolyn Finkle, Medicago’s Chief Operating Officer.
To date, Health Canada has approved four COVID-19 vaccines from international manufacturers for use.
The Moderna, Pfizer-BioNTech, AstraZeneca, and Janssen Inc. (Johnson & Johnson) vaccines are all made overseas, including in the US and India, and shipped to Canada.