Vaccine development and approval in Canada
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Organization: Public Health Agency of Canada
Date published: 2021-04-19
Vaccine development
Exploratory
Scientists develop a new vaccine.
Preclinical
Scientists conduct lab and animal studies before testing on humans.
Clinical Trials
Phase I: 10s of volunteers
- Is the vaccine safe?
- What is a safe dose?
- Are there any side effects?
Phase II: 100s of volunteers
- How well does the vaccine work?
- Is it safe on a larger number of people?
- Safest and most effective dose?
Phase III: 1000s of volunteers
- Does the vaccine prevent disease?
- What are the side effects?
Application
Manufacturer submits application to Health Canada for review.
Review and approval of vaccines
Scientific Review
Teams of Health Canada experts conduct a thorough and independent review of all vaccine data.
Approval
Health Canada approves a vaccine if it is safe, it works, it meets manufacturing standards, and the benefits outweigh the risks.
Distribution
Governments coordinate the purchase, logistics and distribution of vaccines across Canada.
Vaccination
All Canadians have access to the vaccine.
Ongoing Monitoring and Review
Continuous monitoring and review to confirm the safety of the vaccine, and that benefits outweigh risks.